(91 days)
Histoacryl, Histoacryl Blue and Histoacryl Flexible 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. Histoacryl Blue and Histoacryl Flexible may be used in conjunction with, but not in place of, deep dermal sutures.
Histoacryl and Histoacryl Blue are sterile liquid topical skin adhesives composed of n-buty|-2cyanoacrylate monomer. The two products are different in only one respect: Histoacryl is provided as a colorless liquid, and Histoacryl Blue is colored with the dye D&C Violet #2 with intent to ease visualization of the device during application.
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).
The Histoacryl, Histoacryl Blue and Histoacryl Flexible are 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 applicator tip is packaged in a sterile blister pack. The plastic ampoules and applicator tips will be packaged together in a box. 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.
The Histoacryl family will be packaged with a separate sterile blistered applicator tip. The applicator tip is an elastic elastomer which can be placed on the tip of the ampoule. The proposed devices will be packaged as a pack. Equal number of ampoules and applicator tips will be packaged together.
The provided text describes a 510(k) submission for Histoacryl, Histoacryl Blue, and Histoacryl Flexible Topical Skin Adhesives with an Applicator Tip (K140343). This submission aims to demonstrate substantial equivalence to previously cleared predicate devices (K111959 and K121976), particularly regarding the addition of a separate applicator tip.
The document focuses on non-clinical performance testing rather than clinical studies with human participants. Therefore, information related to clinical study design, such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, or MRMC studies, is not applicable or not provided.
Here's an analysis of the acceptance criteria and study as described:
1. Table of Acceptance Criteria and Reported Device Performance:
The document lists several performance tests conducted to demonstrate substantial equivalence, implying that meeting similar performance levels to the predicate devices for these tests serves as the acceptance criteria. Specific quantitative acceptance criteria (e.g., "peel adhesion strength must be >= X N/mm") are not explicitly stated within this summary; instead, the overall finding is that the new device is "substantially equivalent" in performance to the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Equivalent Wound closure strength (as per ASTM F2458-05) | Demonstrated substantially equivalent performance to predicate. |
| Equivalent Peel adhesion strength (as per ASTM F2256-05) | Demonstrated substantially equivalent performance to predicate. |
| Equivalent Lap-shear strength (as per ASTM F2255-05) | Demonstrated substantially equivalent performance to predicate. |
| Equivalent Flexibility | Demonstrated substantially equivalent performance to predicate. |
| Equivalent Heat of polymerization | Demonstrated substantially equivalent performance to predicate. |
| Equivalent Ease of Expression | Demonstrated substantially equivalent performance to predicate. |
| Equivalent Occlusion test results | Demonstrated substantially equivalent performance to predicate. |
| Equivalent Adhesive delivered per area | Demonstrated substantially equivalent performance to predicate. |
| Equivalent Film thickness | Demonstrated substantially equivalent performance to predicate. |
| Equivalent Set-time | Demonstrated substantially equivalent performance to predicate. |
| Retention of microbial barrier properties with applicator tip | Microbial barrier testing conducted; reported as an effective barrier as long as the film remains intact. |
| Biocompatibility of applicator tip (MEM Elution, Intracutaneous, Systemic Toxicity, Maximization, Cytotoxicity) | Raw material and finished applicator tip found non-cytotoxic and non-irritants. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: The document does not specify exact sample sizes for each of the performance tests (e.g., number of samples for peel adhesion, wound closure, etc.). It only states that "Testing was performed."
- Data Provenance: The studies are in vitro (laboratory-based) performance tests, not clinical studies involving human patients. Therefore, terms like "country of origin of the data" or "retrospective or prospective" are not applicable in their usual sense. The tests were conducted to specific ASTM standards in a laboratory setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. As these are in vitro performance tests against specific engineering standards (ASTM), "ground truth" in the sense of expert medical opinion is not established. The "ground truth" for these tests comes from the objective measurements defined by the standardized test methods.
4. Adjudication Method for the Test Set:
- Not applicable. There is no human interpretation or decision-making in the performance tests that would require adjudication. The results are based on objective measurement against established test standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, an MRMC comparative effectiveness study was not done. This device is a topical skin adhesive, and the submission focuses on its physical and biological performance characteristics, not on diagnostic or interpretative capabilities that would involve human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- This question is typically relevant for AI/ML-driven diagnostic devices. For a medical device like a topical skin adhesive, a "standalone algorithm performance" is not applicable. The performance is assessed through its physical and biological properties.
7. The Type of Ground Truth Used:
- The "ground truth" for the performance tests is derived from objective measurements against established ASTM standards and ISO standards (for biocompatibility). For example, wound closure strength or peel adhesion strength is measured quantitatively according to the specified ASTM methods. For microbial barrier testing, the "ground truth" is the observed penetration or non-penetration of specified organisms.
8. The Sample Size for the Training Set:
- Not applicable. This device is a topical skin adhesive, not an AI/ML algorithm that requires a training set.
9. 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.