(86 days)
The Edwards Bovine Pericardial Patch is intended for use as a surgical patch material for: augmenting the patient's own pericardium to assist in closure following open-heart surgery; intracardiac defects; septal defects and annulus repairs; cardiac and vascular reconstruction and repairs; peripheral vascular reconstruction and repairs; great vessel reconstruction and repairs; and suture-line buttressing.
The Edwards Bovine Pericardial Patch is comprised of a rectangular sheet of bovine pericardium that has been preserved in a buffered glutaraldehyde solution. The pericardial patch is in the form of a 10 cm x 15 cm size, and may be tailored during surgery to meet the specific configuration needs of individual circumstances.
The provided text is a 510(k) Summary for the "Edwards Bovine Pericardial Patch." This document outlines the device's characteristics, intended use, and its assertion of substantial equivalence to predicate devices. However, it does not contain specific acceptance criteria or details of a study that objectively proves the device meets such criteria through quantitative performance metrics.
Instead, the submission relies on the concept of substantial equivalence to previously approved devices. This regulatory pathway asserts that the new device is as safe and effective as a legally marketed predicate device because it shares similar technological characteristics and/or intended use.
Therefore, the following points address what can be gleaned from the text, and where information is missing based on your request:
Acceptance Criteria and Study Details
| Criteria | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety and Effectiveness | The device is considered safe and effective if it demonstrates substantial equivalence to predicate devices, meaning it has "the same intended medical use, operates using the same fundamental scientific technology, similar shape, similar processing method, similar sterilization method, and similar packaging and labeling." | The device is manufactured from glutaraldehyde fixed bovine pericardium, the same material used for predicate devices. |
| "The safety and effectiveness of bovine pericardial patches for reconstruction and repair is well established. Pericardial patches have been proven to be effective in achieving the desired result and well tolerated by the host tissue." | ||
| Material | Glutaraldehyde fixed bovine pericardium. | Glutaraldehyde fixed bovine pericardium. |
| Processing Method | Similar to predicate devices. | Similar to predicate devices. |
| Sterilization Method | Similar to predicate devices. | Similar to predicate devices. |
| Packaging and Labeling | Similar to predicate devices. | Similar to predicate devices. |
Study that proves the device meets the acceptance criteria:
The provided document does not describe a specific study with quantitative performance metrics (e.g., sensitivity, specificity, accuracy, or other measurable outcomes) that would typically be associated with proving a device meets acceptance criteria.
Instead, the submission for the Edwards Bovine Pericardial Patch relies on the established safety and effectiveness of its predicate devices and the demonstration of substantial equivalence. The "Functional/Safety Testing" section states, "The safety and effectiveness of bovine pericardial patches for reconstruction and repair is well established. Pericardial patches have been proven to be effective in achieving the desired result and well tolerated by the host tissue." This indicates that the regulatory body accepts the principle that if the new device is materially and functionally identical to previously approved devices from a well-understood class, then specific new clinical studies to re-prove fundamental safety and effectiveness are not required for this type of submission (510(k)).
Additional Information based on Request:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A. The document does not describe a "test set" in the context of a performance study with a specific sample size. The substantial equivalence argument relies on prior knowledge and established clinical use of similar materials rather than new data from a specific test set for this submission.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- N/A. As no specific performance study with a test set is described, there is no mention of experts establishing ground truth for such a set.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A. No test set or performance study requiring adjudication is mentioned.
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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:
- N/A. This device is a medical implant (bovine pericardial patch), not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study is not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- N/A. This device is a medical implant, not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" implicitly relied upon for this 510(k) submission is the long-standing clinical experience and historical outcomes data for predicate bovine pericardial patches. The document states, "The safety and effectiveness of bovine pericardial patches for reconstruction and repair is well established." This suggests that the clinical utility and safety of this class of devices have been confirmed through collective medical experience and perhaps prior studies on similar products that established their efficacy and biocompatibility.
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The sample size for the training set:
- N/A. No training set is applicable as this is not an algorithm-based device.
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How the ground truth for the training set was established:
- N/A. No training set is applicable.
§ 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).