(98 days)
The device is indicated for use in general surgery, gynecology and oncology. The system is designed to destroy tissue by the application of extreme cold temperatures. In addition the system is intended for use in the following indications:
General Surgery
- Ablation of breast fibroadenoma .
- Localization of breast lesions .
Gynecology
- Ablation of malignant neoplasia or benign dysplasia of the female genitalia .
Oncology
- . Ablation of cancerous or malignant tissue
- Ablation of benign tumors .
- Palliative intervention .
The V2 Treatment System consists of a control unit that controls one single-use, disposable V2 ICE Probe. The system utilizes a cryogen as a cooling agent and a resistance heater for thawing.
The V2 Console is a self-contained, mobile unit, which features an easy-to-use touch screen interface for complete control and monitoring of the cryoablation procedure. The touch screen allows users to select treatment modes and times and control the system and its cycles. The screen is mounted on the system and will tilt and swivel as needed. The Console operates off standard 120/240 VAC (60/50 Hz) power.
The V2 ICE Probe is a single use, disposable probe designed for use with the V2 Treatment System. The primary components of the V2 ICE Probes consist of a surgical stainless steel probe with an electrical warming component and an integrated T-Type Thermocouple for internal temperature feedback. The V2 Probe temperature is internally and continuously monitored by the V2 Console.
The Sanarus V2 Treatment System is a cryoablation device, and its performance testing focused on meeting specifications and demonstrating substantial equivalence to a predicate device. This type of submission (Traditional 510k) primarily relies on showing that the new device is as safe and effective as a legally marketed predicate device, rather than conducting extensive clinical studies with specific acceptance criteria that demonstrate disease detection or diagnostic accuracy.
Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication), MRMC studies, standalone performance, and training set ground truth are not explicitly described or required for this type of submission.
Here's a breakdown of what is available and what is typically not found in a 510(k) for a device like this:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as diagnostic performance metrics (e.g., sensitivity, specificity). For a cryoablation system, acceptance criteria would typically relate to engineering specifications for temperature control, cooling rates, thawing rates, probe integrity, safety features, and functional performance.
- Reported Device Performance: The submission states "Performance testing confirms that the Sanarus V2 Treatment system meet its applicable specifications and performance standards and is substantially equivalent to the Sanarus Visica Treatment System predicate device." Specific numerical performance data for these engineering and functional specifications are not provided in the summary.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meeting applicable specifications and performance standards. | Confirmed to meet its applicable specifications and performance standards. |
| Substantial equivalence to predicate device (Sanarus Visica System). | Established as substantially equivalent to the predicate device. |
| Functional performance (e.g., temperature control, cooling/thawing) | Not explicitly detailed in the provided summary, but implied to meet requirements. |
| Safety features and device integrity. | Not explicitly detailed in the provided summary, but implied to meet requirements. |
2. Sample size used for the test set and the data provenance: Not applicable. This 510(k) submission primarily relies on engineering and functional testing, not a clinical study with a "test set" in the context of diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not the focus here.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. These studies are typically for diagnostic imaging devices where human readers interpret images.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a cryoablation system, not an AI algorithm.
7. The type of ground truth used: For a device like this, the "ground truth" for performance testing would likely refer to established engineering standards, physical measurements (e.g., of temperature, volume ablated in a controlled medium), and comparisons to the predicate device's known performance. It would not typically involve expert consensus, pathology, or outcomes data in the way a diagnostic device would.
8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.
Summary regarding the Sanarus V2 Treatment System:
The Sanarus V2 Treatment System is a cryoablation device cleared via a Traditional 510(k) pathway. The primary method of demonstrating its safety and effectiveness was through showing substantial equivalence to a predicate device (Sanarus Visica Treatment System). This involved:
- Demonstrating the same indications for use.
- Highlighting similar technological characteristics.
- Confirming identical patient contact components and materials.
- Ensuring equivalent packaging, sterilization methods, and sterility assurance levels.
- Providing performance testing results that confirmed the device "meet its applicable specifications and performance standards."
The specific details you've asked for related to clinical study design, diagnostic accuracy metrics, and AI/ML model validation are not typically part of a 510(k) for a therapeutic device like a cryoablation system when substantial equivalence is established through engineering and functional comparisons to a predicate device.
§ 878.4350 Cryosurgical unit and accessories.
(a)
Identification —(1)Cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories. A cryosurgical unit with a liquid nitrogen cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold.(2)
Cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories. A cryosurgical unit with a nitrous oxide cooled cryoprobe and accessories is a device intended to destroy tissue during surgical procedures, including urological applications, by applying extreme cold.(3)
Cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories. A cryosurgical unit with a carbon dioxide cooled cryoprobe or a carbon dioxide dry ice applicator and accessories is a device intended to destroy tissue during surgical procedures by applying extreme cold. The device is intended to treat disease conditions such as tumors, skin cancers, acne scars, or hemangiomas (benign tumors consisting of newly formed blood vessels) and various benign or malignant gynecological conditions affecting vulvar, vaginal, or cervical tissue. The device is not intended for urological applications.(b)
Classification. Class II.