(98 days)
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 .
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.
The Sanarus V2 Treatment System is a cryoablation device, and its performance testing focused on meeting specifications and demonstrating substantial equivalence to a predicate device. This type of submission (Traditional 510k) primarily relies on showing that the new device is as safe and effective as a legally marketed predicate device, rather than conducting extensive clinical studies with specific acceptance criteria that demonstrate disease detection or diagnostic accuracy.
Therefore, the requested information regarding acceptance criteria, study details (sample size, data provenance, expert ground truth, adjudication), MRMC studies, standalone performance, and training set ground truth are not explicitly described or required for this type of submission.
Here's a breakdown of what is available and what is typically not found in a 510(k) for a device like this:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as diagnostic performance metrics (e.g., sensitivity, specificity). For a cryoablation system, acceptance criteria would typically relate to engineering specifications for temperature control, cooling rates, thawing rates, probe integrity, safety features, and functional performance.
- Reported Device Performance: The submission states "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." Specific numerical performance data for these engineering and functional specifications are not provided in the summary.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meeting applicable specifications and performance standards. | Confirmed to meet its applicable specifications and performance standards. |
| Substantial equivalence to predicate device (Sanarus Visica System). | Established as substantially equivalent to the predicate device. |
| Functional performance (e.g., temperature control, cooling/thawing) | Not explicitly detailed in the provided summary, but implied to meet requirements. |
| Safety features and device integrity. | Not explicitly detailed in the provided summary, but implied to meet requirements. |
2. Sample size used for the test set and the data provenance: Not applicable. This 510(k) submission primarily relies on engineering and functional testing, not a clinical study with a "test set" in the context of diagnostic accuracy.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not the focus here.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, an MRMC study was not done. These studies are typically for diagnostic imaging devices where human readers interpret images.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. This is a cryoablation system, not an AI algorithm.
7. The type of ground truth used: For a device like this, the "ground truth" for performance testing would likely refer to established engineering standards, physical measurements (e.g., of temperature, volume ablated in a controlled medium), and comparisons to the predicate device's known performance. It would not typically involve expert consensus, pathology, or outcomes data in the way a diagnostic device would.
8. The sample size for the training set: Not applicable. This is not an AI/ML device requiring a training set.
9. How the ground truth for the training set was established: Not applicable.
Summary regarding the Sanarus V2 Treatment System:
The Sanarus V2 Treatment System is a cryoablation device cleared via a Traditional 510(k) pathway. The primary method of demonstrating its safety and effectiveness was through showing substantial equivalence to a predicate device (Sanarus Visica Treatment System). This involved:
- Demonstrating the same indications for use.
- Highlighting similar technological characteristics.
- Confirming identical patient contact components and materials.
- Ensuring equivalent packaging, sterilization methods, and sterility assurance levels.
- Providing performance testing results that confirmed the device "meet its applicable specifications and performance standards."
The specific details you've asked for related to clinical study design, diagnostic accuracy metrics, and AI/ML model validation are not typically part of a 510(k) for a therapeutic device like a cryoablation system when substantial equivalence is established through engineering and functional comparisons to a predicate device.
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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.
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Public Health Service
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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
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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
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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
§ 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.