(32 days)
Not Found
No
The device description focuses on the physical components and energy delivery mechanism (RF and cryogen). There is no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies. The performance studies are based on bench testing and design verification, not algorithmic performance metrics.
Yes
The device is indicated for "electrocoagulation and hemostasis" in "general surgical procedures," which are therapeutic actions.
No.
The device description and intended use clearly state that the Viveve System is used for electrocoagulation and hemostasis in general surgical procedures, which are therapeutic functions, not diagnostic ones.
No
The device description explicitly lists multiple hardware components including an RF Generator, Cooling Module, hand piece, footswitch, and disposable treatment tips. It also mentions accessories like coupling fluid, cryogen, and cables. This clearly indicates it is a hardware-based medical device, not software-only.
Based on the provided information, the Viveve System is not an IVD (In Vitro Diagnostic) 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 applies radiofrequency energy and cryogen directly to tissue. This is consistent with a surgical or therapeutic device, not a device used for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue biopsies, etc.). There is no mention of reagents, assays, or any form of in vitro analysis.
Therefore, the Viveve System is a surgical/therapeutic device, not an In Vitro Diagnostic device.
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 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
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)
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
- 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.
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.
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.
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.
Not Found
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.
0
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);
1
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
2
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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Page 1 of 1
SECTION G
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
3
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
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.
4
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 System
and Accessories
(Subject Device) | Viveve System
(Predicate Device) |
|----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | Subject 510(k) | K162547 |
| Legal Manufacturer | Viveve, Inc. | Viveve, Inc. |
| Contract
Manufacturer | Stellartech Research Corporation | Stellartech Research Corporation |
| Item | Viveve System
and Accessories
(Subject Device) | Viveve System
(Predicate Device) |
| 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 applied to the
surface. | Non-invasive. Device applied to the
surface. |
| Principles of
operations | 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 |
| 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 sinusoidal
waveforms | 6.0 MHz continuous sinusoidal
waveforms |
| 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
5
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
6
- 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.