IALUSET HYDROCOLLOID

K020041 · Institut Biochimique SA (Ibsa) · FRO · Mar 14, 2002 · SU

Device Facts

• Record ID: K020041
• Device Name: IALUSET HYDROCOLLOID
• Applicant: Institut Biochimique SA (Ibsa)
• Product Code: FRO · SU
• Decision Date: Mar 14, 2002
• Decision: SESE
• Submission Type: Traditional
• Device Class: Class U
• Attributes: Therapeutic

Intended Use

IALUSET HYDROCOLLOID may be applied to minor wounds such as abrasions. lacerations, cuts, scalds, or burns by a patient not under the care of a health care professional, and if under the care of a health care professional, it may be applied to leg ulcers, diabetic ulcers, pressure ulcers, surgical wounds, first and second degree burns, and traumatic wounds. If a patient is unsure of the type of wound he or she has, they should consult with a health care professional before using this product.

Device Story

IALUSET HYDROCOLLOID is a 10 cm x 10 cm wound dressing; consists of inner hydrocolloid layer containing sodium hyaluronate and sodium chondroitin sulfate; incorporated into adhesive matrix; spread between polyurethane film and silicone release liner. Absorbs wound exudate to maintain moist healing environment; non-adherent to wound bed to minimize pain/tissue damage during removal. Used in clinical settings by physicians or at home by patients for minor wounds. Provides physical barrier and moisture management to facilitate healing.

Clinical Evidence

Bench testing only. Biocompatibility evaluation included cytotoxicity (L929 murine fibroblast assay), primary skin irritation, skin sensitization, subchronic toxicity, and genotoxicity (Ames test). Cytotoxicity observed at highest concentrations attributed to osmotic effects; otherwise, no untoward responses reported.

Technological Characteristics

Hydrocolloid dressing with sodium hyaluronate and sodium chondroitin sulfate in adhesive matrix; polyurethane film backing; silicone release liner. Dimensions: 10 cm x 10 cm. Sterilization: Gamma irradiation. Self-adhesive, transparent, moisture-absorbent.

Indications for Use

Indicated for OTC use on minor abrasions, lacerations, cuts, scalds, and burns. Indicated for physician-supervised use on leg ulcers (venous/arterial), diabetic ulcers, pressure ulcers (stage I-IV), surgical wounds (postoperative, excisions, donor sites), first/second degree burns, and traumatic wounds.

Predicate Devices

• ConvaTec (K881050)
• Innovative Technologies (K971126)

Submission Summary (Full Text)

{0}------------------------------------------------

K020041

## 510(K) SUMMARY

MAR 1 4 2002

#### Submitter's Name, Address, and Phone/Fax Numbers

Institut Biochimique SA (IBSA) Via Del Piano P.O. Box 266 CH-6915 Pambio-Noranco Switzerland [phone] (phone) [phone] (fax)

#### Contact Person

Clarence Jones, Ph.D. 8602 Mossford Drive Huntington Beach, CA 92646

#### Date 510(k) Summary Prepared

January 4, 2002

#### Name of the Device

Trade Name: IALUSET® HYDROCOLLOID Common Name: Hydrocolloid Wound Dressing Classification Name: Dressing, Wound and Burn, Occlusive (878.4020)

#### Predicate Device

IALUSET HYDROCOLLOID is substantially equivalent to two other hydrocolloid wound dressings, one from ConvaTec (K881050) and the other from Innovative Technologies (K971126).

#### Device Description

IALUSET HYDROCOLLOID is a 10 cm x 10 cm wound dressing comprised of an inner layer of hydrocolloids (containing sodium hyaluronate and sodium chondroitin sulfate) which are incorporated into an adhesive matrix and spread between a polyurethane film and a silicone release liner. The dressing absorbs wound exudate, thereby allowing for a moist environment that is conducive to normal wound healing. It does not adhere to the wound, which minimizes both pain and damage to the underlying tissue when the dressing is removed.

#### Intended Use

IALUSET HYDROCOLLOID may be applied to minor wounds such as abrasions. lacerations, cuts, scalds, or burns by a patient not under the care of a health care

ﻠﺴﺴ

{1}------------------------------------------------

professional, and if under the care of a health care professional, it may be applied to leg ulcers, diabetic ulcers, pressure ulcers, surgical wounds, first and second degree burns, and traumatic wounds. If a patient is unsure of the type of wound he or she has, they should consult with a health care professional before using this product.

| Characteristic | IALUSET<br>HYDROCOLLOID | ConvaTec<br>(K881050) | Innovative Technologies<br>(K971126) |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Composition | Hydrocolloid plus<br>Polyurethane Film | Hydrocolloid plus<br>Polyurethane Film | Hydrocolloid plus<br>Polyurethane Film |
| Surface | Extruded & Laminated | Extruded & Laminated | Extruded & Laminated |
| Indication for Use | Superficial Wounds,<br>Dermal Ulcers,<br>Burns (1st & 2nd Degree),<br>Donor Sites,<br>Postoperative Wounds,<br>Protective Dressings | Superficial Wounds,<br>Dermal Ulcers,<br>Burns (1st & 2nd Degree),<br>Donor Sites,<br>Postoperative Wounds,<br>Protective Dressings | Superficial Wounds,<br>Dermal Ulcers,<br>Burns (1st & 2nd Degree),<br>Donor Sites,<br>Postoperative Wounds,<br>Protective Dressings |
| Transparent | Yes | Yes | Yes |
| Self Adhesive | Yes | Yes | Yes |
| Packaging | Blister Pack | Pouch | Blister Pack |
| Sterilization Method | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation |

# Technological Characteristics in Comparison to Predicate Device

### Non-Clinical Performance Data

Extracts of IALUSET HYDROCOLLOID were evaluated in five standard biocompatibility test systems: Cytotoxicity, Primary Skin Irritation, Skin Sensitization, Subchronic Toxicity, and Genotoxicity (Ames). Except for evidence of cytotoxicity in the L929 murine fibroblast assay at the two highest concentrations tested, presumably due to an osmotic effect, IALUSET HYDROCOLLOID extracts were not found to elicit any untoward responses as compared to a vehicle control.

#### Conclusions

IALUSET HYDROCOLLOID is substantially equivalent to other hydrocolloid wound dressings.

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like shapes, suggesting movement or flight.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 4 2002

Institut Biochimique SA c/o Clarence E. Jones, Ph.D. 8602 Mossford Drive Huntington Beach, CA 92646

Re: K020041

Trade/Device Name: Ialuset® Hydrocolloid Wound Dressing Regulatory Class: Unclassified Product Code: FRO Dated: January 4, 2002 Received: January 7, 2002

Dear Dr. Jones:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

Page 2 - Clarence E. Jones, Ph.D.

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

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 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 device, please contact the Office of Compliance at [phone]. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Muriam C. Provost

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

Enclosure

{4}------------------------------------------------

# INDICATIONS FOR USE FORM

510(k) Number: _ K 0 2 0 0 41

Device Name: IALUSET® HYDROCOLLOID Wound Dressing

Indications for Use:

For over-the-counter use, IALUSET HYDROCOLLOID may be applied to:

- abrasions ●
- lacerations .
- minor cuts ●
- minor scalds ●
- minor burns .

Under the supervision of a physician, IALUSET HYDROCOLLOID may also be applied to:

- leg ulcers (venous stasis ulcers, arterial ulcers) .
- diabetic ulcers .
- pressure ulcers (stage I IV) ●
- surgical wounds (postoperative, dermatological excisions, donor sites) .
- burns (first and second degree only) .
- traumatic wounds ●

Miriam C. Provost

Division of General, Restorative and Neurological Devices

KO20041 510(k) Number -

Concurrence of Office of Device Evaluation, Center for Devices and Radiological Health

Prescription Use:

Over-the-Counter Use

Institut Biochimique SA (IBSA) Pambio-Noranco, Switzerland