(336 days)
No
The summary describes a topical skin adhesive and an adjunct wound closure device. There is no mention of AI or ML in the intended use, device description, or performance studies. The testing focuses on physical and adhesive properties.
No.
The device is a topical skin adhesive intended for wound closure, not for treating or curing a disease or condition.
No
Explanation: The device is a topical skin adhesive intended for wound closure, not for diagnosing medical conditions. Its function is to approximate skin edges and maintain alignment, which is a therapeutic application.
No
The device description clearly outlines a physical product consisting of a liquid topical skin adhesive and a self-adhering mesh, with performance studies focused on physical properties and wound closure strength.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that LiquiBand® XL is for "topical application only to hold closed easily approximated skin edges of wounds". This is a direct application to the body for wound closure, not for testing samples taken from the body to diagnose or monitor a condition.
- Device Description: The description details a topical skin adhesive and a self-adhering mesh, both applied externally to the skin.
- 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 used to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. LiquiBand® XL's function is purely mechanical and topical for wound closure.
N/A
Intended Use / Indications for Use
LiquiBand® XL is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. LiquiBand® XL should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.
Product codes
OMD
Device Description
LiquiBand® XL is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet No. 2. It is provided in a single-use applicator. As applied to skin, the liquid topical skin adhesive is slightly more viscous than water and polymerizes within minutes.
In vitro studies have shown that LiguiBand® XL acts as a barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties.
LiquiBand® XL also incorporates a self-adhering mesh that is approximated skin edges to provide temporary skin edge alignment to an incision until the liquid adhesive is applied to achieve skin closure.
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)
Testing was performed in accordance with the FDA special controls guidance document for "Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin"
The following tests were performed on the LiquiBand® XL to demonstrate substantial equivalence to the predicate device:
- Peel Adhesion of Pressure-Sensitive Tape (ASTM D3330/D3330M-04) ●
- Shear Adhesion of Pressure-Sensitive Tapes (ASTM D3654/D3654M-06) ●
- Tensile Properties of Thin Plastic Sheeting (ASTM D882-12)
- Lap-shear strength (ASTM F2255-05)
- T-peel adhesion strength (ASTM F2256-05)
- Adhesive strength in tension (ASTM F2258-05)
- Wound closure strength (ASTM F2458-05)
- Adhesive degradation study
- Heat of polymerization
- Force to actuate and express
- Viscosity
- Polymerization set time
- Microbial barrier testing
- Quality of adhesive film on mesh
- Accelerant degradation study ●
- Animal wound healing study
Biocompatibility: The biological evaluation of the LiguiBand® XL was performed in accordance with FDA guidance on the use of ISO 10993-1. The following test reports were provided in this submission: Cytotoxicity, Sensitization, Irritation, Material mediated pyrogenicity, Acute systemic toxicity, Chemical characterization and toxicological risk assessment.
Clinical Testing: No clinical testing has been submitted, referenced, or relied upon for determining substantial equivalence.
Conclusions: Based on the intended use, technological characteristics, safety and performance testing, LiquiBand® XL has been demonstrated to be substantially equivalent to the predicate device, Exofin Fusion Skin Closure System.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4011 Tissue adhesive with adjunct wound closure device for topical approximation of skin.
(a)
Identification. A tissue adhesive with adjunct wound closure device intended for the topical approximation of skin is a device indicated for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including punctures from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. It may be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of wound during application of the liquid adhesive.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin.” See § 878.1(e) for the availability of this guidance document.
0
Build Correspondence
Image /page/0/Picture/2 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 23, 2022
Advanced Medical Solutions Limited Martin Mitchell Senior Regulatory Affairs Associate Western Wood Way , Langage Science Park Plymouth, Devon PL7 5BG United Kingdom
Re: K211878
Trade/Device Name: LiquiBand® XL Regulation Number: 21 CFR 878.4011 Regulation Name: Tissue Adhesive With Adjunct Wound Closure Device For Topical Approximation Of Skin Regulatory Class: Class II Product Code: OMD Dated: May 4, 2022 Received: May 4, 2022
Dear Martin Mitchell:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
1
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); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K211878
Device Name LiquiBand® XL
LiquiBand® XL is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. LiquiBand® XL should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of
information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/0 description: The image contains the logo for Advanced Medical Solutions Ltd. The logo features a stylized blue letter "A" with a swoosh extending from the top right. Below the logo, the company name "Advanced Medical Solutions Ltd" is written in blue, sans-serif font. The overall design is clean and professional.
Advanced Medical Solutions Limited Western Wood Way, Langage Science Park, Plymouth, Devon, PL7 5BG, United Kingdom Tel: +44 (0) 1752 209955 Fax: +44 (0) 1752 209956 Web: www.admedsol.com Registered in England 2666957 VAT No. GB 636 5551 27
510(k) Summary
| Submitted by: | Advanced Medical Solutions Limited
Western Wood Way
Langage Science Park
Plymouth, Devon
PL7 5BG
United Kingdom
Tel: +44 (0)1752 209955
Fax: +44 (0) 1752 209956 |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Martin Mitchell
Regulatory Affairs Manager |
| Date of Summary: | 19th May 2022 |
| Device Name: | LiquiBand® XL |
| Common Name: | Cutaneous Tissue Adhesive With Mesh |
| Classification Name: | Tissue adhesive with adjunct wound closure device for topical approximation of skin |
| Regulatory Number: | 21 CFR 878.4011 |
| Device Class: | Class II |
| Product Code: | OMD |
| Predicate Device
Device Name:
510(k) Clearance: | Exofin Fusion Skin Closure System
K191461 |
| Reference Device
Device Name:
510(k) Clearance: | LiquiBand® Plus
K183570 |
Image /page/3/Picture/4 description: The image shows two logos. The first logo is for the UK Authorized Economic Operator, and it features the letters "AEO" in bold black font, with a map of the UK inside of a circle. The second logo is for BSI, and it features a heart-shaped design with the letters "bsi" above it. The certificate number MD 695790 is printed below the BSI logo.
4
Image /page/4/Picture/0 description: The image shows the logo for Advanced Medical Solutions Ltd. The logo features a stylized blue letter A with a swoosh above the text. The text "Advanced Medical Solutions Ltd" is written in blue font below the logo.
Device Description
LiquiBand® XL is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet No. 2. It is provided in a single-use applicator. As applied to skin, the liquid topical skin adhesive is slightly more viscous than water and polymerizes within minutes.
In vitro studies have shown that LiguiBand® XL acts as a barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties.
LiquiBand® XL also incorporates a self-adhering mesh that is approximated skin edges to provide temporary skin edge alignment to an incision until the liquid adhesive is applied to achieve skin closure.
Indications for Use
LiquiBand® XL is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. LiquiBand® XL should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.
Comparison of Technological Characteristics with the Predicate Device
The technological characteristics of the LiquiBand® XL and the predicate device are similar, in that they both contain the same technological characteristics:
| Device | Subject device: LiquiBand® XL | Predicate device: Exofin Fusion Skin
Closure System | Comparison |
|------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------|
| Adhesive | 2-octyl cyanoacrylate adhesive with
D&C Violet #2 colorant | 2-octyl cyanoacrylate adhesive with
D&C Violet #2 colorant | Same |
| Accelerant | Quaternary ammonium salt | Quaternary ammonium salt | Same |
| Applicator | Sterile single use applicator;
comprising of a glass ampoule
(containing the adhesive) within a
plastic applicator body with a
porous block (containing the
accelerant) with a foam applicator
tip | Sterile single use applicator;
comprised of an aluminum tube
(containing the adhesive) with a
porous disk (containing the
accelerant) with an applicator tip | Equivalent |
| Mesh | Polyester mesh with pressure
sensitive adhesive | Polyester mesh with pressure
sensitive adhesive | Same |
Image /page/4/Picture/11 description: The image shows two logos side by side. The first logo on the left has the letters "AEO" in large, bold font, with an image of the United Kingdom inside a circle to the right of the letters. Below the letters, the text "UK Authorised Economic Operator" is printed. The second logo on the right has the letters "bsi" above a heart-shaped design. To the right of this logo is a square containing a crown above a check mark, with the text "UKAS MANAGEMENT SYSTEMS" below. The number "0003" is printed below this text, and the text "Certificate No. MD 695790" is printed below the entire logo.
5
Image /page/5/Picture/0 description: The image contains the logo for Advanced Medical Solutions Ltd. The logo features a stylized blue "A" with a swoosh extending from the top right. Below the logo, the text "Advanced Medical Solutions Ltd" is written in blue, with each word on the same line.
Advanced Medical Solutions Limited Western Wood Way. Langage Science Park, Plymouth. Devon, PL7 5BG, United Kingdom Tel: +44 (0) 1752 209955 Fax: +44 (0) 1752 209956 Web: www.admedsol.com Registered in England 2666957 VAT No. GB 636 5551 27
Performance Data
Testing was performed in accordance with the FDA special controls guidance document for "Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin"
Performance Testing
The following tests were performed on the LiquiBand® XL to demonstrate substantial equivalence to the predicate device:
- Peel Adhesion of Pressure-Sensitive Tape (ASTM D3330/D3330M-04) ●
- Shear Adhesion of Pressure-Sensitive Tapes (ASTM D3654/D3654M-06) ●
- Tensile Properties of Thin Plastic Sheeting (ASTM D882-12)
- Lap-shear strength (ASTM F2255-05)
- T-peel adhesion strength (ASTM F2256-05)
- Adhesive strength in tension (ASTM F2258-05)
- Wound closure strength (ASTM F2458-05)
- Adhesive degradation study
- Heat of polymerization
- Force to actuate and express
- Viscosity
- Polymerization set time
- Microbial barrier testing
- Quality of adhesive film on mesh
- Accelerant degradation study ●
- . Animal wound healing study
Biocompatibility
The biological evaluation of the LiguiBand® XL was performed in accordance with FDA guidance on the use of ISO 10993-1. The following test reports were provided in this submission:
- Cytotoxicity
- Sensitization
- . Irritation
- Material mediated pyrogenicity
- Acute systemic toxicity
- Chemical characterization and toxicological risk assessment ●
Clinical Testing
- No clinical testing has been submitted, referenced, or relied upon for determining substantial ● equivalence.
Conclusions
Based on the intended use, technological characteristics, safety and performance testing, LiquiBand® XL has been demonstrated to be substantially equivalent to the predicate device, Exofin Fusion Skin Closure System.
Image /page/5/Picture/34 description: The image contains three logos. The first logo on the left has the letters AEO in bold black font, with a globe containing the UK to the right of the letters. Below the letters, the text reads "UK Authorised Economic Operator". The second logo is a circle with the letters "bsi" above a heart-shaped figure with a line through it. The third logo is a square with a crown above a circle containing a checkmark. Below the circle, the text reads "UKAS MANAGEMENT SYSTEMS 0003".