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510(k) Data Aggregation
(247 days)
Intended for the reinforcement of tissues during surgical repair. It is indicated for the treatment of incisional hernias, abdominal wall repair, and parietal (i.e. pertaining to the walls) reinforcement of tissues. The non-resorbable three dimensional polyester mesh provides long-term reinforcement of soft tissues.
COVAMESH™ is a surgical mesh used during open procedures (laparotomy) or during laparoscopic procedures. COVAMESHIM is made from polyethylene terephtalate (polyester) and a cross-linked resorbable collagen film of porcine origin. The hydrophilic collagen film physically separates the coated side of the mesh from adjacent tissue, viscera, and organs. A marking with a non-resorbable ink is at the centre of the mesh to help positioning the device. The surgical mesh is obtained by standardized, controlled manufacturing processes. COVAMESHI™ is further sterilized in double-blisters by gamma-imadiation. COVAMESH™ is designed to be non inflammatory and biocompatible to allow reinforcement of soft tissues. When wetted, the surgical mesh is rollable to be easily introduced in a trocar. COVAMESH™ is suturable in place. It is provided in round sheets of 12 cm diameter and 16cm diameter and in rectangular sheets of 15x10 cm, 20x15 cm, 25x20 cm, 30x20 cm, 36x30 cm.
Here's an analysis of the provided text regarding the acceptance criteria and study for COVAMESH™:
It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than establishing novel safety and efficacy criteria through a full clinical trial. Therefore, the information provided below will reflect that context.
Acceptance Criteria and Device Performance for COVAMESH™
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on Predicate) | Reported Device Performance (COVAMESH™) |
|---|---|---|
| Biocompatibility | Pass all standard biocompatibility tests. | Passed all following tests: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity (Acute), Genotoxicity (Ames Mutagenesis, Bone Marrow Micronucleus, Mouse Lymphoma Mutagenesis), Implantation, Pyrogenicity, Sub-Chronic/Chronic Toxicity. |
| Manufacturing Process | Compliant with relevant standards for animal tissue sourcing and viral inactivation. | Complies with United States Food and Drug Administration and European Standards for animal tissue sourcing and viral inactivation. |
| Material Properties | Similar characteristics to predicate surgical mesh (e.g., thickness, pore size, density, tensile strength, suture pullout strength, tear resistance). | Similar performance characteristics to previously cleared surgical mesh for thickness, pore size, density, tensile strength, suture pullout strength, and tear resistance. |
| In Vivo Performance | Elicits similar tissue response and tissue integration as the predicate device. | Elicits a similar tissue response and has similar tissue integration as compared to the PARIETEX® COMPOSITE Mesh predicate device in two representative animal models. |
2. Sample Size and Data Provenance for Test Set (Clinical Studies / Human Data)
- Sample Size: Not applicable/Not mentioned for human clinical testing. This submission primarily relies on non-clinical data (bench testing, animal studies) and comparison to predicate devices, rather than a prospective human clinical trial with a defined test set.
- Data Provenance: Not applicable for clinical test sets. The data presented is from bench testing and animal studies.
3. Number of Experts and Qualifications for Ground Truth of Test Set
- Number of Experts: Not applicable. The "ground truth" in this context is derived from established scientific and regulatory standards for biocompatibility and material performance, as well as the performance of the predicate device. It does not involve expert consensus on human patient data.
- Qualifications of Experts: N/A
4. Adjudication Method for Test Set
- Adjudication Method: Not applicable. There is no human test set or need for adjudication of clinical outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- MRMC Study: No, an MRMC comparative effectiveness study was not done. The device is a surgical mesh, not an AI diagnostic tool that human readers would interpret.
6. Standalone (Algorithm Only) Performance Study
- Standalone Study: Not applicable. This is a medical device (surgical mesh), not an algorithm or AI system.
7. Type of Ground Truth Used
- Type of Ground Truth:
- Bench Test Standards: Performance metrics (thickness, pore size, tensile strength, etc.) are compared against established values and the performance of the predicate device, forming a "ground truth" of acceptable physical characteristics for surgical mesh.
- Biocompatibility Standards: Biocompatibility tests are performed against internationally recognized standards (FDA Blue Book Memorandum G95-1 and ISO 10993-1), where passing these tests constitutes the "ground truth" for material safety.
- Animal Model Observations: The "ground truth" for in-vivo performance is observed tissue response and integration in animal models, compared to the known performance of the predicate device.
8. Sample Size for Training Set
- Sample Size: Not applicable. This device does not use machine learning or AI that would require a "training set."
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: Not applicable, as there is no training set for an AI/ML model.
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