MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX

K100786 · Bsd Medical Corp. · NEY · Aug 13, 2010 · General, Plastic Surgery

Device Facts

• Record ID: K100786
• Device Name: MICROTHERMX MICROWAVE ABLATION SYSTEM, MODELS MTX-180 OR MTX
• Applicant: Bsd Medical Corp.
• Product Code: NEY · General, Plastic Surgery
• Decision Date: Aug 13, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MicroThermX® Microwave Ablation System (MTX) delivers microwave energy for coagulation (ablation) of soft tissue. The system is not intended for use in cardiac procedures. The SynchroWave antennas may be used in open surgical as well as percutaneous ablation procedures. An optional temperature sensor may be used to monitor tissue temperatures.

Device Story

MicroThermX (MTX-180) is a microwave ablation system for soft tissue coagulation. System comprises a mobile generator, microwave antennas, and a closed-circuit saline cooling system. Operator sets time and power parameters via touchscreen; generator delivers 915 MHz microwave energy to up to 3 antennas simultaneously. Optional thermistor-based temperature sensors monitor non-target tissue. Used in intraoperative or percutaneous procedures by physicians. Cooling system prevents antenna overheating. Device provides repeatable ablation zone geometries; synchronous antenna operation enables larger ablation zones. Output allows physician to achieve controlled tissue necrosis; benefits include minimally invasive treatment options for soft tissue lesions.

Clinical Evidence

No clinical data provided. Evidence consists of bench testing and ex-vivo studies in non-perfused animal tissue to demonstrate repeatable ablation zone geometries and system performance. Conformance to safety standards (UL 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-2, IEC 60601-2-6, CISPR 11) and internal requirements for power control, alarm function, cooling circuit integrity, and temperature measurement accuracy was verified.

Technological Characteristics

915 MHz microwave energy delivery; thermistor-based temperature monitoring. System includes mobile generator, peristaltic pump for saline cooling, and microwave antennas. Power output: 180W total, 60W per antenna. Connectivity: touchscreen interface. Standards: UL 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-2-2, IEC 60601-2-6, CISPR 11. Single-use sterile temperature sensors. Reusable antennas with fluid pathway channels.

Indications for Use

Indicated for coagulation (ablation) of soft tissue in open surgical or percutaneous procedures. Contraindicated for cardiac procedures.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• MicroThermX 100 Microwave Ablation System (MTX-100) (K081042)
• Valleylab VivaWave Microwave Ablation System (K053535)
• Vivant Medical VivaTip Microwave Ablation Probe and Accessories (K032702)

Submission Summary (Full Text)

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April 29, 2010 Traditional 510(k) Premarket Notification

K100786

Page 1 of (i)

# SECTION 5: 510(k) SUMMARY

## SPONSOR

BSD Medical Corporation 2188 W 2200 S Salt Lake City UT 84119

AUG 1 3 2010

#### SUBMITTED BY

Dixie Toolson Sells, V.P., Regulatory Affairs BSD Medical Corporation 2188 West 2200 South Salt Lake City UT 84119 801 972 5555 (p) Ext 215 / 801 072 5930 (f) [e-mail]

## CONTACT/ PREPARED BY

Phil Triolo Phil Triolo and Associates LC 148 S. 1200 E. Salt Lake City, UT 84102-1643 .801 699 9846 (p) / 801 328 2399 (f) · [e-mail]

## DATE PREPARED

April 26, 2010

# TRADE OR PROPRIETARY NAME

MicroThermX® Microwave Ablation System (MTX-180 or MTX)

### CLASSIFICATION/ NAME

Class II, (21CFR §878.4400), Electrosurgical cutting and coagulation device and accessories Product Code- NEY

### PREDICATE DEVICES

MicroThermX 100 Microwave Ablation System (MTX-100) (K081042) Valleylab VivaWave Microwave Ablation System (K053535) Vivant Medical VivaTip Microwave Ablation Probe and Accessories (K032702)

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K100786

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April 29, 2010

Traditional 510(k) Premarket Notification

# DEVICE DESCRIPTION

The MicroThermX Microwave Ablation System (MTX-180 or MTX) delivers 915 MHz microwave energy for coagulation (ablation) of soft tissue. The delivery of microwave energy is controlled by time and power parameters set by the operator. The operator can select up to 3 applicators to ablate target tissue.

The MTX-180 consists of a mobile cart with generator and closed-circuit antenna cooling system, microwave antennas, and an optional temperature sensor.

The mobile generator is comprised of a computer, microwave generator, and thermistor-based temperature monitoring system. The operator interface is via the touchscreen monitor of the mobile generator.

The cooling system consists of a bag of sterile isotonic saline (not supplied by BSD); peristaltic pump; cooling circuit tubing and connectors; and fluid pathway channels within the antenna.

The MTX-180 is designed to:

- · Deliver controlled microwave energy to induce coagulation of soft tissue;
- · Provide repeatable ablation zone geometries for a given set of ablation parameters (repeatability demonstrated in ex-vivo studies performed in nonperfused animal tissue);
- · Be used in an intraoperative or minimally invasive percutaneous procedure;
- · Utilize a single SynchroWave antenna or synchronous operation of 2 or 3 antennas during a single procedure to induce larger zones of ablation .; and
- · Utilize an optional sensor to monitor the temperature of non-target tissue during a procedure.

### INTENDED USE

The MicroThermX® Microwave Ablation System (MTX) delivers microwave energy for coagulation (ablation) of soft tissue. The system is not intended for use in cardiac procedures. The SynchroWave antennas may be used in open surgical as well as percutaneous ablation procedures. An optional temperature sensor may be used to monitor tissue temperatures.

# TECHNOLOGICAL COMPARISON

The modified device has the identical intended use and employs the same fundamental technology as the predicate devices.

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K100786

April 29, 2010

Traditional 510(k) Premarket Notifica

The proposed design, material, and labeling changes that triggered the submission of this notification consist of changes in design: maximum total power output increased to 180 Watts; maximum power delivered to each antenna increased to 60W; number of antennas decreased from 4 to 3; cooling circuit added to cool antenna; reusable non-sterile temperature sensors replaced by sterile, pre-calibrated single-use temperature sensors; material changes (shaft material was changed when additional markers on antenna shaft were added to facilitate identification of insertion depth); software modifications to accommodate hardware changes); and labeling modifications to accommodate hardware changes and for clarity.

### PERFORMANCE TESTING

Verification and Validation Studies were conducted to evaluate the equivalence of the new device to the predicate device, or conformance with relevant standards. Testing performed included evaluations to determine conformance with:

- UL 60601-1:2003 R6.03, Medical Electronic Equipment: General . requirements for basic safety and essential performance
- IEC 60601:1988+A1:1991+A2:1995, Medical Electronic Equipment: Particular . requirements for Safety of Microwave Therapy Equipment
- IEC 60601-1-2 (ed 2.1), Medical Electronic Equipment: General requirements . for basic safety and essential performance
- IEC 60601-1-4, Medical Electronic Equipment: Programmable Electrical . Medical Systems
- IEC 60601-2-2 (ed 4), Particular Requirements for the Safety of High . Frequency Surqical Equipment
- . IEC 60601-2-6 (ed.1), Medical Electronic Equipment: Particular requirements for Safety of Microwave Therapy Equipment
- CISPR 11 (2007), Limits and Methods of Measurement of Electromagnetic . Disturbance Characteristics of Industrial, Scientific, and Medical (ISM) Radiofrequency Equipment
- Internal safety and performance requirements for: .
- Software control of delivered power o
- o Alarms and Shut-offs:
- Temperature of applied parts o
- o Cooling circuit function
- Ablation zone sizes o
- Accuracy of temperature measurement by TempSure Temperature o Sensors
- Usability 0

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K100786

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April 29, 2010 Traditional 510(k) Premarket Notification

The results of all testing performed demonstrated conformance with applicable, external standards or internal requirements and/ or equivalence with the predicate device.

# SUMMARY OF SUBSTANTIAL EQUIVALENCE

Based on the results of Verification and Validation Studies, BSD concludes that the modified devices are as safe and effective as, and perform as well as, or better than, the predicate devices.

人

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Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three swooping lines forming its body and wings. The eagle is positioned to the right of a circular text element that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

BSD Medical Corporation % Phil Triolo and Associates LC Phil Triolo, Ph.D. 148 S. 1200 East Salt Lake City, Utah 84102-1643

Re: K100786

Trade/Device Name: MicroThermX® Microwave Ablation System (MTX-180 or MTX) Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: NEY Dated: August 06, 2010 Received: August 09, 2010

Dear Dr. Triolo:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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

AUG 1 3 2010

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### Page 2 - Dr. Phil Triolo

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

http://www.fda.gov/MedicalDevices/ResourceforYou/Industry/default.htm.

Sincerely yours,

Mark A. Milliken

. Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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April 29, 2010 Traditional 510(k) Premarket Notification

## SECTION 4: INDICATIONS FOR USE

510(k) Number (if known): K100786

Device Name:

MicroThermX Microwave Ablation System

### Indications for Use:

The MicroThermX Microwave Ablation System (MTX) delivers microwave energy for coagulation (ablation) of soft tissue. The system is not intended for use in cardiac procedures. The SynchroWave antennas may be used in open surgical as well as percutaneous ablation procedures. An optional temperature sensor may be used to monitor tissue temperatures.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE------------------------------------------------------------------------------------------------------------------------------------------PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

(Posted November 13, 2003)

510(k) Number _

Section 4: Indications for Use Statement

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