IAMIN IMPREGNATED GAUZE DRESSING

K965005 · Procyte Corp. · MGQ · Feb 24, 1997 · SU

Device Facts

• Record ID: K965005
• Device Name: IAMIN IMPREGNATED GAUZE DRESSING
• Applicant: Procyte Corp.
• Product Code: MGQ · SU
• Decision Date: Feb 24, 1997
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

lamin Impregnated Gauze Dressing is intended to be used for the dressing and management of pressure ulcers (stage I-IV), diabetic ulcers, stasis ulcers, 1st and 2nd degree burns, arterial ulcers, pressure sores, cuts, abrasions, irritations of the skin, and skin conditions associated with peristomal care. The dressing is intended to cover a wound or burn on a patient's skin, provide a moist wound environment and protect against abrasion, friction, desiccation, and contamination.

Device Story

Sterile, hydrogel-impregnated cotton-blend non-woven gauze dressing; provides moist wound environment; protects against abrasion, friction, desiccation, and contamination. Applied topically by clinicians or patients to manage various wound types. Acts as a passive barrier dressing; no active electronic or mechanical components.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per FDA Draft Guidance for Non-Interactive Wound and Burn Dressings to support safety for temporary contact with breached or compromised skin.

Technological Characteristics

Sterile, cotton-blend non-woven gauze impregnated with hydrogel. Passive dressing; no energy source or electronic components. Form factor: impregnated gauze pad.

Indications for Use

Indicated for patients with pressure ulcers (stage I-IV), diabetic ulcers, stasis ulcers, 1st and 2nd degree burns, arterial ulcers, pressure sores, cuts, abrasions, skin irritations, and peristomal skin conditions requiring wound protection and a moist healing environment.

Predicate Devices

• Dermagran Wound Dressing
• SteriCare Hydrogel Gauze Dressing
• CarraGauze Hydrogel Wound Dressing
• lamin Hydrating Gel

Submission Summary (Full Text)

{0}

K965005

FEB 24 1997

## 11.5 510(k) Summary

### Submitter's Name and Address:

ProCyte Corporation
12040 115th Ave NE #210
Kirkland, Washington 98034

Contact person and telephone number:

Paul Ketteridge
Regulatory Affairs Officer
Telephone: [phone]
Fax: [phone]

Date summary was prepared: December 12, 1996

### Name of the Device:

Proprietary name: lamin® Impregnated Gauze Dressing
Common name: Hydrogel Dressing
Classification name: Hydrogel and Burn Dressing

### Identification of Predicate Devices to which Substantial Equivalence is Being Claimed:

lamin® Impregnated Gauze Dressing is substantially equivalent in function and intended use to the following non-classified commercially available non-interactive wound and burn dressings:

- Dermagran Wound Dressing
- SteriCare Hydrogel Gauze Dressing
- CarraGauze Hydrogel Wound Dressing
- lamin Hydrating Gel

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{1}

ProCyte Corporation
510(k) Summary
lamin® Impregnated Gauze Dressing
December 13, 1996
Page 2 of 3

## Device Description:

*Explanation of how the device functions:* lamin® Impregnated Gauze Dressing acts to provide a moist wound environment and protect the wound.

*Basic scientific concepts that form the basis for the device:* lamin® Impregnated Gauze Dressing was designed to provide a soothing, moist environment for each application to various types of wounds as an impregnated gauze dressing.

*Significant physical and performance characteristics of the device such as device design, materials used, and physical properties:* lamin® Impregnated Gauze Dressing is sterile impregnated cotton-blend non-woven gauze.

## Statement of the Intended Use of the Device, Including General Description of the Conditions the Device Will Mitigate and the Patient Population for which the Device Is Intended:

An impregnated hydrogel for the dressing and management lamin Impregnated Gauze Dressing is intended to be used for the dressing and management of pressure ulcers (stage I-IV), diabetic ulcers, stasis ulcers, 1st and 2nd degree burns, arterial ulcers, pressure sores, cuts, abrasions, irritations of the skin, and skin conditions associated with peristomal care. The dressing is intended to cover a wound or burn on a patient's skin, provide a moist wound environment and protect against abrasion, friction, desiccation, and contamination.

These indication statements are not different from the predicate devices identified above.

{2}

ProCyte Corporation
510(k) Summary
lamin® Impregnated Gauze Dressing
December 13, 1996
Page 3 of 3

# Statement of how the Technological Characteristics of the Device Compare to those of the Predicate Device:

The technological characteristics of the device such as form, absorptive ability, occlusion, conformability, sterility, moist wound healing and appearance are not different from the predicate devices cited.

# Assessment of Performance Data:

Biocompatibility testing has been performed as recommended in the "Draft Guidance for the Preparation of a Premarket Notification for a Non-Interactive Wound and Burn Dressing." These tests support the safe use of lamin® Impregnated Gauze Dressing as a temporary dressing in contact with breached or compromised skin.