(210 days)
Histoacryl and Histoacryl Blue topical skin adhesives are intended for topical application to hold closed easily approximated skin edges of minimum-tension wounds from clean surgical incisions and simple, thoroughly cleansed, trauma-induced lacerations. They may be used in conjunction with, but not in place of, dermal sutures.
Histoacryl and Histoacryl Blue are sterile liquid topical skin adhesives composed of n-butyl-2-cyanoacrylate monomer. The two products are different in only one respect: Histoacryl is provided as a colorless liquid, and Histoacryl Blue is colored with a royal blue dye D&C Violet #2 with intent to ease visualization of the extent of the device during application. Both tissue adhesives are supplied in 0.5 ml single patient use plastic ampoules. Each ampoule can remain sterile. Both tissue adhesives remain liquid until exposed to water or water-containing substances, after which it cures (polymerizes) and forms a strong, flexible bond.
The provided text describes the 510(k) premarket notification for the Aesculap Histoacryl and Histoacryl Blue Topical Skin Adhesive. It focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria in the traditional sense of a clinical trial or algorithm performance study.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (from FDA's Class II Special Control Guidance Document for Tissue Adhesive for the Topical Skin Approximation of Skin) | Reported Device Performance |
|---|---|
| Tensile strength (ASTM F2458-05) | Performed (details not provided) |
| Set (polymerization) time | Performed (details not provided) |
| Viscosity | Performed (details not provided) |
| GC Chemical Analysis | Performed (details not provided) |
Note: The document states that testing was "performed in accordance to FDA's Class II Special Control Guidance Document for Tissue Adhesive for the Topical Skin Approximation of Skin to demonstrate that the Aesculap Histoacryl and Histoacryl Blue Topical Skin Adhesive is substantially [equivalent]". However, the actual acceptance values (e.g., minimum tensile strength, acceptable range for set time or viscosity) and the numerical results obtained are not provided in this summary. The summary only confirms that these tests were conducted.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not include information on the sample size used for the mechanical and chemical tests, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective). These tests would typically use material samples rather than patient data.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not applicable to the type of testing described (mechanical and chemical property testing for a tissue adhesive). Ground truth for such tests is typically established by standardized laboratory measurements according to specified ASTM or other recognized standards.
4. Adjudication Method
This information is not applicable as the described tests are laboratory-based and do not involve human interpretation requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study was not performed or mentioned. This type of study is more relevant for diagnostic or image-based AI devices where human reader performance is a key metric. The device here is a topical skin adhesive.
6. Standalone Performance Study (Algorithm Only)
A standalone performance study was not performed within the context of an algorithm. The device itself is a physical product (a topical skin adhesive), and its performance data relates to its physical and chemical properties.
7. Type of Ground Truth Used
The ground truth for the performance testing described (tensile strength, set time, viscosity, chemical analysis) would be based on standardized test methods and measurements. For example, the "Tensile strength (ASTM F2458-05)" refers to an established standard for measuring tensile strength, which defines how the 'true' tensile strength is determined.
8. Sample Size for the Training Set
This information is not applicable. The device is a chemical product, not an AI algorithm, so there is no concept of a "training set" in this context.
9. How the Ground Truth for the Training Set Was Established
This information is 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.