MODIFICATION OF BIONECT CLEAR HYDROGEL

K984264 · Fidia Pharmaceutical Corp. · MGQ · Feb 10, 1999 · SU

Device Facts

• Record ID: K984264
• Device Name: MODIFICATION OF BIONECT CLEAR HYDROGEL
• 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® Clear Hydrogel 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 Clear Hydrogel 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.

Device Story

BIONECT® Clear Hydrogel is a clear, colorless hydrogel dressing composed of sodium hyaluronate and purified water. It functions as a non-interactive dressing to maintain a moist wound environment, supporting natural healing processes. Applied topically to the wound site, the gel provides a soothing effect. It is intended for both over-the-counter use for minor skin injuries and professional use for complex wounds, including various dermal ulcers, surgical incisions, and second-degree burns. The device does not accelerate healing or act as a permanent skin substitute.

Clinical Evidence

Bench testing included in vitro and in vivo biocompatibility (cytotoxicity, dermal irritation, dermal sensitization) per ISO-10993. Clinical evidence includes 22 clinical trials (17 controlled) conducted in Europe on various ulcers, burns, and surgical wounds, supporting safety for the intended use.

Technological Characteristics

Hydrogel dressing composed of sodium hyaluronate (polysaccharide biopolymer) and purified water. Clear, colorless, viscous gel form. Non-interactive, moisture-retentive, conformable. 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. Not for third-degree burns.

Predicate Devices

• BIONECT® Hydrogel (K973725)

Reference Devices

• BIONECT® Hydrogel Gauze Pads (K984262)
• BIONECT® Hydrogel Spray (K984266)
• BIONECT® Hydrogel Foam (K984267)
• BIONECT® Hydrogel (K984413)

Submission Summary (Full Text)

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公202 833 7057 13:07 02/01/99

2/10/99

# fidia Pharmaceutical Corporation

February 1, 1999

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#### 510(k) SUMMARY 10.

10.1 Summary Information

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: | BIONECT® Clear Hydrogel |
|----------------------|-----------------------------------------------|
| Common Name: | Hyaluronic acid sodium salt hydrogel dressing |
| Classification Name: | Hydrogel Wound and Burn Dressing |

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fidia Pharmaceutical Corporation

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

BIONECT® Clear Hydrogel 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® Clear Hydrogel provides a moist wound environment that is supportive to wound healing.

Basic scientific concepts that form the basis for the device: BIONECT® Clear Hydrogel 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® Clear Hydrogel is a clear, colorless, hydrogel that 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 gel. BIONECT® Clear Hydrogel, since it is a hydrogel dressing, provides a soothing, moist environment that is supportive to wound healing.

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K984264

510(k) Premarket Notification
K984264 (Previously K973725)
BIONECT® Clear Hydrogel

## 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® Clear Hydrogel 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 Clear Hydrogel 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, highurden level. moist wound healing, and appearance in the wound when hydrated are not different from the predicate device cited.

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## fidia Pharmaceutical Corporation

February 1, 1999

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#### 10.2 Assessment of performance data

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

Clinical experience with BIONECT® Hydrogel and BIONECT® Hydrogel Gauze Pads in 22 clinical trials (17 controlled) conducted in Europe in patients with various types of ulcers, burns, and surgical wounds indicates that BIONECT® Clear Hydrogel 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 shows the seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal are three stylized human profiles facing to the right, stacked on top of each other.

FEB 10 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:

- 1. These devices may not be labeled for use on third degree burns.
- These devices may not be labeled as having any accelerating effect on the rate of 2. wound healing or epithelization.
- These devices may not be labeled as a long-term, permanent, or no-change 3. 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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Pharmaceutical Corporation

### February 1, 1999

#### 2. INDICATIONS FOR USE

K984413 (Previously K963004) 510(k) Number (if known): 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, Gauzo 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 - CONTUNUE ON ANOTHER PAGE IF NEIJDED Concurrence of CDRH, Office of Device Evaluation (ODE)

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Prescription Use (Per 21 CRF 801.109)

Over-the-Counter Use X

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(Division Sign-Off)
Division of General Restorative Devices
510(k) Number
K984262, K984264, K984266

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