(155 days)
Barle Tissue Adhesive 2 topical skin adhesive is intended for topical applications 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. Barle Tissue Adhesive 2 topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
Barle Tissue Adhesive 2 is a sterile, topical tissue adhesive containing 2-octyl cyanoacrylate for wound closure. It is applied to easily approximated skin edges and polymerizes within minutes. Barle Tissue Adhesive 2 is supplied in a single patient use configuration.
The provided text describes a 510(k) summary for a medical device, Barle Tissue Adhesive 2. This document is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. As such, the information provided focuses on demonstrating equivalence rather than establishing novel acceptance criteria and proving performance against them in the same way one would for a new, non-predicate-based device.
Therefore, the document does not contain the acceptance criteria and study details as typically defined for demonstrating the performance of an AI/ML-based device or a novel medical device against specific performance metrics.
Specifically, the document lacks information regarding:
- A table of acceptance criteria and reported device performance because the submission is for substantial equivalence to predicates, not for meeting new performance thresholds.
- Sample sizes used for a test set and data provenance in the context of a performance study.
- Number of experts and their qualifications for establishing ground truth for a test set.
- Adjudication method for a test set.
- MRMC comparative effectiveness study, effect size, or improvement of human readers with AI assistance.
- Standalone (algorithm-only) performance.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How ground truth for the training set was established.
The provided text focuses on the following:
- Device Description: Barle Tissue Adhesive 2 is a sterile, topical tissue adhesive containing 2-octyl cyanoacrylate for wound closure.
- Indications for Use: Intended for topical applications 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.
- Technological Characteristics: Substantially equivalent to predicate devices, with changes being modification of the applicator body design to remove actuation "wings" and addition of a microbial barrier claim.
- Substantial Equivalence Justification: Barle Tissue Adhesive 2 is substantially equivalent to Barle Tissue Adhesive (K123133) and LiquiBand® Flow Control Topical Skin Adhesive (K122446) with regard to Indication For Use, target population, intended application, mechanism of action, and performance. It is also substantially equivalent to LiquiBand® Flow Control regarding the microbial barrier claim.
- Conclusion: Based on extensive design verification, functional, and performance testing conducted in accordance with the "Class II Special Controls Guidance Document: Tissue Adhesive for Topical Approximation of Skin, May 30 2008," Barle Tissue Adhesive 2 is considered safe, effective, and performs as well as the legally marketed predicate devices.
In summary, this document is a 510(k) submission asserting substantial equivalence based on comparable characteristics and adherence to existing guidance documents, not a detailed report of a performance study with specific acceptance criteria and study results against those criteria.
§ 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.