(113 days)
PREVADH™ mesh is indicated for use when a temporary wound support is required in abdominopelvic surgery. The resorbable hydrophilic film minimizes tissue attachment to the mesh in the case of direct contact with the viscera.
PREVADH™ Mesh is sterile and can be anchored. It has three component layers: one porous side made of lyophilized porcine collagen; one non-porous smooth side made of porcine collagen, polyethylene glycol and glycerol; and a multifilament polylactic acid mesh inserted between the two collagen layers. The porous side is soft and hydrophilic, and combined with the highly porous mesh, allows for fast tissue in-growth. The nonporous smooth side minimizes visceral attachment. The entire PREVADH™ Mesh device resorbs. The porous side is resorbed in less than 1 week and the non-porous smooth side is resorbed in approximately 3 weeks. The multifilament polylactic acid mesh is bioresorbable and offers significant mechanical strength during at least 12 weeks to maintain support throughout the critical healing period.
This submission describes the PREVADH™ Mesh, a resorbable surgical mesh indicated for temporary wound support in abdominopelvic surgery. The device consists of three layers: a porous porcine collagen side, a non-porous layer of porcine collagen, polyethylene glycol, and glycerol, and a multifilament polylactic acid mesh inserted between the collagen layers.
Here's an analysis of the provided information regarding acceptance criteria and supportive studies:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria (Stated or Implied) | Reported Device Performance |
|---|---|
| Biocompatibility (materials) | "Comprised of biocompatible materials that are in compliance with ISO 10993-1 and/or USP standards." |
| Mechanical Properties | "Results of mechanical properties testing show that PREVADH™ Mesh has similar performance characteristics to the predicate VICRYL Mesh." |
| Porosity for fast tissue in-growth | "PREVADH™ Mesh is knitted in a design with large pores that allow fast tissue in-growth." |
| Minimization of visceral attachment | "The non-porous smooth side minimizes visceral attachment." and "the hydrophilic collagen film serves to temporarily separate the mesh from adjacent organs to minimize visceral attachment to the mesh which may occur during the healing process." |
| Resorption Profile (Porous side) | "The porous side is resorbed in less than 1 week." |
| Resorption Profile (Non-porous side) | "the non-porous smooth side is resorbed in approximately 3 weeks." |
| Resorption Profile (Polylactic acid mesh) | "The multifilament polylactic acid mesh is bioresorbable and offers significant mechanical strength during at least 12 weeks to maintain support throughout the critical healing period." |
2. Sample Size Used for the Test Set and Data Provenance:
The document states that "Bench and animal testing has been conducted to evaluate the performance characteristics of PREVADH™ Mesh."
- Sample Size for Test Set: Not specified. The document only mentions "Bench and animal testing."
- Data Provenance: Not specified. It's common for animal studies for device clearance to be conducted in-house or by contract research organizations, but the specific origins are not detailed. These studies are typically prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
No mention of human experts establishing ground truth for the "Bench and animal testing." The evaluations appear to be objective measurements (e.g., mechanical properties, resorption rates, tissue response in animals).
4. Adjudication Method for the Test Set:
Not applicable, as there's no mention of human-involved assessment in the "Bench and animal testing" that would require adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, an MRMC comparative effectiveness study was not done. The device is a surgical mesh, and its evaluation focuses on material properties, biocompatibility, and animal efficacy, not interpretation of medical images by multiple readers.
6. Standalone (Algorithm only without human-in-the-loop performance) Study:
Not applicable. This is a medical device (surgical mesh), not an algorithm or AI system.
7. Type of Ground Truth Used:
The ground truth for the performance claims appears to be based on:
- Objective Measurements: Mechanical property tests, resorption rate measurements.
- Animal Observations: Assessment of tissue in-growth, visceral attachment minimization, and overall biological response in animal models.
- Material Standards: Compliance with ISO 10993-1 and/or USP standards for biocompatibility.
8. Sample Size for the Training Set:
Not applicable, as this is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as this is not an AI/ML device requiring a training set.
Summary of Study and Justification for Equivalence:
The 510(k) submission for PREVADH™ Mesh relies on demonstrating substantial equivalence to legally marketed predicate devices: PARIETEX™ COMPOSITE (PCO) Mesh (K040998), Ethicon, Inc. VICRYL Mesh (K810428), and UGYTEX™ Mesh (K033376).
The studies conducted to support this claim include:
- Bench Testing: To evaluate mechanical properties and similarity to predicate VICRYL Mesh.
- Animal Testing: To assess performance characteristics such as tissue in-growth and minimization of visceral attachment, which are key functions of the device, particularly the hydrophilic film (similar to the PCO Mesh predicate).
- Biocompatibility Testing: Materials shown to be in compliance with ISO 10993-1 and/or USP standards.
The acceptance criteria are implied by the desired functional characteristics of a surgical mesh (biocompatibility, appropriate mechanical strength, desirable resorption profile, and minimization of adhesions), and the performance data presented aims to show that the PREVADH™ Mesh meets these characteristics and performs similarly to its predicate devices. The submission concludes that the technological characteristics are similar to the predicate devices, thereby supporting substantial equivalence for its intended use.
§ 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.