(119 days)
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.
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.
The provided text describes a 510(k) premarket notification for a medical device, the Dermabond Prineo Skin Closure System. It focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than proving the device meets specific acceptance criteria through a clinical study involving human-in-the-loop performance, expert ground truth establishment, or MRMC studies.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not present in this document. This submission relies on non-clinical design verification and comparison to a predicate device.
Here's an attempt to extract relevant information and note what is not available based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document lists various tests performed to demonstrate safety and effectiveness for the Dermabond Prineo Skin Closure System (42cm) and its substantial equivalence to the predicate device (22cm). However, it does not provide specific quantitative acceptance criteria or detailed numerical results for each test. Instead, it states that "No new safety or performance issues were raised during the testing." and "The additional size meets the same requirements as the current FDA cleared K133864 device."
Here's a table of the types of tests performed, as listed in the document. The "Reported Device Performance" column reflects the general statement provided in the document.
| Test Category | Specific Test Type | Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance (Summary) |
|---|---|---|---|
| Biocompatibility/In vivoTesting | Irritation (Intracutaneous Reactivity) | (Presumed to meet ISO 10993-1:2009 standards) | Conforms to requirements; no new safety/performance issues |
| Irritation (Modified ISO Skin) | (Presumed to meet ISO 10993-1:2009 standards) | Conforms to requirements; no new safety/performance issues | |
| Sensitization (ISO Guinea Pig Maximization) | (Presumed to meet ISO 10993-1:2009 standards) | Conforms to requirements; no new safety/performance issues | |
| 14 day Porcine Effectiveness Study | (Details of effectiveness criteria not provided) | Conforms to requirements; no new safety/performance issues | |
| Bench Testing | Creep Strength | (Details of criteria not provided) | Conforms to requirements; no new safety/performance issues |
| Peel Strength- mesh only (N/cm) | (Details of criteria not provided) | Conforms to requirements; no new safety/performance issues | |
| Peel adhesion Strength-Mesh with adhesive (N/cm) | (Details of criteria not provided) | Conforms to requirements; no new safety/performance issues | |
| Wound/Tissue holding Strength (Ibf) | (Details of criteria not provided) | Conforms to requirements; no new safety/performance issues | |
| Set Time (Seconds) | (Details of criteria not provided) | Conforms to requirements; no new safety/performance issues | |
| Set Temperature (°C) | (Details of criteria not provided) | Conforms to requirements; no new safety/performance issues |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: The document mentions a "14 day Porcine Effectiveness Study" and various bench tests. However, it does not specify the sample sizes for these tests.
- Data Provenance: Not specified. The studies were non-clinical design verification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This document describes a 510(k) submission based on non-clinical testing and substantial equivalence, not a clinical study involving experts establishing ground truth for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not Applicable. As above, this was not a clinical study with image interpretation requiring adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not Applicable. This device is a skin closure system, not an AI-assisted diagnostic tool. An MRMC study is not relevant to this type of device or this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the non-clinical tests, the "ground truth" would be established by the engineering specifications, material properties, and biological compatibility standards (e.g., ISO 10993). For the porcine effectiveness study, the "effectiveness" would be assessed based on observed outcomes relevant to wound closure. However, specific definitions and methodologies for establishing this "ground truth" (e.g., how "effectiveness" was quantified and assessed in the porcine study) are not detailed in this document.
8. The sample size for the training set
- Not Applicable. This device is not an AI/machine learning algorithm that requires a training set. The submission focuses on non-clinical "design verification."
9. How the ground truth for the training set was established
- Not Applicable. (See point 8).
In Summary:
The provided FDA document is a 510(k) clearance letter for a medical device (Dermabond Prineo Skin Closure System). It outlines the device details and the basis for its substantial equivalence to a predicate device. The "study that proves the device meets the acceptance criteria" in this context refers to a series of non-clinical design verification tests (biocompatibility and bench testing) and a 14-day porcine effectiveness study. The document asserts these tests provide "reasonable assurance that the proposed device has been designed and tested to assure conformance to the requirements for its intended use" and that "No new safety or performance issues were raised during the testing." It does not provide the granular details of acceptance criteria, specific numerical results, sample sizes for all tests, or the methodology for ground truth establishment that would be present in a submission for an AI/ML-based diagnostic device or a comprehensive clinical trial report.
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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 (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
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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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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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: (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
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510(k) Pre-Market Notification Ethicon DERMABOND™ PRINEO™ Skin Closure System Ethicon. Inc.
Predicate Devices:
| Device | Company | ProductCode | 510(k)Number | Predicate for: |
|---|---|---|---|---|
| DERMABOND™PRINEO™ Skin ClosureSystem | Ethicon, Inc. | OMD | K133864 | Fundamental ScientificTechnology, 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
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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).
§ 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.