(145 days)
Not Found
No
The description focuses on delivering microwave energy controlled by time and power parameters set by the operator. There is no mention of AI, ML, or any learning or adaptive capabilities.
Yes.
The device delivers microwave energy for coagulation (ablation) of soft tissue, which is a treatment for a medical condition.
No
The device delivers microwave energy for coagulation (ablation) of soft tissue, which is a therapeutic function rather than a diagnostic one. While it can monitor tissue temperatures, this is used to guide the therapeutic intervention, not to diagnose a condition.
No
The device description explicitly states the system consists of a mobile generator, generator cart, microwave applicators, OTN catheters, and optional temperature sensors, all of which are hardware components.
Based on the provided information, the MicroThermX®-100 Microwave Ablation System (MTX-100) is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "coagulation (ablation) of soft tissue" by delivering microwave energy. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device description details a system that delivers energy for a therapeutic purpose, not for analyzing samples taken from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to be used in vitro (outside the body) to analyze samples and provide diagnostic information. The MTX-100 is an in vivo (within the body) therapeutic device.
N/A
Intended Use / 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.
Product codes
NEY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft 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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K833158, K950301, K011676, K031556, K032702, K040279, K050223, K053535
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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510(k) Summary K081042 BSD Medical Corporation MicroThermX®-100 Microwave Ablation System
-
- 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) 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
3. Device Identification
| Trade Name | MicroThermX®-100 Microwave Ablation System and Accessories |
|---|---|
| Common Name | Microwave Ablation System |
| Classification Name | 21CFR§878.4400 |
| 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.
1
Page 2 of 2
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.
2
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.
3
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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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.
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
4
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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