MODIFICATION OF BIONECT HYDROGEL GAUZE PADS

K984262 · Fidia Pharmaceutical Corp. · MGQ · Feb 10, 1999 · SU

Device Facts

• Record ID: K984262
• Device Name: MODIFICATION OF BIONECT HYDROGEL GAUZE PADS
• 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 Gauze Pads provide a moist wound environment that is supportive to wound healing. They are 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 Gauze Pads may also be used under the care of a health cure 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 Gauze Pads consist of sterile cotton gauze impregnated with a hydrogel composed of sodium hyaluronate and purified water. Device provides a moist, soothing wound environment to support healing. Used in clinical settings or by patients for minor wounds; professional supervision required for complex wounds like ulcers or second-degree burns. Applied topically to the wound site. Acts as a physical barrier/dressing. Benefits include maintenance of moist environment conducive to healing. No active electronic or mechanical components.

Clinical Evidence

Clinical experience across 16 trials (13 controlled) involving approximately 430 patients with various ulcers and burns supports safety. Biocompatibility testing (cytotoxicity, dermal irritation, dermal sensitization) performed on the bulk hydrogel solution.

Technological Characteristics

Sterile cotton gauze pad impregnated with sodium hyaluronate and purified water hydrogel. Polysaccharide biopolymer (sodium hyaluronate) increases gel viscosity. Passive dressing; no energy source. Non-electronic.

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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容202 833 7057

2020

**510(k) Premarket Notification**
**K984262 (Previously K973721)**
**BIONECT® Hydrogel Gauze Pads**

## fidia Pharmaceutical Corporation

12:57

02/01/98

**February 1, 1999**

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10. 510(k) SUMMARY

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

BIONECT® Hydrogel Gauze Pads Trade Name: Common Name: Hyaluronic acid sodium salt hydrogel dressing-impregnated gauze pads Classification Name: Hydrogel Wound and Burn Dressing

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

BIONECT® Hydrogel Gauze Pads are 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: BIONECT Hydrogel Gauze Pads, since they contain a hydrogel, provide a moist wound environment that is supportive to wound healing.

Basic scientific concepts that form the basis for the device: BIONECT Hydrogel Gauze Pads, since they are a hydrogel dressing, were 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 Gauze Pads are sterile cotton gauze pads impregnated with a hydrogel that is prepared from sodium hyaluronate and purfied water to form a hydrogel dressing. Sodium hyaluronate is a polysaccharidc biopolymer that can increase the viscosity of the gel. BIONECT® Hydrogel Gauze Pads, since they are a hydrogel dressing, provide a soothing, moist environment that is supportive to wound healing

## 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

8

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**fidia** Pharmaceutical Corporation

# tement of the intended use of the device, including general lescription of the conditions the device will mitigate and the patient population for which the device is intended

BIONECT® Hydrogel Gauze Pads provide a moist wound environment that is supportive to wound healing. They are 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 Gauze Pads may also be used under the care of a health cure 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.

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.

### 10.2 Assessment of performance data

In vitro and in vivo biocompatibility testing (cytotoxicity, dermal irritation, and dermal sensitization tests) has been performed on the bulk solution that impregnates BIONECT®

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# fidia Pharmaceutical Corporation

510(k) Premarket Notification
K984262 (Previously K973721)
BIONECT® Hydrogel Gauze Pads

**February 1, 1999**

safe use of BIONECT® Hydrogel Gauze Pads as a hydrogel temporary dressing in contact with breached or compromised skin. :::

Clinical experience with BIONECT® Hydrogel Gauze Pads in approximately 430 patients with various types of ulcers and burns in 16 clinical trials (13 controlled), indicates that BIONECT® Hydrogel Gauze Pads are safe for their intended use.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight.

FEB 100 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 vour 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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1028334130

02-02-77 12:584 P.02

## Idia Pharmaceutical Corporation

### February 1, 1999

### INDICATIONS FOR USE 2.

\$10(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 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 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 hurns.

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

Prescription Use (Per 21 CRF 801.109) Or

2

Over-the-Counter Use X

Diolleto

Division **Sign-Off**
Division of General Restorative Devices
510(k) Number
K984262, K984264, K984