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 resulting in coagulation and/or hemostasis.

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 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.

The Viveve treatment tips contained in this package are a sterile single use component of the Viveve® System and designed to deliver radiofrequency (RF) energy from the Viveve console. The Viveve treatment tips can only be used in conjunction with the dedicated Viveve® System.

Accessories include:

Coupling Fluid ●
Cryogen ●
Return Cable
Return Pad ●
. Power Cord

AI/ML Overview

This document is a 510(k) Premarket Notification for the Viveve System, an electrosurgical device. The submission primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a de novo clinical study with new acceptance criteria.

Therefore, the specific information requested regarding acceptance criteria, a study proving the device meets these criteria, sample sizes, expert involvement, ground truth establishment, and MRMC studies is not explicitly presented in the provided text in the way one would expect for a novel device undergoing clinical validation against pre-defined performance metrics.

Instead, the submission argues for substantial equivalence based on:

Identical Indications for Use: "The Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis." (Page 2, 4)
Identical Technological Characteristics: "The technological characteristics of the subject device Viveve System are identical to those of the predicate devices, Viveve System (K180584) and Viveve 2.0 System (K190422)." (Page 4)
Identical Principle of Operation: "The principle of operation between the predicate devices and the subject device remain identical as do all output parameters to tissue." (Page 4)
Minimal Design Modifications: The changes are limited to packaging of the sterile treatment tip, and a software modification to extend the useful life of the handpiece (from 11,000 to 65,000 pulses). This software change was "validated and assessed for additional risk to the patient and was deemed non-significant." (Page 5)
Change in Contract Manufacturer and Sterilizer: Cirtec Medical is now the sole contract manufacturer for the treatment tips, and STERIS will be the contract sterilizer. (Page 6)
Performance Data (Design Verification Testing): "Design verification testing, including bench performance, electrical safety/electromagnetic compatibility, software verification/validation, packaging and shelf-life studies, provided in the subject premarket notification demonstrate that the Viveve System is substantially equivalent to the predicate device, Viveve System." (Page 7)

In summary, this 510(k) does not detail a study proving the device meets new acceptance criteria. Instead, it asserts equivalence to predicate devices that have already met their respective regulatory requirements.

Given this context, I cannot directly fill in the table or answer all sub-questions as they pertain to a new, primary clinical validation study. However, I can infer and state what is available:

Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence Argument):

Acceptance Criteria (Implied for Substantial Equivalence)	Reported Device Performance (as stated for the Subject Device)
Safety and Effectiveness commensurate with predicate devices for:	Demonstrated as Equivalent via:
1. Indications for Use: Safe and effective for general surgical procedures for electrocoagulation and hemostasis. (Implicit criteria: performs coagulation/hemostasis without undue risk or ineffectiveness.)	"The Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis." (Page 2, 4) - Stated as identical to predicate. The claim is that it functions equivalently for this purpose.
2. Technological Characteristics: Output parameters (e.g., RF energy, cryogen delivery, power, frequency, impedance) and principle of operation (selective heating with surface cooling) are equivalent to predicate devices. (Implicit criteria: these parameters are within acceptable ranges for the intended use and do not introduce new safety/performance concerns).	"The technological characteristics of the subject device Viveve System are identical to those of the predicate devices..." (Page 4). "The principle of operation between the predicate devices and the subject device remain identical as do all output parameters to tissue." (Page 4). A table on Pages 6-7 details identical specifications for: Legal Manufacturer, Indication for Use, FDA Classification, CFR/Product Code, Invasiveness of Treatment, Principles of Operation, Energy (RF), Treatment Type (Monopolar), Main Input, Maximum Power (240 Watts), Operating Frequency (6 MHz ±2%), Voltage Waveform (6.0 MHz continuous sinusoidal), Electrode Probe (Monopolar), Impedance Range (25-120 Ω), Tip (5cm and 8cm), Packaging (Tyvek pouch), Sterility (ETO), Cooling Solution (Cryogen). Only Contract Manufacturer and Contract Sterilizer are different, which are addressed through design control and testing.
3. Design Modifications (Handpiece Software): Extended handpiece life does not adversely affect safety or effectiveness. (Implicit criteria: maintains performance, biocompatibility, and safety over the extended life).	"The handpiece software has been slightly modified to extend the useful life of the handpiece from 11,000 radiofrequency emitting pulses to a minimum of 65,000 radiofrequency pulses. The change in pulse number was validated and assessed for additional risk to the patient and was deemed non-significant." (Page 5) This indicates successful validation against implied safety/performance criteria for the extended lifespan.
4. Manufacturing and Sterilization Changes: New manufacturer and sterilizer maintain device quality, sterility, and performance. (Implicit criteria: compliance with quality systems, successful sterilization validation, continued biocompatibility).	"The proposed treatment tip manufacturer and sterilization facility modifications do not raise new questions of the safety or efficacy of the device..." (Page 8). "Cirtec Medical will now be the sole contract manufacturer... STERIS will be the Contract Sterilizer..." (Page 6). Biocompatibility endpoints were conducted on the sterile treatment tip (Page 7). Design Control procedures for Cirtec Medical are referenced (Page 8).
5. Performance Testing (Bench, Electrical Safety, Software, Packaging, Shelf-life): All relevant design verification tests show the device meets specifications congruent with safe and effective operation and equivalence to the predicate. (Implicit criteria: specific pre-defined acceptable limits for each test).	"Design verification testing, including bench performance, electrical safety/electromagnetic compatibility, software verification/validation, packaging and shelf-life studies, provided in the subject premarket notification demonstrate that the Viveve System is substantially equivalent to the predicate device, Viveve System." (Page 7) This general statement confirms results met acceptance criteria for these specific engineering and performance tests, as required for a 510(k).

Detailed Responses to Specific Questions (based on provided text):

A table of acceptance criteria and the reported device performance:
- See the table above, which outlines the implicit acceptance criteria based on the substantial equivalence argument and the reported performance as stated in the document.
Sample size used for the test set and the data provenance:
- The provided text does not describe a clinical test set in the sense of patient data for a comparative study. This submission relies on substantial equivalence.
- The "test set" described relates to design verification testing (bench performance, electrical safety/EMC, software V&V, packaging, shelf-life). The specific sample sizes for these engineering tests are not detailed in this summary document, as is typical for a 510(k) summary (full reports would be in the complete submission).
- Data Provenance: Not applicable for clinical study data. For engineering tests, it's generally laboratory data from the manufacturer or contracted labs.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as there is no mention of a clinical test set requiring expert ground truth establishment (e.g., for image interpretation). The evaluation is based on engineering equivalence and design verification.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable as there is no clinical test set requiring adjudication of findings (e.g., in an image interpretation study).
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:
- No, an MRMC comparative effectiveness study was not conducted or described. This device is an electrosurgical system, not an AI diagnostic/assistive tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is hardware and software for direct patient treatment, not a standalone diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of clinical ground truth for a diagnostic device. For the engineering tests, the ground truth would be the established performance specifications and validated test methods.
The sample size for the training set:
- Not applicable. This document does not describe the development of a machine learning algorithm with a training set. The software changes concern extending the handpiece lifespan, which was validated through engineering tests, not machine learning training.
How the ground truth for the training set was established:
- Not applicable for the same reasons as point 8.

Summary

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November 18, 2020

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

Re: K200472

Trade/Device Name: Viveve System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: October 22, 2020 Received: October 23, 2020

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.

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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) 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 mediation-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, 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) K200472

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)

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

Applicant:	Viveve® Inc.
	345 Inverness Drive South
	Building B, Suite 250
	Englewood, CO 80112

Contact:	Kevin Robisonkrobison@viveve.comC: 317-435-8898F: 720-696-8199
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Date Prepared: November 18, 2020

1.3 SUBJECT DEVICE INFORMATION

Trade Name:	Viveve® System
Common Name:	Electrosurgical System
Product Code:	GEI
Classification Name:	Electrosurgical Cutting and Coagulation Device and Accessories (21CFR 878.4400)
Device Panel:	General Surgery/Restorative Device
Device Classification:	Class II

1.4 PREDICATE DEVICES

Primary Predicate Device: Viveve® System (K180584) Reference Device: Viveve® 2.0 System (K190422)

1.5 DEVICE DESCRIPTION

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

1.7 COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The technological characteristics of the subject device Viveve System are identical to those of the predicate devices, Viveve System (K180584) and Viveve 2.0 System (K190422). 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.

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

1.8 BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The Viveve System is substantially equivalent to the predicate devices listed in K180584 and K190422. The principle of operation between the predicate devices and the subject device remain identical as do all output parameters to tissue.

1.8.1 DESIGN MODIFICATIONS

1.8.1.1 RF Console (Generator)

No changes have been made to the Console. .

1.8.1.2 Footswitch

No changes have been made to the Footswitch. ●

1.8.1.3 Handpiece

. No changes have been made to the Handpiece.

1.8.1.4 Cryogen

. No changes have been made to the Cryogen.

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1.8.1.5 Treatment Tip

viveve

The packaging of the sterile Treatment Tip has changed to align with ● the packaging of the secondary predicate Viveve 2.0 System (K190422) packaging.

1.8.2 SOFTWARE MODIFICATIONS

1.8.2.1 Viveve RF Console Software

No changes have been made to the RF Console Software. .

1.8.2.2 Viveve RF Display Module Software

No changes have been made to the RF Display Module Software. ●

1.8.2.3 Viveve RF Handpiece Software

The handpiece software has been changed since the previous clearance ● (K180584). The handpiece software has been slightly modified to extend the useful life of the handpiece from 11,000 radiofrequency emitting pulses to a minimum of 65,000 radiofrequency pulses. The change in pulse number was validated and assessed for additional risk to the patient and was deemed non-significant. The change was made to allow the customer to use the handpiece for more treatments improving customer satisfaction and lowering operational costs. Further detail on this change can be found in the Viveve Letter to File dated December 5th, 2019 and is available upon request.

1.8.3 HARDWARE MODIFICATIONS

1.8.3.1 Operating System

No changes have been made to the Operating System. ●

1.8.4 LABELING MODIFICATIONS

1.8.4.1 Technical User Manual

No changes have been made to the TUM for the Viveve System. ●

1.8.4.2 Instructions for Use

. No changes have been made to the IFU for the Viveve System.

1.8.5 TECHNICAL/ENVIRONMENTAL SPECIFICATION MODIFICATIONS

1.8.5.1 Environmental and Packaging Specifications

IEC60601, Electrostatic Discharge (ESD) and Voltage Dip are aligned ● with CMO's Quality Management System (QMS) Requirements

1.8.5.2 RF Frequency

No changes have been made to the RF Frequency output. ●

1.8.5.3 Operation temperature

No changes have been made to the Operation Temperature.

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1.8.5.4 Storage pressure

. No changes have been made to the Storage Pressure.

1.8.6 CONTRACT MANUFACTURER AND CONTRACT STERILIZER MODIFICATIONS

Cirtec Medical will now be the sole contract manufacturer of the Viveve . System sterile Treatment Tip replacing Stellartech Research Corporation (SRC) upon clearance of this submission.
. STERIS will be the Contract Sterilizer for the Viveve System sterile Treatment Tips upon clearance of this submission.

All previously outlined modifications to the Viveve System are discussed in further detailed in Section 12: Substantial Equivalence Discussion of this Premarket Notification. A comparison of the technical characteristics of Viveve System are compared to those of the predicate device, Viveve System, in Table 1-1 below.

Item	Viveve System(Subject Device)	Viveve System(Primary Predicate DeviceK180584)
510(k) Number	Subject device	K180584
Legal Manufacturer	Viveve, Inc.	Viveve, Inc.
Contract Manufacturer	Stellartech Medical Systems (Generator and Handpiece)Cirtec Medical (Treatment Tips)	Stellartech Research Corporation (All 3 system components)
Indication for Use	The Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.	The Viveve 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.	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

Table 1-1: Comparison of Technological Characteristics of Viveve System and Cleared Primary Predicate Viveve System (K180584)

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Item	Viveve System(Subject Device)	Viveve System(Primary Predicate DeviceK180584)
	The Treatment Tip is placedon the surface of the skinand the internal tissues areheated while the surfacetissue is protected. (Reversethermal gradient)	surface of the skin and theinternal tissues are heated whilethe surface tissue is protected.(Reversethermal gradient)
Energy	RF	RF
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)	240 Watts	240 Watts
Operating Frequency	6 MHz ±2%.	6 MHz ±2%.
Voltage Waveform	6.0 MHz continuoussinusoidal waveforms	6.0 MHz continuous sinusoidalwaveforms
Electrode Probe	Monopolar	Monopolar
Impedance Range	25 – 120 Ω	25 - 120 Ω
Tip	5cm and 8cm TreatmentTips	5cm and 8cm Treatment Tips
Packaging	Tyvek pouch	Tyvek pouch
Sterility	ETO	ETO
Contract Sterilizer	STERIS	Sterigenics
Cooling Solution	Cryogen	Cryogen

BIOCOMPATIBILITY 1.9

The biocompatibility endpoints for limited contact duration were conducted on the Viveve System sterile Treatment Tip.

1.10 PERFORMANCE DATA

Design verification testing, including bench performance, electrical safety/electromagnetic compatibility, software verification/validation, packaging and shelf-life studies, provided in the subject premarket notification demonstrate that the Viveve System is substantially equivalent to the predicate device, Viveve System.

1.10.1 Performance Data

Design development and control is conducted in phases as described in the Cirtec Design and Development Plan PLN-200054 and VIDA-L Quality Plan QP-200027. The Core Team is responsible for executing and adhering to this VIDA-L Design and Development Plan, and for compliance to Cirtec's

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Quality Management System, unless otherwise stated in the Plan. The Core Team consists of representatives from Cirtec and Viveve.

The following document describes the Design Control of the Viveve System Treatment Tips by Cirtec Medical.

Document Title	Document Number
Design Control Procedure	Cirtec QSP-C110004

1.11 CONCLUSION

The design, technical characteristics, functionality, indications for use, and principle operation of the subject device Viveve System remains unchanged from that of the predicate device, Viveve System (K180584) and reference devicefor K190422. The proposed treatment tip manufacturer and sterilization facility modifications do not raise new questions of the safety or efficacy of the device and the intended use of the Viveve System remains unchanged from that of the cleared predicates.

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.