DERMABOND PRINEO Skin Closure System 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, traumainduced lacerations. DERMABOND PRINEO should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.

Device Description

DERMABOND™ PRINEO™ Skin Closure System is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and colorant D & C Violet No. 2. It is provided in a single-use applicator packaged in a rigid blister. The applicator is composed of a crushable glass ampule contained within a pen applicator with an attached applicator tip. As applied to skin, the liquid topical skin adhesive is slightly more viscous than water and polymerizes within minutes. In vitro studies have shown that DERMABOND PRINEO acts as a barrier to microbial penetration as long as the liquid topical skin adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties.

DERMABOND PRINEO also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment of incisions up to 20 cm in length until the liquid topical skin adhesive is applied to achieve skin closure.

AI/ML Overview

The provided text describes the DERMABOND™ PRINEO™ Skin Closure System, a topical skin adhesive. However, it does not contain a typical acceptance criteria table with performance metrics that would be applicable to an AI/ML device or diagnostic tools in the requested format. Instead, it details the regulatory submission and the overall safety and effectiveness assessment for a medical device.

Therefore, many of the requested sections related to traditional diagnostic performance studies (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, and ground truth establishment methods) are not explicitly present in the provided documentation for this specific device. The information focuses on bench testing, biocompatibility, and substantial equivalence to a predicate device, rather than diagnostic accuracy or AI performance.

Here's an attempt to extract and interpret the information based on the provided text, primarily focusing on the type of study conducted for this specific medical device rather than an AI/ML diagnostic:

Acceptance Criteria and Study for DERMABOND™ PRINEO™ Skin Closure System

Given that this is a 510(k) summary for a topical skin adhesive, the "acceptance criteria" and "study" are framed around demonstrating substantial equivalence to a predicate device and ensuring the safety and effectiveness of the new size variant (up to 20 cm incision length) through nonclinical design verification and biocompatibility testing. There are no explicit performance metrics in the format of "acceptance criteria" with numerical targets and "reported device performance" against those targets as would be expected for a diagnostic device. Instead, the "acceptance criteria" can be inferred as successful completion of various bench and in-vivo tests, demonstrating equivalence and meeting established safety standards.

1. Table of Acceptance Criteria and Reported Device Performance

As explicit numerical acceptance criteria were not listed, this table reflects the types of tests performed and the general outcome of demonstrating conformance and substantial equivalence.

Acceptance Criteria (Inferred from testing performed)	Reported Device Performance (Summary)
Mechanical Performance:
Peel Test requirements met	"Results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." (Implies tests were met)
Creep Test requirements met	"Results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."
Tensile Strength requirements met	"Results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."
Peel Adhesion Strength Test requirements met	"Results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."
Adhesive Characteristics:
Setting Performance within specifications	"Results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."
Viscosity within specifications	"Results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."
Purity/Impurity by GC within specifications	"Results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."
Systematic Hydrolytic Extraction (SHE) within specifications	"Results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."
Water Vapor Transmission Rate within specifications	"Results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."
Applicator Performance:
Adhesive Applicator Dial Torque, Expression Force, and Dispensed Volume within specs	"Results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."
Reliability of Adhesive Applicator Mechanism within specifications	"Results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."
Adhesive Applicator Drip Test satisfactory	"Results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."
Biocompatibility:
Cytotoxicity (ISO Elution)	"All materials used in the proposed device are the same as the predicate device and meet the requirements of ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and Testing within a risk management process." (Implies successful biocompatibility testing)
Irritation (Intracutaneous Reactivity/Modified ISO Skin)	"All materials used in the proposed device are the same as the predicate device and meet the requirements of ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and Testing within a risk management process."
Sensitization (ISO Guinea Pig Maximization)	"All materials used in the proposed device are the same as the predicate device and meet the requirements of ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and Testing within a risk management process."
Acute Systemic Toxicity (IP injection)	"All materials used in the proposed device are the same as the predicate device and meet the requirements of ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and Testing within a risk management process."
Pyrogenicity (Material Mediated)	"All materials used in the proposed device are the same as the predicate device and meet the requirements of ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and Testing within a risk management process."
Intramuscular Implantation	"All materials used in the proposed device are the same as the predicate device and meet the requirements of ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and Testing within a risk management process."
Primary Ocular Irritation (Draize)	"All materials used in the proposed device are the same as the predicate device and meet the requirements of ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and Testing within a risk management process."
Barrier/Shelf Life/Packaging:
Microbial Barrier performance	"In vitro studies have shown that DERMABOND PRINEO acts as a barrier to microbial penetration as long as the liquid topical skin adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties." (Indication of successful in vitro barrier performance, not clinical)
Shelf Life requirements met	"Results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."
Liner Paper Peel Strength Release within specifications	"Results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use."
Package Seal Strength, Seal Integrity, Package Integrity within specifications	"Results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use." (Implies packaging tests were met)
Effectiveness (Limited):
14 day Porcine Effectiveness Study results consistent with intended use	Demonstrated effectiveness for wound closure in a porcine model. The specific metrics and acceptance within the study are not detailed, but the overall conclusion supports substantial equivalence and intended use.
Maintains temporary skin edge alignment for incisions up to 20 cm	The subject device (new variant) is for incisions up to 20 cm, indicating it met the requirements for this size, similar to the predicate device for up to 60 cm.

2. Sample Size Used for the Test Set and Data Provenance

Test Set Sample Size: The document does not specify exact sample sizes for each bench test (e.g., number of tensile strength tests, number of peel tests). For the "14 day Porcine Effectiveness Study," the sample size is not stated.
Data Provenance: The studies are described as "nonclinical design verification" and "in vivo" (porcine model). These are likely conducted internally by Ethicon or contract labs. The "Biocompatibility/In vivo" tests are standard regulatory tests. There is no information regarding country of origin for the data (other than Ethicon being a US company) or whether it was retrospective or prospective in the sense of human clinical trials. The porcine study would be prospective in its design.

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

This section is not applicable (N/A) as the submission details bench and animal (porcine) studies, not studies involving human expert interpretation for ground truth, which is typical for AI/ML diagnostic devices. The "ground truth" for these tests would be the measured physical properties or biological responses against established material and biological safety standards.

4. Adjudication Method for the Test Set

N/A. This is not a human interpretation study requiring adjudication. The results of the physical and biological tests are objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance

N/A. This device is a topical skin adhesive, not an AI/ML diagnostic tool, and therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or applicable.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

N/A. This device is not an algorithm or AI. It is a physical medical device.

7. The Type of Ground Truth Used

The "ground truth" for this device's testing is best described as:

Physical and Mechanical Measurement Standards: For tests like Peel, Tensile Strength, Viscosity, Creep, etc., the ground truth corresponds to accepted engineering and material science standards and specifications for performance.
Biological Safety Standards: For Biocompatibility tests (Cytotoxicity, Irritation, Sensitization, etc.), the ground truth relies on established ISO 10993 standards for biological evaluation of medical devices.
Animal Model Observations: For the "14 day Porcine Effectiveness Study," the ground truth would be direct observation of wound approximation and healing in the animal model, assessed by researchers or veterinarians against clinical endpoints (e.g., wound integrity, closure success).

8. The Sample Size for the Training Set

N/A. This device does not involve a "training set" in the context of AI/ML or a diagnostic model that learns from data.

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

N/A. As there is no training set, this question is not applicable.

Summary

{0}------------------------------------------------

..............................................................................................................................................................................

510(k) Summary

Submitter:	Ethicon Inc. a Johnson & Johnson companyP.O. Box 151Route 22 WestSomerville, NJ 08876-0151
Contact Person:	Donna MarshallManager, Regulatory AffairsEthicon, Inc. a Johnson & Johnson companyPh: (908) 541-3990Fax: (908) 218-2595e-mail: dmarsha2@its.jnj.com
Date Prepared:	December 18, 2013
Device Trade Name:	DERMABOND™ PRINEO™ Skin Closure System
Device Common Name:	Topical Skin Adhesive
Class:	II
Classification Name:	Tissue adhesive with adjunct wound closure device intended for thetopical approximation of skin (21 CFR 878.4011)
Product Code:	OMD

{1}------------------------------------------------

Predicate Device:

Device	Company	ProductCode	510(k)Number	Predicate for
DERMABOND™ PRINEO™Skin Closure System	Ethicon, Inc.	OMD	K082289	Fundamental ScientificTechnology, Design, IntendedUse, Materials, Construction,Performance Characteristics

Device Description:

Indications for Use:

DERMABOND PRINEO Skin Closure System 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. DERMABOND PRINEO should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.

Summary of Technological Characteristics and Performance Testing:

The safety and effectiveness of the DERMABOND™ PRINEO™ Skin Closure System and the substantial equivalence to the predicate device has been demonstrated via data collected in nonclinical design verification. The results of these tests provide reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use. No new safety or performance issues were raised during the testing. All materials used in the proposed device are the same as the predicate device and meet the requirements of ISO 10993-1:2009 Biological evaluation of medical devices - Part 1: Evaluation and Testing within a risk management process.

{2}------------------------------------------------

510(k) K133864 DERMABOND™ PRINEOTM Skin Closure System Ethicon, Inc.

Bench Testing	Bench Testing (continued)	Biocompatibility/In vivoTesting
Peel Test	Systematic Hydrolytic Extraction (SHE)	Cytotoxicity (ISO Elution)
Creep Test	Water Vapor Transmission Rate	Irritation (Intracutaneous Reactivity)
Tensile Strength	Adhesive Applicator Dial Torque,Expression Force, And DispensedVolume	Irritation (Modified ISO Skin)
Peel Adhesion Strength Test	Reliability of Adhesive ApplicatorMechanism	Sensitization (ISO Guinea PigMaximization)
Setting Performance	Adhesive Applicator Drip Test	Acute Systemic Toxicity (IP injection)
Liner Paper Peel Strength Release		Pyrogenicity (Material Mediated)
Shelf Life	Packaging Testing	Intramuscular Implantation
Viscosity	Package Seal Strength	Primary Ocular Irritation (Draize)
Purity/Impurity by GC	Seal Integrity	Modified Skin Draize Test
Microbial Barrier	Package Integrity	14 day Porcine Effectiveness Study

Below you will find a list of non-clinical performance data completed for the DERMABOND™ PRINEO™ Skin Closure System:

Summary of Substantial Equivalence Comparison:

The subject DERMABOND™ Skin Closure System is equivalent to the predicate DERMABOND™ PRINEO™ Skin Closure System described in 510(k) #K082289 with the exception of the size of the mesh patch. The subject device is intended to hold closed incisions up to 20 cm in length and the predicate device is for incisions up to 60 cm in length. The subject device has the same fundamental scientific technology and intended use as the current, legally marketed DERMABOND™ PRINEOTM Skin Closure System. The subject and predicate devices share the same materials, design, fundamental scientific technology (operating principle), labeling components, packaging materials and configuration, shelf life and sterilization process. The additional size meets the same requirements as the current FDA cleared [510(k) K082289] device.

Conclusion:

Based on the intended use, technological characteristics, safety and performance testing, the additional size of DERMABOND™ PRINEO™ Skin Closure System has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the DERMABOND™ PRINEO™ Skin Closure System (K082289).

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, sans-serif font. The words are arranged on a single line and centered horizontally. The text is likely part of a document or presentation related to the Department of Health and Human Services.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

March 10, 2014

Ethicon, Inc. Donna Marshall Manager, Regulatory Affairs P.O. Box 151. Route 22 West Somerville, New Jersey 08876-0151

Re: K133864

Trade/Device Name: DERMABOND™ PRINEO" Skin Closure System Regulation Number: 21 CFR 878.4011 Regulation Name: Tissue adhesive with adjunct wound closure device for topical approximation of skin Regulatory Class: Class II Product Code: OMD Dated: February 07, 2014 Received: February 10, 2014

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

{4}------------------------------------------------

Page 2 - Donna Marshall

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/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

David Krause -S

for

Binita Ashar, MD, MBA, FACS Acting Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K133864

Device Name

DERMABOND™ PRINEO™ Skin Closure System

Indications for Use (Describe)

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

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signalure)

FORM FDA 3881 (1/14)

PSC Petitions Senton (301) 413-6140 Page 22 of 27

Regulation Number and Section

§ 878.4011 Tissue adhesive with adjunct wound closure device for topical approximation of skin.

(a)
Identification. A tissue adhesive with adjunct wound closure device intended for the topical approximation of skin is a device indicated 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. It may be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of wound during application of the liquid adhesive.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin.” See § 878.1(e) for the availability of this guidance document.