Get the free 510(k) Summary - accessdata fda

This document provides a summary of a 510(k) premarket notification for the Tenscare itouch Sure Pelvic Floor Exerciser, detailing device classification, intended use, and safety information.

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Identify the device you are submitting for a 510(k).
2. Gather all relevant information about the device, including intended use and indications for use.
3. Conduct a thorough analysis comparing your device to a legally marketed predicate device.
4. Compile performance data that demonstrates the safety and effectiveness of your device.
5. Draft the 510(k) Summary including the device description, comparison to the predicate, and summary of the performance data.
6. Include labeling information that meets FDA requirements.
7. Submit the completed 510(k) Summary along with any required fees to the FDA.
8. Respond to any additional requests from the FDA promptly.

Who needs 510(k) Summary?

1. Manufacturers looking to market a medical device in the U.S.
2. Companies that are planning to introduce changes or modifications to an existing device.
3. Entities that need to demonstrate substantial equivalence to a predicate device to gain FDA clearance.

People Also Ask about

What are the three types of 510k?

There are three types of 510(k) submissions: Traditional, Abbreviated, and Special. Each type has its own requirements and may be appropriate for different types of medical devices. Traditional, Special, and Abbreviated 510(k)s require the same user fee.

What is the difference between 510k de novo and PMA?

PMA submissions are intended for high-risk devices, whereas De Novo and 510(k) are suitable for lower-risk devices with suitable predicates. Choosing the right submission pathway depends on various factors, including your device's risk level, the availability of predicates, and the resources you have available.

What are the different types of 510k s?

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 are class 1, class 2, and class 3 devices?

Class I (low to moderate risk): general controls. Class II (moderate to high risk): general controls and Special Controls. Class III (high risk): general controls and Premarket Approval (PMA)

What is the 510k pathway?

Section 510(k) of the Food, Drug and Cosmetic Act requires device manufacturers who must register, to notify FDA of their intent to market a medical device at least 90 days in advance. This is known as Premarket Notification - also called PMN or 510(k).

What is the purpose of a 510 K to determine?

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.

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.

What is the difference between 510k cleared and approved?

When a medical device is cleared, this means it has undergone a 510(k) submission, which FDA has reviewed and provided clearance. Approval: For Class III medical devices to be legally marketed they must undergo a rigorous review and approval process.

For pdfFiller’s FAQs

What is 510(k) Summary?

The 510(k) Summary is a document submitted to the FDA that provides a summary of the safety and effectiveness of a medical device that is seeking premarket clearance.

Who is required to file 510(k) Summary?

Manufacturers of medical devices that are not exempt from premarket notification requirements and intend to market their device in the United States must file a 510(k) Summary.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, manufacturers must provide information regarding the device's description, intended use, labeling, performance testing, and how it compares to a legally marketed device.

What is the purpose of 510(k) Summary?

The purpose of the 510(k) Summary is to demonstrate to the FDA that the new device is substantially equivalent to an already legally marketed device in terms of safety and effectiveness.

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

The information that must be reported on the 510(k) Summary includes the device name, intended use, device description, performance data, labeling, and any other relevant details that support substantial equivalence.