Get the free 510(k) Summary of Safety - accessdata fda

This document provides a summary of safety information for the XELIS 3D software device intended for medical imaging applications, conforming to the FDA's 510(k) pre-market notification requirements.

How to fill out 510k summary of safety

How to fill out 510(k) Summary of Safety

1. Identify the device that is subject to the 510(k) submission.
2. Gather all relevant information about the device, including design, materials, and intended use.
3. Conduct a risk analysis to identify potential hazards associated with the device.
4. Compile performance data, including bench tests and clinical studies if applicable.
5. Document the predicate device(s) you are claiming equivalence to.
6. Prepare a summary of the device’s technological characteristics and how it compares to the predicate.
7. Create a summary of safety and effectiveness evidence, including risk mitigation strategies.
8. Review and ensure compliance with FDA guidelines for the format and content of the summary.
9. Submit the 510(k) application electronically through the FDA's submission portal.

Who needs 510(k) Summary of Safety?

1. Manufacturers of medical devices that are significantly equivalent to existing marketed devices.
2. Companies entering the market with a new device that falls under FDA regulation.
3. Entities planning to modify an existing medical device that may alter its safety or effectiveness.

People Also Ask about

What are the three types of 510k?

Types of 510(k)s. If your medical device is eligible under premarket notification criteria, there are three types of 510(k)s: Traditional, Abbreviated, and Special. The FDA offers separate checklists for the Traditional, Abbreviated, and Special 510(k)s in its Refuse to Accept Policy for 510(k)s guidance document.

What is the 501k process?

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 does 501k clearance mean?

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.

How long does 501k approval take?

The focus of the 510(k) process is to prove something called 'substantial equivalence'. In other words, the aim of the game is to prove to the FDA that the medical device you want to bring to market is broadly similar to another device that's already on the market, known as a predicate device.

What is the 510k process?

Domestic manufacturers introducing a device to the U.S. market; Finished device manufacturers must submit a 510(k) if they manufacture a device ing to their own specifications and market it in the U.S. Accessories to finished devices that are sold to the end user are also considered finished devices.

How long does it take to get a 510 K approval?

It is worth noting that the most common time window to clearance (median) is 80-90 days, followed very closely by 50-60 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?

The 510(k) Summary of Safety is a document submitted to the FDA that demonstrates a medical device is safe and effective, showing substantial equivalence to a device already on the market.

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

Manufacturers of medical devices that intend to market a new device or a significant change to an existing device are required to file a 510(k) Summary of Safety with the FDA.

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

To fill out a 510(k) Summary of Safety, manufacturers must provide detailed information about the device, including its intended use, technological characteristics, and evidence supporting substantial equivalence, following the template provided by the FDA.

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

The purpose of the 510(k) Summary of Safety is to provide the FDA with sufficient information to assess whether the device is as safe and effective as the predicate device, thereby facilitating its clearance for market entry.

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

The 510(k) Summary of Safety must report information such as device description, intended use, comparisons to predicate devices, labeling information, and performance testing results.