DERMABOND PRINEO Skin Closure System

K163645 · Ethicon, LLC · OMD · Apr 21, 2017 · General, Plastic Surgery

Device Facts

• Record ID: K163645
• Device Name: DERMABOND PRINEO Skin Closure System
• Applicant: Ethicon, LLC
• Product Code: OMD · General, Plastic Surgery
• Decision Date: Apr 21, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4011
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

DERMABOND™ PRINEO™ 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™ System 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.

Device Story

Dermabond Prineo is a sterile, liquid topical skin adhesive (2-octylcyanoacrylate) and adjunct wound closure system. Device consists of a single-use applicator with a crushable glass ampule and two self-adhering meshes. Used in clinical settings by healthcare providers to close surgical incisions up to 40 cm. Mesh is applied first to provide temporary skin edge alignment; liquid adhesive is then applied over the mesh. Adhesive polymerizes within minutes to form a microbial barrier. System acts as a topical skin closure; must be used with deep dermal stitches. Benefits include efficient skin edge approximation and microbial barrier protection for surgical wounds.

Clinical Evidence

Bench testing only. Testing included creep strength, peel strength (mesh only and mesh with adhesive), wound/tissue holding strength, set time, and set temperature. Biocompatibility testing included intracutaneous reactivity, modified ISO skin irritation, and ISO guinea pig maximization sensitization. A 14-day porcine effectiveness study was also conducted.

Technological Characteristics

Liquid 2-octylcyanoacrylate adhesive with D & C Violet No. 2 colorant. Includes two self-adhering meshes for alignment. Sterile, single-use applicator with glass ampule. Materials comply with ISO 10993-1:2009. Designed for incisions up to 40 cm.

Indications for Use

Indicated for topical closure of easily approximated surgical incisions (including minimally invasive surgery punctures) and simple, cleansed, trauma-induced lacerations in patients requiring wound closure in conjunction with deep dermal stitches.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• DERMABOND™ PRINEO™ Skin Closure System (K133864)

Submission Summary (Full Text)

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

April 21, 2017

Ethicon, LLC Mr. Joice Pappan Regulatory Specialist II Route 22 West, P.O. Box 151 Somerville, New Jersey 08876-0151

Re: K163645 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: January 20, 2017 Received: January 23, 2017

Dear Mr. Pappan:

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 Part 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 (OS) 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 [phone] or [phone] or at its Internet address

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

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 [phone] or [phone] or at its Internet address

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

Sincerely,

# 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

Enclosure

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## Indications for Use

510(k) Number (if known) K163645

Device Name DERMABOND™ PRINEO™ Skin Closure System

#### Indications for Use (Describe)

DERMABOND™ PRINEO™ 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™ System 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.

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

| <span> <span style="font-size: 100%;"> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </span> </span> |
|--------------------------------------------------------------------------------------------------------------|
| <span> <span style="font-size: 100%;"> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |

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510(k) Pre-Market Notification Ethicon DERMABOND™ PRINEO™ Skin Closure System Ethicon, Inc.

Image /page/3/Picture/1 description: The image shows the word "ETHICON" in red, with each letter in a bold, serif font. The letters are evenly spaced and the word is centered. The color of the text is a vibrant red, which contrasts with the white background.

PART OF THE Johnson&Johnson FAMILY OF COMPANIES

# 510(k) Summar

- Submitter: Ethicon Inc. a Johnson & Johnson company P.O. Box 151 Route 22 West Somerville, NJ 08876-0151
- Joice Pappan Contact Person: Specialist II, Regulatory Affairs Ethicon, Inc. a Johnson & Johnson company Ph: [phone] Fax: [phone] E-mail: [e-mail]

April 19, 2017 Date Prepared:

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 the topical approximation of skin (21 CFR 878.4011)

Product Code: OMD

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510(k) Pre-Market Notification Ethicon DERMABOND™ PRINEO™ Skin Closure System Ethicon. Inc.

#### Predicate Devices:

| Device | Company | Product<br>Code | 510(k)<br>Number | Predicate for: |
|----------------------------------------------|---------------|-----------------|------------------|------------------------------------------------------------------------------------------------------------------------|
| DERMABOND™<br>PRINEO™ Skin Closure<br>System | Ethicon, Inc. | OMD | K133864 | Fundamental Scientific<br>Technology, Design, Intended Use,<br>Materials, Construction,<br>Performance Characteristics |

#### Device Description:

DERMABOND™ PRINEO™ Skin Closure System is a sterile, liquid topical skin adhesive containing a monomeric (2-octylcyanoacrylate) formulation and the 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 adhesive is slightly more viscous than water and polymerizes within minutes. In vitro studies have shown that DERMABOND™ PRINEO™ System 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.

DERMABOND™ PRINEOTM System also incorporates 2 self-adhering meshes that are applied to the approximated skin edges to provide temporary skin edge alignment of incisions up to 40 cm in length until the liquid adhesive is applied to achieve skin closure.

#### Indications for Use:

DERMABOND™ PRINEOTM 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™ System 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 subject device DERMABOND™ PRINEO™ Skin Closure System (DP42) and the substantial equivalence to the predicate device DERMABOND™ PRINEO™ Skin Closure System (DP22) has been demonstrated via data collected in non-clinical

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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 to 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.

The following tests were completed for the DERMABOND™ PRINEO™ Skin Closure System (42cm):

| Biocompatibility/In vivoTesting | Bench Testing |
|---------------------------------------------|--------------------------------------------------|
| Irritation (Intracutaneous Reactivity) | Creep Strength |
| Irritation (Modified ISO Skin) | Peel Strength- mesh only (N/cm) |
| Sensitization (ISO Guinea Pig Maximization) | Peel adhesion Strength-Mesh with adhesive (N/cm) |
| 14 day Porcine Effectiveness Study | Wound/Tissue holding Strength (Ibf) |
| | Set Time (Seconds) |
| | Set Temperature (°C) |

#### Summary of Substantial Equivalence Comparison:

The subject DERMABOND™ PRINEO™ Skin Closure System (42 cm) is equivalent to the predicate DERMABOND™ PRINEO™ Skin Closure System (22 cm) described in K133864 with the exception of number of mesh patches. The subject device is intended to hold closed incisions up to 40 cm in length and the predicate device is for incisions up to 20 cm in length. The subject device has the same fundamental scientific technology and intended use as the current, legally marketed DERMABOND™ PRINEO™ Skin Closure System (22cm). The subject and predicate devices share the same materials, design, fundamental scientific technology (operating principle), labeling components, packaging materials and configuration and sterilization process. The additional size meets the same requirements as the current FDA cleared K133864 device.

### Conclusion:

Based on the intended use, technological characteristics, safety and performance testing, the additional size of DERMABOND™ PRINEO™ Skin Closure System (42cm) has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the DERMABOND™ PRINEOTM Skin Closure System (22cm) (K133864).