Exofin® High Viscosity Topical Skin Adhesive 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® High Viscosity Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.

Device Description

Exofin® High Viscosity Topical Skin Adhesive is a sterile liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation for rapid polymerization, and the colorant D&C Violet #2 which aids in visualization during application. It is provided in a single-use, aluminum, collapsible tube fitted with a polyethylene-based applicator tip. The applicator tip consists of three components, a connector fitted with a self-puncturing cap, porous disk and soft elastomeric brush, used to apply and spread the adhesive evenly. The adhesive and applicator tip are packaged together in a polyethylene terephthalate glycol plastic blister pack and sealed with a labeled Tyvek® blister backer. When applied to the skin, the adhesive is distributed through the applicator tip in a syrup-like viscosity and polymerizes within minutes. The increased viscosity in Exofin® High Viscosity Topical Skin Adhesive is intended to reduce the risk of unintended placement of the adhesive during application due to migration of the liquid adhesive from the wound site. In-vitro studies have shown that Exofin® High Viscosity Topical Skin Adhesive acts as a barrier to microbial penetration when 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.

AI/ML Overview

The provided text describes a medical device, Exofin® High Viscosity Topical Skin Adhesive, and its review for substantial equivalence to a predicate device. However, it does not contain information about acceptance criteria or a study that proves the device meets those criteria in the format requested in the prompt.

Specifically, the document focuses on the regulatory submission (510(k)) and comparison to a predicate device (Exofin® High Viscosity Tissue Adhesive). It lists various performance and biocompatibility tests conducted, and states that the device "met all performance criteria," but it does not specify what those criteria are (e.g., a numerical threshold or range for wound closure strength).

Therefore, for aspects of the prompt related to specific numerical acceptance criteria, reported performance values, sample sizes, expert qualifications, adjudication methods, or MRMC studies, that information is not present in the provided text. The document concerns a Class II medical device, which typically relies on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a new clinical efficacy study with defined acceptance criteria and human expert evaluation in the same manner as, for example, an AI diagnostic algorithm.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Cannot be created. The document lists the types of performance tests conducted (e.g., Wound Closure Strength, Adhesive Strength in Tension) and states that the device "met all performance criteria." However, it does not specify the actual numerical acceptance criteria or the measured performance values for these tests. For example, it doesn't say "Wound Closure Strength must be > X N/cm" and "Reported Wound Closure Strength was Y N/cm."

2. Sample size used for the test set and the data provenance

Cannot be determined. The document mentions performance and biocompatibility testing but does not provide details on sample sizes used for these tests, nor does it specify the provenance (e.g., country of origin, retrospective/prospective) of any data beyond indicating "In-vitro studies" for microbial barrier properties.

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

Not applicable / Cannot be determined. This type of information is typically relevant for diagnostic devices, especially those involving image interpretation by human experts. The Exofin® device is a topical skin adhesive. Its evaluation involves laboratory performance tests and biocompatibility, not expert interpretation of diagnostic data to establish a "ground truth" in the requested sense.

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

Not applicable / Cannot be determined. Similar to point 3, adjudication methods are relevant for studies comparing expert interpretations, often in diagnostic settings. This device's testing does not involve such a process.

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

No. An MRMC study is not mentioned. This type of study is typically for evaluating diagnostic accuracy, especially of AI/CAD systems that assist human readers. Exofin® is a therapeutic device (a skin adhesive), not a diagnostic AI.

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

Not applicable. This question pertains to AI algorithms, which Exofin® is not.

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

Ground truth in the context of device performance testing: For the performance tests listed (e.g., Wound Closure Strength, Adhesive Strength), the "ground truth" would be the objective measurement against established ASTM standards and internal specifications, rather than expert consensus or pathology in a clinical diagnostic sense. For biocompatibility, it's against established biological safety endpoints.
The document implies that the device "met all performance criteria," meaning its measured performance values conformed to the pre-defined specifications/acceptance criteria for each test (e.g., ISO, ASTM standards).

8. The sample size for the training set

Not applicable / Cannot be determined. The device is a physical medical product (a skin adhesive), not an AI model that requires a training set.

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

Not applicable. As above, no training set for an AI model is involved.

Summary

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Build Correspondence

December 17, 2020

Chemence Medical, Inc.

Charnelle Thomas Director of Regulatory Affairs 200 Technology Drive Alpharetta, Georgia 30005

Re: K200264

Trade/Device Name: Exofin® High Viscosity Topical Skin Adhesive Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue Adhesive Regulatory Class: Class II Product Code: MPN Dated: November 16, 2020 Received: November 17, 2020

Dear Charnelle Thomas:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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 medical devices and radiation-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,

For Kimberly Ferlin, Ph.D. Assistant Director (Acting) 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) K200264

Device Name Exofin® High Viscosity Topical Skin Adhesive

Indications for Use (Describe)

Exofin® High Viscosity Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.

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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Image /page/3/Picture/0 description: The image shows the logo for Chemence Medical. The logo consists of a red and blue diamond shape with a white "C" in the center. The word "CHEMENCE" is written in red, and the word "MEDICAL" is written in blue below it. The logo is simple and modern.

510(k) Summary

This 510(k) summary is prepared in accordance with 21 CFR 807.92.

1. Submitter

Submitted by:	Chemence Medical, Inc.200 Technology DriveAlpharetta, GA 30005-3926Phone: 844-633-4583Fax: 678-820-3320
Contact Person:	Charnelle ThomasDirector, Regulatory AffairsChemence Medical, Inc.Phone: 678-690-0760Email: cthomas@chemence.com
Date of Summary:	December 14, 2020

1. Device

Device Proprietary Name:	Exofin® High Viscosity Topical Skin Adhesive
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

Legally marketed devices to which equivalence is claimed:

Device Name:	Exofin® High Viscosity Tissue Adhesive
510(k) Clearance:	K152476

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Image /page/4/Picture/0 description: The image shows the logo for Chemence Medical. The logo features a red diamond shape with a blue "C" inside, positioned above the words "CHEMENCE" in red and "MEDICAL" in blue. The "CHEMENCE" text also has a registered trademark symbol next to it.

4. Device Description

5. Intended Use

Exofin® High Viscosity 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. Exofin® High Viscosity Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.

6. Comparison of Technological Characteristics with the Predicate Device

The technological characteristics of Exofin® High Viscosity Topical Skin Adhesive and the predicate device are similar. Both devices:

are 2-octyl cyanoacrylate-based, rapid polymerizing, liquid adhesive formulations
contain D&C violet #2 colorant to aid in visualization during application
provide an applicator tip that comprises of a connector, porous disk and soft elastomeric brush
polymerizes within minutes of application
maintain skin edge approximation and provide a microbial barrier ●
are sterilized by a two-stage process with a sterility assurance level of 10° ●

In addition to a change to the proprietary name, the differences between Exofin® High Viscosity Topical Skin Adhesive and the predicate include:

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Image /page/5/Picture/0 description: The image shows the logo for Chemence Medical. The logo consists of a red diamond shape with a white "C" inside, positioned above the words "CHEMENCE" and "MEDICAL" stacked on top of each other. The word "CHEMENCE" is in red, while "MEDICAL" is in blue.

slight modification to the formulation ●
increased viscosity ●

These differences do not raise different questions of safety and effectiveness.

7. Performance and Safety Data

Testing was performed in accordance with the FDA Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin.

Performance Testing

The following tests were performed on Exofin® High Viscosity Topical Skin Adhesive 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 ●
Hydrolytic Degradation ●
Viscosity
Microbial Barrier Properties ●
Applicator Torque Strength and Expression Force ●
Setting (Tack-Free) Time ●

In these studies, Exofin® High Viscosity Topical Skin Adhesive met all performance criteria.

Biocompatibility Testing

The biological evaluation of Exofin® High Viscosity Topical Skin Adhesive was performed in accordance with ISO 10993-1. "Biological Testing of Medical Devices - Part 1: Evaluation and testing within a risk management process " for a device intended for prolonged contact (>24 hours - 30 days) with breached or compromised skin surface. The results of the studies, listed below, demonstrate that Exofin® High Viscosity Topical Skin Adhesive is safe for its intended use.

Cytotoxicity ●
Sensitization ●
Intracutaneous Irritation ●
Acute Systemic Toxicity ●
Pyrogenicity ●
Systemic Toxicity Study and Local Tissue Response Following Full-Thickness Incisions in ● Rat, 14 days

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Image /page/6/Picture/0 description: The image contains the logo for Chemence Medical. The logo features a red diamond shape with a white "C" inside, positioned above the text "CHEMENCE" in a bold, sans-serif font. Below "CHEMENCE" is the word "MEDICAL" in a similar font, but slightly smaller in size.

8. Conclusion

Exofin® High Viscosity Topical Skin Adhesive was evaluated in accordance with the Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin. Exofin® High Viscosity Topical Skin Adhesive is substantially equivalent to Exofin® High Viscosity Tissue Adhesive with regard to indications for use, mechanism of action and performance characteristics. Both devices contain the same principle chemical ingredient, 2-0ctyl cyanoacrylate. Both devices were shown to be equivalent in all performance and safety tests. Therefore, the slight change in formulation does not raise different questions of safety and effectiveness.

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.