IAMIN WET DRESSING (COPPER-SALINE)

K964468 · Procyte Corp. · MGQ · Feb 3, 1997 · SU

Device Facts

• Record ID: K964468
• Device Name: IAMIN WET DRESSING (COPPER-SALINE)
• Applicant: Procyte Corp.
• Product Code: MGQ · SU
• Decision Date: Feb 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

A hydrogel for the dressing and management of both graft recipient and donor sites, postoperative incisions, pressure ulcers, diabetic ulcers, stasis ulcers, 1st and 2nd degree burns, arterial ulcers, pressure sores, 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, absorb wound exudate, and protect against abrasion, friction, desiccation, and contamination.

Device Story

Sterile saturated cotton-blend non-woven gauze; provides moist wound environment; absorbs exudate; protects against abrasion, friction, desiccation, and contamination. Used in clinical settings for wound/burn management. Applied by healthcare providers to cover compromised skin. Benefits include maintenance of moist environment conducive to healing and protection of wound site.

Clinical Evidence

Biocompatibility testing performed per FDA Draft Guidance for Non-Interactive Wound and Burn Dressings. No clinical data provided.

Technological Characteristics

Sterile saturated cotton-blend non-woven gauze. Hydrogel-based. Non-interactive dressing. Form factor: saturated gauze.

Indications for Use

Indicated for patients requiring management of graft sites, postoperative incisions, pressure/diabetic/stasis/arterial ulcers, 1st and 2nd degree burns, and peristomal skin conditions.

Predicate Devices

• Dermagran Wet Dressing (Zinc-Saline)
• MPM Wet Dressings (Saline)
• lamin Hydrating Gel
• CarraGauze Hydrogel Wound Dressing

Submission Summary (Full Text)

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K964468

11.5 510(k) Summary

FEB - 3 1997

## 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: October 31, 1996

## Name of the Device:

Proprietary name: lamin® Wet Dressing (Copper-Saline)
Common name: Hydrogel Dressing
Classification name: Hydrogel and Burn Dressing

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

lamin® Wet Dressing (Copper-Saline) is substantially equivalent in function and intended use to the following non-classified commercially available non-interactive wound and burn dressings:

- Dermagran Wet Dressing (Zinc-Saline)
- MPM Wet Dressings (Saline)
- lamin Hydrating Gel
- CarraGauze Hydrogel Wound Dressing

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{1}

ProCyte Corporation
510(k) Summary
lamin® Wet Dressing
November 5, 1996
Page 2 of 3

## Device Description:

**Explanation of how the device functions:** lamin® Wet Dressing (Copper-Saline) acts to provide a moist wound environment and protect the wound.

**Basic scientific concepts that form the basis for the device:** lamin® Wet Dressing (Copper-Saline) was designed to provide a soothing, moist environment for each application to various types of wounds as saturated gauze dressing.

**Significant physical and performance characteristics of the device such as device design, materials used, and physical properties:** lamin® Wet Dressing (Copper-Saline) is sterile saturated 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:** A hydrogel for the dressing and management of both graft recipient and donor sites, postoperative incisions, pressure ulcers, diabetic ulcers, stasis ulcers, 1st and 2nd degree burns, arterial ulcers, pressure sores, 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, absorb wound exudate, and protect against abrasion, friction, desiccation, and contamination.

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

27

{2}

ProCyte Corporation
510(k) Summary
lamin® Wet Dressing
November 5, 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® Wet Dressing (Copper-Saline) as a temporary dressing in contact with breached or compromised skin.