(21 days)
Not Found
No
The summary describes a system for electrocoagulation and hemostasis using RF energy and cooling. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices. The performance studies focus on electrical safety, EMC, and software verification for contact quality monitoring, not AI/ML algorithm performance.
Yes
The device is indicated for "general surgical procedures for electrocoagulation and hemostasis," which are therapeutic applications.
No
Explanation: The device is described as being indicated for "electrocoagulation and hemostasis," which are therapeutic procedures, not diagnostic ones. The description of its components (RF generator, handpiece, footswitch, treatment tips) and accessories also points to a device designed to deliver energy for treatment, not to gather information for diagnosis.
No
The device description clearly lists multiple hardware components including an RF Generator, hand piece, footswitch, and disposable treatment tips. The performance studies also mention hardware verification and validation.
Based on the provided information, the Viveve 2.0 System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "for use in general surgical procedures for electrocoagulation and hemostasis." This describes a therapeutic or surgical procedure performed directly on a patient's tissue, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The components described (RF Generator, hand piece, footswitch, treatment tips) are consistent with a device used for applying energy directly to tissue.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
Therefore, the Viveve 2.0 System is a surgical device used for electrocoagulation and hemostasis, not an IVD.
N/A
Intended Use / Indications for Use
The Viveve 2.0 System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The Viveve 2.0 System utilizes monopolar radiofrequency (RF) energy to selectively heat a given volume of tissue beneath the surface, while cryogen is delivered to the inside of the treatment tip to cool the surface tissue. The generator delivers energy to the treatment tip to create an electric field under the treatment tip (electrode). The mechanism of action is the application of RF energy to the tissue causing coagulation and/or hemostasis.
The Viveve® 2.0 System consists of four (4) primary components:
- An RF Generator to provide the heating energy. The Generator incorporates the Cooling Module to supply coolant which provides the cooling energy.
- A hand piece that couples the cooling and heating energy to the tissue through the treatment tip.
- A footswitch that allows the user to turn the RF Energy on or off.
- 5cm or 8cm Sterile Disposable Treatment Tips.
Accessories include:
- Coupling Fluid
- Cryogen
- Return Cable
- Return Pad
- Power Cord
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
Verification testing, including electrical safety/electromagnetic compatibility, software verification/validation were performed for the addition of the Contact Quality Monitoring software and the revised display module software to the Viveve 2.0 System.
- Sparton Medical performed software and hardware verifications to ensure the Contact Quality Monitoring worked appropriately. The following verifications were performed as part of the Sparton Medical Hardware Verification Test Report 140154:
- The RF Generator was tested to ensure CQM contact resistance was working appropriately. The contact resistance measurement range was 0 to 200 Ω with ±10% (100 Ω - 200 Ω range) and ± 10 Ω accuracy (
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & 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 agency's name, "U.S. Food & Drug Administration."
January 16, 2020
Viveve Medical, Inc. Kevin Robison Regulatory Affairs Specialist 345 Inverness Drive South, Building B, Suite 250 Englewood, Colorado 80112
Re: K193611
Trade/Device Name: Viveve 2.0 System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: December 23, 2019 Received: December 26, 2019
Dear Kevin Robison:
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
1
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 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.
Long Chen, PhD Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K193611
Device Name Viveve 2.0 System
Indications for Use (Describe)
The Viveve 2.0 System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.
Type of Use (Select one or both, as applicable)
X 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/1 description: The image shows the word "viveve" in a sans-serif font. The color of the text is a light green. The letters are evenly spaced and the word is horizontally oriented. The background is white.
SECTION 5
510(k) SUMMARY
5.1 REGULATORY AUTHORITY
Safe Medical Devices Act of 1990, 21 CFR 807.92
5.2 APPLICANT INFORMATION
- Viveve Inc. Applicant: 345 Inverness Drive South Building B, Suite 250 Englewood, CO 80112
- Contact: Kevin Robison Regulatory Affairs Specialist krobison@viveve.com C: 317-435-8898 F: 720-696-8199
Date Prepared: December 23, 2019
5.3 SUBJECT DEVICE INFORMATION
| Trade Name: | Viveve® 2.0 System |
|---|---|
| Common Name: | Electrosurgical System |
| Product Code: | GEI |
| Classification Name: | Electrosurgical Cutting and Coagulation Device and Accessories (21 CFR 878.4400) |
| Device Panel: | General Surgery/Restorative Device |
| Device Classification: | Class II |
5.4 PREDICATE DEVICE
Viveve 2.0 System (K190422)
5.5 DEVICE DESCRIPTION
The Viveve 2.0 System utilizes monopolar radiofrequency (RF) energy to selectively heat a given volume of tissue beneath the surface, while cryogen is delivered to the inside of the treatment tip to cool the surface tissue. The generator delivers energy to the treatment tip to create an electric field under the treatment tip (electrode). The mechanism of action is the application of RF energy to the tissue causing coagulation and/or hemostasis.
The Viveve® 2.0 System consists of four (4) primary components:
- . An RF Generator to provide the heating energy. The Generator incorporates the Cooling Module to supply coolant which provides the cooling energy.
- . A hand piece that couples the cooling and heating energy to the tissue through the treatment tip.
- A footswitch that allows the user to turn the RF Energy on or off.
- . 5cm or 8cm Sterile Disposable Treatment Tips.
4
Image /page/4/Picture/1 description: The image shows the word "viveve" in a sans-serif font. The color of the text is a light green. The text is all lowercase.
Accessories include:
- Coupling Fluid
- Cryogen ●
- Return Cable ●
- Return Pad ●
- . Power Cord
5.6 INDICATIONS FOR USE
The Viveve 2.0 System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.
5.7 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The technological characteristics of the subject device Viveve 2.0 System are substantially equivalent to the predicate device, Viveve 2.0 System (K190422). The Viveve 2.0 System is an electrosurgical device that delivers radiofrequency (RF) energy to selectively heat a given area of tissue, while cryogen is delivered to the inside of the treatment tip to cool the surface tissue at the end of energy deposition. The application of RF energy causes the tissue to coagulate and/or become hemostatic. The subject device differs from the predicate device in the addition of Contact Quality Monitoring (CQM). The device software monitors the return pad to determine if it is adequately secured to the patient's body in order to dissipate any residual radiofrequency energy. The display module software differs from that of the predicate device only in the addition of a Contact Map which indicates the amount of contact between the return pad and the patient's skin. In all other regards the display module software is identical. The design specifications of the subject device are identical to the predicate device specifications with the sole exception of the addition of CQM and the modification to the user interface.
This submission application confirms the continued conformance to applicable technical design specifications and performance requirements, including requirements associated with industry safety and performance standards.
5.8 BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE
The Viveve 2.0 System is substantially equivalent to the predicate device listed in K190422. The principle of operation between the predicate device and the subject device remain the same as do all output parameters to tissue.
Specifications of the Viveve 2.0 System are discussed in further detailed in Section 09: Substantial Equivalence Discussion of this Premarket Notification. A comparison of the technical characteristics of Viveve 2.0 System are compared to those of the predicate device, Viveve 2.0 System, in Table 5-1 below.
5
Image /page/5/Picture/1 description: The image shows the word "viveve" in a sans-serif font. The color of the text is a light green. The text is slightly blurred, giving it a soft appearance.
| Item | Viveve 2.0 System
(Subject Device) | Viveve 2.0 System
(Predicate Device K190422) |
|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Subject device | K190422 |
| Legal Manufacturer | Viveve, Inc. | Viveve, Inc. |
| Contract Manufacturer | Sparton Medical Systems Colorado, LLC
•
Cirtec Medical (Treatment Tips)
• | Sparton Medical Systems Colorado, LLC
•
Cirtec Medical (Treatment Tips)
• |
| Indication for Use | The Viveve 2.0 System is indicated for use in general surgical procedures for electrocoagulation and hemostasis. | The Viveve 2.0 System is indicated for use in general surgical procedures for electrocoagulation and hemostasis. |
| FDA Classification | Class II | Class II |
| CFR/Product Code | 21 CFR 878.4400/GEI | 21 CFR 878.4400/GEI |
| Invasiveness of Treatment | Non-invasive. Device applies to the surface. | Non-invasive. Device applies to the surface. |
| Principles of Operation | Radiofrequency (RF) energy selectively heats a given volume of tissue beneath the surface, while cryogen is delivered to the inside of the Treatment Tip to cool the surface tissue. The Treatment Tip is placed on the surface of the skin and the internal tissues are heated while the surface tissue is protected. (Reverse thermal gradient) | Radiofrequency (RF) energy selectively heats a given volume of tissue beneath the surface, while cryogen is delivered to the inside of the Treatment Tip to cool the surface tissue. The Treatment Tip is placed on the surface of the skin and the internal tissues are heated while the surface tissue is protected. (Reverse thermal gradient) |
| Energy | RF | RF |
| Contact Quality Monitoring | Yes | No |
| Treatment Type | Monopolar | Monopolar |
| Main Input
(Input
voltage/Current/Frequency) | 100 - 120 Vac / 10A / 50/60 Hz
220 - 240 Vac / 5A / 50/60 Hz | 100 - 120 Vac / 10A / 50/60 Hz
220 - 240 Vac / 5A / 50/60 Hz |
| Maximum Power
(generator) | 50 Watts | 50 Watts |
| Operating Frequency | 6.78 MHz ±15%. | 6.78 MHz ±15%. |
| Voltage Waveform | 6.78 MHz continuous sinusoidal waveforms | 6.78 MHz continuous sinusoidal waveforms |
| Electrode Probe | Monopolar | Monopolar |
| Item | Viveve 2.0 System
(Subject Device) | Viveve 2.0 System
(Predicate Device K190422) |
| Impedance Range | 20 – 185 Ω | 20 – 185 Ω |
| Tip | 5cm and 8cm Treatment
Tips | 5cm and 8cm Treatment Tips |
| Packaging | Tyvek pouch | Tyvek pouch |
| Sterility | ETO | ETO |
| Cooling Solution | Cryogen | Cryogen |
Table 5-1: Comparison of Technological Characteristics of Subject Viveve 2.0 System and previously cleared Viveve 2.0 System (K190422)
6
Image /page/6/Picture/1 description: The image shows the word "viveve" in a sans-serif font. The color of the text is a light green. The letters are evenly spaced and the word is horizontally oriented. There is a small circle to the right of the last 'e'.
5.9 PERFORMANCE DATA
Verification testing, including electrical safety/electromagnetic compatibility, software verification/validation were performed for the addition of the Contact Quality Monitoring software and the revised display module software to the Viveve 2.0 System.
-
- Sparton Medical performed software and hardware verifications to ensure the Contact Quality Monitoring worked appropriately. The following verifications were performed as part of the Sparton Medical Hardware Verification Test Report 140154:
- The RF Generator was tested to ensure CQM contact resistance was working ● appropriately. The contact resistance measurement range was 0 to 200 Ω with ±10% (100 Ω - 200 Ω range) and ± 10 Ω accuracy (