(52 days)
The DermaStream™ is an occlusive wound dressing which permits the introduction of topical wound treatments such as irrigating solutions, antimicrobial and enzymatic debriding solutions, suspensions, and other solutions. It is intended to provide a moist healing environment and allow debridement to facilitate the normal wound healing process.
The DermaStream™ is an occlusive wound dressing which permits the introduction of topical wound treatments. It is provided as a sterile, single-use, disposable device.
The provided text describes a 510(k) summary for a medical device (DermaStream™ occlusive wound dressing) but does not contain information about acceptance criteria or a study proving device performance against such criteria.
The document focuses on:
- Device Identification: Name, classification, manufacturer, contact.
- Predicate Devices: Identifying similar legally marketed devices (KCI Wound Cell Transparent Wound Dressing, 3M Tegaderm Transparent Dressing, KCI V.A.C. Instillamat).
- Device Description: An occlusive wound dressing permitting topical wound treatment introduction, sterile, single-use, disposable.
- Intended Use: To provide a moist healing environment and allow debridement to facilitate normal wound healing.
- Technological Characteristics Comparison: Stating it is substantially equivalent to predicate devices, being a combination of their features, with the primary difference being solution/drainage provision via gravity vs. vacuum.
- FDA Correspondence: Confirming the substantial equivalence determination.
Therefore, I cannot provide the requested table or elaborations on the study details because the necessary information is not present in the provided text. The document is essentially a regulatory submission summary, not a performance study report.
§ 878.4020 Occlusive wound dressing.
(a)
Identification. An occlusive wound dressing is a nonresorbable, sterile or non-sterile device intended to cover a wound, to provide or support a moist wound environment, and to allow the exchange of gases such as oxygen and water vapor through the device. It consists of a piece of synthetic polymeric material, such as polyurethane, with or without an adhesive backing. This classification does not include an occlusive 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.