(25 days)
The NovoSorb™ BTM Wound Dressing is indicated for use in the management of wounds including: partial and full thickness wounds, pressure ulcers, diabetic ulcers, chronic and vascular ulcers, surgical wounds (donor sites/grafts, post-Moh's surgery, post-laser surgery, podiatric, wound dehiscence), trauma wounds (abrasions, second-degree burns, and skin tears) and draining wounds. The device is for single use only.
The NovoSorb™ BTM Wound Dressing device is a 2mm thick, porous, white biodegradable polyurethane foam bonded with a polyurethane adhesive layer to a fenestrated one-sided transparent sealing membrane. The sealing membrane is designed to physiologically close the wound limiting evaporative water loss during integration of the foam. The adhesive layer and sealing membrane are to be removed and discarded when appropriate leaving only the foam layer to biodegrade in patients.
NovoSorb™ BTM Wound Dressing device is supplied in various sizes, ranging from 4cm² to 800cm². The NovoSorb™ BTM Wound Dressing is a single use, terminally sterilized device, individually packed in a transparent polymer pouch enclosed in a white aluminized pouch contained in a cardboard envelope.
This FDA 510(k) letter ([K172140](https://510k.innolitics.com/search/K172140)) is a notification of an administrative change in product code for the NovoSorb™ BTM Wound Dressing and explicitly states that the submission was not re-reviewed (referencing document {0} and {1}). The original substantial equivalence determination was made on August 11, 2017.
The 510(k) summary (documents {4} and {5}) states that no clinical tests were performed, and the determination of substantial equivalence was not based on an evaluation of clinical performance data. Therefore, the provided documents do not contain information related to acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies that would be typically associated with clinical studies for AI/ML devices.
The NovoSorb™ BTM Wound Dressing is described as a medical device for wound management, not an AI/ML device. The provided text refers to it as a "2mm thick, porous, white biodegradable polyurethane foam bonded with a polyurethane adhesive layer to a fenestrated one-sided transparent sealing membrane." (document {5}). The core of the 510(k) submission was a comparison to a predicate device (BTM Wound Dressing, [K142879](https://510k.innolitics.com/search/K142879)) based on technological characteristics and mechanical testing.
Thus, none of the requested information regarding acceptance criteria, study details, sample sizes, expert ground truth, or multi-reader studies can be extracted from the provided text for an AI/ML device, as this is a traditional medical device submission.
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