(266 days)
Not Found
No
The description focuses on the chemical composition of the adhesive and the mechanical properties of the closure system. There is no mention of AI, ML, image processing, or any data-driven decision-making components.
Yes.
The device is intended to hold closed approximated skin edges of wounds from surgical incisions and lacerations, acting as a physical barrier and aiding in wound closure and healing, which is a therapeutic function.
No
This device is a skin closure system that utilizes a topical adhesive to hold closed skin edges of wounds. Its described function is to physically close wounds, not to diagnose medical conditions or provide diagnostic information.
No
The device description clearly outlines physical components: a sterile, liquid topical skin adhesive, a single-use applicator with a crushable glass ampoule, a pen applicator, an applicator tip, and a self-adhering mesh. The performance studies also focus on physical properties and biocompatibility, not software validation.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states it's for "topical application only to hold closed easily approximated skin edges of wounds". This is a direct application to the body for a therapeutic purpose (wound closure).
- Device Description: The description details a liquid topical skin adhesive and a self-adhering mesh. These are physical components used externally on the skin.
- Lack of Diagnostic Purpose: There is no mention of the device being used to analyze samples from the body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
- Performance Studies: The performance studies focus on the physical properties of the adhesive and its ability to close wounds, not on diagnostic accuracy or analysis of biological samples.
IVD devices are used in vitro (outside the body) to examine specimens from the human body to provide information about a person's health. This device is used in vivo (on the body) for wound closure.
N/A
Intended Use / Indications for Use
The Skin Closure System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple thoroughly cleansed, trauma- induced lacerations. The Skin Closure System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.
Product codes
OMD
Device Description
CM00622 Skin Wound Closure System is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet No. 2. It is provided in a single-use applicator packaged in a rigid blister. The applicator is composed of a crushable glass ampoule contained within a pen applicator with an attached applicator tip. As applied to skin, the liquid topical skin adhesive is slightly more viscous than water and polymerizes within minutes. In vitro studies have shown that following polymerization, CM00622 LINC acts as a physical barrier (for up to 7 days) to microbial penetration as long as the polymerized liquid topical skin 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.
CM00622 LINC also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment of incisions up to 20 cm in length until the liguid topical skin adhesive is applied to achieve skin closure.
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)
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" Issued on: November 10, 2010
The following tests were performed on the CM00622 LINC Skin Closure System to demonstrate substantial equivalence to the predicate device:
- Peel Adhesion of Pressure-Sensitive Tape (ASTM D3330/D3330M-04)
- Shear Adhesion of Pressure-Sensitive Tapes (ASTM D3654/D3654M-06)
- Tensile Properties of Thin Plastic Sheeting (ASTM D882-12) ●
- 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)
- Adhesive degradation study
- Heat of polymerization
- Viscosity
- Dry time
- Microbial barrier testing
- Device Yield and Quality of Film
- Flow Control
- Animal wound healing study
Biocompatibility evaluation was performed in accordance with FDA guidance on the use of ISO 10993-1, including:
- Physical and/or chemical information: Solvent compatibility, Chemical characterization and Toxicological risk assessment.
- Cytotoxicity.
- Sensitization.
- Intracutaneous reactivity.
- Material mediated pyrogenicity.
- Endotoxin mediated pyrogenicity.
- Acute systemic toxicity.
- Implantation (including sub-acute toxicity).
Key results: It was determined through the testing (Bench and Animal) performed in this 510(k) submission, that the subject device is substantially equivalent to the predicate device and any minor differences in performance does not affect safety or efficacy.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4011 Tissue adhesive with adjunct wound closure device for topical approximation of skin.
(a)
Identification. A tissue adhesive with adjunct wound closure device intended for the topical approximation of skin is a device indicated for topical application 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. It may be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of wound during application of the liquid adhesive.(b)
Classification. Class II (special controls). The special control for this device is FDA's “Guidance for Industry and FDA Staff; Class II Special Controls Guidance Document: Tissue Adhesive with Adjunct Wound Closure Device Intended for the Topical Approximation of Skin.” See § 878.1(e) for the availability of this guidance document.
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: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. FOOD & DRUG ADMINISTRATION".
July 15, 2024
Connexicon Medical Ltd. Martin Brennan Director of Quality and Regulatory Affairs Synergy Centre Institute of Technology Tallaght (ITT) Dublin, Dublin D24 A386 Ireland
Re: K233460
Trade/Device Name: CM00622 LINC Skin Closure System (CM00622 LINC) Regulation Number: 21 CFR 878.4011 Regulation Name: Tissue Adhesive With Adjunct Wound Closure Device For Topical Approximation Of Skin Regulatory Class: Class II Product Code: OMD Dated: June 11, 2024 Received: June 13, 2024
Dear Martin Brennan:
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
Julie A.
Morabito -S
Julie Morabito, Ph.D. Assistant Director
2
DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
Submission Number (if known)
Device Name
CM00622 LINC Skin Closure System (CM00622 LINC)
Indications for Use (Describe)
The Skin Closure System is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, including incisions from minimally invasive surgery, and simple thoroughly cleansed, trauma- induced lacerations. The Skin Closure System should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Connexicon Medical Ltd Synergy Centre,
ITT Tallaght
Dublin 24
Dublin 24
D24 A386
Ireland
510(k) Summary
| Submitted by: | Connexicon Medical Limited,
Synergy Centre,
ITT Dublin,
Dublin 24,
D24 A386
Tel +353 1 5334996 |
|-------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|
| Contact Person: | Martin Brennan
Director of Quality and Regulatory Affairs |
| Date of Summary: | 15 July 2024 |
| Device Name: | CM00622 LINC Skin Closure System |
| Common Name: | Cutaneous Tissue Adhesive With Mesh |
| Classification Name: | Tissue adhesive with adjunct wound closure device for topical
approximation of skin |
| Regulatory Number: | 21 CFR 878.4011 |
| Device Class: | Class II |
| Product Code: | OMD |
| Predicate Device
Device Name:
510(k) Clearance: | DERMABOND™ PRINEO™ Skin Closure System
Primary predicate device (K133864) |
5
Device Description
CM00622 Skin Wound Closure System is a sterile, liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation and the colorant D & C Violet No. 2. It is provided in a single-use applicator packaged in a rigid blister. The applicator is composed of a crushable glass ampoule contained within a pen applicator with an attached applicator tip. As applied to skin, the liquid topical skin adhesive is slightly more viscous than water and polymerizes within minutes. In vitro studies have shown that following polymerization, CM00622 LINC acts as a physical barrier (for up to 7 days) to microbial penetration as long as the polymerized liquid topical skin 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.
CM00622 LINC also incorporates a self-adhering mesh that is applied to the approximated skin edges to provide temporary skin edge alignment of incisions up to 20 cm in length until the liguid topical skin adhesive is applied to achieve skin closure.
Indications for Use
CM00622 LINC is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, and simple, thoroughly cleansed, trauma-induced lacerations. CM00622 LINC should be used in conjunction with, but not in place of, deep dermal stitches. Additionally, the adjunct wound closure device component maintains temporary skin edge alignment along the length of the wound during application of the liquid adhesive.
Comparison of Technological Characteristics with the Predicate Device
The technological characteristics of the CM00622 LINC Skin Closure System and the predicate device are similar, in that they both contain the same technological characteristics:
- Adhesive: 2-octyl cyanoacrylate based adhesive with D&C Violet #2 colorant
- . Accelerant: Quaternary ammonium salt
- . Applicator: Sterile single use applicator
- . Mesh: Polyester mesh with pressure sensitive adhesive
Differences compared to the Predicate Device
| Use | The indications for use of the subject and predicate device are identical except the
subject device does not include punctures. The difference is not critical as the
indications are lesser for the subject device. |
|-------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technology | The initiator is located in the filter for the subject device as compared to the mesh
for the predicate device.
The activation method for the subject device involves manually compressing the
applicator body to break the glass ampoule whilst a collar is required to be turned
to break the glass ampoule for the predicate device.
- Performance testing found that the subject device is substantially equivalent to
the predicate device and these differences do not affect safety or efficacy. |
| Performance | It was determined through the testing (Bench and Animal) performed in this 510(k)
submission, that the subject device is substantially equivalent to the predicate
device and any minor differences in performance does not affect safety or efficacy. |
6
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" Issued on: November 10, 2010
Performance Testing
The following tests were performed on the CM00622 LINC Skin Closure System to demonstrate substantial equivalence to the predicate device:
- Peel Adhesion of Pressure-Sensitive Tape (ASTM D3330/D3330M-04)
- Shear Adhesion of Pressure-Sensitive Tapes (ASTM D3654/D3654M-06)
- Tensile Properties of Thin Plastic Sheeting (ASTM D882-12) ●
- 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)
- Adhesive degradation study
- Heat of polymerization
- Viscosity
- Dry time
- Microbial barrier testing
- Device Yield and Quality of Film
- Flow Control
- Animal wound healing study
Biocompatibility
The biological evaluation of the CM00622 LINC Skin Closure System was performed in accordance with FDA guidance on the use of ISO 10993-1.
The following test reports were provided in this submission:
- . Physical and/or chemical information: Solvent compatibility, Chemical characterization and Toxicological risk assessment.
- . Cytotoxicity.
- Sensitization.
- Intracutaneous reactivity.
- Material mediated pyrogenicity.
- Endotoxin mediated pyrogenicity.
- Acute systemic toxicity.
- Implantation (including sub-acute toxicity).
Conclusions
Based on the intended use, technological characteristics, safety and performance testing, CM00622 LINC Skin Closure System has been demonstrated to be substantially equivalent to the predicate device, DERMABOND™ PRINEO™ Skin Closure System