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510(k) Data Aggregation
(394 days)
GLYCAR PERICARDIAL PATCH
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 Pericardial Patches are made of the same material as the predicate device, the Peri-Guard™ tissue patches, which are made from glutaraldehyde-treated bovine pericardium.
The provided text describes a 510(k) submission for the Glycar Pericardial Patch. A 510(k) submission is for demonstrating substantial equivalence to a predicate device, not typically for proving a device meets specific acceptance criteria through a study with performance metrics in the same way a PMA (Premarket Approval) would. Therefore, the document does not contain a study that explicitly demonstrates the device meets quantitative acceptance criteria with reported device performance as would be expected for a novel device.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device, the Bio-Vascular Inc. Peri-Guard™ patch. This demonstration relies on comparing material composition, intended use, sterilization methods, and other performance features.
Here's a breakdown of the information requested, based on the provided text, and highlighting where the information is not present due to the nature of a 510(k) submission.
1. A table of acceptance criteria and the reported device performance
As this is a 510(k) submission for substantial equivalence, the "acceptance criteria" are primarily related to matching or exceeding the predicate device's characteristics and performance attributes rather than specific, quantitative clinical outcomes from a new study. The document lists several performance features that need to be "equal to or better than" the predicate device. However, it does not provide a table with specific numerical acceptance criteria and a corresponding quantitative "reported device performance" from a dedicated study.
| Acceptance Criteria (Demonstration of Substantial Equivalence) | Reported Device Performance (as stated in the 510(k)) |
|---|---|
| Manufactured from the same material (glutaraldehyde-treated bovine pericardium) | "The Glycar Pericardial Patches are made of the same material as the predicate device... which are made from glutaraldehyde-treated bovine pericardium." |
| "There is no difference in the implanted material used for the Glycar Pericardial Patch ... and the predicate device... Both devices are manufactured from glutaraldehyde-treated bovine pericardial tissue." | |
| Have the same intended use (pericardial closure, among others) | "The Glycar Inc., Pericardial Patch has the same intended use, pericardial closure, as the predicate device..." |
| Indications for Use: "pericardial closure, peripheral vascular reconstruction and repair, and cardiac and great vessel reconstruction and repair." (Aligned with predicate, which has been used for pericardial closures for over ten years without reported material failure, and other soft tissue repairs) | |
| Sterilized to a minimum assurance against contamination of 10-6 organisms (Sterility Assurance Level, SAL = 10-6) | "The Glycar Pericardial Patches are labeled as sterile. They are sterilized to an SAL of 10-6 organisms." |
| Other performance features equal to or better than those of the predicate device | Material Attributes: "Glycar's glutaraldehyde-treated pericardium possesses tissue strength equaling that of the predicate device." |
| Pyrogenicity: "Glycar glutaraldehyde-treated bovine pericardium has been found to have negative pyrogenicity." | |
| Manufacturing Material (Proprietary XX): "Glycar Inc. has demonstrated no adverse effects on safety or efficacy of the use of this manufacturing material... rather it improves safety by virtue of the anti-inflammation properties it confers to the material." | |
| Bovine Spongiform Encephalopathy (BSE)-free source | "Pericardium used for the raw material for these devices is obtained from cattle from government approved abbatoirs in Transvaal, S. Africa. The cattle of the Republic of South Africa are certified free from B.S.E." |
The document mentions "See in Addenda , Chart 1, Comparison Chart, under Substantial Equivalence and Breaking Strength under Supporting Data" and "Pyrogenicity under Supporting Data." This suggests that specific data on breaking strength and pyrogenicity would be provided in the full addenda to demonstrate these "other performance features." However, these specific numerical results are not included in the excerpt provided.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the excerpt. A 510(k) submission typically relies on existing predicate device data, preclinical bench testing, and sometimes animal studies for substantial equivalence. It does not ordinarily involve a prospective clinical study with a "test set" in the sense of a pivotal trial for a novel device. The "Supporting Data" mentioned for breaking strength and pyrogenicity would likely be from bench tests or animal studies, but the sample sizes, methodology, and provenance are not detailed here.
The source of the bovine pericardium (raw material) is from "government approved abbatoirs in Transvaal, S. Africa," and is certified BSE-free. This refers to the source of the biological material, not clinical data provenance.
3. 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)
This information is not applicable and therefore not provided in the excerpt. As this is a medical device (tissue patch) for surgical repair, the concept of "ground truth for a test set" established by experts, as seen in AI/diagnostic imaging studies, does not apply. Performance is assessed through material properties, biocompatibility, and manufacturing controls, compared to a predicate. Clinical outcomes, if gathered, would be observed through surgical use over time, not via expert interpretation of a "test set."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable and therefore not provided. The device's performance is not being evaluated through expert adjudication of cases, as would be common in diagnostic imaging or clinical trials.
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
There is no mention of an MRMC study. This type of study (comparative effectiveness of human readers with/without AI assistance) is specific to AI-powered diagnostic tools or imaging analysis and is not relevant to a biological tissue patch.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable and therefore not provided. The Glycar Pericardial Patch is a physical medical device (a tissue patch), not an algorithm or software. Therefore, there is no "standalone performance" of an algorithm without human involvement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the nature of the device (a tissue patch), the "ground truth" for demonstrating substantial equivalence primarily relies on:
- Material Characterization: Chemical composition (glutaraldehyde-treated bovine pericardium).
- Physical Property Testing: Bench testing for tissue strength (e.g., breaking strength).
- Biocompatibility Testing: Pyrogenicity tests.
- Sterility Assurance: Sterility Assurance Level (SAL) verification.
- Predicate Device History: The predicate device's long-standing safe use ("over ten years without reported material failure") serves as critical evidence supporting the safety and effectiveness of the material for the stated intended use.
- Manufacturing Process Controls: Adherence to established manufacturing and sterilization protocols.
There is no mention of "expert consensus," "pathology," or specific "outcomes data" from a new clinical study. The FDA's 510(k) approval also explicitly states: "Please be advised that you may not make any claims about the effectiveness of the anticalcification treatment or durability of the device in any labeling or advertisements for this device until results of human clinical studies are submitted and found to substantiate such claims." This indicates that post-market (or future PMAs) studies would be needed for such specific effectiveness claims, but not for the initial 510(k) clearance based on substantial equivalence.
8. The sample size for the training set
This is not applicable as the Glycar Pericardial Patch is a physical medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
This is not applicable as there is no training set for this type of device.
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