LogoFDA 510(k) Search
K Number
K973717
Device Name
COMBIDERM ACD
Manufacturer
CONVATEC, A BRISTOL-MYERS SQUIBB CO.
Date Cleared
1997-12-17

(79 days)

Product Code
FRO,MGP
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K962590
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

CombiDERM ACD is a moisture retentive dressing and is indicated for use on exuding chronic dermal ulcers including full-thickness wounds, such as pressure ulcers, leg ulcers and diabetic ulcers, and on acute wounds such as abrasions, lacerations, biopsies, and oven and closed surgical wounds. The dressing provides a moist wound environment that is supportive of the healing process.

Device Description

CombiDERM ACD is a moisture retentive dressing and is indicated for use on exuding chronic dermal ulcers, including full thickness wounds such as pressure ulcers and diabetic ulcers and for acute wounds, such as abrasions, lacerations, biopsies, and open and closed surgical wounds. CombiDERM ACD wicks exudate away from the wound and provides a moist wound environment that is supportive of the healing process. The moist environment aids autolytic debridement and allows non-traumatic removal of the dressing without damaging newly formed tissue.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for a medical device (CombiDERM™ ACD™ Absorbent Cover Dressing) to the FDA. It details the device's description, intended use, and comparison to a predicate device, as well as a subsequent FDA clearance letter. However, it does not contain the specific information required to answer your request about acceptance criteria and a study proving the device meets them.

The document discusses:

  • Device description and equivalence: CombiDERM ACD is a moisture-retentive dressing, substantially equivalent to SignaDRESS Hydrocolloid Dressing (K962590).
  • Indications for use: Exuding chronic dermal ulcers (pressure, leg, diabetic) and acute wounds (abrasions, lacerations, biopsies, surgical wounds).
  • Contraindications: Known sensitivity to the dressing or its components.
  • Biocompatibility tests: Demonstrated non-irritating, non-cytotoxic, non-hemolytic, weak allergenic potential (conducted per Good Laboratory Practices).
  • FDA clearance: K973717, cleared on December 17, 1997, with specific limitations on labeling claims.

The document does not include:

  1. A table of acceptance criteria and reported device performance: This would typically involve specific metrics (e.g., absorption rate, wear time, conformability) with defined pass/fail thresholds and actual test results.
  2. Details of a study proving the device meets acceptance criteria: While biocompatibility tests are mentioned, they are not presented as a "study" with a specific design, sample size, or detailed results against predefined acceptance criteria.
  3. Sample size used for a test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set sample size, or ground truth establishment for a training set. These are typically associated with performance studies, especially those involving AI or diagnostic accuracy, which are not relevant to this medical device submission.

Therefore, based on the provided text, I cannot provide the requested information. The document confirms biocompatibility and substantial equivalence but does not detail a study or specific acceptance criteria in the manner you've outlined.

N/A