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This document provides a summary of the premarket notification submission for the SDU-1100 ultrasound device, detailing its intended use, device description, classification, and safety considerations.

How to fill out 510k summary - accessdata

How to fill out 510(k) Summary

1. Identify the device and its intended use.
2. Determine the classification of the device.
3. Gather the necessary information about the device, including design, materials, and performance data.
4. Prepare a description of the device and its technological characteristics.
5. Compare the new device to a legally marketed predicate device.
6. Provide information on the safety and effectiveness of the device.
7. Include any relevant labeling and instructions for use.
8. Complete the 510(k) application form and submit it along with the summary.

Who needs 510(k) Summary?

1. Manufacturers of medical devices who are seeking to market a new device that is similar to an existing, legally marketed device.
2. Companies that wish to demonstrate that their new device is safe and effective for its intended use.

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 by medical device manufacturers, providing evidence that their device is safe and effective, and is substantially equivalent to a device already on the market.

Who is required to file 510(k) Summary?

Manufacturers of medical devices that are not exempt from 510(k) requirements must file a 510(k) Summary before marketing their device in the United States. This includes manufacturers of Class I devices that are not exempt and all Class II and Class III devices.

How to fill out 510(k) Summary?

To fill out a 510(k) Summary, manufacturers need to provide information including their identification, device description, intended use, comparison to predicate devices, device labeling, and any performance testing data. They can also use the FDA's guidelines and templates to assist in the process.

What is the purpose of 510(k) Summary?

The purpose of a 510(k) Summary is to demonstrate to the FDA that a new medical device is as safe and effective as the predicate device, ensuring that it meets the required regulatory standards for market approval.

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

The 510(k) Summary must include the device name, its intended use, a description of the device, a comparison to the predicate device, performance data, and any other relevant information that supports the claims of safety and effectiveness.