ACRYDERM GEL WOUND DRESSING

K970693 · Acrymed, Inc. · MGQ · Mar 21, 1997 · SU

Device Facts

• Record ID: K970693
• Device Name: ACRYDERM GEL WOUND DRESSING
• Applicant: Acrymed, Inc.
• Product Code: MGQ · SU
• Decision Date: Mar 21, 1997
• Decision: SN
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Indications for Use

AcryDerm Gel is an external wound dressing that is designed as a moisture donating substrate for use in promoting natural autolytic debridement by rehydrating necrotic tissues. AcryDerm Gel is indicated for use as an external wound dressing in the management of chronic wounds such as pressure sores, diabetic ulcers, radiation dermatitis, peristomal skin irritations, and stasis ulcers, and acute wounds such as surgical wounds, lacerations, donor site, first and second degree burns, and abrasions. AcryDerm Gel may be used on infected wounds under medical supervision. AcryDerm Gel is not intended as a long duration dressing for the treatment of third degree burns.

Device Story

AcryDerm Gel is an amorphous hydrogel wound dressing; supplied in squeeze tubes (0.5, 1, 3 oz); sterile (gamma radiation). Applied topically by clinician or patient to wound site; provides moisture-donating substrate to rehydrate necrotic tissue; promotes natural autolytic debridement. Used in clinical or home settings for chronic/acute wound management. Benefits include maintenance of moist wound environment to facilitate healing.

Clinical Evidence

Bench testing only. Laboratory tests confirmed moisture release to absorbent substrates. Biocompatibility established per ISO 10993-1.

Technological Characteristics

Amorphous hydrogel composed of modified synthetic polyacrylate polymer, glycerol, carboxymethyl cellulose, ionic buffering salts, polysaccharide, preservatives, and water. Supplied in squeeze tubes; sterilized via gamma radiation. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for management of chronic wounds (pressure sores, diabetic ulcers, radiation dermatitis, peristomal skin irritations, stasis ulcers) and acute wounds (surgical wounds, lacerations, donor sites, 1st/2nd degree burns, abrasions). May be used on infected wounds under medical supervision. Contraindicated for long-duration treatment of 3rd degree burns.

Predicate Devices

• AcryDerm Advanced Wound Dressing (AcryMed, Inc.)
• IntraSite Gel (Smith & Nephew Medical Ltd.)
• Carrasyn Hydrogel Wound Dressing (Carrington Laboratories, Inc.)

Submission Summary (Full Text)

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K970693
MAR 21 1997

# Summary of Safety and Effectiveness

Contact Person: Dr. Bruce L. Gibbins, President & CEO

Date of preparation: February 15, 1997

Device Name (proprietary): AcryDerm Gel Wound Dressing

Common Name: Moist wound dressing

Classification Name: Hydrogel wound dressing

Classification: Unclassified; as recommended by the General and Plastic Surgery Devices Panel 79

Legally marketed device(s) for substantial equivalence comparison:

- AcryDerm Advanced Wound Dressing, (AcryMed, Inc.)
- IntraSite Gel, (Smith & Nephew Medical Ltd.)
- Carrasyn Hydrogel Wound Dressing, (Carrington Laboratories, Inc.)

Description of Device: AcryDerm Gel Wound Dressing is a clear amorphous hydrogel moist wound dressing for external use. AcryDerm Gel will be supplied in the following sizes: 1/2-oz squeeze tube; 1-oz squeeze tube; and 3-oz squeeze tube. AcryDerm Gel will be supplied sterile (gamma radiation), in individual primary squeeze tubes packaged with Instructions for Use into an intermediate labeled box and distributed in various case sizes. Biocompatibility has been established according to Part-1 of the ISO standard (Biological Evaluation of Medical Devices).

Intended Use of the Device: AcryDerm Gel is an external wound dressing that is designed as a moisture donating substrate for use in promoting natural autolytic debridement by rehydrating necrotic tissues. AcryDerm Gel is indicated for use as an external wound dressing in the management of chronic wounds such as pressure sores, diabetic ulcers, radiation dermatitis, peristomal skin irritations, and stasis ulcers, and acute wounds such as surgical wounds, lacerations, donor site, first and second degree burns, and abrasions. AcryDerm Gel may be used on infected wounds under medical supervision. AcryDerm Gel is not intended as a long duration dressing for the treatment of third degree burns.

Technological Characteristics: AcryDerm Gel is composed of a modified synthetic polyacrylate polymer, glycerol, carboxymethyl cellulose ionic buffering salts, polysaccharide, preservatives and water. It is an amorphous gel that carries the same general classification name, "Hydrogel", as do AcryDerm Advanced Wound Dressing, Intrasite Gel and Carrasyn Hydrogel Wound Dressing. The classification, intended uses, composition, and methods of manufacturing of AcryDerm Gel wound Dressing are substantially equivalent to the predicate devices.

Performance Characteristics: AcryDerm Gel is an amorphous gel that is designed to provide intimate contact with the wound or irritated tissues and to donate moisture to tissues surrounding the application site. Laboratory tests have shown that AcryDerm Gel releases moisture to absorbent substrates.

Manufacturing: AcryDerm Gel will be manufactured according to the product specifications and under good manufacturing practices that ensure the device is safe and effective for its intended use.

AcryDerm Gel Pre-market Notification 510(k)
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