CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE STRIPS,CARRASORB M FDG

K962218 · Carrington Laboratories, Inc. · MGQ · Sep 12, 1996 · SU

Device Facts

• Record ID: K962218
• Device Name: CARRASYN HYDROGEL WOUND DRESSING,CARRAGAUZE PADS,CARRAGAUZE STRIPS,CARRASORB M FDG
• Applicant: Carrington Laboratories, Inc.
• Product Code: MGQ · SU
• Decision Date: Sep 12, 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) used for wound management; applied topically to wound site; requires secondary cover dressing. Used in clinical settings for patients with radiation dermatitis or diabetic ulcers. Provides moist wound healing environment. Safety established via biocompatibility testing (dermal/eye irritation).

Clinical Evidence

Clinical experience included two studies: 4 patients with radiation dermatitis and 30 patients with Grade III/IV diabetic foot ulcers. Treatment duration for ulcers was 10 weeks. Endpoints included patient/clinician acceptability, wound/skin appearance, and wound healing environment. Results indicated safety and effectiveness.

Technological Characteristics

Hydrogel-based wound dressings; supplied as smooth, nonoily clear gels or freeze-dried preparations. Topical application. Biocompatibility confirmed via GLP-compliant animal models (Primary Dermal/Eye Irritation).

Indications for Use

Indicated for the management of wounds, including radiation dermatitis and diabetic ulcers (Grades III or IV).

Predicate Devices

• Carrasyn® Hydrogel Wound Dressing (K902345)
• CarraGauze® pads (K915001)
• CarraGauze® strips (K925002)
• CarraSorb M™ Freeze-Dried Gel (K944427)

Submission Summary (Full Text)

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CARRINGTON

K962218

SEP 12 1996

# Device Name:

Classification Name: Dressings, wound and burns, hydrogel

Common Name: Hydrogel Wound Dressings

Proprietary Names: Carrasyn® Hydrogel Wound Dressing
CarraGauze® Pads
CarraGauze® Strips
CarraSorb M™ Freeze-Dried Gel

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® trips (K925002) and CarraSorb M™ Freeze-Dried Gel (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).

| Corporate Office & Manufacturing: | Research & Development: | Distribution Center & Accounting: | Costa Rica |
| --- | --- | --- | --- |
| 2001 Walnut Hill Lane | 1300 E. Rochelle Boulevard | 1909 Hereford Drive | Suite SJO-2632 - Unit C-101 |
| Irving, Texas 75038 | Irving, Texas 75062 | Irving, Texas 75038 | 1601 N.W. 97th Avenue |
| [phone] | [phone] | [phone] | Miami, Florida 33102-5216 |
| [phone] Fax | [phone] Fax | [phone] Fax | 011-506-666-0100 |

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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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