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K Number
K070685
Device Name
KENDALL ANTIMICROBIAL DRAIN DRESSING FOR OTC USE, MODEL 6662
Manufacturer
TYCO HEALTHCARE
Date Cleared
2007-09-14

(186 days)

Product Code
FRO
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K011941
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

The Kendall Antimicrobial Drain Dressing is intended for OTC use. It is used as a primary dressing around drains, IV sites, and tracheotomies.

Device Description

The Kendall Antimicrobial Drain Dressing for OTC use is a sterile, single use wound dressing consisting of a rayon/polyester nonwoven material treated with polyhexamethylene biguanide hydrochloride (0.2%), and is available in sponge form.

AI/ML Overview

I am sorry, but without a dedicated study section detailing acceptance criteria and performance results, I cannot fulfill your request for a table of acceptance criteria and reported device performance.

The provided text {0}-{4} is a 510(k) summary for a medical device (Kendall Antimicrobial Drain Dressing). It focuses on demonstrating substantial equivalence to a predicate device for OTC marketing, not on establishing specific performance criteria for the new device.

Here's what I can extract based on the provided text, and why I cannot complete most of your request:

  • No specific acceptance criteria or quantitative performance measures are mentioned for the Kendall Antimicrobial Drain Dressing itself. The document primarily asserts "substantial equivalence" to a predicate device.
  • No new study is described to "prove the device meets acceptance criteria." Instead, it references prior biocompatibility testing of the predicate device and states the current device "is identical to the predicate device with the exception of OTC labeling."

Therefore, I cannot provide:

  1. A table of acceptance criteria and reported device performance. No such criteria or performance data for this specific device are presented.
  2. Sample size used for the test set and data provenance. No new test set or study for this device's performance is detailed.
  3. Number of experts used, qualifications, or adjudication method for ground truth for a test set. Not applicable, as no new performance study is described.
  4. MRMC comparative effectiveness study or human reader improvement. This type of study is not relevant to a drain dressing and is not mentioned.
  5. Standalone (algorithm only) performance. The device is a physical dressing, not an algorithm.
  6. Type of ground truth used. Not applicable, as no new performance study is described.
  7. Sample size for the training set. Not applicable, as no training set for an algorithm is involved.
  8. How ground truth for the training set was established. Not applicable.

The closest information provided related to testing is in section 7:

  • "Biocompatibility testing of the predicate Kendall Excilon AMD Antimicrobial Drain Sponge, (predicate device), has demonstrated that it meets the requirements of guidelines presented in the 10993 ISO Standard, Part 1, with the FDA modified matrix presented in memorandum G95-1."
    • This indicates that the predicate device met certain biocompatibility standards.
    • It does not provide specific acceptance criteria values or detailed performance results for this new device.

N/A