LiquiBand Exceed

{0}------------------------------------------------ Image /page/0/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 emblem featuring a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 26, 2015 Advanced Medical Solutions (Plymouth) Ltd. Dr. Martin Mitchell Western Wood Way Language Science Park Plymouth, Devon. PL7 BG United Kingdom Re: K151182 Trade/Device Name: LiquiBand Exceed Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue Adhesive Regulatory Class: Class II Product Code: MPN Dated: September 23, 2015 Received: September 28, 2015 Dear Dr. 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. 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 {1}------------------------------------------------ CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, # David Krause -S - for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ## Indications for Use 510(k) Number (if known) K151182 Device Name LiquiBand Exceed ## Indications for Use (Describe) LiquiBand Exceed topical skin adhesive 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 Exceed topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches. | <span></span> | <span></span> Prescription Use (Part 21 CFR 801 Subpart D) | |---------------|------------------------------------------------------------| | <span></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." Type of Use (Select one or both, as applicable) {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the logo for Advanced Medical Solutions (Plymouth) Ltd. The logo features a stylized blue "A" symbol above the company name. The text "Advanced Medical Solutions" is in a larger font size than "(Plymouth) Ltd.", and there is a line underneath the company name. Advanced Medical Solutions (Plymouth) 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 (In accordance with 21 CFR 807.92) ## Advanced Medical Solutions (Plymouth) Ltd LiquiBand Exceed ## 1. Submitter | Submitted by: | Advanced Medical Solutions (Plymouth) Ltd.<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: | Dr Martin Mitchell<br>Regulatory Affairs Associate<br>Advanced Medical Solutions (Plymouth) Ltd | Date of Summary: October 2015 ## 2. Device | Device Name: | LiquiBand Exceed | |-----------------------|-----------------------------------| | Common or Usual Name: | Topical Skin Adhesive | | Classification Name: | Tissue Adhesive (21 CFR 878.4010) | | Regulatory Class: | Class II | | Product Code: | MPN | ## 3. Predicate Device | Device Name: | Barle Tissue Adhesive 2 | |-------------------|-------------------------| | 510(k) Clearance: | K132243 | #### 4. Device Description LiquiBand Exceed 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 Exceed topical skin adhesive product is comprised of a crushable glass ampoule contained within a plastic applicator with attached foam applicator tip. LiquiBand Exceed topical skin adhesive remains liquid until it is applied to the skin. Upon application LiquiBand Exceed topical skin adhesive polymerizes within minutes. Image /page/3/Picture/13 description: The image shows two logos side by side. The logo on the left is the BSI logo, which consists of the letters "BSI" above a heart shape inside of a circle. The logo on the right is the UKAS Quality Management logo, which consists of a crown above a check mark, with the words "UKAS QUALITY MANAGEMENT" below the check mark, and the number "003" below the words. Certificate No. MD 585407 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image contains the logo for Advanced Medical Solutions (Plymouth) Ltd. The logo features a stylized letter "A" in blue, with a swoosh extending from the top right. The text "Advanced Medical Solutions" is written in a blue sans-serif font, with the words underlined. Below that, in a smaller font, is the text "(Plymouth) Ltd." Advanced Medical Solutions (Plymouth) 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 In vitro studies have shown that LiquiBand Exceed 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. A single device contains sufficient adhesive to close wound(s) up to a combined length of 30cm. LiquiBand Exceed topical skin adhesive is suitable for intraoperative reuse, for up to 90 minutes on a single patient. ## 5. Indications for Use LiquiBand Exceed topical skin adhesive is intended for topications 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 Exceed topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches. #### 6. Comparison of Technological Characteristics with the Predicate Device The technological characteristics of LiquiBand Exceed and the predicate device are similar, in that they both contain the same high level elements. - A cyanoacrylate based tissue adhesive ● - An ampoule to house the adhesive - An applicator device to apply the adhesive ● The following technological differences exist between LiquiBand Exceed and the predicate device. - Applicator design ● - Volume of adhesive LiquiBand Exceed also has the following additional claims - A single device contains sufficient adhesive to close wound(s) up to a combined length of 30cm. ● - LiquiBand Exceed topical skin adhesive is suitable for intraoperative reuse, for up to 90 minutes on a single patient. ## 7. Performance Data Testing was performed in accordance with the FDA special controls guidance document for "Tissue Adhesive for the Topical Approximation of Skin" ## Sterilization and Shelf Life LiquiBand Exceed is sterilized by dry heat and ethylene oxide gas. The shelf life of the device has been confirmed through both real time and accelerated aging studies. Image /page/4/Picture/22 description: The image contains two logos side-by-side within a rectangular border. The logo on the left features the letters 'BSI' above a heart shape inside of a circle. The logo on the right has a crown above a check mark with the words 'UKAS QUALITY MANAGEMENT' below it. The number '003' is at the bottom of the right logo. Certificate No. MD 58540 {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for Advanced Medical Solutions (Plymouth) Ltd. The logo features a stylized blue letter "A" with a swoosh extending from the top right. Below the symbol, the text "Advanced Medical Solutions" is written in a clear, sans-serif font, with the words underlined. Underneath that, the text "(Plymouth) Ltd." is written in a smaller font size. Advanced Medical Solutions (Plymouth) 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 Testing The following tests were performed on the LiquiBand Exceed device to demonstrate substantial equivalence to the predicate device and to substantiate the new claims: - Wound closure strength (ASTM F2458-05) ● - Lap-shear strength (ASTM F2255-05) ● - . Peel adhesion strength (ASTM F2256-05) - Adhesive strength in tension (ASTM F2258-05) - Force to actuate - Polymerization set time - Microbial barrier - . Intraoperative reuse - Wound closure length The following tests were performed on the predicate device and were referenced in support of LiquiBand Exceed: - Degradation rate ● - Heat of polymerization ● - Viscosity - Purity - Moisture determination ## Biocompatibility The biological evaluation of the LiquiBand Exceed device was performed in accordance with ISO 1093-1 "Biological evaluation of medical devices. Evaluation and testing". The following test reports were provided in this submission: - Cytotoxicity ● - . Sensitization - Irritation ● - Acute dermal toxicity - . Intramuscular implantation #### Conclusions 8. Extensive design verification, functional and performance testing have been conducted. Based on the testing carried out, LiguiBand Exceed has been demonstrated to be substantially equivalent to the predicate device, Barle Tissue Adhesive 2 (K132243). Image /page/5/Picture/28 description: The image contains two logos side by side. The logo on the left has the letters "BSI" above a heart shape inside of a circle. The logo on the right has a crown above a check mark, with the words "UKAS QUALITY MANAGEMENT" below the check mark. The number "003" is at the bottom of the logo on the right. Certificate No. MD 58540