CARRASYN HYDROGEL WOUND DRESSING/FDG PADS/CARAGAUZE STRIPS/PADS (MODIFICATION)

K960428 · Carrington Laboratories, Inc. · MGQ · Mar 21, 1996 · SU

Device Facts

• Record ID: K960428
• Device Name: CARRASYN HYDROGEL WOUND DRESSING/FDG PADS/CARAGAUZE STRIPS/PADS (MODIFICATION)
• Applicant: Carrington Laboratories, Inc.
• Product Code: MGQ · SU
• Decision Date: Mar 21, 1996
• Decision: SN
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

Carrasyn™ wound dressings are either smooth, nonoily clear hydrogels or freeze-dried preparations of the same. They are supplied in either a liquid or dry state and are designed to be used in conjunction with an appropriate cover dressing and are intended for the management of wounds.

Device Story

Hydrogel wound dressings (liquid or freeze-dried) applied topically to wounds; used in conjunction with secondary cover dressing; intended for wound management; clinical use in treating diabetic ulcers and radiation dermatitis; provides moist wound healing environment; biocompatibility established via animal models (dermal/eye irritation).

Clinical Evidence

Clinical experience from two studies involving 34 patients (4 radiation dermatitis, 30 diabetic ulcers). Grades III/IV diabetic foot ulcers treated for 10 weeks. Evaluated patient/clinician acceptability, wound/skin appearance, and healing environment. Concluded safe and effective.

Technological Characteristics

Hydrogel-based wound dressings; supplied as smooth, nonoily clear gels or freeze-dried preparations; topical application; requires secondary cover dressing; biocompatibility tested per 21 CFR Part 58.

Indications for Use

Indicated for the management of wounds, including diabetic ulcers and radiation dermatitis.

Predicate Devices

• Carrasyn™ Hydrogel Wound Dressing (K902345)
• CarraGauze™ pads (K915001)
• CarraGauze™ strips (K925002)
• Carrasyn™ FDG pads (K944427)

Submission Summary (Full Text)

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MAR 21 1996 K960428

Device Name:

Classification Name: Dressings, wound and burns, hydrogel

Common Name: Hydrogel Wound Dressings

Proprietary Names: Carrasyn™ Hydrogel Wound Dressing
CarraGauze™ Pads
CarraGauze™ Strips
Carrasyn™ FDG Pads

Device Sponsor: Carrington Laboratories, Inc.
2001 Walnut Hill Lane
Irving, TX 75038-4404
Registration No: 162544

Regulatory Classification: Unclassified. (Product code MGQ)

Summary of Safety and Effectiveness:

This 510 (k) Premarket Notification provides for the standardization and clarification of previously cleared indications for the labeling of Carrasyn™ wound dressings. Carrasyn™ Hydrogel Wound Dressing was originally marketed pursuant to 510 (k) Number K902345. The additional wound dressings that are included in this labeling standardization and clarification include CarraGauze™ pads (K915001), CarraGauze™ strips (K925002) and Carrasyn™ FDG pads (K944427).

Carrasyn™ wound dressings are either smooth, nonoily clear hydrogels or freeze-dried preparations of the same. They are supplied in either a liquid or dry state and are designed to be used in conjunction with an appropriate cover dressing and are intended for the management of wounds.

Since the products are for topical use, the safety of these wound gels was established through standard biocompatibility tests. These biocompatibility tests were conducted in standard animal models with preparations of the Carrasyn™ wound dressings. These tests included Primary Dermal Irritation testing and Primary Eye Irritation testing. These studies demonstrated that Carrasyn™ wound dressings are not primary dermal irritants or primary eye irritants. These studies were conducted in conformance with Good Laboratory Practices (GLP) regulations of the United States Food and Drug Administration (21 CFR, Part 58).

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Clinical experience to date has been gained during the course of two studies that involved four patients with radiation dermatitis and 30 with diabetic ulcers. Grades III or IV diabetic ulcers of the foot were treated with Carrasyn™ Hydrogel Wound Dressing for 10 weeks. Acute and subacute radiation dermatitis was treated for various times with Carrasyn™ Hydrogel Wound Dressing. These studies evaluated the acceptability of Carrasyn™ Hydrogel Wound Dressing to both the patients and clinicians, to wound and skin appearance, and to the wound healing environment. These studies concluded that Carrasyn™ wound dressings are safe and effective for their intended use.

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