Viveve 2.0 System

K213814 · Viveve, Inc. · GEI · Feb 2, 2022 · General, Plastic Surgery

Device Facts

Record IDK213814
Device NameViveve 2.0 System
ApplicantViveve, Inc.
Product CodeGEI · General, Plastic Surgery
Decision DateFeb 2, 2022
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 878.4400
Device ClassClass 2
AttributesTherapeutic

Intended Use

The Viveve 2.0 System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.

Device Story

Viveve 2.0 System uses monopolar radiofrequency (RF) energy to heat tissue beneath surface while simultaneously delivering cryogen to treatment tip to cool surface tissue. System comprises RF generator with integrated cooling module, handpiece, footswitch, and sterile disposable treatment tips (5cm or 8cm). Generator creates electric field under electrode to induce coagulation and hemostasis. Used by clinicians in surgical settings. Device output is controlled by user via footswitch; RF energy application provides therapeutic coagulation/hemostasis effect.

Clinical Evidence

Bench testing only. Design verification testing, including bench performance and software verification/validation, was provided to demonstrate substantial equivalence to the predicate device.

Technological Characteristics

Monopolar RF electrosurgical system. Components: RF generator, cooling module, handpiece, footswitch, sterile disposable tips. Energy: RF heating with cryogen surface cooling. Connectivity: Not specified. Sterilization: Sterile disposable tips. Standards: IEC60601 (ESD and Voltage Dip).

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

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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 in blue. Underneath the FDA logo is the word "ADMINISTRATION". February 2, 2022 Viveve, Inc. Kevin Robison Global Manager, Regulatory Affairs 345 Inverness Drive South, Building B, Suite 250 Englewood, Colorado 80112 Re: K213814 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 6, 2021 Received: December 7, 2021 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 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 statutes and {1}------------------------------------------------ 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) 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-devices/medical-device-safety/medical-device-reporting-mdr-howreport-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) 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-devices/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, Ph.D. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K213814 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 letters are a light green color. There is a small circle with an R in it to the right of the last "e" in the word. The background is white. # 510(k) SUMMARY #### 1.1 REGULATORY AUTHORITY Safe Medical Devices Act of 1990, 21 CFR 807.92 #### 1.2 APPLICANT INFORMATION - Viveve® Inc. Applicant: 345 Inverness Drive South Building B, Suite 250 Englewood, CO 80112 - Contact: Kevin Robison Global Manager, Regulatory Affairs krobison@viveve.com C: 317-435-8898 F: 720-696-8199 Date Prepared: December 6, 2021 #### 1.3 SUBJECT DEVICE INFORMATION Trade Name: Viveve® 2.0 System Electrosurgical System Common Name: 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 #### 1.4 PREDICATE DEVICE Viveve® 2.0 System (K212678) #### 1.5 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}------------------------------------------------ Accessories include: - . Coupling Fluid - Cryogen ● - Return Cable ● - Return Pad ● - . Power Cord # 1.6 INDICATIONS FOR USE The Viveve 2.0 System is indicated for use in general surgical procedures for electrocoagulation and hemostasis. ### 1.7 BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE The Viveve 2.0 System is substantially equivalent to the predicate device listed in K212678. The manufacturing site is changing from Sparton Medical in Frederick, CO to Spartronics in Watertown, SD. No changes to the console, handpiece or any other components are being made. No changes to software or indications for use are being updated as part of the manufacturing site change. Also, no changes to the device specifications or labeling are being made. ### 1.7.1 COMPARISON OF TECHNOLOGY CHARACTERISTICS AND SE DETERMINATION #### 1.7.1.1 RF Console (Generator) - The Console is not changing as part of this submission. ● #### 1.7.1.2 Footswitch - The Footswitch is not changing as part of this submission. ● #### 1.7.1.3 Handpiece - The Handpiece is not changing as part of this submission. . #### 1.7.1.4 Crvogen - · Cryogen has not changed as part of this submission. #### 1.7.2 SOFTWARE MODIFICATIONS ### 1.7.2.1 Viveve RF Console Software - Console Software is not changing as part of this submission. . #### 1.7.2.2 Viveve RF Display Module Software - Display Module software is not changing as part of this submission. ● ## 1.7.2.3 Viveve RF Handpiece Software - Handpiece software is not changing as part of this submission. ● # 1.7.3 HARDWARE MODIFICATIONS #### 1.7.3.1 Operating System - The Operating System is not changing as part of this submission. . {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "viveve" in a sans-serif font. The color of the text is a light green. A registered trademark symbol is located to the right of the last "e" in the word. # 1.7.4 LABELING MODIFICATIONS ### 1.7.4.1 Technical User Manual - No changes have been made to the Technical User Manual. ● #### 1.7.4.2 Instructions for Use - . No changes have been made to the Instructions for Use. # 1.7.5 TECHNICAL/ENVIRONMENTAL SPECIFICATION MODIFICATIONS ### 1.7.5.1 Environmental and Packaging Specifications - IEC60601, Electrostatic Discharge (ESD) and Voltage Dip are aligned . with CMO's Quality Management System (QMS) Requirements ### 1.7.6 CONTRACT MANUFACTURER MODIFICATIONS (CMO) - Spartronics in Watertown, SD is now the manufacturing and servicing . provider for the Viveve 2.0 System. ### 1.8 PERFORMANCE DATA Design verification testing, including bench performance and software verification/validation, provided in the subject premarket notification demonstrate that the Viveve 2.0 System is substantially equivalent to the predicate device, Viveve 2.0 System. #### 1.9 CONCLUSION The design, technical characteristics, functionality, indications for use, and principle operation of the subject device Viveve 2.0 System remains unchanged from that of the predicate device, Viveve 2.0 System (K212678). The proposed contract manufacturer modifications do not raise new questions of the safety or efficacy of the device and the intended use of the Viveve 2.0 System remains unchanged from that of the cleared predicate.
Innolitics
510(k) Summary
Decision Summary
Classification Order
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