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K Number
K970266
Device Name
KENDALL HYDROPHILIC POWDER WOUND DRESSING
Manufacturer
KENDALL HEALTHCARE PRODUCTS CO. DIV.OF TYCO HEALTH
Date Cleared
1997-04-23

(90 days)

Product Code
KGN
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K945000
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Like the predicate device, the Kendall Hydrophilic Powder Wound Dressing is indicated for the management of exudating wounds such as dermal ulcers (e.g., venous stasis, pressure, arterial, diabetic), surgical incisions, traumatic wounds (e.g., lacerations, abrasions).

Device Description

The proposed Kendall Hydrophilic Powder Wound Dressing is a sterile composition of maltodextrin, sodium alginate and chitosan chloride. As the powder absorbs wound exudate It converts to a gel. This gel forms a moist environment at the wound interface conducive to healing The product is available in 6 gram, 12 gram and 25 gram packets.

AI/ML Overview

The provided text is a 510(k) summary for the Kendall Hydrophilic Powder Wound Dressing and subsequent FDA correspondence. It focuses on establishing substantial equivalence to a predicate device, rather than presenting a study demonstrating the device meets specific performance acceptance criteria.

Therefore, the document does not contain the information requested for acceptance criteria and a study proving the device meets those criteria. The provided text primarily addresses:

  • Device identification and contact information.
  • Classification and legal marketing identification of a predicate device.
  • Device description and intended use.
  • Product comparison to the predicate device (similar materials, function, indications).
  • Nonclinical testing for biocompatibility.
  • FDA's substantial equivalence determination letter with labeling limitations.

Specifically, regarding the requested information:

  1. A table of acceptance criteria and the reported device performance: Not present. The submission focuses on equivalence, not performance against specific criteria.
  2. Sample size used for the test set and the data provenance: Not applicable, as no performance study is described. Biocompatibility testing is mentioned, but details on sample size or provenance are not provided.
  3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
  4. Adjudication method for the test set: Not applicable.
  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. This device is a wound dressing, not an AI-assisted diagnostic tool.
  6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
  7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable.
  8. The sample size for the training set: Not applicable.
  9. How the ground truth for the training set was established: Not applicable.

The "Nonclinical Testing" section mentions "Biocompatibility testing... based upon guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1." While this indicates testing was performed according to established standards, it does not specify performance acceptance criteria (e.g., cytotoxicity levels, irritation scores) or the specific results of these tests. It only states that the testing "demonstrated that it contains no bioactive components."

N/A