(430 days)
The Glycar Pericardial Patch and Glycar Vascular Patch of the Glycar Tissue Repair Patch line of products are intended for pericardial closure, peripheral vascular reconstruction and repair, and cardiac and great vessel reconstruction and repair.
The Glycar Vascular Repair Patches are made of the same material as the predicate device, the Peri-Guard™ tissue patches, which are made from glutaraldehyde-treated bovine pericardium.
Here's an analysis of the provided text regarding the Glycar Vascular Repair Patch's acceptance criteria and substantiating study information:
The provided text is a 510(k) summary for a medical device called the Glycar Vascular Repair Patch. It outlines the device's characteristics and its proposed equivalence to a predicate device. However, it does not contain information about a study designed to prove the device meets specific acceptance criteria in the way a clinical trial or performance study would.
Instead, the submission focuses on demonstrating substantial equivalence to an already approved predicate device, the Bio-Vascular Inc., Vascu-Guard™ peripheral vascular patch (K942010), and other Glycar products (K942911, K954665). The "acceptance criteria" here are effectively the characteristics and performance of the predicate device, which the Glycar product aims to match or be comparable to.
Therefore, many of the requested sections (sample size, experts, adjudication, MRMC, standalone, training set, ground truth for training) are not applicable as the submission is a demonstration of substantial equivalence, not a de novo performance study with acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Based on Predicate Device Characteristics) | Reported Device Performance (Glycar Vascular Repair Patch) |
|---|---|
| Material Composition: Glutaraldehyde-treated bovine pericardium (same as predicate). | The Glycar Vascular Repair Patches are manufactured from the same material, glutaraldehyde-treated bovine pericardium. |
| Intended Uses: Same as predicate device (Vascu-Guard™: repair of carotid, femoral, iliac, profunda, tibial arteries, revision of arterio-venous access shunts). Prior Glycar products (K942911, K954665) had approved uses for hernia, intraabdominal soft tissue defects, surgical stapling of lung tissue, gastric staplings, rectal/vaginal prolapse, urethral sling, reconstruction of pelvic floor, hernias/defects of diaphragm/thoracic/abdominal wall. New specific intended uses include pericardial closure, peripheral vascular reconstruction and repair, and cardiac and great vessel reconstruction and repair. | The Glycar Inc., Vascular Repair Patch has the same intended uses as the predicate device (Vascu-Guard™). The 510(k) summary also refers to previous approvals for Glycar products, broadening the family of intended uses. The final "Indications For Use" statement approved by the FDA includes: "pericardial closure, peripheral vascular reconstruction and repair, and cardiac and great vessel reconstruction and repair." |
| Material Attributes (Strength): Possesses tissue strength equaling that of the predicate. | Glycar's glutaraldehyde-treated pericardium possesses tissue strength equaling that of the predicate and provides for a durable repair, replacement or reinforcement of natural soft tissue. (References "Chirol Centere Chart 1, Comparison Chart, under Substantial Scc in Audenaul |
| Material Attributes (Pyrogenicity): Negative pyrogenicity. | Glycar glutaraldehyde-treated bovine pericardium has been found to have negative pyrogenicity. (References "Chart 1, Comparison Chart, under Substantial Equivalence and Pyrogenicity under Supporting Data" – this specific data is not provided in the excerpt). |
| Sterility Assurance Level (SAL): Minimum 10^-6 organisms (same as predicate). | The Glycar Vascular Repair Patches are labeled as sterile. They are sterilized to an SAL of 10^-6 organisms. (References "Chart 1, Comparison Chart, under Substantial Equivalence and see Validation of Sterilization Processes under Sterilization Information" – specific validation data not provided in the excerpt). |
| Sterilization Method: Chemical sterilization method (same as predicate, using formaldehyde and propylene oxide). | No difference in the chemical sterilization method used for Glycar Vascular Repair Patches versus that of the predicate device (formaldehyde and propylene oxide under environmental control in a class 100 Clean Room environment). |
| BSE Status: Sourced from BSE-free cattle. | Pericardium is obtained from cattle from government approved abattoirs in Transvaal, S. Africa, certified free from B.S.E. (bovine spongiform encephalopathy). |
| Safety and Efficacy: No adverse effects due to proprietary manufacturing material XX. | Glycar Inc. has demonstrated no adverse effects on safety or efficacy of the use of this manufacturing material. (No specific study data provided in the excerpt to support this, other than the claim itself). |
2. Sample size used for the test set and the data provenance
- Not Applicable. The submission is a demonstration of substantial equivalence, not a performance study with a "test set" in the context of typical algorithm validation. Performance characteristics (like strength, pyrogenicity, SAL) are asserted to be equivalent to the predicate, likely based on internal testing or existing validation data, but not explicitly as a test set for this 510(k). The mention of internal data like "Supporting Data" and "Validation of Sterilization Processes" suggests data exists but is not elaborated upon in this summary.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. See point 2.
4. Adjudication method
- Not Applicable. See point 2.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done
- Not Applicable. This is a medical device for surgical repair (a patch), not an imaging-based AI diagnostic tool that would typically undergo an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used
- Based on Comparison to Predicate Device Characteristics and Internal Testing Standards. The "ground truth" for this submission are the established performance and safety characteristics of the predicate device (Vascu-Guard™) and the conformity to recognized standards for materials (e.g., glutaraldehyde-treated bovine pericardium), sterilization (10^-6 SAL), and biological safety (pyrogenicity, BSE-free source). These are verified through various internal tests and comparisons referenced in the submission (e.g., "See Comparison Chart, Chart 1, in Addenda under Substantial Equivalence and see Supporting Data").
8. The sample size for the training set
- Not Applicable. This is a physical medical device, not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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).