The TomoTherapy Treatment Delivery System with iDMS is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.

Device Description

The TomoTherapy Treatment Delivery System with iDMS is a radiation therapy delivery system that provides Image Guided Radiation Therapy (IGRT) using integral megavoltage CT imaging capabilities and delivers helical (rotational) and fixed-angle (non-rotational) radiation therapy to tumors and other targeted tissues.

The TomoTherapy Treatment Delivery System with iDMS is a modified version of the predicate TomoTherapy Treatment System (last cleared on K121934). The TomoTherapy Treatment Delivery System with iDMS is the same as the predicate device minus the Data Management System and Treatment Planning Station, but substituting the Treatment Delivery Console (TDC) from the Radixact Treatment Delivery System (last cleared on K161146) in place of the predicate Operator Station. The TomoTherapy Treatment Delivery System with iDMS is designed to deliver radiation therapy treatment plans generated on planning systems such as the Accuray Precision™ Treatment Planning System (last cleared on K171086) and stored on data management systems such as the Accuray iDMS™ Integrated Data Management System (last cleared on K161144).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text, focusing on what is present and explicitly stating what is not mentioned:

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not present a formal table of acceptance criteria with corresponding performance metrics for the TomoTherapy Treatment Delivery System with iDMS. Instead, it relies on a comparison to a predicate device, asserting "substantial equivalence." The document states that the new device has "imaging and treatment capabilities equivalent to those of the predicate" and "employs the same fundamental scientific principles, and have substantially equivalent intended uses, principles of operation, performance specifications and technological characteristics."

The only specific performance data mentioned is a general statement: "Results of verification and validation testing confirm that the TomoTherapy Treatment Delivery System with iDMS conforms to design specifications and meets the needs of the intended users." It also notes compliance with "applicable FDA recognized consensus safety standards for radiation therapy medical devices."

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "No animal or clinical tests were required to establish substantial equivalence with the predicate device." This implies that there was no separate "test set" in the traditional sense involving patients or biological samples to evaluate the device's performance against specific clinical acceptance criteria. The evaluation was primarily based on technical comparisons to a predicate device and engineering verification and validation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Since no clinical or animal tests were performed, there was no "test set" requiring ground truth established by experts in the context of clinical performance. The evaluation was based on engineering and design specifications and a comparison to a previously cleared device. Therefore, this information is not applicable/not provided.

4. Adjudication Method for the Test Set

As no clinical or animal test set was used, an adjudication method for such a set is not applicable/not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

An MRMC study was not done, as the document explicitly states: "No animal or clinical tests were required to establish substantial equivalence." This type of study would typically involve human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done

The device described is a treatment delivery system, not an algorithm in the AI sense for diagnosis or interpretation. The performance evaluation focused on the physical device's technical specifications and functional equivalence to a predicate device. Therefore, a "standalone algorithm performance" study as typically understood in AI/medical imaging is not applicable/not provided.

7. The Type of Ground Truth Used

The ground truth used for establishing "substantial equivalence" appears to be the design specifications, performance characteristics, and regulatory clearance of the predicate device (TomoTherapy Treatment System (K121934)), along with compliance to relevant consensus safety standards. The new device was deemed substantially equivalent because its technological characteristics, intended use, and fundamental scientific principles were the same as the predicate.

8. The Sample Size for the Training Set

Since no clinical or animal studies were conducted to establish substantial equivalence for this device, there was no training set used in the context of a statistical or machine learning model. The device's "training" would be analogous to its design and manufacturing process, which adheres to established engineering principles and the specifications of the predicate.

9. How the Ground Truth for the Training Set was Established

As there was no training set in the conventional sense, the establishment of "ground truth" for a training set is not applicable/not provided. The device's functionality is based on its design and manufacturing to meet pre-defined engineering and safety standards, which are continuously refined and validated during product development (verification and validation testing).

Summary of the Study and Device Validation:

The validation of the TomoTherapy Treatment Delivery System with iDMS was primarily a non-clinical equivalency study. The core of the submission relies on demonstrating substantial equivalence to a previously cleared predicate device (TomoTherapy Treatment System (K121934)).

The study involved:

Detailed comparison of technological characteristics: This included comparing system configuration, physical dimensions, environmental parameters, gantry mechanical features, photon beam characteristics, imaging capabilities, laser systems, patient couch, power distribution, operator station, machine control software, data interfaces, and safety features.
Verification and validation testing: This was internal engineering testing to confirm the device conforms to its own design specifications and meets the needs of intended users. Specific details of these tests (e.g., number of test cases, methodologies) are not given in the 510(k) summary, but it's stated that they confirm conformance.
Compliance with recognized safety standards: Testing was performed by an independent certified testing laboratory to ensure compliance with applicable FDA recognized consensus safety standards for radiation therapy medical devices.

The conclusion is that the minor differences between the new device and the predicate do not raise different questions of safety or effectiveness, and the performance data (from verification, validation, and standards compliance) demonstrates substantially equivalent safety and performance. This approach eliminated the need for animal or clinical studies to demonstrate substantial equivalence for this particular 510(k) submission.

Summary

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Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 25, 2017

Accuray Incorporated % Mr. Keith Picker Senior Regulatory Affairs Specialist 1240 Deming Wav Madison. WI 53717

Re: K171837

Trade/Device Name: TomoTherapy Treatment Delivery System with iDMS Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: June 19, 2017 Received: June 20, 2017

Dear Keith Picker:

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 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-

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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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/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 Division of Industry and Consumer Education 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.

Sincerely,

Michael D. O'Hara

Robert A. Ochs, Ph.D Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171837

Device Name

TomoTherapy Treatment Delivery System with iDMS

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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Section 8 510(k) Summary

Submitter

Accuray Incorporated 1209 Deming Way Madison, WI 53717-1954 Phone: 608-824-2800 Fax: 608-824-2996

Contact:	Keith Picker
Date Prepared:	June 19, 2017

Device Identification

Device Name: Trade & Brand Names: Common Name: Regulation Number: Regulation Name: Regulatory Class: Product Code:

TomoTherapy Treatment Delivery System with iDMS TomoTherapy Treatment Delivery System with iDMS Radiation Therapy System 21 CFR 892.5050 Medical charged-particle radiation therapy system Class II IYE

Predicate Device

TomoTherapy Treatment System (K121934)

Device Description

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The TomoTherapy Treatment Delivery System with iDMS is a prescription device that delivers radiation in accordance with a physician approved plan. As with the predicate, the TomoTherapy Treatment Delivery System with iDMS does not diagnose disease, recommend treatment regimens or quantify treatment effectiveness. Accordingly, it is not intended for diagnostic use.

Intended Use

The TomoTherapy Treatment Delivery System with iDMS is intended to be used for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues. The megavoltage x-ray radiation is delivered using rotational, non-rotational, intensity modulated (IMRT), or non-modulated (non-IMRT/three dimensional conformal) treatment techniques and using image-guided (IGRT) or non-image-guided workflows in accordance with the physician approved plan.

Indications for Use

While the indications for use of the TomoTherapy Treatment Delivery System with iDMS are stated slightly differently from those of the predicate, the differences are not critical to the intended use of the devices nor do they affect the safety and/or effectiveness of the new device as compared to the predicate device. Both devices provide the same types of radiation therapy. In fact, the intended use and indications for use statements for the TomoTherapy Treatment Delivery System with iDMS (shown above) are the same as for the Radixact Treatment Delivery System (last cleared on K161146), except for the substitution of the device name.

Technological Characteristics

The TomoTherapy Treatment Delivery System with iDMS has imaging and treatment capabilities equivalent to those of the predicate TomoTherapy Treatment System. In fact, the TomoTherapy Treatment Delivery System with iDMS uses the same CT style gantry, patient couch and power distribution unit (PDU) as the predicate. Further, the clinical workflow is the same as that of the predicate TomoTherapy Treatment System.

The TomoTherapy Treatment Delivery System with iDMS and the predicate device employ the same fundamental scientific principles, and have substantially equivalent intended uses, principles of operation, performance specifications and technological characteristics.

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The main differences between the predicate and the TomoTherapy Treatment Delivery System with iDMS are:

1. The predicate includes integral treatment planning and data management subsystems, whereas the TomoTherapy Treatment Delivery System with iDMS is strictly a radiation treatment delivery device.
1. The TomoTherapy Treatment Delivery System with iDMS uses the Treatment Delivery Console (TDC) of the Radixact Treatment Delivery System (last cleared on K161146) in place of the Operator Station (OS) from the predicate, to which the TDC is functionally equivalent.
1. The TomoTherapy Treatment Delivery System with iDMS includes software changes (due to the use of the TDC from the Radixact Treatment Delivery System) to allow it to connect and work compatibly with the Accuray Precision™ Treatment Planning System (last cleared on K171086) and iDMS™ Integrated Data Management System (K161144).

Where there are technological differences between the TomoTherapy Treatment Delivery System with iDMS and the predicate device, those differences do not raise different questions of safety or effectiveness.

A table comparing the predicate cleared on K121934 and the TomoTherapy Treatment Delivery System with iDMS is presented below:

General Characteristics	Predicate DeviceTomoTherapyTreatment System(K121934)	Subject DeviceTomoTherapyTreatment Delivery Systemwith iDMS
System Configuration	Radiation delivery systemintegrated with data managementsystem and planning system	Stand alone radiation deliverysystem (does not include datamanagement system orplanning system)
General Characteristics	Predicate DeviceTomoTherapyTreatment System(K121934)	Subject DeviceTomoTherapyTreatment Delivery Systemwith iDMS
Vault
	Min. Room Dimensions
	Height*	270 cm	Identical to predicate**
	Width*	462 cm	Identical to predicate **
	Length*	596 cm	Identical to predicate **
	Device Dimensions(gantry and couch)
	HeightWidthLength*Weight	252 cm280 cm466 cm4,943 kg	Identical to predicate Identical to predicate Identical to predicate Identical to predicate
Environment	Line Voltage	380-480V, 3-Phase	Identical to predicate
	Ambient RoomTemperature	68-75 °F (20-24 °C)	Identical to predicate
	Relative Humidity	30%-60%, non-condensing	Identical to predicate
Gantry MechanicalFeatures	Degrees of Rotation	Continuous rotation around Y-axis (axes per IEC 61217)	Identical to predicate
	Direction of Rotation	Clockwise (as viewed from thefoot of the patient couch)	Identical to predicate
	Bore Size	85 cm diameter	Identical to predicate
	Speed of RotationTreatmentImaging	1 to 5 RPM6 RPM	Identical to predicateIdentical to predicate
	Radiation DeliveryModes	HelicalDirect	Identical to predicateIdentical to predicate
General Characteristics	Predicate DeviceTomoTherapyTreatment System(K121934)	Subject DeviceTomoTherapyTreatment Delivery Systemwith iDMS
Photon Beam
Accelerator Type	Standing wave	Identical to predicate
RF Source	Magnetron	Identical to predicate
Nominal Energy	6 MV (single energy)	Identical to predicate
Fixed Field Size	1.0 cm x 40 cm2.5 cm x 40 cm5.0 cm x 40 cm	Identical to predicate
Dynamic Field Size	1.0 - 2.5 cm x 40 cm1.0 - 5.0 cm x 40 cm	Identical to predicate
Dose Rate	850 cGy/min	Identical to predicate
Collimation	Primary collimation, jaws andmulti-leaf collimator (MLC)	Identical to predicate
Imaging
Field of View	39 cm diameter	Identical to predicate
Dose per MVCT image (typical)	0.5 - 3.0 cGy	Identical to predicate
Slice spacing	1, 2, 3, 4 and 6 mmreconstruction intervals	Identical to predicate
Spatial Resolution	1.6 mm spatial resolution	Identical to predicate
General Characteristics	Predicate DeviceTomoTherapyTreatment System(K121934)	Subject DeviceTomoTherapyTreatment Delivery Systemwith iDMS
Laser System
Stationary	Green lasers, identify virtual and actual isocenter	Identical to predicate
Moveable(for patientpositioning andregistration)	Red lasers, offset from virtual isocenter	Identical to predicate
Patient Couch
Biocompatibility	Carbon-fiber top	Identical to predicate
Motion
X-axisY-axis	Independent of other axesCoupled with Z-axis(via couch Cobra motion)	Identical to predicate
Z-axis	Coupled with Y-axis(via couch Cobra motion)	Identical to predicate
Power Distribution
Isolation	Transformer	Identical to predicate
UPS for Data Back-up	Provided	Identical to predicate
Operator Station	User interface to systemfunctions (i.e., patient andprocedure selection, andprocedure delivery)	Uses the Treatment DeliveryConsole (TDC), cleared as partof the Radixact TreatmentDelivery System (K161146),which is functionallyequivalent to the predicateOperator Station
General Characteristics	Predicate DeviceTomoTherapyTreatment System(K121934)	Subject DeviceTomoTherapyTreatment Delivery Systemwith iDMS
Machine ControlSoftware	Controls radiation delivery andpositioning systems (referred toas the RDS - Radiation DeliverySystem)	Functionally equivalent topredicate (referred to as theECS – Embedded ControlsSubsystem)
Data InterfacesOperator Station	Provides measurements andstatus during operation	Functionally equivalent topredicate
Database	Integrated database used forgathering operational data andstorage of procedure data	Works with functionally-equivalent external databasesuch as the Accuray iDMSTMIntegrated Data ManagementSystem (K161144)
Safety Features	Interlock SubsystemsData integrity checking	Functionally equivalent topredicateFunctionally equivalent topredicate

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Dimensions are rounded to the nearest centimeter.

** Information Source: TomoTherapy Treatment Delivery System with iDMS Technical Specifications

Performance Data

Results of verification and validation testing confirm that the TomoTherapy Treatment Delivery System with iDMS conforms to design specifications and meets the needs of the intended users. Additionally, testing performed by an independent certified testing laboratory demonstrates the device complies with the requirements of applicable FDA recognized consensus safety standards for radiation therapy medical devices. These test results demonstrate that the TomoTherapy Treatment Delivery System with iDMS is as safe and effective, and performs as well as the predicate device.

No animal or clinical tests were required to establish substantial equivalence with the predicate device.

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Conclusion

The TomoTherapy Treatment Delivery System with iDMS is substantially equivalent to the predicate device. The intended use, principles of operation, performance specifications and technological characteristics of the TomoTherapy Treatment Delivery System with iDMS are substantially equivalent to those of the predicate device. Minor differences do not raise different questions of safety and effectiveness of the TomoTherapy Treatment Delivery System with iDMS in comparison to the cleared predicate device. Further, performance data demonstrate that the TomoTherapy Treatment Delivery System with iDMS has substantially equivalent safety and performance characteristics in comparison to the predicate device. Accordingly, the TomoTherapy Treatment Delivery System with iDMS is substantially equivalent to the predicate device.

Regulation Number and Section

§ 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.