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K Number
K973807
Device Name
DUODERM HYDROACTIVE PASTE
Manufacturer
CONVATEC, A BRISTOL-MYERS SQUIBB CO.
Date Cleared
1997-12-23

(78 days)

Product Code
FRO,MGP
Regulation Number
N/A
Type
Traditional
Panel
SU
Reference & Predicate Devices
K881302
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

DuoDERM Hydroactive Paste is designed to be used with a secondary dressing such as DuoDERM Dressings for the local management of exudating dermal ulcers, including full thickness wounds, such as leg ulcers, pressure ulcers and diabetic ulcers.

Device Description

The concept of DuoDERM Hydroactive Paste is not significantly different from other commercially available absorbent dressings intended for use in the management of exudating wounds. DuoDERM Hydroactive Paste is indicated for use on exudating dermal ulcers, including full thickness wounds such as leg ulcers, pressure ulcers and diabetic ulcers. It is used in association with other DuoDERM® dressings.

AI/ML Overview

The provided documents pertain to a 510(k) Premarket Notification for DuoDERM® Hydroactive® Paste (K973807). This submission is for a medical device used for wound care, not an AI/ML-driven device. Therefore, the information requested regarding acceptance criteria, study details, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI/ML device is not applicable to this document.

The document discusses the substantial equivalence of the DuoDERM® Hydroactive® Paste to another commercially available device (SignaDRESS Hydrocolloid Dressing) based on intended use and dressing characteristics, rather than performance metrics from a specific study against acceptance criteria.

The key points from the document are:

  • Device: DuoDERM® Hydroactive® Paste.
  • Purpose of 510(k): To request clearance for claims specific to the moist wound healing environment created by the paste.
  • Indication for Use: Management of exudating dermal ulcers, including full thickness wounds such as leg ulcers, pressure ulcers, and diabetic ulcers, used in association with other DuoDERM® dressings.
  • Substantial Equivalence: To ConvaTec's SignaDRESS Hydrocolloid Dressing, based on equivalent intended use and dressing characteristics.
  • Safety Data: Supported by Premarket Notification K881302 and performed in accordance with Good Laboratory Practice Regulations.
  • Limitations (from FDA letter):
    • May not be labeled for use on third-degree burns.
    • May not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
    • May not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
    • May not be labeled as a treatment or a cure for any type of wound.

Since this is a submission for a traditional medical device (wound care paste) and not an AI/ML product, the questions posed about AI/ML specific study design, performance metrics, and data characteristics cannot be answered from the provided text.

N/A