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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION MEMORANDUM. 510(k) Number: K181751 B. Purpose for Submission: Clearance of a new device C. Measured: Hemoglobin D. Type of Test: Quantitative

How to fill out 510k substantial equivalence determination

How to fill out 510k substantial equivalence determination

1. To fill out 510k substantial equivalence determination, follow these steps:
2. Gather all necessary information about the medical device in question, including its intended use, indications for use, and technical specifications.
3. Identify the predicate device(s) that the medical device will be compared to for demonstrating substantial equivalence.
4. Fill out the FDA Form 3514, which includes sections for providing device identification, predicate identification, and a comparison of the two devices.
5. Provide a detailed description of the medical device and its technological characteristics in the appropriate sections of the form.
6. Clearly explain the similarities and differences between the medical device and its predicate device(s) in terms of design, materials, performance, and intended use.
7. Include any necessary supporting documentation, such as test reports, clinical data, or scientific literature, to back up the substantial equivalence claim.
8. Review and double-check all information provided in the form for accuracy and completeness before submission.
9. Submit the completed form and all required supporting documents to the FDA for review and determination of substantial equivalence.

Who needs 510k substantial equivalence determination?

1. Medical device manufacturers who intend to market a new medical device that is not exempt from premarket notification requirements under Section 510(k) of the Food, Drug, and Cosmetic Act need 510k substantial equivalence determination.

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What is 510k substantial equivalence determination?

510k substantial equivalence determination is a process by which the Food and Drug Administration (FDA) determines whether 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?

Manufacturers of new medical devices that are not exempt from the 510(k) requirements are required to file a 510k substantial equivalence determination.

How to fill out 510k substantial equivalence determination?

To fill out a 510k substantial equivalence determination, manufacturers must provide detailed information about the new device, its intended use, technological characteristics, and comparisons to 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 predicate device, thus allowing it to be cleared for marketing by the FDA.

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

Information such as device description, intended use, technological characteristics, performance data, labeling, and predicate device comparison must be reported on a 510k substantial equivalence determination.