(77 days)
LiquiBand Flow Control 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 and simple, thoroughly cleansed, trauma induced lacerations. LiquiBand Flow Control topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
LiquiBand® Flow Control is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate for wound closure. LiquiBand® Flow Control is supplied in a single patient use configuration. The applicator is composed of a crushable glass ampoule contained within a plastic polypropylene applicator. The ampoule is crushed through force applied by the clinician to the 'wings' of the applicator body. It is applied to easily approximated skin edges and polymerizes within 30 seconds. The device is contained within a PET/tyvek blister
The provided text describes the LiquiBand® Flow Control, a topical skin adhesive, and refers to "Microbial barrier testing" studies. However, it does not present specific acceptance criteria in a quantitative format, nor does it detail a study that directly proves the device meets such criteria with reported performance metrics like accuracy, sensitivity, or specificity.
Instead, the document primarily focuses on establishing substantial equivalence to a predicate device and summarizing non-clinical testing. Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the type of testing performed and the conclusion, but does not provide a table with specific numerical acceptance criteria and corresponding device performance data.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Acts as a barrier to microbial penetration from common organisms. | "In vitro studies have shown that LiquiBand Flow Control acts as a barrier to microbial penetration as long as the adhesive film remains intact." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document mentions "Microbial barrier testing was conducted using LiquiBand Flow Control," but not the number of samples or replicate tests.
- Data Provenance: The study was "in vitro," meaning it was conducted in a laboratory setting. The country of origin of the data is not specified, but the submitting company is based in the UK. The study was non-clinical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. This was an in vitro microbial barrier test, not a clinical study requiring expert assessment of outcomes or images. The ground truth would be based on the results of microbiological assays (e.g., presence or absence of microbial penetration).
4. Adjudication Method:
- Not applicable, as this was an in vitro lab test.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document explicitly states: "Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established." This means no human-in-the-loop studies were performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable. This is not an AI/algorithm-based device. The "standalone" performance here refers to the device's inherent physical and chemical properties as a microbial barrier, evaluated in an in vitro setting without human interpretation of results in a clinical context.
7. Type of Ground Truth Used:
- Microbiological Assay Results: The ground truth was established by direct experimental observation of microbial growth or penetration through the adhesive film in an in vitro setting. The test involved challenging the adhesive with "common organisms known to cause infections" at a "minimum concentration of 1 x 10^6 cfu."
8. Sample Size for the Training Set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
§ 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.