(38 days)
Gentrix™ Surgical Matrix 2-layer and 3-layer are intended for implantation to reinforce soft tissue where weakness exists in patients requiring urological, gastroenterological, or plastic & reconstructive surgery. Reinforcement of soft tissue within urological, gastroenterological, and plastic & reconstructive surgery includes, but is not limited to, the following procedures; hernia and body wall repair, colon and rectal prolapse repair, and esophageal repair.
Gentrix™ Surgical Matrix 6-layer and 8-Laver are intended for implantation to reinforce soft tissue where weakness exists in - patients requiring - gastroenterological or plastic & reconstructive surgery. Reinforcement of soft tissue within gastroenterological and plastic & reconstructive surgery includes, but is not limited to, the following procedures: hernia and body wall repair, colon and rectal prolapse repair, tissue repair, and esophageal repair.
Gentrix™ Surgical Matrix 2-Layer, 6-Layer, 8-Layer devices are composed of porcinederived extracellular matrix scaffolds, specifically known as urinary bladder matrix. The devices are supplied in multi-layer sheet configurations in sizes up to 10 cm x 15 cm, and packaged in double peel-open foil pouches. The devices are terminally sterilized using electron beam irradiation.
The provided text is a 510(k) Premarket Notification for a medical device called "Gentrix™ Surgical Matrix." This document is a regulatory submission for a Class II medical device, primarily focusing on demonstrating substantial equivalence to existing predicate devices.
It does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of an AI/ML device.
The performance data included in the document pertains to:
- Biocompatibility Testing: According to ISO-10993-1 for a permanently implanted device.
- Mechanical Testing: Including tensile strength, suture retention strength, ball burst strength, delamination strength, tear strength, and stiffness.
- Material Characterization: Including moisture content, hydration uptake, and hydrated onset temperature.
These tests aim to demonstrate that the Gentrix™ Surgical Matrix is "substantially equivalent" to predicate and reference devices and performs adequately throughout its labeled shelf life. This is typical for a 510(k) submission, where the focus is on comparing a new device to an already legally marketed one.
Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving the device meets those criteria, as there is no specific AI/ML component or associated study described in this document.
The document discusses validation of the packaging system (ANSI/AAMI/ISO 11607-1 and -2) and substantial equivalence to predicate devices based on material, manufacturing, and performance characteristics for surgical mesh, not an AI/ML system.
§ 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.