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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY AND INSTRUMENT COMBINATION TEMPLATE. 510(k) Number: k183375 B. Purpose for Submission: New device C. Measures: Glucose, sodium,

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How to fill out 510k substantial equivalence determination

01

Step 1: Collect all necessary information about the medical device to be evaluated for substantial equivalence.

02

Step 2: Prepare a Cover Letter that includes relevant details such as the device name, manufacturer information, and intended use.

03

Step 3: Develop a Device Description that provides a comprehensive overview of the device's design, components, and materials.

04

Step 4: Conduct a Comparison with a previously cleared predicate device, highlighting the similarities and differences.

05

Step 5: Complete the Traditional or Abbreviated 510(k) Form, providing specific information about the device and its intended use.

06

Step 6: Submit the 510(k) Submission to the U.S. Food and Drug Administration (FDA) for review.

07

Step 7: Respond to any additional requests or inquiries from the FDA during the review process.

08

Step 8: Await the FDA's final determination of substantial equivalence for the medical device.

Who needs 510k substantial equivalence determination?

01

Manufacturers who intend to market a new medical device in the United States that does not qualify for an exemption under the Federal Food, Drug, and Cosmetic Act.

02

Manufacturers who have made significant modifications or changes to a previously cleared medical 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 medical device is substantially equivalent to a predicate device that is already legally marketed.

Who is required to file 510k substantial equivalence determination?

Any manufacturer who intends to market a new medical device in the US must file a 510k substantial equivalence determination with the FDA.

How to fill out 510k substantial equivalence determination?

The manufacturer must provide detailed information about the new device, compare it to a predicate device, and demonstrate that the new device is substantially equivalent in form, fit, and function.

What is the purpose of 510k substantial equivalence determination?

The purpose of 510k substantial equivalence determination is to demonstrate that the new device is as safe and effective as the predicate device and does not raise any new questions of safety and effectiveness.

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

The 510k submission must include device description, intended use, labeling, design controls, materials, performance testing, and any other relevant information.

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