(266 days)
The Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.
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
This document is a 510(k) Premarket Notification for the Viveve System, an electrosurgical device. The submission primarily focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than presenting a de novo clinical study with new acceptance criteria.
Therefore, the specific information requested regarding acceptance criteria, a study proving the device meets these criteria, sample sizes, expert involvement, ground truth establishment, and MRMC studies is not explicitly presented in the provided text in the way one would expect for a novel device undergoing clinical validation against pre-defined performance metrics.
Instead, the submission argues for substantial equivalence based on:
- Identical Indications for Use: "The Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis." (Page 2, 4)
- Identical Technological Characteristics: "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)." (Page 4)
- Identical Principle of Operation: "The principle of operation between the predicate devices and the subject device remain identical as do all output parameters to tissue." (Page 4)
- Minimal Design Modifications: The changes are limited to packaging of the sterile treatment tip, and a software modification to extend the useful life of the handpiece (from 11,000 to 65,000 pulses). This software change was "validated and assessed for additional risk to the patient and was deemed non-significant." (Page 5)
- Change in Contract Manufacturer and Sterilizer: Cirtec Medical is now the sole contract manufacturer for the treatment tips, and STERIS will be the contract sterilizer. (Page 6)
- Performance Data (Design Verification Testing): "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." (Page 7)
In summary, this 510(k) does not detail a study proving the device meets new acceptance criteria. Instead, it asserts equivalence to predicate devices that have already met their respective regulatory requirements.
Given this context, I cannot directly fill in the table or answer all sub-questions as they pertain to a new, primary clinical validation study. However, I can infer and state what is available:
Acceptance Criteria and Device Performance (Inferred from Substantial Equivalence Argument):
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (as stated for the Subject Device) |
|---|---|
| Safety and Effectiveness commensurate with predicate devices for: | Demonstrated as Equivalent via: |
| 1. Indications for Use: Safe and effective for general surgical procedures for electrocoagulation and hemostasis. (Implicit criteria: performs coagulation/hemostasis without undue risk or ineffectiveness.) | "The Viveve System is indicated for use in general surgical procedures for electrocoagulation and hemostasis." (Page 2, 4) - Stated as identical to predicate. The claim is that it functions equivalently for this purpose. |
| 2. Technological Characteristics: Output parameters (e.g., RF energy, cryogen delivery, power, frequency, impedance) and principle of operation (selective heating with surface cooling) are equivalent to predicate devices. (Implicit criteria: these parameters are within acceptable ranges for the intended use and do not introduce new safety/performance concerns). | "The technological characteristics of the subject device Viveve System are identical to those of the predicate devices..." (Page 4). "The principle of operation between the predicate devices and the subject device remain identical as do all output parameters to tissue." (Page 4). A table on Pages 6-7 details identical specifications for: Legal Manufacturer, Indication for Use, FDA Classification, CFR/Product Code, Invasiveness of Treatment, Principles of Operation, Energy (RF), Treatment Type (Monopolar), Main Input, Maximum Power (240 Watts), Operating Frequency (6 MHz ±2%), Voltage Waveform (6.0 MHz continuous sinusoidal), Electrode Probe (Monopolar), Impedance Range (25-120 Ω), Tip (5cm and 8cm), Packaging (Tyvek pouch), Sterility (ETO), Cooling Solution (Cryogen). Only Contract Manufacturer and Contract Sterilizer are different, which are addressed through design control and testing. |
| 3. Design Modifications (Handpiece Software): Extended handpiece life does not adversely affect safety or effectiveness. (Implicit criteria: maintains performance, biocompatibility, and safety over the extended life). | "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." (Page 5) This indicates successful validation against implied safety/performance criteria for the extended lifespan. |
| 4. Manufacturing and Sterilization Changes: New manufacturer and sterilizer maintain device quality, sterility, and performance. (Implicit criteria: compliance with quality systems, successful sterilization validation, continued biocompatibility). | "The proposed treatment tip manufacturer and sterilization facility modifications do not raise new questions of the safety or efficacy of the device..." (Page 8). "Cirtec Medical will now be the sole contract manufacturer... STERIS will be the Contract Sterilizer..." (Page 6). Biocompatibility endpoints were conducted on the sterile treatment tip (Page 7). Design Control procedures for Cirtec Medical are referenced (Page 8). |
| 5. Performance Testing (Bench, Electrical Safety, Software, Packaging, Shelf-life): All relevant design verification tests show the device meets specifications congruent with safe and effective operation and equivalence to the predicate. (Implicit criteria: specific pre-defined acceptable limits for each test). | "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." (Page 7) This general statement confirms results met acceptance criteria for these specific engineering and performance tests, as required for a 510(k). |
Detailed Responses to Specific Questions (based on provided text):
-
A table of acceptance criteria and the reported device performance:
- See the table above, which outlines the implicit acceptance criteria based on the substantial equivalence argument and the reported performance as stated in the document.
-
Sample size used for the test set and the data provenance:
- The provided text does not describe a clinical test set in the sense of patient data for a comparative study. This submission relies on substantial equivalence.
- The "test set" described relates to design verification testing (bench performance, electrical safety/EMC, software V&V, packaging, shelf-life). The specific sample sizes for these engineering tests are not detailed in this summary document, as is typical for a 510(k) summary (full reports would be in the complete submission).
- Data Provenance: Not applicable for clinical study data. For engineering tests, it's generally laboratory data from the manufacturer or contracted labs.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as there is no mention of a clinical test set requiring expert ground truth establishment (e.g., for image interpretation). The evaluation is based on engineering equivalence and design verification.
-
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This question is not applicable as there is no clinical test set requiring adjudication of findings (e.g., in an image interpretation study).
-
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, an MRMC comparative effectiveness study was not conducted or described. This device is an electrosurgical system, not an AI diagnostic/assistive tool for human readers.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is hardware and software for direct patient treatment, not a standalone diagnostic algorithm.
-
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not applicable in the context of clinical ground truth for a diagnostic device. For the engineering tests, the ground truth would be the established performance specifications and validated test methods.
-
The sample size for the training set:
- Not applicable. This document does not describe the development of a machine learning algorithm with a training set. The software changes concern extending the handpiece lifespan, which was validated through engineering tests, not machine learning training.
-
How the ground truth for the training set was established:
- Not applicable for the same reasons as point 8.
§ 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.