(35 days)
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 any computational analysis, image processing, or algorithms that would suggest the use of AI or ML. The "Mentions AI, DNN, or ML" and "Mentions image processing" fields are explicitly marked as "Not Found".
No.
The device is a skin closure system intended for topical application to hold closed skin edges of wounds, which is a structural rather than a therapeutic function.
No.
The device is a topical skin adhesive intended for wound closure, not for diagnosing medical conditions.
No
The device description clearly details 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 wound closure, not for examining specimens in vitro (outside the body) to diagnose a condition.
- Device Description: The description details a topical skin adhesive and a mesh for wound closure. There is no mention of analyzing biological samples or providing diagnostic information.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other biological specimens.
- Providing diagnostic information about a disease or condition.
- Using reagents or assays.
The device is clearly intended for wound closure on the body, which falls under the category of a surgical or wound management device, 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-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 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 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.
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
This section is not applicable, as both nonclinical testing are not necessary to support substantial equivalence since there have been no changes to the technological characteristics of the devices, including the adhesive formulation, design, material and performance; this change is only to reduce adhesive volume for subject device.
Based on the intended use, technological characteristics, safety and performance testing, the subject DERMABOND™ PRINEO™ Skin Closure System with lower adhesive volume has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the predicate DERMABOND™ PRINEO™ Skin Closure System (K133864).
Key Metrics
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.
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December 7, 2021
Ethicon, Inc. Noorhidayah Norizan Sr. Regulatory Affairs Program Lead 1000 Rte. 202 South Raritan, New Jersey 08869
Re: K213512
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: November 1, 2021 Received: November 2, 2021
Dear Noorhidayah Norizan:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
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 of medical device-related adverse events) (21 CFR 803) for
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Julie Morabito, Ph.D. Assistant Director DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K213512
Device Name
DERMABOND™ PRINEO™ Skin Closure System (CLR222US)
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 stiches. Additionally, the adjunct wound closure device component mantains 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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510(k) Summary
Contact Details
Applicant Name: Ethicon, Inc. Applicant Address: 1000 Rte. 202 South Raritan NJ 08869 United States Applicant Contact Telephone: 908-800-6624 Applicant Contact: Ms. Noorhidayah Norizan Applicant Contact Email: nnoriza@its.jnj.com
Device Name
Device Trade Name: DERMABOND™ PRINEO™ Skin Closure System Common Name: Tissue adhesive with adjunct wound closure device for topical approximation of skin Class: II Classification Name: Cutaneous Tissue Adhesive with Mesh Regulation Number: 878.4011 Product Code: OMD
Date Prepared: December 06, 2021
Legally Marketed Predicate Devices:
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
|---|---|---|
| K133864 | DERMABOND™ PRINEO™ Skin Closure System | OMD |
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 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 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.
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
4
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.
Indications for Use Comparison
Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] has been followed and it was determined that subject DERMABOND PRINEO Skin Closure System is substantially equivalent to the predicate DERMABOND PRINEO Skin Closure System in that they share the same indications for use.
Technological Comparison:
Guidance for Industry and Food and Drug Administration Staff: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] has been followed and it was determined that subject DERMABOND PRINEO Skin Closure System is substantially equivalent to the predicate DERMABOND PRINEO Skin Closure System in that they share:
- a) the same fundamental scientific technology,
- b) the same intended use,
- c) the same design,
- d) the same materials.
- e) the same packaging materials and configuration,
- f) the same labeling components
- g) the same sterilization process (Dry Heat & Ethylene Oxide)
- h) the same sterility assurance level (SAL) is 10-6.
Non-Clinical and/or Clinical Tests Summary & Conclusion:
This section is not applicable, as both nonclinical testing are not necessary to support substantial equivalence since there have been no changes to the technological characteristics of the devices, including the adhesive formulation, design, material and performance; this change is only to reduce adhesive volume for subject device.
Based on the intended use, technological characteristics, safety and performance testing, the subject DERMABOND™ PRINEO™ Skin Closure System with lower adhesive volume has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the predicate DERMABOND™ PRINEO™ Skin Closure System (K133864).