(78 days)
Cytal® Wound Matrix is intended for the management of wounds including; partial and full-thickness wounds, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunnel/undermined wounds (donor sites/ grafts, post-Mohs surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, lacerations, second-degree burns, and skin tears), and draining wounds. The device is intended for one-time use.
Cytal" Wound Matrix is composed of porcine-derived extracellular matrix scaffolds, specifically known as urinary bladder matrix. The devices are supplied in single and multi-layer sheet configurations (1 to 8 layers) in sizes up to 10 cm x 15 cm, and can be provided with or without fenestrations in both Ivophilized and vacuum pressed configurations. The device is packaged in double peel-open pouches. The devices are terminally sterilized using electron beam irradiation. The device is intended for one time use.
The technical specifications for the Cytal" Wound Matrix are as follows, depending upon whether the device is fenestrated or unfenestrated:
- . If fenestrated: Device will be provided dry in sheet sizes up to 10 x 15 cm in double sterile barrier packaging. Device will be fenestrated appropriately according to size with parallel slits along the long axis.
- . If unfenestrated: Device will be provided dry in sheet sizes up to 10 x 15 cm in double sterile barrier packaging.
This document is a 510(k) Premarket Notification for the Cytal® Wound Matrix, a medical device. This type of FDA submission is for demonstrating substantial equivalence to a legally marketed predicate device, not for proving a device meets specific acceptance criteria through extensive clinical trials as one might see for novel technologies or pharmacuetical products. Therefore, the information provided focuses on comparative testing rather than detailed clinical performance against predefined metrics.
Here's a breakdown of the requested information based on the provided text, recognizing the nature of a 510(k) submission:
1. Table of Acceptance Criteria and Reported Device Performance
For a 510(k) submission, "acceptance criteria" are typically framed in terms of demonstrating substantial equivalence to a predicate device, often through mechanical, biocompatibility, and sometimes functional comparison, rather than specific clinical performance metrics. The reported "device performance" then describes how the device compares to the predicate or meets general safety standards.
| Acceptance Criteria Category | Acceptance Criteria (Implicit from 510(k)) | Reported Device Performance |
|---|---|---|
| Intended Use Equivalence | Intended use must be substantially similar to the predicate device. | Cytal® Wound Matrix has the "same intended use" as the predicate MatriStem® Wound Matrix (K112409) for the management of various wounds (partial/full-thickness, pressure ulcers, venous ulcers, diabetic ulcers, chronic vascular ulcers, tunnel/undermined wounds, surgical wounds, trauma wounds, draining wounds). |
| Technological Characteristics Equivalence | Technological characteristics must be substantially similar, or differences must not raise new questions of safety/efficacy. | Both Cytal® Wound Matrix and the predicate are comprised of animal tissue-derived, collagen extracellular matrix (ECM) scaffolds, supplied in rectangular sheet configurations, packaged, and terminally sterilized. |
| Dimensions: Subject device sizes (25 - 150 cm²) are consistent with the predicate (16 - 280 cm²). | ||
| Layers: Both consist of multilaminate sheets (1-8 layers). | ||
| Dehydration method (lyophilized vs. vacuum pressed) is noted as a "minor difference" that "does not raise different questions of safety or efficacy." | ||
| Biocompatibility | Must meet established biocompatibility requirements (e.g., ISO 10993-1). | The material underwent ISO-10993-1 testing: cytotoxicity, sensitization, irritation/intracutaneous reactivity, acute systemic toxicity, pyrogenicity, subacute and subchronic toxicity and implantation, genotoxicity, and LAL endotoxin. "Results... provided evidence that the Cytal Wound Matrix meets biocompatibility requirements of the ISO standard." |
| Mechanical Strength | Must provide adequate mechanical strength for its intended application. | Tested for suture retention strength. "Results... provided evidence that the Cytal™ Wound Matrix provides adequate mechanical strength for its application." |
| Sterilization | Must be terminally sterilized and maintain sterility. | Terminally sterilized using electron beam irradiation. Implied to be effective and comparable to predicate. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document describes material-level testing rather than human clinical test sets in the typical sense for performance evaluation in a 510(k).
- Sample Size for Test Set: Not explicitly stated for each test, but standard for material testing (e.g., n=3 or n=5 per batch for mechanical or biocompatibility tests). These are material samples, not patient samples.
- Data Provenance: The tests are likely performed by contracted labs based on industry standards (ISO), not specified by country or whether retrospective/prospective in a clinical context. These are laboratory-based tests.
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 is not applicable for this 510(k) submission. "Ground truth" in this context refers to laboratory and material science standards and the results of the specific tests (e.g., measuring suture retention strength, cell viability in cytotoxicity tests), not clinical expert consensus. The results are objective measurements from scientific testing.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. The tests performed are objective, quantitative measurements (e.g., chemical assays, physical strength tests), not subjective interpretations requiring adjudication among experts.
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 is a medical device for wound management, not an AI or imaging device involving human readers or interpretation.
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 or AI.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the tests described is based on:
- Standardized Test Methods: Adherence to established international standards (e.g., ISO-10993-1 for biocompatibility). The "truth" is whether the material successfully passes the criteria defined within those standards.
- Objective Measurements: Laboratory measurements of physical properties (e.g., suture retention strength) and biological responses (e.g., cytotoxicity levels).
There is no mention of pathology, expert consensus, or clinical outcomes data for defining "ground truth" in this 510(k) filing.
8. The sample size for the training set
Not applicable. This is a physical medical device undergoing material and biocompatibility testing, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable, as no training set is involved.
N/A