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.

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.

AI/ML Overview

Here's an analysis of the provided text to extract information about the acceptance criteria and the study performed for the LiquiBand Exceed:

Important Note: The provided document is a 510(k) summary for a medical device (LiquiBand Exceed topical skin adhesive). This type of document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone clinical trial with acceptance criteria for device performance. As such, the information you're requesting, especially detailed acceptance criteria with specific performance thresholds and a multi-reader multi-case study, is typically not found in this type of submission. The performance tests listed are primarily to show that the new device performs comparably to or at least as well as the predicate device for relevant characteristics.

Response Based on Provided Document:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly state numerical acceptance criteria or specific reported device performance values in a table format for the LiquiBand Exceed itself. Instead, it states that "Testing was performed in accordance with the FDA special controls guidance document for 'Tissue Adhesive for the Topical Approximation of Skin'" and that the results demonstrated "substantial equivalence to the predicate device."

The tests performed, which would have had associated pass/fail criteria (likely defined by the guidance document or established industry standards), are listed as:

Acceptance Criteria (Implied by Test Name)	Reported Device Performance (Implied)
Wound closure strength (ASTM F2458-05)	Demonstrated to meet standards / substantially equivalent to predicate
Lap-shear strength (ASTM F2255-05)	Demonstrated to meet standards / substantially equivalent to predicate
Peel adhesion strength (ASTM F2256-05)	Demonstrated to meet standards / substantially equivalent to predicate
Adhesive strength in tension (ASTM F2258-05)	Demonstrated to meet standards / substantially equivalent to predicate
Force to actuate	Demonstrated to meet standards / substantially equivalent to predicate
Polymerization set time	Demonstrated to meet standards / substantially equivalent to predicate
Microbial barrier	In vitro studies showed barrier to microbial penetration as long as film remains intact.
Intraoperative reuse	Suitable for up to 90 minutes on a single patient.
Wound closure length	Single device contains sufficient adhesive for wounds up to 30cm.
Sterilization and Shelf Life	Confirmed through real-time and accelerated aging studies.
Biocompatibility (Cytotoxicity, Sensitization, Irritation, Acute dermal toxicity, Intramuscular implantation)	Performed in accordance with ISO 10993-1; likely passed all tests for substantial equivalence.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document does not specify sample sizes for any of the performance tests. It also does not provide details on the data provenance, such as country of origin or whether studies were retrospective or prospective. Given the nature of a 510(k) summary and the listed tests (ASTM standards, in-vitro), most of these would be laboratory-based rather than human clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable and not provided in the document. The tests performed are primarily engineering and material science tests (e.g., adhesion strength, polymerization time, sterilization) or laboratory biological tests (biocompatibility, microbial barrier). These types of tests do not typically involve human experts establishing a "ground truth" in the way a diagnostic AI device would.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable and not provided. Adjudication methods are relevant for clinical studies where human assessment of outcomes is necessary, particularly with multiple reviewers. The tests described are objective, laboratory-based measurements.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic devices, particularly those involving image interpretation or AI assistance, which is not the case for a topical skin adhesive.

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

This concept is not applicable to a topical skin adhesive. There is no algorithm or AI component mentioned for the LiquiBand Exceed. The device's performance is standalone in the sense that it's a physical product applied directly.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the in-vitro and ex-vivo performance tests, the "ground truth" would be established by the methods and criteria specified in the referenced ASTM standards and other relevant industry standards (e.g., ISO 10993-1 for biocompatibility). For example, the "ground truth" for wound closure strength would be the measured force required to cause failure, compared against a pre-defined threshold or the predicate device's performance. For shelf-life, it would be the sustained quality metrics over time. Clinical outcomes data are not presented in this 510(k) summary for the LiquiBand Exceed as the primary means of demonstrating substantial equivalence.

8. The sample size for the training set

This information is not applicable and not provided. 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

This information is not applicable as there is no training set for this device.

Summary

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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

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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

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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)

	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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Type of Use (Select one or both, as applicable)

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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.Western Wood WayLangage Science ParkPlymouth, Devon. PL7 5BGUnited KingdomTel: +44 (0)1752 209955Fax: +44 (0) 1752 209956
Contact Person:	Dr Martin MitchellRegulatory Affairs AssociateAdvanced 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

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

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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

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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

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.