(50 days)
CoMatryx Collagen Wound Dressing may be used in the management of partial and full thickness wounds, pressure (stage I-IV) and venous ulcers, ulcers caused by mixed vascular etiologies, venous stasis and diabetic ulcers, 1st and 2nd degree burns, cuts, abrasions, and surgical wounds.
Collagen Wound Dressing, a native bovine Type I Collagen which, when applied to a wound surface, absorbs wound fluid and maintains a moist wound environment in the management of wound healing. The CoMatryx Collagen Wound Dressing is provided sterile in the following patient ready configurations:
- 10 gram Bottle
- 1 gram Vial
- 1 gram pouch
Acceptance Criteria and Device Performance Study for CoMatryx Collagen Wound Dressing
This document analyzes the acceptance criteria and the study performed to demonstrate the substantial equivalence of the CoMatryx Collagen Wound Dressing, as described in the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
The device's acceptance criteria are based on demonstrating substantial equivalence to the predicate device, CollaTek Powder (now Medifil II Particles). The performance data primarily relies on direct comparison of characteristics and functional testing against specified parameters.
| Parameter | Acceptance Criteria (Predicate Reference / Specific Value) | Reported Device Performance (CoMatryx Collagen Wound Dressing) | Test Methods (Standards) |
|---|---|---|---|
| Indications for Use | Same as predicate | Same as predicate | 510k Comparison |
| Product Code | KGN | KGN | 510K |
| Rx Status | Yes | Yes | 510K |
| Physical Shape | Powder | Powder | 510K |
| Color | White to off-white | White to off-white | Visual |
| Single Use | Single use only | Single use only | 510K |
| Package Sizes | 1 gram vial, 1 gram pouch, 10 grams bottle | 1 gram vial, 1 gram pouch, 10 grams bottle | 510K |
| Water Absorption Capacity | NLT 20 times its weight in USP Purified Water | NLT 20 times its weight in USP Purified Water | Strukmyer Procedure #HOMA-AFTP5R |
| Particle Size | Powder | Powder | Strukmyer Procedure #HOMA-AFTPRK |
| Product Type | Collagen | Collagen | 510K |
| Product Description | Type I Bovine Collagen | Type I Bovine Collagen | 510K |
| Animal Tissue | Dermis | Dermis | 510K |
| Sterile | Yes | Yes | 510K |
| Sterilization Method | E-Beam | E-Beam | 510K |
| Product Classification | Unclassified | Unclassified | FDA |
| Moisture Content | ≤ 17% | ≤ 17% | Strukmyer Procedure #HOMA-9YQRG8 |
| pH | ≥ 2.5 | ≥ 2.5 | Strukmyer Procedure #HOMA-9Z9HUM |
| InfraRed Spectroscopy Scan | Characteristic of Material, comparable to predicate | Characteristic of Material, comparable to predicate | Strukmyer Procedure #HOMA-A2CJEJ |
| SDS-PAGE Analysis | Characteristic of Material, comparable to predicate | Characteristic of Material, comparable to predicate | Alamo Labs, Inc. Report#3480-01 |
| Biocompatibility | Meets ISO 10993 standards (excluding cytotoxicity for in-vitro) | Initial cytotoxicity indicated effect, but wound healing study found no impairment. | Cytotoxicity, Sensitization Guinea Pig, Intracutaneous Irritation Test, Acute Systemic Toxicity, Wound Healing Study ( porcine model) |
2. Sample Size for the Test Set and Data Provenance
The document does not explicitly state a specific "test set" in the context of a dataset for an AI device. Instead, the "testing" involves a series of laboratory and animal studies to demonstrate the device's characteristics and safety.
- Sample Size for Biocompatibility Tests: The document does not specify the exact number of samples used for each in vitro biocompatibility test (Cytotoxicity, Sensitization Guinea Pig, Intracutaneous Irritation Test, Acute Systemic Toxicity).
- Sample Size for Physical/Chemical Characterization: The number of samples for each physical and chemical characteristic (e.g., Water Absorption Capacity, Moisture Content, pH, IR Spectroscopy, SDS-PAGE) is not explicitly stated. These are typically performed on a statistically relevant number of production lots.
- Sample Size for Wound Healing Study: The document refers to "a Wound Healing Study" conducted on "porcine wounds." However, the exact number of porcine subjects or wounds used in this study is not provided.
- Data Provenance: The studies appear to be prospective in nature, conducted specifically for the 510(k) submission. The location of the studies is not explicitly mentioned, but "Alamo Labs, Inc." is named for the SDS-PAGE analysis, suggesting a US-based laboratory.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This section is not applicable as the device is a wound dressing, not an AI/diagnostic device that requires expert-established ground truth for a test set. The "ground truth" for this type of device is established through laboratory test methods and animal studies demonstrating physical, chemical, and biological properties.
4. Adjudication Method
This section is not applicable as there is no mention of a human-read diagnostic test set requiring adjudication in this 510(k) submission.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
This section is not applicable. The device is a wound dressing, not a diagnostic AI system, so an MRMC comparative effectiveness study is not relevant to its regulatory approval.
6. Standalone (Algorithm Only) Performance Study
This section is not applicable. The device is a physical wound dressing and does not involve an algorithm or AI component.
7. Type of Ground Truth Used
The "ground truth" for the CoMatryx Collagen Wound Dressing is established through:
- Comparative Analysis: Direct comparison of the device's physical, chemical, and functional characteristics against a legally marketed predicate device (CollaTek Powder/Medifil II Particles).
- Laboratory Testing: Adherence to established scientific and regulatory standards for material characterization (e.g., IR Spectroscopy, SDS-PAGE, pH, moisture content, water absorption).
- Biocompatibility Testing: Adherence to ISO 10993 standards.
- Animal Outcomes Data: The "Wound Healing Study" on porcine wounds provides outcomes data for the cellular response to the dressing and its impact on the healing process, particularly in addressing initial in vitro cytotoxicity concerns.
8. Sample Size for the Training Set
This section is not applicable as the device is a physical wound dressing and does not involve a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
This section is not applicable for the same reason as point 8.
N/A