LiquiShield®-S can also be used in areas that are exposed to friction and shear such as occurs when items, such as bedding, clothing, or shoes, rub against the skin.

LiquiShield®-S helps protect the skin against irritation caused by adhesive products.

Device Description

LiquiShield®-S is a non-cytotoxic (not harmful to the bodv) cyanoacrylate based, rapid drying, liquid barrier film for the protection of the skin. It is applied as a liquid and dries, within 45 seconds, adhering to the contours of the skin to form a transparent flexible film. LiquiShield®-S will wear off, naturally, as the skin regenerates. The applicator and packaging are sterilized.

AI/ML Overview

This document is a 510(k) summary for a medical device called LiquiShield®-S, a liquid barrier film. The submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data with acceptance criteria for device performance. Therefore, many of the requested categories (e.g., sample size for test set, number of experts, MRMC studies, training set details) are not explicitly addressed or applicable in the provided text.

Here's an analysis of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not specify numerical "acceptance criteria" for the device, but rather claims substantial equivalence to the predicate device based on several performance aspects.

Performance Aspect	Acceptance Criteria (Implicit)	Reported Device Performance
Material/Composition	Non-cytotoxic, cyanoacrylate-based	Non-cytotoxic, cyanoacrylate-based
Drying Time	Rapid Drying	Within 45 seconds
Adherence	Adheres to contours of skin	Adheres to contours of skin to form a transparent flexible film
Wear-off	Wears off naturally as skin regenerates	Wears off naturally as skin regenerates
Sterilization	Applicator and packaging are sterilized	Applicator and packaging are sterilized
Biocompatibility	Meets ISO 10993-1 standards	Subjected to appropriate biocompatibility testing in accordance with ISO 10993-1, results confirm product is safe for its intended use
MVTR Rates	Substantially equivalent to predicate device	Demonstrated equivalence to the predicate device
Waterproof Properties	Substantially equivalent to predicate device	Demonstrated equivalence to the predicate device
Friction Reduction	Substantially equivalent to predicate device	Demonstrated equivalence to the predicate device
Barrier Film Duration	Substantially equivalent to predicate device	Demonstrated equivalence to the predicate device
Intended Use	Meets stated intended use	Clinical evaluations conducted to demonstrate LiquiShield®-S meets its intended use

2. Sample Size Used for the Test Set and Data Provenance

The document mentions "clinical evaluations" but does not specify a sample size for any "test set." No information on data provenance (e.g., country of origin, retrospective/prospective) is provided. The focus is on demonstrating equivalence through mechanical and performance testing and biocompatibility, not a clinical trial with a defined test set for a specific performance metric.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. The document does not describe a process for establishing ground truth using experts for a test set, as it is a 510(k) submission focused on substantial equivalence rather than a de novo approval requiring extensive clinical validation with expert adjudication.

4. Adjudication Method for the Test Set

Not applicable. No test set or adjudication method is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No MRMC comparative effectiveness study is mentioned. This type of study is typically used for diagnostic devices involving human interpretation of results, which is not the case for a liquid barrier film.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical barrier film, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" in this context is implicitly established by:

Compliance with Standards: Meeting ISO 10993-1 for biocompatibility.
Equivalence to Predicate Device: Mechanical and performance testing to demonstrate equivalence to the 3M No Sting Barrier Film (K955103) for properties like MVTR, waterproofness, friction reduction, and barrier film duration.
Clinical Evaluation: Mentioned as being conducted to demonstrate the device meets its intended use, but no specifics on how "ground truth" was established within these evaluations are provided.

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As above, there is no training set for this type of device.

Summary of Device Performance and Equivalence Claim:

The submission for LiquiShield®-S asserts that the device is substantially equivalent to the predicate device (3M No Sting Barrier Film) based on:

Intended Use and Application: Both are liquid barrier films for skin protection.
Product Performance: Testing demonstrated equivalence in MVTR rates, waterproof properties, friction reduction, and barrier film duration.
Biocompatibility: Conforms to ISO 10993-1, indicating safety.
Clinical Evaluations: Performed to confirm the device meets its intended use.

The provided document, being a 510(k) summary, focuses on regulatory approval through substantial equivalence rather than detailed clinical trial results for specific performance metrics with defined acceptance criteria.

Summary

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JAN 1 3 2003

510 (k) Notification - LiquiShield®-S

Submitted by:	MedLogic Global LimitedWestern Wood WayLangage Science ParkPlymouth, Devon. PL7 5BG UK+44 1752 209955
Contact Name:	Howard Beaumont
Date prepared:	13th September 2002
Device Trade Name:	LiquiShield®-S
Common Name:	Liquid Barrier Film
Classification name:	Liquid Bandage: CFR 880.5090
Classification	Class 1
Predicate Device:	3M No Sting Barrier Film3M Medical Products GroupK955103

510(k) Summary

Intended Use:

LiquiShield™-S is intended to protect intact or damaged skin from the effects of moisture, friction, (rubbing) or shear (tearing).

LiquiShield™-S helps protect skin exposed to irritation from moisture such as urine, faeces, digestive juices and wound drainage. LiquiShield™-S can also be used in areas that are exposed to friction and shear such as occurs when items, such as bedding, clothing, or shoes, rub against the skin.

LiquiShield™-S helps protect the skin against irritation caused by adhesive products.

Contraindications:

Do not apply directly to deep, open, or bleeding wounds. Do not apply to chronic wounds Do apply to second or third degree burns. Do not apply to infected areas

MedLogic Global Limited - LiquiShield -- S Liquid Barrier Film

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510(k) Summary

Description:

Substantial Equivalence:

LiquiShield®-S Liquid Barrier film is substantially equivalent to the following predicate device:

No Sting Barrier Film - 3M™ Medical Products Group K955103

LiquiShield®-S is applied as a liquid solution, 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 upon intended use, application, product performance, including MVTR rates, waterproof properties, friction reduction and barrier film duration.

Testing Summary:

LiquiShield®-S has been subjected to the appropriate biocompatibility testing in accordance with ISO 10993-1, the results of which confirm that product is safe for its intended use. LiquiShield®-S has also been subjected to mechanical and performance testing to demonstrate equivalence to the predicate device, with clinical evaluations conducted to demonstrate LiquiShield®-S meets its intended use.

MedLogic Global Limited – LiquiShield –S Liquid Barrier Film

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a caduceus, often associated with healthcare.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 3 2003

Mr. Howard Beaumont Director of Quality Assurance and Regulatory Affairs MedLogic Global Limited Western Wood Way Langage Science Park Plympton, Plymouth Devon PL7 5BG England

Re: K023163

Trade/Device Name: LiquiShield® -S Regulation Number: 21 CFR 880.5090 Regulation Name: Liquid Bandage Regulatory Class: I Product Code: KMF Dated: December 23, 2002 Received: December 26, 2002

Dear Mr. Beaumont:

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.

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Page 2 - Mr. Howard Beaumont

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.

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), 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) you may obtain. 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

tal 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) Notification - LiquiShield®-S

Applicant:	MedLogic Global Limited
510(k) Number (if known):
Device Name:	LiquiShield®-S

Indications for Use:

LiquiShield®-S is intended to protect intact or damaged skin from the effects of moisture, friction (rubbing), or shear (tearing).

LiquiShield®-S helps protect skin exposed to irritation from moisture such as urine, faeces, digestive juices, perspiration and wound drainage.

LiquiShield®-S can also be used in areas that are exposed to friction and shear such as occurs when items, such as bedding, clothing, or shoes, rub against the skin.

LiquiShield®-S helps protect the skin against irritation caused by adhesive products.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

(Division Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K023163

Prescription Use (per 21 CFR 801.109) OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

MedLogic Global Limited – LiquiShield –S Liquid Barrier Film

Revised on the 23 Dec 2002

Regulation Number and Section

§ 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.