(98 days)
Not Found
No
The document describes a cryoablation system with a control unit, probe, and touch screen interface. It mentions temperature monitoring and control but does not include any language related to AI, ML, image processing, or data-driven algorithms for decision making or analysis.
Yes
The device is used to destroy tissue and treat conditions like fibroadenoma, neoplasia, and tumors, indicating a therapeutic purpose.
No
The device is designed to destroy tissue by applying extreme cold temperatures (cryoablation), which is a therapeutic intervention, not a diagnostic one. It monitors temperature during treatment, but this is for control of the therapy, not for diagnosing a condition.
No
The device description clearly outlines hardware components including a control unit, a single-use probe, and a console with a touch screen interface, all of which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that the device is a "Treatment System" designed to "destroy tissue by the application of extreme cold temperatures" (cryoablation). It is used directly on the patient's body for therapeutic purposes (ablation of tumors, lesions, etc.).
- Lack of Diagnostic Activity: There is no mention of the device analyzing samples from the body or providing diagnostic information. Its purpose is to physically treat tissue.
The device is a therapeutic medical device used for cryoablation procedures.
N/A
Intended Use / Indications for Use
The device is indicated 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 (comma separated list FDA assigned to the subject device)
GEH
Device Description
The V2 Treatment System consists of a control unit that controls one single-use, disposable V2 ICE Probe. The system utilizes a cryogen as a cooling agent and a resistance heater for thawing.
The V2 Console is a self-contained, mobile unit, which features an easy-to-use touch screen interface for complete control and monitoring of the cryoablation procedure. The touch screen allows users to select treatment modes and times and control the system and its cycles. The screen is mounted on the system and will tilt and swivel as needed. The Console operates off standard 120/240 VAC (60/50 Hz) power.
The V2 ICE Probe is a single use, disposable probe designed for use with the V2 Treatment System. The primary components of the V2 ICE Probes consist of a surgical stainless steel probe with an electrical warming component and an integrated T-Type Thermocouple for internal temperature feedback. The V2 Probe temperature is internally and continuously monitored by the V2 Console.
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)
Performance testing confirms that the Sanarus V2 Treatment system meet its applicable specifications and performance standards and is substantially equivalent to the Sanarus Visica Treatment System predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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
K062896
Sanarus V2 Treatment System
Premarket Submission: Traditional 510k
Section 5: 510(k) Summary
CONTACT INFORMATION
Alan Marquardt Vice President, Regulatory and Clinical Telephone: (925) 460-5730 FAX: (925) 460-0688 E-mail: amarquardt(@sanarus.com
COMPANY INFORMATION
Sanarus Medical, Inc. 4696 Willow Road Pleasanton, CA 94588 Telephone: (925) 460-6080 FAX: (925) 460-0688
DEVICE NAME
Sanarus V2 Treatment System
DEVICE DESCRIPTION
The V2 Treatment System consists of a control unit that controls one single-use, disposable V2 ICE Probe. The system utilizes a cryogen as a cooling agent and a resistance heater for thawing.
The V2 Console is a self-contained, mobile unit, which features an easy-to-use touch screen interface for complete control and monitoring of the cryoablation procedure. The touch screen allows users to select treatment modes and times and control the system and its cycles. The screen is mounted on the system and will tilt and swivel as needed. The Console operates off standard 120/240 VAC (60/50 Hz) power.
The V2 ICE Probe is a single use, disposable probe designed for use with the V2 Treatment System. The primary components of the V2 ICE Probes consist of a surgical stainless steel probe with an electrical warming component and an integrated T-Type Thermocouple for internal temperature feedback. The V2 Probe temperature is internally and continuously monitored by the V2 Console.
JAN - 9 2007
1
INDICATIONS FOR USE
Indications for Use: The device is indicated 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
Sanarus Visica® Treatment System
SUBSTANTIAL EQUIVALENCE
The Sanarus V2 Treatment System is substantially equivalent to the Sanarus Visica Treatment System that was determined to be substantially equivalent on July18, 2006 (reference K061510).
The Sanarus V2 Treatment System has the same indications for use and technological characteristics as the predicate device. The patient contact components and component materials in both the new and predicate device are the same. The packaging materials, packaging configurations, sterilization methods and sterility assurance level are also equivalent.
Based on the indications for use, technological characteristics and performance testing results, the Sanarus V2 Treatment System does not raise significant new questions of safety and effectiveness.
PERFORMANCE TESTING SUMMARY
Performance testing confirms that the Sanarus V2 Treatment system meet its applicable specifications and performance standards and is substantially equivalent to the Sanarus Visica Treatment System predicate device.
2
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services, USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sanarus Medical, Inc. % Mr. Alan Marquardt Vice President of Regulatory and Clinical 4696 Willow Road Pleasanton, California 94588
JAN - 9 2007
Re: K062896
Trade/Device Name: Sanarus V2 Treatment System Regulation Number: 21 CFR 878.4350 Regulation Name: Cryosurgical unit and accessories Regulatory Class: Il Product Code: GEH Dated: December 20, 2006 Received: December 21, 2006
Dear Mr. Marquardt:
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
3
Page 2 - Mr. Alan Marquardt
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.
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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
For
Mark N. Malkerson
Mark J. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Section 4: Indications for Use
Kob2896 510(k) Number: _
Device Name: Sanarus V2 Treatment System
Indications for Use:
The device is indicated 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 .
| Prescription Use | X | AND/OR | Over-The-Counter Use |
|---|---|---|---|
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of General, Restorative and Neurological Devices | |
| 510(k) Number | 4062896 |
Sanarus Medical CONFIDENTIAL
Section 4 Page 1