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K Number
K984597
Device Name
MODIFICATION OF CUTINOVA CAVITY DRESSING
Manufacturer
BEIERSDORF-JOBT, INC.
Date Cleared
1999-03-01

(63 days)

Product Code
FRO
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K952526
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Cutinova cavity is indicated for the management of deep secondary healing wounds such as: Cavity wounds Stage III and IV pressure ulcers Deep leg ulcers Excisions Post-op wound dehiscence

Device Description

Cutinova cavity is a polyurethane dressing that is indicated for the management of deep secondary healing wounds. The current modification involves a change in the material used to make the urethane from an aromatic disocyanate to an aliphatic diisocyanate and does not affect the indications for use.

AI/ML Overview

The provided text describes a 510(k) submission for a modification to a wound dressing, Cutinova cavity, and the FDA's response. It does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML medical device.

The document is a regulatory filing for a medical device (wound dressing), not an AI/ML algorithm. Therefore, the questions related to AI/ML device performance, such as sample sizes for test/training sets, ground truth establishment, expert adjudication, MRMC studies, and standalone performance, are not applicable to this submission.

The "Summary of Safety and Effectiveness" (K984597) states:

  • Modification: Change in the material used to make the urethane from an aromatic diisocyanate to an aliphatic diisocyanate, and the addition of a very small amount of α Tocopherol to improve thermal stability. The indications for use remain unchanged.
  • Study/Testing: "Biological tests were done in accordance with ISO 10993 and showed no negative effects for the modified Cutinova cavity. Performance characteristics were also comparable to the currently marketed product."

Based on this, the "acceptance criteria" appear to be:

  1. Biocompatibility: No negative effects as per ISO 10993.
  2. Performance: Comparable to the previously cleared Cutinova cavity.

However, specific quantitative acceptance criteria (e.g., "tensile strength must be >X MPa") and detailed results of "comparable performance characteristics" are not provided in this summary. The document focuses on establishing substantial equivalence to a predicate device for regulatory approval, rather than a detailed performance study with explicit acceptance criteria for an AI/ML algorithm.

N/A