(90 days)
No
The description focuses on the mechanical and electronic control of the cryoablation process using a CPLD and thermocouples, with no mention of AI or ML algorithms for decision-making, image analysis, or predictive capabilities.
Yes
The device is described as a "Treatment System" intended to destroy tissue and ablate malignant or benign tissues, clearly indicating a therapeutic purpose.
No
The device is described as a "Treatment System" intended to "destroy tissue by the application of extreme cold temperatures" and for "Ablation" of various types of tissue, indicating its purpose is therapeutic, not diagnostic. While it has temperature monitoring capabilities, these are for controlling the treatment, not for diagnosing a condition.
No
The device description clearly outlines hardware components including a control unit, cryoprobe, foot-pedal, and temperature probes, indicating it is not a software-only device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, monitoring, or treatment of a disease or condition.
- Sanarus Visica™ Treatment System Function: The description clearly states that the Sanarus Visica™ Treatment System is designed to destroy tissue by applying extreme cold temperatures. It is a therapeutic device used for ablation and localization.
- Lack of Specimen Analysis: The device does not collect, prepare, or analyze any specimens from the human body. It directly interacts with and treats tissue within the body.
Therefore, based on its intended use and function, the Sanarus Visica™ Treatment System is a therapeutic device, not an In Vitro Diagnostic device.
N/A
Intended Use / 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
Product codes
GEH
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast, female genitalia, general tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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.
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Indications for Use (5)
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 ●
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.
3
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
4
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)