(112 days)
Not Found
No
The device description and performance studies focus on the physical properties and biocompatibility of a liquid barrier film, with no mention of AI or ML technologies.
No.
The device acts as a protective barrier on the skin, preventing irritation rather than treating a disease or condition. While it protects damaged skin, its primary mode of action is preventative and physical, not therapeutic in the sense of actively healing or curing.
No
Explanation: The device is described as a liquid barrier film intended to protect skin from moisture, friction, and irritation. It does not mention any function related to identifying, detecting, or monitoring a disease or condition.
No
The device description clearly states it is a "liquid barrier film" and describes its physical properties and application, indicating it is a physical product, not software.
Based on the provided information, LiquiShield®-S is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use of LiquiShield®-S is to protect intact or damaged skin from external factors like moisture, friction, and shear. This is a topical application for skin protection, not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a liquid barrier film applied to the skin. This aligns with a topical protective product, not a device used for in vitro analysis.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information about a patient's health status.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. LiquiShield®-S does not fit this description.
N/A
Intended Use / 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 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.
Product codes (comma separated list FDA assigned to the subject device)
KMF
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.
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
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 1 3 2003
510 (k) Notification - LiquiShield®-S
| Submitted by: | MedLogic Global Limited
Western Wood Way
Langage Science Park
Plymouth, 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 Film
3M Medical Products Group
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
1
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
2
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.
3
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
4
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