Viveve RF System, Secure

K180584 · Viveve, Inc. · GEI · Apr 6, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K180584
• Device Name: Viveve RF System, Secure
• Applicant: Viveve, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Apr 6, 2018
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

Device Story

Viveve System is an electrosurgical device using monopolar radiofrequency (RF) energy to heat tissue for coagulation and hemostasis. System components include an RF generator with integrated cooling module, handpiece, footswitch, and sterile disposable treatment tips (5 cm and 8 cm). During operation, RF energy creates an electric field beneath the treatment tip to heat internal tissue, while cryogen is delivered to the tip interior to cool surface tissue (reverse thermal gradient). Used in clinical settings by healthcare providers. Output is controlled via footswitch; healthcare providers monitor the procedure to achieve desired coagulation. Benefits include controlled thermal tissue effects while protecting surface layers.

Clinical Evidence

No clinical data was provided. Substantial equivalence was demonstrated through bench testing, including design verification, biocompatibility, electrical safety, and electromagnetic compatibility testing.

Technological Characteristics

Monopolar RF electrosurgical system; 6 MHz continuous sinusoidal waveform; 240W max power; 25-120 Ω impedance range. Features cryogen-based surface cooling. Components: RF generator, handpiece, footswitch, sterile disposable tips. Sterilization: ETO. Standards: IEC 60601-1, IEC 60601-2-2, IEC 60601-1-2, ISO 14972, ISO 10993-1.

Indications for Use

Indicated for use in general surgical procedures for electrocoagulation and hemostasis. No specific patient population, age, or gender restrictions are defined.

Regulatory Classification

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.

Predicate Devices

• Viveve System (K162547)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 6, 2018

Viveve Inc. Suzon Lommel Senior Vice President, Regulatory & Quality Affairs 345 Inverness Drive South, Building B, Suite 250 Englewood, Colorado 80112

Re: K180584

Trade/Device Name: Viveve RF System, Secure Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: February 19, 2018 Received: March 5, 2018

Dear Suzon Lommel:

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, 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

{1}------------------------------------------------

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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely.

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)

### K180584

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)

> 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 [e-mail]

"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."

Page 1 of 1

# SECTION G

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

{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. |
|------------|---------------------------|
| | 345 Inverness Drive South |
| | B-250 |
| | Englewood, CO 80112 |

| Contact: | Suzon Lommel |
|----------|-----------------------------------------------------|
| | Senior VP, Quality Assurance and Regulatory Affairs |
| | [e-mail] |
| | Phone: [phone] |
| | Fax: [phone] |

Date Prepared: February 19, 2018

### SUBJECT DEVICE INFORMATION 7.3

| 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 |

#### 7.4 PREDICATE DEVICE

- . Viveve System (K162547)
### DEVICE DESCRIPTION 7.5

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. ●
- 5 cm and 8cm Sterile Disposable Treatment Tips. ●

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., 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.

#### 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 a design change to add an8 cm 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, the materials and indication for use have not changed, therefore, the subject device is substantially equivalent to the predicate device listed.

| Item | Viveve System<br>and Accessories<br>(Subject Device) | Viveve System<br>(Predicate Device) |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>510(k) Number</b> | Subject 510(k) | K162547 |
| <b>Legal Manufacturer</b> | Viveve, Inc. | Viveve, Inc. |
| <b>Contract<br/>Manufacturer</b> | Stellartech Research Corporation | Stellartech Research Corporation |
| Item | Viveve System<br>and Accessories<br>(Subject Device) | Viveve System<br>(Predicate Device) |
| Indication for Use | The Viveve System is indicated for use<br>in general surgical procedures for<br>electrocoagulation and hemostasis. | The Viveve System is indicated for use<br>in general surgical procedures for<br>electrocoagulation and hemostasis. |
| FDA Classification | Class II | Class II |
| CFR/Product code | 21 CFR 878.4400/GEI | 21 CFR 878.4400/GEI |
| Invasiveness of<br>treatment | Non-invasive. Device applied to the<br>surface. | Non-invasive. Device applied to the<br>surface. |
| Principles of<br>operations | Radiofrequency (RF) energy selectively<br>heats a given volume of tissue beneath<br>the surface, while cryogen is delivered to<br>the inside of the Treatment Tip to cool<br>the surface tissue. The Treatment Tip is<br>placed on the surface of the skin and the<br>internal tissues are heated while the<br>surface tissue is protected. (Reverse<br>thermal gradient) | Radiofrequency (RF) energy selectively<br>heats a given volume of tissue beneath<br>the surface, while cryogen is delivered to<br>the inside of the Treatment Tip to cool<br>the surface tissue. The Treatment Tip is<br>placed on the surface of the skin and the<br>internal tissues are heated while the<br>surface tissue is protected. (Reverse<br>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<br>(generator) | 240 Watts | 240 Watts |
| Operating Frequency | 6 MHz | 6 MHz |
| Voltage waveform | 6.0 MHz continuous sinusoidal<br>waveforms | 6.0 MHz continuous sinusoidal<br>waveforms |
| Electrode probe | Monopolar | Monopolar |
| Impedance range | 25 - 120 Ω | 25 - 120 Ω |
| Tip | 5 cm and 8cm Treatment Tips | 5 cm Treatment tip |
| Packaging | Tyvek Pouch | Tyvek Pouch |
| Sterility | ETO | ETO |
| Cooling solution | Cryogen | Cryogen |

## Table 7.8.1: Summary Comparison of Technical Characteristics

{5}------------------------------------------------

### PERFORMANCE DATA 7.9

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

{6}------------------------------------------------

- 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.

#### 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. 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 as the only change was to the length of the Treatment Tip shell, all internal components are identical.

#### 7.10 CONCLUSION

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 System, therefore, the subject device is substantially equivalent to the predicate device.