(60 days)
O2S OxyBand™ Wound Dressings assist in managing wound healing. O2S OxyBand™ Wound Dressings can be used to protect light to moderate wounds including skin tears, scrapes, minor pressure sores, abrasions, blisters, lacerations, and minor burns, chafed or irritated skin.
OxyBand™ Wound Dressings are intended to provide a moist, oxygen rich environment to facilitate the normal wound healing process. OxyBand™ Wound Dressings can be used to cover and protect wounds and cather sites, or used as a secondary dressing for other wound products such as gauze, alginates, hydrogels, debritement facilitators, or a protective cover over at risk skin. Common applications include: clean dosed surgical incisions, sin graft donor sites, Slage I or II pressure ulcers, pressure sores, superficial wounds such as abrasigns, skirtes, and blisters, lacerations, first and second degree burns, chafed skin, skin continuously exposed to moisture, secondary dressing over gauze, alginates or hydrogels.
The OxyBand™ Wound Dressing is made up of a thin polyurethane film commonly used in other wound dressings, with adhesive that seals around the wound at the perimeter of the dressing. An occlusive oxygen barrier film is sealed over the polyurethane film to hold a layer of oxygen over the high oxygen permeability polyurethan
The provided 510(k) summary for the O2S, LLC OxyBand™ Wound Dressing (K121407) does not contain the information requested in the prompt regarding acceptance criteria, device performance studies, sample sizes, expert involvement, or ground truth establishment.
Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K04063) based on device description and intended use. The core of the submission is that the O2S OxyBand™ Wound Dressing is the "exact same device" as the previously approved one, but manufactured and sold by a new entity (O2S, LLC) for governmental customers.
Therefore, I cannot populate the table or answer the specific questions about device performance studies, as this information is not present in the provided text.
The document states: "This device is the exact same device previously approved for our partner OxyBand Technologies, Inc. This device has previously been cleared for marketing under the OxyBand Technologies, Inc. 510(k), number K04063." This indicates that the regulatory pathway relies on the prior clearance of the predicate device, rather than new performance studies for this specific submission.
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