(11 days)
No
The description details a software-controlled system using a microprocessor and thermocouples for temperature monitoring and control, but there is no mention of AI or ML algorithms for decision-making, image analysis, or other functions. The control appears to be based on direct sensor feedback and pre-programmed logic.
Yes
The device is intended to destroy tissue by extreme cold temperatures for medical conditions such as ablation of breast fibroadenoma, malignant neoplasia, benign dysplasia, cancerous tissue, and benign tumors, which are therapeutic applications.
No
This device is a treatment system that destroys tissue through extreme cold temperatures, not a diagnostic device. While it monitors temperature, this is for controlling the treatment, not for diagnosing a condition.
No
The device description clearly outlines hardware components such as a control unit, cryoprobes, temperature probes, and a microprocessor, in addition to the software.
Based on the provided information, the Sanarus Visica™ Treatment System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to destroy tissue by applying extreme cold temperatures for therapeutic purposes (ablation of fibroadenomas, malignant/benign tissue, palliative intervention). This is a direct treatment of the patient's body.
- Device Description: The device is a surgical system consisting of a control unit and cryoprobes that physically interact with tissue to ablate it. It uses argon gas and thermocouples to control the temperature applied to the tissue.
- Lack of IVD Characteristics: IVD devices are used to examine specimens (like blood, urine, tissue samples) outside the body to provide information for diagnosis, monitoring, or screening. The Visica™ system does not perform any such analysis of specimens.
The device is clearly a therapeutic device used for surgical intervention, not for in vitro diagnostic testing.
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.
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Breast, female genitalia, cancerous or malignant tissue, benign tumors
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 for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
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.
0
8 2002 MAR
Section 2 - Summary of Safety and Effectiveness
Contact Information (1)
Vincent Cutarelli Vice President, Regulatory Affairs Telephone: (949) 768-1184 ext. 105 FAX: (925) 460-6084
Company Information (2)
Sanarus Medical, Inc. 5880 W. Las Positas Blvd., Suite 52 Pleasanton, CA 94588 Telephone: (925) 460-6080 FAX: (925) 460-6084
Device Name (3)
Sanarus Visica™ Treatment System
(4) Device Description
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.
1
KO20605
(ട) 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 .
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)
Endocare Cryocare® Surgical System
Substantial Equivalence (7)
The Sanarus Visica™ Treatment System is substantially equivalent to the Endocare Cryocare® Surgical System that was determined to be substantially equivalent on October 11, 2001 (reference K003811).
(8) Technological Characteristics
The Visica™ Treatment System has the same technological characteristics and performance specifications as the predicate device.
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of a human figure embracing another, with the figures forming a bird-like shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 8 2002
Mr. Vincent Cutarelli Vice President, Regulatory Affairs Sanarus Medical, Inc. 5880 West Las Positas, Suite 52 Pleasanton, California 94588
Re: K020605
Trade Name: Visica™ Treatment System Regulation Number: 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: II Product Code: GEH Dated: February 22, 2002 Received: February 25, 2002
Dear Mr. Cutarelli:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave rottened your have determined the device is substantially equivalent (for the ications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have May 26, 1970, the chargence 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, Condons provisions or the ice, 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 If your device to such additional controls. Existing major regulations affecting your device can may or subject to basil additions, 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 1 loase be actived a determination that your device complies with other requirements of the Act that I Dr Has intact and regulations administered by other Federal agencies. You must or any I vict 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 CI K Fat 6077, idoomig (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" (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,
Miriam C. Provost
Cor 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
U20605
Indications For Use
510(k) Number: _______________________________________________________________________________________________________________________________________________________________
Device Name: Visica™ Treatment System
Indications for Use: The Visica™ Treatment System is intended for use in general moncations for OSC. The Piersa - The system is designed to destroy tissue by the surgery, gyllecology and oncology. "The bytellers and one of 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):
iriam C. Provost
General, Restorative and Neurological Devic
510(k) Number K620605
Prescription Use: __X (Per 21 CFR 801.109)