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K Number
K092712
Device Name
SKIN BARRIER FILM
Manufacturer
LODESTAR PRODUCTS, INC.
Date Cleared
2010-02-23

(173 days)

Product Code
KMF
Regulation Number
880.5090
Type
Traditional
Panel
SU
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Skin Barrier Film is a liquid intended for use as a film-forming product. Upon application to intact or damaged skin, this product forms a long-lasting waterproof barrier, which acts as a protective interface between the skin and bodily wastes, fluids, adhesive products, and friction. It is intended as a primary barrier against irritation from body fluids.

Device Description

Skin Barrier Film is a liquid intended for use as a film-forming product.

AI/ML Overview

I am sorry, but the provided text from the FDA letter does not contain information about the acceptance criteria or a study proving that the device meets acceptance criteria. The document is a 510(k) clearance letter for a "Skin Barrier Film" (K092712), indicating that the device has been found substantially equivalent to a predicate device.

The letter explicitly states:
"We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..."

It then goes on to outline regulatory requirements and disclaimers, but it does not include:

  1. A table of acceptance criteria and reported device performance.
  2. Details about sample sizes, data provenance, or expert qualifications for a test study.
  3. Information about ground truth establishment, adjudication methods, or MRMC comparative effectiveness studies.
  4. Information about standalone algorithm performance or training set details.

Therefore, I cannot fulfill your request based on the provided text.

§ 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.