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This document summarizes the premarket notification (510(k)) submission for the Infinity Cataract Extraction System, detailing device information, predicate devices, intended use, and safety compliance

How to fill out premarket notification 510k summary

How to fill out Premarket Notification 510(k) Summary

1. Gather necessary information about the device, including its intended use and technological characteristics.
2. Identify a predicate device that is legally marketed and similar to your device.
3. Describe the device's design, materials, and manufacturing process.
4. Provide information on performance testing, safety, and effectiveness.
5. Compile labeling information that complies with FDA guidelines.
6. Complete the cover letter summarizing the 510(k) submission.
7. Fill out the 510(k) form with required details and information.
8. Prepare the summary document emphasizing how your device is substantially equivalent to the predicate.
9. Review the submission for accuracy and completeness.
10. Submit the 510(k) summary through the FDA's electronic submission process.

Who needs Premarket Notification 510(k) Summary?

1. Manufacturers of medical devices that are not exempt from premarket review by the FDA.
2. Companies seeking to market a device that is substantially equivalent to a previously marketed device.
3. Startups and established companies introducing new medical technologies that require FDA clearance.

People Also Ask about

What is the difference between premarket notification and 510k?

The first two sections of your 510(k) submission consist entirely of FDA forms for you to complete. Section 1.0 is the Medical Device User Fee Cover Sheet (FDA Form 3601) and Section 2.0 is the CDRH Premarket Review Submission Cover Sheet (FDA Form 3514). Seems pretty straightforward right?

What are the guidelines for 510k submission?

Your 510(k) submission should: Demonstrate your medical device is 'substantially equivalent' to a predicate already on the market. House detailed technical, safety and performance device/test information to show your device is safe and effective. Prove you have a robust medical device quality and risk management system.

What is included in a 510k submission?

The documentation must include drawings, schematics, and a description of the device's intended use and performance. Selection of the most appropriate predicate device — The 510(k) submission must include a comparison of the device under consideration to a predicate device already on the market.

What is a section 510k premarket notification of intent?

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.

What is the difference between 510k and premarket approval?

FDA PMA (Premarket Approval) It involves extensive clinical trials and laboratory testing and has higher standards than the 510(k) process, requiring more detailed and comprehensive evidence of the device's safety and effectiveness. The FDA has 180 days to review and decide on a PMA application.

What is an FDA premarket submission?

Pre-Submissions (Pre-Subs) The main purpose of the Pre-Sub Program (previously known as the Pre-IDE Program) is to provide the opportunity for a sponsor to obtain FDA feedback prior to an intended submission of an IDE or marketing application.

What are the elements of a 510 K premarket notification submission?

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 Premarket Notification 510(k) Summary?

The Premarket Notification 510(k) Summary is a regulatory submission made to the FDA that demonstrates a medical device is safe and effective and substantially equivalent to a previously authorized device. It is a requirement for companies seeking to market medical devices in the U.S.

Who is required to file Premarket Notification 510(k) Summary?

Any manufacturer or importer who intends to market a medical device that is not exempt from premarket notification requirements is required to file a Premarket Notification 510(k) Summary.

How to fill out Premarket Notification 510(k) Summary?

To fill out a Premarket Notification 510(k) Summary, manufacturers must complete the FDA’s 510(k) form, provide general device information, identify the predicate device, describe the device's intended use, and include performance data demonstrating substantial equivalence.

What is the purpose of Premarket Notification 510(k) Summary?

The purpose of the Premarket Notification 510(k) Summary is to ensure that new medical devices are safe and effective for their intended use and to establish that they are substantially equivalent to existing devices already on the market.

What information must be reported on Premarket Notification 510(k) Summary?

The Premarket Notification 510(k) Summary must include device name, intended use, description of the device, labeling information, a comparison to the predicate device, performance testing data, and any other information that supports the claim of substantial equivalence.