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

Device Description

DERMABOND® NX Topical Skin Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation with a viscosity increasing agent, stabilizer, and colorant (D&C Violet #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 easily approximated skin edges in a single layer; the liquid is syrup-like in viscosity and polymerizes within minutes. Studies have shown that following application, DERMABOND NX Topical Skin Adhesive acts as a barrier to prevent microbial penetration.

AI/ML Overview

The provided text describes the 510(k) summary for the DERMABOND® NX Topical Skin Adhesive. The primary focus of the document is to demonstrate substantial equivalence to a predicate device (DERMABOND® Topical Skin Adhesive) rather than to establish acceptance criteria for the new device through a performance study against a specified clinical endpoint. Therefore, the device performance is reported in terms of its equivalence to the predicate device and meeting internal specifications, not against specific numerical acceptance criteria for clinical outcomes.

Here's an analysis of the provided information based on your request:

Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical "acceptance criteria" in the format typically seen for a new clinical performance study. Instead, it demonstrates the new device (DERMABOND® NX) is substantially equivalent to its predicate (DERMABOND® Topical Skin Adhesive) through various tests.

Table of Acceptance Criteria and Reported Device Performance (based on demonstrated equivalence to predicate and internal specifications):

Acceptance Criteria Category	Acceptance Criteria (implied/met by predicate equivalence or internal specs)	Reported Device Performance
Biocompatibility	Substantially equivalent to predicate device for various biocompatibility tests.	Results of acute systemic toxicity, ocular irritation, primary skin irritation, Kligman sensitization, intracutaneous reactivity, subcutaneous implantation, and MEM (cytotoxicity) were substantially equivalent to the predicate device.
Device Activation Force	Met specifications (implied, by demonstrating equivalence to predicate).	DERMABOND NX met specifications.
Compression Force	Met specifications (implied, by demonstrating equivalence to predicate).	DERMABOND NX met specifications.
Expressed Mass	Met specifications (implied, by demonstrating equivalence to predicate).	DERMABOND NX met specifications.
Wound Burst Strength	Met specifications (implied, by demonstrating equivalence to predicate).	DERMABOND NX met specifications.
Flatwise Tensile	Met specifications (implied, by demonstrating equivalence to predicate).	DERMABOND NX met specifications.
Overlap Shear Testing	Met specifications (implied, by demonstrating equivalence to predicate).	DERMABOND NX met specifications.
Skin Tensile	Met specifications (implied, by demonstrating equivalence to predicate).	DERMABOND NX met specifications.
T-Peel Testing	Met specifications (implied, by demonstrating equivalence to predicate).	DERMABOND NX met specifications.
Water Resistance Testing	Met specifications (implied, by demonstrating equivalence to predicate).	DERMABOND NX met specifications.
Heat Dissipation	Improved compared to predicate.	DERMABOND NX demonstrated better heat dissipation.
Viscosity	Higher viscosity compared to predicate.	DERMABOND NX has a higher viscosity to allow precise, single-pass application.
Sterility Assurance Level (SAL)	Minimum 10^-6, same as predicate.	Both dry heat and ethylene oxide (EO) sterilization processes provide a minimum SAL of 10^-6, same as predicate.
Shelf-Life	Two-year shelf life.	Two years equivalent of accelerated testing completed, with 12 months of real-time data supporting a two-year shelf life claim (real-time data collection ongoing).

Study Details:

Sample sizes used for the test set and the data provenance:
- The document describes bench tests and biocompatibility tests, not a "test set" in the context of clinical data for performance evaluation in the typical sense.
- Bench Tests: The document states, "All testing for DERMABOND NX Topical Skin Adhesive has been completed according to Design Control requirements of 21CFR820.30." It does not specify sample sizes for each type of bench test (e.g., wound burst strength, tensile tests). The data provenance is internal testing conducted by Ethicon, Inc. This is prospective testing of the device.
- Biocompatibility Tests: The specific sample sizes for animals or in vitro assays used for biocompatibility are not mentioned. The data provenance is internal testing.
- No information is provided regarding country of origin for the data beyond being conducted by Ethicon, Inc. (Somerville, NJ, USA).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the document describes bench and biocompatibility testing, not a study evaluating human interpretation or clinical endpoints that would require expert-established ground truth. The "ground truth" for the bench tests would be the measurement against predefined engineering specifications.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This pertains to clinical studies involving human assessment of outcomes, which are not described here.
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 a topical skin adhesive, not an AI-powered diagnostic or assistive technology. No MRMC study was performed.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a medical product (adhesive), not an algorithm or AI system. Its performance is inherent to its physical and chemical properties.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For bench testing, the "ground truth" would be established by engineering specifications and measurements from standardized tests. The goal was to meet these specifications and demonstrate equivalence or superiority to the predicate device.
- For biocompatibility testing, the "ground truth" is established by standardized laboratory testing protocols and results interpreted against established safety thresholds and comparison to a known safe predicate device.
The sample size for the training set:
- Not applicable. There is no "training set" as this is not a machine learning model. The device formulation and design were likely developed through R&D (development phase), but this is not discussed in terms of a "training set."
How the ground truth for the training set was established:
- Not applicable. As there is no training set.

Summary

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Page 1 of 13

MAY - 4 2010

510(k) Summary as required by 21 Section 5.

510(k) Owner:

Ethicon, Inc. P.O. Box 151, Route 22 West Somerville, NJ 08876-0151 Telephone: (908) 218-3323 Fax: (908) 218-2595

Contact Person: Neelu Medhekar, WW Director, Regulatory Affairs, Ethicon Products

February 1, 2010 Date:

Trade Name: DERMABOND® NX Topical Skin Adhesive

Common Name: Topical Skin Adhesive

Classification Name: Tissue Adhesive for the Topical Approximation of Skin

Product Code: MPN

Predicate Device: DERMABOND® Topical Skin Adhesive (P960052): Reclassified from Class III PMA to Class II 510(k) - May 5, 2008 - Docket number 2006p-071.

Device Description:

CONFIDENTIAL

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K100423

Indications for Use:

DERMABOND® NX 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, traumainduced lacerations. DERMABOND® NX Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal stitches.

These indications for use are identical to those of Dermabond (predicate device).

Technological Characteristics:

The technological characteristics of DERMABOND NX Topical Skin Adhesive are equivalent in performance to the predicate device, DERMABOND Topical Skin Adhesive.

DERMABOND NX consists of a liguid topical skin adhesive formulation packaged within a dispensing applicator. The device is supplied in a sterile single-use package for use in wound closure procedures. DERMABOND NX is a higher viscosity formulation to allow precise application of the adhesive to the intended area and allow a single application of the adhesive to the wound area. The topical skin adhesive is designed to bond to the skin to provide flexible wound closure maintaining wound approximation and providing a microbial barrier.

The main difference between DERMABOND NX and the predicate device is the adjusted higher viscosity to allow a one pass application and a different compound to increase the heat dissipation, reducing heat generated during the adhesive curing process on the skin.

Determination of Substantial Equivalence:

1. Biocompatibility

The biocompatibility of DERMABOND NX Topical Skin Adhesive device has been evaluated through the use of the recommended biocompatibility tests. Tests included acute systemic toxicity, ocular irritation, primary skin irritation, Kligman sensitization, intracutaneous reactivity, subcutaneous implantation and MEM (cytotoxicity). The results were substantially equivalent to those of the predicate device. These results are not substantially different when compared to the predicate device when the same procedures were used.

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Ki00423

2. Performance Bench Testing:

Page 3 of 3

All testing for DERMABOND NX Topical Skin Adhesive has been completed according to Design Control requirements of 21CFR820.30. The testing plan and results were based on the FDA guidance document "Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin". Bench tests included device activation force, compression force, expressed mass, wound burst strength, flatwise tensile and overlap shear testing, skin tensile and T-peel testing and water resistance testing. In all cases, DERMABOND NX met specifications and demonstrated equivalence to the predicate device with the minor changes of better heat dissipation and increased viscosity.

3. Sterilization and Shelf-Life:

Sterilization of DERMABOND NX Topical Skin Adhesive is the same as the predicate device, DERMABOND family of products (P960052). The sterilization process consists of two parts: 1) The dry heat sterilization of formulation filled ampoules containing liquid topical skin adhesive. And 2) The 100% ethylene oxide (EO) sterilization of the device after final packaging. Both of these processes provide a minimum sterility assurance level (SAL) of 10 which are the same as those used for sterilization of the predicate DERMABOND products.

Both real-time and accelerated stability testing data has been collected in support of this submission. Two years equivalent of accelerated testing has been completed supplementing the real time data of currently 12 months. Real time data will continue to be collected and analyzed to support a two (2) year shelf life labeling claim.

Based on extensive biocompatibility and bench testing, Dermabond NX has been demonstrated to be substantially equivalent to its predicate device from a safety perspective and has also demonstrated higher viscosity and better heat dissipation.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, enclosed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.

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

Ethicon, Inc. % Ms. Neelu Medhekar Director, Regulatory Affairs P.O. Box 151, Route 22 West Somerville, New Jersey 08876-0151

MAY - 4 2010

Re: K100423

Trade/Device Name: DERMABOND® NX Topical Skin Adhesive Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue adhesive Regulatory Class: Class II Product Code: MPN Dated: February 05, 2010 Received: February 16, 2010

Dear Ms. Medhekar;

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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Page 2 - Ms. Neelu Medhekar

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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely vours.

Muli. A. Millerm

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE

510(k) Number (if known):

Device Name: DERMABOND® NX Topical Skin Adhesive

Indications For Use:

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

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Daniel Krone for MKM

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K100423

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.