CURAD

K022645 · Beiersdorf AG · KMF · Nov 5, 2002 · General Hospital

Device Facts

• Record ID: K022645
• Device Name: CURAD
• Applicant: Beiersdorf AG
• Product Code: KMF · General Hospital
• Decision Date: Nov 5, 2002
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

CURAD® Spray Bandage is indicated for providing a covering over minor cuts and scrapes that are clean and dry.

Device Story

CURAD® Spray Bandage is a liquid bandage product packaged in a pressurized aerosol can. The user sprays a light coat onto clean, dry minor cuts or scrapes from a distance of approximately 5 inches. The liquid polymer dries within 2-3 minutes to form a flexible, transparent, water-tight, and germ-sealing film. The bandage adheres for several days and can be removed by dissolving with isopropyl alcohol. The device is intended for over-the-counter use to protect minor wounds from external contaminants while allowing water vapor permeability.

Clinical Evidence

Bench testing only. Performance verified for flexibility, transparency, water-tightness, water vapor permeability, and germ-sealing capabilities. Biocompatibility assessment performed on patient-contact materials with satisfactory results.

Technological Characteristics

Composition: poly(methylacrylate-isobutene-monoisopropylmaleate), ethyl acetate, n-pentane, carbon dioxide, menthol. Form factor: Pressurized aerosol spray. Principle: Liquid polymer film formation upon solvent evaporation. Properties: Water-tight, water vapor permeable, flexible, transparent.

Indications for Use

Indicated for covering minor cuts and scrapes that are clean and dry in patients requiring topical wound protection.

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

• Liquiderm™ liquid adhesive bandage (K002338)

Submission Summary (Full Text)

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# 510(k) Summary for CURAD® Spray Bandage

# KO22645

#### 1. SPONSOR

Beiersdorf AG Hamburg, Germany Mr. Volker Holle Contact Person:

#### 2. Device Name

Proprietary Name: CURAD® Spray bandage Common/Usual Name: Classification Information:

Liquid bandages have been classified as Class I devices under the following classification name:

| Name | Product Code | 21 CFR Ref. | Panel |
|----------------|--------------|-------------|---------------------------|
| Liquid bandage | KMF | 880.5090 | General & Plastic Surgery |

#### PREDICATE DEVICES 3.

Liquiderm™ liquid adhesive bandage, 510(k) No. K002338.

#### DEVICE DESCRIPTION 4.

The product is packaged in a pressurized can. The can is held about 5 inches from affected area, and a light coat is sprayed onto the skin. CURAD® Spray Bandage typically dries in 2-3 minutes. Once dried, additional coats can be applied, if needed.

CURAD® Spray Bandage will typically adhere for several days before losing its adhesive strength. To remove it before it has lost its adhesive strength, the user can apply isopropyl alcohol to the bandage to dissolve it.

CURAD® Spray Bandage is composed of the following ingredients:

poly(methylacrylate-isobutene-monoisopropylmaleate), ethyl acetate, npentane, carbon dioxide, menthol

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The monomers of poly(methylacrylate-isobutene-monoisopropylmaleate) combine randomly with each other without preference.

#### INTENDED USE ડ.

CURAD® Spray Bandage is indicated for providing a covering over minor cuts and scrapes that are clean and dry.

#### TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE 6.

CURAD® Spray Bandage and Liquiderm™ liquid adhesive bandage have slightly different indication statements, but the intended use of the productscovering minor openings in the skin-are the same. Both products use a liquid polymer to cover the wound and have many of the same functional characteristics, such as water-tightness, water vapor permeability and flexibility.

#### PERFORMANCE TESTING 7.

CURAD® Spray Bandage is flexible, transparent, and water-tight, but allows the passage of water vapor. In addition, CURAD® Spray Bandage seals out germs. A summary of testing to support each of these claims has been established and verified. A biocompatibility assessment was performed on the patient-contact materials of CURAD® Spray Bandage with satisfactory results.

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### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

### 5 2002 NOV

Beiersdorf AG c/o Daniel J. Dillon Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, Massachusetts 02760

Re: K022645

Trade/Device Name: CURAD® Spray Bandage Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid Bandage Regulatory Class: Class I Product Code: KMF Dated: August 7, 2002 Received: August 8, 2002

Dear Mr. Dillon:

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.

Image /page/2/Picture/11 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird with three stylized lines forming its body and wings.

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Page 2 - Mr. Daniel Dillon

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,

Miriam C. Provost

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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510(k) Number (if known):

K022645

CURAD® Spray Bandage Device Name:

Indications For Use:

CURAD® Spray Bandage is indicated for providing a covering over minor cuts and scrapes that are clean and dry.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, I morative and Neurological De news

510(k) Number -

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter Use

(Optional Format 1-2-96)

Beiersdorf AG 510(k) CURAD® Spray Bandage August 7, 2002