(63 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on the hardware and basic image-guided radiation therapy delivery, not advanced AI/ML capabilities.
Yes
The device is indicated for the "delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body," which are all forms of therapy.
No
The Device Description explicitly states: "As with the TomoTherapy Treatment System, the Radixact Treatment Delivery System does not diagnose disease, recommend treatment regimens or quantify treatment effectiveness. Accordingly, it is not intended for diagnostic use."
No
The device description explicitly states it is a "radiation therapy delivery system" and mentions "radiation delivery elements," indicating it includes hardware components for delivering radiation.
Based on the provided text, the Radixact Treatment Delivery System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is clearly stated as "delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body". This is a therapeutic function, not a diagnostic one performed on in vitro samples.
- Device Description: The description focuses on delivering radiation and providing image guidance for that delivery. It explicitly states that the device "does not diagnose disease, recommend treatment regimens or quantify treatment effectiveness" and is "accordingly, it is not intended for diagnostic use."
- Lack of IVD Characteristics: IVD devices are designed to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. The Radixact system does not perform this function.
Therefore, the Radixact Treatment Delivery System is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Radixact Treatment Delivery System 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 (comma separated list FDA assigned to the subject device)
IYE
Device Description
The Radixact Treatment Delivery System 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 Radixact Treatment Delivery System is an updated design of the radiation delivery elements of the predicate TomoTherapy Treatment System (last cleared on K121934). The Radixact Treatment Delivery System delivers radiation therapy treatment plans generated on planning systems such as Accuray's Precision™ Treatment Planning System and stored on Accuray's iDMS™ Integrated Data Management System devices. The planning and data management devices are not addressed in this 510(k).
The Radixact Treatment Delivery System is a prescription device that delivers radiation in accordance with a physician approved plan. As with the TomoTherapy Treatment System, the Radixact Treatment Delivery System does not diagnose disease, recommend treatment regimens or quantify treatment effectiveness. Accordingly, it is not intended for diagnostic use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
megavoltage CT imaging
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)
The Radixact Treatment Delivery 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 that the Radixact Treatment Delivery 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 that the Radixact Treatment Delivery System is as safe and effective, and performs as well as the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 24, 2016
Accuray Incorporated % Mr. Keith Picker Regulatory Affairs Specialist 1209 Deming Way MADISON WI 53717
Re: K161146
Trade/Device Name: Radixact Treatment Delivery System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: April 22, 2016 Received: April 22, 2016
Dear Mr. 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-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.
1
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/Resourcesfor You/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 yours.
Michael D'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161146
Device Name
Radixact Treatment Delivery System
Indications for Use (Describe)
The Radixact Treatment Delivery System 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: | April 25, 2016 |
Device Identification
Device Name: Trade & Brand Names: Common Name: Regulation Number: Regulation Name: Regulatory Class: Product Code:
Radixact Treatment Delivery System Radixact Treatment Delivery System 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 Radixact Treatment Delivery System 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 Radixact Treatment Delivery System is an updated design of the radiation delivery elements of the predicate TomoTherapy Treatment System (last cleared on K121934). The Radixact Treatment Delivery System delivers radiation therapy treatment plans generated on planning systems such as Accuray's Precision™ Treatment Planning System and stored on Accuray's iDMS™ Integrated Data Management System devices. The planning and data management devices are not addressed in this 510(k).
The Radixact Treatment Delivery System is a prescription device that delivers radiation in accordance with a physician approved plan. As with the TomoTherapy Treatment System, the Radixact Treatment Delivery System does not diagnose disease, recommend
4
treatment regimens or quantify treatment effectiveness. Accordingly, it is not intended for diagnostic use.
Intended Use
The Radixact Treatment Delivery System 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, nonrotational, 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 Radixact Treatment Delivery System 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 Radixact Treatment Delivery System 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.
Technological Characteristics
The Radixact Treatment Delivery System has imaging and treatment capabilities equivalent to those of the predicate TomoTherapy Treatment System. It also has a similar functionally-equivalent CT style gantry and patient couch. Further, the clinical workflow is the same as that of the predicate TomoTherapy Treatment System.
The Radixact Treatment Delivery System and the predicate device employ the same fundamental scientific principles, and have substantially equivalent technological characteristics and principles of operation. The main difference between the predicate TomoTherapy Treatment System and the Radixact Treatment Delivery System is that the predicate includes integral treatment planning and data management subsystems, whereas the Radixact Treatment Delivery System is strictly a radiation treatment delivery device.
Where there are technological differences between the Radixact Treatment Delivery System 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 Radixact Treatment Delivery System is presented below:
5
| General Characteristics | Predicate Device
TomoTherapy
Treatment System
(K121934) | Subject Device
Radixact
Treatment Delivery System |
|--------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| 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) |
| Vault | | |
| Min. Room Dimensions | | |
| Height* | 270 cm | 274 cm** |
| Width* | 462 cm | 462 cm** |
| Length* | 596 cm | 602 cm** |
| Device Dimensions
(gantry and couch) | | |
| Height* | 252 cm | 255 cm** |
| Width* | 280 cm | 280 cm** |
| Length* | 466 cm | 473 cm** |
| Weight | 4,943 kg | 6580 kg** |
| 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 | 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
10 RPM |
| Couch Support in Bore | Not provided | Provided |
| Radiation Delivery
Modes | Helical
Direct | Identical to predicate
Identical to predicate |
| Photon Beam | | |
| Accelerator Type | Standing wave | Identical to predicate |
| RF Source | Magnetron | Identical to predicate |
| Nominal Energy | 6 MV | 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
Identical to predicate
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
Identical to predicate |
| Dose Rate | 850 cGy/min | 850 cGy/min or 1000 cGy/min
options |
| Collimation | Primary collimation, jaws and
multi-leaf collimator (MLC) | Identical to predicate |
| General Characteristics | Predicate Device
TomoTherapy
Treatment System
(K121934) | Subject Device
Radixact
Treatment Delivery System |
| 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 |
| 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 | Equivalent to predicate |
| Motion
X-axis
Y-axis
Z-axis | Independent of other axes
Coupled with Z-axis
(via couch Cobra motion)
Coupled with Y-axis
(via couch Cobra motion) | Identical to predicate
Independent of other axes
Independent of other axes |
| Power Distribution | | |
| Isolation | Transformer | Equivalent to predicate |
| UPS for Data Back-up | Provided | Equivalent to predicate |
| General Characteristics | Predicate Device
TomoTherapy
Treatment System
(K121934) | Subject Device
Radixact
Treatment Delivery System |
| Operator Station | User interface to system
functions (i.e., patient and
procedure selection, and
procedure delivery) | Functionally equivalent to
predicate |
| 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 |
| Safety Features | Interlock Subsystems
Data integrity checking | Functionally equivalent to
predicate
Functionally equivalent to
predicate |
6
7
8
- Dimensions are rounded to the nearest centimeter.
** Information Source: Radixact Site Planning Guide T-SPG-01000, Rev A.
Performance Data
The Radixact Treatment Delivery 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 that the Radixact Treatment Delivery 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 that the Radixact Treatment Delivery System is as safe and effective, and performs as well as the predicate device.
9
Conclusion
The Radixact Treatment Delivery System is substantially equivalent to the predicate The intended use, major technological characteristics and the principles of device. operation of the Radixact Treatment Delivery System are substantially equivalent to those of the predicate device. Minor differences do not raise different questions of safety and effectiveness of the Radixact Treatment Delivery System in comparison to the predicate device. Further, performance data demonstrate that the Radixact Treatment Delivery System is as safe and effective, and performs as well as the predicate device. Accordingly, the Radixact Treatment Delivery System is substantially equivalent to the predicate device.