Search Results

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 Visica Treatment System consists of a control unit that controls one single-use. disposable (Visica Treatment Device or "cryoprobe"). The system utilizes inert argon gas as a cooling agent and helium for thawing. The control unit operates from standard 120/240 VAC wall power and is control by a CPLD (Complex Programmable Logic Device). An LED screen displays the status of the system. System control is accomplished directly through keys on the console itself.

The cryoprobe operates on the Joule-Thompson principle and the refrigerative capacity is limited only the distal tip of the probe. The cryoprobe incorporates a thermocouple to measure temperature near the probe tip. The thermocouple is mounted inside the cryoprobe tip and its signal is used to monitor and control some operations of the system. The control unit can also accommodate two independent temperature probes to monitor temperatures in the surrounding tissues. The temperature probes use standard T-type needle thermocouples.

The Sanarus Visica Treatment System is substantially equivalent to the Sanarus Visica Treatment System that was determined to be substantially equivalent on Oct 15, 2002 (reference K022314). The predicate device's performance data is used to establish the current device's substantial equivalency.

The submission is for modifications to the cryoprobe, resulting in the addition of an additional cryoprobe configuration to Sanarus Visica Treatment System.

Acceptance Criteria and Device Performance:

No specific performance criteria or metrics (e.g., sensitivity, specificity, accuracy) are provided in this document. The submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting new performance data against pre-defined acceptance criteria for a novel device.

Study Details:

• Sample size used for the test set and the data provenance: Not applicable. This submission is for modifications to an existing device and relies on performance testing to demonstrate equivalence rather than clinical study data with a test set.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
• Adjudication method for the test set: Not applicable.
• 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 is not an AI-assisted device.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable.
• The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" here is the established performance and safety of the predicate device.
• The sample size for the training set: Not applicable.
• How the ground truth for the training set was established: Not applicable.

Summary of the Study:

The study referenced in the document is a "Performance Testing Summary" which confirms that modifications to the cryoprobe, resulting in the addition of an additional cryoprobe configuration to the Sanarus Visica Treatment System, meet applicable specifications and performance standards. This testing also demonstrated equivalency to the predicate device (Sanarus Visica Treatment System, K022314).

The basis for acceptance is "Substantial Equivalence" to the predicate device. The document explicitly states:

• "The Sanarus Visica Treatment System has the same indications for use and technological characteristics as the predicate device."
• "The patient contact components and component materials in both the new and predicate device are the same."
• "The packaging materials, packaging configurations, sterilization methods and sterility assurance level are also equivalent."
• "Based on the indications for use; technological characteristics and performance testing results, the Sanarus Visica Treatment System does not raise significant new questions of safety and effectiveness."

Ask a specific question about this device