(29 days)
Peri-Guard is intended for repair of pericardial structures and for use as a prosthesis for the surgical repair of soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric binding, muscle flap reinforcement, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).
For use as a prosthesis for pericardial closure and soft tissue deficiencies which include: defects of the abdominal and thoracic wall, gastric banding, muscle flap reinforcement, and hernias (diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal and umbilical).
Peri-Guard® Repair Patch (Peri-Guard) is a biologic tissue prepared from bovine pericardium cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Peri-Guard is chemically sterilized using ethanol and propylene oxide. Peri-Guard is treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C.
Supple Peri-Guard® is prepared from bovine pericardium which is cross-linked with glutaraldehyde. The pericardium is procured from cattle originating in the United States. Supple Peri-Guard is chemically sterilized using ethanol and propylene oxide. Supple Peri-Guard has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. Supple Peri-Guard is packaged in a container filled with sterile, non-pyrogenic water containing propylene oxide. The contents of the unopened, undamaged container are sterile.
The provided text describes two devices: "Peri-Guard Repair Patch" and "Supple Peri-Guard Pericardium," both with the same 510(k) number K983162. The information regarding their acceptance criteria and studies is identical across both entries, as they are essentially the same device with a minor manufacturing difference.
Here's an analysis of the acceptance criteria and study information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Physical Properties | No significant difference compared to control (non-NaOH-treated) samples in shrink, suture, and thickness. | Results showed no significant difference between the test (NaOH-treated) and control (non-NaOH-treated) samples for shrink, suture, and thickness testing. |
| Biocompatibility | No significant difference in biocompatibility or inflammation compared to non-NaOH-treated samples. | Results showed that the 1 M NaOH treatment did not produce significant differences in biocompatibility or inflammation when comparing the treated versus non-treated pericardium. |
| Safety Factors | No significant difference in bioburden, sterility, pH, pyrogen, and chemical residuals compared to non-NaOH-treated samples; no additional questions of safety or effectiveness. | Results showed no significant difference between the test and control samples for bioburden, sterility, pH, pyrogen, and chemical residuals testing. The exposure to sodium hydroxide poses no additional questions of safety or effectiveness, and the product performs in a manner substantially equivalent to the product not treated with 1M NaOH. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not explicitly stated. The text mentions "samples" of NaOH-treated and control pericardium were subjected to various tests.
- Data Provenance: Not explicitly stated but clinical data is alluded to by "animal testing" and "biocompatibility" but no human data is provided. The bovine pericardium for the device is procured from cattle originating in the United States and the study was conducted by the manufacturer, Synovis Surgical Innovations, based in St. Paul, MN. This suggests it is likely a retrospective study based on laboratory and animal testing, not a prospective human clinical trial.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable as this study does not involve human readers evaluating images or data against a ground truth established by experts. It's a laboratory and animal study comparing physical, chemical, and biological properties of a medical device.
4. Adjudication Method for the Test Set:
- Not applicable. This is not a study that involves expert adjudication of findings.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done:
- No, an MRMC comparative effectiveness study was not done. This study focuses on the material properties and biological response to the modified implant, not on human interpretation or decision-making with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done:
- Not applicable. This device is a surgical mesh, not an algorithm or AI system.
7. The Type of Ground Truth Used:
- The "ground truth" in this context refers to the established standards for material properties, biocompatibility, and safety within a controlled laboratory and animal testing environment. This includes:
- Physical measurements: Shrinkage, suture retention, thickness.
- Chemical analyses: pH, chemical residuals.
- Biological assays: Bioburden, sterility, pyrogenicity, biocompatibility (e.g., inflammatory response in animal models).
- Comparison to predicate device/control: The non-NaOH-treated pericardium serves as the primary control or "ground truth" against which the modified device is compared to demonstrate substantial equivalence.
8. The Sample Size for the Training Set:
- Not applicable. This study does not involve a training set as it is not an AI/algorithm study.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable as there is no training set for this type of device study.
§ 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.