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 causing 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 the coolant which provides the cooling energy. A hand piece that couples the cooling and heating energy to the tissue through the treatment tip (below). A footswitch that allows the user to turn the RF Energy on or off. 5 cm and 8cm Sterile Disposable Treatment Tips. Accessories include: Coupling Fluid, Cryogen, Return Cable, Return Pad, Power Cord.

AI/ML Overview

The provided document is a 510(k) summary for the Viveve RF System, Secure (K180584). It states that the device is substantially equivalent to a previously cleared predicate device (Viveve System, K162547). The primary change in the subject device is the addition of an 8 cm Treatment Tip, while the predicate device only had a 5 cm Treatment Tip.

Based on the provided text, the acceptance criteria and the study proving the device meets them are described in the context of demonstrating substantial equivalence to a predicate device.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't present a formal table of quantitative acceptance criteria or specific performance metrics in the way one might expect for a new, novel device. Instead, the acceptance criteria are implicitly met by demonstrating that the modifications (the new 8cm tip) do not adversely affect safety, efficacy, or performance compared to the predicate device.

Category	Acceptance Criteria (Implied)	Reported Device Performance (as per submission)
Safety & Essential Performance	Conformance to IEC 60601-1:2005 (2006/07-3rd edition) and IEC 60601-2-2:2009.	"Safety and essential performance testing in accordance with IEC 60601-. 1:2005 (2006/07-3rd edition) and IEC 60601-2-2:2009" was performed. "The modifications made to the Viveve System were found to not affect safety or performance through design verification bench testing, which confirmed the continued conformance to applicable technical design specifications and performance requirements."
Electromagnetic Compatibility (EMC)	Conformance to IEC 60601-1-2:2007.	"Electromagnetic compatibility in accordance with IEC 60601-1-2:2007" was performed. "Electromagnetic compatibility and electrical safety testing was completed in compliance with IEC 60601-1 and IEC 60601-1-2."
Design Verification	Performance within design parameters under proper environmental conditions.	"Design verification testing to ensure the proposed modifications perform within design parameters under the proper environmental conditions" was performed. This "confirmed the continued conformance to applicable technical design specifications and performance requirements."
Software Validation	Performance within design parameters for proposed modifications.	"Software validation was conducted to ensure the proposed modification perform with the design parameters."
Biocompatibility	Meet ISO 10993-1:2009 for patient-contacting components (Treatment Tip and Coupling Fluid).	"Biocompatibility testing was conducted for the Treatment Tip and Coupling Fluid according to ISO 10993-1:2009." "The results met the acceptance criteria."
Risk Analysis	Accordance with criteria based on ISO 14972:2007.	"Risk analysis was also completed in accordance with criteria based on ISO 14972:2007."
Sterilization	Sterilization method and parameters remain the same as the predicate (ETO).	"Sterilization for the subject device remains the same as the predicate device sterilization method and parameters."
Packaging Validation & Shelf Life	Packaging integrity and shelf life maintained.	"Packaging validation testing was also completed against the subject device along with the shelf life testing."
Functional Equivalence	The new 8cm tip does not alter the fundamental function, safety, or efficacy of the device for electrocoagulation and hemostasis.	"The modifications made to the Viveve System were found to not affect safety or performance through design verification bench testing... The results met the acceptance criteria." "The subject device is substantially equivalent to the predicate device."

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

Sample Size: Not specified in terms of clinical test subjects. The testing was primarily non-clinical (bench testing). For the specific non-clinical tests (e.g., electrical safety, EMC, biocompatibility), the sample sizes for components tested are not detailed but are assumed to be sufficient for the standard.
Data Provenance: The testing was "design verification bench testing" and "biocompatibility testing." This is laboratory-based testing, not clinical data from patients. No country of origin for clinical data is applicable as no clinical data was used for substantial equivalence. The document states, "This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence as the only change was to the length of the Treatment Tip shell, all internal components are identical."

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

Not applicable. This was a non-clinical submission relying on engineering and laboratory testing against established standards and design specifications, not expert interpretation of diagnostic images or clinical scenarios.

4. Adjudication method for the test set:

Not applicable. This was not a study requiring adjudication of expert interpretations. Results from technical tests (e.g., PASS/FAIL for standard compliance, measurement within specification) are objective.

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. This submission concerns an electrosurgical device, not an AI-powered diagnostic tool. No MRMC studies were conducted.

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

Not applicable. This is not an AI algorithm. The mention of "Software validation" refers to internal software controlling the device's operational parameters, not a standalone diagnostic algorithm.

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

The ground truth for the non-clinical tests was adherence to established international standards (IEC 60601 series, ISO 10993-1, ISO 14972) and the device's design specifications and performance requirements.

8. The sample size for the training set:

Not applicable. This is not an AI/machine learning device requiring a training set.

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

Not applicable. No training set was used.

Summary

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Image /page/0/Picture/0 description: The image shows 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

April 6, 2018

Viveve Inc. Suzon Lommel Senior Vice President, Regulatory & Quality Affairs 345 Inverness Drive South, Building B, Suite 250 Englewood, Colorado 80112

Re: K180584

Trade/Device Name: Viveve RF System, Secure Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting and Coagulation Device and Accessories Regulatory Class: Class II Product Code: GEI Dated: February 19, 2018 Received: March 5, 2018

Dear Suzon Lommel:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing, 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K180584

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)

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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SECTION G

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

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SECTION 7 510(k) SUMMARY

REGULATORY AUTHORITY 7.1

Safe Medical Devices Act of 1990, 21 CFR 807.92

7.2 APPLICANT INFORMATION

Applicant:	Viveve Inc.
	345 Inverness Drive South
	B-250
	Englewood, CO 80112

Contact:	Suzon Lommel
	Senior VP, Quality Assurance and Regulatory Affairs
	slommel@viveve.com
	Phone: (408) 645-4979
	Fax: (720) 696-8199

Date Prepared: February 19, 2018

SUBJECT DEVICE INFORMATION 7.3

Trade Name:	Viveve 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 Devices
Device Classification:	Class II

7.4 PREDICATE DEVICE

. Viveve System (K162547)

DEVICE DESCRIPTION 7.5

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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 the coolant which provides the cooling energy.
A hand piece that couples the cooling and heating energy to the tissue through the treatment tip (below).
A footswitch that allows the user to turn the RF Energy on or off. ●
5 cm and 8cm Sterile Disposable Treatment Tips. ●

Accessories include:

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

7.6 INDICATION FOR USE

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

7.7 TECHNICAL CHARACTERISTICS

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.

7.8 SUBSTANTIAL EQUIVALANCE

The Viveve System is substantially equivalent to the predicate device listed. The principle of operation between the predicate device and the subject device remain the same, however the subject device is modified with a design change to add an8 cm Treatment Tip. These changes have been tested and verified to have no effect on system functionality, safety, or effectivity. The function of the subject device, the materials and indication for use have not changed, therefore, the subject device is substantially equivalent to the predicate device listed.

Item	Viveve Systemand Accessories(Subject Device)	Viveve System(Predicate Device)
510(k) Number	Subject 510(k)	K162547
Legal Manufacturer	Viveve, Inc.	Viveve, Inc.
ContractManufacturer	Stellartech Research Corporation	Stellartech Research Corporation
Item	Viveve Systemand Accessories(Subject Device)	Viveve System(Predicate Device)
Indication for Use	The Viveve System is indicated for usein general surgical procedures forelectrocoagulation and hemostasis.	The Viveve System is indicated for usein general surgical procedures forelectrocoagulation and hemostasis.
FDA Classification	Class II	Class II
CFR/Product code	21 CFR 878.4400/GEI	21 CFR 878.4400/GEI
Invasiveness oftreatment	Non-invasive. Device applied to thesurface.	Non-invasive. Device applied to thesurface.
Principles ofoperations	Radiofrequency (RF) energy selectivelyheats a given volume of tissue beneaththe surface, while cryogen is delivered tothe inside of the Treatment Tip to coolthe surface tissue. The Treatment Tip isplaced on the surface of the skin and theinternal tissues are heated while thesurface tissue is protected. (Reversethermal gradient)	Radiofrequency (RF) energy selectivelyheats a given volume of tissue beneaththe surface, while cryogen is delivered tothe inside of the Treatment Tip to coolthe surface tissue. The Treatment Tip isplaced on the surface of the skin and theinternal tissues are heated while thesurface tissue is protected. (Reversethermal gradient)
Energy	RF	RF
Treatment Type	Monopolar	Monopolar
Input power	100-240 VAC @ 50/60 Hz	100-240 VAC @ 50/60 Hz
Maximum power(generator)	240 Watts	240 Watts
Operating Frequency	6 MHz	6 MHz
Voltage waveform	6.0 MHz continuous sinusoidalwaveforms	6.0 MHz continuous sinusoidalwaveforms
Electrode probe	Monopolar	Monopolar
Impedance range	25 - 120 Ω	25 - 120 Ω
Tip	5 cm and 8cm Treatment Tips	5 cm Treatment tip
Packaging	Tyvek Pouch	Tyvek Pouch
Sterility	ETO	ETO
Cooling solution	Cryogen	Cryogen

Table 7.8.1: Summary Comparison of Technical Characteristics

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PERFORMANCE DATA 7.9

The modifications made to the Viveve System were found to not affect safety or performance through design verification bench testing, which confirmed the continued conformance to applicable technical design specifications and performance requirements, including requirements associated with industry safety and performance standards, as follows:

Safety and essential performance testing in accordance with IEC 60601-. 1:2005 (2006/07-3rd edition) and IEC 60601-2-2:2009

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Electromagnetic compatibility in accordance with IEC 60601-1-2:2007 ●
Design verification testing to ensure the proposed modifications perform ● within design parameters under the proper environmental conditions.
. Software validation was conducted to ensure the proposed modification perform with the design parameters.

7.9.1 Non-Clinical Performance Data

Design verification and biocompatibility testing was performed to ensure the subject device Viveve System functions according to the intended use. The results met the acceptance criteria. Risk analysis was also completed in accordance with criteria based on ISO 14972:2007. Electromagnetic compatibility and electrical safety testing was completed in compliance with IEC 60601-1 and IEC 60601-1-2. Biocompatibility testing was conducted for the Treatment Tip and Coupling Fluid according to ISO 10993-1:2009. Other components of the Viveve System do not have direct contact with patient tissue, therefore biocompatibility testing was not required. Sterilization for the subject device remains the same as the predicate device sterilization method and parameters. Packaging validation testing was also completed against the subject device along with the shelf life testing.

7.9.2 Clinical Performance Data

This premarket submission did not rely on the assessment of clinical performance data to demonstrate substantial equivalence as the only change was to the length of the Treatment Tip shell, all internal components are identical.

7.10 CONCLUSION

The indications for use and the technical characteristics of the Viveve System has not changed from the predicate device. The results of performance testing demonstrate that the modifications to the Viveve System do not affect the safety, efficacy, or performance of the System, therefore, the subject device 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.