(81 days)
DERMABOND PRINEO Skin Closure 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, traumainduced lacerations. DERMABOND PRINEO should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure 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-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 acts as a barrier to microbial penetration as long as the liquid topical skin 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.
The provided text describes the DERMABOND™ PRINEO™ Skin Closure System, a topical skin adhesive. However, it does not contain a typical acceptance criteria table with performance metrics that would be applicable to an AI/ML device or diagnostic tools in the requested format. Instead, it details the regulatory submission and the overall safety and effectiveness assessment for a medical device.
Therefore, many of the requested sections related to traditional diagnostic performance studies (like sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, and ground truth establishment methods) are not explicitly present in the provided documentation for this specific device. The information focuses on bench testing, biocompatibility, and substantial equivalence to a predicate device, rather than diagnostic accuracy or AI performance.
Here's an attempt to extract and interpret the information based on the provided text, primarily focusing on the type of study conducted for this specific medical device rather than an AI/ML diagnostic:
Acceptance Criteria and Study for DERMABOND™ PRINEO™ Skin Closure System
Given that this is a 510(k) summary for a topical skin adhesive, the "acceptance criteria" and "study" are framed around demonstrating substantial equivalence to a predicate device and ensuring the safety and effectiveness of the new size variant (up to 20 cm incision length) through nonclinical design verification and biocompatibility testing. There are no explicit performance metrics in the format of "acceptance criteria" with numerical targets and "reported device performance" against those targets as would be expected for a diagnostic device. Instead, the "acceptance criteria" can be inferred as successful completion of various bench and in-vivo tests, demonstrating equivalence and meeting established safety standards.
1. Table of Acceptance Criteria and Reported Device Performance
As explicit numerical acceptance criteria were not listed, this table reflects the types of tests performed and the general outcome of demonstrating conformance and substantial equivalence.
| Acceptance Criteria (Inferred from testing performed) | Reported Device Performance (Summary) |
|---|---|
| Mechanical Performance: | |
| Peel Test requirements met | "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." (Implies tests were met) |
| Creep Test requirements met | "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." |
| Tensile Strength requirements met | "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." |
| Peel Adhesion Strength Test requirements met | "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." |
| Adhesive Characteristics: | |
| Setting Performance within specifications | "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." |
| Viscosity within specifications | "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." |
| Purity/Impurity by GC within specifications | "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." |
| Systematic Hydrolytic Extraction (SHE) within specifications | "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." |
| Water Vapor Transmission Rate within specifications | "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." |
| Applicator Performance: | |
| Adhesive Applicator Dial Torque, Expression Force, and Dispensed Volume within specs | "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." |
| Reliability of Adhesive Applicator Mechanism within specifications | "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." |
| Adhesive Applicator Drip Test satisfactory | "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." |
| Biocompatibility: | |
| Cytotoxicity (ISO Elution) | "All materials used in the proposed device are the same as 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." (Implies successful biocompatibility testing) |
| Irritation (Intracutaneous Reactivity/Modified ISO Skin) | "All materials used in the proposed device are the same as 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." |
| Sensitization (ISO Guinea Pig Maximization) | "All materials used in the proposed device are the same as 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." |
| Acute Systemic Toxicity (IP injection) | "All materials used in the proposed device are the same as 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." |
| Pyrogenicity (Material Mediated) | "All materials used in the proposed device are the same as 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." |
| Intramuscular Implantation | "All materials used in the proposed device are the same as 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." |
| Primary Ocular Irritation (Draize) | "All materials used in the proposed device are the same as 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." |
| Barrier/Shelf Life/Packaging: | |
| Microbial Barrier performance | "In vitro studies have shown that DERMABOND PRINEO acts as a barrier to microbial penetration as long as the liquid topical skin adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties." (Indication of successful in vitro barrier performance, not clinical) |
| Shelf Life requirements met | "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." |
| Liner Paper Peel Strength Release within specifications | "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." |
| Package Seal Strength, Seal Integrity, Package Integrity within specifications | "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." (Implies packaging tests were met) |
| Effectiveness (Limited): | |
| 14 day Porcine Effectiveness Study results consistent with intended use | Demonstrated effectiveness for wound closure in a porcine model. The specific metrics and acceptance within the study are not detailed, but the overall conclusion supports substantial equivalence and intended use. |
| Maintains temporary skin edge alignment for incisions up to 20 cm | The subject device (new variant) is for incisions up to 20 cm, indicating it met the requirements for this size, similar to the predicate device for up to 60 cm. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify exact sample sizes for each bench test (e.g., number of tensile strength tests, number of peel tests). For the "14 day Porcine Effectiveness Study," the sample size is not stated.
- Data Provenance: The studies are described as "nonclinical design verification" and "in vivo" (porcine model). These are likely conducted internally by Ethicon or contract labs. The "Biocompatibility/In vivo" tests are standard regulatory tests. There is no information regarding country of origin for the data (other than Ethicon being a US company) or whether it was retrospective or prospective in the sense of human clinical trials. The porcine study would be prospective in its design.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This section is not applicable (N/A) as the submission details bench and animal (porcine) studies, not studies involving human expert interpretation for ground truth, which is typical for AI/ML diagnostic devices. The "ground truth" for these tests would be the measured physical properties or biological responses against established material and biological safety standards.
4. Adjudication Method for the Test Set
N/A. This is not a human interpretation study requiring adjudication. The results of the physical and biological tests are objective measurements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, What was the Effect Size of How Much Human Readers Improve with AI vs without AI Assistance
N/A. This device is a topical skin adhesive, not an AI/ML diagnostic tool, and therefore, an MRMC study comparing human reader performance with and without AI assistance is not relevant or applicable.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
N/A. This device is not an algorithm or AI. It is a physical medical device.
7. The Type of Ground Truth Used
The "ground truth" for this device's testing is best described as:
- Physical and Mechanical Measurement Standards: For tests like Peel, Tensile Strength, Viscosity, Creep, etc., the ground truth corresponds to accepted engineering and material science standards and specifications for performance.
- Biological Safety Standards: For Biocompatibility tests (Cytotoxicity, Irritation, Sensitization, etc.), the ground truth relies on established ISO 10993 standards for biological evaluation of medical devices.
- Animal Model Observations: For the "14 day Porcine Effectiveness Study," the ground truth would be direct observation of wound approximation and healing in the animal model, assessed by researchers or veterinarians against clinical endpoints (e.g., wound integrity, closure success).
8. The Sample Size for the Training Set
N/A. This device does not involve a "training set" in the context of AI/ML or a diagnostic model that learns from data.
9. How the Ground Truth for the Training Set was Established
N/A. As there is no training set, this question is not applicable.
§ 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.