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K Number
K103713
Device Name
ELTA WOUND CLEANSER
Manufacturer
SWISS AMERICAN PRODUCTS, INC.
Date Cleared
2011-06-16

(177 days)

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

Elta Wound Cleanser is intended for the removal of foreign material, such as debris and dirt, from dermal wounds.

Device Description

Not Found

AI/ML Overview

The provided text is a letter from the FDA regarding a 510(k) premarket notification for the "Elta Wound Cleanser." It states that the device is substantially equivalent to legally marketed predicate devices. The document also includes the "Indications for Use" for the device.

However, the text does not contain any information about:

  • Acceptance criteria or reported device performance
  • Details of any study (sample size, data provenance, ground truth, expert qualifications, adjudication, MRMC, standalone performance, training set) that would prove the device meets acceptance criteria.

The letter is a regulatory approval document and not a scientific study report. Therefore, I cannot fulfill your request for the specific details of a study and acceptance criteria based solely on the provided text.

N/A