Exofin® Precision Pen 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® Precision Pen may be used in conjunction with, but not in place of, deep dermal sutures.

Device Description

Exofin® Precision Pen 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. The adhesive is provided in a 1.0g size, single-use, aluminum, collapsible tube that is fitted with a polyethylene-based applicator tip. The applicator tip consists of three components, a connector fitted with a self-puncturing cap, porous disc and soft elastomeric brush. The aluminum tube is housed within a silicone bulb that is connected to a polypropylene pen body and held by the end user during application. The adhesive, applicator tip, silicone bulb and pen body are packaged together in a (PETG) plastic blister pack and sealed with a labeled Tyvek® blister backer. A total of 12 units are packaged in a tray which is covered by a sleeve. 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 assists in the unintended placement of the adhesive during application due to migration of the liguid adhesive from the wound site. The silicone bulb and pen body of the Exofin® Precision Pen were designed to improve ergonomics during application. In-vitro studies have shown that Exofin® Precision Pen acts as a barrier to microbial penetration when the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties.

AI/ML Overview

The provided document is an FDA 510(k) summary for the Exofin® Precision Pen, a topical skin adhesive. It claims substantial equivalence to a predicate device (Exofin® High Viscosity Topical Skin Adhesive, K200264). This means the submission focuses on demonstrating that the new device is as safe and effective as a legally marketed device, rather than providing extensive de novo clinical studies with detailed acceptance criteria and performance metrics for a novel technology.

Therefore, the information required to fully answer your request regarding acceptance criteria, study details, and specific performance metrics for a new device's clinical efficacy, as one might find for an AI medical device, is not present in this document. This document primarily addresses the substantial equivalence of modifications to a previously cleared device.

However, I can extract the available information related to performance testing that was conducted to support this Special 510(k).

Here's a breakdown of what can be gathered from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document does not provide a specific table of quantitative acceptance criteria for clinical performance (e.g., wound closure rates, dehiscence rates) or quantitative performance metrics for the Exofin Precision Pen in the context of human studies. The performance testing section discusses "Mechanical Applicator Testing" and states it "met all performance criteria," but these criteria are not detailed.

Acceptance Criteria Category	Reported Device Performance (Exofin® Precision Pen)	Notes from Document
Mechanical Applicator Testing	Met all performance criteria.	"In these studies, Exofin® Precision Pen met all performance criteria." The specific quantitative criteria (e.g., force required for dispense, flow rate) are not detailed in this summary. This testing relates to the ergonomic "pen" component, not the adhesive's clinical efficacy itself.
Adhesive Performance (Indirect)	No change from predicate device (K200264).	"Because the adhesive, aluminum tube and applicator tip remain unchanged, no additional performance test were done." The performance of the adhesive formulation itself is presumed to be equivalent to the predicate, as it is the same formulation.
Biocompatibility	Not required for the pen component; unchanged for adhesive.	"The pen of subject device does not come into direct contact with the patient or adhesive, therefore, biocompatibility is not required. Because the adhesive is unchanged, no additional biocompatibility tests were performed."
Sterility Assurance Level (SAL)	10⁻⁶	"Exofin® Precision Pen is sterilized in a two-step process by dry heat and ethylene oxide gas at a sterility assurance level (SAL) of 10⁻⁶."
Shelf-Life	12 months	"The data from these studies support a 12-month shelf-life."
Microbial Barrier Properties	Acts as a barrier when intact (in-vitro).	"In-vitro studies have shown that Exofin® Precision Pen acts as a barrier to microbial penetration when the adhesive film remains intact."

2. Sample Size for the Test Set and Data Provenance

Test Set Sample Size: Not specified for any human clinical trials. The performance testing mentioned ("Mechanical Applicator Testing") would involve device units, not human subjects.
Data Provenance: Not applicable for human clinical data, as no new clinical studies were conducted for this Special 510(k). The "in-vitro studies" for microbial barrier properties suggest lab-based testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable as no human clinical test set requiring expert ground truth establishment for a novel device was conducted for this Special 510(k).

4. Adjudication Method for the Test Set

Not applicable as no human clinical test set requiring adjudication was conducted for this Special 510(k).

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging AI devices, whereas the Exofin Precision Pen is a therapeutic device (tissue adhesive).

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. The Exofin Precision Pen is a physical medical device (a topical skin adhesive with an applicator), not an algorithm or AI system.

7. Type of Ground Truth Used

Not applicable in the context of human clinical ground truth (e.g., pathology, outcomes data). The "ground truth" for the mechanical applicator testing would be the engineering specifications and functional requirements for the pen. For the microbial barrier, it would be laboratory culture results.

8. Sample Size for the Training Set

Not applicable as this is a physical medical device, not an AI/machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reason as above.

Summary of Device Rationale for this 510(k):

The Exofin® Precision Pen is presented as a modification to an already cleared device (Exofin® High Viscosity Topical Skin Adhesive, K200264). The changes are specifically:

Addition of a pen (silicone bulb and pen body) for improved ergonomics.
An increase in blister size to accommodate the pen body.
An increase in the number of device units per tray from 10 to 12.

The key claim for substantial equivalence is that the adhesive formulation, aluminum tube, and applicator tip remain unchanged from the predicate device. Therefore, clinical performance related to wound closure, strength, etc., is considered unchanged and relies on the predicate's clearance. The new testing conducted was primarily "Mechanical Applicator Testing" to ensure the new pen component functions as intended, and it reportedly "met all performance criteria." Biocompatibility was deemed unnecessary for the non-patient-contacting pen component, and the adhesive's biocompatibility was already established. Sterilization validation and shelf-life studies were also conducted for the new configuration.

Summary

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September 9, 2021

Chemence Medical, Inc. Charnelle Thomas Director of Regulatory Affairs 200 Technology Drive Alpharetta, Georgia 30115

Re: K212246

Trade/Device Name: Exofin Precision Pen Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue Adhesive Regulatory Class: Class II Product Code: MPN Dated: August 9, 2021 Received: August 10, 2021

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

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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,

Lixin Liu, 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) K212246

Device Name Exofin® Precision Pen

Indications for Use (Describe)

Exofin® Precision Pen 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, traumainduced lacerations. Exofin® Precision Pen 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 contains the word "CHEMENCE" in a bold, sans-serif font. To the left of the word is a blue hexagon-like shape. The shape is made up of three overlapping, rounded rectangles that create a three-dimensional effect. The overall design is clean and modern.

Special 510(k) for Exofin® Precision Pen (K212246)

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 of Regulatory AffairsChemence Medical, Inc.Phone: 678-690-0760Email: cthomas@chemence.com
Date of Summary:	September 8, 2021

1. Device

Device Proprietary Name:	Exofin® Precision Pen
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 Topical Skin Adhesive
510(k) Clearance:	K200264

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Special 510(k) for Exofin® Precision Pen (K212246)

4. Device Description

5. Intended Use

6. Comparison of Technological Characteristics with the Predicate Device

Most technological characteristics of Exofin® Precision Pen and the predicate device are the same. 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 disc and soft elastomeric . brush
polymerizes within minutes of application ●
maintain skin edge approximation and provide a bacterial barrier ●
are sterilized by a two-stage process with a sterility assurance level of 10° ●

The difference between Exofin® Precision Pen and the predicate is the addition of a pen (silicone bulb and pen body) for improved ergonomics during application and a change to increase the blister size to accommodate the pen body. Additionally, there is an increase in the number of device units in each tray from 10 to 12. The adhesive formulation, aluminum tube and applicator tip remain unchanged from the predicate device, Exofin High Viscosity Topical Skin Adhesive (K200264). These differences do not raise different questions of safety and effectiveness.

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Image /page/5/Picture/0 description: The image contains the word "CHEMENCE" in a bold, sans-serif font. To the left of the word is a blue hexagon-like shape. The shape is made up of three curved lines that overlap each other. The overall image appears to be a logo.

Special 510(k) for Exofin® Precision Pen (K212246)

7. Performance 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® Precision Pen to demonstrate substantial equivalence:

· Mechanical Applicator Testing
In these studies, Exofin® Precision Pen met all performance criteria. Because the adhesive, aluminum tube and applicator tip remain unchanged, no additional performance test were done.

Biocompatibility Testing

The pen of subject device does not come into direct contact with the patient or adhesive, therefore,biocompatibility is not required. Because the adhesive is unchanged, no additional biocompatibility tests were performed.

Sterilization and Shelf Life

Exofin® Precision Pen is sterilized in a two-step process by dry heat and ethylene oxide gas at a sterility assurance level (SAL) of 10°. The shelf life of the device has been determined through both real time and accelerated aging studies. The data from these studies support a 12-month shelf-life.

8. Conclusion

Exofin® Precision Pen was evaluated in accordance with the Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin. Exofin® Pen is substantially equivalent to Exofin® High Viscosity Topical Skin Adhesive with regard to indications for use, mechanism of action and performance characteristics. Both devices contain the same principle chemical ingredient, 2-octyl cyanoacrylate. Both devices were shown to be equivalent in performance testing. Therefore, the change of adding a silicone bulb and pen body, for improved ergonomics during application and a change to packaging dimensions to accommodate the pen size, do 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.