(58 days)
The TomoTherapy Treatment System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan.
The TomoTherapy Treatment System is a radiation therapy system that integrates planning, dose calculation, megavoltage CT imaging for IGRT functionality, and helical (rotational) and fixed beam (non-rotational) radiation therapy treatment capabilities into a single comprehensive system. The TomoTherapy Treatment System is a prescription device. It delivers radiation in accordance with a physician approved plan. The device does not diagnose disease, recommend treatment regimens, or quantify treatment effectiveness. The megavoltage CT imaging functionality is not intended for diagnostic use.
The provided text describes the Accuray TomoTherapy Treatment System (K121934), a radiation therapy system. It is a 510(k) submission, indicating that the device is seeking clearance based on its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information provided (or lacking thereof, as is common in 510(k)s for certain types of devices):
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety Standards Compliance | The TomoTherapy Treatment System was tested and shown to be in compliance with the requirements of applicable recognized consensus safety standards for medical devices. |
| Design Specifications | Results of verification and validation testing confirm the TomoTherapy Treatment System conforms to design specifications. |
| User Needs | Results of verification and validation testing confirm the TomoTherapy Treatment System meets the needs of the intended users. |
| Substantial Equivalence | The TomoTherapy Treatment System is substantially equivalent to the predicate device (TomoTherapy Treatment System (K112776)). Its performance data demonstrate it is as safe, as effective, and performs as well as the predicate device. Minor technological differences (enhancements to software for asymmetric positions and dynamic motion of the primary beam limiting device) do not raise new types of safety or effectiveness questions. |
2. Sample Size Used for the Test Set and Data Provenance
The submission states, "No clinical tests were required to establish substantial equivalence." This implies that the performance data primarily relied on non-clinical testing (bench testing, verification, and validation) rather than testing on patient data sets. Therefore, there is no specific sample size for a test set (e.g., patient images or clinical cases) detailed in this submission. The data provenance would be related to the internal testing environment rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
Given that "No clinical tests were required," there is no mention of experts establishing ground truth for a clinical test set. The substantial equivalence is based on engineering and performance validation against internal specifications and consensus standards, rather than expert-adjudicated clinical outcomes or interpretations.
4. Adjudication Method for the Test Set
As there was no clinical test set requiring expert interpretation, no adjudication method is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The device is a radiation therapy system, not a diagnostic imaging device that typically undergoes MRMC studies to evaluate human reader performance with or without AI assistance. The focus here is on the system's ability to plan and deliver radiation accurately and safely, comparable to its predicate.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The document describes the "TomoTherapy Treatment System" as an integrated system, highlighting its planning, dose calculation, and delivery capabilities. Its functions include IGRT (image-guided radiation therapy), which inherently involves a human (e.g., physician, dosimetrist, radiation therapist) in planning and overseeing the treatment. While the software has algorithmic components, the system itself is not purely "standalone" in the AI sense, as it requires human input and clinical judgment for its intended use. The performance data presented refers to the system's compliance with safety standards and design specifications, which would include the performance of its software algorithms within the integrated system, but it's not a "standalone algorithm-only" study in the context of diagnostic AI.
7. Type of Ground Truth Used
For a radiation therapy delivery system, the "ground truth" for non-clinical performance studies would likely be:
- Engineering specifications and design requirements: The system's output (e.g., radiation dose, beam shape, image acquisition parameters) must match predetermined, validated specifications.
- Physical measurements: Using phantoms and dosimeters to verify the accuracy of dose delivery and image quality.
- Compliance with recognized consensus safety standards: Demonstrating adherence to established industry-wide safety and performance metrics (e.g., IEC standards for medical electrical equipment, specific standards for radiation therapy devices).
8. Sample Size for the Training Set
The document does not provide information on a training set sample size. This type of device relies on physics-based models and validated algorithms rather than machine learning models trained on large datasets in the way typical AI/ML devices might. The software enhancements mentioned (asymmetric positions and dynamic motion of the primary beam limiting device) are likely based on deterministic algorithms and physical principles, thoroughly verified, rather than deep learning models requiring extensive training data.
9. How the Ground Truth for the Training Set Was Established
As there's no mention of a training set for machine learning, this information is not applicable or provided. The "ground truth" for the development and verification of the system's physics-based algorithms and control software would be derived from fundamental principles of radiation physics, medical imaging, and robust engineering validation processes.
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K121934
ACCURAY®
TomoTherapy* A wholly owned subsidiary of Accuray
510(k) Summary Section 2
AUG 2 9 2012
Applicant:
Accuray Incorporated 1240 Deming Way Madison, WI 53717-1954 Phone: 608.824.2800 Fax: 608.824.2981
| Contact: | Gregory G. Bange |
|---|---|
| Date Prepared: | June 29, 2012 |
Device Identification:
| Device Name: | TomoTherapy Treatment System |
|---|---|
| Trade & Brand Names: | Hi-Art® and TomoHDTM |
| Common Name: | Radiation Therapy System |
| Classification: | System, Planning, Radiation Therapy Treatment |
| Product Code: | MUJ |
| Regulation Number: | 21 CFR 892.5050 |
| Regulation Description: | Medical charged particle radiation therapy system |
Predicate Device:
TomoTherapy Treatment System (K112776)
Description:
The TomoTherapy Treatment System is a radiation therapy system that integrates planning, dose calculation, megavoltage CT imaging for IGRT functionality, and helical (rotational) and fixed beam (non-rotational) radiation therapy treatment capabilities into a single comprehensive system.
The TomoTherapy Treatment System is a prescription device. It delivers radiation in accordance with a physician approved plan. The device does not diagnose disease, recommend treatment regimens, or quantify treatment effectiveness. The megavoltage CT imaging functionality is not intended for diagnostic use.
Intended Use:
The TomoTherapy Treatment System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital healthy tissue. The megavoltage x-ray radiation is delivered in a rotational, non-rotational, (IMRT), or non-modulated (non-IMRT/three dimensional modulated conformal) format in accordance with the physician approved plan.
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Technological Characteristics:
The technological characteristics of the TomoTherapy Treatment System are substantially equivalent to the predicate. The physical properties of the device are identical to the predicate. Enhancements to software allow for the planning and delivery of radiation therapy that utilize asymmetric positions and dynamic motion of the primary beam limiting device.
Performance Data:
The TomoTherapy Treatment System was tested and shown to be in compliance with the requirements of applicable recognized consensus safety standards for medical devices. Results of verification and validation testing confirm the TomoTherapy Treatment System conforms to design specifications and meets the needs of the intended users. No clinical tests were required to establish substantial equivalence. The performance data demonstrate the TomoTherapy Treatment System is as safe, as effective, and performs as well as the predicate device.
Summary:
The TomoTherapy Treatment System is substantially equivalent to the predicate device. The intended use, major technological characteristics, and the principles of operation of the TomoTherapy Treatment System are identical to those of the predicate device. Minor technological differences do not raise new types of safety or effectiveness questions. Performance data demonstrate the TomoTherapy Treatment System is as safe, as effective, and performs as well as the predicate device.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
AUG 2 9 2012
Mr. Gregory G. Bange Manager of Regulatory Submissions and Standards Accuray Incorporated 1209 Deming Way MADISON WI 53717
Re: K121934
Trade/Device Name: TomoTherapy Treatment System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE and MUJ Dated: June 29, 2012 Received: July 2, 2012
Dear Mr. Bange:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally be device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfed in the encreativent of the enactment date of the Medical Device Amendments, or to conimered print to May 20, 1978, in occordance 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 r ou may, distore, mains 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 class II (Special Controls), it may be subject to such If your device Is classified (300 a00 regulations affecting your device can be found in Title 21, additions: Controls: Existing major regulations (CFR), Parts 800 to 895. 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 Flease be advised that I DA 3 issumes or a race complies with other requirements of the Act that IDA has made a dolormistion and regulations administered by other Federal agencies. You must of any I cuchares and regaratis including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice mourements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as set form in the quality of since & described in your Section 510(k) premarket will anow you to begin mading of substantial equivalence of your device to a legally marketed notification. The I Drivin 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 Parts 801 and If you desire specific ad rice tor your live Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 9 150. Thise 1100, premo 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/ReportaProblem/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 Tou may 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/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Section 1 Indications for Use Form
510(k) Number (if known): K121934
Device Name:
TomoTherapy Treatment System
Indications for use:
The TomoTherapy Treatment System is intended to be used as an integrated system for the planning and precise delivery of radiation therapy, stereotactic radiotherapy, or stereotactic radiosurgery to tumors or other targeted tissues while minimizing the delivery of radiation to vital The megavoltage x-ray radiation is delivered in a healthy tissue. rotational, non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan.
Prescription Use X (Per 21 CFR 801 subpart D) AND/OR
Over-the-Counter Use (Per 21 CFR 801 subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.
Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD)
Division Sign Off
Division Sign-Off Office of In-Vitro Diagnostic Device Evaluation and Safety
510(k) Kia1934
Page 1 of 1
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.