(57 days)
The Viveve 2.0 System is indicated for use in general surgical procedures for electrocoagulation and hemostasis.
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® 2.0 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.
Accessories include:
- . Coupling Fluid
- Cryogen ●
- Return Cable ●
- Return Pad ●
- . Power Cord
This document, K213814, is a 510(k) premarket notification for the Viveve 2.0 System. It describes a change in the manufacturing site from Sparton Medical to Spartronics for the Viveve 2.0 System.
Based on the provided text, there is no detailed study information regarding acceptance criteria and device performance as typically expected for demonstrating clinical efficacy or algorithm performance. This submission is primarily about a manufacturing site change and asserts that because no other aspects of the device have changed, the performance remains the same as the predicate device. Therefore, many of the requested details about studies are not present in this document.
However, I can extract the relevant information that is available and explain why other sections are not applicable.
1. A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria and reported device performance in the context of clinical efficacy or algorithm performance. The core assertion of this 510(k) is that the device (Viveve 2.0 System) is substantially equivalent to its predicate device (Viveve 2.0 System, K212678) because only the manufacturing site has changed, and no other aspects of the device, software, or indications for use have been altered.
Therefore, the "acceptance criteria" here implicitly refer to demonstrating that the device produced by the new manufacturer maintains the same specifications and quality as the previous manufacturer, ensuring it performs identically to the predicate device.
Implicit Acceptance Criteria (for the manufacturing change):
| Acceptance Criteria Category | Reported Device Performance (as stated in the document) |
|---|---|
| Manufacturing Site Location | Changed from Sparton Medical (Frederick, CO) to Spartronics (Watertown, SD) |
| Console/Generator | Not changing as part of this submission. |
| Footswitch | Not changing as part of this submission. |
| Handpiece | Not changing as part of this submission. |
| Cryogen | Not changing as part of this submission. |
| Software Modifications (Console, Display, Handpiece) | Not changing as part of this submission. |
| Hardware Modifications (Operating System) | Not changing as part of this submission. |
| Labeling Modifications (Technical User Manual, Instructions for Use) | No changes have been made. |
| Technical/Environmental Specification Modifications | IEC60601, Electrostatic Discharge (ESD), and Voltage Dip are aligned with the Contract Manufacturing Organization's (CMO) Quality Management System (QMS) Requirements. |
| Safety and Efficacy Implications | The proposed contract manufacturer modifications do not raise new questions of the safety or efficacy of the device, and the intended use remains unchanged. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This 510(k) does not describe a test set or data provenance in the context of evaluating the clinical performance or accuracy of the device itself. The "performance data" mentioned refers to "Design verification testing, including bench performance and software verification/validation" to demonstrate substantial equivalence, rather than a clinical study with a patient test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. As this 510(k) is focused on a manufacturing site change and substantial equivalence without clinical efficacy studies, there's no mention of experts establishing ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no described test set or clinical study requiring an adjudication method.
5. 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
Not applicable. The Viveve 2.0 System is an electrosurgical cutting and coagulation device, not an AI-assisted diagnostic or therapeutic system. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant to this device or its submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. The Viveve 2.0 System is a physical medical device (RF generator, handpiece, etc.) used in general surgical procedures. It does not operate as a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. No ground truth in the context of clinical data or algorithm performance is described in this submission. The "performance data" mentioned refers to "Design verification testing" (e.g., bench testing, software validation) to ensure the device manufactured at the new site meets pre-defined engineering and safety specifications, consistent with the predicate device.
8. The sample size for the training set
Not applicable. As there are no clinical studies or AI algorithms being evaluated in this submission, there is no training set to report.
9. How the ground truth for the training set was established
Not applicable. As above, there is no training set mentioned in this submission.
§ 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.