(89 days)
For use in the management of leg ulcers and pressure sores. The gel provides a moist wound healing environment which encourages natural autolytic debridement.
Comfeel® Purilon Gel is an absorbent hydrogel wound dressing composed of calcium alginate, sodium carboxymethylcellulose and purified water. The product is supplied sterile in 15 g and 25 g plastic bellow tubes.
The provided documents describe a 510(k) premarket notification for a wound dressing, Comfeel® Purilon Gel. This document does not describe a study involving an algorithm or artificial intelligence, nor does it present acceptance criteria or performance data for such a device.
The 510(k) submission establishes substantial equivalence to a predicate device (IntraSite Gel) based on similarity in composition, intended use, and biocompatibility testing. The criteria for acceptance in a 510(k) often revolve around demonstrating this substantial equivalence, rather than specific performance metrics against pre-defined acceptance criteria with statistical rigor as would be expected for a novel AI/algorithm-driven device.
Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert-established ground truth, adjudication, MRMC studies, standalone performance), and training set information is not present in the provided text. The document is for a traditional medical device (wound gel), not an AI device.
§ 878.4022 Hydrogel wound dressing and burn dressing.
(a)
Identification. A hydrogel wound dressing is a sterile or non-sterile device intended to cover a wound, to absorb wound exudate, to control bleeding or fluid loss, and to protect against abrasion, friction, desiccation, and contamination. It consists of a nonresorbable matrix made of hydrophilic polymers or other material in combination with water (at least 50 percent) and capable of absorbing exudate. This classification does not include a hydrogel wound dressing that contains added drugs such as antimicrobial agents, added biologics such as growth factors, or is composed of materials derived from animal sources.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in part 807, subpart E of this chapter subject to the limitations in § 878.9.