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LiquiBand® XL is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. LiquiBand® XL should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.

LiquiBand® XL is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet No. 2. It is provided in a single-use applicator. As applied to skin, the liquid topical skin adhesive is slightly more viscous than water and polymerizes within minutes.
In vitro studies have shown that LiguiBand® XL acts as a barrier to microbial penetration as long as the adhesive film remains intact. Clinical studies were not conducted to demonstrate microbial barrier properties.
LiquiBand® XL also incorporates a self-adhering mesh that is approximated skin edges to provide temporary skin edge alignment to an incision until the liquid adhesive is applied to achieve skin closure.

The device under consideration is the LiquiBand® XL, a tissue adhesive with an adjunct wound closure device for the topical approximation of skin.

Acceptance Criteria and Device Performance:

The document describes performance testing conducted according to the FDA special controls guidance document for "Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin." The table below summarizes the types of tests performed, which inherently represent the acceptance criteria for those specific properties for demonstrating substantial equivalence. The reported device performance is that these tests were performed and the device demonstrated substantial equivalence to the predicate device. Specific numerical acceptance values or performance results are not provided in this summary.

Additional Information:

1. Sample size used for the test set and data provenance: The document does not specify the exact sample sizes for each of the performance tests. The provenance of the data is not explicitly stated in terms of country of origin or whether it was retrospective or prospective. It is implied that these are laboratory and animal studies conducted by the manufacturer to demonstrate performance characteristics.

2. Number of experts used to establish the ground truth for the test set and qualifications of those experts: This is not applicable to the type of performance testing described. The tests are physical, chemical, and biological evaluations, not requiring human expert interpretation in the same way clinical imaging studies might.

3. Adjudication method for the test set: Not applicable for these types of performance tests.

4. Multi-reader multi-case (MRMC) comparative effectiveness study: No MRMC or clinical studies were performed. The document explicitly states: "No clinical testing has been submitted, referenced, or relied upon for determining substantial equivalence."

5. Standalone (i.e. algorithm only without human-in-the loop performance) performance: Not applicable as this is a physical medical device, not an AI/algorithm-based device.

6. Type of ground truth used: The ground truth for the performance tests consists of established scientific and engineering standards (e.g., ASTM standards, ISO 10993-1), and the predicate device's performance profile against these standards. The objective is to show that the LiquiBand® XL performs similarly to the predicate.

7. Sample size for the training set: Not applicable as this is not an AI/algorithm-based device that would require a "training set."

8. How the ground truth for the training set was established: Not applicable.

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