1. steda-100011a osseoscrew instruments

7/23/2019 1. STEDA-100011A OsseoScrew Instruments

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Alphatec Spine Confidential

OsseoScrew (Class I) Instruments

STEDA-100011, Rev. A Page1 of 15

OsseoScrew Instruments

Table of Contents

1.0 Device Description ...................................................................................................3

1.1 Product Summary .................................................................................................31.2 General Information .............................................................................................4

1.3 Product Specification ...........................................................................................7

1.4 Reference to similar and previous generations of the device ..............................7

1.5 Storage Method and Expiration Date ...................................................................71.6 Comparison with Similar Medical Devices (Predicates) .....................................7

2.0 Labeling ...................................................................................................................7

2.1 Instructions for Use and Basis for Establishing Its Contents ...............................72.2 Label Sample .......................................................................................................8

3.0

Device Design Process

.............................................................................................8

4.0 Manufacturing ..........................................................................................................95.0 Design and Manufacturing Site .............................................................................10

6.0 Essential Principles and Evidence of Conformity .................................................10

6.1 Essential Principles ............................................................................................10

6.2 List of Reference Standards ...............................................................................107.0 Risk Analysis and Control Summary .....................................................................11

7.1 Risk Analysis System ........................................................................................11

7.2 Risk Management Report ..................................................................................118.0 Product Validation and Verification ......................................................................12

8.1 Physical and Chemical Properties ......................................................................12

8.2

Biocompatibility

................................................................................................128.3 Cleaning Methods ..............................................................................................13

8.4 Sterilization Method ...........................................................................................13

8.5 Safety and Durability (Shipping Study) .............................................................148.6 Medical Device Design Verification .................................................................14

8.7 Clinical Evaluation .............................................................................................15

8.8 Studies to Support Usage Method (Simulated Use Validation) .........................15

9.0 Declaration of Conformity .....................................................................................15


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List of Tables

List of Figures

Table 1. OsseoScrew Instrument Part Numbers and Descriptions .............................. 3

Table 2. Overview of Materials and Coatings ........................................................... 13Table 3. Validated Sterilization Parameters

.............................................................. 14

Table 4. Shipping Validation Reports by Set Number .............................................. 14

Table 5. Design Verification Reports ........................................................................ 14Table 6. Design Validation / Simulated Use Reports ................................................ 15

Figure 1. OsseoScrew Shown Undeployed and Deployed .......................................... 5

Figure 2. Features of the Instrument for Implantation and Deployment ..................... 6

Figure 3. Sample Label for Individual Instrument

...................................................... 8Figure 4. Design Process Diagram .............................................................................. 9

Figure 5. Risk Management Process (ISO 14971) .................................................... 11

Figure 6. Risk Classification Matrix .......................................................................... 12


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1.0 Device Description

1.1 Product Summary

The OsseoScrew MIS and OsseoScrew Spinal Fixation System facilitates the surgicalcorrection of spinal deformities and mechanical instability by providing temporaryinternal fixation and stabilization during bone graft healing and/or fusion mass

development. The implants are manufactured from surgical grade titanium alloy (Ti-6Al-

4V ELI or Ti-6Al-4V) and commercially pure titanium (Ti grade 2). All implants are

intended for single use only and should not be reused. The OsseoScrew System implantsare pedicle screws with an expanding region on the screw shank that is intended to

improve bony fixation. The OsseoScrew Implants and Single Use Instruments (Class IIb

and Class IIa) are declared conforming in technical file TECH-001020.

The reusable instruments, the subject of this technical file, are listed below in Table 1.

Table 1. OsseoScrew Instrument Part Numbers and Descriptions

Part Number Description

Deployment Shaft(see TECH-001020)

Inserter Instrument Handle

54900

T-Handle54900-02

Polyaxial High Top /MISScrew Drivers54900-03, 54990-03

Trial Probes54900-20-01, 54900-20-02

Retriever tool54900-30

Un-deployment Tools

54900-40, 54990-40


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1.2 General Information

a) A general description including its intended purpose

When used in conjunction with the Zodiac Polyaxial Spinal Fixation System or the Illico

MIS Posterior Fixation System, the OsseoScrew Spinal Fixation System is intended to

aid in the surgical correction of various spinal deformities and pathologies of the spine. Itis intended to provide stabilization during the development of fusion utilizing a bone

graft. The OsseoScrew implant is intended for use in the patient population with

compromised bone.

It is intended that this device, in any system configuration, be removed after developmentof solid fusion mass.

b) Intended patient population and medical condition to be diagnosed and/ortreated and other considerations such as patient selection criteria

The OsseoScrew MIS and OsseoScrew Spinal Fixation System are intended for posterior,

non-cervical, spinal fixation in skeletally mature patients as an adjunct to fusion for thefollowing indications: degenerative disc disease (defined as back pain of discogenicorigin with degeneration of the disc confirmed by history and radiographic studies);

spondylolisthesis; trauma (i.e., fracture or dislocation); spinal stenosis; curvatures (i.e.,

scoliosis, kyphosis and/or lordosis); tumor; pseudarthrosis; and/or failed previous fusion.The OsseoScrew implant is intended for use in patients with compromised bone.

c) Principles of operation

The instruments of the OsseoScrew System are to provide the necessary tools for

insertion and deployment of the OsseoScrew Implant. The implant is intended to provide

surgeons with the ability to place a larger screw in the vertebral body when the pedicle

size limits the size of the pedicle screw that can be placed. For example, if a smallerpedicle would normally limit the surgeon to a maximum size 6.5mm solid shank

pedicle screw, the surgeon can now select the OsseoScrew 6.5mm screw and expand

the shank in the vertebral body up to a final diameter of 10.0mm.

d) Risk class and the applicable classification rule

The instruments of the OsseoScrew System are classified as Class I per MDD

93/42/EEC, Annex VII, Rule 6.

e) An explanation of all novel features

The OsseoScrew implant is a pedicle screw with an expandable section. This implant isinserted into the vertebral body in a reduced configuration. It is initially placed using an

interfacing driver. After the screw is placed, it can be expanded radially to increase the

screw diameter distal to the pedicle as shown in Figure 1. Radial expansion and

expanded refers to the increased diameter of the implant when associatedinstrumentation applies an axial force to compress the implant. The screw can also be

undeployed and removed.


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Figure 1. OsseoScrew Shown Undeployed and Deployed

f) A description of the accessories, other medical devices and other products that

are not medical devices, which are intended to be used in combination with it

A full spinal construct can be built with the OsseoScrew Spinal Fixation System using thecomponents from the previously cleared Zodiac Polyaxial Spinal Fixation System or

Illico Posterior Fixation System. The OsseoScrew Spinal Fixation system is an adjunctsystem to be used with the Zodiac Polyaxial Spinal Fixation or Illico Posterior FixationSystem. The deployment shaft is considered an accessory to the system and is provided

as a single use device.

g) A description or a complete list of the various configuration/variants of the

device that will be made available

The OsseoScrew instruments are sold as part the OsseoScrew MIS and OsseoScrew

Spinal Fixation System. The instruments are available individually and as sets which aredescribed in Table 1. There are no other configurations/variants of this device.

h) A general description of the key functional elements, e.g. its parts/components(including software if appropriate), its formulation, its composition, its

functionality. Where appropriate, this will include: labelled pictorial

representations (e.g. diagrams, photographs, and drawings), clearly indicating keyparts/components, including sufficient explanation to understand the drawings and

diagrams.

The OsseoScrew inserter/deployment instrument is a multi-component item as shown in

Figure 2. During the procedure, the implant is inserted into the pedicle and engaged by

turning the screw driver feature. Once in place, the Deployment Shaft is inserted into the

tip of the implant. The threads on the distal end of the deployment shaft deploy (expand)

the implant and allows the undeployment tool to undeploy the screw for removal.


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Figure 2. Features of the Instrument for Implantation and Deployment

i) A description of the materials incorporated into key functional elements andthose making either direct contact with a human body or indirect contact with the

body

The OsseoScrew Spinal Fixation System Instruments that come into contact with the

human body are transient use instruments defined as being intended for continuous usefor less than 60 minutes (continuous being defined as uninterrupted actual use for its

intended purpose) as per the MDD Directive 93/42/EEC.

All OsseoScrew System instruments are manufactured from biocompatible materials thatare well characterized and widely used for instruments in the orthopedic medical device

industry in the US and EU. A list of materials is provided in Table 2.


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1.3 Product Specification

This implant is a titanium polyaxial pedicle screw with an expansion section as illustrated

in Figure 1. The OsseoScrew implant can be used either deployed or not deployed at the

surgeons discretion using the instruments in the OsseoScrew Set.

Instruments were designed to be intuitive, easy to use, have acceptable ergonomics andperform as intended in user validations. In addition, the instruments repeatedly,

reproducibility, and securely engage an OsseoScrew implant; Detect location of the peak

expansion zone of the screw; Disengage from the implanted OsseoScrew afterimplantation with or without prior deployment; Deploy the OsseoScrew into the vertebral

body; Undeploy the OsseoScrew; Remove screw and screw tip if separate during screw

removal;And require no more than Iwo hands to use. All materials used in theinstrumentation are able to withstand repeated steam sterilizations and are biocompatible.

1.4 Reference to similar and previous generations of the device

The OsseoScrew System is currently CE marked. This STEDA is updating the Technical

File to current standards.

1.5 Storage Method and Expiration Date

Similar to other Alphatec instrument sets, the OsseoScrew Instruments are packaged intray inside of a steam sterilization case. The trays are etched with the outline of the parts

to assist in placing components into the trays. The trays have plastic inserts to hold the

components during transit. The instrument trays fit within the sterilization case which is

labeled with a kit identification label. The instrument sets are provided non-sterile;therefore, there is no expiration date. The components in the set are also available

individually. Components are labeled with part number and lot number and provide in

sealed containers.

1.6

Comparison with Similar Medical Devices (Predicates)The features of the OsseoScrew Expandable Pedicle Screw are similar to standard pedicle

screws such as the Zodiac and Illico Systems. The OsseoScrew implants are inserted into

the pedicle using the same technique and instruments used with standard pedicle screws

using either open procedure or MIS approach. Once the OsseoScrew is in place, uniquetools are used to deploy the expandable section similar to the EBI Omega21 Spinal

Fixation System.

2.0 Labeling

The OsseoScrew System labeling is in compliance with MDD Annex I Section 13, EN 1041 and

ISO 15223. All instruments are laser marked with the part number, lot number, Alphatec logo,

and the CE mark. The package labeling content is based on the requirements of MDD93/42/EEC Annex 1 Section 13. Labeling includes packaging labels, instructions for use (IFU),

and surgical technique guides. Package labeling and IFU are translated into French, Italian,German, Spanish, Greek, and Portuguese.

2.1 Instructions for Use and Basis for Establishing Its Contents

The Instructions For Use (IFU), contains the indications, contraindications, warnings and

precautions, preoperative management, perioperative management, and postoperative


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management. Validated process steps for cleaning and sterilization are also provided in

the IFU.

2.2 Label Sample

Surgical sets, such as the OsseoScrew Instrument Sets, are assigned set identification

labels per PRO-000020 and SOP-021 Surgical Set Configuration Creation and RevisionProcedure. The set IDs are not translated; however, a copy of the translated IFU is

provided in each kit. A sample label for an individual component is shown in Figure 3.

Figure 3. Sample Label for Individual Instrument

3.0

Device Design Process

The instruments were designed to interface with the implants and to meet the user needs. The

Design Control process at Alphatec Spine is controlled and documented per ENG-001 Design

Controls Procedure. This product development procedure assures that appropriate qualityobjectives and requirements are established, and that risk analysis is performed during the

process to assure potential risks are addressed and mitigated. Each phase is designed with the

appropriate deliverables and assigned team member functional requirements. Executive reviewsare conducted at the end of each phase as a requirement to enter the next phase.

Phase I Market Needs Assessment and Business Case

Phase II Design Inputs

Phase III Design Outputs

Phase IV Design Verification and Validation

Phase V Process Validation and Transfer

Phase VI Product Release and Surveillance

The product development process at Alphatec Spine is structured to meet the requirements ofISO 13485 and FDA Design Controls.


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Figure 4. Design Process Diagram

4.0 Manufacturing

The instrument sets consist of purchased components assembled in a sterilization containerpurchased from qualified vendors according to drawings provided by Alphatec Spine. The

OsseoScrew System instruments are laser marked with their respective part number, lot numberand size by the outside vendors. Additionally, the Alphatec Spine logo and the CE mark are also

laser marked onto each instrument. The components are inspected by Quality Control (QC) per

the approved quality inspection report.

System instruments are provided non-sterile. The OsseoScrew instruments are packaged insurgical trays or provided individually in the same manner as other spinal systems offered by

Alphatec Spine Inc. When provided as a system in an aluminum sterilization tray, instruments

are positioned within snapping plastic inserts to prevent movement during transit. The trays areetched with outline of the part to assist in proper placement of devices in the tray.


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5.0 Design and Manufacturing Site

The products described in this summary technical document were designed and developed by

Alphatec Spine Inc. Alphatec Spine has ISO 13485 certified design and manufacturing facilities.

Alphatec Spine is registered with the FDA as well as an EU Authorized Representative andNotified Body. Alphatec Spine facilities, licensing and registrations are listed below:

Facilities:

Design Facility Alphatec Spine, Inc.

5818 El Camino Real

Carlsbad, CA 92008, USA

Manufacturing Site Alphatec Spine, Inc.

5830 El Camino Real

Carlsbad, CA 92008, USA

Licenses and Registrations:

Owner/Operator ID

US FDA Device Establishment Registration

Alphatec Holdings 9072657

Registration Number Alphatec Holdings 2027467

EU

Authorized

Representative

Emergo Europe

Molenstraat 152513 BH, The Hague

The Netherlands

Notified Body Intertek Semko AB

Box 1103, SE-164 22 Kista, Sweden

6.0 Essential Principles and Evidence of Conformity

6.1 Essential Principles

The applicable sections of the essential requirements have been identified and are

documented in the Essential Requirements Checklist. A rationale is provided for anyrequirement(s) deemed not applicable. The Essential Requirements Checklist is located

in the Technical File.

6.2 List of Reference Standards

The OsseoScrew Spinal Fixation System conforms to all applicable referenced standards.

A list of applicable reference standards is located in the Technical File.


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7.0 Risk Analysis and Control Summary

7.1 Risk Analysis System

A risk analysis was conducted per PRO-000003 Risk Management which is in

compliance with ISO-14971. The goals of the risk management process are to:

Determine potential failure modes/hazards associated with product design, productfabrication, product use, human factors and environmental factors.

Estimate the risk associated with each hazardous situation

Assess and implement risk control measures to mitigate risk to an acceptable level.

Evaluate residual risk and risk arising from risk control measures.

Figure 5. Risk Management Process (ISO 14971)

7.2 Risk Management Report

The evaluation of initial risks was identified by the following cross functional members

of the project team performing the risk assessment: Engineering, marketing, medical

education, regulatory affairs, quality, and manufacturing engineering. An evaluation ofpotential risks was performed along with identification of preventive actions. These

actions were designed to ensure that potential risks were mitigated as much as possible

through the design process and that no new risks were identified.

Using the Risk Classification Matrix (Figure 6), green is acceptable, red is unacceptable,

and risks that are yellow are reduced as much as reasonably possible.


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Figure 6. Risk Classification Matrix

Severity

5. Catastrophic RMRP

4. Critical RMRP

3. Serious RMRP

2. Minor RMRP

1. Negligible RMRP RMRP1. Improbable 2. Remote 3. Occasional 4. Probable 5. Frequent

Probability of Failure

After Initial Risk Classification, Preventive Actions were designed to reduce assessedrisk. The purpose of applying risk control measures was to mitigate risk to an acceptable

level. Actions and solutions were identified according to the following priority: Inherent

safety by design, protective measures in the medical device itself or in the manufacturingprocess, and information on safety.

After completion of all mitigating activities, all risks were reduced to an acceptable level.

The team has determined that all risk control measures were implemented effectively to

reduce the overall risk of the OsseoScrew Spinal Fixation System Instruments toacceptable, and the benefits of this system outweigh the risks.

8.0 Product Validation and Verification

The verifications and validations performed for the OsseoScrew Spinal Fixation System are

listed below. All acceptance criteria were met. The system does not: contain software,

medicinal substances, or a power source, have issues with electromagnetic compatibility, emit

radiation, have moving parts, or require animal studies.

8.1 Physical and Chemical Properties

The OsseoScrew System Instruments are manufactured from medical grade materials(conforming to ASTM standards) widely used in surgical instruments. A Certificate of

Conformity (C of C) accompanies each shipment and provides test results as proof ofconformance for physical and chemical properties.

8.2 Biocompatibility

The OsseoScrew Spinal Fixation System Instruments are reusable surgically invasivedevices and as such, are classified as Class I devices as per the MDD Directive

93/42/EEC. The device is classified in accordance with ISO 10993-1 as:

Category: External Communicating Device

Contact: Tissue/Bone/Dentin

Contact Duration: A, Limited Exposure

The instruments are manufactured from medical grade materials that are commonly usedfor surgical instruments: 455, 465, 17-4, 17-7 and 18-8 Stainless Steel, and RADEL are

acceptable biocompatible material for manufacturing of surgical instruments.

The metal instruments are passivated, electropolished, or chromium coated that is

common to these types of instruments. An overview of the raw materials and coatingsfor the proposed instruments and the biocompatibility standards met are given in Table 2

below.


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All materials and finishes used in the OsseoScrew instruments have been historically

used in previously released Alphatec Products and within the medical industry and

therefore are deemed acceptable for use within the OsseoScrew System. Thebiocompatibility assessment, BIO-100047, is available in the technical file.

Table 2. Overview of Materials and Coatings

Material Specification ISO-10993 Classification

Instruments RADEL R-5000 PPSU

Stainless Steel, 18-8,

Stainless Steel 455, 465, 17-4

Titanium Ti-6Al-4V

Aluminum Alloy AL-6061

ASTM D6394

ASTM A276

ASTM A564 / A564M

ASTM F1472

ASTM B211. B210, B221

Category: External

communicating device

Contact: Tissue/bone/dentin

Contact duration: A

limited (24hrs)Instrument

FinishChromium Coat

ASTM B177, ASTM A380,

ASTM B849, ASTM B850,

ASTM B254

8.3 Cleaning Methods

The instrument sets are provided non-sterile with instructions for cleaning prior to

sterilization. The instructions for use contain step by step procedures for manual andautomated machine cleaning. The acceptance criteria for the test items was to be visiblyclean with an unaided eye and achieve a 3-log10reduction in bioburden after cleaning.

The cleaning method developed is a series of rinses, enzymatic, and detergent cleaning

followed by a reverse osmosis/deionized water rinse. The instruments can be dried usingfiltered compressed air or a clean lint free cloth.

Manual Cleaning

The manual cleaning method met protocol requirements. The prescribed method achieved

a 3-log10reduction in bioburden for G. stearothermophilus andE. Coli.The manual

cleaning method left all devices visibly clean with the unaided eye. Reference test report:

TR-545 OsseoScrew Cleaning Validation Report

When using the automated cleaning method, the instructions for use requires a set of pre-

cleaning steps be performed prior to running the machine cycle. These steps include a

series of rinses, enzymatic and detergent cleaning followed by a reverseosmosis/deionized water rinse before placing in the automatic cleaner in the open

position. The automated cleaning cycle parameters are to use an enzyme wash, a

detergent wash, and purified hot water rinse.

Automated Cleaning

The automated cleaning method met protocol requirements. The prescribed methodachieved a 3-log10

8.4 Sterilization Method

reduction in bioburden for G. stearothermophilus andE. Coli. The

pre-cleaning with the automated cleaning left all devices visibly clean with the unaidedeye.

Steam Sterilization Validations were conducted for the surgical instrument set. The test

sample, considered worst case, was represented by a fully populated set with regards to

material, mass and sterilant flow. The instruments were cleaned using the validatedcleaning method and placed in the sterilization case. The sterilization used the

parameters listed in Table 3.


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Table 3. Validated Sterilization Parameters

Set numberSterilization

MethodSterilization

TypeTemperature

CycleTime

DryTime

SKIF-52111-05SKIF-52111-06

Steam Pre-Vacuum270 F 4F

(132C 2C)4 30

The results showed that the OsseoScrew System Sets were sterilized to a SAL of 10-6using the BI overkill method using Geobacillus stearothermophilus as the indicator

organism. Dry time testing was successfully completed using full cycle parameters.

Both SAL and dry time testing were successfully completed and that the providedsterilization parameters are validated to ensure that the acceptance criteria of a SAL10

-

6

8.5 Safety and Durability (Shipping Study)

were met.

The shipping validations for the OsseoScrew System were tested in accordance withISTA-3A. Two shipping validations were performed to ensure that the OsseoScrew

System can withstand the stresses of the distribution and shipping environment. Both

shipping validations passed the acceptance criteria and are considered successful. Thereport numbers are shown in Table 4.

Table 4. Shipping Validation Reports by Set Number

Set number Test Report

TR-517 OsseoScrew Ship Test Report

TR-505 Shipping Report for Development Shaft

The results demonstrate that the OsseoScrew Instrument Sets can withstand the stresses

of the distribution and shipping environment and the shipping validations are consideredsuccessful.

8.6 Medical Device Design Verification

Design verification testing performed, on the OsseoScrew System, is listed inTable 5.

Table 5. Design Verification Reports

Report Process

TR-196 OsseoScrew Deployment Instrument Verification testing

TR-199 Osseoscrew Instruments Design Validation and Feedback on Prototypes

TR-281 Verification Strength of the Snap Ring Stop for the 21107 Actuator

TR-304 Verification Friction of Actuator after Repeat Processing Through Autoclave Cycle

TR-310 Verif. Wear Resistance & Friction of the Actuator after Cycle Testing Under Load

TR-332 Verif. Friction of Actuator with Thrust Washer after Repeat Autoclave Cycle

TR-333 Verification Wear Resistance & Friction of the Actuator w/ Thrust Washer After

Cycle Testing under Load

TR-388 OsseoScrew Deployment shaft life cycle testingTR-389 Driver hex cannulation testing

TR-527 OsseoScrew Surgical Set Sterilization Validation

TR-545 OsseoScrew Instrument Cleaning Validation

TR-559 Undeployed Instrument Verification Testing

REC-000123 Design Validation of OsseoScrew MIS Driver and Trial Probes


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8.7 Clinical Evaluation

A clinical data compilation was completed of relevant scientific literature currently

available on the intended purpose of the device. A compilation of pertinent clinical data

from published literature for this product has been conducted in accordance withAlphatec Spine procedure REG-009, Conducting a Clinical Data Compilation for CE

Marking.

The clinical condition and safety of patients, the safety and health of users, and any risks

when weighed against the benefits to the patient, are compatible with a high level ofpatient and user health and protection. The clinical evaluation report, CE-016, is

provided in the Technical File.

8.8 Studies to Support Usage Method (Simulated Use Validation)

The goal of the simulated use validation process is to evaluate performance of the

instruments under various conditions per the design intent. Surgeons were asked toimplant the OsseoScrew, in a cadaver lab setting, using the instruments in the set. They

were required to complete a survey with their evaluation on performance of each

instrument. There were three successful studies performed and the results aredocumented inthe reports listed inTable6.

Table 6. Design Validation / Simulated Use Reports

Report# Description

TR-199 OsseoScrew Instruments Design Validation

TR-550 OsseoScrew Instrument Design Validation

TR-708 Design Validation of OsseoScrew MIS Driver and Trial Probes

9.0 Declaration of Conformity

Alphatec Spine, Inc. issued a declaration of conformity for the OsseoScrew Spinal FixationSystem Instruments when used in a manner consistent with the intended use. The EC

Declaration of Conformity and the applicable device part numbers can be found the Technical

File.

1. steda-100011a osseoscrew instruments

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