(175 days)
Not Found
No
The 510(k) summary describes a topical skin adhesive and its physical and performance characteristics. There is no mention of AI or ML technology in the intended use, device description, or performance studies.
No
The device is a topical skin adhesive intended to hold closed approximated skin edges of wounds. It does not actively treat or modify a physiological process to heal the wound, but rather assists in the physical closure of the wound.
No
Explanation: The device is a topical skin adhesive intended to hold skin edges together, not to diagnose or identify medical conditions. Its function is therapeutic/supportive (wound closure), not diagnostic.
No
The device description clearly states it is a sterile, liquid topical skin adhesive provided in a single patient use applicator with a crushable glass ampoule and plastic applicator. This is a physical product, 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 the device is for "topical applications only, to hold closed easily approximated skin edges of wounds". This is a direct application to the body for a physical purpose (holding skin together).
- Device Description: The description details a sterile liquid adhesive that polymerizes on the skin. This is a physical/chemical interaction with the body's surface.
- Lack of In Vitro Diagnostic Characteristics: An IVD is a medical device that is used to perform tests on samples taken from the human body (such as blood, urine, tissue) to provide information about a person's health. The description and intended use of LiquiBand Exceed do not involve testing samples from the body.
Therefore, LiquiBand Exceed is a topical medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
LiquiBand Exceed 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 Exceed 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 Exceed 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 Exceed topical skin adhesive product is comprised of a crushable glass ampoule contained within a plastic applicator with attached foam applicator tip. LiquiBand Exceed topical skin adhesive remains liquid until it is applied to the skin. Upon application LiquiBand Exceed topical skin adhesive polymerizes within minutes.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing was conducted in accordance with the FDA special controls guidance document for "Tissue Adhesive for the Topical Approximation of Skin."
Tests performed on LiquiBand Exceed:
- Wound closure strength (ASTM F2458-05)
- Lap-shear strength (ASTM F2255-05)
- Peel adhesion strength (ASTM F2256-05)
- Adhesive strength in tension (ASTM F2258-05)
- Force to actuate
- Polymerization set time
- Microbial barrier
- Intraoperative reuse
- Wound closure length
Tests performed on the predicate device and referenced in support of LiquiBand Exceed:
- Degradation rate
- Heat of polymerization
- Viscosity
- Purity
- Moisture determination
Biocompatibility evaluation was performed in accordance with ISO 1093-1 "Biological evaluation of medical devices. Evaluation and testing," including:
- Cytotoxicity
- Sensitization
- Irritation
- Acute dermal toxicity
- Intramuscular implantation
Conclusion: Based on the testing carried out, LiquiBand Exceed has been demonstrated to be substantially equivalent to the predicate device, Barle Tissue Adhesive 2 (K132243).
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.
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.
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 26, 2015
Advanced Medical Solutions (Plymouth) Ltd. Dr. Martin Mitchell Western Wood Way Language Science Park Plymouth, Devon. PL7 BG United Kingdom
Re: K151182
Trade/Device Name: LiquiBand Exceed Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue Adhesive Regulatory Class: Class II Product Code: MPN Dated: September 23, 2015 Received: September 28, 2015
Dear Dr. 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. 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
1
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 contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,
David Krause -S
- for Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K151182
Device Name
LiquiBand Exceed
Indications for Use (Describe)
LiquiBand Exceed 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 Exceed topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Type of Use (Select one or both, as applicable)
3
Image /page/3/Picture/0 description: The image shows the logo for Advanced Medical Solutions (Plymouth) Ltd. The logo features a stylized blue "A" symbol above the company name. The text "Advanced Medical Solutions" is in a larger font size than "(Plymouth) Ltd.", and there is a line underneath the company name.
Advanced Medical Solutions (Plymouth) 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 (In accordance with 21 CFR 807.92)
Advanced Medical Solutions (Plymouth) Ltd LiquiBand Exceed
1. Submitter
| Submitted by: | Advanced Medical Solutions (Plymouth) Ltd.
Western Wood Way
Langage Science Park
Plymouth, Devon. PL7 5BG
United Kingdom
Tel: +44 (0)1752 209955
Fax: +44 (0) 1752 209956 |
|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Dr Martin Mitchell
Regulatory Affairs Associate
Advanced Medical Solutions (Plymouth) Ltd |
Date of Summary: October 2015
2. Device
| Device Name: | LiquiBand Exceed |
|---|---|
| Common or Usual Name: | Topical Skin Adhesive |
| Classification Name: | Tissue Adhesive (21 CFR 878.4010) |
| Regulatory Class: | Class II |
| Product Code: | MPN |
3. Predicate Device
| Device Name: | Barle Tissue Adhesive 2 |
|---|---|
| 510(k) Clearance: | K132243 |
4. Device Description
LiquiBand Exceed 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 Exceed topical skin adhesive product is comprised of a crushable glass ampoule contained within a plastic applicator with attached foam applicator tip. LiquiBand Exceed topical skin adhesive remains liquid until it is applied to the skin. Upon application LiquiBand Exceed topical skin adhesive polymerizes within minutes.
Image /page/3/Picture/13 description: The image shows two logos side by side. The logo on the left is the BSI logo, which consists of the letters "BSI" above a heart shape inside of a circle. The logo on the right is the UKAS Quality Management logo, which consists of a crown above a check mark, with the words "UKAS QUALITY MANAGEMENT" below the check mark, and the number "003" below the words.
Certificate No. MD 585407
4
Image /page/4/Picture/0 description: The image contains the logo for Advanced Medical Solutions (Plymouth) Ltd. The logo features a stylized letter "A" in blue, with a swoosh extending from the top right. The text "Advanced Medical Solutions" is written in a blue sans-serif font, with the words underlined. Below that, in a smaller font, is the text "(Plymouth) Ltd."
Advanced Medical Solutions (Plymouth) 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
In vitro studies have shown that LiquiBand Exceed 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.
A single device contains sufficient adhesive to close wound(s) up to a combined length of 30cm.
LiquiBand Exceed topical skin adhesive is suitable for intraoperative reuse, for up to 90 minutes on a single patient.
5. Indications for Use
LiquiBand Exceed topical skin adhesive is intended for topications 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 Exceed topical skin adhesive may be used in conjunction with, but not in place of, deep dermal stitches.
6. Comparison of Technological Characteristics with the Predicate Device
The technological characteristics of LiquiBand Exceed and the predicate device are similar, in that they both contain the same high level elements.
- A cyanoacrylate based tissue adhesive ●
- An ampoule to house the adhesive
- An applicator device to apply the adhesive ●
The following technological differences exist between LiquiBand Exceed and the predicate device.
- Applicator design ●
- Volume of adhesive
LiquiBand Exceed also has the following additional claims
- A single device contains sufficient adhesive to close wound(s) up to a combined length of 30cm. ●
- LiquiBand Exceed topical skin adhesive is suitable for intraoperative reuse, for up to 90 minutes on a single patient.
7. Performance Data
Testing was performed in accordance with the FDA special controls guidance document for "Tissue Adhesive for the Topical Approximation of Skin"
Sterilization and Shelf Life
LiquiBand Exceed is sterilized by dry heat and ethylene oxide gas. The shelf life of the device has been confirmed through both real time and accelerated aging studies.
Image /page/4/Picture/22 description: The image contains two logos side-by-side within a rectangular border. The logo on the left features the letters 'BSI' above a heart shape inside of a circle. The logo on the right has a crown above a check mark with the words 'UKAS QUALITY MANAGEMENT' below it. The number '003' is at the bottom of the right logo.
Certificate No. MD 58540
5
Image /page/5/Picture/0 description: The image shows the logo for Advanced Medical Solutions (Plymouth) Ltd. The logo features a stylized blue letter "A" with a swoosh extending from the top right. Below the symbol, the text "Advanced Medical Solutions" is written in a clear, sans-serif font, with the words underlined. Underneath that, the text "(Plymouth) Ltd." is written in a smaller font size.
Advanced Medical Solutions (Plymouth) 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 Testing
The following tests were performed on the LiquiBand Exceed device to demonstrate substantial equivalence to the predicate device and to substantiate the new claims:
- Wound closure strength (ASTM F2458-05) ●
- Lap-shear strength (ASTM F2255-05) ●
- . Peel adhesion strength (ASTM F2256-05)
- Adhesive strength in tension (ASTM F2258-05)
- Force to actuate
- Polymerization set time
- Microbial barrier
- . Intraoperative reuse
- Wound closure length
The following tests were performed on the predicate device and were referenced in support of LiquiBand Exceed:
- Degradation rate ●
- Heat of polymerization ●
- Viscosity
- Purity
- Moisture determination
Biocompatibility
The biological evaluation of the LiquiBand Exceed device was performed in accordance with ISO 1093-1 "Biological evaluation of medical devices. Evaluation and testing". The following test reports were provided in this submission:
- Cytotoxicity ●
- . Sensitization
- Irritation ●
- Acute dermal toxicity
- . Intramuscular implantation
Conclusions 8.
Extensive design verification, functional and performance testing have been conducted. Based on the testing carried out, LiguiBand Exceed has been demonstrated to be substantially equivalent to the predicate device, Barle Tissue Adhesive 2 (K132243).
Image /page/5/Picture/28 description: The image contains two logos side by side. The logo on the left has the letters "BSI" above a heart shape inside of a circle. The logo on the right has a crown above a check mark, with the words "UKAS QUALITY MANAGEMENT" below the check mark. The number "003" is at the bottom of the logo on the right.
Certificate No. MD 58540