RESTORE WOUND CLEANSER

K040779 · Hollister, Inc. · KMF · May 17, 2004 · General Hospital

Device Facts

• Record ID: K040779
• Device Name: RESTORE WOUND CLEANSER
• Applicant: Hollister, Inc.
• Product Code: KMF · General Hospital
• Decision Date: May 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The restore Wound Cleanser is intended for the removal of foreign material such as dirt and debris from dermal wounds.

Device Story

Restore Wound Cleanser is a buffered, isotonic, water-based surfactant solution; clear, colorless, slightly viscous liquid. Packaged in 8oz spray bottle with trigger spray closure. Used to irrigate and remove foreign material (dirt, debris) from dermal wounds. Suitable for low, medium, or high exudating wounds. Applied topically by clinician or patient to the wound area. Facilitates mechanical cleaning of the wound bed.

Clinical Evidence

No clinical data. Biocompatibility and safety established via in-vitro and in-vivo laboratory evaluations following ISO 10993, USP, and FHSA guidelines.

Technological Characteristics

Buffered isotonic water-based surfactant solution. Form factor: 8oz spray bottle with trigger spray closure. Biocompatibility testing conducted per ISO 10993, USP, and 21 CFR Part 58 (GLP).

Indications for Use

Indicated for removal of foreign material (dirt, debris) from dermal wounds, including low, medium, or high exudating wounds.

Regulatory Classification

Identification

A liquid bandage is a sterile device that is a liquid, semiliquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant.

Predicate Devices

• Carrington Carra Klenz Wound Cleanser (K022670)
• Allclenz Wound Cleanser (K965120)
• Derma Sciences Dermagran Wound Cleanser with Zinc (K945802)

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 7 - 2004

Mr. Joseph S. Tokarz Director, Regulatory Affairs Hollister Incorporated 2000 Hollister Drive Libertyville, Illinois 60048

Re: K040779

Trade/Device Name: Restore Wound Cleanser Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid bandage Regulatory Class: I Product Code: KMF Dated: March 24, 2004 Received: March 26, 2004

Dear Mr. Tokarz:

This letter corrects our substantially equivalent letter of May 17, 2004 regarding the identification of the Restore Wound Cleanser as a prescription device. The device will be marketed as an over-the-counter (OTC) product.

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 (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 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.

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Page 2 - Mr. Joseph S. Tokarz

This letter will allow you to continue 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 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]. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at their toll free number [phone] or at [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,
Mark A. Milherson

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

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# Indications for Use

510(k) Number (if known): ___ K040779

Device Name:____ Restore Wound Cleanser

Indications For Use:

The restore Wound Cleanser is intended for the removal of foreign material such as dirt and debris from dermal wounds.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use × (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

> Concurrence of CDRH. Offic Device Evaluation (ODE)

Mark A. Millerson

Division Division of General, Restorative, and Neurological Devices

510(k) Number K040779

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K040 779

page 1 of 2

MAY 1 7 2004

Hollister Incorporated Restore Wound Cleanser Pre-market notification -510(k)

# 510(k) Summary

## 1. Sponsor's name, Address and Contact Person

| Sponsor | Contact Person |
|--------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Hollister Incorporated<br>2000 Hollister Drive<br>Libertyville IL. 60048 | Joseph S. Tokarz<br>Director, Regulatory Affairs<br>Hollister Incorporated<br>2000 Hollister Drive<br>Libertyville, IL 60048<br>Ph: [phone]<br>Fax: [phone] |

Date Summary Prepared - March 23, 2004

#### 2. Name of Device:

Restore Wound Cleanser

#### 3. Name of Predicate Device(s)

- · Carrington Carra Klenz Wound Cleanser K022670
- · Allclenz Wound Cleanser K965120
- · Derma Sciences Dermagran Wound Cleanser with Zinc K945802

#### 4. Description of Device

The Restore Wound Cleanser is a buffered isotonic water based surfactant solution that is a clear colorless slightly viscous liquid that is intended to remove foreign material such as dirt is a debris from dermal wounds. The device can be used on low, medium or high exudating and wounds. The product is available in an 80z. spray bottle. The Restore Wound Cleanser is applied to the dermal wound area using a trigger spray closure that helps facilitate the removal of foreign material such as dirt and debris.

#### 5. Statement of Intended Use

The Restore Wound Cleanser is intended for the removal of foreign material such as dirt and debris from dermal wounds.

## 6. Statement of Technological Characteristics and Substantial Equivalence

The Restore wound cleanser is substantially equivalent to the predicate devices identified in item 3 above in its intended use. All of the wound cleansers are intended for use on dermal wounds and abrasions. The R and the predicate devices are all indicated for high, medium, and low exudating dermal wounds.estore Wound Cleanser

Issues of biomaterial safety or biocompatibility have been addressed based upon biomaterial history or in separate in-vitro or in-vivo laboratory evaluations using licensed commercial reference laboratories. This assessment has been conducted based on the principles

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KOYO779
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and guidelines established by various governmental regulatory agencies and standard setting organizations.

Among these are the following:

- ISO 10993, International Standard Organization (ISO) Standard --
- General Program Memorandum #G95-1, U.S. FDA Office of Device Evaluation --
- United Stated Pharmacopoeia (USP) --
- Federal Hazardous Substances Act Regulations (FHSA), 16CFR Part 1500 --
- FDA Good Laboratory Practice (GLP) Regulations, 21CFR Part 58

The biocompatibility tests that have been performed demonstrate that the Restore Wound Cleanser is considered appropriate for its intended use.

#### 7. Conclusion

--

Based on the information presented above it is concluded that the proposed Restore Wound Cleanser is safe and effective for its intended use and is substantially equivalent to the identified predicate devices.