. 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

The provided document describes the Viveve 2.0 System, an electrosurgical device that delivers radiofrequency energy. The primary change in this 510(k) submission (K193611) compared to its predicate device (K190422) is the addition of Contact Quality Monitoring (CQM) software and a modified user interface. The study focuses on demonstrating the safety and effectiveness of this added feature.

Here's a breakdown of the requested information based on the document:

1. Table of Acceptance Criteria and Reported Device Performance

Feature/Test	Acceptance Criteria	Reported Device Performance
CQM Contact Resistance Measurement	0 to 200 Ω with ±10% (100 Ω - 200 Ω range) and ± 10 Ω accuracy (< 100 Ω)	The CQM reading was as expected between 50 Ω ± 10 Ω with the RF Activated.
CQM Circuit Response Time Constant	< 20 ms	The voltage on channel 1 of the oscilloscope transitioned 63% of the way from low to high in <= 20 ms.
RF Output Disable on Loss of Patient Contact	The RF Generator hardware shall support detection and provide means to disable the RF output for the following operating condition error: Loss of patient contact.	The RF Generator did fault when the CQM circuit was not complete, resulting in radiofrequency interruption to the patient.
CONTACT MAP Graphic Illumination (GUI)	Not illuminated when the Return Pad is not connected to the phantom tissue; illuminated green when the Return Pad is connected to the phantom tissue.	The CONTACT MAP graphic within the Graphic User Interface was not illuminated when the Return Pad was not connected and was illuminated green when connected.
Error Message on Inadequate Return Pad Contact	When the Return Pad is not adequately connected to the phantom tissue, the RF Generator will fault and result in an E63 - Check Tip Contact error. Acknowledge the error by selecting OK. Place the Return Pad securely on the phantom tissue so that the CONTACT MAP is illuminated and ensure a pulse is delivered.	An E63 - Check Tip Contact error was generated when the Return Pad was not adequately connected. A pulse was delivered after the Return Pad was securely placed and the CONTACT MAP illuminated.
Overall Software Performance (CQM Updates)	Meet the impacted customer requirements identified within ENG-017 Impact Analysis for CQM Updates.	All tested functions performed as expected, and the CQM updates met the identified customer requirements.
Electrical Safety / EMC Testing	Conformance to various IEC and EMC standards (detailed in Section 5.9).	All parameters in applicable standards were met and recorded as PASS results.

2. Sample size used for the test set and the data provenance

The document does not specify a specific "test set" in terms of patient data. The testing described for the CQM and software validation was performed on the device itself, likely using phantom tissue (pork belly) for functional tests of the return pad contact. The data provenance is internal testing performed by Viveve and by contract manufacturer Sparton Medical, as well as third-party testing by Intertek. There is no information about country of origin of data or whether it was retrospective or prospective, as it's not a clinical study on human subjects but rather device verification and validation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The ground truth for this device modification is based on engineering specifications and compliance with established electrical safety and software validation standards, not expert clinical interpretation of data. The "ground truth" is that the device correctly identifies and reports contact quality and disables RF output when necessary.

4. Adjudication method for the test set

Not applicable. This was device verification and validation against engineering specifications and international standards, not a clinical study requiring adjudication of expert interpretations.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No. This document does not describe an MRMC comparative effectiveness study. The submission is for a modification to an electrosurgical device, specifically related to a safety feature (Contact Quality Monitoring). It does not involve human readers interpreting medical images or data from an AI system.

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

Yes, in a sense. The testing described for the CQM feature and software verification is a standalone evaluation of the algorithm's performance in monitoring contact and issuing alerts or disabling RF output. There is no mention of a "human-in-the-loop performance" study described in this document for the specific change being cleared. The device's safety mechanisms (like CQM) are designed to operate automatically.

7. The type of ground truth used

The ground truth used for this submission is based on:

Engineering specifications and design requirements: The device's expected behavior and performance characteristics (e.g., resistance range, response time for CQM).
International standards conformance: Compliance with established electrical safety and electromagnetic compatibility standards (e.g., AAMI ES60601-1, IEC 60601-1-6, IEC 60601-2-2, IEC 60601-1-2).
Functional validation against known states: Demonstrating that the system responds correctly to scenarios like adequate vs. inadequate return pad contact using phantom tissue.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set of data. The "software" in question is for Contact Quality Monitoring, a rules-based or algorithmic safety feature, not a learning algorithm.

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

Not applicable, as there is no training set for an AI/ML algorithm in this context.

Summary

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January 16, 2020

Viveve Medical, Inc. Kevin Robison Regulatory Affairs Specialist 345 Inverness Drive South, Building B, Suite 250 Englewood, Colorado 80112

Re: K193611

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 23, 2019 Received: December 26, 2019

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 combination 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

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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) 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-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

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/device-advice-comprehensive-regulatory-assistance) and 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-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, PhD Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K193611

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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SECTION 5

510(k) SUMMARY

5.1 REGULATORY AUTHORITY

Safe Medical Devices Act of 1990, 21 CFR 807.92

5.2 APPLICANT INFORMATION

Viveve Inc. Applicant: 345 Inverness Drive South Building B, Suite 250 Englewood, CO 80112
Contact: Kevin Robison Regulatory Affairs Specialist krobison@viveve.com C: 317-435-8898 F: 720-696-8199

Date Prepared: December 23, 2019

5.3 SUBJECT DEVICE INFORMATION

Trade Name:	Viveve® 2.0 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 Device
Device Classification:	Class II

5.4 PREDICATE DEVICE

Viveve 2.0 System (K190422)

5.5 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

5.6 INDICATIONS FOR USE

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

5.7 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The technological characteristics of the subject device Viveve 2.0 System are substantially equivalent to the predicate device, Viveve 2.0 System (K190422). The Viveve 2.0 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. The subject device differs from the predicate device in the addition of Contact Quality Monitoring (CQM). The device software monitors the return pad to determine if it is adequately secured to the patient's body in order to dissipate any residual radiofrequency energy. The display module software differs from that of the predicate device only in the addition of a Contact Map which indicates the amount of contact between the return pad and the patient's skin. In all other regards the display module software is identical. The design specifications of the subject device are identical to the predicate device specifications with the sole exception of the addition of CQM and the modification to the user interface.

This submission application confirms the continued conformance to applicable technical design specifications and performance requirements, including requirements associated with industry safety and performance standards.

5.8 BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The Viveve 2.0 System is substantially equivalent to the predicate device listed in K190422. The principle of operation between the predicate device and the subject device remain the same as do all output parameters to tissue.

Specifications of the Viveve 2.0 System are discussed in further detailed in Section 09: Substantial Equivalence Discussion of this Premarket Notification. A comparison of the technical characteristics of Viveve 2.0 System are compared to those of the predicate device, Viveve 2.0 System, in Table 5-1 below.

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Item	Viveve 2.0 System(Subject Device)	Viveve 2.0 System(Predicate Device K190422)
510(k) Number	Subject device	K190422
Legal Manufacturer	Viveve, Inc.	Viveve, Inc.
Contract Manufacturer	Sparton Medical Systems Colorado, LLC•Cirtec Medical (Treatment Tips)•	Sparton Medical Systems Colorado, LLC•Cirtec Medical (Treatment Tips)•
Indication for Use	The Viveve 2.0 System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.	The Viveve 2.0 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 applies to the surface.	Non-invasive. Device applies to the surface.
Principles of Operation	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
Contact Quality Monitoring	Yes	No
Treatment Type	Monopolar	Monopolar
Main Input(Inputvoltage/Current/Frequency)	100 - 120 Vac / 10A / 50/60 Hz220 - 240 Vac / 5A / 50/60 Hz	100 - 120 Vac / 10A / 50/60 Hz220 - 240 Vac / 5A / 50/60 Hz
Maximum Power(generator)	50 Watts	50 Watts
Operating Frequency	6.78 MHz ±15%.	6.78 MHz ±15%.
Voltage Waveform	6.78 MHz continuous sinusoidal waveforms	6.78 MHz continuous sinusoidal waveforms
Electrode Probe	Monopolar	Monopolar
Item	Viveve 2.0 System(Subject Device)	Viveve 2.0 System(Predicate Device K190422)
Impedance Range	20 – 185 Ω	20 – 185 Ω
Tip	5cm and 8cm TreatmentTips	5cm and 8cm Treatment Tips
Packaging	Tyvek pouch	Tyvek pouch
Sterility	ETO	ETO
Cooling Solution	Cryogen	Cryogen

Table 5-1: Comparison of Technological Characteristics of Subject Viveve 2.0 System and previously cleared Viveve 2.0 System (K190422)

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5.9 PERFORMANCE DATA

Verification testing, including electrical safety/electromagnetic compatibility, software verification/validation were performed for the addition of the Contact Quality Monitoring software and the revised display module software to the Viveve 2.0 System.

1. Sparton Medical performed software and hardware verifications to ensure the Contact Quality Monitoring worked appropriately. The following verifications were performed as part of the Sparton Medical Hardware Verification Test Report 140154:
- The RF Generator was tested to ensure CQM contact resistance was working ● appropriately. The contact resistance measurement range was 0 to 200 Ω with ±10% (100 Ω - 200 Ω range) and ± 10 Ω accuracy (< 100 Ω).
- The RF Generator shall have a CQM circuit response time constant of <20 ● ms.).
- The RFG hardware shall support detection and provide means to disable the RF output for the following operating condition error: Loss of patient contact.
1. Intertek performed the following IEC and EMC testing on the Viveve 2.0 System with CQM added:
- Constructional Data Report according to: ●
  - o Medical Electrical Equipment Part 1: General Requirements For Basic Safety And Essential Performance (R2012) [AAMI ES60601-1:2005 + C1;A2}
  - Medical Electrical Equipment Part 1: General Requirements for O Basic Safety and Essential Performance (R2013) {CSA C22.2#60601-1:2008 Ed.2 + C2]
  - Medical Electrical Equipment Part 1-6: General Requirements O For Basic Safety and Essential Performance - Collateral Standard: Usability [IEC 60601-1-1-6:2010 Ed.3+A1]
  - Medical Electrical Equipment Part 2-2: Particular Requirements O For The Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories [IEC 60601-2-2:2017 Ed.6]
- EMC Test Report according to:
  - IEC 60601-1-2 ed. 4.0 (2014-02): Medical Electrical Equipment -O Part 1-2: General Requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -

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Requirements and tests (With EMC deviations per IEC 60601-2-2:2017:03)

Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance according to:
- IEC 60601-1:2005, OR1:2006, COR2:2007, AMD1:2012 (or IEC o 60601-1:2012 reprint)
Medical Electrical Equipment Part 1-6: General Requirements for Safety -● Collateral Standard: Usability according to:
- o IEC 60601-1-6:2010, AMD1:1013 for use in conjunction with IEC 62366:2007, AMD1:2014 and IEC 60601-1:2005, OR1:2006, COR2:2007, AMD1: 2012 or equivalent consolidated version IEC 60601-1:2012 (Edition 3.1)
Medical Electrical Equipment Part 2: Particular Requirements for the Basic Safety and Essential Performance of High Frequency Surgical Equipment and High Frequency Surgical Accessories according to:
- IEC 60601-2-2: 2017 for use in conjunction with IEC 60601- O 1:2005, COR1:2006, COR 2:2007, AMD1:2012 or IEC 60601-1:2012

All the above Intertek test reports are on file at Viveve and are available in full upon request.

1. Viveve performed a master Viveve 2.0 System Validation to ensure the CQM software performs appropriately. The following parameters were tested:
- Ensure the CONTACT MAP graphic within the Graphic User Interface is not ● illuminated when the Return Pad is not connected to the phantom tissue (pork belly) and is illuminated green when the Return Pad is connected to the phantom tissue.
- . When the Return Pad is not adequately connected to the phantom tissue, the RF Generator will fault and result in an E63 - Check Tip Contact error. Acknowledge the error by selecting OK. Place the Return Pad securely on the phantom tissue so that the CONTACT MAP is illuminated and ensure a pulse is delivered.

The Verifications, EMC and IEC Testing, and Validation ensure that the CQM addition to the Viveve 2.0 System are performing to the correct specifications for safety and efficacy of the device.

5.10 CONCLUSION

The following results were achieved referencing the tests performed in 1-3 above:

1. The RF Generator performed as expected when the contact resistance was measured at the appropriate values. The CQM reading was as expected between 50 Ω± 10 Ω with the RF Activated. The voltage on channel 1 of the oscilloscope transitioned 63% of the way from low too high in <= 20ms. The RF Generator did fault when the CQM circuit was not complete resulting in radiofrequency interruption to the patient. All of the above parameters were met and were recorded as PASS results.
1. Intertek performed the above tests according to the applicable standards. All of the above parameters were met and were recorded as PASS results.

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1. During the execution of the protocol, all tested functions performed as expected. Test results indicated that the CQM updates to the Viveve 2.0 System have met the impacted customer requirements, identified within ENG-017 Impact Analysis for CQM Updates.
  The Viveve 2.0 System successfully passed all functional testing performed in the protocol.

Noting all testing performed above, considering the risk and safety of the device, the Viveve 2.0 System performed as expected after the addition of the CQM Software. The changes to the Viveve 2.0 System Software do not raise questions of safety or efficacy of the overall system; therefore, the Viveve 2.0 System is substantially equivalent to the predicate device.

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.