(266 days)
Not Found
No
The device description and intended use clearly define a chemical adhesive product. There is no mention of any computational or analytical functions that would involve AI or ML. The performance studies focus on physical and chemical properties of the adhesive.
Yes
The device is a topical skin adhesive intended to hold closed skin edges of wounds, which is a therapeutic function for wound management.
No
The device is a topical skin adhesive designed to close wounds, not to diagnose a condition or disease. Its function is to approximate skin edges, which is a treatment, not a diagnostic process.
No
The device description clearly outlines physical components (liquid adhesive, glass ampoule, plastic tube, silicone brush tip) and the performance studies focus on physical properties and biological interactions, not software functionality.
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 application only, to hold closed easily approximated skin edges of wounds". This describes a direct application to the body for a physical purpose (holding skin together).
- Device Description: The description details a sterile liquid adhesive that polymerizes when applied to the skin. This is a physical/chemical process happening on the body surface.
- Lack of Diagnostic Purpose: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. IVDs are used to test samples like blood, urine, tissue, etc., outside of the body.
Therefore, this device falls under the category of a medical device used for wound closure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
CM005 Standard Topical Skin Adhesive is indicated 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. CM005 STANDARD Topical Skin Adhesive may be used in conjunction with, but not in place of deep dermal stitches. CM005 STANDARD Topical Skin Adhesive should be applied by trained medical or nursing staff.
CM004 Mini Topical Skin Adhesive is indicated 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. CM004 Mini Topical Skin Adhesive may be used in conjunction with, but not in place of deep dermal stitches. CM004 Mini Topical Skin Adhesive should be applied by trained medical or nursing staff.
Product codes
MPN
Device Description
CM005 Standard Topical Skin Adhesive 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 as a single-use applicator in a blister package. The pen style applicator is composed of a crushable glass ampoule contained within a plastic tube and plastic enclosure with silicone brush tip. When applied to the skin, the liquid adhesive polymerizes within minutes. In vitro studies have shown that following application and polymerization, CM005 STANDARD Topical Skin Adhesive acts as a physical barrier to prevent 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.
CM004 Mini Topical Skin Adhesive 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 singleuse applicator packaged in a blister pack. The applicator is comprised of a crushable glass ampoule contained within a plastic tube and plastic enclosure with silicone brush tip. When applied to the skin, the liquid adhesive polymerizes within minutes. In vitro studies have shown that following polymerization, CM004 Mini Topical Skin Adhesive acts as a physical 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
trained medical or nursing staff
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:
- 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
- Set time
- Microbial barrier testing
- Device Yield and Quality of Film
- Flow Control
- Animal wound healing study
Key Results: It was determined through the testing (Bench and Animal) performed in this 510(k) submission, that the subject devices are substantially equivalent to the predicate devices and any minor differences in performance does not affect safety or efficacy.
Biocompatibility:
- Physical and/or chemical information: Solvent compatibility, Chemical characterization, and Toxicological risk assessment.
- Cytotoxicity.
- Sensitization.
- Intracutaneous reactivity.
- Material mediated pyrogenicity.
- Acute toxicity
- Subacute toxicity
- Implantation
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/0 description: The image contains 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 includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
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: K233458
Trade/Device Name: CM005 Standard (CM005); CM004 Mini (CM004) Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue Adhesive Regulatory Class: Class II Product Code: MPN 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 (QS) 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 DHT4B: Division of Infection Control and Plastic and Reconstructive Surgery Devices
2
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)
K233458
Device Name
CM005 Standard (CM005); CM004 Mini (CM004)
Indications for Use (Describe)
The indication for use for both devices is shown below:
CM005 Standard Topical Skin Adhesive is indicated 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. CM005 STANDARD Topical Skin Adhesive may be used in conjunction with, but not in place of deep dermal stitches. CM005 STANDARD Topical Skin Adhesive should be applied by trained medical or nursing staff.
CM004 Mini Topical Skin Adhesive is indicated 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. CM004 Mini Topical Skin Adhesive may be used in conjunction with, but not in place of deep dermal stitches. CM004 Mini Topical Skin Adhesive should be applied by trained medical or nursing staff.
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)
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4
Connexicon Medical Ltd Synergy Centre, IT Tallaght Dublin 24 D24 A386 Ireland
510(k) Summary
| Submitted by: | Connexicon Medical Limited,
Synergy Centre,
ITT Dublin,
Dublin 24,
D24 A386
Ireland
Tel +353 (0)1 5334996 |
|-----------------------------------|-----------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Martin Brennan
Director of Quality and Regulatory Affairs |
| Date of Summary: | 15 July 2024 |
| Device Name: | CM005 Standard Topical Skin Adhesive and CM004
Mini Topical Skin Adhesive |
| Common Name: | Topical Skin Adhesive |
| Classification Name: | Tissue adhesive for the Topical Approximation of Skin |
| Regulatory Number: | 21 CFR 878.4010 |
| Device Class: | Class II |
| Product Code: | MPN |
| Predicate Devices
Device Name: | DERMABOND Advanced™ Topical Skin Adhesive
and High Viscosity DERMABOND® Mini Topical
Skin Adhesive |
| 510(k) Clearance: | K152096 |
Device Description CM005 Standard
CM005 Standard Topical Skin Adhesive 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 as a single-use applicator in a blister package. The pen style applicator is composed of a crushable glass ampoule contained within a plastic tube and plastic enclosure with silicone brush tip. When applied to the skin, the liquid adhesive polymerizes within minutes. In vitro studies have
5
nnexicon Medical Ltd
shown that following application and polymerization, CM005 STANDARD Topical Skin Adhesive acts as a physical barrier to prevent 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.
Device Description CM004 Mini
CM004 Mini Topical Skin Adhesive 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 singleuse applicator packaged in a blister pack. The applicator is comprised of a crushable glass ampoule contained within a plastic tube and plastic enclosure with silicone brush tip. When applied to the skin, the liquid adhesive polymerizes within minutes. In vitro studies have shown that following polymerization, CM004 Mini Topical Skin Adhesive acts as a physical 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 CM005 Standard
CM005 Standard Topical Skin Adhesive is indicated 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. CM005 Standard Topical Skin Adhesive may be used in conjunction with, but not in place of deep dermal stitches. CM005 Standard Topical Skin Adhesive should be applied by trained medical or nursing staff.
Indications for Use CM004 Mini
CM004 Mini Topical Skin Adhesive 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. CM004 Mini Topical Skin Adhesive may be used in conjunction with, but not in place of deep dermal stitches. CM004 Mini Topical Skin Adhesive should be applied by trained medical or nursing staff.
Comparison of Technological Characteristics with the Predicate Device
The technological characteristics of the CM005 Standard Topical Skin Adhesive and CM004 Mini Topical Skin Adhesive and the predicate devices are similar, in that they all 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
6
Differences compared to the Predicate Device
| Use | The indications for use of the subject devices specify that the adhesive should be
applied by trained medical or nursing staff. The difference is not critical as both the
subject and predicate device are prescription devices, and both are indicated as such
throughout the labelling. |
|-------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Technology | The CM004 Mini has a silicone brush tip compared to the predicate device (High
Viscosity DERMABOND® Mini Topical Skin Adhesive) which has a plastic tip. The
silicone brush tip allows for adhesive control during application. Performance testing
found that the subject device is substantially equivalent to the predicate device and
this difference does not affect safety or efficacy. |
| Performance | It was determined through the testing (Bench and Animal) performed in this 510(k)
submission, that the subject devices are substantially equivalent to the predicate
devices and any minor differences in performance does not affect safety or efficacy. |
Performance Data
Testing was performed in accordance with the FDA special controls guidance document for "Tissue Adhesive for the Topical Approximation of Skin - Class II Special Controls Guidance for Industry and FDA Staff".
Performance Testing
The following tests were performed on the both the CM005 Standard Topical Skin Adhesive and CM004 Mini Topical Skin Adhesive to demonstrate substantial equivalence to the respective predicate devices:
- 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
- Set time
- Microbial barrier testing
- Device Yield and Quality of Film
- Flow Control
- Animal wound healing study
Biocompatibility
The biological evaluation of CM005 Standard Topical Skin Adhesive and CM004 Mini Topical Skin Adhesive 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.
7
- Material mediated pyrogenicity. ●
- Acute toxicity
- Subacute toxicity
- Implantation
Conclusions
Based on the intended use, technological characteristics, safety and performance testing, CM005 Standard Topical Skin Adhesive and CM004 Mini Topical Skin Adhesive has been demonstrated to be substantially equivalent the respective predicate devices, DERMABOND Advanced™ Topical Skin Adhesive and High Viscosity DERMABOND® Mini Topical Skin Adhesive.
Connexicon Medical Ltd Synergy Centre, ITT Tallaght Dublin 24 D24 A386 Ireland