slide 1 of 19 rob packard, president rob@13485cert.com
Post on 26-Dec-2015
216 Views
Preview:
TRANSCRIPT
Slide 1 of 19
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
http://bit.ly/Substantial-Equiv-Guidance
Slide 2 of 19
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Agenda
• New FDA guidance & flow chart• Intended Use• Technological Characteristics • Split Predicates • Multiple Predicates• Examples• Reference Device• Presentation of Equivalence Data
Slide 3 of 19
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Most Critical Sections
• 4 – Indications for Use (1st)• 5 - 510(k) Summary (4th)• 10 – Executive Summary (my last)• 11 - Device Description (2nd)• 12 – Substantial Equivalence (3rd)
• RTA Checklist is a great quality
Slide 4 of 19
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
How FDA Evaluates SE?
Slide 5 of 19
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
6 Questions
1. Is the predicate device legally marketed?
2. Do the devices have the same intended use?
3. Do the devices have the same technological characteristics?
4. Do the different technological characteristics raise different questions of safety and effectiveness?
5. Are the methods of evaluating new/different characteristics acceptable?
6. Does the data demonstrate substantial equivalence?
Slide 6 of 19
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Legally Marketed?
Registration and listing database
http://bit.ly/CDRH-Registration-Listing-Database
A 510(k) is not enough!
Slide 7 of 19
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Same Intended for Use?
• Compare with Applicable Regulation• Compare with Primary Predicate• Carefully Justify Differences with Subject Device
– More Narrow Scope
– Broader Scope
Slide 8 of 19
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Technological Characteristics?
• Materials• Design• Energy Source• Other Features• Same ≠ Equivalent
– Does not raise DIFFERENT issues of safety or effectiveness
– Must be as safe and effective as predicate
Slide 9 of 19
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Split Predicates
• 1st Predicate has same intended use• 2nd Predicate has same technological
characteristics
This is not allowed.
Slide 10 of 19
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Multiple Predicates Allowed…
• Option 1:– Two predicates with different technological
characteristics, but the same intended use• Option 2:
– A device with more than one intended use• Options 3:
– More than one indication under the same intended use
Slide 11 of 19
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Examples
• Example 1 – Hemodialysis catheter– Predicate A has same extension design– Predicate B has same tip design– Both A & B predicates have the same intended use
• Example 2 – Fracture fixation plate– Predicate A is indicated for middle bone fractures– Predicate B is indicated for bone tip fractures– Both A & B predicates are intended for long bone
fractures– New performance testing may be required
Slide 12 of 19
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Examples (continued)
• Example 3 – Laser hand piece– Predicate A Er:YAG laser hand piece – Predicate B Q-Switch Nd:YAG laser hand piece– Both A & B predicates have the same general intended use
of lasers: “incision, excision, ablation, vaporization of soft tissue.”
– New performance testing may be required– A single predicate could have been used, but the inclusion
of a second predicate is helpful in establishing substantial equivalence with regard to specific indications and technological characteristics.
Slide 13 of 19
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Examples (continued)
• Example 4 – Multi-parameter monitor– New monitor includes different technologies– Predicate for each parameter– Monitoring of each parameter cannot interfere with
the others– New performance testing may be required
Slide 14 of 19
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Examples (continued)
• Example 5 – Temperature measuring urinary catheter– Urinary catheter is primary predicate– Thermometer is secondary predicate added as a
convenience– Two predicates fall under different classifications– The additional feature cannot alter the risk profile of
the urinary catheter
Slide 15 of 19
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Use of Reference Device
• Must first pass decision point questions 1-4• Example of a knee implant with a new coating:
– Predicate is a legally marketed– Predicate has the same intended use– Predicate has different technological characteristics
(i.e., the coating)– Predicate and subject device have the same
questions of safety & effectiveness (i.e., biocompatability)
Slide 16 of 19
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Why Questions 1-4 first?Predicate = Metal-Ceramic Total Shoulder
Subject Device = Metal-Ceramic Total Knee
1. Yes legally marketed device N/A
2. Intended use for resurfacing joint 2. Intended use for resurfacing joint
3. Semi-constrained ceramic humeral ball on a cobalt chrome shaft wearing against a cobalt chrome glenoid articulating surface
3. Semi-constrained femoral head made of ceramic wearing against cobalt chrome tibial plateau
4. No weight bearing function of a total shoulder and metal shalt supporting ceramic ball; less likely to fracture ceramic
4. Weight bearing function of a total knee and no metal supporting ceramic femoral head; more likely to fracture ceramic requires greater loading during cyclic testing
The different risks associated with the different indications for use and the fact that the fixation of the two ceramic articulating surfaces is very different make it impossible to say that the devices do not present different risks. The conclusion would be NSE and a reference device for cyclic testing would be irrelevant.
Slide 17 of 19
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Equivalence Data
• Intended Use• Technological Characteristics
– Materials, Design, Energy Source, Other Features• Performance Data
– Biocompatibility– Electrical Safety & Electromagnetic compatibility (EMC)– Software verification and validation– Mechanical and acoustic testing– Animal Study– Clinical Study
Slide 18 of 19
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Q & A
rob@13485cert.com
Slide 19 of 19
Rob Packard, Presidentwww.MedicalDeviceAcademy.com
rob@13485cert.com
Need a quotation for a510(k) Submission?
Rob Packard
rob@13485cert.com
+1.802.281.4381
rob13485
top related