(78 days)
For repair of carotid endarterectomy and vascular patch grafting.
The Shelhigh No-React® VascuPatch™ is a made of glutaraldehyde fixed bovine pericardium, rinsed with the detoxification process No-React®. It is stored in 2% Benzyl alcohol like the Shelhigh No-React® pericardial patch. The material exhibits good tensile strength, shrink temperature, excellent biocompatibility and suture retention. It is soft and pliable making it convenient to implant. Bovine pericardial material has been used successfully as a tissue patch for pericardial closure. Glutaraldehyde processed bovine pericardium has a long history of success as a permanently implanted material.
This document is a 510(k) summary for the Shelhigh No-React® VASCUPATCH™, specifically addressing its substantial equivalence to predicate devices rather than providing detailed acceptance criteria and study results in the context of device performance metrics like sensitivity, specificity, or reader improvement.
Therefore, many of the requested categories cannot be filled directly from the provided text. The document focuses on demonstrating that the new device is "substantially equivalent" to existing, legally marketed devices based on material properties and intended use.
Here's an attempt to answer the questions based only on the provided text, with clear indications where the information is not present:
Acceptance Criteria and Study for Shelhigh No-React® VASCUPATCH™
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-Clinical/Animal Tests: | |
| Cytocompatibility | Shelhigh No-React® patch shows higher level of biocompatibility compared to conventional glutaraldehyde treated patch. |
| Material/Physical/Mechanical Properties: | |
| Suture retention | Exhibits substantially equivalent properties to predicate device. |
| Tensile strength | Exhibits substantially equivalent properties to predicate device. |
| Shrink temperature | Exhibits substantially equivalent properties to predicate device. |
| Flexibility | Identical to predicate device. |
| Wall thickness | Identical to predicate device. |
| Storage solution | Stored in bezyle alcohol, identical to predicate device. |
2. Sample size used for the test set and the data provenance:
- Sample Size (Test Set): Not specified. The document mentions "An animal study," but does not provide details on the number of animals or samples used.
- Data Provenance: The animal study was conducted to compare the Shelhigh No-React® patch with a conventional glutaraldehyde treated patch. No country of origin is specified. This was a nonclinical/animal test.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The study described is an animal study evaluating material properties and biocompatibility, not an assessment requiring expert interpretation of diagnostic images or clinical outcomes in humans to establish "ground truth."
4. Adjudication method for the test set:
- Not applicable. As noted above, this was an animal study of material properties and biocompatibility, not a study requiring adjudication of expert interpretations.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This device is a cardiovascular patch, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a cardiovascular patch.
7. The type of ground truth used:
- For the animal study on biocompatibility, the "ground truth" would be established through histological analysis, cellular assays, and potentially macroscopic observation of the animal tissue responses to the implanted materials.
- For the physical/mechanical properties, the "ground truth" is based on standardized laboratory testing methods for suture retention, tensile strength, and shrink temperature.
8. The sample size for the training set:
- Not applicable. This is a medical device (cardiovascular patch), not a machine learning algorithm requiring a training set in the conventional sense.
9. How the ground truth for the training set was established:
- Not applicable. (See #8)
Summary of Device Equivalence from the Document:
The provided text describes the Shelhigh No-React® VASCUPATCH™ as being substantially equivalent to a predicate device (Knitted MiniCrimp Vascupatch manufactured by Meadox Medical, Inc. #K905496) and identical to another currently manufactured device (Shelhigh No-React® pericardial patch K974914). The equivalence is based on:
- Material: Glutaraldehyde fixed bovine pericardium, rinsed with No-React® detoxification process.
- Physical/Mechanical Properties: Substantially equivalent suture retention, tensile strength, and shrink temperature. Identical flexibility, wall thickness, and storage in benzyl alcohol.
- Intended Use: Repair of carotid endarterectomy and vascular patch grafting.
- Biocompatibility: An animal study showed higher cytocompatibility for the Shelhigh No-React® vs. conventional glutaraldehyde treated patches.
§ 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).