U.S. Food & Drug Administration 10903 New Hampshire Avenue D o c I D # 0 4 0 1 7 . 0 2 . 1 1 Silver Spring, MD 20993 www.fda.gov

Wuxi Hisky Medical Technologies Co., Ltd. June 22nd, 2018 ℅ Mr. Ray Wang General Manager Beijing Believe-Med Technology Service Co., Ltd. 5-402, Building #27, No. 56, LiangXiang East Rd., FangShan District Beijing, 102401 CHINA Re: K173595

Trade/Device Name: Shear Wave Quantificational Ultrasound Diagnostic System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: IYO, ITX, IYN Dated: May 23, 2018 Received: May 29, 2018

Dear Mr. Wang: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good

Page 2 – Mr. Ray Wang K173595

manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely, for Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

FORM FDA 3881 (8/14) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120Expiration Date: January 31, 2017See PRA Statement below.

510(k) Number (if known)K173595

Device NameShear Wave Quantificational Ultrasound Diagnostic System

Indications for Use (Describe)Shear Wave Quantificational Ultrasound Diagnostic System, Model FT9000, is intended to measure the speed of 50Hz shear wave with 2.5MHz ultrasound wave in the liver. The shear wave speed may be used as an aid to clinical management of patients with liver disease. Shear Wave Quantificational Ultrasound Diagnostic System, Model FT9000, is intended for general purpose pulse echo ultrasound imaging and Doppler flow analysis of the human body. It can be used in the following applications: Abdominal.Details please refer to the attached pages.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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4-1

Diagnostic Ultrasound Indications For UseSystem: Shear Wave Quantificational Ultrasound Diagnostic System, Model FT9000Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendixNote 1: A modeNote 2: Vibration Controlled Transient Elastography at 50Hz

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)____________________________________________________________________________________

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)Prescription Use: _ _ OR Over-the Counter Use: ____(Per 21 CFR 801.109) (Per 21 CFR 807)

4-2

Diagnostic Ultrasound Indications For UseSystem: Shear Wave Quantificational Ultrasound Diagnostic System, Model FT9000Transducer: FT-2.5D9Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendixNote 1: A modeNote 2: Vibration Controlled Transient Elastography at 50Hz

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)____________________________________________________________________________________

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)Prescription Use: _ _ OR Over-the Counter Use: ____(Per 21 CFR 801.109) (Per 21 CFR 807)

4-3

Diagnostic Ultrasound Indications For UseSystem: Shear Wave Quantificational Ultrasound Diagnostic System, Model FT9000Transducer: FT-3.5R65, ConvexIntended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:

N = new indication; P = previously cleared by FDA; E = added under this appendixNote 1: Vibration Controlled Transient Elastography at 50Hz

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)____________________________________________________________________________________

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)Prescription Use: _ _ OR Over-the Counter Use: ____(Per 21 CFR 801.109) (Per 21 CFR 807)

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510(k) Summary

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Tab #3 510(k) Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance

with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K173595

1. Date of Preparation: 5/23/2018

2. Sponsor Identification

Wuxi Hisky Medical Technologies Co., Ltd.

Room B401, 530 Plaza, University Science Park, Taihu International Science & Technology Park,

214135Wuxi, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA

Establishment Registration Number: not registered

Contact Person: Jinhua Shao

Position: General Manager

Tel: 86-10-82151572

Fax: 86-10-82151571

Email: shaojh@fibrotouch.com

3. Designated Submission Correspondent

Mr. Ray Wang

Beijing Believe-Med Technology Service Co., Ltd.

5-402, Building #27, No. 56, LiangXiang East Rd.,

FangShan District, BeiJing, China 102401

Tel: +86-18910677558

Fax: +86-10-52214696

Email: ray.wang@believe-med.com

510(k) Summary

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4. Identification of Proposed Device

Trade Name: Shear Wave Quantificational Ultrasound Diagnostic System

Common Name: Diagnostic Ultrasound System with Accessories

Model(s): FT9000

Regulatory Information

Classification Name: 1) Ultrasonic Pulsed Echo Imaging System; 2) Diagnostic Ultrasound

Transducer; 3) Ultrasonic Pulsed Doppler Imaging System;

Classification:II

Product Code:IYO & ITX&IYN

Regulation Number:21 CFR 892.1550 & 21 CFR 892.1560&21 CFR 892.1570

Review Panel:Radiology;

Intended Use Statement:

Shear Wave Quantificational Ultrasound Diagnostic System, Model FT9000, is intended to measure

the speed of 50Hz shear wave with 2.5MHz ultrasound wave in the liver. The shear wave speed may

be used as an aid to clinical management of patients with liver disease.

Shear Wave Quantificational Ultrasound Diagnostic System, Model FT9000, is intended for general

purpose pulse echo ultrasound imaging and Doppler flow analysis of the human body. It can be used

in the following applications: Abdominal.

Device Description

The Shear Wave Quantificational Ultrasound Diagnostic System, Model FT9000, is a general

purpose, mobile, software-controlled, diagnostic ultrasound system with an on-screen display for

thermal and mechanical indices related to potential bioeffect mechanisms. The system is equipped

with two probes, a fibrosis scanning probe used in elastography mode and an imaging probe used in

imaging mode. The fibrosis scanning probe is used for elasticity measurement while the imaging

probe is a convex probe used for ultrasound imaging.

Under elastography mode, the system uses transient elastography to measure shear wave speed

non-invasively and estimate tissue stiffness in liver. A mechanical vibrator produces low-amplitude

shear waves at 50 Hz that travel through the skin and intercostal space into the liver. The

propagation speed of the shear wave is measured using ultrasound at 2.5 MHz.

Under imaging mode, the system acquires and displays ultrasound images in B, B/B, B/D, B/C

(CFM), B/C/D (CPWD) modes. The system uses convex array probe with a frequency range of

2.1MHz to 5 MHz on abdomen for general purpose pulse echo ultrasound imaging and Doppler flow

analysis of the human body. The ultrasonic imaging also helps to find a proper location for the

transient elastography examination.

510(k) Summary

3-3

Table 7-1 Transducer List

Transducer Model Type Frequency Application

FT-2.5D9 Round probe 2.5MHz(deviation≤±15%) Liver, elasticity measurement

FT-3.5R65 convex probe 3.5MHz(nominal),

2.1 , 2.5, 3.1, 5.0 (broadband

frequency)

Abdomen, general purpose pulse

echo ultrasound imaging and

Doppler flow analysis

Fig 7-1 Working Frame of FT9000

Ultrasound Imaging System

Digital Beam 

Synthesis

Signal & Image 

Processing

Highspeed A/D 

Conversion

Real‐time Control

System Control CPU

ELastography System

Signal Processing & Numerical Calculation

Pre‐amplification

 Signal Processing

Signal Excitation Device

Transmitting / Receiving

Power

Keyboard Monitor

Transmitting / 

Receiving

Pre‐amplificatio

n

5. Identification of Predicate Device(s)

Predicate Device 1 ：

510(k) Number: K123806

Product Name: FibroScan○R

Manufacturer:

Echosens

Predicate Device 2 ：

510(k) Number: K072164

Product Name: Diagnostic Ultrasound System

Model Name: DC-6

Manufacturer:

Shenzhen Mindray Bio-Medical Electronics Co., Ltd.

510(k) Summary

3-4

6. Non-Clinical Test Conclusion

Non clinical tests were conducted to verify that the proposed device met all design specifications as

was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the

proposed device complies with the following standards:

a. IEC 60601-1:2005+A1:2012, Medical Electrical Equipment- Part 1: General requirements for basic

safety and essential performance

b. IEC 60601-1-2:2007, Medical Electrical Equipment-Part 1-2: General Requirements For Basic

Safety And Essential Performance - Collateral Standard: Electromagnetic Compatibility-

Requirements And Tests

c. NEMAUD 2-2004 (R2009), Acoustic Output Measurement Standard For Diagnostic Ultrasound

Equipment Revision 3. (Radiology)

d. ISO 10993-5:2009, Biological Evaluation of Medical Device, Part 5-Tests for Vitro cytotoxicity.

e. ISO 10993-10:2010 Standard, Biological Evaluation of Medical Device, Part 10-Test for irritation

and delay-type hypersensitivity

7. Clinical Test Conclusion

No clinical study is included in this submission.

510(k) Summary

3-5

8. Substantially Equivalent (SE) Comparison

Table 7-1 Comparison of Technology Characteristics to K123806

Item Proposed Device(s)Predicate Device 1

(K123806)

Device name FT9000 Shear Wave Quantificational Ultrasound Diagnostic System FibroScan○R

Classification Name

1) Ultrasonic Pulsed Echo Imaging System;

2) Diagnostic Ultrasound Transducer;

3) Ultrasonic Pulsed Doppler Imaging System;

1) Ultrasonic pulsed echo imaging system

2)Diagnostic Ultrasonic Transducer

Product Code

IYO

ITX

IYN

IYO

ITX

Regulation Number

892.1550;

892.1560;

892.1570;

892.1560;

892.1570;

Intended Use

Shear Wave Quantificational Ultrasound Diagnostic System, Model

FT9000, is intended to measure the speed of 50Hz shear wave with

2.5MHz ultrasound wave in the liver. The shear wave speed may be

used as an aid to clinical management of patients with liver disease.

Shear Wave Quantificational Ultrasound Diagnostic System, Model

FT9000, is intended for general purpose pulse echo ultrasound

imaging and Doppler flow analysis of the human body. It can be

used in the following applications: Abdominal.

The FibroScan® system is intended to provide 50Hz shear wave speed

measurements through internal structures of the body.

FibroScan® is indicated for noninvasive measurement of shear wave

speed at 50 Hz in the liver. The shear wave speed may be used as an

aid to clinical management of patients with liver disease.

510(k) Summary

3-6

Probe TypesFibrosis scanning probe FT-2.5D9 M+ probe

XL+ probe

Probe frequencyFibrosis scanning probe (FT-2.5D9):

2.5MHz

M+ probe: 3.5 MHz

XL+ probe: 2.5 MHz

Modes of OperationM-mode

A-mode

M-mode

A-mode

Applied Standards:

Biocompatibility ISO10993-5&ISO10993-10 ISO10993-5&ISO10993-10

Electrical Safety IEC60601-1 IEC60601-1

EMC IEC60601-1-2 IEC60601-1-2

Performance UD2 UD2

The subject device is similar to the predicate devices:

　 Has the same intended use and indications for use

　 Utilizes the same operating principle

　 Incorporates the same basic design

　 Incorporates the same technological characteristics

　 Tested to the same electrical and electromagnetic safety standards for medical electrical equipment

Manufactured under a quality system

510(k) Summary

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Table 7-2 Comparison of Technology Characteristics to K072164

Item Proposed Device(s)Predicate Device 2

(K072164)

Device name FT9000 Shear Wave Quantificational Ultrasound Diagnostic System DC-6 Diagnostic Ultrasound System

Classification Name

Ultrasonic Pulsed Echo Imaging System;

Diagnostic Ultrasound Transducer;

Ultrasonic Pulsed Doppler Imaging System;

Ultrasonic pulsed echo imaging system

Product Code

IYO

ITX

IYN

IYO

ITX

IYN

Regulation Number

892.1550;

892.1560;

892.1570;

892.1550;

892.1560;

892.1570;

Intended Use

Shear Wave Quantificational Ultrasound Diagnostic System, Model

FT9000, is intended to measure the speed of 50Hz shear wave with

2.5MHz ultrasound wave in the liver. The shear wave speed may be used

as an aid to clinical management of patients with liver disease.

Shear Wave Quantificational Ultrasound Diagnostic System, Model

FT9000, is intended for general purpose pulse echo ultrasound imaging and

Doppler flow analysis of the human body. It can be used in the following

applications: Abdominal.

The device is intended for use by a qualified physician for

ultrasound evaluation of abdominal, cardiac, small parts (breast,

testes, thyroid, etc.), peripheral vascular, fetal, transrectal,

transvaginal, pediatric,neonatal cephalic, musculoskeletal (general

and superficial), Urology/Prostate and intraoperative (liver,

gallbladder, pancreas)

Probe Types Convex probe

Convex probe

Linear probe

Micro-Convex Probe

510(k) Summary

3-8

Endocavity Probe

Modes of Operation

B Mode, B-Mode

N/A M-Mode

Pulsed (PW) Doppler Mode Pulsed (PW) Doppler mode

N/A Continuous wave (CW) Doppler mode

Color Doppler Mode Color Doppler Mode

N/A Amplitude Doppler Mode

N/A 3D Imaging or Harmonic Imaging

N/A 4D Imaging

Applied Standards:

Biocompatibility ISO10993-5&ISO10993-10 ISO10993-5&ISO10993-10

Electrical Safety IEC60601-1 IEC60601-1

EMC IEC60601-1-2 IEC60601-1-2

Performance UD2IEC60601-2-37

UD2

Acoustic Output Track 1 & Track 3 Track 3

510(k) Summary

3-9

9. Substantially Equivalent (SE) Conclusion

SEAnalysis :

The subject device has same classification information, same intended use, same indication for use,

similar product design, similar specification, same safety elements, similar applied Standards as predicate

device.

The differences are included as followings:

1) Difference between Fibroscan○R (k123806) and FT9000

FT9000 has one additional imaging probe, FT-3.5R65, which is a convex Ultrasonic Imaging Probe for

image guiding.

Instead of FibroScan’s two elasticity probes(M+, XL+), FT9000 come with one fibrosis scanning probe

(FT-2.5D9).

2) Difference between Mindray DC-6 (k072164) and FT9000

No Continuous Wave (CW) Doppler Mode, Amplitude Doppler Mode, 3D/4D Imaging or Harmonic

Imaging Mode for FT9000, due to the less variety of ultrasound probes for FT9000, one convex probe,

other than Mindray’s DC-6 multiple ultrasound probes.

　

FT9000 follows Track 1 and Track 3 of FDA ultrasound submission, and Mindray DC-6 follows Track 3,

but this difference does not raise issues in safety since FT9000 follows UD2 acoustic output standard and

FDA guidance: Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound

Systems and Transducers (Issued on 9/9/2008).

FibroScan® k123806 FT9000 Conclusion / Discussion

Transient elastography Transient elastography Same

Vibration control

elastography imaging

Vibration control

elastography imaging

Same

Frequency range(2.5MHz,3.5MHz) Frequency: 2.5MHz Similar

M-mode, A-mode M-mode, A-mode Same

N/A Ultrasound-B imaging Additional 2D imaging.

Stiffness

Bias: (-13.9%) – (1.3%)

Precision: (0%) – (3.1%)

Stiffness

Bias: (-16.7%) – (8.6%)

Precision: (0.9%) – (2.0%)

Similar

510(k) Summary

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Analyse 1：The device and predicate device have difference in performance specification, But the propose

device have tested for measurement accuracy by accuracy testing and software validation, so these

difference can prove the effectiveness of propose device.

Analyse 2：FT9000 follows Track 1 of FDA ultrasound submission, and Mindray DC-6 follows Track 3,

but this difference does not raise issues in safety since FT9000 follows UD2 acoustic output standard.

Conclusion: The proposed device is Substantially Equivalent (SE) to the predicate device which is US

legally market device. Therefore, the subject device is determined as safe and effectiveness.