(177 days)
The Shelhigh No-React® Pericardial patch is intended for use during cardiac surgical procedure as a patch for closure of the patient's pericardium after open heart surgery, The patch may be tailored during surgery to meet the surgeon's needs.
The Shelhigh No-React® Pericardial patch is intended for use during cardiac surgical procedure as an intracardiac patch for open heart surgery, as well as to close intercavitary defect, and enlarge the aortic root . The patch may be tailored during surgery to meet the surgeon's needs.
The Shelhigh No-React® Pericardial patch is a glutaraldehyde fixed sheet of bovine pericardium, rinsed with the detoxification process No-React®. The device is provided sterile in benzyl alcohol solution. The material exhibits good tensile strength, shrink temperature and suture retention. The material reapproximates well around suture holes. It is soft and pliable making it convenient to implant.
The material exhibits excellent biocompatibility. Bovine pericardial material has been used successfully as a tissue patch for pericardial closure. Glutaraldhyde processed bovine pericardium has a long history of success as a permanently implanted material.
The provided text describes a medical device, the Shelhigh No-React® Pericardial Patch, and its substantial equivalence to a predicate device for 510(k) clearance. However, it does not contain information about specific acceptance criteria, a detailed study proving the device meets those criteria, or most of the requested metrics for a clinical/performance study.
The document focuses on demonstrating substantial equivalence primarily through non-clinical (physical/mechanical properties) and animal testing, rather than human clinical trials with defined acceptance criteria and performance metrics.
Here's a breakdown of the available information based on your request, and where the information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Physical/Mechanical Properties: | Substantially equivalent to predicate device. |
| - Suture retention | - Equivalent performance. |
| - Tensile strength | - Equivalent performance. |
| - Shrink temperature | - Equivalent performance. |
| - Flexibility | - Identical. |
| - Wall thickness | - Identical. |
| - Shapes and sizes | - Identical. |
| Biocompatibility: | Higher level of biocompatibility. Demonstrated in animal study comparing to conventional glutaraldehyde treated patch. |
| Cytocompatibility: | High level of cytocompatibility. Demonstrated in non-clinical/animal testing compared to conventional glutaraldehyde treated and stored. |
| Safety and Effectiveness: | No new questions of safety and effectiveness compared to the predicate device due to the detoxification process. |
2. Sample size(s) used for the test set and the data provenance
- Test Set Sample Size: Not specified in terms of number of animals or specific measurements.
- Data Provenance: Animal study. The country of origin for the animal study is not specified, but the submission is to the US FDA. The study is prospective in the sense that it was conducted specifically to support this regulatory submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. The "ground truth" for physical/mechanical properties would be direct measurements. For biocompatibility, it's evaluated through animal study outcomes, not expert consensus interpreting data.
4. Adjudication method for the test set
- Not applicable/Not provided. Adjudication methods (like 2+1, 3+1) are typically used for interpreting results in human clinical trials or image-based studies where expert consensus is needed. The non-clinical and animal studies described here would rely on objective measurements and pathological assessment.
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
- No. This device is a pericardial patch, not an AI or image-reading device. Therefore, MRMC studies are not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a physical implantable medical device, not an algorithm.
7. The type of ground truth used
- Physical/Mechanical Properties: Direct laboratory measurements (e.g., tensile strength, suture retention force, temperature at which shrinkage occurs).
- Biocompatibility/Cytocompatibility: Histopathological evaluation of tissue response in animal models, and potentially in vitro cell culture assays for cytocompatibility.
8. The sample size for the training set
- Not applicable. This device is not an AI algorithm that requires a "training set." The materials used for manufacturing and testing are described, but not as a training set.
9. How the ground truth for the training set was established
- Not applicable, as there is no "training set."
Summary of what the document does provide regarding acceptance criteria and studies:
The document primarily addresses substantial equivalence by comparing the Shelhigh No-React® Pericardial Patch to a predicate device (Shelhigh pericardial patch #K964467). The "acceptance criteria" can be inferred from this comparison:
- Physical/Mechanical Properties: The device must demonstrate "substantially equivalent physical/mechanical properties" as measured by suture retention, tensile strength, and shrink temperature, and "identical flexibility, wall thickness, shapes and sizes" to the predicate.
- Biocompatibility: The device must demonstrate acceptable biocompatibility, and ideally, higher level of biocompatibility as a result of the "No-React®" detoxification process, without raising new questions of safety and effectiveness.
The study that "proves" these criteria are met is described as:
- Nonclinical/Animal Tests: These tests demonstrated that the Shelhigh No-React® patch shows:
- Substantially equivalent physical/mechanical properties to the predicate.
- A higher level of biocompatibility and high level of cytocompatibility when compared with conventional glutaraldehyde-treated and stored material.
The document concludes that the differences (the addition of the No-React® detoxification process) do not pose new questions of safety and effectiveness, thus qualifying it as substantially equivalent.
§ 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).