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K Number
K022670
Device Name
CARRAKLENZ AND ULTRAKLENZ
Manufacturer
CARRINGTON LABORATORIES, INC.
Date Cleared
2002-10-17

(66 days)

Product Code
FRO
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K965120,K954743,K945802
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Carrington Wound Cleansers are surfactant wound cleansers intended for the removal of foreign material such as dirt and debris from dermal wounds. CarraKlenz is a wound cleanser that is indicated for high, medium, and low exudating wounds. UltraKlenz is a gentle wound cleanser which is used on intact skin.

Device Description

The Carrington CarraKlenz Wound Cleansers are wound cleaning solutions that are intended for the cleansing and irrigation of dermal wounds. The Carrington Wound Cleansers work by mechanical action on the dermal wounds. The pressure of the liquid flowing onto the wound aids in the removal of the debris from the wound. The Carrington Wound Cleansers are offered in various bottle sizes.

AI/ML Overview

The provided 510(k) summary (K022670) for Carrington Laboratories CarraKlenz and UltraKlenz Wound Cleansers does not contain any information regarding clinical studies, acceptance criteria, or performance data for the device.

This submission is a premarket notification (510(k)), which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing extensive clinical trial data or performance metrics against defined acceptance criteria. The core of this 510(k) is to assert that the CarraKlenz and UltraKlenz wound cleansers are "substantially equivalent" to existing, cleared predicate devices (Aliclenz Wound Cleanser K965120 and Derma Sciences Dermagran Wound Cleanser with Zinc K954743 and K945802).

Therefore, based solely on the provided document, I cannot fulfill your request for:

  1. A table of acceptance criteria and the reported device performance: This information is not present. The submission focuses on substantial equivalence in terms of intended use, technological characteristics, and mechanism of action, not on specific performance metrics or acceptance criteria derived from a study.
  2. Sample size used for the test set and the data provenance: No test set is described.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No ground truth establishment is described.
  4. Adjudication method for the test set: No test set is described.
  5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is a wound cleanser, not an AI-assisted diagnostic device, and no MRMC study is mentioned.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical wound cleanser.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): No ground truth is described.
  8. The sample size for the training set: No training set is described.
  9. How the ground truth for the training set was established: No training set or ground truth is described.

In summary, the 510(k) provided focuses on substantial equivalence claims rather than presenting primary clinical or performance study data against specific acceptance criteria. Such detailed performance data and study methodologies are typically required for different types of regulatory submissions or for devices with higher risk classifications or novel technology.

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