BEAMSCAN

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes entwined around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is a common symbol associated with healthcare and medicine. 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) #### 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}------------------------------------------------ # 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.<br>Pychlau GmbH | |-------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 2. | Address: | Loerracher Strasse 7<br>79115 Freiburg<br>Germany<br>www.ptw.de | | 3. | Contact Person: | Dr. Sándor-Csaba Áts<br>Tel. +49 (0) 761 49055 896<br>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<br>Name: Medical charged-particle radiation therapy system,<br>Product Code: IYE | | 9. | Predicate Device: | K954165<br>PTW-MP3 & PTW-MP3S AUTOMATIC WATER PHANTOM<br>PTW Freiburg | | 10. | Device Description: | The BEAMSCAN system is comprised of a PMMA tank with a<br>moving mechanism and a radiation detector. Further main com-<br>ponents are a lifting carriage with built-in electrometer and con-<br>trol unit with separate control pendant. The lifting carriage either<br>includes a water reservoir or a separate reservoir is used. A<br>positioning device can be mounted on top of the lifting carriage<br>and allows the water phantom to be aligned manually. The<br>whole system is controlled with software for data display and<br>processing. | | 11. | Intended Use: | The PTW water phantom system (BEAMSCAN) is intended for<br>dosimetry measurements in the context of a radiotherapy sys-<br>tem. The device is intended to determine the beam characteris-<br>tics of the radiotherapy system (beam data acquisition) during<br>the commissioning and/or for periodic quality assurance proce-<br>dures according to the QA plan of the responsible medical<br>physicist. | | 12. | Indications: | The BEAMSCAN system is intended to collect beam data in<br>water under the aspect of machine QA for the following purpos-<br>es:<br>– acceptance testing and/or commissioning of a radiation<br>therapy system.<br>– measurements after repair or replacement of major treat-<br>ment unit components.<br>– beam data analysis according to international therapy do-<br>simetry protocols.<br>– acquisition, formatting and transfer of basic data to treat-<br>ment planning systems.<br>– periodic QA procedures, e.g. constancy checks. | | 13. | Contraindications: | The BEAMSCAN system is for QA purposes and must not be<br>used while a patient is present.<br>It must not be used for Particle Beam dosimetry, for Diagnostic<br>Radiology, and in an MR environment.<br>The resulting measurement data must not be used to control<br>the radiotherapy device | | 14. | Intended User: | The BEAMSCAN system must be used only by qualified per-<br>sonnel as medical physicists. | | 15. | Substantial equivalence | While the wording is not identical, the intended use, the indica-<br>tions for use and the characteristics of this device are substan-<br>tively the same as of the predicate devices identified on the<br>comparison chart, which is provided with the premarket notifica-<br>tion submission. It is our opinion that BEAMSACAN does not<br>have functions and technological characteristics that raise addi-<br>tional types of questions related to terms of safety and effec-<br>tiveness. | | | Differences to the predi-<br>cate devices: | Aggregation of all formerly discrete components, e.g. water<br>phantom tank, electrometer, several control units, all cables and<br>water reservoir, to one physical unit and replacing cable by<br>wireless connection.<br>Automated levelling by calculating ideal coordinate axes with<br>respect to the measured water surface.<br>Continuous measuring alternatively to repeatedly positioning of<br>the detector and subsequent measuring at discrete measuring<br>points.<br>Improved dosimetry detector with respect to 3D characteristics.<br>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<br>patient is present. Since the contact of the operator with the<br>device occurs only with uninjured skin and the surface of the<br>device components contains no critical material, the contact<br>with the operator is biologically uncritical. | | Electrical & mechanical<br>safety and electromagnetic<br>compatibility (EMC): | Electrical safety and EMC testing were conducted by independ-<br>ent test laboratories. BEAMSCAN is certified as in compliance<br>with IEC 61010-1:2010 (with no patient contact of the product<br>the focus is directed to user safety) and IEC 60601-1-2:2007<br>(emission and immunity) / CISPR 22:2008 (RF technology) and<br>47 CFR Part 15 Subpart B. | | | Software Verification and<br>Validation Testing: | Software verification and validation testing results were con-<br>ducted and submitted according to the Guidance for the Con-<br>tent of Premarket Submissions for Software Contained in Medi-<br>cal Devices (2005). | | | Bench and Non-clinical<br>Testing: | Verification and validation testing demonstrated that BEAM-<br>SCAN fulfils the design specification and its intended use. Non-<br>clinical performance testing was performed according to IEC<br>60731 A1:2016 and to specific properties of water phantom<br>systems which included radiotherapy dose measurements i.e.<br>with step by step and continuous measurements and also<br>measurement accuracy with respect to detector positioning,<br>reproducibility and mechanical alignment. The verification of the<br>design output against the design input was performed in<br>BEAMSCAN system testing. Validation of the clinical workflow<br>has been conducted in BEAMSCAN validation testing with qual-<br>ified medical physicists and experienced PTW staff. Testing<br>with a patient present was not required since BEAMSCAN acts<br>as a pre-treatment quality assurance while no patient is present. | | | Conclusions: | The comparison of the indications for use, the technological<br>characteristics, the performance, safety and effectiveness of the<br>predicate and the subject device has shown that the PTW<br>BEAMSCAN water tank system is as safe and effective as the<br>predicate device and that the application is as well or better.<br>With respect to the use the device do not raised new questions<br>of safety and effectiveness. | | {4}------------------------------------------------ # BEAMSCAN System Image /page/4/Picture/1 description: The image shows the logo for PTW. The logo consists of the letters "PTW" in a simple, sans-serif font. A red triangle is positioned above the "T", pointing downwards. The letters are black, and the triangle is red. ## 510(k) premarket notification {5}------------------------------------------------ ## BEAMSCAN System Image /page/5/Picture/1 description: The image shows a logo with the letters "PTGW" in a bold, sans-serif font. A red triangle is positioned above the "T", pointing downwards. The letters are black, and the triangle is red. The logo is enclosed within a thin black rectangular border. ### 510(k) premarket notification 17.