(121 days)
No
The device description and performance studies focus on the physical and chemical properties of a tissue adhesive, with no mention of AI or ML technologies.
No
Explanation: The device is a tissue adhesive used for closing skin edges of wounds, which is a supportive function in the healing process rather than directly treating a disease or condition.
No
The device is a tissue adhesive used for closing skin edges of wounds after surgery or from trauma, not for diagnosing medical conditions.
No
The device description clearly states it is a sterile, liquid topical skin adhesive provided in a tube with applicators, which are physical components, 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 device is a tissue adhesive that polymerizes on the skin. This is a physical/chemical interaction with the body's surface, not an in vitro test.
- No mention of in vitro testing: The description and performance studies focus on the physical properties of the adhesive and its ability to close wounds, not on analyzing samples taken from the body.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform such a function.
N/A
Intended Use / Indications for Use
derma+flex® QS ™ 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. derma+flex® QS ™ High Viscosity Tissue Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.
Product codes
MPN
Device Description
derma+flex® QS™ 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/1095B uncoated Tyvek pouch also containing 2 Indothene HD Grade HD50MA 180 applicator tips. The dauber applicator is comprised of a self-puncturing cap and a foam surface, which allows spreading of the adhesive with uniformity. The nozzle applicator is also a self-puncturing cap with an elongation that enables detailed application of the adhesive. As applied to the skin, the liquid is syrup-like in viscosity and polymerizes within minutes. The increased viscosity of derma+flex® QS™ 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.
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
Shelf-life studies were performed to show that the minor differences in sterilization conditions did not change the performance of the device over time. Testing included: Wound Closure Strength (according to ASTM F2458-05), Tensile Strength (according to ASTM F2258-05), T-Peel Strength (according to ASTM F2256 -05), Lap Shear Strength (according to ASTM F2255-05), Viscosity, Polymerization Time, Purity, Water Content.
Key Metrics
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
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 stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 22, 2016
Chemence Medical Inc. Kenneth Broadley, Ph.D. Executive Vice President 200 Technology Drive Alpharetta, GA 30005 US
Re: K162352
Trade/Device Name: derma+flex QS High Viscosity Tissue Adhesive Regulation Number: 21 CFR 878.4010 Regulation Name: Tissue adhesive Regulatory Class: Class II Product Code: MPN Dated: November 21, 2016 Received: November 22, 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 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.
1
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,
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) K162352
Device Name derma+flex® QSTM
Indications for Use (Describe)
derma+flex® QS ™ 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.
derma+flex® QS ™ 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) |
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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 on top, with the word "CHEMENCE" in red and the word "MEDICAL" in blue underneath. The diamond shape is divided into two triangles, with the top triangle being red and the bottom triangle being blue. There is a white plus sign in the red triangle.
510(k) Summary (In accordance with 21 CFR 807.92)
Chemence Medical, Inc. Derma+flex® QS™ 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
Executive Vice President |
| Date of Summary: | December 20th, 2016 |
| 2. Device | |
| Device Trade Name:
Common or Usual Name:
Classification Name:
Regulatory Class:
Product Code: | derma+flex® QS™ High Viscosity Tissue Adhesive
Topical Skin Adhesive
Tissue Adhesive (21 CFR 878.4010)
Class II
MPN |
| 3. Predicate Devices | |
| Proprietary Name:
510(k) Clearance: | derma+flex® QS™
K101276 |
| 4. Device Description | |
derma+flex® QS™ 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
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" inside. The word "CHEMENCE" is written in red, and the word "MEDICAL" is written in blue below the diamond shape. The logo is simple and modern, and the colors are eye-catching.
Film/1095B uncoated Tyvek pouch also containing 2 Indothene HD Grade HD50MA 180 applicator tips. The dauber applicator is comprised of a self-puncturing cap and a foam surface, which allows spreading of the adhesive with uniformity.
The nozzle applicator is also a self-puncturing cap with an elongation that enables detailed application of the adhesive. As applied to the skin, the liquid is syrup-like in viscosity and polymerizes within minutes. The increased viscosity of derma+flex® QS™ 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.
5. Intended Use:
derma+flex® QS™ High Viscosity Tissue Adhesive is intended for topical application only to hold closed easily approximated skin edges of wounds from surgical incision, including incisions from minimally invasive surgery, and simple, thorough cleansed, trauma-induced lacerations. derma+flex® QS™ High Viscosity Tissue Adhesive may be used in conjunction with, but not in place of, deep dermal sutures.
6. Comparison of Technological Characteristics with Predicate
derma+flex® QS™ High Viscosity Tissue Adhesive is practically identical to the predicate with regards to Indication for use, formulation, technology, target population, intended application, mechanism of action and performance at achieving their intended use. Both devices present that same main chemical characteristics (2-Octyl Cyanoacrylate) and the same formulating materials. The minor differences between derma+flex® QS™ High Viscosity Tissue Adhesive and the predicate center around the sterilization processes. Like the predicate, derma+flex® QS™ is sterilized in two steps during the production process involving dry heat and ethylene oxide to a Sterility Assurance Level of 106. While the sterilizing agents are the same the conditions have been changed. These differences do not raise new questions of safety and effectiveness.
7. Shelf-Life.
Shelf-life studies were performed to show that the minor differences in sterilization conditions did not change the performance of the device over time. Testing included:
Wound Closure Strength (according to ASTM F2458-05)
Tensile Strength (according to ASTM F2258-05) T-Peel Strength (according to ASTM F2256 -05) Lap Shear Strength (according to ASTM F2255-05)
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 above the words "CHEMENCE" and "MEDICAL". The word "CHEMENCE" is in red, and the word "MEDICAL" is in blue. The diamond shape is split in half, with the left half being red and the right half being blue. There is a white "C" in the center of the diamond shape.
Viscosity Polymerization Time Purity Water Content
8. Conclusion
Based on the studies carried out, the minor changes in the sterilization process between derma+flex® QS™ and the predicate device have not altered its performance indicating derma+flex® QS™ High Viscosity Tissue Adhesive is substantially equivalent to the predicate.