(21 days)
No
The summary describes a radiofrequency energy delivery system for electrocoagulation and hemostasis, with no mention of AI or ML in the device description, intended use, or performance studies. The submission focuses on adding alternative return pads.
No
The device is indicated for use in general surgical procedures for electrocoagulation and hemostasis, which are surgical functions, not therapeutic.
No
Explanation: The "Intended Use / Indications for Use" section states that the device is "indicated for use in general surgical procedures for electrocoagulation and hemostasis," which describes a therapeutic function, not a diagnostic one. The "Device Description" also details how it applies energy to tissue for coagulation and hemostasis, which are treatment actions.
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, cryogen, return cable, return pad, and power cord. This is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "general surgical procedures for electrocoagulation and hemostasis." This describes a therapeutic or surgical intervention performed directly on a patient's tissue.
- Device Description: The description details a system that delivers radiofrequency energy and cryogen to tissue for heating and cooling, with the mechanism of action being "application of RF energy to the tissue causing coagulation and/or hemostasis." This is a physical interaction with the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body) to diagnose a condition, monitor treatment, or screen for diseases.
IVD devices are specifically designed to examine specimens obtained from the human body to provide information for diagnostic purposes. This device operates directly on the patient's tissue for surgical procedures.
N/A
Intended Use / Indications for Use
The Viveve System and Viveve 2.0 System are indicated for use in general surgical procedures for electrocoagulation and hemostasis.
Product codes
GEI
Device Description
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. ●
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
Prescription Use (Part 21 CFR 801 Subpart D)
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 electrical safety/electromagnetic compatibility, software verification/validation have been performed on both the Viveve System and Viveve 2.0 System.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Viveve System (K200472), Viveve 2.0 System (K193611)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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
2
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 South
Building B, Suite 250
Englewood, 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 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:
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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
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. ●
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.
5
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.