(35 days)
No
The summary does not mention AI, ML, or related terms, and the description focuses on hardware modifications and integration with existing systems.
Yes.
The device's intended use is for "delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues," which clearly indicates a therapeutic purpose.
No
Explanation: The device is indicated for the delivery of radiation therapy and provides Image Guided Radiation Therapy (IGRT) using megavoltage CT imaging capabilities for treatment delivery, not for diagnosing conditions.
No
The device description clearly states it is a "radiation therapy delivery system" and includes physical components like a Treatment Delivery Console, indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, the TomoTherapy Treatment Delivery System with iDMS is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is the delivery of radiation therapy to tumors or other targeted tissues. This is a therapeutic intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is described as a radiation therapy delivery system that uses imaging for guidance. It's a treatment delivery system, not a system for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.) or the detection of specific analytes.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The TomoTherapy system's function is to deliver radiation for treatment, which falls under the category of therapeutic devices.
N/A
Intended Use / 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.
Product codes
IYE
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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
megavoltage CT
Anatomical Site
anywhere in the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed medical practitioner
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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)
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) | |
|---|---|
| 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
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:
-
- 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.
-
- 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.
-
- 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
TomoTherapy
Treatment System
(K121934) | Subject Device
TomoTherapy
Treatment Delivery System
with iDMS | |
|--------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|
| System Configuration | Radiation delivery system
integrated with data management
system and planning system | Stand alone radiation delivery
system (does not include data
management system or
planning system) | |
| General Characteristics | Predicate Device
TomoTherapy
Treatment System
(K121934) | Subject Device
TomoTherapy
Treatment Delivery System
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
(gantry and couch) | | |
| | Height*
Width*
Length*
Weight | 252 cm
280 cm
466 cm
4,943 kg | Identical to predicate **
Identical to predicate **
Identical to predicate **
Identical to predicate ** |
| Environment | Line Voltage | 380-480V, 3-Phase | Identical to predicate |
| | Ambient Room
Temperature | 68-75 °F (20-24 °C) | Identical to predicate |
| | Relative Humidity | 30%-60%, non-condensing | Identical to predicate |
| Gantry Mechanical
Features | Degrees of Rotation | Continuous rotation around Y-
axis (axes per IEC 61217) | Identical to predicate |
| | Direction of Rotation | Clockwise (as viewed from the
foot of the patient couch) | Identical to predicate |
| | Bore Size | 85 cm diameter | Identical to predicate |
| | Speed of Rotation
Treatment
Imaging | 1 to 5 RPM
6 RPM | Identical to predicate
Identical to predicate |
| | Radiation Delivery
Modes | Helical
Direct | Identical to predicate
Identical to predicate |
| General Characteristics | Predicate Device
TomoTherapy
Treatment System
(K121934) | Subject Device
TomoTherapy
Treatment Delivery System
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
2.5 cm x 40 cm
5.0 cm x 40 cm | Identical to predicate | |
| Dynamic Field Size | 1.0 - 2.5 cm x 40 cm
1.0 - 5.0 cm x 40 cm | Identical to predicate | |
| Dose Rate | 850 cGy/min | Identical to predicate | |
| Collimation | Primary collimation, jaws and
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
reconstruction intervals | Identical to predicate | |
| Spatial Resolution | 1.6 mm spatial resolution | Identical to predicate | |
| General Characteristics | Predicate Device
TomoTherapy
Treatment System
(K121934) | Subject Device
TomoTherapy
Treatment Delivery System
with iDMS | |
| Laser System | | | |
| Stationary | Green lasers, identify virtual and actual isocenter | Identical to predicate | |
| Moveable
(for patient
positioning and
registration) | Red lasers, offset from virtual isocenter | Identical to predicate | |
| Patient Couch | | | |
| Biocompatibility | Carbon-fiber top | Identical to predicate | |
| Motion | | | |
| X-axis
Y-axis | Independent of other axes
Coupled 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 system
functions (i.e., patient and
procedure selection, and
procedure delivery) | Uses the Treatment Delivery
Console (TDC), cleared as part
of the Radixact Treatment
Delivery System (K161146),
which is functionally
equivalent to the predicate
Operator Station | |
| General Characteristics | Predicate Device
TomoTherapy
Treatment System
(K121934) | Subject Device
TomoTherapy
Treatment Delivery System
with iDMS | |
| Machine Control
Software | Controls radiation delivery and
positioning systems (referred to
as the RDS - Radiation Delivery
System) | Functionally equivalent to
predicate (referred to as the
ECS – Embedded Controls
Subsystem) | |
| Data Interfaces
Operator Station | Provides measurements and
status during operation | Functionally equivalent to
predicate | |
| Database | Integrated database used for
gathering operational data and
storage of procedure data | Works with functionally-
equivalent external database
such as the Accuray iDMSTM
Integrated Data Management
System (K161144) | |
| Safety Features | Interlock Subsystems
Data integrity checking | Functionally equivalent to
predicate
Functionally equivalent to
predicate | |
6
7
8
9
- 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.