(85 days)
Not Found
No
The device description and intended use focus on a topical skin adhesive and a self-adhering mesh for wound closure. There is no mention of AI or ML in the provided text, and the "Mentions AI, DNN, or ML" field is marked as "Not Found".
No.
The device functions as a skin adhesive for closing wounds, not for treating a disease or condition.
No
Explanation: The device is a skin closure system used for topical application to hold approximated skin edges of wounds. Its function is to facilitate the healing process by securing wounds, not to diagnose medical conditions or diseases.
No
The device description clearly outlines physical components like a liquid adhesive, applicator, glass ampule, and self-adhering mesh, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for topical application to hold closed skin edges of wounds. This is a direct application to the body for a therapeutic purpose (wound closure).
- Device Description: The device is a skin closure system consisting of a liquid adhesive and a mesh. It is applied externally to the skin.
- Lack of In Vitro Diagnostic Characteristics: An IVD is a medical device that is used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. This device does not perform any such tests on biological samples.
The "in vitro studies" mentioned in the performance studies refer to testing done outside of a living organism (e.g., in a lab setting) to evaluate the device's properties, not to its use as a diagnostic tool on patient samples.
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-octyl cyanoacrylate) 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 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 liquid adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties.
DERMABOND™ PRINEO™ System also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment 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
Skin
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)
Not Found
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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 border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles facing to the right, suggesting a sense of community and support.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 25, 2015
ETHICON, Inc. Donna Marshall Manager, Regulatory Affairs Route 22 West, P.O. Box 151, Somerville, NJ 08876-0151
Re: K152490
Trade/Device Name: DERMABOND PRINEO Skin Closure System Regulation Number: 21 CFR 878.4011 Regulation Name: Tissue Adhesive with Adjunct Wound Closure Regulatory Class: Class II Product Code: OMD Dated: August 31, 2015 Received: September 1, 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
1
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.
Sincerely yours,
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
DERMABOND™ PRINEOTM 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)
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Ethicon, Inc.
510(k) Change Being Effected DERMABOND™ PRINEOTM Skin Closure System
PART OF THE JOHNOW 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: | August 31, 2015 |
|---|---|
| Device Trade Name: | DERMABOND™ PRINEOTM Skin Closure System |
| Device Common Name: | Topical Skin Adhesive |
| Class: | II |
| Classification Name: | Tissue Adhesive with adjunct wound closure device intended for |
| topical approximation of skin (21 CFR 878.4011) | |
| Product Code: | OMD |
| Predicate Device | 510(k) Number |
|---|---|
| DERMABOND™ PRINEO™ Skin Closure System | K082289/DEN090005 |
| DERMABOND™ PRINEO™ Skin Closure System | K133864 |
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Device Description:
DERMABOND™ PRINEO™ Skin Closure System 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 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 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 liquid adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties.
DERMABOND™ PRINEO™ System also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment 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:
DERMABOND™ PRINEO™ System is identical to the DERMABOND™ PRINEO™ System (K082289/DEN090005) 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:
DERMABOND™ PRINEO™ System is identical to the DERMABOND™ PRINEO™ System 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.
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510(k) Change Being Effected DERMABOND™ PRINEOTM Skin Closure System
Conclusion:
DERMABOND™ PRINEO™ System is identical to the DERMABOND™ PRINEO™ System marketed device with respect to technological characteristics. There are no material, construction, specification, manufacturing or sterilization process changes to the currently marketed devices. DERMABOND™ PRINEO™ is considered to be substantially equivalent to the predicate device.