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This document summarizes the safety and effectiveness of the AtlantisTM PV Imaging Catheter and includes details such as device characteristics, intended use, regulatory information, and performance

How to fill out 510k summary of safety

How to fill out 510(k) Summary of Safety and Effectiveness

1. Identify the device for which you are submitting the 510(k).
2. Include the device's name, model number, and a clear description.
3. Provide the intended use and indications for the device.
4. List the regulatory history, including prior submissions and clearances.
5. Describe the materials used in the device and their safety.
6. Include performance testing data that demonstrates safety and effectiveness.
7. Provide a comparison with predicate devices, highlighting similarities and differences.
8. Include labeling information that complies with FDA regulations.
9. Ensure all supporting documents, including risk analysis, are attached.
10. Review the summary for completeness before submission.

Who needs 510(k) Summary of Safety and Effectiveness?

1. Manufacturers of medical devices that are not exempt and require FDA clearance to market.
2. Companies introducing a new medical device that is substantially equivalent to an already marketed device.
3. Entities seeking the approval of modifications to existing devices.

People Also Ask about

What is the 501k process?

The 510(k) regulatory pathway is a submission process that medical device manufacturers use to get clearance from the FDA to market an eligible product in the U.S. Under the 510(k) pathway, a medical device manufacturer submits a premarket notification to the FDA, which includes information about the device's intended

What is the rejection rate for 510k?

The FDA 510(k) Program is occasionally referred to as premarket notification. It allows a new medical device to gain FDA approval by establishing a set of similarities to a current medical device that is already on the market.

What is the content of 510k summary?

The 510(k) Statement is a certification that the 510(k) owner will provide safety and effectiveness information supporting the FDA finding of substantial equivalence to ANY person within 30 days of a written request.

How long does FDA 510 K approval take?

The FDA 510(k) submission process is a critical gateway for medical device manufacturers seeking approval for their products in the United States. However, a concerning trend has emerged – a staggering 25% of these submissions are facing rejection due to lack of completeness.

What are the three types of 510k?

There are three types of Premarket Notification 510(k)s that may be submitted to the FDA: Traditional, Special, and Abbreviated. In 1998, the FDA developed both the Special and Abbreviated 510(k) Programs to facilitate the review of certain types of submissions subject to 510(k) requirements.

How long does 501k approval take?

Generally, 510(k) applicants can expect submission acceptance review decisions within 15 calendar days; substantive review decisions within 60 days; and final decisions within 90 days. Applicants with outstanding review issues will be notified within 100 days.

Is 510k safe and effective?

A 510(k) is a premarket submission made to FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent, to a legally marketed device (section 513(i)(1)(A) FD&C Act).

For pdfFiller’s FAQs

What is 510(k) Summary of Safety and Effectiveness?

The 510(k) Summary of Safety and Effectiveness is a document submitted to the FDA that includes information demonstrating that a medical device is safe and effective for its intended use. It is part of the premarket notification process required for certain devices.

Who is required to file 510(k) Summary of Safety and Effectiveness?

Manufacturers of medical devices that are not significantly different from a device already legally marketed in the U.S. are required to file a 510(k) Summary of Safety and Effectiveness before they can market their device.

How to fill out 510(k) Summary of Safety and Effectiveness?

To fill out a 510(k) Summary of Safety and Effectiveness, gather and organize data on the device's safety and effectiveness, identify the predicate device for comparison, complete the FDA's required forms, and ensure that all necessary documentation is included before submission.

What is the purpose of 510(k) Summary of Safety and Effectiveness?

The purpose of the 510(k) Summary of Safety and Effectiveness is to provide the FDA with evidence that a new medical device is substantially equivalent to an already marketed device, thereby ensuring its safety and effectiveness.

What information must be reported on 510(k) Summary of Safety and Effectiveness?

The 510(k) Summary must include information such as the device's intended use, description of the device, labeling, performance data, safety and effectiveness information, and comparisons to predicate devices.