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510(k) Data Aggregation
(329 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
This document is a 510(k) Pre-market Notification for a topical skin adhesive (LiquiBand Flow Control) and as such focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel acceptance criteria and proving their fulfillment through extensive clinical studies. Therefore, many of the requested items (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, standalone AI performance) are not applicable or detailed in this type of submission.
However, I can extract information related to the comparative testing performed to demonstrate substantial equivalence:
1. Table of Acceptance Criteria and Reported Device Performance
The submission demonstrates substantial equivalence based on a comparison to predicate devices rather than specific quantitative acceptance criteria with predefined thresholds for each test. The "acceptance criteria" here are implicitly that the new device performs comparably to the predicate devices in the listed tests.
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance (Summary) |
|---|---|
| Tensile strength (ASTM F2255-05, F2258-05, F2458-05) | Demonstrated substantially equivalent performance to predicate devices |
| Set (polymerization) time | Demonstrated substantially equivalent performance to predicate devices |
| Heat of polymerization | Demonstrated substantially equivalent performance to predicate devices |
| Viscosity | Demonstrated substantially equivalent performance to predicate devices |
| GC Chemical Analysis | Demonstrated substantially equivalent performance to predicate devices |
| Force to actuate | Demonstrated substantially equivalent performance to predicate devices |
| Biocompatibility (ISO 10993) | Safe and biocompatible for intended use, substantially equivalent to predicates |
| Sterilization (SAL 10⁻⁶ by ebeam) | Same as predicate LiquiBand (K083531) |
| Shelf Life | 18 months (supported by real-time and accelerated stability data) |
2. Sample size used for the test set and the data provenance
The document does not specify detailed sample sizes for each of the nonclinical tests (tensile strength, set time, etc.). These are typically laboratory-based tests. Data provenance is implied to be from internal testing by the manufacturer (Advanced Medical Solutions (Plymouth) Ltd.), which would generally be considered proprietary and therefore not explicitly detailed in terms of country of origin for each test dataset, nor whether it's retrospective or prospective in the clinical sense.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The tests performed are nonclinical, laboratory-based functional and chemical analyses, not requiring expert ground truth in the medical imaging or diagnostic sense.
4. Adjudication method for the test set
Not applicable, as no expert review or adjudication process is described for these nonclinical tests.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This device is a topical skin adhesive, not an AI or imaging diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is a topical skin adhesive, not an AI or algorithm-based device.
7. The type of ground truth used
For the nonclinical tests (tensile strength, polymerization time, etc.), the "ground truth" would be the measured physical and chemical properties of the device, assessed against established industry standards (e.g., ASTM standards for tensile strength) and compared to the properties of the predicate devices. For biocompatibility, the ground truth is the successful completion of ISO 10993 tests, demonstrating the absence of adverse biological reactions.
8. The sample size for the training set
Not applicable. This device is not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, this device does not utilize a training set in the AI context.
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(207 days)
LiquiBand Dual 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. LiguiBand Dual topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
LiquiBand® Dual is a sterile, topical tissue adhesive containing n-butyl-2-cyanoacrylate for initial wound closure and a blend of 30% n-butyl-cyanoacrylate and 70% 2-octyl cyanoacrylate for subsequent over layers . LiquiBand® Dual is supplied in a single patient use dual applicator configuration.
The provided text describes a 510(k) submission for a medical device named LiquiBand® Dual, a topical skin adhesive. The submission aims to demonstrate substantial equivalence to a predicate device, LiquiBand® Ultima (K100284).
However, the document does not provide specific acceptance criteria in terms of performance metrics (e.g., accuracy, precision, sensitivity, specificity) for the device's efficacy. Instead, it outlines comparative testing summary that was performed to demonstrate substantial equivalence to the predicate device.
Given the information, I can construct a table for the "Acceptance Criteria and Reported Device Performance" as it relates to the types of tests performed and the comparative nature of the results, rather than quantitative performance thresholds. The study mentioned is a "Clinical Study" as part of the substantial equivalence testing.
Here's the breakdown of the requested information based on the provided text:
Acceptance Criteria and Study Details for LiquiBand® Dual (K102076)
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied by Comparative Testing) | Reported Device Performance (Comparative to Predicate) |
|---|---|
| • Tensile strength (ASTM F2255-05, F2258-05, F2458-05) | Substantially equivalent to LiquiBand® Ultima |
| • Set (polymerization) time | Substantially equivalent to LiquiBand® Ultima |
| • Heat of polymerization | Substantially equivalent to LiquiBand® Ultima |
| • Viscosity | Substantially equivalent to LiquiBand® Ultima |
| • GC Chemical Analysis | Substantially equivalent to LiquiBand® Ultima |
| • Clinical Performance (related to Indication For Use, formulation, technology, target population, intended application, mechanism of action, and achieving intended use) | Substantially equivalent to LiquiBand® Ultima |
Explanation: The acceptance criteria are implicitly met by demonstrating "substantially equivalent performance" to the predicate device, LiquiBand® Ultima, across the listed parameters. The document states that the "following comparative testing demonstrated substantially equivalent performance between LiquiBand Dual and LiquiBand Ultima". This means the acceptance criteria were that LiquiBand Dual performed as well as or acceptably close to LiquiBand Ultima in these areas.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: The document explicitly mentions a "Clinical Study" but does not provide details on the sample size used within this study or for any other comparative tests.
- Data Provenance: The document does not specify the country of origin of the data or whether it was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided in the document. The type of device (topical skin adhesive) and the nature of the “substantially equivalent” claim suggest that ground truth would likely be established through objective physical/chemical testing and clinical outcomes, rather than expert interpretation of complex data (like imaging). If a clinical study involved expert assessment, the details are not included.
4. Adjudication method for the test set
- This information is not provided in the document.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic or interpretive devices and is not applicable to a topical skin adhesive. The LiquiBand® Dual is a physical device, not an AI system.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No, a standalone (algorithm only) performance study was not done. This is not an AI/algorithm-based device.
7. The type of ground truth used
- The ground truth for the comparative tests would have been established by:
- Objective physical and chemical measurements: For tensile strength, set time, heat of polymerization, viscosity, and GC chemical analysis, the ground truth is derived from standardized laboratory measurements according to ASTM or other accepted methodologies.
- Clinical Outcomes: For the "Clinical Study," the ground truth would typically involve observed clinical outcomes such as wound dehiscence, infection rates, cosmetic results, or other relevant endpoints related to wound closure efficacy and safety. The document does not detail the specific clinical endpoints used.
8. The sample size for the training set
- This concept is not applicable as the LiquiBand® Dual is not an AI/machine learning device that requires a training set.
9. How the ground truth for the training set was established
- This question is not applicable as the device is not an AI/machine learning device.
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