Search Results

The Ventrio ST Hernia Patch is indicated for use in the reinforcement of soft tissue, where weakness exists, in procedures involving soft tissue repair, including repair of hernias.

The proposed device, Ventrio ST Hernia Patch, is a self-expanding bioresorbable coated, partially absorbable, sterile prosthesis, containing 2 distinct layers stitched with PTFE monofilament, forming a positioning pocket. The top layer is knitted polypropylene mesh, 0.004" in monofilament diameter, and the bottom layer is Sepramesh IP Mesh. Sepramesh IP Mesh is co-knitted using polypropylene (PP) and polyglycolic acid (PGA) fibers to result in a two-sided mesh with a PP surface and a PGA surface. The mesh is coated on the PGA surface with a bioresorbable, chemically modified sodium hyaluronate (HA), carboxymethylcellulose (CMC) and polyethylene glycol (PEG) based hydrogel. The fascial side of the mesh allows a prompt fibroblastic response through the interstices of the mesh, allowing for tissue ingrowth into the mesh. The visceral side of the mesh is a bioresorbable coating, separating the mesh from underlying tissue and organ surfaces to minimize tissue attachment to the mesh. Shortly after placement, the biopolymer coating becomes a hydrated gel that is resorbed from the site in less than 30 days.

The device contains Sorbaflex Memory Technology, which provides memory and stability to the device, facilitating ease of initial insertion, proper placement, and fixation of the device. The Sorbaflex Memory Technology is comprised of an extruded polydioxanone (PDO) monofilament that is contained within a knitted polypropylene mesh tube. The extra large oval size patches contain two separate Sorbaflex PDO monofilaments. The Sorbaflex PDO monofilament fully degrades in vivo by means of hydrolysis. Absorption is essentially complete in 6-8 months.

This document describes a 510(k) summary for the Ventrio ST Hernia Patch, a surgical mesh, seeking substantial equivalence to existing predicate devices. It does not contain information about a diagnostic AI device or associated studies. Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, or MRMC studies for an AI device.

The provided text focuses on:

• Device Description: The composition and characteristics of the Ventrio ST Hernia Patch, detailing its layers (polypropylene mesh, Sepramesh IP Mesh with PGA and bioresorbable coating), and Sorbaflex Memory Technology (PDO monofilament).
• Intended Use: Reconstruction of soft tissue deficiencies and repair of hernias, identical to predicate devices.
• Similarities and Differences: Comparisons to predicate devices (Ventrio Hernia Patch and Sepramesh IP Mesh), highlighting the replacement of certain layers with Sepramesh IP Mesh.
• Performance Data: Mention of laboratory bench testing for physical characteristics (mesh weave, pore size, density, thickness, stiffness), performance evaluations (burst strength, suture pullout strength, etc.), and preclinical studies (pig study for tissue attachment, contracture, ingrowth; rat study for degradation).
• Biocompatibility Testing: Conducted per ISO 10993 standards.

The document concludes that the Ventrio ST Hernia Patch is substantially equivalent to predicate devices based on this testing, indicating safety and effectiveness for its intended use. There is no information about AI, algorithm performance, or human reader studies.

Ask a specific question about this device