(372 days)
Under the supervision of a health care professional, CoFlex -X AFD® and the CoFlex -X AFD® Pad contact wound dressings are indicated for use in light to heavy exuding partial and full thickness wounds, including decubitus and diabetic ulcers, 1st and 2nd degree burns, and donor sites. These dressings may also be used over debrided and partial thickness wounds.
For over the-counter use, PowerFlex NL - X AFD® and CoFlex - X AFD® First Aid contact wound dressings are indicated for first aid management of minor abrasions, cuts, scrapes, scalds and burns.
The Andover Healthcare, Inc. X AFD Dressings are offered in four configurations for both over the counter use or prescription use. The dressings are described below:
CoFlex - X AFD® foam dressings are comprised of three layers: a polyurethane foam pad containing X-STATIC® metallic silver coated nylon fibers (1.5% by weight, as a preservative) evenly dispersed throughout, a waterproof and moisture vapor permeable polyurethane film layer and a latex-free cohesive elastic bandage wrap which is used to rapidly facilitate the placement and wrapping of the dressing over the wound. They are absorbent, sterile (EtO), flat, flexible and non-adherent. CoFlex - X AFD® dressings are designed to intimately contact the wound as a primary barrier dressing. This barrier, in combination with the X-STATIC® silver (1.5%), as determined by barrier strike through testing, prevents the penetration of microbes through the outer surface and into the dressing.
CoFlex - X AFD® First Aid foam dressings are comprised of three layers: a polyurethane foam pad containing X-STATIC® metallic silver coated nylon fibers (1.5% by weight, as a preservative) evenly dispersed throughout, a waterproof and moisture vapor permeable polyurethane film layer and a latex-free cohesive elastic bandage wrap which is used to rapidly facilitate the placement and wrapping of the dressing over the wound. They are absorbent, sterile (EtO), flat, flexible and nonadherent. CoFlex - X AFD® First Aid dressings are designed to intimately contact the wound as a primary dressing.
CoFlex - X AFD® Pad foam dressings are comprised of three layers: a polyurethane foam pad containing X-STATIC® metallic silver coated nylon fibers (1.5% by weight, as a preservative) evenly dispersed throughout, a waterproof and moisture vapor permeable polyurethane film layer and a latex-free cohesive elastic backing which will readily adhere to a latex-free cohesive elastic bandage wrap, rapidly facilitating the placement and wrapping of the dressing over the wound. They are absorbent, sterile (EtO), flat, flexible and non-adherent. CoFlex - X AFD® Pad dressings are designed to intimately contact the wound as a primary barrier dressing. This barrier, in combination with the X-STATIC® silver (1.5%), as determined by barrier strike through testing, prevents the penetration of microbes through the outer surface and into the dressing.
PowerFlex NL - X AFD® foam dressings are comprised of three layers: a polyurethane foam pad containing X-STATIC® metallic silver coated nylon fibers (1.5% by weight, as a preservative) evenly dispersed throughout, a waterproof and moisture vapor permeable polyurethane film layer and a latex-free cohesive elastic bandage wrap which is used to rapidly facilitate the placement and wrapping of the dressing over the wound. They are absorbent, sterile (EtO), flat, flexible and nonadherent. PowerFlex NL - X AFD® dressings are designed to intimately contact the wound as a primary dressing.
This document describes a 510(k) premarket notification for wound dressings and does not involve AI/ML. Therefore, many of the requested categories are not applicable.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Safe for intended use (non-cytotoxic, non-sensitizing, non-irritating) | "All tests were performed in accordance with Part-10993 of the International Standard Organization (ISO) Standard (Biological Evaluation of Medical Devices) by North American Science Associates Inc. (NAMSA). The studies indicate that Andover Healthcare, Inc. X AFD Dressings are safe for their intended use." |
| Microbial Barrier | Prevents penetration of microbes through the outer surface and into the dressing | "Barrier strike through testing was performed demonstrating that the Andover Healthcare, Inc. X AFD Dressings prevent the penetration of microbes through the outer surface and into the dressing." |
| Substantial Equivalence | Demonstrates equivalence in design, function, intended use, and silver content to predicate devices | Detailed comparison to predicate devices for intended use (OTC, Rx), design, and 1.5% silver content in the foam pad. |
2. Sample size used for the test set and the data provenance
The document does not specify a quantitative sample size for the biocompatibility or barrier strike through testing. These are typically material property tests, not clinical studies with human participants.
- Data Provenance: The biocompatibility tests were conducted by North American Science Associates Inc. (NAMSA), an independent testing facility. The document does not specify the country of origin for the data (e.g., if it was in vitro or in vivo with animal models from a particular region). The study type is not explicitly stated as retrospective or prospective in detail, but standard biocompatibility testing often involves a series of in vitro and in vivo (animal) studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not a study requiring expert-established ground truth in the context of medical image analysis or similar diagnostic device studies. The performance is based on standardized laboratory tests and a comparison of material properties and intended use.
4. Adjudication method for the test set
Not applicable. There was no clinical study described that would require an adjudication method by 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 device is a wound dressing, not an AI/ML diagnostic or assistive tool for human readers.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a wound dressing, not an AI/ML algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the performance testing:
- Biocompatibility: Ground truth is established by passing predefined standards (ISO 10993) for cytotoxicity, sensitization, and irritation.
- Microbial Barrier: Ground truth is established by demonstration of prevention of microbial penetration via "barrier strike through testing," which implies a laboratory standard.
- Substantial Equivalence: Ground truth is established by direct comparison of characteristics (design, material composition, intended use) to legally marketed predicate devices.
8. The sample size for the training set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/ML device that requires a training set.
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