(87 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 prescribed and 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 TomoTherapy Treatment System with Fast Optimizer is a modification that allows for increased efficiency and speed during the treatment planning process through the use of modified hardware and software.
The provided text describes a 510(k) premarket notification for the "TomoTherapy Treatment System Next Generation Fast Optimizer." This filing is for a modification to an existing device, the TomoTherapy Hi-Art System (K082005), to increase efficiency and speed during the treatment planning process. The key takeaway is that the modification primarily involves new hardware (Graphics Processing Unit (GPU)) and revised software to accommodate it, while maintaining unchanged dose accuracy constraints and not affecting the radiation delivery system.
Therefore, the performance data presented focuses on demonstrating that these modifications do not degrade performance and that the updated system remains as safe and effective as the predicate device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Conformance to applicable recognized consensus standards for medical devices. | "The TomoTherapy Treatment System Next Generation Fast Optimizer was tested and it was demonstrated that there are no changes to the conformance to the requirements of applicable recognized consensus standards for medical devices." |
| Performance within design specifications. | "Results of verification and validation tests confirm the TomoTherapy Treatment System Next Generation Fast Optimizer performance is within design specifications." |
| Dose accuracy constraints maintained (unchanged from predicate). | "As the modification is limited to faster operation of the Planning sub-system with unchanged dose accuracy constraints..." (This implies the performance met these existing constraints, as no new questions of safety or effectiveness regarding dose accuracy were raised by the modification). |
| Safety and effectiveness (comparable to predicate device). | "These performance data demonstrate the TomoTherapy Treatment System Next Generation Fast Optimizer is as safe, as effective, and performs as well as the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide specific details about the sample size used for the test set or the data provenance (e.g., country of origin, retrospective/prospective). It generally refers to "verification and validation tests." Given the nature of the modification (software/hardware for faster optimization), it's highly likely these tests would involve in silico simulations and phantom measurements rather than patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not mention the involvement of experts in establishing ground truth for the test set. Given that the focus is on a technical upgrade to a simulation and planning system, ground truth would likely be established through physical dosimetry measurements (phantoms) and computational models (physics-based simulations) rather than expert clinical review.
4. Adjudication Method for the Test Set
The document does not describe any adjudication method. This is consistent with a technical performance evaluation where quantitative measurements and computational comparisons are the primary means of verification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "No clinical tests were required to establish substantial equivalence." This type of study would involve human readers and clinical cases.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, implicitly, a standalone evaluation of the algorithm's performance (specifically the "Fast Optimizer" component) was done. The performance data section refers to "verification and validation tests" that confirmed performance within design specifications and conformance to standards. These tests would evaluate the algorithm's output (e.g., dose calculations, plan optimization speed) directly, without human intervention in the loop of measuring that performance itself. However, it's important to note that the device is a "prescription device" and intended to be used with a physician-approved plan, meaning a human is always in the loop for the end-to-end clinical process. The standalone performance here refers to the technical accuracy and speed of the planning system's calculations.
7. The Type of Ground Truth Used
The ground truth for this device's performance evaluation would primarily be derived from:
- Physics-based models and calculations: For dose accuracy and optimization.
- Physical phantom measurements: For verifying radiation dose delivery and distribution against the planned dose.
- Industry standards and regulatory requirements: For demonstrating conformance.
8. The Sample Size for the Training Set
The document does not provide any information about a training set size. This modification focuses on optimizing the speed and efficiency of an existing planning algorithm, rather than developing a new AI model that requires a large training dataset in the conventional sense. The "Fast Optimizer" component likely involves algorithmic improvements and hardware acceleration rather than a machine learning model trained on a data set.
9. How the Ground Truth for the Training Set Was Established
As no specific training set is mentioned in the context of conventional machine learning, this question is not directly applicable. If "training" refers to the development and refinement of the optimization algorithms, the "ground truth" would have been established through a combination of physics principles, engineering specifications, and iterative testing against known or simulated scenarios to ensure the algorithm generates accurate and clinically acceptable treatment plans while achieving the desired speed improvements.
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Image /page/0/Picture/2 description: The image contains the logo for TomoTherapy. The logo consists of a stylized image to the left of the company name. The company name is written in a bold, sans-serif font. A period follows the company name.
DEC 2 2 2011
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Section 2 510(k) Summary
Applicant:
TomoTherapy, Inc. 1209 Deming Way Madison, WI 53717-1954 Phone: 608.824.2800 Fax: 608.824.2981
Contact:
Gregory G. Bange gbange@accuray.com
Date Prepared:
October 25, 2011 (with corrected device name)
Device Identification:
| Device Name: | TomoTherapy Treatment System |
|---|---|
| Trade Names | Hi-Art® and TomoHD™ |
| 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 Hi-Art System (modified) K082005
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.
The TomoTherapy Treatment System with Fast Optimizer is a modification that allows for increased efficiency and speed during the treatment planning process through the use of modified hardware and software. The device name remains unchanged as "TomoTherapy Treatment System", and the modification itself is referred to as TomoTherapy Treatment System Fast Optimizer.
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
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TomoTherapy.
delivered in a rotational, non-rotational, modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) format in accordance with the physician approved plan.
Technological Characteristics:
The technological characteristics of the TomoTherapy Treatment System Next Generation Fast Optimizer are substantially equivalent to the predicate. The TomoTherapy Treatment System Next Generation Fast Optimizer introduces new hardware, a Graphics Processing Unit (GPU), and revised software to accommodate this new hardware to allow for substantially increased speed and efficiency during the performance of optimization and dose calculation processes. All other primary subassemblies remain unchanged, and therefore this modification is comparable in key safety and effectiveness features, utilizes substantially similar design, construction, materials, energies, and it has an intended use that is identical to that of the predicate device.
As the modification is limited to faster operation of the Planning sub-system with unchanged dose accuracy constraints, and the changes do not affect the radiation delivery system, this modification does not alter the performance claims for the product. These technological enhancements do not raise new types of safety or effectiveness questions.
Performance Data:
The TomoTherapy Treatment System Next Generation Fast Optimizer was tested and it was demonstrated that there are no changes to the conformance to the requirements of applicable recognized consensus standards for medical devices. Results of verification and validation tests confirm the TomoTherapy Treatment System Next Generation Fast Optimizer performance is within design specifications. No clinical tests were required to establish substantial equivalence. These performance data demonstrate the TomoTherapy Treatment System Next Generation Fast Optimizer is as safe, as effective, and performs as well as the predicate device.
Summary:
The TomoTherapy Treatment System Next Generation Fast Optimizer is substantially equivalent to the predicate device. The intended use, major technological characteristics, and principles of operation of the TomoTherapy Treatment System Fast Optimizer 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 Fast Optimizer 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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure embracing or protecting something, often interpreted as representing health and well-being.
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
Mr. Gregory Bange Manager of Regulatory Submissions and Standards TomoTherapy, Inc. 1209 Deming Way MADISON WI 53717-1954
DEC 2 2 2011
Re: K112776
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: MUJ Dated: November 10, 2011 Received: November 14, 2011
Dear Mr. Bange:
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 for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to eonimered processified 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal 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 r roase be active and in that your device complies with other requirements of the Act that I Drimas Intacted and regulations administered by other Federal agencies. You must or any I vith all the Act's requirements, 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 medical device-lefated adverse events) (21 CFR Part 820), and 2010 (21 CFR Part 820). This letter requirements as set form in the quality by with ( <<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<<< will anow you to begil marketing your device of your device to a legally marketed notification. The I DAY miding of oubsitification 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 II you desire specific advice for your don't of the Diagnostic Device Evaluation and Safety at (31) 796-807), please contact the regulation entitled, "Misbranding by reference to premarket 5430. Also, please note the regarding the regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDK regulation (21 CFR Pac 000), presso go of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the You may other built built general informational 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,
Mary Patel
Mary S. Pastel, Sc.D. 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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Indications for Use Form Section 1
KII 2776 510(k) Number (if known):
''
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 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 prescribed and approved plan.
Prescription Use__________X (Per 21 CFR 801 subpart D) AND/OR
Over-the-Counter Use _ (Per 21 CFR 801 subpart C)
continue on another page if PLEASE DO NOT WRITE BELOW THIS LINE. NEEDED.
Concurrence of CDRH, Office of In-Vitro Diagnostics (OIVD)
Muchel D'Ollum
Division Sign-Off Office of In-Vitro Diagnostic Device Evaluation and Safety
510(k) K112776
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.