(116 days)
No
The summary describes standard image acquisition and reconstruction techniques for CT imaging, with no mention of AI or ML algorithms for image processing, analysis, or treatment planning.
Yes
The device is described as a "radiation therapy delivery system" that delivers "radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body," which are therapeutic interventions.
No
The device is described as a radiation therapy delivery system, indicated for "delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues". While it uses imaging for guidance (Image Guided Radiation Therapy), its primary function is therapy delivery, not diagnosis. The imaging feature itself is for "acquisition of kV x-ray images... and returning reconstructed 3D images" to aid in treatment delivery, not for diagnosing medical conditions.
No
The device description explicitly states that the kVCT Imaging Feature is designed for use with the Radixact Treatment Delivery System, which is a radiation therapy delivery system including hardware components like kV x-ray and megavoltage CT imaging capabilities. The feature's functions involve acquiring and processing images from this hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the delivery of radiation therapy to tumors or other targeted tissues anywhere in the body. This is a therapeutic application, not a diagnostic one performed on samples taken from the body.
- Device Description: The device is a radiation therapy delivery system that uses imaging for guidance (Image Guided Radiation Therapy - IGRT). While it acquires images, the primary function is to deliver radiation, not to diagnose a condition based on analysis of a sample.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The imaging feature is used to guide the radiation treatment, which is a therapeutic procedure performed directly on the patient's body.
N/A
Intended Use / Indications for Use
The kVCT Imaging 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 kVCT Imaging Feature is designed for use with the predicate Radixact Treatment Delivery System last cleared on K161146. The primary functions of the kVCT Imaging Feature are: 1) acquisition of kV x-ray images according to input protocols in concert with other subsystems, 2) correcting 2D images and 3) returning reconstructed 3D images.
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.
Neither the Radixact Treatment Delivery System nor the kVCT Imaging Feature diagnose disease, recommend treatment regimens or quantify treatment effectiveness. Accordingly, they are not intended for diagnostic use.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
kVCT, Megavoltage Computed Tomography
Anatomical Site
anywhere in the body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
licensed medical practitioner / Not Found
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 kVCT Imaging 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 kVCT Imaging Feature on the Radixact Treatment Delivery System conforms to design specifications and meets the needs of the intended users.
No animal or clinical tests are being submitted to establish substantial equivalence with the predicate device. The performance data demonstrate that the kVCT Imaging Feature is compatible with the Radixact Treatment Delivery System, and the Radixact Treatment Delivery System with the use of the kVCT Imaging 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 kVCT Imaging 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)
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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December 18, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Accuray Incorporated % Keith Picker Senior Regulatory Affairs Specialist 1240 Deming Way MADISON WI 53717
Re: K202412
Trade/Device Name: kVCT Imaging 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: November 24, 2020 Received: November 25, 2020
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. Although this letter refers to your product as a device, please be aware 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/cfpmp/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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (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
1
https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K202412
Device Name
kVCT Imaging Feature for the Radixact Treatment Delivery System
Indications for Use (Describe)
The kVCT Imaging 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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Image /page/3/Picture/0 description: The image shows the Accuray logo. The logo consists of a stylized atom symbol in teal, green, and purple, followed by the word "ACCURAY" in teal, with a registered trademark symbol next to it. The logo is clean and modern.
Section 8 510(k) Summary
Submitter
Accuray Incorporated 1240 Deming Way Madison, WI 53717 Phone: 608-824-3069 Fax: 608-824-2996
| Contact: | Keith Picker |
|---|---|
| Date Prepared: | November 24, 2020 |
Device Identification
Device Name: kVCT Imaging Feature for the Radixact Treatment Deliverv System Trade & Brand Names: ClearRT Helical kVCT 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)
Reference Device:
Motion Tracking And Compensation Feature For The Radixact Treatment Delivery System (K182687)
Device Description
The kVCT Imaging Feature is designed for use with the predicate Radixact Treatment Delivery System last cleared on K161146. The primary functions of the kVCT Imaging Feature are: 1) acquisition of kV x-ray images according to input protocols in concert with other subsystems, 2) correcting 2D images and 3) returning reconstructed 3D images.
The Radixact Treatment Delivery System is a radiation therapy delivery system that provides Image Guided Radiation Therapy (IGRT) using integral megavoltage CT
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imaging capabilities and delivers helical (rotational) and fixed-angle (non-rotational) radiation therapy to tumors and other targeted tissues.
Neither the Radixact Treatment Delivery System nor the kVCT Imaging Feature diagnose disease, recommend treatment regimens or quantify treatment effectiveness. Accordingly, they are not intended for diagnostic use.
Intended Use
The kVCT Imaging 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 kVCT Imaging 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 kVCT Imaging 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 as kVCT Imaging is a type of Image Guided Radiotherapy (IGRT).
Technological Characteristics
The Radixact Treatment Delivery System with the use of the kVCT Imaging Feature has imaging and treatment capabilities equivalent to those of the predicate Radixact Treatment Delivery System. It also has a similar functionally-equivalent CT style gantry and patient couch.
The intended use and indications for use of the kVCT Imaging 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 kVCT Imaging 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 kVCT Imaging 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 kVCT Imaging Feature and the predicate device is presented below in Table 5.5.1. The minor differences between the subject and predicate devices do not raise different questions of safety or effectiveness.
A table comparing the similarities and differences between the Radixact Treatment Delivery System with the use of the kVCT Imaging Feature and the reference device (K182687) is provided in Table 5.5.2 below. The minor differences between the subject and predicate devices do not raise different questions of safety or effectiveness. The kV Imaging subsystem provides three-dimensional CT images with equivalent or better performance than the predicate device (MVCT). The kVCT energy range offer improved intrinsic tissue contrast and image quality characteristics compared to that of MVCT imaging.
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Table 5.5.1 Device Comparison Table: Radixact Treatment Delivery System with kVCT Imaging Feature
| Device
Characteristic | Predicate Device
Radixact Treatment
Delivery System
(K161146) | Subject Device
Radixact Treatment
Delivery System with
kVCT Imaging
Feature | Analysis |
|----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| System Description | | | |
| 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, 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. | The kVCT Imaging
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. | Identical |
| Device
Characteristic | Predicate Device
Radixact Treatment
Delivery System
(K161146) | Subject Device
Radixact Treatment
Delivery System with
kVCT Imaging
Feature | Analysis |
| 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. | The kVCT Imaging
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. | Identical |
| Classification | §892.5050 Medical
charged-particle radiation
therapy system, class II | 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 added
(does not include data
management system or
planning system) | Substantially
equivalent. The
introduction of
the kVCT
imaging feature
does not raise
different issues
of safety or
effectiveness.
The risk
acceptability
determination
was not
impacted by the
modified design. |
| Device
Characteristic | Predicate Device
Radixact Treatment
Delivery System
(K161146) | Subject Device
Radixact Treatment
Delivery System with
kVCT Imaging
Feature | Analysis |
| 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 + 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 | 7000 kg (approximate) | Substantially
equivalent. The
added mass due to
the kVCT imaging
subsystem does not
result in different
questions of safety
or effectiveness. |
| Line Voltage | 380 - 480 Vac 3-
Phase | 380 - 480 Vac 3-Phase | Identical |
| Ambient Room
Temperature | 20 - 24 °C | 20 - 24 °C | Identical |
| Relative
Humidity
(non-
condensing) | 30 - 60 % | 30 - 60 % | Identical |
| Device
Characteristic | Predicate Device
Radixact Treatment
Delivery System
(K161146) | Subject Device
Radixact Treatment
Delivery System with
kVCT Imaging
Feature | Analysis |
| Gantry Mechanical Features | | | |
| Bore Diameter | 85 cm | 85 cm | Identical |
| Degrees of
Rotation | Continuous rotation
around Y- axis
(axes per IEC 61217) | Continuous rotation
around Y- axis
(axes per IEC 61217) | Identical |
| Direction of
Rotation | Clockwise | Clockwise | Identical |
| Rotational
Speed
(Treatment) | 1 - 5 RPM | 1 - 5.08 RPM | Substantially
equivalent. Minor
differences are
negligible and do
not result in
different questions
of safety or
effectiveness. |
| Rotational
Speed (Imaging) | 10 RPM | Up to 10 RPM | Substantially
equivalent.
Rotational speed is
unchanged for
MVCT imaging.
Slower speeds are
used for some
kVCT imaging
applications. |
| Couch Support
in Bore | Provided | Provided | Identical |
| Radiation Delivery Modes | | | |
| Description | Helical, Direct | Helical, Direct | Identical |
| Device
Characteristic | Predicate Device
Radixact Treatment
Delivery System
(K161146) | Subject Device
Radixact Treatment
Delivery System with
kVCT Imaging
Feature | Analysis |
| Photon Beam | | | |
| Accelerator
Type | Standing wave | Standing wave | Identical |
| RF Source | Magnetron | Magnetron | Identical |
| Nominal Energy | 6 MV | 6 MV | Identical |
| Fixed Field Size | 1.0 cm x 40 cm
2.5 cm x 40 cm
5.0 cm x 40 cm | 1.0 cm x 40 cm
2.5 cm x 40 cm
5.0 cm x 40 cm | Identical |
| Dynamic Field
Size | 1.0 – 2.5 cm x 40 cm
1.0 – 5.0 cm x 40 cm | 1.0 – 2.5 cm x 40 cm
1.0 – 5.0 cm x 40 cm | Identical |
| Dose Rate | 850 cGy/min standard
1000 cGy/min
optional | 850 cGy/min standard
1000 cGy/min optional | Identical |
| MV Beam Collimation | | | |
| Description | Primary collimation,
jaws and multi-leaf
collimator (MLC) | Primary collimation,
jaws and multi-leaf
collimator (MLC) | Substantially equivalent. kVCT
does not change
the behavior of the
jaws. |
| Device
Characteristic | Predicate Device
Radixact Treatment
Delivery System
(K161146) | Subject Device
Radixact Treatment
Delivery System with
kVCT Imaging
Feature | Analysis |
| MVCT Imaging | | | |
| Source | Megavoltage
Computed
Tomography | Megavoltage
Computed
Tomography | Identical |
| Field of View
(FOV) | 39 cm diameter | 39 cm diameter | Identical |
| Scan Length
[Specification
not detailed in
K161146] | 135 cm | 135 cm | Identical |
| Imaging Dose | 0.5 - 3.0 cGy
(imaging dose near
center of Tomo-
Phantom) | 1.1 - 3.4 cGy
(CTDIvol, Head)
0.8 - 2.5 cGy
(CTDIvol, Body) | Identical.
Differences shown
are due to
additional detail
provided and dose
characterized in
CTDIvol |
| Slice Spacing | 1, 2, 3, 4 and 6 mm
reconstruction
Intervals | 1, 2, 3, 4 and 6 mm
reconstruction
Intervals | Identical |
| Spatial
Resolution | 1.6 mm | 1.6 mm (at 3.2 mm
intervals) | Substantially
equivalent |
| Image Size
[Specification
not detailed in
K161146] | 512 x 512 pixels | 512 x 512 pixels | Identical |
| Image
Uniformity
[Specification
not detailed in
K161146] | Within 25 HU | Within 25 HU | Identical |
| Device
Characteristic | Predicate Device
Radixact Treatment
Delivery System
(K161146) | Subject Device
Radixact Treatment
Delivery System with
kVCT Imaging
Feature | Analysis |
| Image Noise
[Specification
not detailed in
K161146] | Less than 43 HU | Less than 43 HU | Substantially
equivalent |
| Contrast
Resolution
[Specification
not detailed in
K161146] | 3% contrast for 30 mm
object | 3% contrast for 30 mm
object or better | Substantially
equivalent |
| Acquisition
Trajectory
[Specification
not detailed in
K161146] | Helical | Helical | Identical |
| Device
Characteristic | Predicate Device
Radixact
Treatment
Delivery System
(K161146) | Subject Device
Radixact Treatment
Delivery System with
kVCT Imaging Feature | Analysis |
| kVCT Imaging | | | |
| Imaging Dose | Feature not present | 0.6 - 4.3 (CTDIvol, Head)
0.4 - 2.3 (CTDIvol, Body) | |
| Acquisition
Trajectory | Feature not present | Helical | |
| Slice Spacing | Feature not present | 1.2, 1.8, 3.6 mm | Substantially
equivalent. The kV |
| Spatial
Resolution | Feature not present | 1.0 mm (at 2.0 mm
intervals) | Imaging subsystem
provides three- |
| Image Size | Feature not present | 512 x 512 pixels | dimensional CT
images with
equivalent or better
performance than
the predicate
device (MVCT).
The kVCT energy
range offer
improved intrinsic
tissue contrast and
image quality |
| Scan Length | Feature not present | Up to 135 cm | |
| Field of View
(FOV) | Feature not present | 25 - 50 cm | |
| Image
Uniformity | Feature not present | Within 15 HU (Head)
Within 25 HU (Body) | |
| Image Noise | Feature not present | Less than 10 HU (Head)
Less than 20 HU (Body) | |
| Contrast
Resolution | Feature not present | 1% contrast for 10 mm
object (Head)
2% contrast for 15 mm
object (Body) | characteristics
compared to that
of MVCT imaging. |
| Image Display | Feature not present | Simultaneous acquisition
and reconstruction; real
time display | |
| Device
Characteristic | Predicate Device
Radixact Treatment
Delivery System
(K161146) | Subject Device
Radixact Treatment
Delivery System with
kVCT Imaging
Feature | Analysis |
| Laser System | | | |
| Stationary | Green lasers, identify
virtual and actual
isocenter | Green lasers, identify
virtual and actual
isocenter | Substantially
equivalent. Minor
differences are
negligible and do |
| Moveable
(for patient
positioning
and registration) | Red lasers, offset from
virtual isocenter | Red lasers, offset from
virtual isocenter | negligible and do
not result in
different questions
of safety or
effectiveness. |
| Patient Couch | | | |
| Motion | Independent of each of
the other axes | Independent of each of
the other axes | Identical |
| Biocompatibility | | | |
| Couch Top | Carbon-fiber top | Carbon-fiber top | Identical |
| Power Distribution | | | |
| Isolation | Transformer | Transformer | Substantially
equivalent. This
feature is still
present. |
| UPS for Data
Back-up | Provided | Provided | Substantially
equivalent. This
feature is still
present. |
| Operator Station (Treatment Delivery Console) | | | |
| Description | User interface to
system functions (i.e.,
patient and procedure
selection, and
procedure delivery) | User interface to
system functions (i.e.,
patient and procedure
selection, and
procedure delivery) | Substantially
equivalent. The
modified device
does not change
this architecture. |
| Device
Characteristic | Predicate Device
Radixact Treatment
Delivery System
(K161146) | Subject Device
Radixact Treatment
Delivery System with
kVCT Imaging
Feature | Analysis |
| Machine Control Software | | | |
| Description | Controls radiation
delivery and
positioning systems
(referred to as the ECS – Embedded Controls
Subsystem) | Controls radiation
delivery and
positioning systems
(referred to as the ECS – Embedded Controls
Subsystem) | Substantially
equivalent, except
for the following:
Controls were
added for the
dynamic kV
Collimator and kV
Panel Actuator,
and kV triggering |
| Database | | | |
| Data Interfaces
Operator Station | Provides
measurements and
status during operation | Provides
measurements and
status during operation | Substantially
equivalent. The
kVCT imaging
functionality was
added to the
existing design. No
different issues of
safety or
effectiveness. |
| Database
Description | External database used
for gathering
operational data and
storage of procedure
data | External database used
for gathering
operational data and
storage of procedure
data | Substantially
equivalent. The
introduction of the
kVCT imaging
feature does not
modify this design
outside of
accommodating for
more data. |
| Device
Characteristic | Predicate Device
Radixact Treatment
Delivery System
(K161146) | Subject Device
Radixact Treatment
Delivery System with
kVCT Imaging
Feature | Analysis |
| Safety Features | | | |
| Interlock
Subsystems | Interlock Subsystems | Present | Substantially
equivalent. The kV
subsystem is
integrated into the
Safety Interlocks.
No different issues
of safety or
effectiveness. |
| Data Integrity
Checking | Data Integrity
Checking | Present | Substantially
equivalent. This
feature is still
present in the
modified device. |
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| Device
Characteristic | Reference Device
Motion Tracking and
Compensation for
Radixact
(K182687) | Subject Device
Radixact Treatment
Delivery System with
kVCT Imaging
Feature | Analysis |
|--------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| MV Beam
Collimation | Primary collimation,
jaws and multi-leaf
collimator (MLC) | Primary collimation,
jaws and multi-leaf
collimator (MLC) | kVCT does not
change the
behavior of the
jaws. Identical to
the dynamic
behavior
introduced in
K182687. |
| Machine
Control
Software | Controls radiation
delivery and
positioning systems
(referred to as the ECS
– Embedded Controls
Subsystem) | Controls radiation
delivery and
positioning systems
(referred to as the ECS
– Embedded Controls
Subsystem) | Substantially
equivalent, except
for the following:
Controls were
added for the
dynamic kV
Collimator and kV
Panel Actuator,
and kV triggering
was modified.
These controls are
similar in nature to
those introduced in
K182687. |
| Device
Characteristic | Reference Device
Motion Tracking and
Compensation for
Radixact
(K182687) | Subject Device
Radixact Treatment
Delivery System with
kVCT Imaging
Feature | Analysis |
| kV Imaging Beam | | | |
| Source | 50 – 150 kV
Radiography Class I
(60601-2-28) X-ray
tube assembly | 40 – 150 kV
Radiography Class I
(60601-2-28) X-ray
tube assembly | |
| Focal Spot Size | 0.6 mm x 0.6 mm
(small spot)
1.0 mm x 1.0 mm
(large spot) | 0.6 mm x 0.6 mm
(small spot)
1.2 mm x 1.2 mm
(large spot) | Substantially
equivalent. The X-
ray generation
assembly
(including the
tube) has been
updated to handle |
| Anode Heat
Capacity | 600 KHU | 1500 KHU | the increased
demands of kVCT
imaging over the
solely 2-D
radiograph
imaging available |
| Tube Heat
Management
[Specification
not detailed in
K182687] | Passive | Active oil cooled, 2.4 kW | in the predicate. |
| Generator
specifications
[Specification
not detailed in
K182687] | 400/480 V, 45 kW | 400/480 V, 80 kW | |
| Source to axis
distance
[Specification
not detailed in
K182687] | 575 mm | 1040 mm | Substantially
equivalent. The
combination of
source to axis
|
| Source to
detector distance
[Specification
not detailed in
K182687] | 1130 mm | 1560 mm | detector distance
and pixel pitch
have been
modified in the
subject device with
no material impact. |
| Device
Characteristic | Reference Device
Motion Tracking and
Compensation for
Radixact
(K182687) | Subject Device
Radixact Treatment
Delivery System with
kVCT Imaging
Feature | Analysis |
| kV Beam Filtering & Collimation | | | |
| kV Collimation
(description)
[Specification
not detailed in
K182687] | Static collimation | Dynamic IEC-Xb
collimating blades,
Dynamic IEC-Yb
collimating blades | Substantially
equivalent. This
impacts kV
radiographs, since
the modified
device now limits
the imaging beam
to the active area
of the kV detector
using the
collimator blades,
as opposed to the
static collimation
used in the
predicate. |
| kV Spectral
Filtering
(description)
[Specification
not detailed in
K182687] | 0.5 mm copper | Dynamically
selectable filter of
0.2 mm, 0.3, or
0.5 mm copper, or
open air | Substantially
equivalent. There
is no impact
relative to the
reference device,
since the modified
device continues to
use the 0.5 mm
copper filter
available |
Table 5.5.2: Device Comparison Table: Radixact Treatment Delivery System with kVCT Imaging Feature and the Reference Device
18
19
20
| Device
Characteristic | Reference Device
Motion Tracking and
Compensation for
Radixact
(K182687) | Subject Device
Radixact Treatment
Delivery System with
kVCT Imaging
Feature | Analysis |
|--------------------------------------------------------------|--------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| kV Detector | | | |
| Active Area
[Specification
not detailed in
K182687] | 410 mm x 410 mm
1024x1024 pixels, 0.4
mm pitch | 432 mm x 432 mm
2880x2880 pixels,
0.15 mm pitch | Substantially
equivalent. The
subject device
provides the same
or better active
area with the same
or better pixel
resolution as
compared to the
reference device. |
| Detector
Configuration | Flat panel CsI: Tl
Thallium activated
Cesium Iodide | Flat panel CsI: Tl
Thallium activated
Cesium Iodide | Substantially
equivalent. The
materials have not
changed. |
| Actuation | Feature not present | -225 to +25 mm along
the IEC-Xr axis (axes
per IEC 61217) | Substantially
equivalent. The
modified device
can dynamically
collimate the beam
to the detector
position |
21
Performance Data
The Radixact Treatment Delivery System with the use of the kVCT Imaging 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 kVCT Imaging Feature on the Radixact Treatment Delivery System conforms to design specifications and meets the needs of the intended users.
No animal or clinical tests are being submitted to establish substantial equivalence with the predicate device. The performance data demonstrate that the kVCT Imaging Feature is compatible with the Radixact Treatment Delivery System, and the Radixact Treatment Delivery System with the use of the kVCT Imaging 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 kVCT Imaging Feature has substantially equivalent safety and performance characteristics in comparison to the predicate device.
Conclusion
The Radixact Treatment Delivery System with the use of the kVCT Imaging Feature is substantially equivalent to the predicate device. The intended use and indications for use of the kVCT Imaging Feature fit within those of the predicate Radixact Treatment Delivery System. Additionally, the major technological characteristics and the principles of operation of the Radixact Treatment Delivery System with the use of the kVCT Imaging Feature 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 with the use of the kVCT Imaging Feature in comparison to the predicate device. Further, the performance data demonstrate that the kVCT Imaging Feature is compatible with the Radixact Treatment Delivery System, and the Radixact Treatment Delivery System with the use of the kVCT Imaging Feature is as safe and effective and performs as well as the predicate device. Therefore, the Radixact Treatment Delivery System with the use of the kVCT Imaging Feature is substantially equivalent to the predicate device.