(444 days)
No
The device description and performance studies focus on the physical and chemical properties of the adhesive, with no mention of AI or ML.
No
This device is a topical skin adhesive used to close skin edges and acts as a barrier, not to treat a disease or condition.
No
The device, LiquiBand® Plus, is a topical skin adhesive intended to hold closed skin edges of wounds. It does not perform any diagnostic function such as identifying a disease or condition.
No
The device description clearly states it is a sterile, liquid topical skin adhesive provided in a single patient use applicator comprised of a crushable glass ampoule within a plastic applicator with an attached foam applicator tip. This describes a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that LiquiBand® Plus is for "topical applications only, to hold closed easily approximated skin edges of wounds". This describes a therapeutic or wound closure function, not a diagnostic test performed in vitro (outside the body) on biological samples to diagnose a condition.
- Device Description: The description details a topical skin adhesive that polymerizes on the skin. This is consistent with a wound closure device, not a diagnostic device.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze biological samples (like blood, urine, tissue, etc.) or to provide information for the diagnosis of a disease or condition.
IVD devices are used to perform tests on samples taken from the human body to provide information about a person's health. LiquiBand® Plus does not fit this description.
N/A
Intended Use / Indications for Use
LiquiBand® Plus 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® Plus may be used in conjunction with, but not in place of, deep dermal stitches.
Product codes
MPN
Device Description
LiquiBand® Plus topical skin adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-Octyl-cyanoacrylate) formulation and the colorant D&C Violet #2. It is provided in a single patient use applicator and packaged in a pouch. The LiquiBand® Plus topical skin adhesive product is comprised of a crushable glass ampoule contained within a plastic applicator with attached foam applicator tip. LiquiBand® Plus topical skin adhesive remains liquid until it is applied to the skin. Upon application LiquiBand® Plus topical skin adhesive polymerizes within minutes.
In vitro studies have shown that LiquiBand® Plus topical skin adhesive 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin
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
Testing was performed in accordance with the FDA special controls guidance document for "Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin"
Performance Testing:
- Lap-shear strength (ASTM F2255-05)
- T-peel adhesion strength (ASTM F2256-05)
- Adhesive strength in tension (ASTM F2258-05)
- Wound closure strength (ASTM F2458-05)
- Degradation rate
- Accelerant degradation assessment
- Heat of polymerisation
- Force to actuate and express
- Viscosity
- Polymerization set time and clog time
- Microbial barrier testing
- Quality of film testing
- Animal wound healing study
Biocompatibility: The biological evaluation of LiquiBand® Plus was performed in accordance with FDA guidance on the use of ISO 10993-1. The following endpoints were addressed as part of the submission:
- Cytotoxicity
- Sensitization
- Irritation
- Acute systemic toxicity
- Implantation
- Subacute systemic toxicity
- Material-mediated pyrogenicity
Key Results: Based on the intended use, technological characteristics, safety and performance testing, LiquiBand® Plus has been demonstrated to be substantially equivalent to the predicate device, LiquiBand® Exceed.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.
March 9, 2020
Advanced Medical Solutions Limited Martin Mitchell Senior Regulatory Affairs Associate Western Wood Way , Langage Science Park Plymouth, PL7 5BG Gb
Re: K183570
Trade/Device Name: LiquiBand Plus Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue Adhesive Regulatory Class: Class II Product Code: MPN Dated: March 9, 2020 Received: March 9, 2020
Dear Martin Mitchell:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Kimberly M. Ferlin, Ph.D. Assistant Director (Acting) DHT4B: Division of Infection Control and Plastic Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183570
Device Name LiquiBand Plus
Indications for Use (Describe)
LiquiBand® Plus 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® Plus may be used in conjunction with, but not in place of, deep dermal stitches.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
K183570 – Page 1 of 3
Image /page/3/Picture/1 description: The image shows the logo for Advanced Medical Solutions Ltd. The logo features a stylized blue "A" with a swoosh extending from the top right. Below the logo, the company name "Advanced Medical Solutions Ltd" is written in blue font. The logo is simple and professional, conveying a sense of innovation and expertise.
Advanced Medical Solutions Ltd Western Wood Way, Langage Science Park, Plympton, Plymouth, Devon, PL7 5BG, UK Tel : +44 (0)1752 209955 Fax : +44 (0)1752 209956 Web : www.admedsol.com
510(k) Summary
| Submitted by: | Advanced Medical Solutions Limited
Western Wood Way
Langage Science Park
Plymouth, Devon. PL7 5BG
United Kingdom
Tel: +44 (0)1752 209955
Fax: +44 (0) 1752 209956 |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Martin Mitchell
Senior Regulatory Affairs Associate |
| Date of Summary: | 5th March 2020 |
| Device Name: | LiquiBand® Plus |
| Common Name: | Topical Skin Adhesive |
| Classification Name: | Tissue adhesive |
| Regulatory Number: | 21 CFR 878.4010 |
| Device Class: | Class II |
| Product Code: | MPN |
| Predicate Device
Device Name: | LiquiBand® Exceed |
| 510(k) Clearance: | K151182 |
| Reference Device
Device Name: | High Viscosity Dermabond® Mini Topical Skin Adhesive |
| 510(k) Clearance: | K152096 |
Image /page/3/Picture/5 description: The image contains two logos and a certificate number. The first logo on the left is the BSI logo, which features the letters "bsi" above a heart shape, all enclosed in a circle. The second logo on the right includes a checkmark above the words "UKAS MANAGEMENT SYSTEMS" and the number "003". Below the logos is the text "Certificate No. MD 695793".
4
K183570 – Page 2 of 3
Image /page/4/Picture/1 description: The image shows the logo for Advanced Medical Solutions Ltd. The logo features a stylized blue "A" with a swoosh extending from the right side. Below the logo, the company name "Advanced Medical Solutions Ltd" is written in blue font.
Advanced Medical Solutions Ltd Western Wood Way, Langage Science Park, Plympton, Plymouth, Devon, PL7 5BG, UK Tel : +44 (0)1752 209955 Fax : +44 (0)1752 209956 Web : www.admedsol.com
Device Description
LiquiBand® Plus topical skin adhesive is a sterile, liquid topical skin adhesive containing a monomeric (2-Octyl-cyanoacrylate) formulation and the colorant D&C Violet #2. It is provided in a single patient use applicator and packaged in a pouch. The LiquiBand® Plus topical skin adhesive product is comprised of a crushable glass ampoule contained within a plastic applicator with attached foam applicator tip. LiquiBand® Plus topical skin adhesive remains liquid until it is applied to the skin. Upon application LiquiBand® Plus topical skin adhesive polymerizes within minutes.
In vitro studies have shown that LiquiBand® Plus topical skin adhesive 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.
Indications for Use
LiquiBand® Plus 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® Plus may be used in conjunction with, but not in place of, deep dermal stitches.
Comparison of Technological Characteristics with the Predicate Device
A comparison of the technological characteristics of LiquiBand® Plus and the predicate device are outlined below:
- . Applicator tip: LiquiBand® Plus has a polyethylene tip base and foam. The predicate has a polypropylene tip base and a polyurethane foam.
- . Adhesive accelerant: LiquiBand® Plus contains an accelerant in the foam tip.
- . Applicator body: The LiquiBand® Plus applicator has the same design but is 10mm shorter in length compared to the predicate.
- Adhesive: Both devices contain a 2-octyl cyanoacrylate based adhesive with D&C Violet #2 colorant. LiquiBand® Plus contains 0.41g and the predicate contains 0.80g of adhesive.
Image /page/4/Picture/14 description: The image shows two certification logos. The first logo on the left is the BSI (British Standards Institution) logo, which features the letters "bsi." above a heart shape, all enclosed in a circle. The second logo on the right is the UKAS (United Kingdom Accreditation Service) Management Systems logo, which includes a crown above a checkmark, with the text "UKAS MANAGEMENT SYSTEMS" and the number "003" below. The text "Certificate No. MD 695793" is printed below the logos.
5
K183570 – Page 3 of 3
Image /page/5/Picture/1 description: The image shows the logo for Advanced Medical Solutions Ltd. The logo features a stylized blue "A" with a swoosh extending from the top right. Below the logo is the company name, "Advanced Medical Solutions Ltd," also in blue.
Advanced Medical Solutions Ltd Western Wood Way, Langage Science Park, Plympton, Plymouth, Devon, PL7 5BG, UK Tel : +44 (0)1752 209955 Fax : +44 (0)1752 209956 Web : www.admedsol.com
Performance Data
Testing was performed in accordance with the FDA special controls guidance document for "Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin"
Performance Testing
The following tests were performed on LiquiBand® Plus to demonstrate substantial equivalence to the predicate device:
- Lap-shear strength (ASTM F2255-05)
- T-peel adhesion strength (ASTM F2256-05)
- . Adhesive strength in tension (ASTM F2258-05)
- Wound closure strength (ASTM F2458-05)
- Degradation rate
- Accelerant degradation assessment
- Heat of polymerisation
- Force to actuate and express
- Viscosity
- Polymerization set time and clog time
- Microbial barrier testing
- Quality of film testing
- Animal wound healing study
Biocompatibility
The biological evaluation of LiquiBand® Plus was performed in accordance with FDA guidance on the use of ISO 10993-1. The following endpoints were addressed as part of the submission:
- Cytotoxicity
- . Sensitization
- . Irritation
- Acute systemic toxicity
- Implantation
- Subacute systemic toxicity
- Material-mediated pyrogenicity
Conclusions
Based on the intended use, technological characteristics, safety and performance testing, LiquiBand® Plus has been demonstrated to be substantially equivalent to the predicate device, LiquiBand® Exceed.
Image /page/5/Picture/31 description: The image contains two logos. The logo on the left is a circle with the letters "bsi." above a heart-shaped symbol. The logo on the right has a crown above a check mark with the words "UKAS MANAGEMENT SYSTEMS" below it. The number "003" is at the bottom of the right logo, and the text "Certificate No. MD 695793" is below both logos.