FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING

• K Number: K984539
• Device Name: FERRIS POLYMEM CALCIUM ALGINATE STERILE WOUND DRESSING
• Manufacturer: FERRIS MFG. CORP.
• Date Cleared: 1999-03-01 ( 70 days)
• Product Code: KMF
• Regulation Number: 880.5090
• Type: Traditional
• Panel: SU
• Reference & Predicate Devices: N/A

Intended Use

For the management of
Leg ulcers
Venous ulcers
Diabetic ulcers
Arterial ulcers
Abrasions
Second degree burns
Full and partial thickness pressure ulcers
Dehisced incisions

Device Description

Ferris PolyMem Calcium Alginate Dressing

AI/ML Overview

The provided document is a 510(k) clearance letter from the FDA for the Ferris PolyMem Calcium Alginate Dressing. It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or ground truth establishment.

Therefore, I cannot answer your request based on the provided text. The document is a regulatory approval, not a technical report detailing study results.

Regulation Number and Section

§ 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.