(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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| K102076 | |
|---|---|
| 5.0 | TRADITIONAL 510(K) SUMMARYFEB 18 2011 |
| Submitted by: | MedLogic Global, Ltd.Western Wood WayLangage Science ParkPlymouth, Devon, UK PL 5 BG |
| Contact Person: | Michael BrowneQuality and Regulatory Affairs ManagerMedLogic Global, Ltd |
| Date of Summary: | 21st July 2010 |
| Device Trade Name: | LiquiBand® Dual |
| Product Code: | LBD 001 |
| Common or Usual Name: | Topical Skin Adhesive |
| Classification Name: | Tissue Adhesive (21 CFR 878.4010) |
| Predicate Device(s): | LiquiBand® Ultima (K100284) |
| Device Description: | LiquiBand® Dual is a sterile, topical tissue adhesive containingn-butyl-2-cyanoacrylate for initial wound closure and a blend of30% n-butyl-cyanoacrylate and 70% 2-octyl cyanoacrylate forsubsequent over layers . LiquiBand® Dual is supplied in a singlepatient use dual applicator configuration. |
| Indication for Use: | LiquiBand® Dual is indicated for the closure of topical skinincisions including laparoscopic incisions, and trauma-inducedlacerations in areas of low skin tension that are simple,thoroughly cleansed, and have easily approximated edges.LiquiBand® Dual may be used in conjunction with, but not inplace of, deep dermal stitches. |
| Substantial Equivalence: | LiquiBand® Dual is substantially equivalent to LiquiBand UltimaTopical Skin Adhesive (K100284) with regard to Indication ForUse, formulation, technology, target population, intendedapplication, mechanism of action and performance at achievingtheir intended use. |
. . . . . .
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Substantial Equivalence Testing Summary:
The following comparative testing demonstrated substantially equivalent performance between LiquiBand Dual and LiquiBand Ultima :
- Tensile strength (ASTM F2255-05, F2258-05, F2458-05) ..
- . Set (polymerization) time
- . Heat of polymerization
- . Viscosity
- GC Chemical Analysis .
- . Clinical Study
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its head turned to the left. The eagle is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the eagle.
Food and Druq Administration 10903 New Hampshire Avenue Document Control Room W-066-0609 Silver Spring, MD 20993-0002
MedLogic Global Limited % Mr. Michael Browne Quality and Regulatory Affairs Manager Western Wood Way Langage Science Park Plymouth, Devon, UK PL 5 BG
Re: K102076
FEB 18 201
Trade/Device Name: LiquiBand® Dual Regulation Number: 21 CFR 878.4010(a) Regulation Name: Tissue adhesive Regulatory Class: II Product Code: MPN Dated: December 21, 2010 Received: December 28, 2010
Dear Mr. Browne:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act
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Page 2 - Mr. Michael Browne
or any Federal statutes and regulations administered by other l'ederal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its tolloffre number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
A. B. Ph
fr
Mark N. Melkerson Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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KID2076 INDICATIONS FOR USE STATEMENT 4.0
510(k) Number:
- LiquiBand® Dual Device Name:
Model Number: LBD 001
Indications For Use: 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.
Prescription Use: YES AND/OR Over-the-Counter Use: NO (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Krasnobaev MXM
(Division Sion Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K102076
§ 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.