(77 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
The provided text describes the LiquiBand® Flow Control, a topical skin adhesive, and refers to "Microbial barrier testing" studies. However, it does not present specific acceptance criteria in a quantitative format, nor does it detail a study that directly proves the device meets such criteria with reported performance metrics like accuracy, sensitivity, or specificity.
Instead, the document primarily focuses on establishing substantial equivalence to a predicate device and summarizing non-clinical testing. Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes the type of testing performed and the conclusion, but does not provide a table with specific numerical acceptance criteria and corresponding device performance data.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Acts as a barrier to microbial penetration from common organisms. | "In vitro studies have shown that LiquiBand Flow Control acts as a barrier to microbial penetration as long as the adhesive film remains intact." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated. The document mentions "Microbial barrier testing was conducted using LiquiBand Flow Control," but not the number of samples or replicate tests.
- Data Provenance: The study was "in vitro," meaning it was conducted in a laboratory setting. The country of origin of the data is not specified, but the submitting company is based in the UK. The study was non-clinical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. This was an in vitro microbial barrier test, not a clinical study requiring expert assessment of outcomes or images. The ground truth would be based on the results of microbiological assays (e.g., presence or absence of microbial penetration).
4. Adjudication Method:
- Not applicable, as this was an in vitro lab test.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No. The document explicitly states: "Clinical studies were not conducted to demonstrate microbial barrier properties and a correlation between microbial barrier properties and a reduction in infection have not been established." This means no human-in-the-loop studies were performed.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
- Not applicable. This is not an AI/algorithm-based device. The "standalone" performance here refers to the device's inherent physical and chemical properties as a microbial barrier, evaluated in an in vitro setting without human interpretation of results in a clinical context.
7. Type of Ground Truth Used:
- Microbiological Assay Results: The ground truth was established by direct experimental observation of microbial growth or penetration through the adhesive film in an in vitro setting. The test involved challenging the adhesive with "common organisms known to cause infections" at a "minimum concentration of 1 x 10^6 cfu."
8. Sample Size for the Training Set:
- Not applicable. This is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable.
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TRADITIONAL 510(K) SUMMARY 5.0
| Submitted by: | Advanced Medical Solutions (Plymouth) Ltd.Western Wood WayLangage Science ParkPlymouth, Devon, UK PL7 5BGTel: United Kingdom + 44 (0)1752 209955 |
|---|---|
| Contact Person: | Michael BrowneQuality and Regulatory Affairs ManagerAdvanced Medical Solutions (Plymouth) Ltd |
| Date of Summary: | 8th August 2012 |
| Device Trade Name: | LiquiBand® Flow Control |
| Product Codes: | MPN |
| Common or Usual Name: | Topical Skin Adhesive |
| Classification Name: | Tissue Adhesive (21 CFR 878.4010) |
| Predicate Device(s): | LiquiBand® Flow Control (K110184) |
| Device Description: | LiquiBand® Flow Control is a sterile, topical tissue adhesivecontaining n-butyl-2-cyanoacrylate for wound closure.LiquiBand® Flow Control is supplied in a single patient useconfiguration. The applicator is composed of a crushable glassampoule contained within a plastic polypropylene applicator.The ampoule is crushed through force applied by the clinician tothe 'wings' of the applicator body. It is applied to easilyapproximated skin edges and polymerizes within 30 seconds.The device is contained within a PET/tyvek blister |
| Indication for Use: | LiquiBand Flow Control topical skin adhesive is intended fortopical applications only, to hold closed easily approximatedskin edges of wounds from surgical incisions, includingpunctures from minimally invasive surgery and simple.thoroughly cleansed, trauma induced lacerations. LiquiBandFlow Control topical skin adhesive may be used in conjunctionwith, but not in place of, deep dermal stitches. |
| TechnologicalCharacteristics | The technological characteristics of LiquiBand Flow Control aresubstantially equivalent to the predicate device. All use n-butylcyanoacrylate technology to facilitate wound closure. |
| LiquiBand Flow Control consists of a liquid topical skin adhesiveformulation packaged within a dispensing applicator. Thedevice is supplied in a sterile single use package for use inwound closure procedures. LiquiBand Flow Control designallows for precise application of the adhesive to the wound area.The topical skin adhesive is designed to bond to the skin toprovide wound closure maintaining wound approximation. | |
| In vitro studies have shown that LiquiBand Flow Control acts asa barrier to microbial penetration as long as the adhesive filmremains intact. Clinical studies were not conducted todemonstrate microbial barrier properties and a correlationbetween microbial barrier properties and a reduction in infectionhave not been established. | |
| Substantial Equivalence: | LiquiBand® Flow Control is identical to the predicate device(K110184) |
| Testing Summary: | Microbial barrier testing was conducted using LiquiBand FlowControl. The method was a strike through test that wasconducted with common organisms known to cause infectionsand represent gram positive, gram negative, motile and non-motile as well as fungi. The challenge was at a minimumconcentration of 1 x 106 cfu. |
| Conclusion | Based on the nonclinical testing carried out LiquiBand FlowControl is considered as safe, as effective and performs as wellor better than the legally marketed predicate devices.LiquiBand Flow Control was evaluated in tests to establish aperformance and safety profile in accordance with the Class IISpecial Controls Guidance Document: Tissue Adhesive forTopical Approximation of Skin. |
| In vitro studies have shown that LiquiBand Flow Control acts asa barrier to microbial penetration as long as the adhesive filmremains intact. Clinical studies were not conducted todemonstrate microbial barrier properties and a correlationbetween microbial barrier properties and a reduction in infectionhave not been established. |
:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized symbol resembling an eagle or bird in flight, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Advanced Medical Solutions (Plymouth) Limited % Mr. Michael Browne Quality and Regulatory Affairs Manager Western Wood Way Langage Science Park Plymouth, Devon UK PL7 5BG
Re: K122446
Trade/Device Name: LiquiBand® Flow Control Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue adhesive Regulatory Class: Class II Product Code: MPN Dated: August 08, 2012 Received: August 10, 2012
OCT 26 2012
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 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
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Page 2 - Mr. Michael Browne
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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Mark A. Wilkinson
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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INDICATIONS FOR USE STATEMENT 4.0
K122446 510(k) Number: LiquiBand® Flow Control Device Name: LiquiBand Flow Control - LFC 002 Model Number: LiquiBand Flow Control topical skin adhesive is intended for topical Indications For Use:
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 Flow Control topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
Prescription Use: YES (Part 21 CFR 801 Subpart D) AND/OR
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 Kine for MM
(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices
510(k) Number K122446
§ 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.