LIQUISHIELD-S (0.7G), MODEL LS 0010, LIQUISHIELD-S (2.0G), MODEL LS 0020

K023163 · Medlogic Global Limited · KMF · Jan 13, 2003 · General Hospital

Device Facts

• Record ID: K023163
• Device Name: LIQUISHIELD-S (0.7G), MODEL LS 0010, LIQUISHIELD-S (2.0G), MODEL LS 0020
• Applicant: Medlogic Global Limited
• Product Code: KMF · General Hospital
• Decision Date: Jan 13, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5090
• Device Class: Class 1

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.

Device Story

LiquiShield®-S is a cyanoacrylate-based liquid barrier film; applied topically to skin; dries within 45 seconds to form a transparent, flexible, waterproof film; wears off naturally as skin regenerates. Used to protect skin from moisture, friction, shear, and adhesive irritation. Applicator and packaging are sterilized. No complex electronics or software involved.

Clinical Evidence

Biocompatibility testing performed per ISO 10993-1. Mechanical and performance testing conducted to demonstrate equivalence to predicate. Clinical evaluations conducted to demonstrate device meets intended use.

Technological Characteristics

Cyanoacrylate-based liquid barrier film; non-cytotoxic; forms transparent flexible film upon drying; sterilized applicator and packaging. Biocompatibility testing per ISO 10993-1.

Indications for Use

Indicated for protection of intact or damaged skin from moisture (urine, feces, digestive juices, perspiration, wound drainage), friction, shear, and irritation from adhesive products. Contraindicated for deep, open, or bleeding wounds, chronic wounds, second or third-degree burns, and infected areas.

Regulatory Classification

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.

Predicate Devices

• 3M No Sting Barrier Film (K955103)

Submission Summary (Full Text)

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JAN 1 3 2003

# 510 (k) Notification - LiquiShield®-S

| Submitted by: | MedLogic Global Limited<br>Western Wood Way<br>Langage Science Park<br>Plymouth, Devon. PL7 5BG UK<br>[phone] |
|----------------------|-----------------------------------------------------------------------------------------------------------------------|
| 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 Film<br>3M Medical Products Group<br>K955103 |

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:

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.

### 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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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 [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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