(76 days)
The PeriPatch Sheet is intended for use as a surgical patch material for: cardiac and vascular reconstruction and repair, soft tissue deficiency repair and reinforcing the suture line during general surgical procedures.
The PeriPatch™ Sheet is a quadrilateral shaped xenograft patch made from a sheet of glutaraldehyde fixed bovine pericardium selected for even thickness. It is designed to repair the body's natural organs and functions like natural tissue. It is intended for intra-cardiac repair procedures. It is identical to other marketed bovine pericardial patches. Extensive quality control procedures assure a consistent, high quality product for clinical use.
This document describes a 510(k) premarket notification for the "PeriPatch™ Sheet," a processed bovine pericardial patch. The submission claims substantial equivalence to previously cleared devices.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state "acceptance criteria" in a formalized, quantifiable manner for biological performance. Instead, it demonstrates substantial equivalence to predicate devices through comparisons of physical, chemical, and manufacturing characteristics. The reported device performance is presented as direct comparisons to these predicates.
| Characteristic | PM Devices Inc. PeriPatch (Reported Performance) | Predicate Device (e.g., BioVascular, Extracorporeal) | Significance (as stated in document) |
|---|---|---|---|
| Material | Bovine Pericardium | Bovine Pericardium | SE (Substantially Equivalent) |
| Cross-linking | Glutaraldehyde cross-linking | Glutaraldehyde cross-linking | SE |
| Shape | Flat, square & Rectangular | Flat, square & Rectangular | SE |
| Sizes (cm) | 1.5x8, 1.5x16, 4x4, 4x6, 6x8, 10x16 | Range of sizes, with overlaps with PeriPatch | SE |
| Packaging | Sealed, sterile container | Sealed, sterile container | SE |
| Thickness (mm) | 0.58 ± 0.17 | 0.25 (BioVascular), 0.5 ± 0.25 (BioVascular), 0.35 (Extracorporeal) | SE |
| Weight (g/m²) | 1172 ± 311 g/m² | 1080 ± 330 g/m² (BioVascular), 4360 ± 1600 g (Extracorporeal) | SE |
| Melting Point (°C) | 86.2°C | 83.6°C (Extracorporeal) | SE |
| Tensile Elongation (g) | 969 ± 114 | 1121 ± 102 (BioVascular), 1280 ± 108 (Extracorporeal) | SE |
| Tensile Strength (g) | 46.1 ± 5.4 | Unknown (BioVascular), 31.2 ± 6.0 (Extracorporeal) | SE |
| Burst Strength (mmHg) | 8200 / 159 | 7033 / 136 (BioVascular) | SE |
| Sterilization Agent | 0.2% Glutaraldehyde / PBS | Propylene oxide in water (BioVascular, Glycar) | SE |
| Rinsing Conditions | Two 2 min. rinses | One 3 min. Rinse (BioVascular), Three 2 min. rinse (Extracorporeal) | SE |
| Sterility Method | Liquid Alcoholic | Liquid Alcoholic (BioVascular, Extracorporeal) | SE |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of a clinical study or a specific, independent dataset used to evaluate the device's performance against defined acceptance criteria. Instead, it relies on comparisons of its physical and performance characteristics to predicate devices. The data provenance is derived from the manufacturing and characterization of the PeriPatch™ Sheet itself and "literature" and "validations" cited in Appendix A and D respectively, which are not provided in this excerpt. This is a retrospective comparison to existing, legally marketed devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. No independent "test set" with a ground truth established by experts is described. The document focuses on demonstrating substantial equivalence to predicate devices through technical comparisons rather than an independent clinical validation.
4. Adjudication Method for the Test Set
Not applicable. No "test set" or adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Reader Improvement
No. A MRMC comparative effectiveness study was not done. This is a premarket notification for a medical device (a xenograft patch), not an AI-assisted diagnostic tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No. This question applies to AI/ML software, not to a physical medical device like the PeriPatch™ Sheet.
7. The Type of Ground Truth Used
The "ground truth" in this context is the established performance and safety profiles of the predicate devices, as detailed in their 510(k) clearances and scientific literature. The PeriPatch™ Sheet aims to demonstrate that its characteristics are similar enough to these established devices to be considered substantially equivalent. It is based on engineering and material property comparisons rather than clinical outcomes or pathology data from a new study.
8. The Sample Size for the Training Set
Not applicable. This is a physical medical device, not an AI/ML system. There is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. There is no "training set" for this type of device.
§ 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.