Indications for Use 510(k) Submission, Section 4

1. Indications for Use510(k) Submission, Section 4

2. Organization of Your 510(k) http://medicaldeviceacademy.com/510k-project-management-an-inside-look-at-our-process/

3. Where the Indications for Use Appear 510(k) Cover letter Vol 4 – Indications for Use Vol 5 – 510(k) Summary Vol 9 – Declaration of Conformity & Summary Reports Vol 10 – Executive Summary Vol 11 – Device Description Vol 12 – Substantial Equivalence Vol 13 – Labeling (must appear in the IFU)

4. Why I Prepare Section 4 First This section is short and mandatory. This section can be completed even if the design is in progress. The header identifies the title of the submission which will be used in all other sections. The content identifies the proposed primary predicate. The content identifies the indications for use stated in the applicable regulation.

5. Product Classification http://medicaldeviceacademy.com/fda-device-classification/ Identify a device similar to yours Use the registration and listing database http://bit.ly/CDRH-Registration-Listing-Database Identify the 3-letter product code Click on the code to go to the product classification page Click on the TPLC link http://bit.ly/FDATPLC

6. Case Study Example http://medicaldeviceacademy.com/510k-submission-fda-case-study/ Topical skin adhesive Special controls guidance Multiple predicates to choose within the MPN product code

7. 21 CFR 878.4010

8. Indications from Regulation “A device intended for topical closure of surgical incisions, including laparoscopic incisions, and simple traumatic lacerations that have easily approximated skin edges. Tissue adhesives for the topical approximation of skin may be used in conjunction with, but not in place of, deep dermal stitches.”

9. Primary Predicate 510(k) Summary If the company submitted a 510(k) Summary after February 1996, then the Indications for Use page will be included in the 510(k) Summary as a single page. If the company submitted a 510(k) Statement, then you will need to find the Indications from another source: Option 1 – request a copy of submission Option 2 – search their website

10. Indications from Primary Predicate “Surgiseal™ Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations. Surgiseal™ Topical Skin Adhesive may be used in conjunction with, but not in place of, dermal sutures.”

11. Indications for Subject Device “Krazyseal™ Topical Skin Adhesive is intended for topical applications only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, simple, thoroughly cleansed, trauma induced lacerations. Krazyseal™ Topical Skin Adhesive may be used in conjunction with, but not in place of, dermal sutures.”

12. Section 2 - Table of Contents http://bit.ly/510k-Format 20 Sections Create a Template (http://bit.ly/510k-ToC) eCopy Guidance (http://bit.ly/FDA-eCopy) RTA Checklist (http://bit.ly/Acceptance-Checklist)

13. Content of Volume 4, Doc 1 Copy of Indications from Applicable Regulation Copy of Indications from Primary Predicate Copy of Indications for Subject Device Reference to Volume 4, Doc 2

14. Content of Volume 4, Doc 2 • 510(k) Number – if known (typically not known) • Leave it blank or type “Unknown” if a 510(k) number has not been assigned • Device Name – the brand can change anytime; therefore, I always recommend using a simple descriptive title for the submission • Indications for Use – should match the predicate and be very similar to the regulation • Type of Use – you can pick one or both

15. Where to Download FDA Form 3881 http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/forms/ucm360431.pdf You need Adobe Acrobat to complete this in a way that you can make changes and save as a PDF. Otherwise you need to print and scan from Adobe Reader.

16. Error Message! http://www.fda.gov/downloads/aboutfda/reportsmanualsforms/forms/ucm360431.pdf May not be able to see the form using Google Chrome viewer.

17. Broader Indications • Expanding the indications: • Different Patient Population (e.g., pediatrics) • Different part of the body (e.g., extremities) • Making Performance Claims • Healing time • Reduction in adverse events • Claims and Indications like the above often require clinical evidence

18. More Narrow Indications You can always select an more narrow indication, however, you may have difficulty in later submissions if you try to use your own device as a predicate.

19. 510(k) Project Management Webinar http://medicaldeviceacademy.com/510k-project-management-webinar/

20. Q & A rob@13485cert.com

21. rob13485 rob@13485cert.com +1.802.281.4381 Rob Packard Do You Need Help with Your 510(k)?