(316 days)
Histoacryl Flexible topical skin adhesive is 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. Histoacryl Flexible may be used in conjunction with, but not in place of, deep dermal sutures.
Histoacryl Flexible Topical Skin Adhesive is a sterile liquid topical skin adhesive composed of n-butyl-2-cyanoacrylate monomer, softener, stabilizer, and colorant (D&C Violet #2). It is provided in 0:5 ml single patient use plastic ampoules. Each ampoule is sealed within a foil pouch so the exterior of the ampoule can remain sterile. The tissue adhesives remain liquid until exposed to water or water-containing substances including tissue, after which it cures (polymerizes) and forms a film that bonds to the underlying surface.
Here's an analysis of the provided text regarding the Histoacryl Flexible Topical Skin Adhesive, focusing on acceptance criteria and supporting studies:
This document describes a 510(k) submission for a medical device seeking substantial equivalence to existing predicate devices, rather than a clinical trial proving a device meets specific clinical performance acceptance criteria in a comparative effectiveness study. Therefore, many of the requested categories (like MRMC study effect size, sample sizes for test/training sets, or number/qualifications of experts) are not applicable or explicitly stated in this type of submission. The "acceptance criteria" here refer to demonstrating performance equivalent to predicate devices through non-clinical testing.
Acceptance Criteria and Reported Device Performance
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Condition (Implicit) | Reported Device Performance (Summary) |
|---|---|---|---|
| Mechanical Performance | Lap Shear Strength | Substantially equivalent to predicates | Demonstrated substantially equivalent performance (comparative testing) |
| Peel Adhesion Strength | Substantially equivalent to predicates | Demonstrated substantially equivalent performance (comparative testing) | |
| Impact Strength | Substantially equivalent to predicates | Demonstrated substantially equivalent performance (comparative testing) | |
| Material Properties | Set (Polymerization) Time | Substantially equivalent to predicates | Demonstrated substantially equivalent performance (comparative testing) |
| Heat of Polymerization | Substantially equivalent to predicates | Demonstrated substantially equivalent performance (comparative testing) | |
| Viscosity | Substantially equivalent to predicates | Demonstrated substantially equivalent performance (comparative testing) | |
| GC Chemical Analysis | Substantially equivalent to predicates | Demonstrated substantially equivalent performance (comparative testing) | |
| Hydrolytic Degradation | Substantially equivalent to predicates | Demonstrated substantially equivalent performance (comparative testing) | |
| Handling Characteristics | Ease of Expression | Substantially equivalent to predicates | Demonstrated substantially equivalent performance (comparative testing) |
| Biocompatibility | MEM Cytotoxicity | Pass (non-toxic) | Results provide evidence Histoacryl Flexible is safe and biocompatible |
| Intracutaneous Reactivity | Pass (non-reactive) | Results provide evidence Histoacryl Flexible is safe and biocompatible | |
| Maximization Sensitization | Pass (non-sensitizing) | Results provide evidence Histoacryl Flexible is safe and biocompatible | |
| Systemic Toxicity | Pass (non-toxic) | Results provide evidence Histoacryl Flexible is safe and biocompatible | |
| Muscle Implantation | Pass (acceptable tissue response) | Results provide evidence Histoacryl Flexible is safe and biocompatible | |
| Microbial Barrier | Microbial Barrier Test (Strike Through Test with specific organisms) | Barrier maintained | Barrier maintained as long as the adhesive film remains intact. |
| Sterilization & Shelf-Life | Sterilization efficacy (ETO & Gamma) | Effective sterilization | Sterilization is the same as predicate (ETO ampoule, gamma pouch); sterility of liquid by membrane filtration/aseptic filling. |
| Shelf-Life (Real-time data) | Stable for specified duration | Current data supports a 24-month shelf life. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated for any of the performance tests (e.g., lap shear, peel adhesion). This type of submission usually focuses on demonstrating equivalence through comparative testing rather than proving a specific performance target with a statistically powered clinical sample.
- Data Provenance: The tests are in-vitro ("In vitro studies have shown...") or non-clinical laboratory tests. No information suggests country of origin for data as it's not clinical patient data. The manufacturer is Aesculap, Inc. based in Center Valley, PA, USA. The tests were performed "in accordance to FDA's Class II Special Control Guidance Document for Tissue Adhesive."
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
- Not applicable. This submission relies on objective, standardized laboratory test methods (e.g., ASTM standards like F2255-05, F2256-05, F2458-05, and ISO 10993 for biocompatibility) to establish performance characteristics, not expert consensus or ground truth derived from clinical interpretation.
4. Adjudication Method for the Test Set:
- Not applicable. See point 3. Testing is based on established protocols and measurements, not subjective adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No. An MRMC comparative effectiveness study was not done. This is a 510(k) premarket notification for a Class II medical device, primarily demonstrating substantial equivalence through non-clinical performance and biocompatibility testing, not human clinical comparative efficacy in a reader study scenario.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- Not applicable. This device is a physical topical skin adhesive, not an algorithm or AI system.
7. The Type of Ground Truth Used:
- The "ground truth" for the performance tests is based on standardized test methods and measurements (e.g., ASTM and ISO standards for mechanical properties, material characteristics, and biocompatibility). For substantial equivalence, the "truth" is that its performance metrics fall within an acceptable range compared to the predicate devices.
8. The Sample Size for the Training Set:
- Not applicable. This device does not involve machine learning or AI, so there is no concept of a "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. See point 8.
§ 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.