(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.
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LiquiBand® Ultima
Traditional 510(k) Premarket Notification
Page 5-1
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| 5.0 | TRADITIONAL 510(K) SUMMARYAPR - 9 2010 |
|---|---|
| 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: | 17th March 2010 |
| Device Trade Name: | LiquiBand® Ultima |
| Product Code: | LUT 003 |
| Common or Usual Name: | Topical Skin Adhesive |
| Classification Name: | Tissue Adhesive (21 CFR 878.4010) |
| Predicate Device(s): | LiquiBand® LB 0004 (K083531) |
| Device Description: | LiquiBand® Ultima is a sterile, topical tissue adhesive containingn-butyl-2-cyanoacrylate. LiquiBand® Ultima is supplied in asingle patient use dual tip configuration. |
| Indication for Use: | LiquiBand® Ultima 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® Ultima may be used in conjunction with, but not inplace of, deep dermal stitches. |
| Substantial Equivalence: | LiquiBand® Ultima is substantially equivalent to LiquiBandTopical Skin Adhesive (K083531) with regard to Indication ForUse, formulation, technology, target population, intendedapplication, mechanism of action and performance at achievingtheir intended use. |
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LiquiBand® Ultima Traditional 510(k) Premarket Notification
Page 2 of (2)
Substantial Equivalence Testing Summary:
The following comparative testing demonstrated substantially equivalent performance between LiquiBand Ultima and LiquiBand:
- Tensile strength (ASTM F2255-05, F2258-05, F2458-05) l
- Set (polymerization) time .
- Heat of polymerization .
- י Viscosity
- GC Chemical Analysis .
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features the department's name encircling the perimeter, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. In the center of the seal is a stylized image of an eagle, which is a common symbol used in US government seals. The eagle is depicted with its wings spread, conveying a sense of strength and national identity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002
APR - 9 2010
MedLogic Global, Ltd. % Mr. Michael Browne Quality and Regulatory Affairs Manager Western Wood Way - Langage Science Park Plymouth, Devon, PL7 5BG, United Kingdom
Re: K100284
Trade/Device Name: LiquiBand® Ultima Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue adhesive Regulatory Class: Class II Product Code: MPN Dated: March 17, 2010 Received: March 22, 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 he 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 or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21
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Page 2 - Mr. Michael Browne
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 toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Mark N. Melkerson
Mark N. Melk Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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INDICATIONS FOR USE STATEMENT 4.0
| 510(k) Number: | K100284 |
|---|---|
| Device Name: | LiquiBand® Ultima |
| Model Number: | LUT 003 |
| Indications For Use: | 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. |
Prescription Use: YES AND/OR (Part 21 CFR 801 Subpart D)
Over-the-Counter Use: NO (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel Kiane for MKM
(Division Sign-Off) (Division Sign-city), Orthopedic, and Restorative Devices
510(k) Number K100284
Page 4-1
§ 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.