(89 days)
CURAD® Spray Bandage is indicated for providing a covering over minor cuts and scrapes that are clean and dry.
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
Here's an analysis of the provided text regarding the CURAD® Spray Bandage's acceptance criteria and studies, organized as requested:
Acceptance Criteria and Study for CURAD® Spray Bandage
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Claimed | Reported Device Performance |
|---|---|
| Flexible | Flexible |
| Transparent | Transparent |
| Water-tight | Water-tight |
| Allows passage of water vapor | Allows passage of water vapor |
| Seals out germs | Seals out germs |
| Biocompatible | Biocompatibility assessment performed with satisfactory results |
| Adheres for several days | Typically adheres for several days |
| Dries in 2-3 minutes | Typically dries in 2-3 minutes |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not explicitly state the sample size used for the test set for any of the performance claims. It also does not specify the data provenance (e.g., country of origin, retrospective/prospective). The document states that "A summary of testing to support each of these claims has been established and verified," implying that tests were conducted, but the details are omitted.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts
The provided 510(k) summary does not mention the use of experts to establish ground truth for the test set. The performance claims appear to be based on physical/material property testing rather than expert-derived diagnoses or assessments.
4. Adjudication Method for the Test Set
Since the ground truth appears to be based on objective physical/material property testing rather than expert consensus on subjective assessments, an adjudication method for a test set is not applicable and not mentioned in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in the provided document. The device in question is a liquid bandage, and the performance claims relate to its physical properties, not diagnostic accuracy where human readers would typically be involved.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
This concept is not applicable to this device. The CURAD® Spray Bandage is a physical product, not a software algorithm that performs diagnostic or analytical tasks. Therefore, a "standalone algorithm performance" study was not conducted.
7. Type of Ground Truth Used
The ground truth used for the performance claims appears to be based on objective physical and material property measurements/testing. Examples include evaluating flexibility, transparency, water-tightness, water vapor permeability, germ sealing capability, drying time, adhesion duration, and biocompatibility.
8. Sample Size for the Training Set
There is no mention of a "training set" in the context of this device. A training set is typically associated with machine learning algorithms, which are not relevant to the CURAD® Spray Bandage.
9. How the Ground Truth for the Training Set Was Established
Since there is no training set for this device, the question of how its ground truth was established is not applicable.
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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 (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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):
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
§ 880.5090 Liquid bandage.
(a)
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.(b)
Classification. Class I (general controls). When used only as a skin protectant, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 880.9.