Exofin Fusion Skin Closure System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. Exofin Fusion 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

Exofin® Fusion Skin Closure System 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-use applicator packaged in a rigid blister. As applied to skin, the liquid is slightly more viscous than water and polymerizes within minutes. In vitro studies have shown that Exofin® Fusion Skin Closure System 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. Exofin Fusion Skin Closure System 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 each in length until the liquid adhesive is applied to achieve skin closure.

AI/ML Overview

The provided text is a 510(k) Summary for the Exofin® Fusion Skin Closure System. It details the device, its intended use, and comparison to predicate devices, along with non-clinical testing performed to demonstrate substantial equivalence. However, it does not contain the specific information required to address the request regarding acceptance criteria, study details, expert involvement, or AI-related metrics.

Specifically, the document states: "No clinical testing has been submitted, referenced, or relied upon for Clinical Testing: determining substantial equivalence." This means there are no clinical study results to describe in terms of direct clinical performance, acceptance criteria, or human reader improvement with AI.

Therefore, I cannot fulfill the request for information on the study that proves the device meets acceptance criteria, sample sizes for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, type of ground truth, or details about the training set, as these aspects are not present in the provided 510(k) summary.

The document focuses on non-clinical testing to demonstrate substantial equivalence to a predicate device, as outlined in the "Non-clinical Testing" section:

Acceptance Criteria and Reported Performance (based on non-clinical testing available):

Acceptance Criteria (Test Standard)	Reported Device Performance (Implied Acceptance)
Wound closure strength (ASTM F2458-05)	The testing was performed in accordance with the FDA Class II Special Controls Guidance Document, demonstrating substantial equivalence to the predicate. (Specific numerical performance not provided, but implies meeting the standard for substantial equivalence).
Adhesive strength in tension (ASTM F2258-05)	The testing was performed in accordance with the FDA Class II Special Controls Guidance Document, demonstrating substantial equivalence to the predicate. (Specific numerical performance not provided, but implies meeting the standard for substantial equivalence).
T-peel adhesion strength (ASTM F2256-05)	The testing was performed in accordance with the FDA Class II Special Controls Guidance Document, demonstrating substantial equivalence to the predicate. (Specific numerical performance not provided, but implies meeting the standard for substantial equivalence).
Lap-shear strength (ASTM F2255-05)	The testing was performed in accordance with the FDA Class II Special Controls Guidance Document, demonstrating substantial equivalence to the predicate. (Specific numerical performance not provided, but implies meeting the standard for substantial equivalence).
Heat of polymerization	The testing was performed in accordance with the FDA Class II Special Controls Guidance Document, demonstrating substantial equivalence to the predicate. (Specific numerical performance not provided, but implies meeting the standard for substantial equivalence).
Microbial barrier effectiveness	The testing was performed in accordance with the FDA Class II Special Controls Guidance Document, demonstrating substantial equivalence to the predicate. (Specific numerical performance not provided, but implies meeting the standard for substantial equivalence).
Extractables and Leachables	The testing was performed in accordance with the FDA Class II Special Controls Guidance Document, demonstrating substantial equivalence to the predicate. (Specific numerical performance not provided, but implies meeting the standard for substantial equivalence).
Biocompatibility Testing (ISO 10993-1)	Conducted according to the requirements for a surface device in prolonged contact with a breached or compromised surface, demonstrating substantial equivalence. (Specific numerical performance not provided, but implies meeting the standard for substantial equivalence).

Remaining requested information, not found in the provided text:

Sample size used for the test set and the data provenance: Not provided, as clinical testing was not relied upon. The non-clinical tests would have their own sample sizes, but these are not detailed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no clinical ground truth established or relied upon.
Adjudication method for the test set: Not applicable.
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 not an AI-based diagnostic device where human-in-the-loop performance with AI assistance would be relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For non-clinical tests, the "ground truth" would be the established testing parameters and results as per ASTM and ISO standards, demonstrating compliance. Clinical or expert consensus ground truth is not reported.
The sample size for the training set: Not applicable, as there is no mention of an algorithm or AI model requiring a training set.
How the ground truth for the training set was established: Not applicable.

Summary

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June 5, 2020

Chemence Medical, Inc. Kenneth Broadley Executive Vice President 200 Technology Drive Alpharetta, Georgia 30005

Re: K191461

Trade/Device Name: Exofin Fusion Skin Closure System 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: May 4, 2020 Received: May 6, 2020

Dear Kenneth Broadley:

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

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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 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 (OS) 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,

Anjana Jain, Ph.D. Acting Assistant Director 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) K191461

Device Name Exofin Fusion Skin Closure System

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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510(k) Summary

Submitted By:	Chemence Medical, Inc.200 Technology DriveAlpharetta, GA 3005-3926Phone: 844-633-4583Fax: 678-820-3320
Contact Person:	Dr. Kenneth N. BroadleyChief Regulatory and Quality OfficerPhone: 678-689-0761Email: kbroadley@chemence.com
Date of Summary:	June 5, 2020
Trade Name:	Exofin® Fusion Skin Closure System
Common Name:	Topical Adhesive with Mesh
Classification Name:	Tissue Adhesive with Adjunct Wound Closure Device for TopicalApproximation of Skin (21 CFR 878.4011)
Regulatory Class:	Class II
Product Code:	OMD
Device Description:	Exofin® Fusion Skin Closure System is a sterile, liquid topical skin adhesivecontaining a monomeric (2- octyl cyanoacrylate) formulation and thecolorant D & C Violet #2. It is provided in a single-use applicator packagedin a rigid blister. As applied to skin, the liquid is slightly more viscous thanwater and polymerizes within minutes. In vitro studies have shown thatExofin® Fusion Skin Closure System acts as a barrier to microbialpenetration as long as the adhesive film remains intact. Clinical studieswere not conducted to demonstrate microbial barrier properties and acorrelation between microbial barrier properties and a reduction ininfection have not been established. Exofin Fusion Skin Closure Systemalso incorporates a self-adhering mesh that is applied to theapproximated skin edges to provide temporary skin edge alignment ofincisions up to 20 cm each in length until the liquid adhesive is applied toachieve skin closure.

Exofin® Fusion Skin Closure System is intended for topical application Intended Use: 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. exofin®

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Fusion 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.

Predicate Devices:	K171442	Exofin® Fusion Skin Closure System
Reference Device:	K152476	Exofin® High Viscosity Tissue Adhesive

Comparison of Technological Characteristics with the Predicate Devices:

Exofin® Fusion® Skin Closure System is the same as the predicate device with regard to intended use, mechanism of action and performance characteristics. Both devices contain a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment of wounds of up to 20 cm in length until a liquid topical adhesive is applied to achieve wound closure. The liquid adhesive formulations, the mesh materials, and the method of adhesive application are all the same.

The predicate included two mesh strips of 22 cm in length by 4 cm in width, accompanied by 4 gm of liquid adhesive housed in an aluminum tube, while the subject device is provided with a single 22 X 4 cm mesh and 2 x 1.75 gm of adhesive in the aluminum tubes.

Both the subject device and the predicate device utilize a chemical that initiates the polymerization (curing) of the adhesive as it is applied. However, in the subject device the chemical is impregnated into the porous disk within the applicator assembly, instead of being coated on the mesh as in the predicate. Additionally, the impregnated porous disk of the subject Exofin Fusion Skin Closure system also includes a chemical that accelerates the polymerization of the adhesive; this chemical is not present in the predicate device.

Comparison Table:

Attribute	Subject device	Predicate	Comparison
Trade Name	Exofin Fusion Skin ClosureSystem	Exofin Fusion Skin ClosureSystem	Same
510(k) No.	K191461	K171442	NA
CommonName	Cutaneous Tissue Adhesivewith Mesh	Cutaneous Tissue Adhesivewith Mesh	Same
Product Code	OMD	OMD	Same
Regulation	21 CFR 878.4011	21 CFR 878.4011	Same
Attribute	Subject device	Predicate Device	Comparison
Indications	Exofin Fusion® Skin ClosureSystem is intended for topicalapplication only to hold easilyclosed approximated skinedges of wounds fromsurgical incisions, includingincisions from minimallyinvasive surgery, and simplethoroughly cleansed, trauma-induced lacerations.Exofin Fusion® Skin ClosureSystemshould be used inconjunction with, but not inplace of, deep dermalstitches. Additionally, theadjunct wound closure device	Exofin Fusion® Skin ClosureSystemis intended fortopical application only tohold easily closedapproximated skin edges ofwounds from surgicalincisions, including incisionsfrom minimally invasivesurgery, and simplethoroughly cleansed,trauma-induced lacerations.Exofin Fusion® Skin ClosureSystem should be used inconjunction with, but not inplace of, deep dermalstitches. Additionally, theadjunct wound closuredevice componentmaintains temporary skinedge alignment along thelength of the wound duringapplication of the liquidadhesive.	Same
AdhesiveFormulation	2-octylcyanoacrylate basedformulation	2-octylcyanoacrylate basedformulation	Same
Mesh	Polyester with acrylicpressure sensitive adhesive	Polyester with acrylicpressure sensitive adhesive	Same
Activator	Quaternary ammonium salt inapplicator	Quaternary ammonium salton mesh	Equivalent
Accelerant	Crown ether in applicator	Crown ether on mesh	Equivalent
ProductSterilization	Heat and ethylene oxide	Heat and ethylene oxide	Same

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Non-clinical Testing: Testing was performed in accordance with the FDA Class II Special Controls Guidance Document: Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin. The following tests were performed on Exofin® Fusion Skin Closure System to demonstrate substantial equivalence:

Wound closure strength (ASTM F2458-05) ●
Adhesive strength in tension (ASTM F2258-05) ●
T-peel adhesion strength (ASTM F2256-05) ●
Lap-shear strength (ASTM F2255-05)
Heat of polymerization
Microbial barrier effectiveness
Extractables and Leachables

Biocompatibility Testing: Biocompatibility testing was conducted according to the requirements of FDA Guidance Document Use of International Standard ISO 10993-1 "Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process" for a surface device in prolonged contact with a breached or compromised surface.

No clinical testing has been submitted, referenced, or relied upon for Clinical Testing: determining substantial equivalence.
Conclusion: Based on the intended use, technological characteristics, and performance testing, the subject Exofin® Fusion Skin Closure System has been shown to be substantially equivalent to the predicate.

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.