(147 days)
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.
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.
This document describes the MicroThermX® Microwave Ablation System (MTX-180 or MTX), a device that delivers 915 MHz microwave energy for the coagulation (ablation) of soft tissue. The 510(k) premarket notification (K100786) was submitted for changes in design from a predicate device (MicroThermX 100 Microwave Ablation System, K081042).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are not explicitly stated as quantitative values with clear pass/fail thresholds in the provided text. Instead, the document refers to conformance with various external standards and internal requirements, and equivalence with a predicate device. The "reported device performance" is a general statement of successful conformance.
| Acceptance Criteria (Internal Requirements/Standards) | Reported Device Performance |
|---|---|
| External Standards Conformance: | |
| UL 60601-1:2003 R6.03: Medical Electronic Equipment: General requirements for basic safety and essential performance | Demonstrated conformance |
| IEC 60601:1988+A1:1991+A2:1995: Medical Electronic Equipment: Particular requirements for Safety of Microwave Therapy Equipment | Demonstrated conformance |
| IEC 60601-1-2 (ed 2.1): Medical Electronic Equipment: General requirements for basic safety and essential performance | Demonstrated conformance |
| IEC 60601-1-4: Medical Electronic Equipment: Programmable Electrical Medical Systems | Demonstrated conformance |
| IEC 60601-2-2 (ed 4): Particular Requirements for the Safety of High Frequency Surgical Equipment | Demonstrated conformance |
| IEC 60601-2-6 (ed.1): Medical Electronic Equipment: Particular requirements for Safety of Microwave Therapy Equipment | Demonstrated conformance |
| CISPR 11 (2007): Limits and Methods of Measurement of Electromagnetic Disturbance Characteristics of Industrial, Scientific, and Medical (ISM) Radiofrequency Equipment | Demonstrated conformance |
| Internal Safety and Performance Requirements: | |
| Software control of delivered power | Demonstrated conformance |
| Alarms and Shut-offs | Demonstrated conformance |
| Temperature of applied parts | Demonstrated conformance |
| Cooling circuit function | Demonstrated conformance |
| Ablation zone sizes | Demonstrated conformance |
| Accuracy of temperature measurement by TempSure Temperature Sensors | Demonstrated conformance |
| Usability | Demonstrated conformance |
| Equivalence to Predicate Device: | |
| Safety and Effectiveness | Demonstrated substantial equivalence |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions "ex-vivo studies performed in nonperfused animal tissue" for demonstrating repeatability of ablation zone geometries, but details on sample size for these or other tests are not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Information regarding the number and qualifications of experts used to establish ground truth for the test set is not provided in the document. The study primarily focuses on engineering and performance verification against standards and predicate device equivalence.
4. Adjudication Method for the Test Set
The document does not describe any adjudication methods related to human interpretation or expert review of test results. The evaluation appears to be based on direct measurement and engineering verification against pre-defined standards and requirements.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed as this device is not an AI/imaging diagnostic tool that assists human readers. It is a medical device for microwave ablation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was done
This question is not applicable in the context of this device. The device is a physical medical system, not an algorithm. Its performance is evaluated through direct physical and electrical testing, and its function involves an operator controlling parameters. The device's "standalone" performance would be its ability to consistently deliver microwave energy and create ablation zones as designed, which was evaluated through "Verification and Validation Studies."
7. The Type of Ground Truth Used
The "ground truth" for the performance testing appears to be primarily defined by:
- Established industry standards: UL, IEC, and CISPR standards for medical electrical equipment, safety, and electromagnetic compatibility.
- Internal engineering specifications: Requirements for software control, alarms, cooling, ablation zone sizes, temperature measurement accuracy, and usability.
- Predicate device performance: Used as a benchmark for equivalence in safety and effectiveness.
- Direct physical measurements: For parameters like ablation zone geometries (e.g., through ex-vivo studies).
There is no mention of "expert consensus," "pathology," or "outcomes data" being used as ground truth in the context of this 510(k) submission, which focuses on device modifications and substantial equivalence.
8. The Sample Size for the Training Set
This question is not applicable. The MicroThermX Microwave Ablation System is a hardware device with software controls, not a machine learning or AI algorithm that requires a "training set" in the conventional sense. The "training" of the system would be its design, calibration, and manufacturing processes, rather than data-driven model training.
9. How the Ground Truth for the Training Set was Established
This question is not applicable, as there is no "training set" for an AI model in this context (see point 8). The device's "ground truth" for its design and manufacturing is established through engineering principles, relevant medical device standards, and the performance characteristics of predicate devices.
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April 29, 2010 Traditional 510(k) Premarket Notification
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) dsells@bsdmc.com
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) · philt@philt.com
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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Page 2 of 4
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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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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Page 4 of (4)
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.
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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 (800) 638-2041 or (301) 796-7100 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
Page 12
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
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.(b)
Classification. Class II.