CONVATEC ODOR CONTROL WOUND DRESSING

• K Number: K972530
• Device Name: CONVATEC ODOR CONTROL WOUND DRESSING
• Manufacturer: CONVATEC, A DIVISION OF E.R. SQUIBB & SONS
• Date Cleared: 1997-10-01 ( 86 days)
• Product Code: KMF
• Regulation Number: 880.5090
• Type: Traditional
• Panel: General & Plastic Surgery
• Reference & Predicate Devices: N/A
• Predicate For: N/A

Intended Use

ConvaTec Odor Control Wound Dressing is indicated for the management of malodorous acute and chronic wounds such as pressure ulcers, leg ulcers, and diabetic ulcers. It may be used as a primary dressing for superficial wounds or with deeper wounds as a secondary dressing.

Device Description

ConvaTec Odor Control Wound Dressing is a sterile, non-adhesive dressing with an absorbent wound contact laver, a water-resistant film layer, an activated charcoal central pad, a non-woven absorbent pad layer and a smooth water- resistant outer film layer.

AI/ML Overview

This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) premarket notification for a wound dressing, demonstrating substantial equivalence to a predicate device. It includes:

• Device Description: ConvaTec Odor Control Wound Dressing, a sterile, non-adhesive dressing with multiple layers and an activated charcoal pad.
• Intended Use: Management of malodorous acute and chronic wounds (pressure ulcers, diabetic ulcers), as a primary or secondary dressing.
• Contraindications: Individuals with known sensitivity to the dressing or its components.
• Substantial Equivalence Claim: To Hollister Odor-Absorbent Dressing, based on similar intended uses, characteristics, construction, and central carbon layer.
• Bench Testing: Comparative bench testing was conducted on both devices.
• Biocompatibility Testing: ConvaTec Odor Control Wound Dressing was subjected to ISO 10993 Part I demonstrating it is nonsensitizing, non-toxic, non-hemolytic, and a negligible irritant.
• FDA Response: The FDA reviewed the 510(k) and determined the device is substantially equivalent, allowing it to be marketed subject to general controls and specific labeling limitations (not for third-degree burns, no claims of accelerating healing, not a long-term/permanent dressing, not a treatment/cure).

There is no mention of specific acceptance criteria or performance metrics, nor a study designed to demonstrate the device meets such criteria. The "study" mentioned is "Comparative bench testing" and "biocompatibility testing," which are used to establish substantial equivalence and safety, not to meet pre-defined performance acceptance criteria.

Regulation Number and Section

§ 880.5090 Liquid bandage.

(a)
Identification. A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.