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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.

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