(73 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 ™Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.
SURGISEALTM Topical Skin Adhesive is a sterile, professional liquid skin adhesive containing a monomeric (2-octyl 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. When SURGISEAL is applied to the skin, it polymerizes in minutes.
The provided text is a Premarket Notification Summary (510(k)) for the SurgiSeal Topical Skin Adhesive. This document focuses on demonstrating substantial equivalence to a predicate device (Dermabond) based on bench testing and biocompatibility. It is not a study that provides detailed acceptance criteria and reported performance for a device against a pre-defined set of metrics from a clinical or imaging study.
Therefore, many of the requested fields cannot be directly extracted from this document, as they pertain to clinical or AI algorithm performance studies, which are not described here.
Here's a breakdown of what can be inferred or stated based on the provided text, and what cannot:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial Equivalence to Dermabond in: | SurgiSeal uses the same active ingredient (2-Octyl Cyanoacrylate) as Dermabond. |
| - ASTM Standardized Tests for Adhesion | Results comparable to Dermabond. |
| - ISO10993 Biocompatibility Tests for Safety | Equivalent to Dermabond. |
| - Animal Test for effect on healing | Equivalent to Dermabond. |
| - Performance profile in accordance with Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin. (Bench Tests) | Results comparable to Dermabond. |
| Moisture Vapor Transmission Rate | Higher results than Dermabond, suggesting greater transmission of moisture and oxygen to the wound, with potential for faster healing. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document refers to "bench tests" and "animal tests" but does not provide details on sample sizes or specific methodologies for these tests.
- Data Provenance: Not specified. The nature of the tests (bench, animal) implies laboratory conditions, but no geographic origin is mentioned, nor whether it was retrospective or prospective (these terms are more relevant to clinical studies).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. The tests described are laboratory-based (adhesion, biocompatibility, animal healing) and do not involve human expert interpretation or ground truth establishment in the way an imaging diagnostic device would.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study involving human interpretation or adjudication of results.
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
- Not applicable. This is not an AI device or a diagnostic device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a medical device (topical skin adhesive), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the bench tests (adhesion, biocompatibility, moisture vapor transmission): The "ground truth" would be established by the standardized test methodologies themselves and the physical/chemical properties measured according to those standards.
- For animal tests: Histological analysis, wound healing assessments, or other physiological markers would likely serve as the "ground truth," but details are not provided.
8. The sample size for the training set
- Not applicable. This document describes premarket notification for a physical medical device, not a machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
- Not applicable. As above, this is not a machine learning algorithm.
§ 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.