(322 days)
Not Found
No
The summary describes a system for collecting beam data for radiation therapy QA, focusing on mechanical components, detectors, and software for data display and processing. There is no mention of AI, ML, or related concepts.
No
The BEAMSCAN system is intended for quality assurance (QA) in radiation therapy, specifically to collect beam data for acceptance testing, commissioning, repair, and ongoing QA of radiation therapy systems. It is used by medical physicists and performs measurements on the therapy system itself, not on a patient. Therefore, it is not a therapeutic device used to treat patients.
No
The device is used for quality assurance of radiation therapy systems and beam data analysis, not for diagnosing medical conditions in patients. It supports the treatment planning and consistency of radiation therapy rather than identifying a disease state.
No
The device description explicitly lists hardware components such as a PMMA tank, moving mechanism, radiation detector, lifting carriage, electrometer, control unit, and control pendant. While software is mentioned for control, it is part of a larger hardware system.
Based on the provided information, the BEAMSCAN system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use clearly states that the BEAMSCAN system is for collecting beam data in water for machine QA in radiation therapy. This is related to the performance and calibration of the radiation therapy equipment itself, not for testing samples taken from the human body (which is the definition of in vitro diagnostics).
- Device Description: The description details a system for measuring radiation beams in a water phantom, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. The device interacts with radiation beams in a water medium.
Therefore, the BEAMSCAN system falls under the category of a medical device used for quality assurance of radiation therapy equipment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BEAMSCAN system 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 radiation therapy system.
- measurements after repair or replacement of major treatment unit components.
- 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 checks.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
The BEAMSCAN system is comprised of a PMMA tank with a moving mechanism and a radiation detector. Further main components are a lifting carriage with built-in electrometer and control unit with separate control pendant. The lifting carriage either includes a water reservoir or a separate reservoir is used. A positioning device can be mounted on top of the lifting carriage and allows the water phantom to be aligned manually. The whole system is controlled with software for data display and processing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The BEAMSCAN system must be used only by qualified personnel as medical physicists.
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)
Software verification and validation testing results were conducted and submitted according to the Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (2005).
Verification and validation testing demonstrated that BEAMSCAN fulfils the design specification and its intended use. Non-clinical performance testing was performed according to IEC 60731 A1:2016 and to specific properties of water phantom systems which included radiotherapy dose measurements i.e. with step by step and continuous 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 system testing. Validation of the clinical workflow has been conducted in BEAMSCAN validation testing with qualified medical physicists and experienced PTW staff. Testing with a patient present was not required since BEAMSCAN acts as a pre-treatment quality assurance while no patient is present.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.5050 Medical charged-particle radiation therapy system.
(a)
Identification. A medical charged-particle radiation therapy system is a device that produces by acceleration high energy charged particles (e.g., electrons and protons) intended for use in radiation therapy. This generic type of device may include signal analysis and display equipment, patient and equipment supports, treatment planning computer programs, component parts, and accessories.(b)
Classification. Class II. When intended for use as a quality control system, the film dosimetry system (film scanning system) included as an accessory to the device described in paragraph (a) of this section, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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May 19, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Ptw-Freiburg Physikalisch Technische-Werksraetten Dr. Pychlau GmbH % Dr. Sandor-Csaba Ats Regulatory Affairs Manager Loerracher Strasse 7 Freiburg, BW 79115 GERMANY
Re: K161807
Trade/Device Name: BEAMSCAN Regulation Number: 21 CFR 892.5050 Regulation Name: Medical charged-particle radiation therapy system Regulatory Class: II Product Code: IYE Dated: May 10, 2017 Received: May 15, 2017
Dear Dr. 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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
For Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K161807
Device Name BEAMSCAN
Indications for Use (Describe)
The BEAMSCAN system 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 radiation therapy system.
- measurements after repair or replacement of major treatment unit components.
- 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 checks.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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3
BEAMSCAN System
510(k) premarket notification
Image /page/3/Picture/2 description: The image shows a logo with the letters PTW in a stylized font. A red triangle is positioned above the letter T, pointing downwards. The letters are black and the background is white. The logo is enclosed in a black border.
510(k) Summary
| 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: | May 10, 2017 |
| 5. | Device Name: | BEAMSCAN |
| 6. | Proprietary Name: | BEAMSCAN |
| 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: | K954165
PTW-MP3 & PTW-MP3S AUTOMATIC WATER PHANTOM
PTW Freiburg |
| 10. | Device Description: | The BEAMSCAN system is comprised of a PMMA tank with a
moving mechanism and a radiation detector. Further main com-
ponents are a lifting carriage with built-in electrometer and con-
trol unit with separate control pendant. The lifting carriage either
includes a water reservoir or a separate reservoir is used. A
positioning device can be mounted on top of the lifting carriage
and allows the water phantom to be aligned manually. The
whole system is controlled with software for data display and
processing. |
| 11. | Intended Use: | The PTW water phantom system (BEAMSCAN) is intended for
dosimetry measurements in the context of a radiotherapy sys-
tem. The device is intended to determine the beam characteris-
tics of the radiotherapy system (beam data acquisition) during
the commissioning and/or for periodic quality assurance proce-
dures according to the QA plan of the responsible medical
physicist. |
| 12. | Indications: | The BEAMSCAN system is intended to collect beam data in
water under the aspect of machine QA for the following purpos-
es:
– acceptance testing and/or commissioning of a radiation
therapy system.
– measurements after repair or replacement of major treat-
ment unit components.
– beam data analysis according to international therapy do-
simetry protocols.
– acquisition, formatting and transfer of basic data to treat-
ment planning systems.
– periodic QA procedures, e.g. constancy checks. |
| 13. | Contraindications: | The BEAMSCAN system is for QA purposes and must not be
used while a patient is present.
It must not be used for Particle Beam dosimetry, for Diagnostic
Radiology, and in an MR environment.
The resulting measurement data must not be used to control
the radiotherapy device |
| 14. | Intended User: | The BEAMSCAN system must be used only by qualified per-
sonnel as medical physicists. |
| 15. | Substantial equivalence | While the wording is not identical, the intended use, the indica-
tions for use and the characteristics of this device are substan-
tively the same as of the predicate devices identified on the
comparison chart, which is provided with the premarket notifica-
tion submission. It is our opinion that BEAMSACAN does not
have functions and technological characteristics that raise addi-
tional types of questions related to terms of safety and effec-
tiveness. |
| | Differences to the predi-
cate devices: | Aggregation of all formerly discrete components, e.g. water
phantom tank, electrometer, several control units, all cables and
water reservoir, to one physical unit and replacing cable by
wireless connection.
Automated levelling by calculating ideal coordinate axes with
respect to the measured water surface.
Continuous measuring alternatively to repeatedly positioning of
the detector and subsequent measuring at discrete measuring
points.
Improved dosimetry detector with respect to 3D characteristics.
No additional type of safety issue is raised by these changes. |
| | 16. | Performance Data: |
| | 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. |
| Electrical & mechanical
safety and electromagnetic
compatibility (EMC): | Electrical safety and EMC testing were conducted by independ-
ent test laboratories. BEAMSCAN is certified as in compliance
with IEC 61010-1:2010 (with no patient contact of the product
the focus is directed to user safety) and IEC 60601-1-2:2007
(emission and immunity) / CISPR 22:2008 (RF technology) and
47 CFR Part 15 Subpart B. | |
| 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). | |
| Bench and Non-clinical
Testing: | Verification and validation testing demonstrated that BEAM-
SCAN fulfils the design specification and its intended use. Non-
clinical performance testing was performed according to IEC
60731 A1:2016 and to specific properties of water phantom
systems which included radiotherapy dose measurements i.e.
with step by step and continuous 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 system testing. Validation of the clinical workflow
has been conducted in BEAMSCAN validation testing with qual-
ified medical physicists and experienced PTW staff. Testing
with a patient present was not required since BEAMSCAN acts
as a pre-treatment quality assurance while no patient is present. | |
| 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 the PTW
BEAMSCAN water tank system is as safe and effective as the
predicate device and that the application is as well or better.
With respect to the use the device do not raised new questions
of safety and effectiveness. | |
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BEAMSCAN System
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510(k) premarket notification
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BEAMSCAN System
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