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This document provides a summary of the 510(k) safety and effectiveness information for the enSpire Discectomy System, a single-use device designed to cut, grind, and aspirate intervertebral disc

How to fill out traditional 510k discectomy system

How to fill out Traditional 510(k) Discectomy System

1. Gather all necessary documentation, including device descriptions and intended use.
2. Identify the predicate device for comparison to establish substantial equivalence.
3. Complete the 510(k) application form including applicant and device information.
4. Include detailed descriptions of the device components, materials, and manufacturing processes.
5. Provide labeling information that complies with FDA requirements.
6. Conduct required performance tests and provide data to support safety and effectiveness.
7. Compile all information into a single submission package.
8. Submit the completed 510(k) application to the FDA electronically or via hard copy.

Who needs Traditional 510(k) Discectomy System?

1. Surgeons specialized in spinal procedures who perform discectomy surgeries.
2. Hospitals and surgical centers that offer spinal surgery services.
3. Medical device companies looking to market a new discectomy system.
4. Patients requiring treatment for herniated discs that may benefit from discectomy.

People Also Ask about

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 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.

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.

How long does 501k clearance take?

The average length of time for clearance under the traditional 510(k) pathway is 177 days, or nearly six months. Just 19% of devices on the 510(k) pathway are cleared within three months. The average number of days it takes to clear a device via 510(k) varies ing to the device category.

What does 510 K clearance mean?

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).

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 is traditional 510 k?

The Traditional 510(k) Program can be used under any circumstance to seek marketing authorization of a device through the 510(k) Program. There is no Premarket Notification 510(k) "form" to complete. A 510(k) is a submission containing information required under 21 CFR 807.87.

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)

For pdfFiller’s FAQs

What is Traditional 510(k) Discectomy System?

The Traditional 510(k) Discectomy System is a premarket submission to the FDA that demonstrates the equivalence of a new medical device to a legally marketed predicate device. It is specifically designed for discectomy procedures, which involve the removal of intervertebral disc material to relieve pressure on spinal nerves.

Who is required to file Traditional 510(k) Discectomy System?

Manufacturers of new discectomy devices that seek to market their products in the United States are required to file a Traditional 510(k) to obtain FDA clearance, specifically if the device is intended to perform similar functions as an existing legally marketed device.

How to fill out Traditional 510(k) Discectomy System?

To fill out a Traditional 510(k), manufacturers need to complete the appropriate forms available on the FDA website, including device description, labeling, indications for use, and performance data showing substantial equivalence to a predicate device. A fee may also be required.

What is the purpose of Traditional 510(k) Discectomy System?

The purpose of the Traditional 510(k) Discectomy System is to allow manufacturers to obtain FDA clearance for new medical devices based on their equivalence to existing devices, ensuring that they meet necessary safety and effectiveness standards before being marketed to the public.

What information must be reported on Traditional 510(k) Discectomy System?

Information that must be reported includes the device's identification, description, intended use, labeling, technology characteristics, performance testing data, and any known adverse events associated with the predicate devices.