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The Sanarus Visica™ Treatment System is intended 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 .
  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 to eight single-use, disposable cryoprobes. The control unit is software-controlled and operates off standard 110/230 VAC wall power. A 486 IBM-compatible microprocessor serves as the host computer and a screen displays the status of the system. System control is accomplished either directly through keys on the console itself (e.g., 1-probe system) or through a remote control keypad (e.g., 4 and 8-probe system). The cryoprobes operate on the Joule-Thompson principle and the refrigerative capacity is limited only to the distal tip of the probe. The cryoprobes incorporate a thermocouple to measure temperatures at the probe tip. The thermocouple is mounted inside each cryoprobe tip and its signal is used to monitor and control some operations of the system. The control unit can also control one to eight independent temperature probes to monitor temperatures in surrounding tissues. The temperature probes are standard T-type needle thermocouples.

The system utilizes inert argon gas as a cooling agent. The system is available in 1, 4 and 8-Cryoprobe configurations. The performance characteristics and internal design of each model are equivalent. The primary differences are the number of valves to control the cryoprobes (e.g., 1-8), number of thermocouple inputs (e.g., 1-8) and the size of the outer case.

This document, K020605, is a 510(k) premarket notification for the Sanarus Visica™ Treatment System. It does not contain a study providing acceptance criteria and performance data for the device. Instead, it is a submission to the FDA demonstrating substantial equivalence to a predicate device, the Endocare Cryocare® Surgical System.

Therefore, I cannot extract the requested information regarding acceptance criteria and a study that proves the device meets them from this document. The document primarily focuses on:

• Device Description: What the Visica™ Treatment System is and how it works.
• Indications for Use: The medical conditions and procedures for which the device is intended.
• Predicate Device: The existing legally marketed device to which the Visica™ system is compared.
• Substantial Equivalence Claim: The assertion that the Visica™ system is as safe and effective as the predicate device.
• FDA Clearance Letter: The FDA's determination that the device is substantially equivalent.

Without a performance study included in this submission, I cannot complete any of the requested sections about acceptance criteria, sample sizes, ground truth establishment, or human reader performance.

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