(24 days)
Not Found
No
The description focuses on the physical components and energy delivery mechanism (RF and cryogen) for electrocoagulation and hemostasis. There is no mention of AI, ML, image processing, or data-driven decision making within the device's operation.
Yes
The device is indicated for use in general surgical procedures for electrocoagulation and hemostasis, which are therapeutic actions.
No
The device description states its use is for "electrocoagulation and hemostasis" in "general surgical procedures," indicating a therapeutic rather than diagnostic purpose.
No
The device description clearly outlines multiple hardware components (RF Generator, hand piece, footswitch, treatment tip) and accessories (coupling fluid, cryogen, cables, pad, power cord). The performance studies also include hardware-related testing (safety, essential performance, EMC, biocompatibility, shelf life, packaging). While software validation is mentioned, it is only one part of the overall system validation, indicating the device is not solely software.
Based on the provided information, the Viveve System is not an In Vitro Diagnostic (IVD) 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 intervention performed directly on a patient's tissue, not a test performed on a sample taken from the body.
- Device Description: The description details a system that delivers radiofrequency energy and cryogen to tissue for heating and cooling, causing coagulation and hemostasis. This is a physical interaction with the body, not an analysis of a biological sample.
- Mechanism of Action: The mechanism of action is the application of RF energy to tissue causing coagulation and/or hemostasis. This is a direct effect on the tissue, not a diagnostic process.
- Components and Accessories: The components (generator, hand piece, footswitch, treatment tip) and accessories (coupling fluid, cryogen, return cable, return pad, power cord) are consistent with a surgical or therapeutic device, not an IVD device which would typically involve reagents, analyzers, and sample handling components.
IVD devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The Viveve System does not perform this function.
N/A
Intended Use / Indications for Use
The Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.
Product codes
GEI
Device Description
The Viveve 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 System consists of four (4) primary components:
- . An RF Generator to provide the heating energy. The Generator incorporates the Cooling Module to supply the coolant which provides the cooling energy.
- A hand piece that couples the cooling and heating energy to the tissue through ● the treatment tip (below).
- A footswitch that allows the user to turn the RF Energy on or off. ●
- Sterile Disposable Treatment Tip. ●
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
The modifications made to the Viveve System were found to not affect safety or performance through design verification bench testing, which confirmed the continued conformance to applicable technical design specifications and performance requirements, including requirements associated with industry safety and performance standards, as follows:
- Safety and essential performance testing in accordance with IEC 60601-1:2005 (2006/07-3rd edition) and IEC 60601-2-2:2009
- Electromagnetic compatibility in accordance with IEC 60601-1-2:2007 ●
- . Design verification testing to ensure the proposed modifications perform within design parameters under the proper environmental conditions.
- Software validation was conducted to ensure the proposed modification . perform with the design parameters.
Non-Clinical Performance Data: Design verification and biocompatibility testing was performed to ensure the subject device Viveve System functions according to the intended use. The results met the acceptance criteria. Risk analysis was also completed in accordance with criteria based on ISO 14972:2007. Electromagnetic compatibility and electrical safety testing was completed in compliance with IEC 60601-1 and IEC 60601-1-2. Biocompatibility testing was conducted for the Treatment Tip and Coupling Fluid according to ISO 10993-1:2009. Other components of the Viveve System do not have direct contact with patient tissue, therefore biocompatibility testing was not required. Sterilization for the subject device remains the same as the predicate device sterilization method and parameters. However, shelf life for the Treatment Tips was tested and verified to extend to three years. Packaging validation testing was also completed against the subject device along with the shelf life testing.
Clinical Performance Data: This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure in profile, with three overlapping faces.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 6, 2016
Viveve Inc. Mr. Jim Talbot Vice President Quality and Regulatory Affairs 150 Commercial Street Sunnyvale, California 94086
Re: K162547
Trade/Device Name: Viveve System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: September 9, 2016 Received: September 12, 2016
Dear Mr. Talbot:
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 of medical devicerelated 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/ResourcesforYou/Industry/default.htm. 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
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,
Jennifer R. Stevenson -A
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)
Device Name Viveve System
Indications for Use (Describe)
The Viveve 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)
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3
SECTION 7
510(k) SUMMARY
REGULATORY AUTHORITY 7.1
Safe Medical Devices Act of 1990, 21 CFR 807.92
7.2 APPLICANT INFORMATION
| Applicant: | Viveve Inc.
150 Comercial Street
Sunnyvale, CA 94086 USA |
|------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Jim Talbot
Vice President, Quality Assurance and Regulatory Affairs
jtalbot@viveve.com
Phone: (408) 470-3206
Fax: (408) 530-1919 |
Date Prepared: September 9, 2016
7.3 SUBJECT DEVICE INFORMATION
| Trade Name: | Viveve 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 Devices |
| Device Classification: | Class II |
PREDICATE DEVICE 7.4
- TivaMed Cooled RF System (K082962) .
7.5 DEVICE DESCRIPTION
The Viveve 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.
4
The Viveve System consists of four (4) primary components:
- . An RF Generator to provide the heating energy. The Generator incorporates the Cooling Module to supply the coolant which provides the cooling energy.
- A hand piece that couples the cooling and heating energy to the tissue through ● the treatment tip (below).
- A footswitch that allows the user to turn the RF Energy on or off. ●
- Sterile Disposable Treatment Tip. ●
Accessories include:
- Coupling Fluid
- Cryogen ●
- Return Cable ●
- . Return Pad
- Power Cord
7.6 INDICATION FOR USE
The Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.
7.7 TECHNICAL CHARACTERISTICS
The Viveve System is an electrosurgical device that delivers radiofrequency (RF) energy to selectively heat a given area of tissue beneath the surface, while cryogen is delivered to the inside of the treatment tip to cool the surface tissue. The application of RF energy causes the tissue to coagulate and/or become hemostatic.
7.8 SUBSTANTIAL EQUIVALANCE
The Viveve System is substantially equivalent to the predicate device listed. The principle of operation between the predicate device and the subject device remain the same, however the subject device is modified with various design changes to the Generator, Hand Piece, and Treatment Tip. These changes have been tested and verified to have no effect on system functionality, safety, or effectivity. The function of the subject device and indication for use have not changed, therefore, the subject device is substantially equivalent to the predicate device listed.
| Item | Viveve System
and Accessories
(Subject Device) | TivaMed Cooled RF System
(now Viveve System)
(Predicate Device) |
|------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Subject 510(k) | K082962 |
| Legal Manufacturer | Viveve, Inc. | TivaMed, Inc. (now Viveve, Inc.) |
| Contract
Manufacturer | Stellartech Research Corporation | Stellartech Research Corporation |
| Item | Viveve System
and Accessories
(Subject Device) | TivaMed Cooled RF System
(now Viveve System)
(Predicate Device) |
| Indication for Use | The Viveve System is indicated for use
in general surgical procedures for
electrocoagulation and hemostasis. | The TivaMed Cooled RF 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 applied to the
surface. | Non-invasive. Device applied to the
surface. |
| Principles of
operations | 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 |
| Treatment Type | Monopolar | Monopolar |
| Input power | 100-240 VAC @ 50/60 Hz | 100-240 VAC @ 50/60 Hz |
| Maximum power
(generator) | 240 Watts | 240 Watts |
| Operating Frequency | 6 MHz | 6 MHz |
| Voltage waveform | 6.0 MHz continuous sinusoidal
waveforms | 6.0 MHz continuous sinusoidal
waveforms |
| Electrode probe | Monopolar | Monopolar |
| Impedance range | 25 - 120 Ω | 25 - 120 Ω |
| Packaging | Tyvek Pouch | Tyvek Pouch |
| Sterility | ETO | ETO |
| Cooling solution | Cryogen | Cryogen |
Table 7.8.1: Summary Comparison of Technical Characteristics
5
7.9 PERFORMANCE DATA
The modifications made to the Viveve System were found to not affect safety or performance through design verification bench testing, which confirmed the continued conformance to applicable technical design specifications and performance requirements, including requirements associated with industry safety and performance standards, as follows:
- Safety and essential performance testing in accordance with IEC 60601-1:2005 (2006/07-3rd edition) and IEC 60601-2-2:2009
- Electromagnetic compatibility in accordance with IEC 60601-1-2:2007 ●
6
- . Design verification testing to ensure the proposed modifications perform within design parameters under the proper environmental conditions.
- Software validation was conducted to ensure the proposed modification . perform with the design parameters.
7.9.1 Non-Clinical Performance Data
Design verification and biocompatibility testing was performed to ensure the subject device Viveve System functions according to the intended use. The results met the acceptance criteria. Risk analysis was also completed in accordance with criteria based on ISO 14972:2007. Electromagnetic compatibility and electrical safety testing was completed in compliance with IEC 60601-1 and IEC 60601-1-2. Biocompatibility testing was conducted for the Treatment Tip and Coupling Fluid according to ISO 10993-1:2009. Other components of the Viveve System do not have direct contact with patient tissue, therefore biocompatibility testing was not required. Sterilization for the subject device remains the same as the predicate device sterilization method and parameters. However, shelf life for the Treatment Tips was tested and verified to extend to three years. Packaging validation testing was also completed against the subject device along with the shelf life testing.
7.9.2 Clinical Performance Data
This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence.
CONCLUSION 7.10
The indications for use and the technical characteristics of the Viveve System has not changed from the predicate device. The results of performance testing demonstrate that the modifications to the Viveve System do not affect the safety, efficacy, or performance of the generator, therefore, the subject device is substantially equivalent to the predicate device.