ACTABOND Topical Skin Adhesive is intended for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. ACTABOND Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal stitches.

Device Description

ACTABOND Topical Skin Adhesive is a skin closure device that is comprised of a 2-octyl cyanoacrylate liquid adhesive formulation containing D & C Violet #2. The liquid adhesive is supplied sterile within a single use dispensing applicator, which is used to deliver the adhesive to the skin. Once applied, the liquid adhesive polymerizes to form a thin film with strong bonding and tensile properties. In vitro studies have shown that following application, ACTABOND Adhesive acts as a barrier to prevent bacterial penetration. The barrier properties of ACTABOND Adhesive have not been studied in clinical or animal models.

AI/ML Overview

This document is a 510(k) premarket notification for the ACTABOND Topical Skin Adhesive. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with strict acceptance criteria and performance metrics for a novel AI or diagnostic device. Therefore, much of the requested information regarding AI-specific assessments (MRMC studies, stand-alone performance, training set details) is not applicable or cannot be extracted from this type of regulatory submission.

However, I can extract information related to the performance testing performed to demonstrate equivalence to the predicate device.

Here's the breakdown of the information that can be extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Specific numerical acceptance criteria are not explicitly stated in the provided text as this is a substantial equivalence submission rather than a de novo marketing authorization or a clinical trial report with pre-defined endpoints for efficacy. Instead, the performance studies aimed to demonstrate "equivalence to the predicate device." The "acceptance criteria" can be inferred as achieving comparable results to the predicate device in the listed tests.

Performance Test	Acceptance Criteria (inferred)	Reported Device Performance
Wound closure strength	Equivalent to predicate (ASTM F2458-05)	Demonstrated equivalence to the predicate device.
Tensile strength	Equivalent to predicate (ASTM F2258-05)	Demonstrated equivalence to the predicate device.
Lap shear strength	Equivalent to predicate (ASTM F2255-05)	Demonstrated equivalence to the predicate device.
Heat of polymerization	Equivalent to predicate	Demonstrated equivalence to the predicate device.
Applicator Functionality	Acceptable and comparable to predicate	Demonstrated equivalence to the predicate device.
Viscosity	Met specifications, comparable to predicate	Evaluated. Conclusion: Demonstrated equivalence to the predicate device.
Setting time	Met specifications, comparable to predicate	Evaluated. Conclusion: Demonstrated equivalence to the predicate device.
Purity	Met specifications, comparable to predicate	Evaluated. Conclusion: Demonstrated equivalence to the predicate device.
Moisture	Met specifications, comparable to predicate	Evaluated. Conclusion: Demonstrated equivalence to the predicate device.
Hydrolytic degradation	Met specifications, comparable to predicate	Evaluated. Conclusion: Demonstrated equivalence to the predicate device.
Bacterial barrier	Met specifications, comparable to predicate	Evaluated. In vitro studies showed it acts as a barrier. Not studied in clinical/animal models.
Acute wound closure (Porcine)	No remarkable differences from predicate	No remarkable differences between subject and predicate device groups.
Maintenance of wound closure (Porcine)	No remarkable differences from predicate	No remarkable differences between subject and predicate device groups; both maintained wound closure.
Support of normal wound healing (Porcine)	No remarkable differences from predicate	No remarkable differences between subject and predicate device groups; both supported normal healing without delay and showed complete epidermal re-epithelialization at 14 days.
Histological evaluation (Porcine)	No remarkable differences from predicate	No remarkable differences between subject and predicate device groups.
Biocompatibility (Cytotoxicity)	Met ISO 10993-5:2009(R)2014 standards	Demonstrated safe for intended use.
Biocompatibility (Irritation/Intracutaneous reactivity)	Met ISO 10993-10:2010 standards	Demonstrated safe for intended use.
Biocompatibility (Systemic Injection)	Met ISO 10993-11:2006(R)2010 standards	Demonstrated safe for intended use.
Biocompatibility (Sensitization/Kligman Maximization)	Met ISO 10993-10:2010 standards	Demonstrated safe for intended use.
Biocompatibility (Intramuscular implantation)	Met ISO 10993-6:2007(R)2010 standards	Demonstrated safe for intended use.
Sterility Assurance Level (e-beam & EO)	10⁻⁶	Validated to provide a Sterility Assurance Level of 10⁻⁶.
Shelf-life	Confirmed through real-time aging studies	Confirmed through real-time aging studies.

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

Bench Studies: Sample sizes for individual bench tests (viscosity, setting time, strength tests, etc.) are not provided.
Animal Study: The sample size for the porcine study is not explicitly stated. It refers to "a surgically induced, full thickness, linear wound healing model" and "Both groups" (subject and predicate device groups), implying at least two groups of animals, but the number of animals per group is not specified.
Data Provenance: The studies were conducted by Bergen Medical Products, Inc. (USA) as part of their design control requirements. The porcine study is an animal model, not human data.

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

Bench Studies: Not applicable. These are objective physical/chemical measurements.
Animal Study: A "histological evaluation was also performed." This implies expert pathologists were involved, but the number and qualifications are not specified.

4. Adjudication method for the test set

Bench Studies: Not applicable. These are quantitative measurements.
Animal Study: Not specified for the histological evaluation.

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 submission is for a medical device (topical skin adhesive), not an AI or diagnostic imaging device that involves human readers.

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

Not applicable. This submission is for a physical medical device (topical skin adhesive), not a standalone algorithm.

7. The type of ground truth used

Bench Studies: Objective physical and chemical measurements (e.g., ASTM standards for strength, measured properties like viscosity, purity).
Animal Study: Clinical observations of wound healing and histological analysis (microscopic examination of tissue by experts) were used as "ground truth" to compare the wound healing outcomes between the subject and predicate devices.
Biocompatibility: Standardized ISO methods and biological responses (e.g., cytotoxicity, irritation).

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set. The device formulation and performance are based on established material science and empirical testing.

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

Not applicable. As there is no training set mentioned.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 4, 2016

Bergen Medical Products, Inc. Mr. Tom Stephens Vice President, Regulatory Affairs and Ouality Assurance 16 Wing Drive Cedar Knolls, NJ 07927 US

Re: K161050

Trade/Device Name: ACTABOND Topical Skin Adhesive Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue adhesive Regulatory Class: II Product Code: MPN Dated: September 1, 2016 Received: September 2, 2016

Dear Mr. Stephens:

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. 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 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. for

Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known)

K161050

Device Name

ACTABOND Topical Skin Adhesive

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)
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Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image contains the logo for Bergen Medical Products. The logo consists of a blue circle with a white "B" inside, followed by the words "BERGEN MEDICAL" in blue, stacked on top of each other. Below "MEDICAL" is the word "PRODUCTS" in a smaller font size, with the letters spaced out.

1. Submitter

Submitted by:	Bergen Medical Products, Inc.16 Wing DriveCedar Knolls, New Jersey, 07927Phone: 855-855-3682Fax: 855-855-3682
Contact Person:	Tom StephensVice President, Regulatory Affairs & Quality Assurancetom.stephens@bergenmedicalproducts.comPhone: 855-855-3682 x703

Date of Summary: September 1, 2016

2. Device

Trade Name:	ACTABOND™ Topical Skin Adhesive
Common or Usual Name:	Topical skin adhesive
Classification Name:	Tissue adhesive for the topical approximation of skin
Classification Panel:	General and Plastic Surgery Devices
Regulation:	21 CFR 878.4010(a) – Class II
Product Code:	MPN

3. Predicate Device

Device Name:	DERMABOND® NX Topical Skin Adhesive (currently marketed asDERMABOND® Advanced Topical Skin Adhesive)
510(k) Clearance:	K100423
Regulation:	21 CFR 878.4010(a) – Class II
Product Code:	MPN

4. Device Description

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Image /page/4/Picture/1 description: The image contains the logo for Bergen Medical Products. The logo features a blue circle with a white letter "B" inside. To the right of the circle, the word "BERGEN" is written in a bold, dark blue font, and below that, "MEDICAL" is written in a lighter blue. Underneath "MEDICAL", the word "PRODUCTS" is written in smaller, light blue letters.

5. Indications for Use

ACTABOND 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. ACTABOND Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal stitches.

6. Comparison of Technological Characteristics with Predicate

The technological characteristics of ACTABOND Topical Skin Adhesive and the predicate device are closely comparable. Both devices:

트 are 2-octyl cyanoacrylate-based liquid adhesive formulations containing D&C violet #2
l are sterilized in their final packaging to an SAL of 10th using ethylene oxide
provide a pen-style single use applicator that is delivered sterile in a peel open package
incorporate a flexible bulb tip that is squeezed to apply the adhesive from the applicator
l polymerize within minutes to form a film with strong bonding and tensile properties
l maintain skin edge approximation and provide a bacterial barrier

The minor differences between the ACTABOND and DERMABOND devices include:

I different primary packaging
. different sterilization method for the adhesive in the primary packaging
different applicator actuation mechanism that avoids glass shards

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

7. Performance Data

The testing plan for the ACTABOND device was developed in consideration of the FDA guidance document "Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin", May 30, 2008, as well as design control requirements and risk analysis. Testing to establish substantial equivalence of the ACTABOND Topical Skin Adhesive to the predicate device has been completed according to Bergen Medical procedures in compliance with the requirements of 21 CFR 820.30 – Design Control.

Performance Testing:

Bench studies have been performed to evaluate the device properties:

l Viscosity
l Setting time
I Purity
Moisture
Hydrolytic degradation
Bacterial barrier

BERGEN MEDICAL PRODUCTS, INC 16 WING DRIVE, CEDAR KNOLLS, NJ 07642 855 855 3682 - BERGENMEDICALPRODUCTS.COM

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K161050 ACTABOND™ Topical Skin Adhesive 510(k) Summary Page 3 of 4

Image /page/5/Picture/1 description: The image contains the logo for Bergen Medical Products. The logo features a blue circle with a white letter B inside. To the right of the circle, the word "BERGEN" is written in large, bold, blue letters. Below "BERGEN", the word "MEDICAL" is written in the same style. Below "MEDICAL", the word "PRODUCTS" is written in smaller, lighter blue letters.

Performance studies have been performed to demonstrate equivalence to the predicate device. In all cases, the ACTABOND device demonstrated equivalence to the predicate.

트 Wound closure strength (ASTM F2458-05)
. Tensile strength (ASTM F2258-05)
Lap shear strength (ASTM F2255-05)
l Heat of polymerization
Applicator Functionality

Animal Studies:

A porcine study was conducted to compare the safety and effectiveness of ACTABOND Topical Skin Adhesive to the predicate device in a surgically induced, full thickness, linear wound healing model. This study evaluated acute wound closure, maintenance of wound closure, and support of normal wound healing for 14 days. A histological evaluation was also performed to evaluate healing after 14 days.

The results of this study demonstrated no remarkable differences between the subject and predicate device study groups for clinical wound observations and histological analysis. Both groups maintained wound closure, supporting a normal wound healing process without delay and showed complete epidermal re-epithelialization at 14 days.

Biocompatibility:

The biocompatibility of the ACTABOND Topical Skin Adhesive device has been evaluated according to the studies recommended in AAMI/ANSI/ISO 10993-1:2009/(R)2013, "Biological evaluation 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 skin. The results of these studies, listed below, demonstrate that the ACTABOND Topical Skin Adhesive device is safe for its intended use.

Cytotoxicity (ISO 10993-5:2009(R)2014)
Irritation/Intracutaneous reactivity (ISO 10993-10:2010)
I Systemic Injection (ISO 10993-11:2006(R)2010)
트 Sensitization/Kligman Maximization (ISO 10993-10:2010)
I Intramuscular implantation (ISO 10993-6:2007(R)2010)

Sterilization and Shelf-Life:

The ACTABOND device is sterilized in two steps during device production. The liquid adhesive formulation is sterilized in its primary packaging by electron beam radiation in compliance with the requirements of ISO 11137- 2:2013. After device assembly and packaging, the finished device is sterilized by exposure to ethylene oxide gas in compliance with the requirements of ISO 11135:2014. Both sterilization processes are validated to provide a Sterility Assurance Level of 10°. The shelf life of the device has been confirmed through real-time aging studies.

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Image /page/6/Picture/1 description: The image shows the logo for Bergen Medical Products. The logo features a blue circle with a white "B" inside. To the right of the circle, the word "BERGEN" is written in large, blue letters. Below "BERGEN", the word "MEDICAL" is written in the same blue color and font size. Below "MEDICAL", the word "PRODUCTS" is written in smaller, blue letters.

8. Conclusions

The ACTABOND Topical Skin Adhesive device and predicate device, DERMABOND NX Topical Skin Adhesive (K100423), have identical indications for use, function according to the same fundamental scientific technology, and are closely comparable with regard to device design. Minor differences between the ACTABOND device and the predicate with regard to the primary package for the adhesive, the sterilization method for the adhesive in its primary package, and the mechanism for device actuation do not raise different questions of safety or effectiveness. In vitro and in vivo testing results provided in the 510(k) submission demonstrate that the ACTABOND device meets its specifications and is substantially equivalent to the DERMABOND NX Topical Skin Adhesive predicate.

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.