(246 days)
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No
The summary describes a system for collecting beam data in water for machine QA in MRI-radiation therapy systems. It details hardware components and software for control and data processing, but there is no mention of AI, ML, or related concepts in the intended use, device description, or performance studies. The focus is on precise physical measurements and data handling according to established protocols.
No
The device is used for quality assurance (QA) and commissioning of MRI-radiation therapy systems, and for collecting beam data, not for directly treating patients.
No
The device is used for quality assurance and calibration of radiation therapy systems, not for diagnosing medical conditions in patients. It collects beam data for machine QA, acceptance testing, and data transfer to treatment planning systems.
No
The device description explicitly states that the system is comprised of hardware components including a PMMA tank, moving mechanism, radiation detectors, carriage with electrometer, control unit, and control interface. While software controls the system, it is not a software-only device.
Based on the provided information, the BEAMSCAN MR system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for collecting beam data in water for machine QA purposes in combined MRI-radiation therapy systems. This involves measuring the characteristics of the radiation beam itself, not analyzing biological samples from a patient.
- Device Description: The description details a system for measuring radiation in a water phantom, not for analyzing biological specimens.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or other biological samples, which are the hallmarks of IVD devices.
The BEAMSCAN MR system is a device used for quality assurance and calibration of radiation therapy equipment, which falls under the category of medical devices, but not specifically IVD devices.
N/A
Intended Use / Indications for Use
The BEAMSCAN MR system is used preferably in combined MRI-radiation therapy systems with static magnetic fields of up to 1.5T and is intended to collect beam data in water under the aspect of machine QA for the following purposes:
- acceptance testing and/or commissioning of a combined MRI-radiation therapy system
- measurements after repair or replacement of major treatment unit components of a combined MRI-Radiation therapy system
- beam data analysis according to international therapy dosimetry protocols
- acquisition, formatting and transfer of basic data to treatment planning systems
- periodic QA procedures, e.g. constancy check
- high precision data acquisition for scientific research (not a medical device indication)
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
The BEAMSCAN MR system is comprised of a PMMA tank with a moving mechanism and radiation detectors. Further main components are a carriage with built-in electrometer, control unit and control interface. The carriage includes a water reservoir. The whole system is controlled by software for data display and processing.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
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Intended User / Care Setting
The BEAMSCAN MR system must be used only by qualified personnel, usually the medical physicist responsible for the radiotherapy system or an authorized person.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification and validation testing demonstrated that BEAMSCAN MR fulfils the design specification and its intended use. Non-clinical performance testing was performed according to IEC 60731:2016 and to specific properties of water phantom systems which included radiotherapy dose measurements i.e. with step by step measurements and also measurement accuracy with respect to detector positioning, reproducibility and mechanical alignment. The verification of the design output against the design input was performed in BEAMSCAN MR system testing. Validation of the clinical workflow has been conducted in BEAMSCAN MR validation testing with qualified medical physicists and experienced PTW staff. Testing with a patient present was not required since BEAMSCAN MR acts as a pre-treatment quality assurance tool while no patient is present.
The FDA has not published any performance standards for this product.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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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Image /page/0/Picture/0 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.
February 21, 2020
PTW-Freiburg Physikalisch-Technische-Werkstaetten-Dr. Pychlau GmbH % Sandor-Csaba Ats Regulatory Affairs Manager Loerracher Strasse 7 79115 Freiburg, BW GERMANY
Re: K191646
Trade/Device Name: BEAMSCAN MR Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: Class II Product Code: IYE Dated: January 14, 2020 Received: January 17, 2020
Dear Sandor-Csaba Ats:
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/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
1
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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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,
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
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Indications for Use
510(k) Number (if known) K191646
Device Name BEAMSCAN MR
Indications for Use (Describe)
The BEAMSCAN MR system is used preferably in combined MRI-radiation therapy systems with static magnetic fields of up to 1.5T and is intended to collect beam data in water under the aspect of machine QA for the following purposes:
-
acceptance testing and/or commissioning of a combined MRI-radiation therapy system
-
measurements after repair or replacement of major treatment unit components of a combined MRI-Radiation therapy system
-
beam data analysis according to international therapy dosimetry protocols
-
acquisition, formatting and transfer of basic data to treatment planning systems
-
periodic QA procedures, e.g. constancy check
-
high precision data acquisition for scientific research (not a medical device indication)
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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BEAMSCAN MR water phantom system
510(k) premarket notification
| 510(k) Summary | K191646 | ||
|---|---|---|---|
| 1. | Applicant: | PTW-Freiburg Physikalisch-Technische-Werkstaetten Dr. | |
| Pychlau GmbH | |||
| 2. | Address: | Loerracher Strasse 7 | |
| 79115 Freiburg | |||
| Germany | |||
| www.ptw.de | |||
| 3. | Contact Person: | Dr. Sándor-Csaba Áts | |
| Tel. +49 (0) 761 49055 896 | |||
| sandor.ats@ptw.de | |||
| 4. | Preparation Date: | June 14, 2019 | |
| 5. | Device Name: | BEAMSCAN MR | |
| 6. | Proprietary Name: | BEAMSCAN MR | |
| 7. | Common Name: | Water Phantom | |
| 8. | Classification: | Regulation number: 21 CFR 892.5050 | |
| Name: Medical charged-particle radiation therapy system, | |||
| Product Code: IYE | |||
| 9. | Predicate Device: | K161807 | |
| BEAMSCAN water phantom system | |||
| PTW Freiburg | |||
| 10. | Device Description: | The BEAMSCAN MR system is comprised of a PMMA tank with | |
| a moving mechanism and radiation detectors. Further main | |||
| components are a carriage with built-in electrometer, control | |||
| unit and control interface. The carriage includes a water reservoir. The whole system is controlled by software for data display | |||
| and processing. | |||
| 11. | Intended Use: | The PTW water phantom system BEAMSCAN MR is intended | |
| for dosimetry measurements in radiotherapy systems. | |||
| The device is intended to determine the beam characteristics of | |||
| the radiotherapy system (beam data acquisition) during the | |||
| commissioning and/or for periodic quality assurance procedures | |||
| according to the QA plan of the responsible medical physicist. | |||
| The system can also be used at combined MRI-Radiation Therapy systems with static magnetic fields of up to 1.5T | |||
| 12. | Indications: | The BEAMSCAN MR system is used preferably in combined | |
| MRI-radiation therapy systems with static magnetic fields of up | |||
| to 1.5T and is intended to collect beam data in water under the | |||
| aspect of machine QA for the following purposes: acceptance testing and/or commissioning of a combined | |||
| MR-radiation therapy system. measurements after repair or replacement of major treat- | |||
| ment unit components of a combined MRI-radiation therapy system beam data analysis according to international therapy dosimetry protocols acquisition, formatting and transfer of basic data to treatment planning systems periodic QA procedures, e.g. constancy check high precision data acquisition for scientific research (not a medical device indication) | |||
| 13. | Contraindications: | The BEAMSCAN MR system is intended for QA purposes and | |
| must not be used while a patient is present. | |||
| It must not be used for Particle Beam dosimetry nor for Diagnostic Radiology. | |||
| It must not be used while an MR-Linac is taking MR-images | |||
| The resulting measurement data must not be used to control | |||
| the radiotherapy device. | |||
| 14. | Intended User: | The BEAMSCAN MR system must be used only by qualified | |
| personnel, usually the medical physicist responsible for the radiotherapy system or an authorized person. | |||
| 15. | Summary of the Product | ||
| Change: | The intended use is the same compared to the predicate device | ||
| but will be carried out within a MR Radiation Therapy system. | |||
| Differences to the predicate devices: | In order to use the device with a MR-linac, the PMMA tank was | ||
| made to be removable for putting it on the linac treatment table | |||
| and the size was adapted to move it into the MRT tube. This led | |||
| to a smaller size of the entire device. | |||
| Ferromagnetic components were replaced by non-ferrous material to finally be "MR conditional" in a static 1.5 Tesla magnetic | |||
| field. | |||
| The software contains no new functions. | |||
| 16. | Performance Data: | The FDA has not published any performance standards for this | |
| product. | |||
| Biocompatibility: | The device is used for pre-treatment quality assurance while no | ||
| patient is present. Since the contact of the operator with the | |||
| device occurs only with uninjured skin and the surface of the | |||
| device components contains no critical material, the contact | |||
| with the operator is biologically uncritical. |
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Image /page/4/Picture/2 description: The image shows a logo with the letters "PTW" in a stylized font. The "T" in the logo has a red triangle pointing downwards above it. The letters are black and the background is white. The logo is simple and modern.
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510(k) premarket notification
| Electrical & mechanical
safety and electromagnetic
compatibility (EMC): | Electrical safety, EMC testing and MR safety testing were con-
ducted by independent test laboratories. BEAMSCAN MR is
certified as in compliance with IEC 61010-1:2010 (with no pa-
tient contact of the product the focus is directed to user safety)
and IEC 60601-1-2:2014 (emission and immunity) according to
IEC/CISPR 11:2009 (modified + A1:2010). MR safety testing
was performed according to ASTM F2052-15. |
|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software Verification and
Validation Testing: | Software verification and validation testing results were con-
ducted and submitted according to the Guidance for the Con-
tent of Premarket Submissions for Software Contained in Medi-
cal Devices (2005). The BEAMSCAN software contains no new
functions and was previously cleared with 510(k) #K161807 and
is thus not part of this submission. |
| Bench and Non-clinical
Testing: | Verification and validation testing demonstrated that BEAM-
SCAN MR fulfils the design specification and its intended use.
Non-clinical performance testing was performed according to
IEC 60731:2016 and to specific properties of water phantom
systems which included radiotherapy dose measurements i.e.
with step by step measurements and also measurement accu-
racy with respect to detector positioning, reproducibility and
mechanical alignment. The verification of the design output
against the design input was performed in BEAMSCAN MR
system testing. Validation of the clinical workflow has been
conducted in BEAMSCAN MR validation testing with qualified
medical physicists and experienced PTW staff. Testing with a
patient present was not required since BEAMSCAN MR acts as
a pre-treatment quality assurance tool while no patient is pre-
sent. |
| Conclusions: | The comparison of the indications for use, the technological
characteristics, the performance, safety and effectiveness of the
predicate and the subject device has shown that, when used
within a MR Radiation Therapy system, the PTW BEAMSCAN
MR system is as safe and effective as the predicate device
within a non-MR environment. |