(125 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-ocylt cyanoacrylate) formulation and the colorant D&C Violet #2. Each applicator consists of a thermoformed blister tray with a heat sealed lid with an attached applicator sponge tip. This applicator tray with sponge tip is contained in an outer Tyvek pouch.
This document describes the regulatory submission for SURGISEAL® Topical Skin Adhesive, specifically focusing on a labeling change rather than a new device or a new AI/Machine Learning (AI/ML) device. Therefore, many of the requested criteria related to AI/ML or direct performance studies are not explicitly stated or applicable in this context.
Here's an analysis based on the provided text, addressing the points where information is available and noting where it is not applicable for this particular submission type:
1. Table of acceptance criteria and the reported device performance:
The document describes performance testing relative to a predicate device and specifications, rather than detailing specific acceptance criteria with numerical targets.
| Acceptance Criterion Type | Reported Device Performance |
|---|---|
| Wound Closure Strength | Met specifications and demonstrated equivalence to predicate device(s). |
| Set-time | Met specifications and demonstrated equivalence to predicate device(s). |
| Linear Coverage | Met specifications and demonstrated equivalence to predicate device(s). |
| Film Thickness | Met specifications and demonstrated equivalence to predicate device(s). |
| Tissue Approximation Time | Met specifications and demonstrated equivalence to predicate device(s). |
| Biocompatibility | Considered non-toxic, non-irritating, non-sensitizing, and biocompatible, based on previous testing of the identical predicate device (K082993) per ISO-10993. |
| Sterilization | Maintained and identical to predicate device (electron beam irradiation per ISO 11137-2:2006). |
| Shelf-Life | Maintained and identical to predicate device (2 years), with no impact from labeling change. |
2. Sample size used for the test set and the data provenance:
The document mentions "Additional bench testing was performed to support the modification to the currently marketed product," but it does not specify the sample size for this bench testing. Similarly, data provenance (e.g., country of origin, retrospective/prospective) is not provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable or provided as this submission is for a labeling change to a medical device (topical skin adhesive), not an AI/ML device requiring expert ground truth for interpretation of images or clinical data. The performance is assessed through bench tests.
4. Adjudication method for the test set:
This is not applicable or provided as the evaluation relies on physical bench tests, not expert interpretation requiring 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:
This is not applicable as the submission is for a topical skin adhesive, not an AI/ML medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable as the submission is for a topical skin adhesive, not an AI/ML medical device.
7. The type of ground truth used:
For the performance testing mentioned, the "ground truth" would be defined by the specifications and established performance benchmarks of the predicate device and industry standards for wound closure products. For biocompatibility, the ground truth was established by adherence to ISO-10993 standards.
8. The sample size for the training set:
This is not applicable as this is not an AI/ML device and therefore does not involve a training set.
9. How the ground truth for the training set was established:
This is not applicable as this is not an AI/ML device and therefore does not involve a training set.
Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is described as "extensive bench performance testing" and biocompatibility testing.
- Biocompatibility Testing: Previously conducted on the currently marketed device, SURGISEAL (K082993), per the International Standard ISO-10993, "Biological Evaluation of Medical Devices, Part 1: Evaluation and Testing." The results considered the device non-toxic, non-irritating, non-sensitizing, and biocompatible. No additional biocompatibility testing was deemed necessary for this K123936 submission as the subject device is identical to K082993.
- Performance Testing: "Additional bench testing was performed to support the modification to the currently marketed product." These tests included:
- Wound closure strength
- Set-time
- Linear coverage
- Film thickness
- Tissue approximation time
The document states: "In all cases, the modified labeled SURGISEAL Topical Skin Adhesive met specifications and demonstrated equivalence to the predicate device(s)."
The overall conclusion is: "Based on extensive bench performance testing, the modified labeled device, SURGISEAL has demonstrated to be substantially equivalent to its predicate devices from a safety and performance perspective, and has demonstrated that a single layer of the low viscosity product maintains approximation of wound edges."
§ 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.