The 510(k) summary is an abstract of the details related to the proposed device included in the 510(k) file and the supporting information.

This document will include details about the device, manufacturer, predicate device chosen and substantial equivalence comparison with the predicate device selected. The details of the various nonclinical tests and clinical trials (if needed) performed to establish the safety and performance of the device are also mentioned in this document.

Contents of 510k summary

A. NAME AND ADDRESS OF MANUFACTURER

B.  DEVICE DETAILS

Device Trade Name :
Device Common Name :
Model(s) :
Classification &Regulation Number :
 Product Code :

C.  DEVICE DESCRIPTION

D.  INTENDED USE

E.  SUMMARY OF FUNCTIONS OF THE DEVICE AND INTENDED USE AND TECHNOLOGY

Device Functions

Technological Characteristics

F.  COMPARISON OF THE PROPOSED DEVICE WITH PREDICATE DEVICE

Sl. No Features compared Proposed Device Predicate Device
General Information
  1. 510(k) Number
  2. Manufacturer
  3. Common Name
  4. Classification Name
  5. Regulation number
  6. Product Code
  7. Indication For Use
  8. Model specifications
Materials
  1. Type
 2. Specification
 3. OTC Use
 4. Sterility
5. Reusability
Non-Clinical Testing
Tests Performed
1.
2.
 3.
4.

G.  PERFORMANCE TESTING-BENCH RESULT SUMMARY

SL No. Test Name Test Result Pass/ Fail
1.
2.
3.

H.  SUBSTANTIAL EQUIVALENCE DISCUSSION