BIONECT CREAM

K963004 · Fidia Pharmaceutical Corp. · MGQ · Feb 12, 1997 · SU

Device Facts

• Record ID: K963004
• Device Name: BIONECT CREAM
• Applicant: Fidia Pharmaceutical Corp.
• Product Code: MGQ · SU
• Decision Date: Feb 12, 1997
• Decision: SN
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

BIONECT® Cream is indicated for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), wounds including cuts, abrasions, donor sites, and post-operative incisions, irritations of the skin, and first and second degree burns. The dressing is intended to cover a wound or burn on a patient's skin, and protect against abrasion, friction, and desiccation.

Device Story

BIONECT® Cream is a hydrogel wound and burn dressing composed of sodium hyaluronate and purified water. Applied topically to wounds, it functions by maintaining a moist wound environment and providing a protective barrier against abrasion, friction, and desiccation. It is intended for use in clinical or home settings to manage various skin lesions and burns. The device aids healing by protecting the wound site and preventing dehydration of the tissue.

Clinical Evidence

Clinical experience includes 21 clinical trials (18 controlled) involving approximately 600 patients with ulcers, burns, and surgical wounds. Data indicates the device is safe for its intended use. Biocompatibility testing was performed per FDA draft guidance for non-interactive wound and burn dressings.

Technological Characteristics

Hydrogel dressing composed of sodium hyaluronate (polysaccharide biopolymer) and purified water. Provides moist wound environment. Non-interactive, occlusive, and conformable.

Indications for Use

Indicated for patients with partial to full thickness dermal ulcers (pressure, venous stasis, arterial, diabetic), wounds (cuts, abrasions, donor sites, post-operative incisions), skin irritations, and first/second degree burns.

Predicate Devices

• Argidene™ Gel (K945835)
• Carrasyn™ Hydrogel Wound Dressing (K902345)
• DuoDERM Hydroactive™ Gel (K830708)

Submission Summary (Full Text)

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FEB 12 1997
510(k) No. K963004
BIONECT® Cream
Amendment No. 3
fidia Pharmaceutical Corporation
November 26, 1996

10. 510(k) SUMMARY
K963004

## 10.1 Summary Information

### 10.1.1 Submitter's name and address

FIDIA Pharmaceutical Corporation
1401 Eye Street, NW, Suite 900
Washington, DC 20005

Contact person and telephone number:

Roberto Fiorentini, M.D., President
Telephone: [phone]
Telefax: [phone]

Date summary was prepared:

November 26, 1996

### 10.1.2 Name of the Device

Trade Name: BIONECT® Cream
Common Name: Hyaluronic acid sodium salt hydrogel dressing
Classification Name: Hydrogel Wound and Burn Dressing

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510(k) No. K963004
BIONECT® Cream
Amendment No. 3
November 26, 1996
fidia Pharmaceutical Corporation

## 10.1.3 Identification of predicate device to which substantial equivalence is being claimed

BIONECT® Cream is substantially equivalent in function and intended use to the following commercially available non-interactive wound and burn dressings:

- Argidene™ Gel (K945835) (Telios Pharmaceuticals, Inc.)
- Carrasyn™ Hydrogel Wound Dressing (K902345) (Carrington Laboratories, Inc.)
- DuoDERM Hydroactive™ Gel (K830708) (ConvaTec.)

## 10.1.4 Device description

**Explanation of how the device functions:** BIONECT® Cream acts to provide a moist wound environment and protect the wound.

**Basic scientific concepts that form the basis for the device:** BIONECT® Cream was designed to provide a soothing, moist environment for easy application to various types of wounds as a hydrogel dressing.

**Significant physical and performance characteristics of the device such as device design, materials used, and physical properties:** BIONECT® Cream is prepared from sodium hyaluronate and purified water to form a hydrogel dressing. Sodium hyaluronate is a polysaccharide biopolymer that can increase the viscosity of the

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510(k) No. K963004
BIONECT® Cream
Amendment No. 3
November 26, 1996
fidia Pharmaceutical Corporation

gel. BIONECT® Cream was designed to provide a moist wound healing environment.

## 10.1.5 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

BIONECT® Cream is indicated for the dressing and management of partial to full thickness dermal ulcers (pressure sores, venous stasis ulcers, arterial ulcers, diabetic ulcers), wounds including cuts, abrasions, donor sites, and post-operative incisions, irritations of the skin, and first and second degree burns. The dressing is intended to cover a wound or burn on a patient's skin, and protect against abrasion, friction, and desiccation.

These indication statements are not different from the predicate device identified in paragraph (3) of this section.

## 10.1.6 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, occlusion, conformability, bioburden level, moist wound healing, and appearance in the wound when hydrated are not different from the predicate devices cited.

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fidia Pharmaceutical Corporation
510(k) No. K963004
BIONECT® Cream
Amendment No. 3
November 26, 1996

## 10.2 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 all support the safe use of BIONECT® Cream as a hydrogel temporary dressing in contact with breached or compromised skin.

Clinical experience in approximately 600 patients with various types of ulcers, burns, and surgical wounds in 21 clinical trials (18 controlled) conducted in Europe indicates that BIONECT® Cream is safe for its intended use.

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