(77 days)
DERMABOND NX Topical Skin Adhesive is intended for topical application only, to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. DERMABOND NX Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
DERMABOND® NX Topical Skin Adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation with a viscosity increasing agent, stabilizer, and colorant (D&C Violet #2). It is provided as a single use applicator in a blister package. The pen style applicator is composed of a crushable ampoule contained within a plastic applicator. As it is applied to easily approximated skin edges in a single layer; the liquid is syrup-like in viscosity and polymerizes within minutes. Studies have shown that following application, DERMABOND NX Topical Skin Adhesive acts as a barrier to prevent microbial penetration.
The provided text describes the 510(k) summary for the DERMABOND® NX Topical Skin Adhesive. The primary focus of the document is to demonstrate substantial equivalence to a predicate device (DERMABOND® Topical Skin Adhesive) rather than to establish acceptance criteria for the new device through a performance study against a specified clinical endpoint. Therefore, the device performance is reported in terms of its equivalence to the predicate device and meeting internal specifications, not against specific numerical acceptance criteria for clinical outcomes.
Here's an analysis of the provided information based on your request:
Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical "acceptance criteria" in the format typically seen for a new clinical performance study. Instead, it demonstrates the new device (DERMABOND® NX) is substantially equivalent to its predicate (DERMABOND® Topical Skin Adhesive) through various tests.
Table of Acceptance Criteria and Reported Device Performance (based on demonstrated equivalence to predicate and internal specifications):
| Acceptance Criteria Category | Acceptance Criteria (implied/met by predicate equivalence or internal specs) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Substantially equivalent to predicate device for various biocompatibility tests. | Results of acute systemic toxicity, ocular irritation, primary skin irritation, Kligman sensitization, intracutaneous reactivity, subcutaneous implantation, and MEM (cytotoxicity) were substantially equivalent to the predicate device. |
| Device Activation Force | Met specifications (implied, by demonstrating equivalence to predicate). | DERMABOND NX met specifications. |
| Compression Force | Met specifications (implied, by demonstrating equivalence to predicate). | DERMABOND NX met specifications. |
| Expressed Mass | Met specifications (implied, by demonstrating equivalence to predicate). | DERMABOND NX met specifications. |
| Wound Burst Strength | Met specifications (implied, by demonstrating equivalence to predicate). | DERMABOND NX met specifications. |
| Flatwise Tensile | Met specifications (implied, by demonstrating equivalence to predicate). | DERMABOND NX met specifications. |
| Overlap Shear Testing | Met specifications (implied, by demonstrating equivalence to predicate). | DERMABOND NX met specifications. |
| Skin Tensile | Met specifications (implied, by demonstrating equivalence to predicate). | DERMABOND NX met specifications. |
| T-Peel Testing | Met specifications (implied, by demonstrating equivalence to predicate). | DERMABOND NX met specifications. |
| Water Resistance Testing | Met specifications (implied, by demonstrating equivalence to predicate). | DERMABOND NX met specifications. |
| Heat Dissipation | Improved compared to predicate. | DERMABOND NX demonstrated better heat dissipation. |
| Viscosity | Higher viscosity compared to predicate. | DERMABOND NX has a higher viscosity to allow precise, single-pass application. |
| Sterility Assurance Level (SAL) | Minimum 10^-6, same as predicate. | Both dry heat and ethylene oxide (EO) sterilization processes provide a minimum SAL of 10^-6, same as predicate. |
| Shelf-Life | Two-year shelf life. | Two years equivalent of accelerated testing completed, with 12 months of real-time data supporting a two-year shelf life claim (real-time data collection ongoing). |
Study Details:
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Sample sizes used for the test set and the data provenance:
- The document describes bench tests and biocompatibility tests, not a "test set" in the context of clinical data for performance evaluation in the typical sense.
- Bench Tests: The document states, "All testing for DERMABOND NX Topical Skin Adhesive has been completed according to Design Control requirements of 21CFR820.30." It does not specify sample sizes for each type of bench test (e.g., wound burst strength, tensile tests). The data provenance is internal testing conducted by Ethicon, Inc. This is prospective testing of the device.
- Biocompatibility Tests: The specific sample sizes for animals or
in vitroassays used for biocompatibility are not mentioned. The data provenance is internal testing. - No information is provided regarding country of origin for the data beyond being conducted by Ethicon, Inc. (Somerville, NJ, USA).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the document describes bench and biocompatibility testing, not a study evaluating human interpretation or clinical endpoints that would require expert-established ground truth. The "ground truth" for the bench tests would be the measurement against predefined engineering specifications.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This pertains to clinical studies involving human assessment of outcomes, which are not described here.
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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 technology. No MRMC study was performed.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a medical product (adhesive), not an algorithm or AI system. Its performance is inherent to its physical and chemical properties.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For bench testing, the "ground truth" would be established by engineering specifications and measurements from standardized tests. The goal was to meet these specifications and demonstrate equivalence or superiority to the predicate device.
- For biocompatibility testing, the "ground truth" is established by standardized laboratory testing protocols and results interpreted against established safety thresholds and comparison to a known safe predicate device.
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The sample size for the training set:
- Not applicable. There is no "training set" as this is not a machine learning model. The device formulation and design were likely developed through R&D (development phase), but this is not discussed in terms of 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.
§ 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.