MODIFICATION OF BIONECT HYDROGEL SPRAY

K984266 · Fidia Pharmaceutical Corp. · MGQ · Feb 10, 1999 · SU

Device Facts

• Record ID: K984266
• Device Name: MODIFICATION OF BIONECT HYDROGEL SPRAY
• Applicant: Fidia Pharmaceutical Corp.
• Product Code: MGQ · SU
• Decision Date: Feb 10, 1999
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

BIONECT® Hydrogel Spray provides a moist wound environment that is supportive to wound healing. It indicated for the dressing and management of minor burns; superficial cuts, lacerations, and abrasions; and minor irritations of the skin. A health care professional may be consulted prior to the first use of this product to determine whether these conditions exist. BIONECT Hydrogel Spray may also be used under the care of a health care professional for wounds such as partial to full thickness dermal ulcers (pressure ulcers, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (post-operative incisions and donor sites), and second degree burns.

Device Story

BIONECT® Hydrogel Spray is a clear, aqueous hydrogel dressing composed of sodium hyaluronate and purified water. It functions by maintaining a moist wound environment to support healing. The device is applied topically to the wound site. It is intended for both over-the-counter use for minor skin conditions and professional use for chronic ulcers, surgical wounds, and second-degree burns. The spray form allows for easy application to the wound surface. By providing a soothing, moist environment, it aids in the management of various wound types. It is not indicated for third-degree burns or as a permanent skin substitute.

Clinical Evidence

Clinical experience included 2 clinical trials (1 controlled) conducted in Europe with approximately 45 patients presenting with various ulcers and surgical wounds. Results indicated the device is safe for its intended use. Biocompatibility testing (cytotoxicity, dermal irritation, and dermal sensitization) was performed on the bulk solution per ISO-10993 standards.

Technological Characteristics

Aqueous hydrogel dressing; composition: sodium hyaluronate and purified water. Polysaccharide biopolymer increases gel viscosity. Form factor: spray. Non-interactive dressing. Biocompatibility tested per ISO-10993.

Indications for Use

Indicated for dressing/management of minor burns, superficial cuts, lacerations, abrasions, and minor skin irritations. Also indicated for professional use on partial to full thickness dermal ulcers (pressure, venous stasis, arterial, diabetic), surgical wounds (incisions, donor sites), and second-degree burns.

Predicate Devices

• BIONECT® Hydrogel

Submission Summary (Full Text)

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13:03

K984266

510(k) Premarket Notifica K984266 (Previously K973 BIONECT® Hydrogel Spray

# fidia Pharmaceutical Corporation

February 1, 1999

#### 10. 510(k) SUMMARY

Summary Information 10.1

10.1.1 Submitter's name and address

FIDIA Pharmaceutical Corporation 2000 K Street, NW, Suite 700 Washington, DC 20006

Contact person and telephone number:

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

Date summary was prepared:

February 1, 1999

### 10.1.2 Name of the Device

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

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984266

**510(k) Premarket Notification**
**K984266 (Previously K973724)**
**BIONECT
Hydrogel Spray**

# fidia Pharmaceutical Corporation

**February 1, 1999**

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

BIONECT® Hydrogel Spray is substantially equivalent in function and intended use to the following cleared non-interactive wound and burn dressing: BIONECT® Hydrogel.

## 10.1.4 Device description

Explanation of how the device functions: Since it is a hydrogel, BIONECT® Hydrogel Spray provides a moist wound environment that is supportive to wound healing.

Basic scientific concepts that form the basis for the device: BIONECT® Hydrogel Spray was designed to provide a soothing, moist environment that is supportive to wound healing.

Significant physical and performance characteristics of the device such as device design, materials used, and physical properties: BIONECT® Hydrogel Spray is a clear, colorless, aqueous solution that is prepared from sodium hyaluronate and purificd water to form a hydrogel dressing. Sodium hyaluronate is a polysaccharide biopolymer that can increase the viscosity of the gel. BIONECT® Hydrogel Spray, since it is a hydrogel dressing, provides a soothing, moist environment that is supportive to wound healing.

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K984266

K984266 (Previously ) BIONECT® Hydrogel Spra

## fidia Pharmaceutical Corporation

February 1, 1999

# 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® Hydrogel Spray provides a moist wound environment that is supportive to wound healing. It indicated for the dressing and management of minor burns; superficial cuts, lacerations, and abrasions; and minor irritations of the skin. A health care professional may be consulted prior to the first use of this product to determine whether these conditions exist. BIONECT Hydrogel Spray may also be used under the care of a health care professional for wounds such as partial to full thickness dermal uicers (pressure ulcers, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (post-operative incisions and donor sites), and second degree burns.

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 device cited.

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K984266

510(k) Premarket Notification K973724 BIONECT® Hydrogel Spray

# fidia Pharmaceutical Corporation

#### Assessment of Performance Data 10.2

In vitro and in vivo biocompatibility testing (cytotoxicity, dermal irritation, and dermal sensitization tests) has been performed on the BIONECT® Hydrogel Spray bulk solution in accordance with FDA recommendations. These tests all support the safe use of BIONECT® Hydrogel Spray as a hydrogel temporary dressing in contact with breached or compromised skin.

Clinical experience with BIONECT® Hydrogel Spray in approximately 45 patients with various types of ulcers and surgical wounds in 2 clinical trials (1 controlled), all conducted in Europe, indicates that BIONECT® Hydrogel Spray is safe for its intended use.

¹ Office of Device Evaluation General Program Memorandum #695-1, International Standard ISO-10993, "Biological Evaluation of Medical Devices part 1: Evaluation and Testing," dated 1 May 1995.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure, with three overlapping profiles suggesting a sense of community and support. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure, emphasizing the organization's name and national affiliation.

FEB 1 0 1999

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Roberto Fiorentini President Fidia Pharmaceutical Corp. 2000 K Street, N.W. - Suite 700 Washington, D.C. 20006

Re: K984262-BIONECT Hydrogel Gauze Pads K984264-BIONECT Clear Hydrogel K984266-BIONECT Hydrogel Spray K984267-BIONECT Hydrogel Foam K984413-BIONECT Hydrogel Regulatory Class: Unclassified Product Code: MGQ Dated: November 17, 1998 Received: November 17, 1998

Dear Mr. Fiorentini:

We have reviewed your Section 510(k) notifications of intent to market the devices referenced above and we have determined the devices are substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act). You may, therefore, market your devices subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (Act) and the following limitations:

- These devices may not be labeled for use on third degree burns. 1.
- 2. These devices may not be labeled as having any accelerating effect on the rate of wound healing or epithelization.
- 3. These devices may not be labeled as a long-term, permanent, or no-change dressing, or as an artificial (synthetic) skin.
- 4. These devices may not be labeled as a treatment or a cure for any type of wound.

The labeling claims listed above would be considered a major modification in the intended use of the devices and would require a premarket notification submission (21 CFR 807.81).

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### Page 2 - Mr. Roberto Fiorentini

The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practices, labeling, and prohibitions against misbranding and adulteration.

If your devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval) it may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations (CFR), Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practices (GMP) for Medical Devices: General GMP regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your devices in the Federal Register. Please note: this response to your premarket notification submissions does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notifications. The FDA finding of substantial equivalence of your devices to a legally marketed predicate device results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its tollfree number [phone] or 301-443-6597 or at its internet address http://www.fda.gov/cdrh/dsmamain.html.

Sincerely yours,

Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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-4A NH4.1 4848334130

u2-02-77 12:582 P.02

## IQIa Pharmaceutical Corporation

## February 1, 1999

### INDICATIONS FOR USF 2.

510(k) Number (if known); K984413 (Previously K963004) K984262 (Previously K973721) K984267 (Previously K973722) K984266 (Previously K973725) K984264 (Previously K973725)

Device Name:

BIONECT® Hydrogel BIONECT® Hydrogel Gauze Pads BIONECT® Hydrogel Foam BIONECT® Hydrogel Spray BIONECT® Clear Hydrogel

Indications for Use:

BIONECT® Hydrogel, Gauze Pads, Foam, Spray, and Clear Hydrogel are indicated for the dressing and munagement of minor burns: superficial cuts, lacerations, and abrasions; and minor irritations of the skin. A health care professional may be consulted prior to the first use of these products to determine whether these conditions exist. BIONECT Hydrogel, Gauze Pads, Fourn, Spray, and Clear Hydrogel may also be used under the care of a health care professional for wounds such as partial to full thickness dermal ulcers (pressure ulcers, venous stasis ulcers, arterial ulcers, diabetic ulcers), surgical wounds (post-operative incisions and donor sites), and second degree burns.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEJIDED Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CRF 801.109) ਮ

2

Over-the-Counter Use X

(Division Sign-Off)
Division of General Restorative Devices
510(k) Number
K984262, K984264, K98