(57 days)
Not Found
No
The description focuses on the physical components and energy delivery mechanism (RF and cryogen) for electrocoagulation and hemostasis, with no mention of AI or ML technologies.
No.
The device is indicated for general surgical procedures for electrocoagulation and hemostasis, which are surgical functions rather than therapeutic treatments for a disease or condition.
No
The device description and intended use indicate that the Viveve 2.0 System uses radiofrequency energy for electrocoagulation and hemostasis in general surgical procedures, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly lists multiple hardware components including an RF Generator, hand piece, footswitch, and disposable treatment tips. It also mentions accessories like coupling fluid, cryogen, return cable, return pad, and power cord. The mechanism of action involves the application of RF energy and cryogen, which are physical processes requiring hardware.
Based on the provided information, the Viveve 2.0 System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "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 (which is the hallmark of an IVD).
- Mechanism of Action: The device uses radiofrequency energy and cryogen to directly heat and cool tissue for coagulation and hemostasis. This is a physical interaction with the tissue, not an analysis of biological samples.
- Device Description: The components (generator, handpiece, footswitch, treatment tips) and accessories (coupling fluid, cryogen, return cable/pad) are consistent with a surgical energy delivery system, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents for testing, or any form of diagnostic analysis.
Therefore, the Viveve 2.0 System is a surgical device used for therapeutic purposes, 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
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
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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
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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)
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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.
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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. .
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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.