ADVANCED CARE HYDROPHILIC WOUND DRESSINGS

K961662 · Mariner Biomedical, Inc. · KMF · Jun 13, 1996 · General Hospital

Device Facts

• Record ID: K961662
• Device Name: ADVANCED CARE HYDROPHILIC WOUND DRESSINGS
• Applicant: Mariner Biomedical, Inc.
• Product Code: KMF · General Hospital
• Decision Date: Jun 13, 1996
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The Mariner Biomedical, Inc. ADVANCED CARE™ Sterile Wound Dressing is intended for use in the local management of surgical incisions, lacerations, trauma inflicted wounds, abrasions, superficial burns, secondary dressing for packed wounds and donor sites. The dressing is also appropriate for pressure, diabetic and venous stasis ulcers. It is intended to be used to protect skin from potential irritation, maceration, and to manage exudate.

Device Story

Hydrophilic polyurethane foam wound dressing; various thicknesses (100 mil to 0.05") and sizes (up to 25"x25"); sterile, individually packaged. Used in clinical or home settings for wound management; protects skin from irritation/maceration; manages exudate. Applied by healthcare providers or patients to surgical incisions, lacerations, trauma wounds, abrasions, burns, and ulcers.

Clinical Evidence

bench testing only

Technological Characteristics

Material: hydrophilic polyurethane foam. Form factor: sheets up to 25"x25", thickness 100 mil to 0.05". Sterilization: sterile.

Indications for Use

Indicated for local management of surgical incisions, lacerations, trauma wounds, abrasions, superficial burns, packed wounds, donor sites, and pressure, diabetic, or venous stasis ulcers. Protects skin from irritation/maceration and manages exudate.

Regulatory Classification

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.

Predicate Devices

• Rynel Medical Epitech HPF-L00562 Sterile Wound Dressing

Submission Summary (Full Text)

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K961662

JUN 13 1996

# SECTION VI

## 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION

April 27, 1996

The following constitutes a "510(k) Summary" as required by section 807.92(c).

1. Contact Person:
Richard E. Galardy Tel: [phone]
73 Faulkner Dr. Fax: [phone]
Guilford, CT 06437

2. Device Name, including the trade or proprietary name if applicable, the common or usual name, and the classification name.
Trade name - Advanced Care™ Hydrophilic Wound Dressing
Common name - Foam Wound Dressing
Classification name - Liquid Bandage

3. Predicate Device:
Rynel Medical Epitech HPF-L00562 Sterile Wound Dressing

4. Device Description Including Intended Use:
The ADVANCED CARE™ Hydrophilic Wound Dressings will be manufactured from hydrophilic polyurethane foam in various thicknesses and configurations in sizes up to 25" by 25" squares, and thicknesses from 100 mil to 0.05".
The dressings will be offered as sterile stand alone polyurethane dressings individually packaged.
The Mariner Biomedical, Inc. ADVANCED CARE™ Sterile Wound Dressing is intended for use in the local management of surgical incisions, lacerations, trauma inflicted wounds, abrasions, superficial burns, secondary dressing for packed wounds and donor sites. The dressing is also appropriate for pressure, diabetic and venous stasis ulcers. It is intended to be used to protect skin from potential irritation, maceration, and to manage exudate.

5. Technological Characteristics Compared With The Predicate Device:
Physical characteristics of the ADVANCED CARE™ Wound Dressing are identical to those of the predicate device.

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file 510k2.28b