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510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY. 510(k) Number: K181443 B. Purpose for Submission: This is a new 510(k) submission for the determination of Substantial Equivalence for

How to fill out 510k substantial equivalence determination

How to fill out 510k substantial equivalence determination

1. To fill out a 510k substantial equivalence determination, follow these steps:
2. Start by gathering all necessary information about the medical device being evaluated.
3. Begin the submission process by completing the appropriate forms and providing all required documentation.
4. Clearly state the purpose of the substantial equivalence determination and indicate the device that will be used as a predicate.
5. Provide detailed information about the device under evaluation, including its design, materials, intended use, and technological characteristics.
6. Conduct a thorough risk assessment that identifies and analyzes any potential hazards associated with the device.
7. Compare the device under evaluation to the predicate device, focusing on device performance, safety, and intended use.
8. Provide supporting data, test results, and scientific evidence to demonstrate substantial equivalence.
9. Prepare a comprehensive summary that summarizes the similarities and differences between the two devices.
10. Submit the completed substantial equivalence determination to the appropriate regulatory authority for review and evaluation.
11. Be prepared to address any additional questions or requests for further information during the review process.

Who needs 510k substantial equivalence determination?

1. Anyone seeking to market a new medical device in the United States that is not exempt from the 510k requirements needs to go through the process of 510k substantial equivalence determination.
2. Manufacturers, developers, and distributors of medical devices must submit a 510k application if their device has different technological characteristics or intended use compared to an already marketed device.

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What is 510k substantial equivalence determination?

510k substantial equivalence determination is a process where a medical device manufacturer demonstrates that a new device is substantially equivalent to a device that is already legally marketed, known as a predicate device.

Who is required to file 510k substantial equivalence determination?

Manufacturers of medical devices seeking to market a new device in the United States 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 need to provide detailed information on the new device, compare it to a predicate device, and demonstrate that they are substantially equivalent.

What is the purpose of 510k substantial equivalence determination?

The purpose of 510k substantial equivalence determination is to ensure that new medical devices are safe and effective for use by demonstrating their similarity to devices that are already on the market.

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

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