TomoTherapy Treatment Delivery System with iDMS

K171837 · Accuray Incorporated · IYE · Jul 25, 2017 · Radiology

Device Facts

• Record ID: K171837
• Device Name: TomoTherapy Treatment Delivery System with iDMS
• Applicant: Accuray Incorporated
• Product Code: IYE · Radiology
• Decision Date: Jul 25, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.5050
• Device Class: Class 2
• Attributes: Therapeutic

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.

Device Story

Radiation therapy delivery system; provides Image Guided Radiation Therapy (IGRT) using megavoltage CT imaging; delivers helical (rotational) and fixed-angle (non-rotational) radiation. System comprises gantry, patient couch, and Treatment Delivery Console (TDC). Operates as standalone delivery unit; receives treatment plans from external planning systems (e.g., Accuray Precision) and data from management systems (e.g., iDMS). Used in clinical settings by radiation oncology staff. Physician approves treatment plan; system delivers radiation accordingly. Does not diagnose, recommend regimens, or quantify effectiveness. Benefits patient via precise, image-guided tumor targeting.

Clinical Evidence

No clinical or animal testing performed. Substantial equivalence established via bench testing, verification, and validation of design specifications, and compliance with FDA-recognized consensus safety standards for radiation therapy devices.

Technological Characteristics

6 MV standing wave linear accelerator; magnetron RF source; multi-leaf collimator (MLC) for beam shaping. CT-style gantry (85 cm bore) with continuous rotation (1-5 RPM treatment, 6 RPM imaging). Patient couch with carbon-fiber top. Power: 380-480V, 3-Phase. Connectivity: Networked interface with external treatment planning and data management systems. Software: Embedded controls subsystem (ECS) for radiation delivery and positioning. Sterilization: N/A (non-invasive).

Indications for Use

Indicated for 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.

Regulatory Classification

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.

Predicate Devices

• TomoTherapy Treatment System (K121934)

Reference Devices

• Radixact Treatment Delivery System (K161146)
• Accuray Precision Treatment Planning System (K171086)
• Accuray iDMS Integrated Data Management System (K161144)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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 direction of a licensed medical practitioner.

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------|----------------------------------------------------------------------|
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |

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Image /page/3/Picture/0 description: The image shows the Accuray logo. The logo consists of a stylized graphic to the left of the word "ACCURAY". The graphic is made up of three curved lines in green, purple, and blue. The word "ACCURAY" is in a sans-serif font and is colored blue. A registered trademark symbol is to the right of the word.

#### Section 8 510(k) Summary

#### Submitter

Accuray Incorporated 1209 Deming Way Madison, WI 53717-1954 Phone: [phone] Fax: [phone]

| 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

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).

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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

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.

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.
- 2) 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.
- 3) 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 Device<br>TomoTherapy<br>Treatment System<br>(K121934) | Subject Device<br>TomoTherapy<br>Treatment Delivery System<br>with iDMS | |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| System Configuration | Radiation delivery system<br>integrated with data management<br>system and planning system | Stand alone radiation delivery<br>system (does not include data<br>management system or<br>planning system) | |
| General Characteristics | Predicate Device<br>TomoTherapy<br>Treatment System<br>(K121934) | Subject Device<br>TomoTherapy<br>Treatment Delivery System<br>with 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<br>(gantry and couch) | | |
| | Height*<br>Width*<br>Length*<br>Weight | 252 cm<br>280 cm<br>466 cm<br>4,943 kg | Identical to predicate **<br>Identical to predicate **<br>Identical to predicate **<br>Identical to predicate ** |
| Environment | Line Voltage | 380-480V, 3-Phase | Identical to predicate |
| | Ambient Room<br>Temperature | 68-75 °F (20-24 °C) | Identical to predicate |
| | Relative Humidity | 30%-60%, non-condensing | Identical to predicate |
| Gantry Mechanical<br>Features | Degrees of Rotation | Continuous rotation around Y-<br>axis (axes per IEC 61217) | Identical to predicate |
| | Direction of Rotation | Clockwise (as viewed from the<br>foot of the patient couch) | Identical to predicate |
| | Bore Size | 85 cm diameter | Identical to predicate |
| | Speed of Rotation<br>Treatment<br>Imaging | 1 to 5 RPM<br>6 RPM | Identical to predicate<br>Identical to predicate |
| | Radiation Delivery<br>Modes | Helical<br>Direct | Identical to predicate<br>Identical to predicate |
| General Characteristics | Predicate Device<br>TomoTherapy<br>Treatment System<br>(K121934) | Subject Device<br>TomoTherapy<br>Treatment Delivery System<br>with 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 cm<br>2.5 cm x 40 cm<br>5.0 cm x 40 cm | Identical to predicate | |
| Dynamic Field Size | 1.0 - 2.5 cm x 40 cm<br>1.0 - 5.0 cm x 40 cm | Identical to predicate | |
| Dose Rate | 850 cGy/min | Identical to predicate | |
| Collimation | Primary collimation, jaws and<br>multi-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 mm<br>reconstruction intervals | Identical to predicate | |
| Spatial Resolution | 1.6 mm spatial resolution | Identical to predicate | |
| General Characteristics | Predicate Device<br>TomoTherapy<br>Treatment System<br>(K121934) | Subject Device<br>TomoTherapy<br>Treatment Delivery System<br>with iDMS | |
| Laser System | | | |
| Stationary | Green lasers, identify virtual and actual isocenter | Identical to predicate | |
| Moveable<br>(for patient<br>positioning and<br>registration) | Red lasers, offset from virtual isocenter | Identical to predicate | |
| Patient Couch | | | |
| Biocompatibility | Carbon-fiber top | Identical to predicate | |
| Motion | | | |
| X-axis<br>Y-axis | Independent of other axes<br>Coupled with Z-axis<br>(via couch Cobra motion) | Identical to predicate | |
| Z-axis | Coupled with Y-axis<br>(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 system<br>functions (i.e., patient and<br>procedure selection, and<br>procedure delivery) | Uses the Treatment Delivery<br>Console (TDC), cleared as part<br>of the Radixact Treatment<br>Delivery System (K161146),<br>which is functionally<br>equivalent to the predicate<br>Operator Station | |
| General Characteristics | Predicate Device<br>TomoTherapy<br>Treatment System<br>(K121934) | Subject Device<br>TomoTherapy<br>Treatment Delivery System<br>with iDMS | |
| Machine Control<br>Software | Controls radiation delivery and<br>positioning systems (referred to<br>as the RDS - Radiation Delivery<br>System) | Functionally equivalent to<br>predicate (referred to as the<br>ECS – Embedded Controls<br>Subsystem) | |
| Data Interfaces<br>Operator Station | Provides measurements and<br>status during operation | Functionally equivalent to<br>predicate | |
| Database | Integrated database used for<br>gathering operational data and<br>storage of procedure data | Works with functionally-<br>equivalent external database<br>such as the Accuray iDMSTM<br>Integrated Data Management<br>System (K161144) | |
| Safety Features | Interlock Subsystems<br>Data integrity checking | Functionally equivalent to<br>predicate<br>Functionally equivalent to<br>predicate | |

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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.