(30 days)
CV Peri-Guard is intended for use as a patch material for intracardiac defects, great vessel, septal defect and annulus repair, and suture-line buttressing.
Vascu-Guard is intended for peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.
Supple 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 banding, muscle flap reinforcement, rectal and vaginal prolapse, reconstruction of the pelvic floor, and hernias (including diaphragmatic, femoral, incisional, inguinal, lumbar, paracolostomy, scrotal, and umbilical hernias).
CV Peri-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde.
Vascu-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde.
Supple Peri-Guard is prepared from bovine pericardium which is cross-linked with glutaraldehyde.
The provided 510(k) summaries (K983602 for CV Peri-Guard, Vascu-Guard, and Supple Peri-Guard) do not describe a study involving acceptance criteria in the typical sense of a diagnostic or AI device performance study. Instead, these summaries focus on establishing substantial equivalence to predicate devices by comparing the technological characteristics of a modified manufacturing process (1M NaOH treatment).
The acceptance criteria here are implicitly met by demonstrating "no significant difference" in various tests between the NaOH-treated pericardium and the control (non-NaOH-treated) pericardium. The study performed is a series of laboratory and animal tests to support the safety and effectiveness of the modified product.
Here's a breakdown of the information requested, based on the provided documents:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| No significant difference in shrink testing between treated and control samples. | Results showed no significant difference between the test and control samples. |
| No significant difference in suture testing between treated and control samples. | Results showed no significant difference between the test and control samples. |
| No significant difference in thickness testing between treated and control samples. | Results showed no significant difference between the test and control samples. |
| No significant difference in bioburden between treated and control samples. | Results showed no significant difference between the test and control samples. |
| No significant difference in sterility between treated and control samples. | Results showed no significant difference between the test and control samples. |
| No significant difference in pH between treated and control samples. | Results showed no significant difference between the test and control samples. |
| No significant difference in pyrogenicity between treated and control samples. | Results showed no significant difference between the test and control samples. |
| No significant difference in chemical residuals between treated and control samples. | Results showed no significant difference between the test and control samples. |
| No significant differences in biocompatibility when comparing treated versus non-treated pericardium. | Results showed that the 1M NaOH treatment did not produce significant differences in biocompatibility when comparing the treated versus non-treated pericardium. |
| No significant differences in inflammation when comparing treated versus non-treated pericardium. | Results showed that the 1M NaOH treatment did not produce significant differences in inflammation when comparing the treated versus non-treated pericardium. |
| Does not pose additional questions of safety or effectiveness. | Bio-Vascular believes that product subjected to 1M NaOH treatment performs in a manner substantially equivalent to the product not treated with 1M NaOH, and that the exposure to sodium hydroxide poses no additional questions of safety or effectiveness. (This is the conclusion based on all the above tests, supporting substantial equivalence rather than explicit performance metrics against a defined threshold.) |
2. Sample Size for the Test Set and Data Provenance
The documents do not specify the exact sample sizes used for each individual test (shrink, suture, thickness, bioburden, sterility, pH, pyrogen, chemical residuals, biocompatibility, and animal testing). The data provenance is implied to be from in vitro laboratory testing and in vivo animal testing. No country of origin for the data is explicitly stated, but the applicant is based in the USA. The studies would be considered prospective in the context of evaluating the new manufacturing process.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This type of study (material characterization and animal testing for substantial equivalence) does not typically involve "experts establishing ground truth" in the way a diagnostic imaging study would. The acceptance criteria are based on measurable physical, chemical, and biological properties, which are assessed by standard laboratory methodologies. The interpretation of animal testing results would be done by qualified veterinarians and pathologists, but their number and specific qualifications are not detailed.
4. Adjudication Method for the Test Set
Not applicable. This is not a study that involves human interpretation requiring adjudication. Performance is based on objective laboratory measurements and animal observations.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. This is not a diagnostic device or an AI system that would typically undergo an MRMC study. The study compares material properties and biological responses of a physical patch, not human reader performance 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 physical patch material, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this study is derived from:
- Objective laboratory measurements: For physical characteristics (shrink, suture, thickness) and chemical/biological properties (bioburden, sterility, pH, pyrogen, chemical residuals).
- Animal testing results: For biocompatibility and inflammation, which would involve macroscopic and microscopic observations by trained personnel (e.g., pathologists).
The comparison is made against the control samples (non-NaOH-treated pericardium), which represent the established predicate device's characteristics.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning study, so 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 evaluation.
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).