DERMABOND ADVANCED™ 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. DERMABOND ADVANCED™ Adhesive may be used in conjunction with, but not in place of, deep dermal stitches.

High viscosity DERMABOND® Adhesive is intended 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. High viscosity DERMABOND® Adhesive may be used in conjunction with. but not in place of, deep dermal stitches.

Device Description

DERMABOND ADVANCED™ 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 ampoule contained within a plastic applicator. As it is applied to the skin, the liquid is syrup-like in viscosity and polymerizes within minutes. Studies have shown that following application, DERMABOND ADVANCED™ Adhesive acts as a barrier to prevent microbial penetration as long as the adhesive remains.

High viscosity DERMABOND® Topical Skin Adhesive 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 blister pouch. The applicator is composed of a crushable glass ampule contained within a plastic vial with attached applicator tip. As applied to skin, the liquid is syrup-like in viscosity and polymerizes within minutes. In vitro studies have shown that high viscosity DERMABOND® Adhesive 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.

High viscosity DERMABOND® Adhesive is different from the regular, or low viscosity DERMABOND® Adhesive due to the increased viscosity of the liquid adhesive formulation. Low viscosity DERMABOND® Adhesive has a viscosity slightly greater than water, while high viscosity DERMABOND® Adhesive has a syrup-like viscosity. The increased viscosity of high viscosity DERMABOND® 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.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding two topical skin adhesives: DERMABOND Advanced™ Topical Skin Adhesive and High Viscosity DERMABOND® Mini Topical Skin Adhesive.

Based on the provided document, the device described is DERMABOND Advanced™ Topical Skin Adhesive and High Viscosity DERMABOND® Mini Topical Skin Adhesive. This is a medical device, specifically a tissue adhesive, and not an AI/ML powered device.

Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML powered device cannot be fulfilled from this document. The document primarily focuses on establishing "substantial equivalence" to predicate devices, which is the regulatory pathway for medical devices that are not AI/ML systems.

There is no information in this document about:

A table of acceptance criteria and reported device performance in the context of AI/ML.
Sample sizes used for a test set in the context of AI/ML.
Data provenance for AI/ML training or test sets.
Number of experts used to establish ground truth for an AI/ML test set.
Qualifications of experts for AI/ML ground truth.
Adjudication methods for an AI/ML test set.
Multi-Reader Multi-Case (MRMC) comparative effectiveness studies for AI assistance.
Effect size of human readers improving with AI vs. without AI assistance.
Standalone (algorithm only) performance for an AI/ML device.
Type of ground truth used (expert consensus, pathology, outcomes data) for an AI/ML device.
Sample size for a training set for an AI/ML device.
How ground truth for a training set was established for an AI/ML device.

The document explicitly states:

"DERMABOND ADVANCED™ Topical Skin Adhesive and High Viscosity DERMABOND® Mini Topical Skin Adhesive are identical to the DERMABOND ADVANCED™ Topical Skin Adhesive and High Viscosity DERMABOND® Mini Topical Skin Adhesive marketed device with respect to technological characteristics. There are no material, construction, specification, manufacturing or sterilization process changes to the currently marketed devices. The devices differ only in the labeling (Instructions for Use) that have been revised to add a contraindication, as well as other clarifications to ensure safer, more effective use of the device."

This statement is the core of their substantial equivalence argument. They are not introducing new technology that would require performance studies like those typical for AI/ML devices; they are seeking approval for minor labeling changes to existing, identical devices.

In summary, this document does not contain the information requested because the device is not an AI/ML powered device, and the submission is for labeling changes to an existing, substantially equivalent product.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of a human figure in profile, with three overlapping faces suggesting community and connection. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the figure.

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

October 22, 2015

Ethicon Incorporated Ms. Donna Marshall Regulatory Affairs Manager Route 22 West, P.O. Box 151 Somerville, New Jersey 08876

Re: K152096

Trade/Device Name: DERMABOND Advanced™ Topical Skin Adhesive and High Viscosity DERMABOND® Mini Topical Skin Adhesive Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue adhesive Regulatory Class: Class II Product Code: MPN Dated: July 27, 2015 Received: July 28, 2015

Dear Ms. Marshall:

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

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CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.

for

Sincerely yours,

David Krause -S

Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K152096

Device Name

DERMABOND Advanced™ Topical Skin Adhesive

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Page 15

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K152096

Device Name

High Viscosity DERMABOND® Mini Topical Skin Adhesive

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

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510(k) Change Being Effected DERMABOND Advanced Topical Skin Ad And DERMABOND Mini Topical Skin Adhesive Ethicon. Inc.

K152096 Page 1 of 3

PART OF THE JOHNSON&JOHNSON FAMILY OF COMPANIES

510(k) Summary

Submitter:

Ethicon, Inc. a Johnson & Johnson company P.O. Box 151 Route 22 West Somerville, NJ 08876-0151 USA

Contact Person:

Donna Marshall Manager, Regulatory Affairs Ethicon, Inc. a Johnson & Johnson company Ph: (908) 541-3990 Fax: (908) 218-2595 e-mail: dmarsha2@its.jnj.com

Date Prepared:

July 27, 2015

DERMABOND ADVANCED™ Topical Skin Adhesive and Device Trade Name: High Viscosity DERMABOND® Mini Topical Skin Adhesive

Device Common Name: Topical Skin Adhesive

Class:

Tissue Adhesive for the Topical Approximation of Skin (21 CFR 878.4010)

Product Code:

Classification Name:

MPN

Predicate Device	510(k) Number
DERMABOND ADVANCED™ Topical Skin Adhesive	K100423
High Viscosity DERMABOND® Mini Topical Skin Adhesive	P960052

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Device Description DERMABOND ADVANCED™:

Device Description High Viscosity DERMABOND® Mini Topical Skin Adhesive:

Indications for Use DERMABOND ADVANCED:

Indications for Use High Viscosity DERMABOND® Mini Topical Skin Adhesive:

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Summary of Technological Characteristics:

DERMABOND ADVANCED™ Topical Skin Adhesive and High Viscosity DERMABOND® Mini Topical Skin Adhesive are identical to the DERMABOND ADVANCED™ Topical Skin Adhesive and High Viscosity DERMABOND® Mini Topical Skin Adhesive marketed device with respect to technological characteristics. There are no material, construction, specification, manufacturing or sterilization process changes to the currently marketed devices. The devices differ only in the labeling (Instructions for Use) that have been revised to add a contraindication, as well as other clarifications to ensure safer, more effective use of the device.

Substantial Equivalence:

Conclusion:

DERMABOND ADVANCED™ Topical Skin Adhesive and High Viscosity DERMABOND® Mini Topical Skin Adhesive are identical to the DERMABOND ADVANCED™ Topical Skin Adhesive and High Viscosity DERMABOND® Mini Topical Skin Adhesive marketed device with respect to technological characteristics. There are no material, construction, specification, manufacturing or sterilization process changes to the currently marketed devices. DERMABOND ADVANCED™ Topical Skin Adhesive and High Viscosity DERMABOND® Mini Topical Skin Adhesive are considered to be substantially equivalent to the predicate devices.

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.