(112 days)
No
The document describes advanced optical surface tracking and 3D reconstruction using structured light and optical triangulation. While this involves sophisticated image processing and data analysis, there is no mention of AI, ML, or deep learning techniques being used for tasks like pattern recognition, prediction, or decision-making beyond basic positional deviation detection and gating based on predefined thresholds. The focus is on accurate measurement and comparison to a reference setup.
No.
The device's intended use is to accurately set up, position, and monitor patients during radiation therapy, providing information about patient position and triggering beam disablement for large movements. It does not directly treat or diagnose a disease.
No
This device is used for patient setup, positioning, and monitoring during radiation therapy, and it does not diagnose medical conditions.
No
The device description explicitly states that the Catalyst system "contains a new hardware device" and describes the hardware components, including a scanner unit with a projector and camera.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the Catalyst system is for "accurately set-up and position patients in a reproducible way prior to treatment, and to monitor the patient continuously during treatment" in radiation therapy clinics. This is a therapeutic application, not a diagnostic one.
- Device Description: The description focuses on optical surface tracking for patient positioning and monitoring during radiotherapy. It describes how it works by reconstructing a 3D surface of the patient using structured light. This is a physical measurement and tracking system, not a system that analyzes biological samples.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples (blood, urine, tissue, etc.) which is a core characteristic of IVD devices.
- Focus on Patient Positioning and Motion: The primary functions described are patient positioning, motion detection, and respiratory tracking, all of which are related to the physical setup and monitoring of the patient during treatment.
IVD devices are designed to perform tests on biological samples to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The Catalyst system does not fit this definition.
N/A
Intended Use / Indications for Use
The Catalyst system is intended for use in radiation therapy clinics to accurately set-up and position patients in a reproducible way prior to treatment, and to monitor the patient continuously during treatment. The system provides information about a patient's position and the adjustments required in order to position the patient as close as possible to a reference setup. During monitoring, the system reports deviations in the patient's position during treatment and disables the treatment beam in case of large detected movements. The system can also track the patient's respiratory motion for supporting synchronized image acquisition or gated treatment delivery.
The system shall only be used by hospital personnel, qualified to work in radiation therapy or diagnostic imaging departments.
Product codes
IYE
Device Description
The Catalyst system is a further development of the Sentinel system and is using the same software platform but contains a new hardware device which enables overall higher performance and the possibility to run multiple applications in parallel.
Catalyst is an advanced system based on optical surface tracking for patient monitoring during the radiotherapy treatment process. The Catalyst platform is based on advanced structured light measurements with multipurpose software modules covering different tasks in the treatment procedure. The c4D multi-application software supports all modes of operation in one integrated package. The software is user friendly and requires a minimum of user interaction in the daily clinical workflow, while providing the advanced user with sophisticated data management, analysis and reporting functionalities. The software is designed to integrate with existing systems at the clinic, such as CT, linacs and R&V systems, and with motorized couch tops.
Catalyst includes three application modules, cPosition for fast and accuracy patient positioning, cMotion for motion detection during the treatment delivery procedure, and cRespiration for detecting respiratory motion and generating a gating signal for synchronized imaging or gated treatment delivery.
The Catalyst hardware consists of a single scanner unit containing the projector and camera, mounted in the celling in front of the gantry. The scanner is connected to the PC running the c4D software.
During patient surface acquisition, a sequence of structured light patterns is illuminating the patient while the camera records a number of images. From the data acquired, a complete 3D surface of the patient can be reconstructed using the principles of optical triangulation. Information from the system is shown on a PC monitor in the treatment room as well as the control area. The system can also project a high resolution multi-color light field onto the patient surface, thus avoiding the need for the personnel to look at the PC monitor when setting up the patient. The system optionally records data which can be used for further analysis of actual patient motion during each treatment session.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Structured visible light pattern
Anatomical Site
No specific restrictions
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Hospital personnel, qualified to work in radiation therapy or diagnostic imaging departments.
Care Setting: Hospital
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 measurement accuracy is better than 1 mm for Catalyst and its predicates. The performance test results are presented in the application.
Further is an overview of all verification and validation activities presented.
The results from the verification of the Catalyst product shows that all important requirements and safety keys have been implemented and are functioning according to the requirement specification. The verification and validation also shows that all residual risks regarding the identified safety requirement keys listed in are acceptable and the product is safe for use.
The validation performed at Varian Medical Systems, UAS and Malmö shows that the Catalyst application for patient positioning, monitoring and respiratory gating is functioning according to its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Measurement accuracy better than 1 mm.
Predicate Device(s)
Reference Device(s)
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
K113276 PAD
FEB 2 7 2012
510(k) SUMMARY
Owner
C-RAD Positioning AB Bredgränd 18 753 20 Uppsala Phone no: +46 18 666930 Fax no: +46 18 126930
Contact person
Janina Östling Quality Manager Phone no: +46 18 666940
Date of preparation
October 25, 2011
Trade name of device Catalyst
Common name
Radiotherapy positioning system
Classification name
Medical charged-particle radiation therapy system Regulation: 21 CFR 892.5050
Predicate marketed devices
Sentinel (K082582) - C-RAD Positioning AB GateCT-RT (K072171) - Vision RT Ltd.
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Image /page/1/Picture/0 description: The image shows the logo for C-RAD. The logo consists of a stylized letter "C" followed by the text "-RAD". The "C" is a solid black color, while the "RAD" is outlined in black. The logo is simple and modern.
Device description
The Catalyst system is a further development of the Sentinel system and is using the same software platform but contains a new hardware device which enables overall higher performance and the possibility to run multiple applications in parallel.
Catalyst is an advanced system based on optical surface tracking for patient monitoring during the radiotherapy treatment process. The Catalyst platform is based on advanced structured light measurements with multipurpose software modules covering different tasks in the treatment procedure. The c4D multi-application software supports all modes of operation in one integrated package. The software is user friendly and requires a minimum of user interaction in the daily clinical workflow, while providing the advanced user with sophisticated data management, analysis and reporting functionalities. The software is designed to integrate with existing systems at the clinic, such as CT, linacs and R&V systems, and with motorized couch tops.
Catalyst includes three application modules, cPosition for fast and accuracy patient positioning, cMotion for motion detection during the treatment delivery procedure, and cRespiration for detecting respiratory motion and generating a gating signal for synchronized imaging or gated treatment delivery.
The Catalyst hardware consists of a single scanner unit containing the projector and camera, mounted in the celling in front of the gantry. The scanner is connected to the PC running the c4D software.
During patient surface acquisition, a sequence of structured light patterns is illuminating the patient while the camera records a number of images. From the data acquired, a complete 3D surface of the patient can be reconstructed using the principles of optical triangulation. Information from the system is shown on a PC monitor in the treatment room as well as the control area. The system can also project a high resolution multi-color light field onto the patient surface, thus avoiding the need for the personnel to look at the PC monitor when setting up the patient. The system optionally records data which can be used for further analysis of actual patient motion during each treatment session.
cPosition
Once the treatment planning has been performed, the resulting plan can be transferred to the Catalyst system through import from the industry-standard DICOM format, creating the reference data necessary for patient positioning. Reference data can also be by created using the Catalyst scanner. In the treatment room, synchronization with the LINAC or R & V (Record and Verify) system ensures that the correct reference data is called up automatically when the patient is selected for treatment, and also eliminates the need for any manual selection of the patient in the Catalyst system.
By advanced surface registration algorithms the actual patient position is compared to the predefined reference, suggesting within seconds a correction in six degrees of freedom of the patient's position. With interface to major accelerator vendors the suggested patient position is transferred to the respective couch control system and fast and accurate alignment is achieved. Suggested corrections are also projected directly onto the patient's skin to further simplify the set-up process.
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Image /page/2/Picture/0 description: The image shows the logo for C-RAD. The logo consists of a stylized letter N, followed by the text "C-RAD". The letters are black and have a bold, outlined appearance.
cMotion
cMotion monitors the movement of the patient during treatment delivery and warns if the patient moves outside the allowed tolerances. A beam hold signal is also produced by the system, which enables automatic interruption of the treatment delivery in case of large detected patient motion.
cRespiration
In the treatment room, the patient's respiratory motion is monitored and the treatment beam will be turned on only when the signal is within a predetermined gating window. An imaging system can be triggered so that image acquisition is synchronized to the same gating window. Alternatively, so-called 4D reconstruction is possible by providing the recorded respiratory signal for retrospective gating of the acquired images.
Intended use
The Catalyst system is intended for use in radiation therapy clinics to accurately set-up and position patients in a reproducible way prior to treatment, and to monitor the patient continuously during treatment. The system provides information about a patient's position and the adjustments required in order to position the patient as close as possible to a reference setup. During monitoring, the system reports deviations in the patient's position during treatment and disables the treatment beam in case of large detected movements. The system can also track the patient's respiratory motion for supporting synchronized image acquisition or gated treatment delivery.
The system shall only be used by hospital personnel, qualified to work in radiation therapy or diagnostic imaging departments.
Technological comparison
The difference between the Catalyst system and the Sentinel and GateCT-RT systems is mainly in the technology used for image acquisition, but would not affect safety or effectiveness.
The Catalyst system uses a structured light projector/camera system to acquire a set of 3D contours that represents the patient surface, while the Sentinel uses a laser camera and the GateCT-RT system instead uses a fixed projected light pattern and two cameras. All three systems use a triangulation technique to calculate the 3D positions from the acquired 2D images.
Since the Catalyst system and its predicate devices all perform with the same measurement accuracy, and Catalyst has the same functionality as the Sentinel system for patient positioning and monitoring, and the same functionality for the GateCT-RT system for interrupting the treatment beam and synchronized imaging, no new safety concerns are raised.
The submitted verification and validation documentation demonstrates that the Catalyst is suitable for its intended use and is safe to use.
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Image /page/3/Picture/0 description: The image shows the logo for C-RAD. The logo consists of a stylized letter N, followed by the letters C, a dash, R, A, and D. The letters are all in a bold, sans-serif font. The logo is simple and modern.
Device comparison table
| | C-RAD Catalyst
(K113276) | C-RAD Sentinel
(K082582) | VisionRT GateCT-RT
(K072171) |
|------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The Catalyst system is
intended for use in
radiation therapy clinics to
accurately set-up and
position patients in a
reproducible way prior to
treatment, and to monitor
the patient continuously
during treatment. The
system provides
information about a
patient's position and the
adjustments required in
order to position the
patient as close as possible
to a reference setup.
During monitoring, the
system reports deviations
in the patient's position
during treatment and
disables the treatment
beam in case of large
detected movements. The
system can also track the
patient's respiratory
motion for supporting
synchronized image
acquisition or gated
treatment delivery.
The system shall only be
used by hospital personnel,
qualified to work in
radiation therapy or
diagnostic imaging
departments. | Identical
capabilities
except that the
Sentinel system
cannot interrupt
or gate the
radiation therapy
treatment beam. | Identical capabilities for
tracking of respiratory
motion, synchronized
image acquisition and
gated radiation therapy
treatment. |
| Indications for use | Same as above | Same as above | Same as above |
| Target population | External-beam radiation
therapy patients | Identical | Identical |
| Anatomical sites | No specific restrictions | No specific
restrictions | No specific restrictions |
| Where used | Hospital | Hospital | Hospital |
| Energy used and/or
delivered | Visible light (LED) | Visible light
(laser) | Visible light |
| Human factors | Only qualified and trained
personnel are allowed to | Identical | Identical |
| | | | |
| | run the system. Usability
validation tests performed
in collaboration with
Hospitals. | | |
| Design | Optical triangulation
measurement system using
structured visible light
pattern using one LED
light source and one digital
camera. Additional LED
light sources for projecting
visible light patterns. | Optical
triangulation
measurement
system using one
line laser and one
digital camera. | Optical triangulation
measurement system
using one light
projector and two
digital cameras. |
| Performance | Measurement accuracy
better than 1 mm. | Measurement
accuracy better
than 1 mm. | Measurement accuracy
better than 1 mm. |
| Standards met | EN/IEC 60601-1 | EN/IEC 60601-1,
EN/IEC 60825 | EN/IEC 60601-1 |
| Materials | No hazardous materials
used, system not in direct
contact with patients. | No hazardous
materials used,
system not in
direct contact
with patients. | No hazardous materials
used, system not in
direct contact with
patients. |
| Biocompatibility | N/A | N/A | N/A |
| Compatibility with
the environment
and other devices | EMC according to EN/IEC
60601-1-2 | EMC according
to EN/IEC 60601-
1-2 | EMC according to
EN/IEC 60601-1-2 |
| Sterility | N/A | N/A | N/A |
| Electrical safety | EN/IEC 60601-1 | EN/IEC 60601-1 | EN/IEC 60601-1 |
| Mechanical safety | EN/IEC 60601-1 | EN/IEC 60601-1 | EN/IEC 60601-1 |
| Chemical safety | N/A | N/A | N/A |
| Thermal safety | N/A | N/A | N/A |
| Radiation safety | N/A | N/A | N/A |
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Image /page/4/Picture/0 description: The image shows the logo for C-RAD. The logo consists of a stylized letter "N" followed by the text "C-RAD". The "N" is a geometric shape with black and white shading. The text "C-RAD" is in a simple, sans-serif font.
Performance data
The measurement accuracy is better than 1 mm for Catalyst and its predicates. The performance test results are presented in the application.
Further is an overview of all verification and validation activities presented.
The results from the verification of the Catalyst product shows that all important requirements and safety keys have been implemented and are functioning according to the requirement specification. The verification and validation also shows that all residual risks regarding the identified safety requirement keys listed in are acceptable and the product is safe for use.
The validation performed at Varian Medical Systems, UAS and Malmö shows that the Catalyst application for patient positioning, monitoring and respiratory gating is functioning according to its intended use.
5
Image /page/5/Picture/0 description: The image shows the logo for C-RAD. The logo consists of a stylized letter "N" followed by the text "C-RAD". The letters are bold and outlined in black. The logo appears to be for a company or organization called C-RAD.
Conclusion
The Catalyst system is substantially equivalent to the predicate devices in terms of their intended use and performance.
Performance data has been submitted to show that Catalyst achieves its intended use, is safe to use and that the technological differences between Catalyst and its predicates raise no new effectiveness or safety concerns.
6
Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, a symbol often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Janina Östling OualityManager C-RAD Positioning AB Bredgränd 18 753 20 Uppsala SWEDEN
FEB 2 7 2012
Re: K113276
Trade/Device Name: Catalyst Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: February 16, 2012 Received: February 21, 2012
Dear Ms. Östling:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
8
C-RAD
INDICATIONS FOR USE
510(k) Number (if known): K113276
Device Name: Catalyst
Indications for use:
The Catalyst system is intended for use in radiation therapy clinics to accurately set-up and position patients in a reproducible way prior to treatment, and to monitor the patient continuously during treatment. The system provides, information about a patient's position and the adjustments required in order to position the patient as close as possible to a reference setup. During monitoring, the system reports deviations in the patient's position during treatment and disables the treatment beam in case of large detected movements. The system can also track the patient's respiratory motion for supporting synchronized image acquisition or treatment delivery.
The system shall only be used by hospital personnel, qualified to work in radiation therapy or diagnostic imaging departments.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary S. Potter
(Division Sign-Off)
Division of Radiological Devices Office of In Vitro Diagnostic Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
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