(95 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 Stylus and Stylus Twist Topical Skin Adhesive are sterile, professional liquid topical skin adhesives containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet #2. Each applicator is comprised of a plastic ampoule container contained within an applicator sleeve with the applicator tip.
This Stylus applicator tray is contained in an outer Tyvek pouch. When SURGISEAL is applied to the skin, it polymerizes in minutes.
Here's a summary of the acceptance criteria and study findings for the SURGISEAL Stylus™ and Stylus Twist™ Topical Skin Adhesives, based on the provided text:
Acceptance Criteria and Device Performance
The submission discusses performance criteria generally, stating that the new applicator designs "demonstrated that the applicator design modification to the currently marketed product does not impact the performance specification criteria identified for the SURGISEAL product family." Specific numerical acceptance criteria are not provided in the excerpt.
The general performance attributes tested and the qualitative results are:
| Acceptance Criteria Category | Specific Test | Reported Device Performance |
|---|---|---|
| Biocompatibility | Cytotoxicity (ISO 10993-Part 5) | No Cytotoxic Effect (PASS) |
| ISO Intracutaneous Reactivity (ISO 10993-10) | No Dermal Reactions (PASS) | |
| Primary Skin Irritation (ISO 10993-10) | No Dermal Irritations (Pass) | |
| Device Performance | Flexibility | Does not impact performance specification criteria |
| In-vitro wound closure | Does not impact performance specification criteria | |
| Viscosity | Does not impact performance specification criteria | |
| Set-time | Does not impact performance specification criteria | |
| Purity | Does not impact performance specification criteria | |
| Surface Coverage | Does not impact performance specification criteria | |
| Linear Coverage | Does not impact performance specification criteria | |
| Sterilization | Sterilization by gamma irradiation (ISO 11137-2:2006) | Achieves 10^-6^ SAL |
| Sterilization by ethylene oxide (ISO 11135-1:2008 & 11135-2:2008) | Achieves 10^-6^ SAL | |
| Shelf-Life | Real-time and accelerated aging studies | Same performance characteristics as predicate (2-year expiration) |
Study Details
Here's the breakdown of the study details based on the provided text:
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated in terms of number of units or measurements for each performance test. The biocompatibility tests mention specific "Lots" (e.g., Lot James A, Lot x 5923, Lot 121512i), implying multiple samples were tested from these production batches.
- Data Provenance: Not explicitly stated (e.g., country of origin). The studies appear to be bench testing ("In-vitro," "bench performance testing") and animal studies (implied by "Intracutaneous Reactivity," "Primary Skin Irritation"), rather than clinical studies on human subjects, based on the descriptive nature of the provided summary. All data appears to be retrospective as it compares to an already marketed device.
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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 these performance and biocompatibility tests is based on objective, standardized test methods (e.g., ISO standards) and measurable outcomes, rather than expert interpretation of images or clinical cases.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. As the tests are objective and based on standardized protocols with pass/fail criteria or measurements, there's no mention of an adjudication process by human experts.
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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 device is a topical skin adhesive, not an AI-powered diagnostic or assistive tool for human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device itself is a product for wound closure, not an algorithm. The performance tests are for the physical and biological characteristics of the adhesive and its applicator.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The ground truth for the biocompatibility tests is defined by the objective results of the ISO 10993 standards (e.g., absence of cytotoxic effect, dermal reactions, or irritations). For the performance tests, the ground truth is against pre-established "performance specification criteria identified for the SURGISEAL product family" (presumably internal quantitative targets for flexibility, viscosity, set-time, etc.).
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The sample size for the training set: Not applicable. This is not a machine learning or AI device that requires a training set.
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How the ground truth for the training set was established: Not applicable, as there is no training set for this type of device.
§ 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.