(77 days)
Not Found
No
The description focuses on the chemical composition and mechanical application of a topical skin adhesive, with no mention of AI or ML.
No
The device is a topical skin adhesive intended for wound closure, not for treating diseases or health conditions.
No
The device is a topical skin adhesive intended for wound closure, not for diagnosing any medical condition.
No
The device description clearly outlines a physical product (topical tissue adhesive, applicator with glass ampoule and plastic body) and its physical application process, indicating it is a hardware-based medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the topical application of an adhesive to hold closed skin edges of wounds. This is a direct application to the body for a physical purpose (wound closure).
- Device Description: The device is a topical tissue adhesive.
- Lack of In Vitro Testing: While there is mention of in vitro microbial barrier testing, this is a performance test of the adhesive's properties, not a diagnostic test performed on a sample taken from the body.
- No Mention of Analyzing Samples: IVD devices are designed to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a physiological state, disease, or condition. This device does not do that.
The device is a medical device used for wound closure, but it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
MPN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Microbial barrier testing was conducted using LiquiBand Flow Control. The method was a strike through test that was conducted with common organisms known to cause infections and represent gram positive, gram negative, motile and non-motile as well as fungi. The challenge was at a minimum concentration of 1 x 10^6 cfu.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
LiquiBand® Flow Control (K110184)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Ocr
TRADITIONAL 510(K) SUMMARY 5.0
| Submitted by: | Advanced Medical Solutions (Plymouth) Ltd.
Western Wood Way
Langage Science Park
Plymouth, Devon, UK PL7 5BG
Tel: United Kingdom + 44 (0)1752 209955 |
|----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Michael Browne
Quality and Regulatory Affairs Manager
Advanced 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 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 |
| Indication for Use: | 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. |
| Technological
Characteristics | The technological characteristics of LiquiBand Flow Control are
substantially equivalent to the predicate device. All use n-butyl
cyanoacrylate technology to facilitate wound closure. |
| | LiquiBand Flow Control consists of a liquid topical skin adhesive
formulation packaged within a dispensing applicator. The
device is supplied in a sterile single use package for use in
wound closure procedures. LiquiBand Flow Control design
allows for precise application of the adhesive to the wound area.
The topical skin adhesive is designed to bond to the skin to
provide wound closure maintaining wound approximation. |
| | In vitro studies have shown that LiquiBand Flow Control 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 and a correlation
between microbial barrier properties and a reduction in infection
have not been established. |
| Substantial Equivalence: | LiquiBand® Flow Control is identical to the predicate device
(K110184) |
| Testing Summary: | Microbial barrier testing was conducted using LiquiBand Flow
Control. The method was a strike through test that was
conducted with common organisms known to cause infections
and represent gram positive, gram negative, motile and non-
motile as well as fungi. The challenge was at a minimum
concentration of 1 x 106 cfu. |
| Conclusion | Based on the nonclinical testing carried out LiquiBand Flow
Control is considered as safe, as effective and performs as well
or better than the legally marketed predicate devices.
LiquiBand Flow Control was evaluated in tests to establish a
performance and safety profile in accordance with the Class II
Special Controls Guidance Document: Tissue Adhesive for
Topical Approximation of Skin. |
| | In vitro studies have shown that LiquiBand Flow Control 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 and a correlation
between microbial barrier properties and a reduction in infection
have not been established. |
:
1
2
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
3
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
4
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