(91 days)
ColActive™ Collagen Wound Dressing is indicated for the management of full and partial thickness wounds including:
- Pressure ulcers
- Diabetic ulcers
- Ulcers caused by mixed vascular etiologies
- Venous ulcers
- Second degree burns
- Donor and graft sites
- Abrasions
- Dehisced surgical wounds
- Traumatic wounds healing by secondary intention
ColActive™ Collagen Wound Dressing is an advanced wound care dressing composed of collagen and sodium alginate provided in a sterile sheet or rope form. Collagen Wound Dressings are pliable, absorbent dressings that absorb moisture such as wound fluid forming a gel, thus maintaining a moist environment at the wound surface that aids in the formation of granulation tissue and epithelialization. The dressings can be cut to fit specific wounds and are able to be layered for the management of deep wounds.
The provided text is a 510(k) Notification for the ColActive™ Collagen Wound Dressing. This document is a premarket submission made to the FDA to demonstrate that the device to be marketed is at least as safe and effective, that is, substantially equivalent, to a legally marketed predicate device. This type of submission generally does not include clinical studies with acceptance criteria and detailed performance data in the same way a PMA (Premarket Approval) submission would.
In this context, the "study that proves the device meets the acceptance criteria" refers to the demonstration of "substantial equivalence" to a predicate device, as required for 510(k) clearance. The acceptance criteria are implicit in the FDA's requirements for substantial equivalence, which primarily revolve around demonstrating similar materials, intended use, and functioning compared to an already approved device, along with biocompatibility.
Here's an analysis based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance/Evidence from Submission |
|---|---|
| Biocompatibility (Safety): Device materials are safe for patient contact. | ColActive™ Collagen Wound Dressings have been demonstrated to be safe wound dressings. Safety tests were conducted in accordance with ISO 10993 Part 1 Biological Evaluation of Medical Devices. All test results demonstrated the dressings to be safe topical wound dressings in accordance with ISO 10993-1. |
| Substantial Equivalence in Materials, Intended Use, and Function: The device is as safe and effective as a legally marketed predicate device. | ColActive™ Collagen Wound Dressings are "substantially equivalent in materials of construction and intended use and identical in function" to FIBRACOL PLUS Collagen Wound Dressing with Alginate (Johnson & Johnson Medical) and SkinTemp Kollagen Wound Management Material (Biocore Medical Technologies). The Indications for Use are listed and align with typical wound care dressings. The description of the device (collagen and sodium alginate, pliable, absorbent, forms a gel, maintains moist environment) supports its functional equivalence. |
| Performance (related to intended use, e.g., absorbency, wound healing support): While not explicitly quantified with numerical targets, the device's functional description implies performance consistent with predicate devices. | The dressing "absorb moisture such as wound fluid forming a gel, thus maintaining a moist environment at the wound surface that aids in the formation of granulation tissue and epithelialization." This describes the expected mechanism of action and performance for a wound dressing of this type. |
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not contain information about a "test set" in the context of clinical performance data or a specific dataset used for evaluation related to efficacy or diagnostic accuracy. The "tests" mentioned are biocompatibility tests (ISO 10993).
- Sample Size for Biocompatibility: Not specified in the document. Biocompatibility testing typically involves in vitro and/or in vivo studies on materials, not human-patient "test sets" for performance evaluation in the same way clinical trials do.
- Data Provenance: Not applicable for clinical trial data. For biocompatibility, the tests were conducted according to ISO 10993-1, an international standard.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
This information is not applicable to this 510(k) submission. There is no mention of a "test set" requiring expert ground truth for performance evaluation (e.g., image interpretation, disease diagnosis). The submission focuses on substantial equivalence based on material composition, intended use, function, and biocompatibility.
4. Adjudication Method for the Test Set
This information is not applicable as there is no specific "test set" or clinical performance study described that would require an adjudication method.
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
This is not applicable. The device is a physical wound dressing, not an AI or diagnostic imaging device that would involve human readers or MRMC studies.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is a physical wound dressing and does not involve an algorithm.
7. The Type of Ground Truth Used
The ground truth used for this submission is based on:
- Predicate Device Characteristics: The established safety and effectiveness of the identified predicate devices (FIBRACOL PLUS Collagen Wound Dressing with Alginate and SkinTemp Kollagen Wound Management Material) served as the primary "ground truth" for substantial equivalence.
- Biocompatibility Standards: ISO 10993-1 outlines the scientific principles and methods for evaluating the biological safety of medical devices, which acts as a "ground truth" for material safety.
8. The Sample Size for the Training Set
This is not applicable. There is no "training set" in the context of machine learning or clinical trials described for this wound dressing.
9. How the Ground Truth for the Training Set Was Established
This is not applicable as there is no training set mentioned.
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