(119 days)
Not Found
No
The 510(k) summary describes a topical skin adhesive system and its physical components. There is no mention of AI, ML, image processing, or any software-driven analytical capabilities. The performance studies focus on physical properties and biocompatibility.
Yes
The device is intended for topical application to hold closed approximated skin edges of wounds, which is a therapeutic function for wound closure.
No
This device is intended for topical application to close skin edges, acting as a barrier and for alignment, not for identifying or investigating the nature or cause of a disease or condition.
No
The device description clearly outlines physical components including a liquid adhesive, applicator with a glass ampule, and self-adhering meshes. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for "topical application only to hold closed easily approximated skin edges of wounds from surgical incisions... and simple, thoroughly cleansed, trauma-induced lacerations." This describes a device used directly on the body for wound closure, not for testing samples taken from the body.
- Device Description: The description details a liquid topical skin adhesive and self-adhering meshes, which are applied externally to the skin. This aligns with the intended use and not with the typical components of an IVD (e.g., reagents, test strips, analyzers).
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting specific analytes, or providing diagnostic information based on in vitro testing.
Therefore, the DERMABOND™ PRINEO™ System is a medical device used for wound closure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
Product codes
OMD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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 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: Irritation (Intracutaneous Reactivity), Irritation (Modified ISO Skin), Sensitization (ISO Guinea Pig Maximization), 14 day Porcine Effectiveness Study
Bench Testing: Creep Strength, Peel Strength- mesh only (N/cm), Peel adhesion Strength-Mesh with adhesive (N/cm), Wound/Tissue holding Strength (Ibf), Set Time (Seconds), Set Temperature (°C)
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.
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
1
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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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
2
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)
| ☑ 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."
3
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: (908) 218-2113 Fax: (908) 218-2595 E-mail: Jpappan@its.jnj.com
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
4
510(k) Pre-Market Notification Ethicon DERMABOND™ PRINEO™ Skin Closure System Ethicon. Inc.
Predicate Devices:
| Device | Company | Product
Code | 510(k)
Number | Predicate for: |
|----------------------------------------------|---------------|-----------------|------------------|------------------------------------------------------------------------------------------------------------------------|
| DERMABOND™
PRINEO™ Skin Closure
System | Ethicon, Inc. | OMD | K133864 | Fundamental Scientific
Technology, Design, Intended Use,
Materials, Construction,
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
5
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).