BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)

{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) | | |---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------| | <div> <span> </span> <span>Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span> </span> <span>Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | ### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ K232738 # 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<br>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);<br>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<br>(part of DoseView 3D) | | Perform detector positioning in water phantom | Yes | Yes | | Enter detector settings | Yes | Yes | | Set electrometer settings<br>- Bias (HV)<br>- Range<br>- 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,<br>section 6.2.1 | | | LOW 20 pC ... 22 μC<br>MED 200 pC ... 400μC<br>HIGH 2 nC ... 5 mC | | | Current | LOW 2 pA ... 2.2 nA<br>MED 20 pA ... 40 nA<br>HIGH 200 pA ... 500 nA | | | Zero drift | ≤ ± 0.5 % | | | Non-linearity | ≤ ± 0.5 % | IEC 60731,<br>section 6.3.2 | ### Effect of influence quantities according to IEC 60731 for BEAMSCAN electrometer: | Influence quantity | Nominal useful<br>range of the<br>influence quantity | Device<br>characteristic | Max. change | Reference | |--------------------|------------------------------------------------------|--------------------------|-----------------------|-----------------------------| | Range changing | all ranges | response | ≤ ± 1 % | IEC 60731,<br>section 6.3.4 | | Stabilization time | 5 min | response | < ± 0.5 % | IEC 60731,<br>section 6.2.5 | | Temperature | (+ 10 ... + 40) °C | response<br>zero drift | < ± 0.25 %<br>± 0.5 % | IEC 60731,<br>section 6.4.6 | | Stray radiation | (0 ... 0.2) mSv/h | zero drift<br>zero shift | ≤ ± 1 %<br>≤ ± 1 % | IEC 60731,<br>section 6.3.8 | | Dose rate | ± 2 pA ... ± 2.2 nA | response | < ± 0.5 % | IEC 60731,<br>section 6.4.3 | {7}------------------------------------------------ # 510(k) premarket notification Image /page/7/Picture/2 description: The image shows the letters PTW in a stylized font. The letters are black, and there is a red triangle pointing down above the T. The letters are inside of a white box with a black border. ### Measuring specifications according to IEC 60731 for TANDEM and TANDEM*98: | | TANDEM | TANDEMXDR | Reference | |----------------------------------------|-------------------------------------------------------|-------------------------------------------------------|-----------------------------| | Ranges<br>Charge<br>LOW<br>MED<br>HIGH | 50 pC ... 10 μC<br>500 pC ... 100μC<br>5 nC ... 1 mC | 500 pC ... 100 μC<br>5 nC ... 1 mC<br>50 nC ... 10 mC | IEC 60731,<br>section 6.2.1 | | Current<br>LOW<br>MED<br>HIGH | 5 pA ... 1 nA<br>50 pA ... 10 nA<br>500 pA ... 100 nA | 50 pA ... 10 nA<br>500 pA ... 100 nA<br>5 nA ... 1 μA | | | Zero drift | ≤ ± 1 % | ≤ ± 1 % | IEC 60731,<br>section 6.3.1 | | Non-linearity | ≤ ± 0.5 % | ≤ ± 0.5 % | IEC 60731,<br>section 6.3.2 | ### Effect of influence quantities according to IEC 60731 for TANDEM and TANDEM*BP. | Influence quantity | Nominal useful<br>range of the<br>influence quantity | Device<br>characteristic | Max. change | Reference | |--------------------|------------------------------------------------------|--------------------------|--------------------------------------------------------------|-----------------------------| | Range changing | all ranges | response | $\pm$ (0.5 % + 1 digit)<br>of display | IEC 60731,<br>section 6.3.4 | | Stabilization time | 5 min | response | $\pm$ (0.5 % + 1 digit)<br>of display | IEC 60731,<br>section 6.2.5 | | Temperature | (+ 10 ... + 40) °C | response | $\pm$ (1 % + 1 digit)<br>of display | IEC 60731,<br>section 6.4.6 | | | | zero drift | $\pm$ (1 % + 1 digit)<br>(lower limit of<br>measuring range) | | | Stray radiation | (0 ... 0.2) mSv/h | zero drift | $\pm$ (1 % + 1 digit)<br>(lower limit of<br>measuring range) | IEC 60731,<br>section 6.3.8 | | | | zero shift | $\pm$ (1 % + 1 digit)<br>(lower limit of<br>measuring range) | | | Dose rate | $\pm$ 2 pA ... $\pm$ 2.2 nA | response | < $\pm$ 0.5 % | IEC 60731,<br>section 6.4.3 | Measuring specifications and effect of influence quantities according to IEC 60731 for MULTIDOS, UNIDOS E, UNIDOS webline, UNIDOS Tango, and UNIDOS Romeo are similar and stated in their respective IFUs in the section "Technical Specifications". The device passed verification and validation testing and was deemed safe and effective for its intended use. Since both, the subject and the predicate device claim to be compliant to this standard, fulfilment of the standard requirements for the subject device proves to be substantially equivalent to the predicate device. Based on results of this testing the device was found to have a safety and effectiveness profile similar to the predicate device, supporting the claim of substantial equivalence. {8}------------------------------------------------ # 510(k) premarket notification Image /page/8/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, and a thin black line borders the image on the left and top. #### 7 Summary The comparison of the indications for use, the technological characteristics, the performance, safety and effectiveness of the predicate devices and the subject device has shown that the BeamDose software is substantially equivalent to the predicate devices and that the application is as well or better. With respect to the use the device, no new questions of safety and effectiveness could be determined.