Slide 1 of 22 Rob Packard, President 510(k) Project Management

Slide 2 of 22 Rob Packard, President Agenda Overview Device Classification Predicate Selection Table of Contents Team Member Selection Performance Testing Plan FDA Pre-Sub Meetings

Slide 3 of 22 Rob Packard, President 510(k) Overview

Slide 4 of 22 Rob Packard, President Product Classification 1.Identify a device similar to yours 2.Use the registration and listing database 3.Identify the 3-letter product code 4.Click on the code to go to the product classification page 5.Click on the TPLC link

Slide 5 of 22 Rob Packard, President Find Classification Other Ways

Slide 6 of 22 Rob Packard, President Predicate Selection 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 7 of 22 Rob Packard, President How FDA Evaluates SE?

Slide 8 of 22 Rob Packard, President Section 2 - Table of Contents 20 Sections Create a Template ( ) eCopy Guidance ( ) RTA Checklist ( )

Slide 9 of 22 Rob Packard, President Use ToC as Planning Tool red = the information does not appear to be available yellow = document requires revision and/or reformatting of content blue = ready for the client’s review and approval green = ready for submission Add a column to assign team responsibilities Prioritize task completion

Slide 10 of 22 Rob Packard, President Example of ToC Tool

Slide 11 of 22 Rob Packard, President Team Member Selection Boilerplate – 1, 3, 6 & non-applicable 9 - Declarations of Conformity ( FDA Form 3654 ) Biocompatibility & Sterility – 14 & 15 Software & EMC – 16 & 17 Labeling - 13 Performance Testing – Bench Testing - 18 – Animal Testing - 19 – Clinical Studies – 20 + Sections 7 & 8

Slide 12 of 22 Rob Packard, President Most Critical Sections 4 – Indications for Use (1 st ) (k) Summary (4 th ) 10 – Executive Summary (my last) 11 - Device Description (2 nd ) 12 – Substantial Equivalence (3 rd ) RTA Checklist is a great quality 

Slide 13 of 22 Rob Packard, President Planning Performance Testing Look for a special controls guidance document 1 st. Look for any device-specific standards (e.g., ASTM F483) Review each of the possible 510(k) Summaries carefully Order 510(k) submissions through FOI

Slide 14 of 22 Rob Packard, President Bench Testing ASTM testing methods Simulated use experiments Validation tools (known input data for software/hardware devices) Finite Element Analysis (FEA) Cadaveric studies

Slide 15 of 22 Rob Packard, President Animal Studies The agency allows rationales for reduction of sample number in order to spare the lives of animals. Try to find another submission or 510(k) summary that specifies the number of animals Test more than once per animal or your device and the predicate in each animal (i.e., animal is it’s own control) Small animal vs. large animal and duration…

Slide 16 of 22 Rob Packard, President Human Studies 10-15% of 510(k) submissions require clinical study data Steps: – Study Synopsis – Investigator Package – Protocol Approval – Conduct Study – Summary Report Non-significant risk studies do not require IDE IRB approval is always required Paper data collection vs. electronic data collection

Slide 17 of 22 Rob Packard, President FDA Pre-Sub Meetings Guidance released February 18, 2014 Consultants and RA Experts have used these for years, but weren’t called “pre-sub” meetings Do your homework 1 st In-person vs. Tcon Timing = Prior to Performance Testing Identify Proposed Predicate Device(s)

Slide 18 of 22 Rob Packard, President Pre-Sub Questions Is justification of no carcinogenicity testing acceptable? Does FDA agree with “worst-case” rationale? Is software “moderate level of concern”? Is planned approach for human factors acceptable? Are there concerns of predicate selected? Have an expert present that can “kick you”.

Slide 19 of 22 Rob Packard, President What not to do for Pre-Sub… Do not ask if data is acceptable? Do not bother if you already did your testing? Do not argue, because you don’t have to agree with the agency.

Slide 20 of 22 Rob Packard, President

Slide 21 of 22 Rob Packard, President Q & A

Slide 22 of 22 Rob Packard, President Need a quotation for a 510(k) Submission? Rob Packard rob13485