(59 days)
SURGISEAL 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, simple, thoroughly cleansed, trauma induced lacerations.
SURGISEAL may be used in conjunction with, but not in place of, deep dermal sutures.
SURGISEAL® Topical Skin Adhesive is a sterile, professional liquid skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D&C Violet #2. It incorporates the Teardrop applicator that consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. The Stylus applicator incorporates the identical adhesive formula but incorporates the Stylus applicator that consists of a plastic ampoule, which houses the adhesive, contained with the longer plastic sleeve within a longer plastic sleeve with an attached applicator tip. When SURGISEAL is applied to the skin with either Applicator, it polymerizes in minutes.
In vitro studies have shown that SURGISEAL acts as a physical barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established.
The provided document describes a 510(k) submission for SURGISEAL® Topical Skin Adhesive and SURGISEAL Stylus™ Topical Skin Adhesive. The submission is for a labeling change to include a "Microbial Barrier description." The document explicitly states: "In vitro studies have shown that SURGISEAL acts as a physical barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established." Furthermore, it clarifies that the 510(k) submission is for a labeling change to characterize the ease, safety, or effective use of the product based on extensive bench performance testing, which has demonstrated to be safe & efficacious.
Therefore, the requested information regarding "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of clinical studies, ground truth, sample sizes, and expert adjudication cannot be extracted accurately for the microbial barrier claim, as no clinical studies were performed. The "Performance Testing" section mentions "Microbial Barrier Tests and Film Thickness determinations for each of the two applicators" as bench tests.
However, based on the information provided about the bench performance testing for the microbial barrier property, here's what can be inferred and stated:
1. Table of acceptance criteria and the reported device performance:
| Acceptance Criteria (Bench Test for Microbial Barrier) | Reported Device Performance (Bench Test for Microbial Barrier) |
|---|---|
| Not explicitly stated in the document, but implicitly tied to the general intent of demonstrating a "physical barrier to microbial penetration." | "In vitro studies have shown that SURGISEAL acts as a physical barrier to microbial penetration as long as the adhesive film remains intact." |
2. Sample size used for the test set and the data provenance:
- Sample size: Not specified in the provided text for the in vitro microbial barrier studies.
- Data provenance: "In vitro studies," meaning laboratory-based studies. The location/country of the lab is not specified, but it's a retrospective assessment of prior in vitro work.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. The ground truth for in vitro microbial barrier studies would typically be established through standardized microbiological testing protocols, not human expert consensus.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as it was an in vitro laboratory test, not a subjective assessment requiring human adjudication.
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:
- No, an MRMC comparative effectiveness study was not done. The submission is for a topical skin adhesive, not an AI-assisted diagnostic or interpretive device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No, not applicable. This is for a medical device (topical skin adhesive), not an algorithm.
7. The type of ground truth used:
- For the microbial barrier claim: The ground truth was based on the results of in vitro microbiological testing demonstrating the physical barrier property.
8. The sample size for the training set:
- Not applicable. This is not a machine learning or algorithm-based device requiring a training set in that context. The "training" here refers to the development and testing of the physical adhesive product.
9. How the ground truth for the training set was established:
- Not applicable in the context of a "training set" for an algorithm. The development of the adhesive product was likely based on various bench tests and physicochemical characterizations to achieve desired properties, which would serve as "ground truth" for product development.
§ 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.