(58 days)
Unknown
The description mentions "predicts tumor location based upon a respiration amplitude measurement device" and "real-time adjustments" but does not explicitly state the use of AI/ML for this prediction or adjustment. The lack of mention of training/test sets or AI/ML terms makes it difficult to confirm.
Yes
The device, the Radixact Treatment Delivery System with the Motion Tracking and Compensation Feature, is explicitly indicated for "the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues", which are therapeutic interventions.
No.
The device is a radiation therapy delivery system designed to treat tumors, not diagnose them. It uses imaging for guidance and compensation during treatment, but its primary function is therapeutic.
No
The device is described as a "Feature" of the Radixact Treatment Delivery System, which is a hardware-based radiation therapy delivery system. While the feature likely involves software for motion tracking and compensation, it is integrated into and relies on the hardware of the Radixact system and a respiration amplitude measurement device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is a radiation therapy delivery system used to treat tumors and other targeted tissues. It uses imaging and motion tracking to deliver radiation directly to the body.
- Lack of Sample Analysis: The device does not analyze samples taken from the body. It uses imaging of the body and a respiration measurement device to track and compensate for motion during radiation delivery.
The device is a therapeutic device used for delivering radiation treatment, not a diagnostic device that analyzes biological samples.
N/A
Intended Use / Indications for Use
The Motion Tracking and Compensation Feature is an option within the indications for use of the Radixact Treatment Delivery System. 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
IYE
Device Description
The Motion Tracking and Compensation Feature is designed for use with the predicate Radixact Treatment Delivery System last cleared on K161146. The Motion Tracking and Compensation Feature measures tumor location and motion using images provided by a kV imaging subsystem and predicts tumor location based upon a respiration amplitude measurement device. The Radixact Treatment Delivery System then compensates for tumor motion by making real-time adjustments.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
kV Imaging (Radiography Class I X-ray tube assembly), MVCT (Megavoltage Computed Tomography)
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 with the use of the Motion Tracking and Compensation Feature was tested and shown to comply with the requirements of applicable FDA recognized consensus safety standards for radiation therapy equipment. Results of verification and validation testing confirm that the use of the Motion Tracking and Compensation Feature on the Radixact Treatment Delivery System conforms to design specifications and meets the needs of the intended users.
No animal or clinical tests were required to establish substantial equivalence with the predicate device. The performance data demonstrate that the Motion Tracking and Compensation Feature is compatible with the Radixact Treatment Delivery System, and the Radixact Treatment Delivery System with the use of the Motion Tracking and Compensation Feature is as safe and effective and performs as well as the predicate device. Further, these test results demonstrate that the Radixact Treatment Delivery System with the use of the Motion Tracking and Compensation Feature has substantially equivalent safety and performance characteristics in comparison to 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.
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.
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November 23, 2018
Accuray Incorporated % Keith Picker Senior Regulatory Affairs Specialist 1240 Deming Way MADISON WI 53717
Re: K182687
Trade/Device Name: Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: September 25, 2018 Received: September 26, 2018
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael D. O'Hara For
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) K182687
Device Name
Motion Tracking and Compensation Feature for the Radixact Treatment Delivery System
Indications for Use (Describe)
The Motion Tracking and Compensation Feature is an option within the indications for use of the Radixact Treatment Delivery System. 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 | |
|---|---|
| 1240 Deming Way | |
| Madison, WI 53717 | |
| Phone: 608-824-3069 | |
| Fax: 608-830-3778 | |
| Contact: | Keith Picker |
| Date Prepared: | September 25, 2018 |
Device Identification
| Device Name: | Motion Tracking and Compensation Feature for the
Radixact Treatment Delivery System |
|----------------------|----------------------------------------------------------------------------------------|
| Trade & Brand Names: | Motion Tracking and Compensation Feature for the
Radixact Treatment Delivery System |
| Common Name: | Radiation Therapy System |
| Regulation Number: | 21 CFR 892.5050 |
| Regulation Name: | Medical charged-particle radiation therapy system |
| Regulatory Class: | Class II |
| Product Code: | IYE |
Predicate Device
Radixact Treatment Delivery System (K161146)
Device Description
The Motion Tracking and Compensation Feature is designed for use with the predicate Radixact Treatment Delivery System last cleared on K161146. The Motion Tracking and Compensation Feature measures tumor location and motion using images provided by a kV imaging subsystem and predicts tumor location based upon a respiration amplitude measurement device. The Radixact Treatment Delivery System then compensates for tumor motion by making real-time adjustments.
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.
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Neither the Radixact Treatment Delivery System nor the Motion Tracking and Compensation Feature disease, recommend treatment regimens or quantify treatment effectiveness. Accordingly, they are not intended for diagnostic use.
Intended Use
The Motion Tracking and Compensation Feature is an option within the intended use of the Radixact Treatment Delivery System. 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, 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 Motion Tracking and Compensation Feature is an option within the indications for use of the Radixact Treatment Delivery System. 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.
The intended use and indications for use statements for the Motion Tracking and Compensation Feature (shown above) are the same as for the Radixact Treatment Delivery System (last cleared on K161146), except for the addition of the introductory sentence.
Technological Characteristics
The Radixact Treatment Delivery System with the use of the Motion Tracking and Compensation Feature has imaging and treatment capabilities equivalent to those of the predicate Radixact Treatment Delivery System. It also has a similar functionallyequivalent CT style gantry and patient couch.
The intended use and indications for use of the Motion Tracking and Compensation Feature fit within those of the predicate Radixact Treatment Delivery System. Additionally, the predicate and subject devices have substantially equivalent performance specifications and technological characteristics. Further, the Radixact Treatment Delivery System with the use of the Motion Tracking and Compensation Feature and the predicate device employ the same fundamental scientific principles and have substantially equivalent principles of operation. The main difference between the predicate and the subject device is the use of the motion tracking and compensation feature. Where there are technological differences between the subject and predicate devices, those differences do not raise different questions of safety or effectiveness.
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A substantial equivalence table comparing the similarities and differences between the Radixact Treatment Delivery System with the use of the Motion Tracking and Compensation Feature and the predicate device is presented below. The minor differences between the subject and predicate devices do not raise different questions of safety or effectiveness.
| Device
Characteristic | Predicate Device
Radixact Treatment
Delivery System
(K161146) | Subject Device
Radixact Treatment Delivery
System with Motion Tracking
and Compensation Feature | Analysis |
|--------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System Description | | | |
| Intended Use | Omitted for brevity.
Reference 510(k)
Summary (Section 8
of 510(k) submission) | Same as predicate | Identical |
| Indications for Use | Omitted for brevity.
Reference 510(k)
Summary (Section 8
of 510(k) submission) | Same as predicate | Identical |
| System
Configuration | Stand-alone radiation
delivery system (does
not include data
management system
or planning system) | Stand-alone radiation delivery
system with kV imaging and
motion tracking and
compensation added (does not
include data management
system or planning system) | Substantially
equivalent. The
introduction of the
Motion Tracking and
Compensation Feature
does not raise different
issues of safety or
effectiveness. |
| Vault (Treatment Room) | | | |
| Minimum Room
Dimensions
(HWL) | 274 x 462 x 602 cm | 274.3 x 463 x 602 cm | Substantially
equivalent. Minor
differences are
negligible. |
| Device
Dimensions
(gantry and couch)
(HWL) | 255 x 280 x 473 cm | 255 x 280 x 470.5 cm | Substantially
equivalent. Minor
differences are
negligible. |
| Device Mass (kg) | 6580 kg | 6580 kg plus 235 kg for kV
subsystem components | The weight added due
to the kV subsystem
does not result in
different questions of
safety or effectiveness |
| Device
Characteristic | Predicate Device
Radixact Treatment
Delivery System
(K161146) | Subject Device
Radixact Treatment Delivery
System with Motion Tracking
and Compensation Feature | Analysis |
| Line Voltage | 380 - 480 V ac
3-Phase | Same as predicate | Identical |
| Ambient Room
Temperature | 20 – 24 °C | Same as predicate | Identical |
| Relative Humidity
(non-condensing) | 30 – 60 % | Same as predicate | Identical |
| Gantry Mechanical Features | | | |
| Bore Diameter | 85 cm | Same as predicate | Identical |
| Degrees of
Rotation | Continuous rotation
around Y- axis (axes
per IEC 61217) | Same as predicate | Identical |
| Direction of
Rotation | Clockwise (as viewed
from the foot of the
couch) | Same as predicate | Identical |
| Rotational Speed
(Treatment) | 1 – 5 RPM | Same as predicate | Identical |
| Rotational Speed
(Imaging) | 10 RPM | Same as predicate | Identical |
| Couch Support in
Bore | Provided | Same as predicate | Identical |
| Radiation Delivery Modes | | | |
| Description | Helical, Direct | Same as predicate | Identical |
| Photon Beam | | | |
| Accelerator Type | Standing wave | Same as predicate | Identical |
| RF Source | Magnetron | Same as predicate | Identical |
| Nominal Energy | 6 MV | Same as predicate | Identical |
| Fixed Field Size | 1.0 cm x 40 cm
2.5 cm x 40 cm
5.0 cm x 40 cm | Same as predicate | Identical |
| Dynamic Field
Size | 1.0 – 2.5 cm x 40 cm
1.0 - 5.0 cm x 40 cm | Same as predicate | Identical |
| Dose Rate | 850 cGy/min
standard
1000 cGy/min
optional | Same as predicate | Identical |
| Collimation | | | |
| Description | Primary collimation,
jaws and multi-leaf | Primary collimation, jaws and
multi-leaf collimator | Substantially
equivalent. Jaws have |
| Device
Characteristic | Predicate Device
Radixact Treatment
Delivery System
(K161146) | Subject Device
Radixact Treatment Delivery
System with Motion Tracking
and Compensation Feature | Analysis |
| | collimator | | a new dynamic
behavior for motion
managed plans. Jaws
will continually be
adjusted to repoint the
beam at the moving
target (in IEC-Y)
while maintaining the
same field size. |
| MVCT Imaging | | | |
| Source | Megavoltage
Computed
Tomography
(MVCT) | Same as predicate | Identical |
| Field of View
(MVCT) | 39 cm diameter | Same as predicate | Identical |
| Dose per MVCT
Image (typical) | 0.5 - 3.0 cGy | Same as predicate | Identical |
| Slice Spacing
(MVCT) | 1, 2, 3, 4 and 6 mm
reconstruction
intervals | Same as predicate | Identical |
| Spatial Resolution
(MVCT) | 1.6 mm | Same as predicate | Identical |
| kV Imaging | | | |
| Source | Feature not present | 50-150 kV Radiography Class I
(60601-2-28) X-ray tube
assembly | The kV Imaging
subsystem provides
two-dimensional low- |
| Field of View | Feature not present | 20 cm x 20 cm | dose radiographic |
| Spatial Resolution
(kV) | Feature not present |