ATRIUM MEDICAL CORPORATION C-QUR MESH

• K Number: K050311
• Device Name: ATRIUM MEDICAL CORPORATION C-QUR MESH
• Manufacturer: ATRIUM MEDICAL CORP.
• Date Cleared: 2006-03-31 ( 416 days)
• Product Code: FTL
• Regulation Number: 878.3300
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

Atrium C-QUR™ Mesh is indicated for use in soft tissue deficiencies including hernia repair, chest wall reconstruction, traumatic or surgical wounds and other fascial surgical intervention procedures requiring reinforcement with a supportive material.

Device Description

Not Found

AI/ML Overview

I am sorry, but the provided text is a 510(k) premarket notification decision letter from the FDA for the Atrium C-Qur Mesh. This document only states that the device has been found substantially equivalent to a predicate device for certain indications for use.

It does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or multi-reader multi-case studies.

Therefore, I cannot provide the requested information based on this input.

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.