LiquiBand Plus

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. March 9, 2020 Advanced Medical Solutions Limited Martin Mitchell Senior Regulatory Affairs Associate Western Wood Way , Langage Science Park Plymouth, PL7 5BG Gb # Re: K183570 Trade/Device Name: LiquiBand Plus Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue Adhesive Regulatory Class: Class II Product Code: MPN Dated: March 9, 2020 Received: March 9, 2020 # 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. 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 {1}------------------------------------------------ 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, Kimberly M. Ferlin, Ph.D. Assistant Director (Acting) 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) K183570 Device Name LiquiBand Plus #### Indications for Use (Describe) LiquiBand® Plus is intended for topical applications 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. LiquiBand® Plus may be used in conjunction with, but not in place of, deep dermal stitches. | Type of Use (Select one or both, as applicable) | | |------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------| | <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;"> </span> 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 PRAStaff@fda.hhs.gov "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}------------------------------------------------ K183570 – Page 1 of 3 Image /page/3/Picture/1 description: The image shows 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 company name "Advanced Medical Solutions Ltd" is written in blue font. The logo is simple and professional, conveying a sense of innovation and expertise. Advanced Medical Solutions Ltd Western Wood Way, Langage Science Park, Plympton, Plymouth, Devon, PL7 5BG, UK Tel : +44 (0)1752 209955 Fax : +44 (0)1752 209956 Web : www.admedsol.com #### 510(k) Summary | Submitted by: | Advanced Medical Solutions Limited<br>Western Wood Way<br>Langage Science Park<br>Plymouth, Devon. PL7 5BG<br>United Kingdom<br>Tel: +44 (0)1752 209955<br>Fax: +44 (0) 1752 209956 | |----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Martin Mitchell<br>Senior Regulatory Affairs Associate | | Date of Summary: | 5th March 2020 | | Device Name: | LiquiBand® Plus | | Common Name: | Topical Skin Adhesive | | Classification Name: | Tissue adhesive | | Regulatory Number: | 21 CFR 878.4010 | | Device Class: | Class II | | Product Code: | MPN | | Predicate Device<br>Device Name: | LiquiBand® Exceed | | 510(k) Clearance: | K151182 | | Reference Device<br>Device Name: | High Viscosity Dermabond® Mini Topical Skin Adhesive | | 510(k) Clearance: | K152096 | Image /page/3/Picture/5 description: The image contains two logos and a certificate number. The first logo on the left is the BSI logo, which features the letters "bsi" above a heart shape, all enclosed in a circle. The second logo on the right includes a checkmark above the words "UKAS MANAGEMENT SYSTEMS" and the number "003". Below the logos is the text "Certificate No. MD 695793". {4}------------------------------------------------ K183570 – Page 2 of 3 Image /page/4/Picture/1 description: The image shows the logo for Advanced Medical Solutions Ltd. The logo features a stylized blue "A" with a swoosh extending from the right side. Below the logo, the company name "Advanced Medical Solutions Ltd" is written in blue font. Advanced Medical Solutions Ltd Western Wood Way, Langage Science Park, Plympton, Plymouth, Devon, PL7 5BG, UK Tel : +44 (0)1752 209955 Fax : +44 (0)1752 209956 Web : www.admedsol.com #### Device Description LiquiBand® Plus topical skin adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-Octyl-cyanoacrylate) formulation and the colorant D&C Violet #2. It is provided in a single patient use applicator and packaged in a pouch. The LiquiBand® Plus topical skin adhesive product is comprised of a crushable glass ampoule contained within a plastic applicator with attached foam applicator tip. LiquiBand® Plus topical skin adhesive remains liquid until it is applied to the skin. Upon application LiquiBand® Plus topical skin adhesive polymerizes within minutes. In vitro studies have shown that LiquiBand® Plus topical skin adhesive 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 and a correlation between microbial barrier properties and a reduction in infection have not been established. #### Indications for Use LiquiBand® Plus is intended for topical applications 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. LiquiBand® Plus may be used in conjunction with, but not in place of, deep dermal stitches. #### Comparison of Technological Characteristics with the Predicate Device A comparison of the technological characteristics of LiquiBand® Plus and the predicate device are outlined below: - . Applicator tip: LiquiBand® Plus has a polyethylene tip base and foam. The predicate has a polypropylene tip base and a polyurethane foam. - . Adhesive accelerant: LiquiBand® Plus contains an accelerant in the foam tip. - . Applicator body: The LiquiBand® Plus applicator has the same design but is 10mm shorter in length compared to the predicate. - Adhesive: Both devices contain a 2-octyl cyanoacrylate based adhesive with D&C Violet #2 colorant. LiquiBand® Plus contains 0.41g and the predicate contains 0.80g of adhesive. Image /page/4/Picture/14 description: The image shows two certification logos. The first logo on the left is the BSI (British Standards Institution) logo, which features the letters "bsi." above a heart shape, all enclosed in a circle. The second logo on the right is the UKAS (United Kingdom Accreditation Service) Management Systems logo, which includes a crown above a checkmark, with the text "UKAS MANAGEMENT SYSTEMS" and the number "003" below. The text "Certificate No. MD 695793" is printed below the logos. {5}------------------------------------------------ K183570 – Page 3 of 3 Image /page/5/Picture/1 description: The image shows 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 is the company name, "Advanced Medical Solutions Ltd," also in blue. Advanced Medical Solutions Ltd Western Wood Way, Langage Science Park, Plympton, Plymouth, Devon, PL7 5BG, UK Tel : +44 (0)1752 209955 Fax : +44 (0)1752 209956 Web : www.admedsol.com ## 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 LiquiBand® Plus to demonstrate substantial equivalence to the predicate device: - 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) - Degradation rate - Accelerant degradation assessment - Heat of polymerisation - Force to actuate and express - Viscosity - Polymerization set time and clog time - Microbial barrier testing - Quality of film testing - Animal wound healing study #### Biocompatibility The biological evaluation of LiquiBand® Plus was performed in accordance with FDA guidance on the use of ISO 10993-1. The following endpoints were addressed as part of the submission: - Cytotoxicity - . Sensitization - . Irritation - Acute systemic toxicity - Implantation - Subacute systemic toxicity - Material-mediated pyrogenicity #### Conclusions Based on the intended use, technological characteristics, safety and performance testing, LiquiBand® Plus has been demonstrated to be substantially equivalent to the predicate device, LiquiBand® Exceed. Image /page/5/Picture/31 description: The image contains two logos. The logo on the left is a circle with the letters "bsi." above a heart-shaped symbol. The logo on the right has a crown above a check mark with the words "UKAS MANAGEMENT SYSTEMS" below it. The number "003" is at the bottom of the right logo, and the text "Certificate No. MD 695793" is below both logos.