(266 days)
No
The description focuses on the physical components and energy delivery mechanism (RF and cryogen) and does not mention any AI/ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
Explanation: The device is indicated for use in general surgical procedures for electrocoagulation and hemostasis, which are therapeutic applications, but the "Intended Use / Indications for Use" section focuses on procedural outcomes rather than diagnosing, treating, or mitigating a disease or condition in the traditional sense of a therapeutic medical device designed for a specific medical condition. It's a surgical tool for tissue manipulation.
No
The Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis, which describes a therapeutic function rather than a diagnostic one.
No
The device description clearly outlines multiple hardware components including an RF Generator, hand piece, footswitch, and disposable treatment tips, in addition to accessories like coupling fluid and a return pad. This indicates it is a hardware-based medical device with associated software for control and operation, not a software-only device.
Based on the provided information, the Viveve System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is "for use in general surgical procedures for electrocoagulation and hemostasis." This describes a therapeutic or surgical intervention performed directly on a patient's tissue, not a test performed on a sample taken from the body.
- Device Description: The description details a system that delivers radiofrequency energy and cryogen to tissue for heating and cooling, resulting in coagulation and hemostasis. This is a physical interaction with the body, not an analysis of a biological sample.
- Mechanism of Action: The mechanism of action is the application of RF energy to tissue, leading to coagulation and/or hemostasis. This is a direct therapeutic effect on the tissue.
- Components: The components (generator, handpiece, footswitch, treatment tips) are designed for delivering energy and cryogen to the body, not for processing or analyzing biological samples.
IVD devices are used to examine specimens derived from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The Viveve System does not perform this function. It is a surgical device used for therapeutic purposes.
N/A
Intended Use / Indications for Use
The Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
1
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
2
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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Image /page/3/Picture/2 description: The image shows the word "VIVEVE" in a sans-serif font. The letters are a light green color. The letters are all lowercase except for the first letter, which is uppercase. There is a registered trademark symbol after the last letter.
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 Robison
krobison@viveve.com
C: 317-435-8898
F: 720-696-8199 |
| ---------- | ---------------------------------------------------------------------------- |
|---|
- 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 (21 |
| CFR 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 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.
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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 small circle with an R in it to the right of the last "e".
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
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 Device
K180584) |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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 Device
K180584) |
|----------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| | 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) | surface of the skin and the
internal tissues are heated while
the surface tissue is protected.
(Reverse
thermal gradient) |
| Energy | RF | RF |
| Treatment Type | Monopolar | Monopolar |
| Main Input
(Input
voltage/Current/Frequency) | 100 - 120 Vac / 10A / 50/60 Hz
220 - 240 Vac / 5A / 50/60 Hz | 100 - 120 Vac / 10A / 50/60 Hz
220 - 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 continuous
sinusoidal waveforms | 6.0 MHz continuous sinusoidal
waveforms |
| Electrode Probe | Monopolar | Monopolar |
| Impedance Range | 25 – 120 Ω | 25 - 120 Ω |
| Tip | 5cm and 8cm Treatment
Tips | 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.