(21 days)
The Viveve System and Viveve 2.0 System are 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® 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.
This document, a 510(k) Summary for the Viveve System and Viveve 2.0 System (K212678), describes a device that has been found substantially equivalent to a predicate device, focusing on a change related to the electrosurgical return pads. This is not a typical AI/ML medical device submission where acceptance criteria are based on diagnostic performance metrics (e.g., sensitivity, specificity, AUC) and proven through reader studies or standalone algorithm performance.
Instead, this submission is for an electrosurgical cutting and coagulation device. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the technical and safety performance requirements for the new component (return pads) and how their equivalence to the original component was demonstrated.
Here's an analysis based on the provided document, addressing your questions where applicable given the nature of this submission:
Device Description:
The Viveve System and Viveve 2.0 System are electrosurgical devices utilizing monopolar radiofrequency (RF) energy for electrocoagulation and hemostasis, with cryogenic cooling of the surface tissue.
Purpose of this Submission (K212678):
The primary change in this 510(k) submission is the addition of new, compatible electrosurgical return pad options. Previously, the system specified and supplied the 3M model 9160 return pad, which became unavailable. This submission seeks to allow the use of any US FDA-cleared split return pad meeting specific characteristics.
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" here are the specifications for the new return pads, and the "reported device performance" is the manufacturer's claim of equivalence based on testing.
| Acceptance Criteria (for new return pads) | Reported Device Performance (as stated in the document) |
|---|---|
| United States FDA clearance | Tested and approved return pads with these specifications will be distributed. Assumes selected pads possess this clearance. |
| A split pad with no cord attached. | Viveve "performed testing on three similar return pads." The document states "pads with the above specifications perform equivalent to each other when used with both the Viveve System and Viveve 2.0 System." The equivalence in performance regarding these physical characteristics is the key. |
| Conducted area between 40 cm² and 120 cm² | Same as above. Testing confirmed equivalence of pads meeting these specifications. |
| Measured impedance between 20-140 ohms. | Same as above. Testing confirmed equivalence of pads meeting these specifications. |
Important Note: The "study" proving acceptance criteria here is not a clinical trial or reader study in the conventional sense of AI/ML devices. It's a design verification and bench testing effort to demonstrate functional equivalence and safety of the new components with the existing system. The document explicitly states: "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."
Study Details (as inferable from the document)
Given that this is a 510(k) for a change in an accessory (return pad) for an electrosurgical device, many of the questions related to AI/ML device performance studies (like MRMC, ground truth establishment by experts, training set details) are not applicable or are addressed indirectly through the concept of "substantial equivalence" and bench testing.
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A table of acceptance criteria and the reported device performance: Provided above.
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Sample sizes used for the test set and the data provenance:
- Test Set (for the return pads): The document states "Viveve has performed testing on three similar return pads." This indicates a sample size of 3 different return pads (brands/models) were tested to establish equivalence.
- Data Provenance: The testing was "performed by Viveve" (implies in-house or by a contracted lab for design verification). This is not retrospective/prospective data from human subjects or clinical outcomes, but rather engineering/bench testing data. The country of origin of the data is not explicitly stated but is implicitly within the regulatory framework of the US FDA submission process.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the typical AI/ML sense. Ground truth for an electrosurgical device's accessory performance is established through engineering specifications, international standards (e.g., IEC 60601 for electrical safety), and bench testing protocols. The "experts" would be the engineers and technicians performing the design verification and assessing compliance with established performance parameters (e.g., RF energy delivery, temperature profiles, impedance). No external clinical experts are mentioned for establishing "ground truth" related to this specific change.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This relates to clinical expert consensus for challenging cases in diagnostic AI studies. Here, the "adjudication" is based on objective measurements and comparison against established performance specifications for electrosurgical accessories.
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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. This is not an AI-assisted diagnostic device. The study is a technical verification that changes in a physical component (return pads) do not adversely affect the safety and fundamental performance of the electrosurgical system.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is an electrosurgical medical device, not an algorithm. The performance evaluated is the physical and electrical function of the device with the new return pads.
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The type of ground truth used:
- Engineering/Bench Test Data and Compliance with Standards. The ground truth is the demonstration that the "new" return pads, when used with the Viveve System, maintain the same safe and effective performance characteristics as the original specified pad. This is demonstrated through design verification testing, including electrical safety/electromagnetic compatibility, and software verification/validation (for the overall system, which remained unchanged). The key is demonstrating functional equivalence and safety.
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The sample size for the training set:
- Not applicable. This is not a machine learning device that requires a "training set."
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How the ground truth for the training set was established:
- Not applicable.
Conclusion from the Document:
The submission concludes that the design, technical characteristics, functionality, indications for use, and principle of operation of the Viveve system remain unchanged. 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 deemed substantially equivalent to the predicate devices.
§ 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.