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2 LCL 95. 6 and 22. 1 LCL 17. 7 respectively. Non-US Sites LCL 97. 9 LCL 50. 2 are 98. 7 LCL 92. 9 and 27. 2 LCL 19. 6 respectively. Combined Sites LCL 91. 3 LCL 42. 3 are 99. 0 LCL 96. 5 and 23. 9 LCL 19. 9 respectively. 1 LCL 8. 3 LCL 90. 4 LCL 35. 3 The NPV and PPV shown in the table above US sites were standardized to a prevalence of 15 within the intended use population. The standardized NPV and PPV are 99. In K093626 the clinical cut-off for DVT was established using INNOVANCE DDimer in...

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How to fill out 510k substantial equivalence determination

01

Step 1: Gather all necessary information and documentation related to your medical device.

02

Step 2: Identify the predicate device that your device will be compared to for substantial equivalence determination.

03

Step 3: Review FDA guidance documents and regulations related to the substantial equivalence determination.

04

Step 4: Prepare the required forms and documents, including the 510(k) submission.

05

Step 5: Provide detailed information about the similarities between your device and the predicate device.

06

Step 6: Submit the completed 510(k) submission to the FDA for review.

07

Step 7: Respond to any questions or requests for additional information from the FDA.

08

Step 8: Await the FDA's decision on the substantial equivalence determination.

Who needs 510k substantial equivalence determination?

01

Medical device manufacturers who intend to market a new device that is not exempt from 510(k) requirements.

02

Manufacturers who have made modifications to an existing device that may potentially affect its safety and effectiveness.

03

Companies seeking to introduce a device to the U.S. market that is significantly equivalent to a legally marketed predicate device.

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What is 510k substantial equivalence determination?

510k substantial equivalence determination is a premarket submission made to FDA to demonstrate that a new device is substantially equivalent to a predicate device and does not raise new questions of safety or effectiveness.

Who is required to file 510k substantial equivalence determination?

Manufacturers of medical devices that are non-exempt and are not subject to premarket approval are required to file 510k substantial equivalence determination.

How to fill out 510k substantial equivalence determination?

To fill out 510k substantial equivalence determination, manufacturers must provide information about the device, predicate device, intended use, testing data, labeling, and any differences between the new device and the predicate device.

What is the purpose of 510k substantial equivalence determination?

The purpose of 510k substantial equivalence determination is to demonstrate that a new medical device is as safe and effective as a legally marketed device that is not subject to premarket approval.

What information must be reported on 510k substantial equivalence determination?

Information such as device description, intended use, labeling, comparison to predicate device, performance data, biocompatibility, sterilization, and clinical data if applicable must be reported on 510k substantial equivalence determination.

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