(67 days)
LiquiBand Ultima 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 Ultima topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
LiquiBand® Ultima is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate. LiquiBand® Ultima is supplied in a single patient use dual tip configuration.
The provided document describes the K100284 510(k) premarket notification for the LiquiBand® Ultima topical skin adhesive. It focuses on demonstrating substantial equivalence to a predicate device (LiquiBand® LB 0004, K083531) rather than establishing new performance criteria through a clinical study with acceptance criteria.
Therefore, many of the requested elements for a study proving device performance against acceptance criteria are not applicable or cannot be extracted directly from this type of regulatory submission. The submission is a "Traditional 510(k)" which typically relies on demonstrating equivalence to an already legally marketed device.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't define explicit acceptance criteria with specific thresholds for performance metrics. Instead, it states that comparative testing "demonstrated substantially equivalent performance" to the predicate device.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Tensile strength equivalent to predicate device (K083531) | Substantially equivalent (ASTM F2255-05, F2258-05, F2458-05) |
| Set (polymerization) time equivalent to predicate device (K083531) | Substantially equivalent |
| Heat of polymerization equivalent to predicate device (K083531) | Substantially equivalent |
| Viscosity equivalent to predicate device (K083531) | Substantially equivalent |
| GC Chemical Analysis equivalent to predicate device (K083531) | Substantially equivalent |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the sample sizes for the comparative physical and chemical tests (tensile strength, set time, heat of polymerization, viscosity, GC chemical analysis). There's no information on data provenance (country of origin, retrospective/prospective) for these material and performance characteristic tests, as they are likely lab-based measurements on manufactured product samples.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. The "ground truth" for demonstrating substantial equivalence here is the established performance of the predicate device, not expert consensus on clinical outcomes. The tests are laboratory-based physical and chemical characterizations.
4. Adjudication Method for the Test Set:
Not applicable. There's no clinical trial or expert review necessitating an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. This is a medical device, specifically a tissue adhesive. MRMC studies are typically for diagnostic imaging devices where human readers interpret results.
6. Standalone (Algorithm Only) Performance:
No. This is a physical medical device, not an algorithm or AI.
7. Type of Ground Truth Used:
The "ground truth" or reference for evaluating LiquiBand® Ultima's performance is the performance characteristics of the predicate device, LiquiBand® LB 0004 (K083531), as measured through various ASTM standards and chemical analyses.
8. Sample Size for the Training Set:
Not applicable. This device is not an AI/machine learning algorithm, so there is no "training set." The product is manufactured and tested according to specifications.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no training set. The "ground truth" for the comparative testing was the pre-existing data and performance profiles of the predicate 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.