The 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

Device Description

The Visica™ Treatment System consists of a control unit that controls one single-use, disposable cryoprobe. The system utilizes inert argon gas as a cooling agent and helium for thawing. The control unit operates off standard 110/230 VAC wall power and is controlled 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. A remote foot-pedal can be used to start and stop the system.

The cryoprobe overates on the Joule-Thompson principle and the refrigerative canacity is limited only to the distal tip of the probe. The cryoprobe incorporates 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 2 independent temperature probes to monitor temperatures in surrounding tissues. The temperature probes are standard T-type needle thermocouples.

AI/ML Overview

The provided text describes the Sanarus Visica™ Treatment System but does not contain information about specific acceptance criteria or a study proving that the device meets those criteria. The document is a 510(k) premarket notification for a cryosurgical unit, and it primarily focuses on establishing substantial equivalence to a predicate device.

Therefore, I cannot fulfill your request for the detailed table and study information as the necessary data is not present in the provided text.

Here's a breakdown of why I cannot answer each point based on the given information:

A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on the intended use and technological characteristics rather than specific performance metrics against pre-defined acceptance criteria.
Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): No test set or clinical study data is provided in the document.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): No ground truth establishment or expert involvement for a test set is mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: No test set or adjudication method is described.
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 MRMC study or AI assistance is mentioned. This device is a cryosurgical system, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a medical device for tissue ablation, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): As no study data is presented, no ground truth type is specified.
The sample size for the training set: No training set is mentioned as there's no machine learning or AI component to this device.
How the ground truth for the training set was established: Not applicable for the same reason as above.

The document's purpose is to demonstrate that the "new" Sanarus Visica™ Treatment System is substantially equivalent to a previously cleared Sanarus Visica™ Treatment System (K020605). This type of submission relies on showing that the new device has "the same technological characteristics and performance specifications as the predicate device" rather than presenting new clinical study data against defined acceptance criteria.

Summary

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KOZI211

JUN 2 6 2002

Section 2 - Summary of Safety and Effectiveness

(1) Contact Information

Vincent Cutarelli Vice President, Regulatory Affairs Telephone: (949) 768-1184 ext. 105 FAX: (925) 460-6084

(2) Company Information

Sanarus Medical, Inc. 5880 W. Las Positas Blvd., Suite 52 Pleasanton, CA 94588 Telephone: (925) 460-6080 FAX: (925) 460-6084

(3) Device Name

Sanarus Visica™ Treatment System

(4) Device Description

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Koz1211

Indications for Use (ട)

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 ●

(6) Name of Predicate or Legally Marketed Device

Sanarus Visica™ Treatment System -

Substantial Equivalence (7)

The Sanarus Visica™ Treatment System is substantially equivalent to the Sanarus Visica™ Treatment System that was determined to be substantially equivalent on March 8, 2002 (reference K020605).

Technological Characteristics (8)

The Visica™ Treatment System has the same technological characteristics and performance specifications as the predicate device.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains an image of an eagle with three heads. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is written around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 6 2002

Mr. Vincent Cutarelli Vice President, Regulatory Affairs Sanarus Medical, Inc. 5880 W. Las Positas Boulevard, Suite 52 Pleasanton, CA 94588

Re: K021211

Trade/Device Name: Sanarus Visica™ Treatment System Regulation Number: 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GEH Dated: May 20, 2002 Received: May 28, 2002

Dear Mr. Cutarelli:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Mr. Vincent Cutarelli

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If vou desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Stypk Rlvods

M. Witten, Ph.D., M.D. Celia Director Division of General. Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications For Use

Kozall 510(k) Number: ______________________________________________________________________________________________________________________________________________________________

Device Name: Visica™ Treatment System

Indications for Use: The 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

Concurrence of CDRH, Office of Device Evaluation (ODE):

Hyatt Hurly

Sign-Off) Division of General, Restorative and Neurological Devices

510(k) Number K021211

Prescription Use: _ X_ (Per 21 CFR 801.109)

Regulation Number and Section

§ 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.