The Skin Closure System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple thoroughly cleansed, trauma- induced lacerations. The Skin Closure System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.

Device Description

CM00622 Skin Wound Closure System is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet No. 2. It is provided in a single-use applicator packaged in a rigid blister. The applicator is composed of a crushable glass ampoule contained within a pen applicator with an attached applicator tip. As applied to skin, the liquid topical skin adhesive is slightly more viscous than water and polymerizes within minutes. In vitro studies have shown that following polymerization, CM00622 LINC acts as a physical barrier (for up to 7 days) to microbial penetration as long as the polymerized liquid topical skin 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.

CM00622 LINC also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment of incisions up to 20 cm in length until the liguid topical skin adhesive is applied to achieve skin closure.

AI/ML Overview

The provided text is a 510(k) Summary for the CM00622 LINC Skin Closure System. It is a submission to the FDA to demonstrate substantial equivalence to a predicate device, not a study describing the device performance against specific acceptance criteria in a clinical or standalone setting as would be applicable to AI/ML devices. Therefore, much of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth establishment is not present in this document.

However, I can extract information related to performance testing conducted to support the claim of substantial equivalence.

Here's a summary based on the provided text:

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

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' Issued on: November 10, 2010" and that "Performance testing found that the subject device is substantially equivalent to the predicate device and these differences do not affect safety or efficacy."

While specific numerical acceptance criteria and reported performance values are not provided in this summary, the general acceptance criterion is substantial equivalence to the predicate device (DERMABOND™ PRINEO™ Skin Closure System) based on various performance tests. The reported performance is that the device met this criterion, indicating that results from the tests were comparable to the predicate within acceptable limits.

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

This information is not provided in the document. The performance tests listed are bench and animal studies (pre-clinical), not clinical studies with a human test set.

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

Not applicable, as this is not a study assessing diagnostic performance against a ground truth established by experts. The performance tests are largely objective physical and biological tests.

4. Adjudication method for the test set:

Not applicable.

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. This device is a medical product (skin closure system), not an AI/ML diagnostic or assistive device.

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

Not applicable. This device is a medical product, not an algorithm.

7. The type of ground truth used:

For the performance tests, the "ground truth" (or reference standard) would be the established methods and expected performance characteristics for such devices, as outlined in the FDA guidance and industry standards (e.g., ASTM standards). For the animal study, the ground truth would be observed wound healing outcomes compared to a control or predicate.

8. The sample size for the training set:

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable.

Summary of what was included:

The document lists the following performance tests conducted to demonstrate substantial equivalence:

Peel Adhesion of Pressure-Sensitive Tape (ASTM D3330/D3330M-04)
Shear Adhesion of Pressure-Sensitive Tapes (ASTM D3654/D3654M-06)
Tensile Properties of Thin Plastic Sheeting (ASTM D882-12)
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)
Adhesive degradation study
Heat of polymerization
Viscosity
Dry time
Microbial barrier testing (Note: Clinical studies were not conducted to demonstrate microbial barrier properties, and a correlation between these properties and infection reduction has not been established.)
Device Yield and Quality of Film
Flow Control
Animal wound healing study

Biocompatibility tests:

Physical and/or chemical information: Solvent compatibility, Chemical characterization and Toxicological risk assessment.
Cytotoxicity.
Sensitization.
Intracutaneous reactivity.
Material mediated pyrogenicity.
Endotoxin mediated pyrogenicity.
Acute systemic toxicity.
Implantation (including sub-acute toxicity).

The conclusion states that based on these tests, the CM00622 LINC Skin Closure System has been demonstrated to be substantially equivalent to the predicate device.

Summary

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July 15, 2024

Connexicon Medical Ltd. Martin Brennan Director of Quality and Regulatory Affairs Synergy Centre Institute of Technology Tallaght (ITT) Dublin, Dublin D24 A386 Ireland

Re: K233460

Trade/Device Name: CM00622 LINC Skin Closure System (CM00622 LINC) Regulation Number: 21 CFR 878.4011 Regulation Name: Tissue Adhesive With Adjunct Wound Closure Device For Topical Approximation Of Skin Regulatory Class: Class II Product Code: OMD Dated: June 11, 2024 Received: June 13, 2024

Dear Martin Brennan:

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 (the 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 available 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.

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Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

Julie A.
Morabito -S

Julie Morabito, Ph.D. Assistant Director

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DHT4B: Division of Infection Control and Plastic and Reconstructive 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

Submission Number (if known)

K233460

Device Name

CM00622 LINC Skin Closure System (CM00622 LINC)

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

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Connexicon Medical Ltd Synergy Centre,
ITT Tallaght
Dublin 24
Dublin 24
D24 A386
Ireland

510(k) Summary

Submitted by:	Connexicon Medical Limited,Synergy Centre,ITT Dublin,Dublin 24,D24 A386Tel +353 1 5334996
Contact Person:	Martin BrennanDirector of Quality and Regulatory Affairs
Date of Summary:	15 July 2024
Device Name:	CM00622 LINC Skin Closure System
Common Name:	Cutaneous Tissue Adhesive With Mesh
Classification Name:	Tissue adhesive with adjunct wound closure device for topicalapproximation of skin
Regulatory Number:	21 CFR 878.4011
Device Class:	Class II
Product Code:	OMD
Predicate DeviceDevice Name:510(k) Clearance:	DERMABOND™ PRINEO™ Skin Closure SystemPrimary predicate device (K133864)

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Device Description

Indications for Use

CM00622 LINC is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, and simple, thoroughly cleansed, trauma-induced lacerations. CM00622 LINC should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.

Comparison of Technological Characteristics with the Predicate Device

The technological characteristics of the CM00622 LINC Skin Closure System and the predicate device are similar, in that they both contain the same technological characteristics:

Adhesive: 2-octyl cyanoacrylate based adhesive with D&C Violet #2 colorant
. Accelerant: Quaternary ammonium salt
. Applicator: Sterile single use applicator
. Mesh: Polyester mesh with pressure sensitive adhesive

Differences compared to the Predicate Device

Use	The indications for use of the subject and predicate device are identical except thesubject device does not include punctures. The difference is not critical as theindications are lesser for the subject device.
Technology	The initiator is located in the filter for the subject device as compared to the meshfor the predicate device.The activation method for the subject device involves manually compressing theapplicator body to break the glass ampoule whilst a collar is required to be turnedto break the glass ampoule for the predicate device.- Performance testing found that the subject device is substantially equivalent tothe predicate device and these differences do not affect safety or efficacy.
Performance	It was determined through the testing (Bench and Animal) performed in this 510(k)submission, that the subject device is substantially equivalent to the predicatedevice and any minor differences in performance does not affect safety or efficacy.

Use

The indications for use of the subject and predicate device are identical except thesubject device does not include punctures. The difference is not critical as theindications are lesser for the subject device.

Technology

The initiator is located in the filter for the subject device as compared to the meshfor the predicate device.The activation method for the subject device involves manually compressing theapplicator body to break the glass ampoule whilst a collar is required to be turnedto break the glass ampoule for the predicate device.- Performance testing found that the subject device is substantially equivalent tothe predicate device and these differences do not affect safety or efficacy.

Performance

It was determined through the testing (Bench and Animal) performed in this 510(k)submission, that the subject device is substantially equivalent to the predicatedevice and any minor differences in performance does not affect safety or efficacy.

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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" Issued on: November 10, 2010

Performance Testing

The following tests were performed on the CM00622 LINC Skin Closure System to demonstrate substantial equivalence to the predicate device:

Peel Adhesion of Pressure-Sensitive Tape (ASTM D3330/D3330M-04)
Shear Adhesion of Pressure-Sensitive Tapes (ASTM D3654/D3654M-06)
Tensile Properties of Thin Plastic Sheeting (ASTM D882-12) ●
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)
Adhesive degradation study
Heat of polymerization
Viscosity
Dry time
Microbial barrier testing
Device Yield and Quality of Film
Flow Control
Animal wound healing study

Biocompatibility

The biological evaluation of the CM00622 LINC Skin Closure System was performed in accordance with FDA guidance on the use of ISO 10993-1.

The following test reports were provided in this submission:

. Physical and/or chemical information: Solvent compatibility, Chemical characterization and Toxicological risk assessment.
. Cytotoxicity.
Sensitization.
Intracutaneous reactivity.
Material mediated pyrogenicity.
Endotoxin mediated pyrogenicity.
Acute systemic toxicity.
Implantation (including sub-acute toxicity).

Conclusions

Based on the intended use, technological characteristics, safety and performance testing, CM00622 LINC Skin Closure System has been demonstrated to be substantially equivalent to the predicate device, DERMABOND™ PRINEO™ Skin Closure System

Regulation Number and Section

§ 878.4011 Tissue adhesive with adjunct wound closure device for topical approximation of skin.

(a)
Identification. A tissue adhesive with adjunct wound closure device intended for the topical approximation of skin is a device indicated for topical application 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. It may be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of wound during application of the liquid adhesive.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin.” See § 878.1(e) for the availability of this guidance document.