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This document provides a summary of the 510(k) submission for the NexSys PCS® Plasma Collection System with Persona™ Technology developed by Haemonetics Corporation. It includes device information, indications for use, non-clinical and clinical testing summaries, and comparisons with the predicate device.

How to fill out 510k summary

How to fill out 510k summary

1. Identify the product and its intended use.
2. Conduct a literature review to ensure your device is substantially equivalent to an existing one.
3. Gather data on the device's design, manufacturing, and performance.
4. Prepare appropriate labeling, including instructions for use and any warnings.
5. Compile any clinical data that supports your claims of safety and efficacy.
6. Fill out the FDA 510(k) application form accurately.
7. Include a summary of the device's technological characteristics and any performance testing results.
8. Submit the 510(k) to the FDA along with the required fees.

Who needs 510k summary?

1. Manufacturers of medical devices that intend to market devices in the United States.
2. Companies seeking to demonstrate that their device is substantially equivalent to an already marketed device.
3. Entrepreneurs developing new medical technologies requiring approval to enter the market.

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What is 510k summary?

The 510(k) summary is a document that provides specific information about a medical device and its intended use, demonstrating that the device is safe and effective and is substantially equivalent to a legally marketed device.

Who is required to file 510k summary?

Manufacturers of medical devices that are intended for commercial distribution in the U.S. and are not exempt from premarket notification requirements are required to file a 510(k) summary.

How to fill out 510k summary?

To fill out a 510(k) summary, manufacturers must complete a form detailing the device description, intended use, substantial equivalence to a predicate device, and any performance test results that support their claims.

What is the purpose of 510k summary?

The purpose of the 510(k) summary is to inform the FDA about the device and its equivalency to existing devices, enabling the FDA to assess safety and efficacy before the device is marketed.

What information must be reported on 510k summary?

The 510(k) summary must report device identification, intended use, technological characteristics, summary of safety and effectiveness, and a comparison with a predicate device.