LiquiBand® Topical Skin Adhesive is indicated for the closure of topical skin incisions including laparoscopic incisions, and trauma-induced lacerations in areas of low skin tension that are simple, thoroughly cleansed, and have easily approximated edges. LiquiBand Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal stitches.

Device Description

LiquiBand Topical Skin Adhesive is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate. LiquiBand Topical Skin Adhesive is supplied in a single patient use 0.5g High Density Polyethylene ampoule with polypropylene applicator tip.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the LiquiBand Topical Skin Adhesive and focuses on demonstrating its substantial equivalence to a predicate device, Indermil® Tissue Adhesive. However, it does not contain information about acceptance criteria, device performance metrics, or a study design in the way one would typically describe for an AI/software as a medical device (SaMD).

The submission categorizes the testing as "Substantial Equivalence Testing Summary," indicating that the purpose was to show that LiquiBand performs similarly to the predicate device, not necessarily to meet specific, pre-defined quantitative acceptance criteria or to conduct a clinical trial demonstrating improvement in human readers or standalone performance.

Therefore, many of the requested sections cannot be filled from the provided text.

Here's a breakdown of what can and cannot be answered:

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

The document does not explicitly state quantitative acceptance criteria or specific performance values for a device being measured against an established standard. Instead, it lists types of comparative tests performed to demonstrate substantial equivalence to a predicate device. The performance is implied to be "substantially equivalent" to the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Demonstrated substantial equivalence in Tensile strength	Met (Implied by FDA clearance)
Demonstrated substantial equivalence in Set (polymerization) time	Met (Implied by FDA clearance)
Demonstrated substantial equivalence in Heat of polymerization	Met (Implied by FDA clearance)
Demonstrated substantial equivalence in Viscosity	Met (Implied by FDA clearance)
Demonstrated substantial equivalence in Hydrolytic degradation	Met (Implied by FDA clearance)
Demonstrated substantial equivalence in Applicator expression force	Met (Implied by FDA clearance)
Demonstrated substantial equivalence in Water vapor transmission rate	Met (Implied by FDA clearance)
Demonstrated substantial equivalence in GC Chemical Analysis	Met (Implied by FDA clearance)

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

Sample Size for Test Set: Not specified in the provided text. The document refers to "comparative testing," but details about the number of samples or subjects used in these tests are not included.
Data Provenance: Not specified.

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 provided. The testing described is physical and chemical performance testing of the adhesive and applicator, not a clinical study requiring expert ground truth for interpretation.

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

This information is not provided. As the testing is primarily physical and chemical, an adjudication method for ground truth establishment by experts is not relevant in this context.

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

There is no MRMC study mentioned, as this is a topical skin adhesive, not an AI/SaMD.

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

This is not applicable as the device is a physical medical device (topical skin adhesive), not an algorithm or AI.

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

The concept of "ground truth" as typically applied to AI/SaMD is not directly applicable here. The "truth" for the performance tests would be the measurement against a standard or the performance of the predicate device, not an expert-derived clinical ground truth. For example:

Tensile Strength: Measured directly according to ASTM standards.
Set Time: Measured directly.
Chemical Analysis: Measured using GC (Gas Chromatography).

8. The sample size for the training set

This is not applicable as there is no AI/ML model for training.

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

This is not applicable as there is no AI/ML model for training.

Summary of what the document does provide regarding the study:

The study described is a series of comparative physical and chemical tests conducted to demonstrate that the LiquiBand Topical Skin Adhesive is "substantially equivalent" to an existing predicate device, Indermil® Tissue Adhesive. The tests performed include:

Tensile strength (according to ASTM F2255-05, F2258-05, F2458-05)
Set (polymerization) time
Heat of polymerization
Viscosity
Hydrolytic degradation
Applicator expression force
Water vapor transmission rate
GC Chemical Analysis

The FDA's clearance (K083531) indicates that these tests were sufficient to establish substantial equivalence for the stated Indications for Use.

Summary

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LiquiBand® Topical Skin Adhesive LB 0004 Traditional 510(k) Premarket Notification

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Page 5-1

Traditional 510(k) Premarket Notification

K083531

Page 1 of 2

5.0 TRADITIONAL 510(K) SUMMARY

Submitted by:
MedLogic Global, Ltd.
Western Wood Way
Langage Science Park
Plymouth, Devon, UK PL 5 BG

FEB 12 2009

Contact Person:
Tierney Norsted Ph.D., M.P.H.
Exec Vice President, Sr. Principal Advisor
Regulatory & Clinical Research Institute, Inc.
5353 Wayzata Blvd., Suite 505
Minneapolis, Minnesota 55416
952-746-8021
tnorsted@rcri-inc.com

Date of Summary:
February 11, 2009

Device Trade Name:
LiquiBand® Topical Skin Adhesive

Product Code:
LB 0004

Common or Usual Name:
Topical Skin Adhesive

Classification Name:
Tissue Adhesive (21 CFR 878.4010)

Predicate Device(s):
Indermil® Tissue Adhesive (P010002)

Device Description:
LiquiBand Topical Skin Adhesive is a sterile, topical tissue
adhesive containing n-butyl-2-cyanoacrylate. LiquiBand Topical
Skin Adhesive is supplied in a single patient use 0.5g High
Density Polyethylene ampoule with polypropylene applicator tip.

Indication for Use:
LiquiBand Topical Skin Adhesive is indicated for the closure of
topical skin incisions including laparoscopic incisions, and
trauma-induced lacerations in areas of low skin tension that are
simple, thoroughly cleansed, and have easily approximated
edges. LiquiBand Topical Skin Adhesive may be used in
conjunction with, but not in place of, deep dermal stitches.

Substantial Equivalence:
LiquiBand Topical Skin Adhesive is substantially equivalent to
Indermil Tissue Adhesive (P010002) with regard to Indication
For Use, formulation, technology, target population, intended
application, mechanism of action and performance at achieving
their intended use.

{1}------------------------------------------------

LiquiBand
Topical Skin Adhesive LB 0004
Traditional 510(k) Premarket Notification

Substantial Equivalence Testing Summary:

ﻨﺎ

.. "

The following comparative testing demonstrated substantially equivalent performance between LiquiBand Topical Skin Adhesive and Indermil Tissue Adhesive:

Page 5-2

Tensile strength (ASTM F2255-05, F2258-05, F2458-05) E
Set (polymerization) time ■
Heat of polymerization t
Viscosity ■
Hydrolytic degradation .
Applicator expression force 트
Water vapor transmission rate l
GC Chemical Analysis 1

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three bars forming its body and wings. The eagle faces right and appears to be in flight. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 2 2009

MedLogic Global Ltd. % Tierney Norsted, Ph.D., M.P.H. Regulatory & Clinical Research Institute, Inc. 5353 Wayzata Blyd. Minneapolis, MN 55416

Re: K083531

Trade/Device Name: LiquiBand Tissue Adhesive Regulation Number: 21 CFR 878.4010 (a) Regulation Name: Tissue adhesive for topical approximation of skin Regulatory Class: II Product Code: MPN Dated: November 26, 2008 Received: November 28, 2008

Dear Dr. Norsted:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 801); 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.

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Page 2 - Tierney Norsted, Ph.D., M.P.H.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark A. Milliken

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT 4.0

510(k) Number:	K083531
Device Name:	LiquiBand® Topical Skin Adhesive
Model Number:	LB 0004
Indications For Use:	LiquiBand® Topical Skin Adhesive is indicated for the closure of topical skin incisions including laparoscopic incisions, and trauma-induced lacerations in areas of low skin tension that are simple, thoroughly cleansed, and have easily approximated edges. LiquiBand Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal stitches.

Prescription Use: YES (Part 21 CFR 801 Subpart D) AND/OR

Over-the-Counter Use: NO (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Marl A. Melleur

(Division Sign-Off) Division c.º General, Restorative, and Neurological Devices

510(k) Number K083531

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.