(89 days)
Not Found
No
The device description and performance studies focus on the physical properties and ingredients of a spray bandage, with no mention of AI or ML technologies.
No
A therapeutic device intends to treat or cure a disease or condition. This device provides a covering over minor cuts and scrapes but does not actively treat or cure them.
No
The device is described as a "spray bandage" that provides a covering over minor cuts and scrapes. Its intended use is to protect an area, not to diagnose a condition.
No
The device description clearly indicates it is a physical product packaged in a pressurized can and composed of chemical ingredients, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to provide a covering over minor cuts and scrapes on the skin. This is a topical application for wound care.
- Device Description: The device is a spray applied to the skin. Its function is to create a physical barrier.
- Lack of Diagnostic Purpose: There is no mention of the device being used to test or analyze samples from the human body (like blood, urine, tissue, etc.) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
IVD devices are specifically designed for in vitro (outside the body) examination of specimens. This device is applied directly to the body for a protective purpose.
N/A
Intended Use / Indications for Use
CURAD® Spray Bandage is indicated for providing a covering over minor cuts and scrapes that are clean and dry.
Product codes
KMF
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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
1
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.
2
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
4
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