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This document is a summary of the premarket notification for the REXTAR LCD, a portable X-ray system used for dental radiographic examination and diagnosis. It details the device owner, intended use,

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Determine if your device is a Class II device that requires a 510(k).
2. Identify an appropriate predicate device that is legally marketed.
3. Gather necessary data about your device, including technical specifications and intended use.
4. Prepare performance data to demonstrate that your device is as safe and effective as the predicate.
5. Compile all required documentation, including labeling, indications for use, and device description.
6. Complete the FDA 510(k) submission form, including a summary of safety and effectiveness.
7. Submit the completed 510(k) application to the FDA for review.
8. Respond to any requests for additional information from the FDA during the review process.

Who needs 510(k) Summary?

1. Manufacturers of Class II medical devices in the U.S. seeking to market their products.
2. Companies developing new devices that are substantially equivalent to existing, legally marketed devices.
3. Importers looking to bring a Class II device into the U.S. market.

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 submitted to the FDA that provides information about a medical device and demonstrates that it is substantially equivalent to a device already legally marketed in the United States.

Who is required to file 510(k) Summary?

Manufacturers of certain medical devices that intend to market a device in the U.S. and believe their device is substantially equivalent to a device already cleared by the FDA must file a 510(k) Summary.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, manufacturers must provide necessary details about the device, including its intended use, technological characteristics, performance data, and comparisons to a predicate device.

What is the purpose of 510(k) Summary?

The purpose of the 510(k) Summary is to inform the FDA and the public about the medical device being submitted, demonstrating that it is safe and effective for its intended use.

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

The 510(k) Summary must report information such as the device name, regulatory information, description, intended use, comparison to predicate devices, safety and effectiveness data, and any clinical study information.