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

AI/ML Overview

This document, K213814, is a 510(k) premarket notification for the Viveve 2.0 System. It describes a change in the manufacturing site from Sparton Medical to Spartronics for the Viveve 2.0 System.

Based on the provided text, there is no detailed study information regarding acceptance criteria and device performance as typically expected for demonstrating clinical efficacy or algorithm performance. This submission is primarily about a manufacturing site change and asserts that because no other aspects of the device have changed, the performance remains the same as the predicate device. Therefore, many of the requested details about studies are not present in this document.

However, I can extract the relevant information that is available and explain why other sections are not applicable.

1. A table of acceptance criteria and the reported device performance

This document does not provide a table of acceptance criteria and reported device performance in the context of clinical efficacy or algorithm performance. The core assertion of this 510(k) is that the device (Viveve 2.0 System) is substantially equivalent to its predicate device (Viveve 2.0 System, K212678) because only the manufacturing site has changed, and no other aspects of the device, software, or indications for use have been altered.

Therefore, the "acceptance criteria" here implicitly refer to demonstrating that the device produced by the new manufacturer maintains the same specifications and quality as the previous manufacturer, ensuring it performs identically to the predicate device.

Implicit Acceptance Criteria (for the manufacturing change):

Acceptance Criteria Category	Reported Device Performance (as stated in the document)
Manufacturing Site Location	Changed from Sparton Medical (Frederick, CO) to Spartronics (Watertown, SD)
Console/Generator	Not changing as part of this submission.
Footswitch	Not changing as part of this submission.
Handpiece	Not changing as part of this submission.
Cryogen	Not changing as part of this submission.
Software Modifications (Console, Display, Handpiece)	Not changing as part of this submission.
Hardware Modifications (Operating System)	Not changing as part of this submission.
Labeling Modifications (Technical User Manual, Instructions for Use)	No changes have been made.
Technical/Environmental Specification Modifications	IEC60601, Electrostatic Discharge (ESD), and Voltage Dip are aligned with the Contract Manufacturing Organization's (CMO) Quality Management System (QMS) Requirements.
Safety and Efficacy Implications	The proposed contract manufacturer modifications do not raise new questions of the safety or efficacy of the device, and the intended use remains unchanged.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. This 510(k) does not describe a test set or data provenance in the context of evaluating the clinical performance or accuracy of the device itself. The "performance data" mentioned refers to "Design verification testing, including bench performance and software verification/validation" to demonstrate substantial equivalence, rather than a clinical study with a patient test set.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. As this 510(k) is focused on a manufacturing site change and substantial equivalence without clinical efficacy studies, there's no mention of experts establishing ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. There is no described test set or clinical study requiring an adjudication method.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. The Viveve 2.0 System is an electrosurgical cutting and coagulation device, not an AI-assisted diagnostic or therapeutic system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device or its submission.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The Viveve 2.0 System is a physical medical device (RF generator, handpiece, etc.) used in general surgical procedures. It does not operate as a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. No ground truth in the context of clinical data or algorithm performance is described in this submission. The "performance data" mentioned refers to "Design verification testing" (e.g., bench testing, software validation) to ensure the device manufactured at the new site meets pre-defined engineering and safety specifications, consistent with the predicate device.

8. The sample size for the training set

Not applicable. As there are no clinical studies or AI algorithms being evaluated in this submission, there is no training set to report.

9. How the ground truth for the training set was established

Not applicable. As above, there is no training set mentioned in this submission.

Summary

{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 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.

Regulation Number and Section

§ 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.