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
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

Device Description

The Visica™ Treatment System consists of a control unit that controls one single-use, disposable cryoprobe (Visica™ Treatment Device). 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 operates on the Joule-Thompson principle and the refrigerative capacity 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 two independent temperature probes to monitor temperatures in surrounding tissues. The temperature probes are standard T-type needle thermocouples.

AI/ML Overview

The provided text does not contain information about the acceptance criteria or a study that proves the device meets specific performance metrics. It primarily focuses on regulatory approval (510(k)) and establishing substantial equivalence to predicate devices, rather than detailed performance studies with acceptance criteria, ground truth, or sample sizes for testing or training sets.

Therefore, I cannot provide the requested information from the given text.

Here's why each point cannot be addressed:

A table of acceptance criteria and the reported device performance: No such criteria or performance data are present.
Sample size used for the test set and the data provenance: No test set or study details are provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No information about ground truth establishment or experts.
Adjudication method: Not mentioned.
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 component is discussed.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No standalone algorithm performance is discussed.
The type of ground truth used: Not mentioned.
The sample size for the training set: No training set or algorithm is discussed.
How the ground truth for the training set was established: Not applicable as no training set is mentioned.

The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed clinical trial results with specific performance metrics and acceptance criteria for this specific submission. It states that the "Visica™ Treatment System has comparable technological characteristics and performance specifications to the predicate devices," but doesn't elaborate on what those specifications are or how they were met for this current submission.

Summary

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OCT 1 5 2002

Kóz2314 1/2

Section 2 - Summary of Safety and Effectiveness

Contact Information (1)

Seth Stabinsky, M.D. Vice President, Clinical Affairs Telephone: (925) 460-6081 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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Indications for Use (5)

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 ●

Name of Predicate or Legally Marketed Device (6)

Sanarus Visica™ Treatment System SenoRx Anchor Guide™ Localization Device

(7) Substantial Equivalence

The Sanarus Visica™ Treatment System for the localization of breast lesions is substantially equivalent to the Sanarus Visica™ Treatment System that was determined to be substantially equivalent on June 26, 2002 (reference K021211) and the SenoRx Anchor Guide™ Localization Device that was determined to be substantially equivalent on September 12, 2001 (reference K012023).

Technological Characteristics (8)

The Visica™ Treatment System has comparable technological characteristics and performance specifications to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of three human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 1 5 2002

Sanarus Medical, Inc. Vincent Cutarelli Vice President, Regulatory Affairs 5880 West Las Positas, Suite 52 Pleasanton, California 94588

Re: K022314

Trade/Device Name: Sanarus Visica™ Treatment System Regulation Number: 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Class II Product Code: GEH Dated: July 16, 2002 Received: July 17, 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, listing 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 you 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" (21 CFR 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,

Muriam C. Provozt

for Celia M. Witten, Ph.D., M.D. 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

510(k) Number: _KOZZZ14

Device Name: Sanarus Visica™ Treatment System

Indications for Use: 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 ●
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 .

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

Muriam C. Provost

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

510(k) Number K6 223/4

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.