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K 134020 Page I of 5 Traditional 510(k). Submission IN CONTROL MEDICAL, 'TX,4TNEMV 3225 Gateway Road, Ste. 250 53045 Brookfield, WEI 7. 510(k) Summary Submission Date December 2 7th 2013 Submitter

How to fill out in control traditional 510k

How to fill out in control traditional 510k

1. Gather all necessary information, including device description, intended use, indications for use, labeling, and clinical data.
2. Prepare a cover letter addressing the FDA regarding your submission, including the type of submission and the reason for it.
3. Complete Form FDA 3514 and include any relevant attachments, such as a device master file or proposed labeling.
4. Prepare a summary or statement addressing the substantial equivalence of your device to a legally marketed predicate device.
5. Compile all supporting documentation, such as testing reports, performance data, and risk analysis.
6. Submit the filled-out form, cover letter, and all supporting documents to the FDA.
7. Wait for the FDA's review and feedback on your submission.
8. Address any concerns or requests for additional information from the FDA.
9. If approved, proceed with the commercialization of your device.
10. Monitor and report any adverse events or post-market studies as required by the FDA.

Who needs in control traditional 510k?

1. Manufacturers of medical devices that are not exempted from the 510(k) requirements need to file an in-control traditional 510(k) submission.
2. The in-control traditional 510(k) is typically applicable when a new device has the same intended use and technological characteristics as a legally marketed predicate device but does not meet the criteria of a Special 510(k) submission.
3. The manufacturer needs to demonstrate the substantial equivalence of their device to a predicate device in terms of safety and effectiveness to obtain FDA clearance.
4. This submission is required to show that the device has the same intended use and does not raise different questions of safety and effectiveness than the predicate device.
5. Only manufacturers who meet these criteria need to submit an in-control traditional 510(k).

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What is in control traditional 510k?

In control traditional 510k is a submission to the FDA that demonstrates a medical device is substantially equivalent to a device that is already legally marketed (predicate device).

Who is required to file in control traditional 510k?

Manufacturers of medical devices who intend to market the device in the United States are required to file an in control traditional 510k.

How to fill out in control traditional 510k?

To fill out an in control traditional 510k, manufacturers must provide detailed information on the device's intended use, design, materials, performance, and comparison to a predicate device.

What is the purpose of in control traditional 510k?

The purpose of in control traditional 510k is to demonstrate the safety and effectiveness of a medical device by showing it is substantially equivalent to a legally marketed device.

What information must be reported on in control traditional 510k?

Information such as device description, intended use, technological characteristics, performance data, and labeling must be reported on in control traditional 510k.