(271 days)
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.
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.
Here's a breakdown of the acceptance criteria and study information based on the provided text for the LiquiShield™ Liquid Bandage:
Acceptance Criteria and Study Information for LiquiShield™ Liquid Bandage
This device is not an AI/ML powered device, therefore some sections are not applicable (N/A) as they relate specifically to AI device evaluation.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly state quantitative acceptance criteria for device performance. Instead, it relies on demonstrating substantial equivalence to a predicate device and meeting intended use requirements through various testing.
| Aspect of Performance | Acceptance Criteria (Inferred from Substantial Equivalence and Intended Use) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Confirmation that the product is safe for its intended use (in accordance with BSENISO 10993-1). | "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." |
| Mechanical & Performance Equivalence | Equivalence to the predicate device (LIQUIDERM™ Liquid Adhesive Bandage) in properties such as application, drying, barrier formation, haemostatic, quick drying, keeps out dirt and germs, waterproof, and flexibility. | "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. Substantial equivalence is also based on intended use, application, product performance, haemostatic, quick drying, keeps out dirt and germs, waterproof and flexibility properties." The device "is applied as a liquid and dries, within approximately 45 seconds, adhering to the contours of the skin to form a transparent, flexible film." and "wears off naturally as the skin regenerates." |
| Intended Use Requirements | Ability to cover minor cuts and scrapes, minor irritations of the skin, and help protect them from infection. | "Clinical evaluations conducted to demonstrate that LiquiShield™ Liquid Bandage meets its intended use requirements." |
| Sterility | Supplied sterile and suitable for aseptic techniques. | "The applicator and contents are supplied sterile, and the device is, therefore, suitable for aseptic techniques." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified in the provided text. The document mentions "appropriate biocompatibility testing" and "mechanical and performance testing" along with "clinical evaluations," but does not detail the sample sizes for these tests.
- Data Provenance: Not specified. The document does not indicate the country of origin of the data or whether the studies were retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
4. Adjudication Method for the Test Set
- Adjudication Method: Not specified. This type of device evaluation (for a liquid bandage) typically does not involve expert adjudication in the same way an AI diagnostic device would.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- Was an MRMC study done? No. This type of study is typically relevant for diagnostic devices involving interpretation by multiple readers, often with AI assistance. It is not applicable to a liquid bandage.
- Effect Size of AI improvement: N/A, as no AI was involved.
6. Standalone (Algorithm Only) Performance Study
- Was a standalone study done? No. This is also not applicable as the device is a physical product (liquid bandage), not a standalone algorithm.
7. Type of Ground Truth Used
The ground truth for this device's evaluation appears to be based on:
- Established Biocompatibility Standards: BSENISO 10993-1.
- Direct Measurement/Observation of Physical Properties: Such as drying time, film formation, adherence, waterproof nature, flexibility, and ability to keep out dirt and germs.
- Clinical Observation: To demonstrate that the product "meets its intended use requirements" for covering minor cuts/scrapes and protecting from infection.
- Comparison to Predicate Device: The predicate device serves as the benchmark for "substantial equivalence" across various performance aspects.
8. Sample Size for the Training Set
- Sample Size for Training Set: N/A. This concept is relevant for AI/ML models that require training data. The LiquiShield™ Liquid Bandage is a conventional medical device and does not have a "training set."
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth Was Established: N/A, as there is no training set for this conventional device.
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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 209955Fax: 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 infectionDeep puncture woundsAnimal bitesSerious burns |
:
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031321(P.2 of 2)
| Description: | LiquiShield™ Liquid Bandagebiocompatible cyanoacrylate-based,drying, liquid barrier film for the protectionthe skin. It is applied as a liquid and dries,within approximately 45 seconds, adhering tothe contours of the skin to form a transparent,flexible film. LiquiShield™ Liquid Bandagewears off naturally as the skin regenerates.The applicator and contents are suppliedsterile, and the device is, therefore, suitable foraseptic techniques. |
|---|---|
| Substantial equivalence: | LiquiShield™ Liquid Bandage is substantiallyequivalent to the following predicate device:LIQUIDERM™ Liquid Adhesive Bandagemanufactured by Closure Medical Corp.,K002338, (Marketed as Johnson & JohnsonBand-Aid® Liquid Bandage).LiquiShield™ Liquid Bandage is applied as aliquid, which, upon contact with the skin, driesto form a barrier film, which is substantiallyequivalent to the predicate device. Substantialequivalence 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 beensubjected to the appropriate biocompatibilitytesting in accordance with BSENISO 10993-1,the results of which confirm that the product issafe for its intended use. LiquiShield™ LiquidBandage has also been subjected tomechanical and performance testing todemonstrate equivalence to the predicatedevice, with clinical evaluations conducted todemonstrate that LiquiShield™ Liquid Bandagemeets its intended use requirements. |
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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.
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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
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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
: ·
Page 1 of 1
Neurological Devices
್ತಾರೆ. ಈ ದಿ, Pentorative
§ 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.