(35 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-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.
This is a 510(k) premarket notification for a medical device (DERMABOND™ PRINEO™ Skin Closure System) applying for clearance from the FDA. This document primarily focuses on establishing substantial equivalence to a predicate device, rather than presenting a de novo study with detailed acceptance criteria and performance data.
Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a new device cannot be fully extracted from this document in the manner typically expected for a new device submission.
Here's a breakdown of why and what can be extracted:
1. A table of acceptance criteria and the reported device performance
- Not Applicable in the traditional sense. This document explicitly states: "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."
- Since there were no new non-clinical or clinical studies conducted to demonstrate performance against new acceptance criteria, such a table cannot be created from this document. The submission is based on the premise that the modified device (reduced adhesive volume) performs equivalently to the predicate, which has already met its acceptance criteria.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable. No new test set data is presented for performance evaluation because no new studies were deemed necessary. The assessment hinges on the predicate device's existing data and the argument that a reduced adhesive volume does not alter the fundamental safety or effectiveness.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable. No new test set requiring expert ground truth establishment was conducted.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. No new test set requiring adjudication was conducted.
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 physical medical device (skin closure system), not an AI-powered diagnostic or interpretive tool. Therefore, MRMC studies involving human "readers" or AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. As above, this is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable. No new ground truth for performance evaluation was established for this submission. The "ground truth" for demonstrating substantial equivalence relies on the established performance and safety of the predicate device.
8. The sample size for the training set
- Not Applicable. This document does not pertain to the development of a predictive model or AI, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As above, there is no training set.
Summary based on the provided document:
The core of this 510(k) submission is to demonstrate substantial equivalence of the modified DERMABOND™ PRINEO™ Skin Closure System (with reduced adhesive volume) to its predicate device (K133864).
The document explicitly states that non-clinical and clinical testing were not necessary to support substantial equivalence because "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."
Therefore, the "proof" that the device meets acceptance criteria implicitly relies on:
- The predicate device (K133864) having already met its acceptance criteria through its original clearance.
- The argument that a reduction in adhesive volume does not compromise the fundamental safety and effectiveness of the device, given that all other technological characteristics, materials, design, intended use, and manufacturing processes remain identical to the cleared predicate.
In a situation like this, the "acceptance criteria" are effectively met by demonstrating that the changes are minor and do not affect the established performance characteristics of the predicate device. No new study data is presented to prove independent performance against new acceptance criteria.
§ 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.