(35 days)
For Over-the-Counter Use, PolyFIT™+ Absorbing Antimicrobial Dressings and PolyFIT™+ High Absorbing Antimicrobial Dressings may be used for minor abrasions, minor lacerations, minor cuts, minor scalds, and minor burns.
Under the supervision of a healthcare professional, PolyFIT™+ Absorbing Antimicrobial Dressings and PolyFIT™+ High Absorbing Antimicrobial Dressings may be used for the management of:
PolyFIT+ Absorbing Antimicrobial Dressings are intended as effective barriers to inhibit microbial proliferation within the dressing and reduce microbial penetration through the dressing. PolyFIT+ Absorbing Antimicrobial Dressings are for use as adjunctive treatment in the management of exudating wounds, partial and full-thickness wounds, such as pressure ulcers lower extremity ulcers (venous or arterial), diabetic foot ulcers, surgical or traumatic wounds (including those left open to heal by secondary intention). They are not intended for wounds with exposed tendon or bone, or for 30 degree burns.
PolyFIT+ Absorbing Antimicrobial Dressings are soft, sterile dressings designed for the management of exudating wounds and are intended as effective barriers to inhibit microbial proliferation within the dressing and reduce microbial penetration through the dressing. PolyFIT+ Absorbing Antimicrobial Dressings are made of synthetic, hvdrophilic, fibers embedded with a 0.3% concentration of Polyhexamethylene Biguanide (PHMB).
PolyRemedy employs an electrospinnng process to manufacture the ingredients: polyethylene oxide (PEO), polyethylene-co-vinyl-alcohol (EVOH), polycaprolactone (PCL) and PHMB into fibers, forming consistent and congruent dressings. Within the PolyFIT+ Absorbing Antimicrobial Dressings, the PEO gelling fibers are supported by the EVOH and PCL fibers for structural integrity. While absorbing wound exudate, the fibers transform from a dry dressing into a fiber gelling dressing that rapidly absorbs excess exudate away from the wound surface and retains it in the dressing. When exudate is absorbed into the PolyFIT+ Absorbing Antimicrobial Dressing, the PHMB embedded in the fibers ensures that when bacteria come in contact with the PHMB molecule the outer cell wall of the bacteria is disrupted, resulting in leakage of cytoplasm and cell death. As a consequence, bacterial numbers decrease, replication ceases and mutation cannot occur.
The acceptance criteria and study proving device efficacy are described as follows:
This submission is for PolyFIT™+ Absorbing Antimicrobial Dressings. This device is a wound dressing containing Polyhexamethylene Biguanide (PHMB) to inhibit microbial proliferation and reduce microbial penetration.
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Devices | PolyFIT+ Absorbing Antimicrobial Dressings are determined to be substantially equivalent in intended use, principle of operation, and technological characteristics to the legally marketed predicate devices: PolyFIT Absorbing Antimicrobial Wound Dressing (K092351), Kendall Kerlix AMD Antimicrobial Wound Dressing (K070653), and Convatec Aquacel Ag Hydrofiber Antimicrobial Dressings (K080383). |
| Safety and Effectiveness | All necessary verification and validation testing has been performed to assure substantial equivalence. |
| Physical and Technical Characteristics | PolyFIT+ Absorbing Antimicrobial Dressings have similar physical and technical characteristics to the predicate devices. |
| Indication for Use (OTC) | May be used for minor abrasions, minor lacerations, minor cuts, minor scalds, and minor burns. |
| Indication for Use (Healthcare Professional Supervision) | May be used for the management of exudating wounds, partial and full-thickness wounds, such as pressure ulcers, lower extremity ulcers (venous or arterial), diabetic foot ulcers, surgical or traumatic wounds (including those left open to heal by secondary intention). Intended as effective barriers to inhibit microbial proliferation within the dressing and reduce microbial penetration through the dressing. |
| Exclusions for Use | Not intended for wounds with exposed tendon or bone, for 3rd-degree burns (or 30-degree burns as written in one section), or for dry wounds. |
2. Sample size used for the test set and the data provenance:
The document states, "This submission does not rely on clinical data to determine substantial equivalency to the predicate devices." Therefore, there is no test set or associated data provenance from a clinical study for this specific submission. The determination of substantial equivalence is based on non-clinical performance data and comparison to predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
As no clinical data was submitted for this device to prove substantial equivalence, there is no information regarding experts used to establish ground truth for a test set.
4. Adjudication method for the test set:
Not applicable, as no clinical test set was used for this submission.
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-assisted diagnostic tool or imaging device that would typically involve MRMC studies or human reader improvement with AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a medical product (wound dressing), not a software algorithm.
7. The type of ground truth used:
The "ground truth" for the substantial equivalence determination for this medical device is the existing performance and regulatory clearance of the predicate devices. The new device's non-clinical performance data and technical characteristics are compared against these established benchmarks.
8. The sample size for the training set:
Not applicable. This submission is for a medical device (wound dressing), not an AI-based system that requires a "training set" in the context of machine learning.
9. How the ground truth for the training set was established:
Not applicable, as no training set was used.
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