(32 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 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.
The provided document is a 510(k) summary for the Viveve RF System, Secure (K180584). It states that the device is substantially equivalent to a previously cleared predicate device (Viveve System, K162547). The primary change in the subject device is the addition of an 8 cm Treatment Tip, while the predicate device only had a 5 cm Treatment Tip.
Based on the provided text, the acceptance criteria and the study proving the device meets them are described in the context of demonstrating substantial equivalence to a predicate device.
Here's the breakdown of the information requested:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present a formal table of quantitative acceptance criteria or specific performance metrics in the way one might expect for a new, novel device. Instead, the acceptance criteria are implicitly met by demonstrating that the modifications (the new 8cm tip) do not adversely affect safety, efficacy, or performance compared to the predicate device.
| Category | Acceptance Criteria (Implied) | Reported Device Performance (as per submission) |
|---|---|---|
| Safety & Essential Performance | Conformance to IEC 60601-1:2005 (2006/07-3rd edition) and IEC 60601-2-2:2009. | "Safety and essential performance testing in accordance with IEC 60601-. 1:2005 (2006/07-3rd edition) and IEC 60601-2-2:2009" was performed. "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." |
| Electromagnetic Compatibility (EMC) | Conformance to IEC 60601-1-2:2007. | "Electromagnetic compatibility in accordance with IEC 60601-1-2:2007" was performed. "Electromagnetic compatibility and electrical safety testing was completed in compliance with IEC 60601-1 and IEC 60601-1-2." |
| Design Verification | Performance within design parameters under proper environmental conditions. | "Design verification testing to ensure the proposed modifications perform within design parameters under the proper environmental conditions" was performed. This "confirmed the continued conformance to applicable technical design specifications and performance requirements." |
| Software Validation | Performance within design parameters for proposed modifications. | "Software validation was conducted to ensure the proposed modification perform with the design parameters." |
| Biocompatibility | Meet ISO 10993-1:2009 for patient-contacting components (Treatment Tip and Coupling Fluid). | "Biocompatibility testing was conducted for the Treatment Tip and Coupling Fluid according to ISO 10993-1:2009." "The results met the acceptance criteria." |
| Risk Analysis | Accordance with criteria based on ISO 14972:2007. | "Risk analysis was also completed in accordance with criteria based on ISO 14972:2007." |
| Sterilization | Sterilization method and parameters remain the same as the predicate (ETO). | "Sterilization for the subject device remains the same as the predicate device sterilization method and parameters." |
| Packaging Validation & Shelf Life | Packaging integrity and shelf life maintained. | "Packaging validation testing was also completed against the subject device along with the shelf life testing." |
| Functional Equivalence | The new 8cm tip does not alter the fundamental function, safety, or efficacy of the device for electrocoagulation and hemostasis. | "The modifications made to the Viveve System were found to not affect safety or performance through design verification bench testing... The results met the acceptance criteria." "The subject device is substantially equivalent to the predicate device." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified in terms of clinical test subjects. The testing was primarily non-clinical (bench testing). For the specific non-clinical tests (e.g., electrical safety, EMC, biocompatibility), the sample sizes for components tested are not detailed but are assumed to be sufficient for the standard.
- Data Provenance: The testing was "design verification bench testing" and "biocompatibility testing." This is laboratory-based testing, not clinical data from patients. No country of origin for clinical data is applicable as no clinical data was used for substantial equivalence. The document states, "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."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. This was a non-clinical submission relying on engineering and laboratory testing against established standards and design specifications, not expert interpretation of diagnostic images or clinical scenarios.
4. Adjudication method for the test set:
- Not applicable. This was not a study requiring adjudication of expert interpretations. Results from technical tests (e.g., PASS/FAIL for standard compliance, measurement within specification) are objective.
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. This submission concerns an electrosurgical device, not an AI-powered diagnostic tool. No MRMC studies were conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm. The mention of "Software validation" refers to internal software controlling the device's operational parameters, not a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth for the non-clinical tests was adherence to established international standards (IEC 60601 series, ISO 10993-1, ISO 14972) and the device's design specifications and performance requirements.
8. The sample size for the training set:
- Not applicable. This is not an AI/machine learning device requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable. No training set was used.
§ 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.