(267 days)
Not Found
No
The summary describes a software for controlling electrometers and water phantoms for absolute dose measurements in radiotherapy, performing calculations based on calibration factors and physical parameters. There is no mention of AI or ML techniques being used for data analysis, prediction, or decision-making. The calculations appear to be based on established physical principles and calibration data.
No.
Explanation: The device is a software used for absolute dose measurements and monitor calibration in radiotherapy, and explicitly states that "The measured absolute dose values must not be used directly in radiation therapy." This indicates it's a measurement and quality assurance tool, not a device directly used to deliver therapy or treat patients.
No
The document describes a software for absolute dose measurements and detector positioning in radiotherapy, which are quality assurance and calibration tasks, not diagnostic imaging or analysis.
No
The device description explicitly states that the software "measures with" and "controls the positioning of detectors in" various hardware components (electrometers and water phantoms). While the software is a key part of the system, it is designed to interact with and operate specific hardware, making it a component of a larger medical device system, not a standalone software-only device.
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 software is for purposes in radiotherapy, specifically for absolute dose measurements, monitor calibration, and positioning of detectors in water phantoms. These are all activities related to the delivery and measurement of radiation for therapeutic purposes, not for diagnosing diseases or conditions from in vitro samples.
- Device Description: The description reinforces the intended use by detailing how the software interacts with electrometers and water phantoms to measure and calculate absolute dose values and control detector positioning.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information about a patient's health status.
The device is a software tool used in the field of medical physics for quality assurance and calibration of radiotherapy equipment. While it plays a crucial role in ensuring accurate radiation delivery, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
BeamDose is a software for the following purposes in radiotherapy:
- absolute dose measurements as field class dosemeter (according to IEC 60731)
- monitor calibration
- positioning of detectors in PTW water phantoms
The software enables the user of a BEAMSCAN, TANDEM, TANDEM XDR, UNIDOS E, UNIDOS webline, UNIDOS Tango, UNIDOS Romeo or MULTIDOS electrometer to operate the electrometer as a therapy dosemeter in accordance with IEC 60731.
The software establishes the communication with the electrometer, provides callbration and correction factors for various detectors and displays the measurement results.
Additionally, the software enables the positioning of a measuring detector in the desired measuring depth with a motorized PTW water phantom.
The measured absolute dose values must not be used directly in radiation therapy. They have to be checked for plausibility by qualified personnel.
The software must be used only by qualified personnel, usually the medical physicist responsible for the radiotherapy system or an authorized person.
Product codes (comma separated list FDA assigned to the subject device)
IYE
Device Description
The software measures with BEAMSCAN, TANDEM, TANDEM XDR, UNIDOS E, UNIDOS webline, UNIDOS Tango, UNIDOS Romeo, and MULTIDOS and calculates absolute dose values.
The software controls the positioning of detectors in BEAMSCAN, MP3, MP2, and MP1 water phantoms.
The software comprises the readout of the detector data from a data base (Detector Library) with calibration factors and other detector parameters.
The software corrects measurement data according to temperature and atmospheric pressure and with user correction factor.
The software supports RS232 and TCP/IP interfaces to read out measurement data from the electrometers and to operate the water phantoms.
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 software must only be used by qualified personnel, usually medical professionals including, radiologists, nuclear medicine physicians, radiation oncologists, dosimetrists and medical physicists or authorized persons.
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 BeamDose software was tested to evaluate and verify that it meets the required performance specifications which are defined in the product standard IEC 60731:2011 (Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy) which is specifically for reference class dosimeter systems and which were performed together with the respective electrometers.
Measuring specifications according to IEC 60731 for BEAMSCAN electrometer:
Ranges:
Charge - LOW 20 pC ... 22 μC, MED 200 pC ... 400μC, HIGH 2 nC ... 5 mC
Current - LOW 2 pA ... 2.2 nA, MED 20 pA ... 40 nA, HIGH 200 pA ... 500 nA
Zero drift: ≤ ± 0.5 %
Non-linearity: ≤ ± 0.5 %
Effect of influence quantities according to IEC 60731 for BEAMSCAN electrometer:
Range changing (all ranges) - Response: ≤ ± 1 %
Stabilization time (5 min) - Response:
§ 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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
PTW-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla % Sandor-Csaba Ats Regulatory Affairs Manager Loerracher Strasse 7 Freiburg, BW 79115 GERMANY
Re: K232738
Trade/Device Name: BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002) Regulation Number: 21 CFR 892.5050 Regulation Name: Medical Charged-Particle Radiation Therapy System Regulatory Class: Class II Product Code: IYE Dated: April 26, 2024 Received: April 30, 2024
May 31, 2024
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
Locon Weidner
Lora D. Weidner, Ph.D. Assistant Director Radiation Therapy Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232738
Device Name BeamDose software (S080053): BEAMSCAN software, option reference dosimetry (S080054.002)
Indications for Use (Describe)
BeamDose is a software for the following purposes in radiotherapy:
- absolute dose measurements as field class dosemeter (according to IEC 60731)
- monitor calibration
- positioning of detectors in PTW water phantoms
The software enables the user of a BEAMSCAN, TANDEM, TANDEM XDR, UNIDOS E, UNIDOS webline, UNIDOS Tango, UNIDOS Romeo or MULTIDOS electrometer to operate the electrometer as a therapy dosemeter in accordance with IEC 60731.
The software establishes the communication with the electrometer, provides callbration and correction factors for various detectors and displays the measurement results.
Additionally, the software enables the positioning of a measuring detector in the desired measuring depth with a motorized PTW water phantom.
The measured absolute dose values must not be used directly in radiation therapy. They have to be checked for plausibility by qualified personnel.
The software must be used only by qualified personnel, usually the medical physicist responsible for the radiotherapy system or an authorized person.
| 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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3
BeamDose software
510(k) premarket notification
Image /page/3/Picture/3 description: The image shows a logo with the letters PTW in a bold, sans-serif font. A red triangle is positioned above the letter T, pointing downwards. The letters are black against a white background, and the logo is contained within a rectangular frame.
Executive Summary
Submitter's Information 1
| Company name: | PTW-Freiburg Physikalisch-Technische-Werkstaetten
Dr. Pychlau GmbH |
|---------------------------------|---------------------------------------------------------------------------------------------|
| Company address: | Loerracher Strasse 7, 79115 Freiburg, Germany |
| Contact name: | Dr. Sándor-Csaba Áts (Regulatory Affairs Manager) |
| Contact phone: | +49 761 49055-896 |
| Proprietary name: | BeamDose software (S080053);
BEAMSCAN software, option reference dosimetry (S080054.002) |
| Common name: | Reference dosimetry software |
| 510(k) number: | K232738 |
| Regulation number: | 21 CFR 892.5050 |
| Regulation name: | Medical charged-particle radiation therapy system |
| Classification name: | Accelerator, Linear, Medical |
| Product code: | IYE |
| Device class: | Class II |
| Date of preparing this summary: | 2024-05-31 |
Predicate Device Information 2
| Proprietary name: | DoseView 3D |
|---|---|
| Common name: | Water Phantom Scanning System |
| 510(k) number: | K103193 |
| Regulation number: | 21 CFR 892.5050 |
| Regulation name: | Medical charged-particle radiation therapy system |
| Classification name: | Accelerator, Linear, Medical |
| Product code: | IYE |
| Device class: | Class II |
| Manufacturer: | Standard Imaging, Inc. |
| Submitted: | December 27, 2010 |
4
510(k) premarket notification
Image /page/4/Picture/2 description: The image shows the letters PTW in a bold, sans-serif font. A red triangle is positioned above the T, pointing downwards. The letters are black against a white background.
Device Description 3
The software measures with BEAMSCAN, TANDEM, TANDEM XDR, UNIDOS E, UNIDOS webline, UNIDOS Tango, UNIDOS Romeo, and MULTIDOS and calculates absolute dose values.
The software controls the positioning of detectors in BEAMSCAN, MP3, MP2, and MP1 water phantoms.
The software comprises the readout of the detector data from a data base (Detector Library) with calibration factors and other detector parameters.
The software corrects measurement data according to temperature and atmospheric pressure and with user correction factor.
The software supports RS232 and TCP/IP interfaces to read out measurement data from the electrometers and to operate the water phantoms.
Intended Use Statement র্ব
BeamDose is a software for the following purposes in radiotherapy:
- absolute dose measurements as field class dosemeter (according to IEC 60731) .
- . monitor calibration
- . positioning of detectors in PTW water phantoms
The software enables the user of a BEAMSCAN, TANDEM, TANDEM XDR, UNIDOS E, UNIDOS webline, UNIDOS Tango, UNIOS Romeo or MULTIDOS electrometer to operate the electrometer as a therapy dosemeter in accordance with IEC 60731.
The software establishes the communication with the electrometer, provides calibration and correction factors for various detectors and displays the measurement results.
Additionally, the software enables the positioning of a measuring detector in the desired measuring depth with a motorized PTW water phantom.
The measured absolute dose values must not be used directly in radiation therapy. They have to be checked for plausibility by qualified personnel.
The software must only be used by qualified personnel, usually medical professionals including, radiologists, nuclear medicine physicians, radiation oncologists, dosimetrists and medical physicists or authorized persons.
5
510(k) premarket notification
Image /page/5/Picture/2 description: The image shows a logo with the letters PTW in a stylized font. A small red triangle is positioned above the 'T', pointing downwards. The letters are black against a white background, and the overall design is simple and modern.
Substantial Equivalence 5
5.1 Technological Characteristics
Both, the Standard Imaging software and the PTW software are software to control water phantoms and collect data from electrometers for quality assurance in radiation therapy. Its technological characteristics are equivalent to the Standard Imaging software.
In combination with a water phantom and an electrometer the BeamDose software is for
- absolute dose measurements as field class dosemeter (according to IEC 60731) ●
- . monitor calibration
- positioning of detectors in PTW water phantoms .
The DoseView 3D system also consists among others of a controlling software, a water phantom and an electrometer, which is used for
- Collection of dose depth data for radiation treatment planning system use. ●
- Completion of clinical dosimetry protocols and calibrations. ●
This corresponds to the intended use of the BeamDose software.
5.2 Device Comparison Table
The following table compares the BeamDose software with the predicate devices regarding to their performance data: These properties are software functions and no further acceptance criteria can be provided.
The predicate device has a larger range of functions than the subject device. Therefore, only the relevant functions which are implemented in the BeamDose software are considered.
| Manufacturer | PTW Freiburg | Standard Imaging |
|---|---|---|
| Product name | BeamDose software | DoseView software |
| (part of DoseView 3D) | ||
| Perform detector positioning in water phantom | Yes | Yes |
| Enter detector settings | Yes | Yes |
| Set electrometer settings |
- Bias (HV)
- Range
- Measurement mode | Yes | Yes |
| Perform zero adjustment | Yes | Yes |
| Enter correction factors | Yes | No |
| Enter temperature & air pressure | Yes | Yes |
| Readout electrometer | Yes | Yes |
| Control a 1D or 3D water phantom | Yes | Yes |
| Export data to a .csv file | Yes | Yes |
Both, the BeamDose software and the predicate device provide the same functions relevant to the intended use of BeamDose which proves substantial equivalence with the predicate device.
6
510(k) premarket notification
Image /page/6/Picture/2 description: The image shows the letters PTW in a bold, sans-serif font. A red triangle is positioned above the letter T. The letters are black and the background is white.
Performance Data 6
The following performance data in combination with the stated electrometer were provided in support of substantial equivalence:
The BeamDose software was tested to evaluate and verify that it meets the required performance specifications which are defined in the product standard IEC 60731:2011 (Medical electrical equipment - Dosimeters with ionization chambers as used in radiotherapy) which is specifically for reference class dosimeter systems and which were performed together with the respective electrometers.
Measuring specifications according to IEC 60731 for BEAMSCAN electrometer:
| Ranges | BEAMSCAN | Reference |
|---|---|---|
| Charge | IEC 60731, | |
| section 6.2.1 | ||
| LOW 20 pC ... 22 μC | ||
| MED 200 pC ... 400μC | ||
| HIGH 2 nC ... 5 mC | ||
| Current | LOW 2 pA ... 2.2 nA | |
| MED 20 pA ... 40 nA | ||
| HIGH 200 pA ... 500 nA | ||
| Zero drift | ≤ ± 0.5 % | |
| Non-linearity | ≤ ± 0.5 % | IEC 60731, |
| section 6.3.2 |
Effect of influence quantities according to IEC 60731 for BEAMSCAN electrometer:
| Influence quantity | Nominal useful
range of the
influence quantity | Device
characteristic | Max. change | Reference |
|--------------------|------------------------------------------------------|--------------------------|-----------------------|-----------------------------|
| Range changing | all ranges | response | ≤ ± 1 % | IEC 60731,
section 6.3.4 |
| Stabilization time | 5 min | response |