(82 days)
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- Venous stasis ulcers.
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- Pressure sores Stages 1, 2, 3, & 4.
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- Ulcers triggered by trauma.
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- Drainage dressing for tracheostomy and gastrostomy tubes.
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- Post operative incisions.
Bioderm Foam wound Dressing
The provided text is a 510(k) clearance letter from the FDA for a wound dressing, not a study report or a document detailing acceptance criteria and device performance. Therefore, I cannot extract the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, or multi-reader multi-case studies.
The document only states that the device, "Bioderm Foam Wound Dressing," is "substantially equivalent" to legally marketed predicate devices for the following indications for use:
- Venous stasis ulcers.
- Pressure sores Stages 1, 2, 3, & 4.
- Ulcers triggered by trauma.
- Drainage dressing for tracheostomy and gastrostomy tubes.
- Post operative incisions.
It also lists limitations on labeling claims, such as not being labeled for use on third-degree burns, or as having an accelerating effect on wound healing.
To provide the requested information, a different type of document, such as a clinical study report or a detailed summary of the premarket submission, would be necessary.
§ 880.5090 Liquid bandage.
(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.