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® System and Viveve® 2.0 System consist 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

The return pad is the subject of this submission. Previously, Viveve specified and supplied the user with the 3M model 9160 electrosurgical return pad. Viveve is seeking to add additional return pad options for the user with the following characteristics:

United States FDA clearance
A split pad with no cord attached.
Conducted area is between 40 cm2 and 120 cm2.
Measured impedance between 20-140 ohms.

AI/ML Overview

This document, a 510(k) Summary for the Viveve System and Viveve 2.0 System (K212678), describes a device that has been found substantially equivalent to a predicate device, focusing on a change related to the electrosurgical return pads. This is not a typical AI/ML medical device submission where acceptance criteria are based on diagnostic performance metrics (e.g., sensitivity, specificity, AUC) and proven through reader studies or standalone algorithm performance.

Instead, this submission is for an electrosurgical cutting and coagulation device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the technical and safety performance requirements for the new component (return pads) and how their equivalence to the original component was demonstrated.

Here's an analysis based on the provided document, addressing your questions where applicable given the nature of this submission:

Device Description:
The Viveve System and Viveve 2.0 System are electrosurgical devices utilizing monopolar radiofrequency (RF) energy for electrocoagulation and hemostasis, with cryogenic cooling of the surface tissue.

Purpose of this Submission (K212678):
The primary change in this 510(k) submission is the addition of new, compatible electrosurgical return pad options. Previously, the system specified and supplied the 3M model 9160 return pad, which became unavailable. This submission seeks to allow the use of any US FDA-cleared split return pad meeting specific characteristics.

Acceptance Criteria and Reported Device Performance

The "acceptance criteria" here are the specifications for the new return pads, and the "reported device performance" is the manufacturer's claim of equivalence based on testing.

Acceptance Criteria (for new return pads)	Reported Device Performance (as stated in the document)
United States FDA clearance	Tested and approved return pads with these specifications will be distributed. Assumes selected pads possess this clearance.
A split pad with no cord attached.	Viveve "performed testing on three similar return pads." The document states "pads with the above specifications perform equivalent to each other when used with both the Viveve System and Viveve 2.0 System." The equivalence in performance regarding these physical characteristics is the key.
Conducted area between 40 cm² and 120 cm²	Same as above. Testing confirmed equivalence of pads meeting these specifications.
Measured impedance between 20-140 ohms.	Same as above. Testing confirmed equivalence of pads meeting these specifications.

Important Note: The "study" proving acceptance criteria here is not a clinical trial or reader study in the conventional sense of AI/ML devices. It's a design verification and bench testing effort to demonstrate functional equivalence and safety of the new components with the existing system. The document explicitly states: "Viveve has performed testing on three similar return pads. The testing revealed that the pads with the above specifications perform equivalent to each other when used with both the Viveve System and Viveve 2.0 System."

Study Details (as inferable from the document)

Given that this is a 510(k) for a change in an accessory (return pad) for an electrosurgical device, many of the questions related to AI/ML device performance studies (like MRMC, ground truth establishment by experts, training set details) are not applicable or are addressed indirectly through the concept of "substantial equivalence" and bench testing.

A table of acceptance criteria and the reported device performance: Provided above.
Sample sizes used for the test set and the data provenance:
- Test Set (for the return pads): The document states "Viveve has performed testing on three similar return pads." This indicates a sample size of 3 different return pads (brands/models) were tested to establish equivalence.
- Data Provenance: The testing was "performed by Viveve" (implies in-house or by a contracted lab for design verification). This is not retrospective/prospective data from human subjects or clinical outcomes, but rather engineering/bench testing data. The country of origin of the data is not explicitly stated but is implicitly within the regulatory framework of the US FDA submission process.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the typical AI/ML sense. Ground truth for an electrosurgical device's accessory performance is established through engineering specifications, international standards (e.g., IEC 60601 for electrical safety), and bench testing protocols. The "experts" would be the engineers and technicians performing the design verification and assessing compliance with established performance parameters (e.g., RF energy delivery, temperature profiles, impedance). No external clinical experts are mentioned for establishing "ground truth" related to this specific change.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This relates to clinical expert consensus for challenging cases in diagnostic AI studies. Here, the "adjudication" is based on objective measurements and comparison against established performance specifications for electrosurgical accessories.
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. This is not an AI-assisted diagnostic device. The study is a technical verification that changes in a physical component (return pads) do not adversely affect the safety and fundamental performance of the electrosurgical system.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is an electrosurgical medical device, not an algorithm. The performance evaluated is the physical and electrical function of the device with the new return pads.
The type of ground truth used:
- Engineering/Bench Test Data and Compliance with Standards. The ground truth is the demonstration that the "new" return pads, when used with the Viveve System, maintain the same safe and effective performance characteristics as the original specified pad. This is demonstrated through design verification testing, including electrical safety/electromagnetic compatibility, and software verification/validation (for the overall system, which remained unchanged). The key is demonstrating functional equivalence and safety.
The sample size for the training set:
- Not applicable. This is not a machine learning device that requires a "training set."
How the ground truth for the training set was established:
- Not applicable.

Conclusion from the Document:
The submission concludes that the design, technical characteristics, functionality, indications for use, and principle of operation of the Viveve system remain unchanged. The addition of compatible return pads "do not raise questions of safety or efficacy of the overall system." Therefore, the Viveve System and Viveve 2.0 System are deemed substantially equivalent to the predicate devices.

Summary

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September 14, 2021

Viveve Medical, Inc. Kevin Robison Global Manager, Regulatory Affairs 345 Inverness Drive South, Building B, Suite 250 Englewood, Colorado 80109

Re: K212678

Trade/Device Name: Viveve System, 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: August 23, 2021 Received: August 24, 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 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements,

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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-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 (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatorythe DICE website assistance/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) K212678

Device Name Viveve System and Viveve 2.0 System

Indications for Use (Describe)

The Viveve System and Viveve 2.0 System are 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. REGULATORY AUTHORITY

Safe Medical Devices Act of 1990, 21 CFR 807.92

2. APPLICANT INFORMATION

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

Contact: Kevin Robison Global Manager, Regulatory Affairs krobison@viveve.com C: 317-435-8898 F: 720-696-8199
Date Prepared: August 23, 2021

3. SUBJECT DEVICE INFORMATION

Trade Name: Viveve® System and 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

4. PREDICATE DEVICE

Viveve System (K200472) and Viveve 2.0 System (K193611)

5. DEVICE DESCRIPTION

The Viveve® System and Viveve® 2.0 System consist of four (4) primary components:

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Image /page/4/Picture/0 description: The image shows the word "viveve" in a sans-serif font. The color of the text is a light green. The word is all lowercase, and there is a registered trademark symbol after the last "e".

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

United States FDA clearance
A split pad with no cord attached.
Conducted area is between 40 cm2 and 120 cm2. ●
Measured impedance between 20-140 ohms. ●

Viveve has performed testing on three similar return pads. The testing revealed that the pads with the above specifications perform equivalent to each other when used with both the Viveve System and Viveve 2.0 System.

The reason for this change is because the 3M model 9160 electrosurgical return pad is currently unavailable worldwide. Also of note is that Viveve supplies the return pad for its users. Only tested and approved return pads with the above specifications will be distributed for treatment.

6. INDICATIONS FOR USE

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

7. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The technological characteristics of the subject devices Viveve System and Viveve 2.0 System are identical to the predicate devices, Viveve System (K200472) and Viveve 2.0 System (K193611). The Viveve System and Viveve 2.0 System are electrosurgical devices that deliver radiofrequency (RF) energy to selectively heat a given area of tissue. In contrast, 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.

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

The Viveve System and Viveve 2.0 System are identical to the systems cleared in K 193611 and K200472, respectively. The systems may now use different Viveve supplied models of return pads, provided the pads meet the following specifications:

United States FDA clearance
A split pad with no cord attached. ●
Conducted area is between 40 cm2 and 120 cm2.
Measured impedance between 20-140 ohms. ●

8. BASIS FOR DETERMINATION OF SUBSTANTIAL EQUIVALENCE

The Viveve System and Viveve 2.0 System are substantially equivalent to the predicate device listed in K200472 and K193611. The principle of operation between the predicate device and the subject device remains the same as do all output parameters to tissue.

8.1 DESIGN SPECIFICATIONS

8.1.1 RF Console (Generator)

Overall footprint of the RF Console and corresponding case (weight, shape and size) is identical to the predicate device.

8.1.2 Footswitch

The footswitch is identical to the predicate device. ●

8.1.3 Handpiece

The handpiece is identical to the predicate device. ●

8.1.4 Cryogen

R134a (1,1,2 tetrafluoroethane) or 1234ze (trans 1,3,3,3-Tetrafluoroprop-● 1-ene) is the Cryogen used with the Viveve 2.0 System.

8.1.5 Treatment Tip

The Contract Manufacturing Organization of the Viveve 2.0 System ● Treatment Tips is Cirtec Medical.
The Contract Sterilizer remains STERIS Isomedix Services.
. Treatment Tip packaging remains identical to the cleared device.

8.1.6 Return Pad

The return pad is a xxcm2 grounding pad that is utilized for the safe retum ● of electrosurgical energy from the patient's body back to the electrosurgical unit. A return pad is required for the same and effective use of the Viveve System and Viveve 2.0 Systems.
Viveve is seeking the addition of any return pad with the specifications ● listed in Section 5.5 instead of specifying the 3M model 9160 return pad.

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K212678

8.2 SOFTWARE SPECIFICATIONS

8.2.1 Viveve RF Console Software

The software in the console is identical to the predicate devices. ●

8.2.2 Viveve RF Display Module Software

The software in the display module is identical to the predicate devices. ●

8.2.3 Viveve RF Handpiece Software

The software in the handpiece is identical to the predicate devices. ●

8.3 HARDWARE

8.3.1 Operating System

The operating system is identical to the predicate devices. ●

8.4 LABELING MODIFICATIONS

8.4.1 Technical User's Manual

The Technical User's Manual (TUM) for both systems will be updated to . include the specifications listed in Section 5.5 instead of specifying the user to use the 3M model 9160 return pad. REDLINE and FINAL versions of the TUM are included as part of this submission.

8.4.2 Instructions for Use

The Instructions for Use are identical to the predicate devices. ●

8.5 TECHNICAL/ENVIRONMENTAL SPECIFICATIONS

8.5.1 Environmental and Packaging Specifications

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

8.5.2 RF Frequency

Remains identical to the predicate devices. ●

8.5.3 Operation temperature

The operational temperature remains identical to the predicate devices. ●

8.5.4 Storage pressure

Range is aligned with that outlined in packaging and environmental testing. ●

8.6 CONTRACT MANUFACTURER ORGANIZATIONS (CMO)

Spartronics is the contract manufacturer of the display and handpiece for the ● Viveve 2.0 System.
. The Viveve System display and handpiece were manufactured by Stellartech Research Corporation. (The Viveve System is no longer in active production, though many systems are still being utilized for treatments.)

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Cirtec Medical remains the manufacturer of the 5cm and 8cm Treatment . Tips.
. STERIS Isomedix Services remains the contract sterilizer of the Treatment Tips.

Specifications of the Viveve System and Viveve 2.0 Systems are discussed in further detailed in Section 7: Comparison of Technological Characteristics with the Predicate Device of this Premarket Notification.

9. PERFORMANCE DATA

Design verification testing, including electrical safety/electromagnetic compatibility, software verification/validation have been performed on both the Viveve System and Viveve 2.0 System.

10. 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 devices, Viveve System (K200472) and Viveve 2.0 System (K193611).

The addition of compatible return pads do not raise questions of safety or efficacy of the overall system; therefore, the Viveve System and Viveve 2.0 System are substantially equivalent to the predicate devices.

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.