(86 days)
DERMABOND ADVANCED™ Adhesive is intended for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. DERMABOND ADVANCED™ Adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
High viscosity DERMABOND® Adhesive 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. High viscosity DERMABOND® Adhesive may be used in conjunction with. but not in place of, deep dermal stitches.
DERMABOND ADVANCED™ Topical Skin Adhesive 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 as a single-use applicator in a blister package. The pen style applicator is composed of a crushable ampoule contained within a plastic applicator. As it is applied to the skin, the liquid is syrup-like in viscosity and polymerizes within minutes. Studies have shown that following application, DERMABOND ADVANCED™ Adhesive acts as a barrier to prevent microbial penetration as long as the adhesive remains.
High viscosity DERMABOND® Topical Skin Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet #2. It is provided in a single-use applicator packaged in a blister pouch. The applicator is composed of a crushable glass ampule contained within a plastic vial with attached applicator tip. As applied to skin, the liquid is syrup-like in viscosity and polymerizes within minutes. In vitro studies have shown that high viscosity DERMABOND® Adhesive 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.
High viscosity DERMABOND® Adhesive is different from the regular, or low viscosity DERMABOND® Adhesive due to the increased viscosity of the liquid adhesive formulation. Low viscosity DERMABOND® Adhesive has a viscosity slightly greater than water, while high viscosity DERMABOND® Adhesive has a syrup-like viscosity. The increased viscosity of high viscosity DERMABOND® Adhesive is intended to reduce the risk of unintended placement of the adhesive during application due to migration of the liquid adhesive from the wound site.
This document is a 510(k) Premarket Notification from the FDA regarding two topical skin adhesives: DERMABOND Advanced™ Topical Skin Adhesive and High Viscosity DERMABOND® Mini Topical Skin Adhesive.
Based on the provided document, the device described is DERMABOND Advanced™ Topical Skin Adhesive and High Viscosity DERMABOND® Mini Topical Skin Adhesive. This is a medical device, specifically a tissue adhesive, and not an AI/ML powered device.
Therefore, the request for "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/ML powered device cannot be fulfilled from this document. The document primarily focuses on establishing "substantial equivalence" to predicate devices, which is the regulatory pathway for medical devices that are not AI/ML systems.
There is no information in this document about:
- A table of acceptance criteria and reported device performance in the context of AI/ML.
- Sample sizes used for a test set in the context of AI/ML.
- Data provenance for AI/ML training or test sets.
- Number of experts used to establish ground truth for an AI/ML test set.
- Qualifications of experts for AI/ML ground truth.
- Adjudication methods for an AI/ML test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness studies for AI assistance.
- Effect size of human readers improving with AI vs. without AI assistance.
- Standalone (algorithm only) performance for an AI/ML device.
- Type of ground truth used (expert consensus, pathology, outcomes data) for an AI/ML device.
- Sample size for a training set for an AI/ML device.
- How ground truth for a training set was established for an AI/ML device.
The document explicitly states:
"DERMABOND ADVANCED™ Topical Skin Adhesive and High Viscosity DERMABOND® Mini Topical Skin Adhesive are identical to the DERMABOND ADVANCED™ Topical Skin Adhesive and High Viscosity DERMABOND® Mini Topical Skin Adhesive marketed device with respect to technological characteristics. There are no material, construction, specification, manufacturing or sterilization process changes to the currently marketed devices. The devices differ only in the labeling (Instructions for Use) that have been revised to add a contraindication, as well as other clarifications to ensure safer, more effective use of the device."
This statement is the core of their substantial equivalence argument. They are not introducing new technology that would require performance studies like those typical for AI/ML devices; they are seeking approval for minor labeling changes to existing, identical devices.
In summary, this document does not contain the information requested because the device is not an AI/ML powered device, and the submission is for labeling changes to an existing, substantially equivalent product.
§ 878.4010 Tissue adhesive.
(a)
Tissue adhesive for the topical approximation of skin —(1)Identification. A tissue adhesive for the topical approximation of skin is a device intended for topical closure of surgical incisions, including laparoscopic incisions, and simple traumatic lacerations that have easily approximated skin edges. Tissue adhesives for the topical approximation of skin may be used in conjunction with, but not in place of, deep dermal stitches.(2)
Classification. Class II (special controls). The special control for this device is FDA's “Class II Special Controls Guidance Document: “Tissue Adhesive for the Topical Approximation of Skin.” See § 878.1(e) of this chapter for the availability of this guidance document.(b)
Tissue adhesive for non-topical use —(1)Identification. A tissue adhesive for non-topical use, including adhesives intended for use in the embolization of brain arteriovenous malformation or for use in ophthalmic surgery, is a device used for adhesion of internal tissues and vessels.(2)
Classification. Class III (premarket approval). As of May 28, 1976, an approval under section 515 of the act is required before this device may be commercially distributed. See § 878.3 of this chapter.