(145 days)
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.
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.
The provided text describes the 510(k) summary for the BSD Medical Corporation MicroThermX®-100 Microwave Ablation System. It focuses on demonstrating substantial equivalence to predicate devices for regulatory approval, rather than a clinical study establishing specific acceptance criteria and detailed device performance metrics in a clinical setting.
Therefore, many of the requested elements (acceptance criteria table, sample size for test set, data provenance, ground truth establishment, MRMC study, effect size, standalone performance, training set details) are not present in the provided document. The document primarily outlines regulatory compliance and non-clinical testing.
Here's what can be extracted and inferred from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific, quantified acceptance criteria for performance (e.g., ablation zone size, success rate, complication rate) are provided in the document from a clinical efficacy perspective. The "acceptance criteria" discussed are largely related to regulatory standards, safety, and manufacturing.
| Acceptance Criteria (Implied/Regulatory) | Reported Device Performance (as per document) |
|---|---|
| Biocompatibility safety | Successfully completed in accordance with FDA Memo G95-1e and ISO 10993-1. |
| Electrical safety | Successfully completed in accordance with UL 60601-1, IEC 60601-1-2, IEC 60601-2-2, IEC 60601-2-6, CISPR 11. |
| Accessory performance | Verification completed in accordance with in-house protocols and relevant standards. |
| Usability | Usability testing successfully completed. |
| Substantial Equivalence | Demonstrated to one or more predicate devices based on intended use, technology, principles of operation, basic design, and materials. ([K833158](https://510k.innolitics.com/device/K833158), [K950301](https://510k.innolitics.com/device/K950301), [K011676](https://510k.innolitics.com/device/K011676), [K031556](https://510k.innolitics.com/device/K031556), [K032702](https://510k.innolitics.com/device/K032702), [K040279](https://510k.innolitics.com/device/K040279), [K050223](https://510k.innolitics.com/device/K050223), [K053535](https://510k.innolitics.com/device/K053535)) |
2. Sample size used for the test set and the data provenance:
- Sample Size for Test Set: Not applicable/Not provided. The document states "No clinical data were necessary in order to support the safety and efficacy of the device." The "testing" mentioned refers to non-clinical verification and validation.
- Data Provenance: Not applicable/Not provided (as clinical data was not used).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable/Not provided, as no clinical test set with expert-established ground truth was detailed. The "ground truth" for the non-clinical tests would be defined by the specifications of the standards (e.g., electrical safety limits, biocompatibility requirements).
4. Adjudication method for the test set:
Not applicable/Not provided, as no clinical test set requiring adjudication was described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a microwave ablation system, not an AI-assisted diagnostic or interpretation tool. The document does not mention any AI component or MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a treatment system, not an algorithm. Its operation requires a human operator to set parameters and insert applicators.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical tests conducted (biocompatibility, electrical safety, accessory performance, usability), the "ground truth" was based on established industry standards, regulatory guidelines (FDA Memo G95-1e, ISO 10993-1), and internal protocols. These define the acceptable ranges and performance criteria for the specific types of tests.
8. The sample size for the training set:
Not applicable. This document describes a medical device, not a machine learning model. There is no concept of a "training set" in this context.
9. How the ground truth for the training set was established:
Not applicable, as there is no training set mentioned.
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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§878.4400System, 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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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.
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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 (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
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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
Page 1 of 1
§ 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.