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.

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.

AI/ML Overview

The provided text describes the 510(k) summary for the medical device LiquiBand Plus, a topical skin adhesive. It outlines its indications for use, technological characteristics, and performance data from various tests. However, the document does not explicitly state acceptance criteria in a quantitative manner or provide specific performance results against those criteria in a table format. It focuses on demonstrating substantial equivalence to a predicate device through various performance and biocompatibility tests.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance with numerical values, nor can I quantify the sample sizes for test sets, the number or qualifications of experts for ground truth, or an adjudication method. The document does not contain information about multi-reader multi-case studies, standalone algorithm performance, or specific ground truth methodologies for any studies, as the device is a physical medical device (skin adhesive), not an AI/software device that would typically involve such studies.

Here's a breakdown of what can be extracted from the provided text, while acknowledging the limitations regarding the core request:

1. Table of Acceptance Criteria and Reported Device Performance:

Not available in the provided text. The document states that "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'". It lists several tests, but does not provide specific numerical acceptance criteria for these tests or the quantitative performance results achieved by LiquiBand Plus against those criteria. It only states that the testing demonstrated substantial equivalence.

2. Sample size used for the test set and the data provenance:

Not available in the provided text. The document lists the types of tests performed (e.g., Lap-shear strength, Animal wound healing study) but does not disclose the sample sizes used for these tests or the data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/available in the provided text. This device is a topical skin adhesive, not an AI/software for interpretation. "Ground truth" in the context of expert review for image or data interpretation is not relevant here. The evaluation focuses on physical and biological properties.

4. Adjudication method for the test set:

Not applicable/available in the provided text. As above, adjudication methods like 2+1 or 3+1 are typically for resolving discrepancies in expert interpretation, which is not relevant for this device type.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

Not applicable/available in the provided text. This type of study is for AI-assisted diagnostic or interpretative devices. LiquiBand Plus is a physical medical device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

Not applicable/available in the provided text. This is relevant for AI/software and not a physical medical device.

7. The type of ground truth used:

Various methods depending on the test, but not explicitly detailed as "ground truth" in the context of expert review. For a physical device like LiquiBand Plus, the "ground truth" would be established through the methodologies of the specific performance tests listed (e.g., standardized testing protocols for strength, degradation, biocompatibility endpoints like cytotoxicity). The document mentions "in vitro studies" and "animal wound healing study," but details on specific ground truth establishment for these are not provided.

8. The sample size for the training set:

Not applicable/available in the provided text. There is no "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established:

Not applicable/available in the provided text. There is no "training set" for this device.

In summary, the provided FDA 510(k) summary for LiquiBand Plus details the regulatory classification, indications for use, and a list of performance and biocompatibility tests conducted to demonstrate substantial equivalence to a predicate device. However, it does not provide the quantitative acceptance criteria, specific performance results against those criteria, sample sizes for the studies, or details related to expert ground truth establishment, as these are typically applicable to AI/software devices for diagnostic or interpretative tasks, not physical medical devices like the one described.

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K183570

Device Name LiquiBand Plus

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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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 LimitedWestern Wood WayLangage Science ParkPlymouth, Devon. PL7 5BGUnited KingdomTel: +44 (0)1752 209955Fax: +44 (0) 1752 209956
Contact Person:	Martin MitchellSenior 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 DeviceDevice Name:	LiquiBand® Exceed
510(k) Clearance:	K151182
Reference DeviceDevice 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".

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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

Indications for Use

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.

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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.

Regulation Number and Section

§ 878.4010 Tissue adhesive.

(a)
Tissue adhesive for the topical approximation of skin —(1)Identification. A tissue adhesive for the topical approximation of skin is a device intended for topical closure of surgical incisions, including laparoscopic incisions, and simple traumatic lacerations that have easily approximated skin edges. Tissue adhesives for the topical approximation of skin may be used in conjunction with, but not in place of, deep dermal stitches.(2)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: “Tissue Adhesive for the Topical Approximation of Skin.” See § 878.1(e) of this chapter for the availability of this guidance document.(b)
Tissue adhesive for non-topical use —(1)Identification. A tissue adhesive for non-topical use, including adhesives intended for use in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery, is a device used for adhesion of internal tissues and vessels.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 878.3 of this chapter.