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This document outlines the 510(k) premarket notification for the Zip Open Forceps with Electrosurgical Cut, detailing its classification, intended use, and equivalence to predicate devices.

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Determine the type of device you are submitting.
2. Identify a predicate device that is already cleared by the FDA.
3. Gather necessary data about your device, including safety and effectiveness information.
4. Prepare the 510(k) Submission, including the 510(k) Summary or 510(k) Statement.
5. Include device description, indications for use, and technology comparison with the predicate device.
6. Provide any performance testing data and labeling information.
7. Review your submission for completeness and accuracy.
8. Submit your 510(k) to the FDA, along with applicable fees.

Who needs 510(k) Summary?

1. Manufacturers of medical devices that are considered not substantially different from a predicate device.
2. Companies looking to market a new device that is similar to an existing device.
3. Entities that need to establish safety and effectiveness for their medical device before marketing.

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?

A 510(k) Summary is a document that manufacturers submit to the FDA to demonstrate that their medical device is substantially equivalent to a legally marketed device. It provides a summary of safety and effectiveness data.

Who is required to file 510(k) Summary?

Any manufacturer of a medical device that intends to market a device in the United States and believes the device is significantly different from a previously marketed device must file a 510(k) Summary.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, manufacturers must collect and present data regarding the device's design, intended use, and performance, including any testing results. Specific sections must be completed according to FDA guidelines, and the format must follow their requirements.

What is the purpose of 510(k) Summary?

The purpose of the 510(k) Summary is to provide the FDA with sufficient information to determine whether the new device is as safe and effective as an already marketed device, thereby allowing it to be marketed for use.

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

The 510(k) Summary must include information such as the name of the device, the manufacturer's details, a description of the device, intended use, technological characteristics, performance testing results, and any comparison to predicate devices.