(85 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 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.
This document is a 510(k) premarket notification for the DERMABOND™ PRINEO™ Skin Closure System, seeking clearance for a new revision of the device's labeling. The document explicitly states that the device itself has not changed in any material, construction, specification, manufacturing, or sterilization process. Therefore, it does not contain a study demonstrating new device performance against acceptance criteria.
The submission claims substantial equivalence to previously cleared DERMABOND™ PRINEO™ devices (K082289/DEN090005 and K133864). Since the device itself is identical to a previously cleared predicate and the changes are only to labeling (adding a contraindication and other clarifications), no new performance data or studies are presented in this document to demonstrate the device meets acceptance criteria. The document relies on the substantial equivalence of the unchanged device to the predicate device.
Therefore, I cannot provide the requested information from this document, as the core of the submission is about labeling changes to an already cleared and unchanged device, not a new study proving performance against acceptance criteria for the device itself.
§ 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.