MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES

K081042 · Bsd Medical Systems Corp. · NEY · Sep 3, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081042
• Device Name: MICROTHERMX-100 MICROWAVE ABLATION SYSTEM AND ACCESSORIES
• Applicant: Bsd Medical Systems Corp.
• Product Code: NEY · General, Plastic Surgery
• Decision Date: Sep 3, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MicroThermX®-100 Microwave Ablation System (MTX-100) delivers microwave energy for coagulation (ablation) of soft tissue. The system is not intended for use in cardiac procedures. The MTX-100 microwave applicators, which are inserted using the provided OTN catheters, may be use in open surgical as well as percutaneous ablation procedures. Optional temperature sensors may be used to monitor tissue temperatures.

Device Story

MicroThermX-100 (MTX-100) delivers microwave energy for soft tissue coagulation. System comprises mobile generator, generator cart, microwave applicators, Over-The-Needle (OTN) catheters, and optional temperature sensors/positioning tubes. Operator sets time and power parameters via touchscreen interface. Used in open surgical or percutaneous settings by clinicians. Generator includes computer, microwave source, and temperature monitoring system. Provides thermal ablation to target tissue; temperature sensors allow real-time monitoring during procedure. Benefits include controlled tissue coagulation.

Clinical Evidence

No clinical data were necessary to support safety and efficacy. Evidence consists of bench testing, including biocompatibility assessments, electrical safety/EMC testing per IEC/UL standards, accessory performance verification, and usability testing.

Technological Characteristics

Mobile microwave generator with touchscreen interface. Includes microwave applicators, OTN catheters, and optional temperature sensors. Materials comply with ISO 10993-1. Electrical safety standards: UL 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-6, CISPR 11. Energy source: microwave. System is mobile/cart-based.

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

• K833158
• K950301
• K011676
• K031556
• K032702
• K040279
• K050223
• K053535

Submission Summary (Full Text)

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#### 510(k) Summary K081042 BSD Medical Corporation MicroThermX®-100 Microwave Ablation System

- 1. Preparation Date: August 26, 2008
#### 2. Submitted By:

SEP - 3 2008

Dixie Toolson Sells, V.P., Requiatory 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]

#### 3. Device Identification

| Trade Name | MicroThermX®-100 Microwave Ablation System and Accessories |
|---------------------|---------------------------------------------------------------|
| Common Name | Microwave Ablation System |
| Classification Name | 21CFR§878.4400<br>System, Ablation, Microwave and Accessories |

#### 4. Predicate Device(s)

K833158, K950301, K011676, K031556, K032702, K040279, K050223, K053535

#### 5. Device Description

The MicroThermX®-100 Microwave Ablation System (MTX-100) delivers 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 system consists of a mobile generator, generator cart, microwave applicators, Over-The-Needle (OTN) catheters for applicator can minorwing and optional temperature sensors and temperature sensor positioning tubes. The mobile generator is comprised of a computer, microwave generator, theoring the based temperature monitoring system, and thermal calibration well. The operator interface is via a touchscreen monitor.

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#### K081042 BSD Medical Corporation MicroThermX®-100 Microwave Ablation System

510 kt Summary

#### 6. Intended Use

The MicroThermX®-100 Microwave Ablation System (MTX-100) delivers microwave energy for coagulation (ablation) of soft tissue. The system is not intended for use in cardiac procedures.

The MTX-100 microwave applicators, which are inserted using the provided OTN catheters, may be use in open surgical as well as percutaneous ablation procedures. Optional temperature sensors may be used to monitor tissue temperatures.

## 7. Summary of Technological Characteristics in relation to Predicate Device(s)

The BSD MTX-100 System combines the characteristics of the predicate devices into one convenient system. The intended use, technology employed, principles of operation, basic design, and materials of construction are substantially equivalent to one, or more, of the predicate devices.

### 8. Assessment of Performance Data used to Justify Substantial Equivalence Claim

Verification and Validation testing that was successfully completed included:

- A biocompatibility safety assessment in accordance with FDA Memo G95-1 e and ISO 10993-1:
- Evaluation of the safety and performance of the MTX-100 System, in . accordance with all, or part, of the following standards:
- ে UL 60601-1, ed. 1
- IEC 60601-1-2, ed. 2.1 o
- IEC 60601-2-2. ed. 4 o
- IEC 60601-2-6, ed. 1 ্
- CISPR 11: o
- Verification of accessory performance in accordance with in-house protocols ● and relevant standards; and
- Usability testing. .

No clinical data were necessary in order to support the safety and efficacy of the device.

#### 9. Conclusion

Based on the acceptable safety and performance of the subject MTX-100 System and the similarities between the subject System and the predicate devices, BSD Medical asserts that the MTX-100 System and Accesspries are substantially equivalent to the predicate devices and are safe and effective for their intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES · USA

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

## SEP - 3 2008

BSD Medical Corporation % Phil Triolo and Associates Phil Triolo, PhD 148 S. 1200 E. Salt Lake City, Utah 84102-1643

Re: K081042

Trade/Devicc Name: MicroThermX®-100 Microwave Ablation System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: NEY Dated: August 13, 2008 Received: August 13, 2008

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 state i 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.

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Page 2 - Phil Triolo, PhD

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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/cdrh/industry/support/index.html.

Sincerely vours.

Mark M. Wilkinson

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Kw81.042

# Indications for Use

510(k) Number (if known): 081042

Device Name: BSD Medical MicroThermX®-100 Microwave Ablation System

Indications For Use:

The MicroThermX®-100 Microwave Ablation System (MTX-100) delivers microwave energy for coagulation (ablation) of soft tissue. The system is not intended for use in cardiac procedures.

The MTX-100 microwave applicators, which are inserted using the provided OTN catheters, may be used in open surgical as well as percutaneous ablation procedures. Optional temperature sensors may be used to monitor tissue temperatures.

Prescription Use X AND/OR 801 Subpart D) (21 CFR 801 Subpart C)

Over-The-Counter Use ____________ (Part 21 CFR

(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 *k081092*

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