CM005 Standard Topical Skin Adhesive is indicated 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. CM005 STANDARD Topical Skin Adhesive may be used in conjunction with, but not in place of deep dermal stitches. CM005 STANDARD Topical Skin Adhesive should be applied by trained medical or nursing staff.

CM004 Mini Topical Skin Adhesive is indicated 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. CM004 Mini Topical Skin Adhesive may be used in conjunction with, but not in place of deep dermal stitches. CM004 Mini Topical Skin Adhesive should be applied by trained medical or nursing staff.

Device Description

CM005 Standard Topical Skin Adhesive 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 as a single-use applicator in a blister package. The pen style applicator is composed of a crushable glass ampoule contained within a plastic tube and plastic enclosure with silicone brush tip. When applied to the skin, the liquid adhesive polymerizes within minutes.

AI/ML Overview

This document is a 510(k) summary for medical devices (CM005 Standard and CM004 Mini Topical Skin Adhesives) and as such does not contain a study addressing acceptance criteria in the manner requested (i.e., with statistical performance metrics against a defined ground truth, typical for AI-software devices).

The provided text describes performance testing conducted to demonstrate substantial equivalence to predicate devices, rather than a study with acceptance criteria against a clinical outcome or expert ground truth for an AI/software device. The devices are topical skin adhesives, not AI/software devices. Therefore, a table of acceptance criteria vs. device performance, sample sizes for test/training sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or methods for establishing ground truth for training data are not applicable in the context of this document.

The "acceptance criteria" for these devices are demonstrated through a series of performance tests and biocompatibility assessments, showing that they are substantially equivalent to already cleared predicate devices.

Here's a summary of the type of performance criteria and tests carried out (as described in the document), rather than a direct answer to the prompt's table due to the nature of the device:

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

Since this is not an AI/software device, there aren't explicit numeric "acceptance criteria" in the traditional sense of diagnostic accuracy (e.g., sensitivity, specificity). Instead, substantial equivalence is demonstrated by performing various tests to show that the new devices perform comparably to predicate devices. The document states:

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

The specific performance tests conducted were:

Performance Test	Description / Outcome
Lap-shear strength	Tested in accordance with ASTM F2255-05. (Implied: Demonstrated performance comparable to predicate).
T-peel adhesion strength	Tested in accordance with ASTM F2256-05. (Implied: Demonstrated performance comparable to predicate).
Adhesive strength in tension	Tested in accordance with ASTM F2258-05. (Implied: Demonstrated performance comparable to predicate).
Wound closure strength	Tested in accordance with ASTM F2458-05. (Implied: Demonstrated performance comparable to predicate).
Adhesive degradation study	Performed. (Implied: Demonstrated degradation properties comparable to predicate or acceptable for safety/efficacy).
Heat of polymerization	Measured. (Implied: Demonstrated polymerization characteristics comparable to predicate or acceptable for safety/efficacy).
Viscosity	Measured. (Implied: Demonstrated viscosity characteristics comparable to predicate or acceptable for manufacturing/application).
Set time	Measured. (Implied: Demonstrated set time comparable to predicate or acceptable for clinical use).
Microbial barrier testing	Performed. "In vitro studies have shown that following application and polymerization, CM005 STANDARD Topical Skin Adhesive acts as a physical barrier to prevent 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."
Device Yield and Quality of Film	Performed. (Implied: Demonstrated acceptable device yield and film quality).
Flow Control	Performed. (Implied: Demonstrated acceptable flow control).
Animal wound healing study	Performed. (Implied: Demonstrated wound healing characteristics comparable to predicate or acceptable for safety/efficacy).
Biocompatibility	Tests performed per ISO 10993-1: Solvent compatibility, chemical characterization, toxicological risk assessment, cytotoxicity, sensitization, intracutaneous reactivity, material mediated pyrogenicity, acute toxicity, subacute toxicity, implantation. (Implied: All tests passed, demonstrating biological safety).

2. Sample size 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 each individual test or their provenance. The tests were bench and animal studies (laboratory and pre-clinical, respectively).

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 is not applicable to a non-AI/software device submission. Ground truth for these physical and biochemical tests is established by standardized testing protocols (e.g., ASTM standards) and animal study observations.

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

Not applicable for a non-AI/software device. The tests follow established protocols.

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, as this is not an AI-assisted device.

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

Not applicable, as this is not an AI/software device.

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

For the performance tests, the "ground truth" is defined by the accepted results or outcomes of standardized physical, chemical, and biological tests (e.g., tensile strength measurements, viscosity values, lack of cytotoxicity as per ISO 10993-1). For the animal wound healing study, the ground truth would be histological assessment and observation of wound closure and healing characteristics.

8. The sample size for the training set

Not applicable, as this is not an AI/software device.

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

Not applicable, as this is not an AI/software 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: K233458

Trade/Device Name: CM005 Standard (CM005); CM004 Mini (CM004) Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue Adhesive Regulatory Class: Class II Product Code: MPN 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 (QS) 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 DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices

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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)

K233458

Device Name

CM005 Standard (CM005); CM004 Mini (CM004)

Indications for Use (Describe)

The indication for use for both devices is shown below:

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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K233458

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

510(k) Summary

Submitted by:	Connexicon Medical Limited,Synergy Centre,ITT Dublin,Dublin 24,D24 A386IrelandTel +353 (0)1 5334996
Contact Person:	Martin BrennanDirector of Quality and Regulatory Affairs
Date of Summary:	15 July 2024
Device Name:	CM005 Standard Topical Skin Adhesive and CM004Mini Topical Skin Adhesive
Common Name:	Topical Skin Adhesive
Classification Name:	Tissue adhesive for the Topical Approximation of Skin
Regulatory Number:	21 CFR 878.4010
Device Class:	Class II
Product Code:	MPN
Predicate DevicesDevice Name:	DERMABOND Advanced™ Topical Skin Adhesiveand High Viscosity DERMABOND® Mini TopicalSkin Adhesive
510(k) Clearance:	K152096

Device Description CM005 Standard

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nnexicon Medical Ltd

shown that following application and polymerization, CM005 STANDARD Topical Skin Adhesive acts as a physical barrier to prevent 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.

Device Description CM004 Mini

CM004 Mini Topical Skin Adhesive 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 singleuse applicator packaged in a blister pack. The applicator is comprised of a crushable glass ampoule contained within a plastic tube and plastic enclosure with silicone brush tip. When applied to the skin, the liquid adhesive polymerizes within minutes. In vitro studies have shown that following polymerization, CM004 Mini Topical Skin Adhesive acts as a physical 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.

Indications for Use CM005 Standard

CM005 Standard Topical Skin Adhesive is indicated 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. CM005 Standard Topical Skin Adhesive may be used in conjunction with, but not in place of deep dermal stitches. CM005 Standard Topical Skin Adhesive should be applied by trained medical or nursing staff.

Indications for Use CM004 Mini

CM004 Mini Topical Skin Adhesive 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. CM004 Mini Topical Skin Adhesive may be used in conjunction with, but not in place of deep dermal stitches. CM004 Mini Topical Skin Adhesive should be applied by trained medical or nursing staff.

Comparison of Technological Characteristics with the Predicate Device

The technological characteristics of the CM005 Standard Topical Skin Adhesive and CM004 Mini Topical Skin Adhesive and the predicate devices are similar, in that they all 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

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Differences compared to the Predicate Device

Use	The indications for use of the subject devices specify that the adhesive should beapplied by trained medical or nursing staff. The difference is not critical as both thesubject and predicate device are prescription devices, and both are indicated as suchthroughout the labelling.
Technology	The CM004 Mini has a silicone brush tip compared to the predicate device (HighViscosity DERMABOND® Mini Topical Skin Adhesive) which has a plastic tip. Thesilicone brush tip allows for adhesive control during application. Performance testingfound that the subject device is substantially equivalent to the predicate device andthis difference does not affect safety or efficacy.
Performance	It was determined through the testing (Bench and Animal) performed in this 510(k)submission, that the subject devices are substantially equivalent to the predicatedevices and any minor differences in performance does not affect safety or efficacy.

Performance Data

Testing was performed in accordance with the FDA special controls guidance document for "Tissue Adhesive for the Topical Approximation of Skin - Class II Special Controls Guidance for Industry and FDA Staff".

Performance Testing

The following tests were performed on the both the CM005 Standard Topical Skin Adhesive and CM004 Mini Topical Skin Adhesive to demonstrate substantial equivalence to the respective predicate devices:

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
Set time
Microbial barrier testing
Device Yield and Quality of Film
Flow Control
Animal wound healing study

Biocompatibility

The biological evaluation of CM005 Standard Topical Skin Adhesive and CM004 Mini Topical Skin Adhesive 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.

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Material mediated pyrogenicity. ●
Acute toxicity
Subacute toxicity
Implantation

Conclusions

Based on the intended use, technological characteristics, safety and performance testing, CM005 Standard Topical Skin Adhesive and CM004 Mini Topical Skin Adhesive has been demonstrated to be substantially equivalent the respective predicate devices, DERMABOND Advanced™ Topical Skin Adhesive and High Viscosity DERMABOND® Mini Topical Skin Adhesive.

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

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.