(162 days)
Not Found
No
The device description and performance studies focus on the physical and chemical properties of the tissue adhesive, with no mention of AI or ML.
No
The device is a tissue adhesive intended for topical application to hold skin edges closed, which is a supportive function rather than directly treating a disease or condition. While it aids in wound closure, it does not provide therapy in the sense of healing or disease management.
No
This device is a tissue adhesive used for topical application to approximate skin edges. It is a treatment device, not a diagnostic one, as it does not diagnose, detect, or monitor a condition.
No
The device description clearly states it is a sterile, liquid topical skin adhesive containing a chemical formulation and colorant, provided in a tube with an 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 is for the topical application to hold closed skin edges of wounds. This is a direct application to the body for a physical purpose (wound closure).
- Device Description: The description details a sterile liquid topical skin adhesive that polymerizes on the skin. This is a physical material applied externally.
- Lack of In Vitro Testing: The performance studies focus on physical properties like wound closure strength, adhesive strength, and biocompatibility. There is no mention of testing biological samples (like blood, urine, tissue) outside of the body to diagnose or monitor a condition.
- Anatomical Site: The anatomical site is the skin, which is an external application site. IVDs typically interact with internal biological samples.
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 Viscosty Tissue Adhesive is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations.
Exofin® High Viscosity Tissue Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.
Product codes (comma separated list FDA assigned to the subject device)
MPN
Device Description
Exofin® High Viscosity Tissue 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 use aluminum collapsible tube packaged in a RXM 48gaPET-200LDPE Film/1059B uncoated Tyvek pouch containing an applicator. The applicator is comprised of a self-puncturing cap and a soft elastomeric brush, which allows the adhesive to spread uniformly. As applied to skin, the liquid is syrup-like in viscosity and polymerizes within minutes. Exofin® High Viscosity Tissue Adhesive has a syrup-like viscosity. The increased viscosity 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 Tissue 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Testing was performed in accordance with the FDA Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin.
The following tests were performed on Exofin® High Viscosity Tissue 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 F2258-05)
- Heat of polymerization
- Degradation rate
- Viscosity
- Microbial barrier properties
Biocompatibility Testing:
The biological evaluation of Exofin® High Viscosity Tissue Adhesive was performed in accordance with ISO 10993-1, "Biological Testing of Medical Devices – Part 1: Evaluation and testing within a risk management process. The following test reports were provided in this submission:
- Cytotoxicity
- Intracutaneous irritation
- . Sensitization
Under the conditions of the studies, Exofin® High Viscosity Tissue Adhesive was considered to be noncytotoxic, non-irritating and non-sensitizing.
Sterilization and Shelf Life:
Exofin® High Viscosity Tissue Adhesive is sterilized by dry heat and ethylene oxide gas. The shelf life of the device has been determined through both real time and accelerated aging studies.
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 features the department's name encircling a symbol. The symbol is a stylized representation of human figures in profile, layered to create a sense of depth and connection. The figures are silhouetted in black, contrasting with the white background.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 9, 2016
Chemence Medical Products, Inc. Kenneth Broadley, Ph.D. Vice President Regulatory Affairs, Quality Assurance and NPD 200 Technology Drive Alpharetta, Georgia 30005
Re: K152476
Trade/Device Name: Exofin High Viscosity Tissue Adhesive Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue adhesive Regulatory Class: Class II Product Code: MPN Dated: January 13, 2016 Received: January 14, 2016
Dear Dr. Broadley:
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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
1
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 vours.
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
Indications for Use
510(k) Number (if known) K152476
Device Name Exofin® High Viscosity Tissue Adhesive
Indications for Use (Describe)
Exofin® High Viscosty Tissue Adhesive is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations.
Exofin® High Viscosity Tissue 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) |
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."
3
Image /page/3/Picture/0 description: The image contains the logo for Chemence Medical. The logo consists of a red diamond shape with a white "C" inside, above the word "CHEMENCE" in red and the word "MEDICAL" in blue. The "CHEMENCE" text also has a registered trademark symbol next to it.
510(k) Summary (In accordance with 21 CFR 807.92)
Chemence Medical, Inc. Exofin® High Viscosity Tissue Adhesive
1. Submitter
| Submitted by: | Chemence Medical, Inc. |
|---|---|
| 200 Technology Drive | |
| Alpharetta, GA 3005-3926 | |
| Phone: 844-633-4583 | |
| Fax: 678-820-3320 | |
| Contact Person: | Dr. Kenneth N. Broadley |
| Vice President | |
| Regulatory Affairs, Quality Assurance and | |
| New Product Development | |
| Chemence Medical, Inc. |
- Date of Summary: February 4th, 2016
2. Device
| Device Trade Name: | Exofin® High Viscosity Tissue 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 Devices
Legally marketed devices to which equivalence is claimed:
| Device Name: | Derma+Flex QS Tissue Adhesive |
|---|---|
| 510(k) Clearance: | K101276 |
| Device Name: | Dermabond NX Topical Skin Adhesive |
| 510(k) Clearance: | K100423 |
4
Image /page/4/Picture/0 description: The image shows the logo for Chemence Medical. The logo consists of a red and blue diamond shape with a stylized "C" in the center, where the left side of the "C" is red and the right side is blue. Below the diamond shape, the word "CHEMENCE" is written in red, and below that, the word "MEDICAL" is written in blue.
4. Device Description:
Exofin® High Viscosity Tissue 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 use aluminum collapsible tube packaged in a RXM 48gaPET-200LDPE Film/1059B uncoated Tyvek pouch containing an applicator. The applicator is comprised of a self-puncturing cap and a soft elastomeric brush, which allows the adhesive to spread uniformly. As applied to skin, the liquid is syrup-like in viscosity and polymerizes within minutes. Exofin® High Viscosity Tissue Adhesive has a syrup-like viscosity. The increased viscosity 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 Tissue 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.
5. Intended Use:
Exofin® High Viscosity Tissue Adhesive is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incisions from minimally invasive surgery, and simple, thoroughly cleansed, trauma-induced lacerations. Exofin® High Viscosity Tissue Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.
6. Comparison of Technological Characteristics with the Predicate Device.
Exofin® High Viscosity Tissue Adhesive is very similar to Dermabond NX Topical Skin Adhesive and derma+flex QS with regard to intended use, mechanism of action and performance characteristics. All devices contain the same principle chemical ingredient, 2-octyl cyanoacrylate. Exofin® High Viscosity Tissue Adhesive has a different applicator from either of the two predicates and also has a larger volume of adhesive.
7. Performance Data
Testing was performed in accordance with the FDA Class II Special Controls Guidance Document: Tissue Adhesive for the Topical Approximation of Skin.
5
Image /page/5/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. Below the diamond shape is the word "CHEMENCE" in red, and below that is the word "MEDICAL" in blue. The Chemence logo is a registered trademark.
Performance Testing
The following tests were performed on Exofin® High Viscosity Tissue 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 F2258-05)
- Heat of polymerization
- Degradation rate ●
- Viscosity ●
- Microbial barrier properties
Biocompatibility Testing
The biological evaluation of Exofin® High Viscosity Tissue Adhesive was performed in accordance with ISO 10993-1, "Biological Testing of Medical Devices – Part 1: Evaluation and testing within a risk management process. The following test reports were provided in this submission:
- Cytotoxicity
- Intracutaneous irritation
- . Sensitization
Under the conditions of the studies, Exofin® High Viscosity Tissue Adhesive was considered to be noncytotoxic, non-irritating and non-sensitizing.
Sterilization and Shelf Life
Exofin® High Viscosity Tissue Adhesive is sterilized by dry heat and ethylene oxide gas. The shelf life of the device has been determined through both real time and accelerated aging studies.
8. Conclusion
Based on the testing carried out, Exofin® High Viscosity Tissue Adhesive is substantially equivalent to the predicate devices.