(271 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a liquid bandage, with no mention of AI or ML technologies.
No
The device is a liquid bandage intended to cover minor cuts and scrapes and protect them from infection, which aligns with the definition of a therapeutic device designed to treat, mitigate, or prevent disease or injury.
No
The device description and intended use indicate it is a liquid bandage applied to cover and protect skin, not to diagnose any condition.
No
The device description clearly states it is a "biocompatible cyanoacrylate-based, drying, liquid barrier film," which is a physical substance applied to the skin, 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 cover and protect minor cuts, scrapes, and skin irritations. This is a topical application for wound care and protection, not for diagnosing a condition or analyzing a sample from the body.
- Device Description: The description details a liquid barrier film applied to the skin. It doesn't mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.).
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing a sample from the human body.
- Providing information for diagnosis, monitoring, or screening.
- Using reagents or assays.
Therefore, LiquiShield™ Liquid Bandage is a medical device for wound care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
LiquiShield™ Liquid Bandage is intended for over the counter (OTC) use to cover minor cuts and scrapes and minor irritations of the skin and help protect them from infection.
Product codes
KMF
Device Description
LiquiShield™ Liquid Bandage biocompatible cyanoacrylate-based, drying, liquid barrier film for the protection the skin. It is applied as a liquid and dries, within approximately 45 seconds, adhering to the contours of the skin to form a transparent, flexible film. LiquiShield™ Liquid Bandage wears off naturally as the skin regenerates. The applicator and contents are supplied sterile, and the device is, therefore, suitable for aseptic techniques.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
Indicated Patient Age Range
Not Found
Intended User / Care Setting
over the counter (OTC) use
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)
LiquiShield™ Liquid Bandage has been subjected to the appropriate biocompatibility testing in accordance with BSENISO 10993-1, the results of which confirm that the product is safe for its intended use. LiquiShield™ Liquid Bandage has also been subjected to mechanical and performance testing to demonstrate equivalence to the predicate device, with clinical evaluations conducted to demonstrate that LiquiShield™ Liquid Bandage meets its intended use requirements.
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
JAN 2 1 2004
031321 (P.1042)
| Appendix 2 | |
|---|---|
| 510(k) Summary | |
| Submitted by: | MedLogic Global Limited, |
| Western Wood Way, | |
| Langage Science Park, | |
| Plymouth, | |
| Devon, | |
| PL7 5BG, | |
| England | |
| Telephone: 44 1752 209955 | |
| Fax: 44 1752 209956 | |
| Contact name: | Richard Stenton, Managing Director |
| Date prepared: | 23rd October 2003 |
| Device trade name: | LiquiShield™ Liquid Bandage |
| Common name: | Liquid Bandage |
| Classification name: | Liquid Bandage |
| Classification regulation no.: | 880.5090 |
| Classification: | Class 1 |
| Predicate device: | LIQUIDERM™ Liquid Adhesive Bandage manufactured by Closure Medical Corp., K002338, (Marketed as Johnson & Johnson Band-Aid® Liquid Bandage). |
| Intended use: | LiquiShield™ Liquid Bandage is intended for over the counter (OTC) use to cover minor cuts and scrapes and minor irritations of the skin and help protect them from infection. |
| Contraindications: | Application to: |
| Burns or wounds with active signs of infection | |
| Deep puncture wounds | |
| Animal bites | |
| Serious burns |
:
1
031321(P.2 of 2)
| Description: | LiquiShield™ Liquid Bandage
biocompatible cyanoacrylate-based,
drying, liquid barrier film for the protection
the skin. It is applied as a liquid and dries,
within approximately 45 seconds, adhering to
the contours of the skin to form a transparent,
flexible film. LiquiShield™ Liquid Bandage
wears off naturally as the skin regenerates.
The applicator and contents are supplied
sterile, and the device is, therefore, suitable for
aseptic techniques. |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Substantial equivalence: | LiquiShield™ Liquid Bandage is substantially
equivalent to the following predicate device:
LIQUIDERM™ Liquid Adhesive Bandage
manufactured by Closure Medical Corp.,
K002338, (Marketed as Johnson & Johnson
Band-Aid® Liquid Bandage).
LiquiShield™ Liquid Bandage is applied as a
liquid, which, upon contact with the skin, dries
to form a barrier film, which is substantially
equivalent to the predicate device. Substantial
equivalence is also based on intended use,
application, product performance, haemostatic,
quick drying, keeps out dirt and germs,
waterproof and flexibility properties. |
| Testing summary: | LiquiShield™ Liquid Bandage has been
subjected to the appropriate biocompatibility
testing in accordance with BSENISO 10993-1,
the results of which confirm that the product is
safe for its intended use. LiquiShield™ Liquid
Bandage has also been subjected to
mechanical and performance testing to
demonstrate equivalence to the predicate
device, with clinical evaluations conducted to
demonstrate that LiquiShield™ Liquid Bandage
meets its intended use requirements. |
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines extending from its back, representing the department's mission to promote health and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 1 2004
Mr. Mel Longhurst MedLogic Global Limited Western Wood Way Langage Science Park Plymouth, Devon, PL7 5BG England
Re: K031321
Trade/Device Name: Liquishield Liquid Bandage Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid bandage Regulatory Class: I Product Code: KMF Dated: November 7, 2003 Received: November 12, 2003
Dear Mr. Longhurst:
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 (OS) 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 – Mr. Mel Longhurst
This letter will allow you to begin marketing your device as described in your Scction 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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation cntitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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
ん( 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
510(k) Number (if known): __ K031321
Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
LiquiShield™ Liquid Bandage is intended to cover minor cuts and scrapes and minor irritations of the skin and help protect them from infection.
Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use OTC USE (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Muriam C. Provost
: ·
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Neurological Devices
್ತಾರೆ. ಈ ದಿ, Pentorative