(318 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of the adhesive and its application mechanism, with no mention of AI or ML.
No
The device is a topical skin adhesive intended to hold closed approximated skin edges of wounds; it does not treat or cure a disease or condition.
No
The device is a topical skin adhesive intended to hold closed skin edges of wounds. Its purpose is therapeutic, not diagnostic; it does not analyze or interpret patient data to identify a condition or disease.
No
The device description clearly outlines a physical product consisting of a sterile liquid adhesive, an applicator tip with multiple components, and packaging. It describes the physical properties of the adhesive and applicator, and the performance studies focus on physical characteristics and biocompatibility, 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 is for topical application to hold closed skin edges of wounds. This is a direct therapeutic application to the patient's body.
- Device Description: The device is a topical skin adhesive that polymerizes on the skin. It is applied externally to the wound.
- Lack of In Vitro Testing: The description of performance studies includes mechanical strength tests, biocompatibility tests, and microbial barrier properties (though clinical correlation is not established). There is no mention of testing biological samples (like blood, urine, tissue) in vitro to diagnose a condition or provide information about a patient's health status.
IVD devices are designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Exofin® High Viscosity Topical Skin Adhesive is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations.
Exofin® High Viscosity Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.
Product codes
MPN
Device Description
Exofin® High Viscosity Topical Skin Adhesive is a sterile liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation for rapid polymerization, and the colorant D&C Violet #2 which aids in visualization during application. It is provided in a single-use, aluminum, collapsible tube fitted with a polyethylene-based applicator tip. The applicator tip consists of three components, a connector fitted with a self-puncturing cap, porous disk and soft elastomeric brush, used to apply and spread the adhesive evenly. The adhesive and applicator tip are packaged together in a polyethylene terephthalate glycol plastic blister pack and sealed with a labeled Tyvek® blister backer. When applied to the skin, the adhesive is distributed through the applicator tip in a syrup-like viscosity and polymerizes within minutes. The increased viscosity in Exofin® High Viscosity Topical Skin Adhesive is intended to reduce the risk of unintended placement of the adhesive during application due to migration of the liquid adhesive from the wound site. In-vitro studies have shown that Exofin® High Viscosity Topical Skin Adhesive acts as a barrier to microbial penetration when 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
Prescription Use
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:
- Wound Closure Strength (ASTM F2458-05) ●
- Adhesive Strength in Tension (ASTM F2258-05) ●
- T-Peel Adhesion Strength (ASTM F2256-05) ●
- Lap-Shear Strength (ASTM F2255-05) ●
- Heat of Polymerization ●
- Hydrolytic Degradation ●
- Viscosity
- Microbial Barrier Properties ●
- Applicator Torque Strength and Expression Force ●
- Setting (Tack-Free) Time ●
Key results: In these studies, Exofin® High Viscosity Topical Skin Adhesive met all performance criteria.
Biocompatibility Testing:
- Cytotoxicity ●
- Sensitization ●
- Intracutaneous Irritation ●
- Acute Systemic Toxicity ●
- Pyrogenicity ●
- Systemic Toxicity Study and Local Tissue Response Following Full-Thickness Incisions in ● Rat, 14 days
Key results: The results of the studies demonstrate that Exofin® High Viscosity Topical Skin Adhesive is safe for its intended use.
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
§ 878.4010 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
Build Correspondence
December 17, 2020
Chemence Medical, Inc.
Charnelle Thomas Director of Regulatory Affairs 200 Technology Drive Alpharetta, Georgia 30005
Re: K200264
Trade/Device Name: Exofin® High Viscosity Topical Skin Adhesive Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue Adhesive Regulatory Class: Class II Product Code: MPN Dated: November 16, 2020 Received: November 17, 2020
Dear Charnelle Thomas:
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 medical devices and radiation-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,
For Kimberly 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) K200264
Device Name Exofin® High Viscosity Topical Skin Adhesive
Indications for Use (Describe)
Exofin® High Viscosity Topical Skin Adhesive is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions, incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations.
Exofin® High Viscosity Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.
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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3
Image /page/3/Picture/0 description: The image shows the logo for Chemence Medical. The logo consists of a red and blue diamond shape with a white "C" in the center. The word "CHEMENCE" is written in red, and the word "MEDICAL" is written in blue below it. The logo is simple and modern.
510(k) Summary
This 510(k) summary is prepared in accordance with 21 CFR 807.92.
-
- Submitter
| Submitted by: | Chemence Medical, Inc.
200 Technology Drive
Alpharetta, GA 30005-3926
Phone: 844-633-4583
Fax: 678-820-3320 |
|------------------|----------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Charnelle Thomas
Director, Regulatory Affairs
Chemence Medical, Inc.
Phone: 678-690-0760
Email: cthomas@chemence.com |
| Date of Summary: | December 14, 2020 |
-
- Device
| Device Proprietary Name: | Exofin® High Viscosity Topical Skin Adhesive |
|---|---|
| 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
Legally marketed devices to which equivalence is claimed:
| Device Name: | Exofin® High Viscosity Tissue Adhesive |
|---|---|
| 510(k) Clearance: | K152476 |
4
Image /page/4/Picture/0 description: The image shows the logo for Chemence Medical. The logo features a red diamond shape with a blue "C" inside, positioned above the words "CHEMENCE" in red and "MEDICAL" in blue. The "CHEMENCE" text also has a registered trademark symbol next to it.
4. Device Description
Exofin® High Viscosity Topical Skin Adhesive is a sterile liquid topical skin adhesive containing a monomeric (2-octyl cyanoacrylate) formulation for rapid polymerization, and the colorant D&C Violet #2 which aids in visualization during application. It is provided in a single-use, aluminum, collapsible tube fitted with a polyethylene-based applicator tip. The applicator tip consists of three components, a connector fitted with a self-puncturing cap, porous disk and soft elastomeric brush, used to apply and spread the adhesive evenly. The adhesive and applicator tip are packaged together in a polyethylene terephthalate glycol plastic blister pack and sealed with a labeled Tyvek® blister backer. When applied to the skin, the adhesive is distributed through the applicator tip in a syrup-like viscosity and polymerizes within minutes. The increased viscosity in Exofin® High Viscosity Topical Skin Adhesive is intended to reduce the risk of unintended placement of the adhesive during application due to migration of the liquid adhesive from the wound site. In-vitro studies have shown that Exofin® High Viscosity Topical Skin Adhesive acts as a barrier to microbial penetration when 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.
5. Intended Use
Exofin® High Viscosity 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. Exofin® High Viscosity Topical Skin Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.
6. Comparison of Technological Characteristics with the Predicate Device
The technological characteristics of Exofin® High Viscosity Topical Skin Adhesive and the predicate device are similar. Both devices:
- are 2-octyl cyanoacrylate-based, rapid polymerizing, liquid adhesive formulations
- contain D&C violet #2 colorant to aid in visualization during application
- provide an applicator tip that comprises of a connector, porous disk and soft elastomeric brush
- polymerizes within minutes of application
- maintain skin edge approximation and provide a microbial barrier ●
- are sterilized by a two-stage process with a sterility assurance level of 10° ●
In addition to a change to the proprietary name, the differences between Exofin® High Viscosity Topical Skin Adhesive and the predicate include:
5
Image /page/5/Picture/0 description: The image shows the logo for Chemence Medical. The logo consists of a red diamond shape with a white "C" inside, positioned above the words "CHEMENCE" and "MEDICAL" stacked on top of each other. The word "CHEMENCE" is in red, while "MEDICAL" is in blue.
- slight modification to the formulation ●
- increased viscosity ●
These differences do not raise different questions of safety and effectiveness.
7. Performance and Safety Data
Testing was performed in accordance with the FDA Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin.
Performance Testing
The following tests were performed on Exofin® High Viscosity Topical Skin Adhesive to demonstrate substantial equivalence:
- Wound Closure Strength (ASTM F2458-05) ●
- Adhesive Strength in Tension (ASTM F2258-05) ●
- T-Peel Adhesion Strength (ASTM F2256-05) ●
- Lap-Shear Strength (ASTM F2255-05) ●
- Heat of Polymerization ●
- Hydrolytic Degradation ●
- Viscosity
- Microbial Barrier Properties ●
- Applicator Torque Strength and Expression Force ●
- Setting (Tack-Free) Time ●
In these studies, Exofin® High Viscosity Topical Skin Adhesive met all performance criteria.
Biocompatibility Testing
The biological evaluation of Exofin® High Viscosity Topical Skin Adhesive was performed in accordance with ISO 10993-1. "Biological Testing of Medical Devices - Part 1: Evaluation and testing within a risk management process " for a device intended for prolonged contact (>24 hours - 30 days) with breached or compromised skin surface. The results of the studies, listed below, demonstrate that Exofin® High Viscosity Topical Skin Adhesive is safe for its intended use.
- Cytotoxicity ●
- Sensitization ●
- Intracutaneous Irritation ●
- Acute Systemic Toxicity ●
- Pyrogenicity ●
- Systemic Toxicity Study and Local Tissue Response Following Full-Thickness Incisions in ● Rat, 14 days
6
Image /page/6/Picture/0 description: The image contains the logo for Chemence Medical. The logo features a red diamond shape with a white "C" inside, positioned above the text "CHEMENCE" in a bold, sans-serif font. Below "CHEMENCE" is the word "MEDICAL" in a similar font, but slightly smaller in size.
8. Conclusion
Exofin® High Viscosity Topical Skin Adhesive was evaluated in accordance with the Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin. Exofin® High Viscosity Topical Skin Adhesive is substantially equivalent to Exofin® High Viscosity Tissue Adhesive with regard to indications for use, mechanism of action and performance characteristics. Both devices contain the same principle chemical ingredient, 2-0ctyl cyanoacrylate. Both devices were shown to be equivalent in all performance and safety tests. Therefore, the slight change in formulation does not raise different questions of safety and effectiveness.