Proteus XR/f, Models ST and ET, Multirad and Multirad NET Radiographic Systems

{0}------------------------------------------------ February 1, 2021 Image /page/0/Picture/1 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 seal on the left and the FDA acronym and full name on the right. The FDA acronym is in a blue square, and the full name "U.S. Food & Drug Administration" is in blue text. SEDECAL SA % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct NAPLES FL 34114 ### Re: K203537 Trade/Device Name: Proteus XR/f, Models ST and ET, Multirad NET Radiographic Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR, MQB Dated: December 1, 2020 Received: December 3, 2020 ## Dear Mr. Kamm: 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 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 (QS) 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, For 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K203537 Device Name Proteus XR/f , Models ST and ET, Multirad and Multirad NET Radiographic Systems Indications for Use (Describe) These radiographic systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|---------| | Prescription Use (Part 21 CFR 801 Subpart D) | checked | | Over-The-Counter Use (21 CFR 801 Subpart C) | | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. 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Río de Janeiro 28110 Algete, Madrid España (Spain) Tel .- +34 91 6280544 Fax.- +34 91 6280574 Date Prepared: February 1, 2021 Contact: Mª Luisa Gómez de Agüero, Quality and Regulatory Manager - 1) Identification of the Device: Trade/Device Name: Proteus XR/f , Models ST and ET, Multirad and Multirad NET Radiographic Systems Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Codes: KPR, MQB. Common/Usual Name: Diagnostic X-Ray System - 2) Equivalent legally marketed device: K090279 Trade/Device Name: Sedecal "Millennium Plus Digital Diagnostic X-Ray System" Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Codes: KPR, MQB. Common/Usual Name: Digital Diagnostic X-Ray System - 3) Reference device: We employ this cleared device without modification: Trade/Device Name: Konica Minolta Wireless Detector SKR3000 Submission number: K182688 Regulation Number: 21 CFR 892. 1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB - 4) Indications for Use: These radiographic systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. - 5) Description of the Device: Proteus Radiographic System, Models XR/f ST and XR/f ET; MULTIRAD and MULTIRAD NET. These radiographic systems are designed for general radiography in hospitals, {4}------------------------------------------------ clinics, radiology imaging centers and medical practices. It is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. Patients may be physically abled, disabled, immobilized or in state of a shock. The Radiographic Systems are not intended for mammography applications. If children are to be examined, they should always be accompanied by an adult. Radiographic System Proteus XR/f has been interfaced with the Digital Imaging System of Konica Minolta Inc consisting of the image receptor and application for image acquisition (control console & image processing controller). The following table describes all available configurations. | Image receptor, SKR3000 Series<br>included in K182688 | Image acquisition SW<br>included in K182688 | |-------------------------------------------------------|---------------------------------------------| | AeroDR 2 1417S (AeroDR P-52) | | | AeroDR 3 1417HD (AeroDR P-61) | CS-7 | | AeroDR 3 1717HD (AeroDR P-71) | | | AeroDR 3 1012HQ (AeroDR P-81) | | All functions, displays and controls are logically arranged, easily accessible and identified to prevent confusion. Technique factors and functions are selected on the Control Console CS- 7. The Radiographic Systems Proteus XR/f ST and Proteus XR/f ET units employ a tube stand that supports the X-ray source assembly with the control panel, radiographic table for patient positioning and Wall Stand. | | MULTIRAD | PROTEUS XR/f<br>ST | MULTIRAD NET | PROTEUS XR/f ET | |-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------| | RAD Table | MULT-FWFTTD | | NET4000-ST | | | Wall<br>Stand | MILL-WBS<br>or<br>MULT-WBS | MILL-WBS | MILL-WBS<br>or<br>MULT-WBS | MILL-WBS | | Image<br>System | Not included.<br>Ready to be<br>interfaced with<br>any image<br>acquisition system<br>after performing<br>the task related<br>with the interface. | Konica Minolta<br>(See table<br>above) with CS-7<br>Software | Not included. Ready to<br>be interfaced with any<br>image acquisition<br>system after<br>performing the task<br>related with the<br>interface. | Konica Minolta<br>(See table above)<br>with CS-7<br>Software | | Tube<br>Stand | MULT-FMTS | | | | | Generator | SHFR Series 50 KW, 65 KW, or 80 KW | | | | | Collimator | Ralco R 225 DHHS | | | | {5}------------------------------------------------ | DAP | VacuDAP-OEM | |-------|-------------| | Meter | | Tube stand MULT-FMTS includes Control Panel and X-ray source assembly. Column can be moved horizontally with a manual movement trough the rail and rotate on its vertical axis between ± 180 °, with detents at -90º, 0º and 90º position. Dosimeter device and Mechanical tracking Link to center the image receptor of the RAD table with the tube stand are optional items. The Control Panel is ergonomically built, equipped with logically arranged and easily accessible controls. Column movements are driven by the Control Panel hand-grips. Brakes to allow vertical, horizontal, rotational and transversal travels are released by a slight thumb pressure on the control push-buttons. The control panel includes a SID Display to indicate Source Image Distance and Angle Display to indicate the angle between X-ray source assembly and image receptor. The system includes a Dose Area Product Measuring System, Model VacuDAP-OEM made by Vacutec. | Characteristic | K090279 Trade/Device Name: Sedecal<br>"Millennium Plus Digital Diagnostic X-Ray<br>System" | Proteus XR/f , Models ST and ET, Multirad and<br>Multirad NET Radiographic Systems | |---------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications for<br>Use | These Digital Radiographic Systems are<br>intended for use by a qualified/trained doctor<br>or technician on both adult and pediatric<br>subjects for taking diagnostic radiographic<br>exposures of the skull, spinal column, chest,<br>abdomen, extremities, and other body<br>parts. Applications can be performed with the<br>patient sitting, standing, or lying in the prone<br>or supine position | These radiographic systems are intended for<br>use by a qualified/trained doctor or technician<br>on both adult and pediatric subjects for taking<br>diagnostic radiographic exposures of the skull,<br>spinal column, chest, abdomen, extremities,<br>and other body parts. Applications can be<br>performed with the patient sitting, standing,<br>or lying in the prone or supine position.<br>(Essentially the same. Wording allows for<br>both digital and traditional versions) | | Photo | Image: Sedecal "Millennium Plus Digital Diagnostic X-Ray System" | Image: Proteus XR/f Radiographic System | | Digital<br>Receptor<br>panel/panel<br>sizes | Canon models<br>Model 40G: K023750<br>Model 40C: K031633<br>Model 50G: K031447<br>Model 50C: K060433 | Konica Minolta Wireless Detector<br>SKR3000, K182688 | | Characteristic | K090279 Trade/Device Name: Sedecal<br>"Millennium Plus Digital Diagnostic X-Ray<br>System" | Proteus XR/f, Models ST and ET, Multirad and<br>Multirad NET Radiographic Systems | | Panel<br>properties | $160 \mu m$ , 2208 × 2688<br>14 x 17 panel size, 12 bit | $100 \mu m / 200 \mu m$ 1,994 x 2,430.<br>14 x 17 and 17 x 17 panel sizes, 16 bit. | | Typ MTF/DQE | 0.70 @ 1 lp/mm<br>0.30 @ 1 lp/mm | 0.53 at 1cycle/mm<br>0.51 at 1 cycle/mm Similar performance | | Tube mount | Wall/Floor Suspension | SAME | | Image<br>acquisition<br>Software | Canon control software CXDI-NE | Konica Minolta CX-7 provided with panel | | Panel Interface | Ethernet | SAME or Wi-Fi wireless | | Meets US<br>Performance<br>Standard | YES<br>21 CFR 1020.30 Diagnostic x-ray systems and<br>their major components.<br>21 CFR 1020.31 Radiographic equipment. | SAME | | X-ray<br>generator | SHF Family Output power: 32, 40 kW, 64 kW,<br>80 kW. | SHFR Family Output power: 50 KW, 65 KW,<br>80 KW SIMILAR RANGE OF OUTPUT POWER. | | | kVp From 40 kV to 125 kV or 150 kV in 1 kV<br>steps. Accuracy: ±(3% + 1 kVp) | kVp From 40 kV to 150 kV in 1 kV steps<br>Accuracy: ±(3% + 1 kVp) | | | mA From 10 mA to 800 mA through the<br>following mA stations:<br>10, 12.5, 16, 20, 25, 32, 40, 50, 64, 80, 100,<br>125, 160, 200, 250, 320, 400, 500, 640, 800.<br>(Depending on the Generator model)<br>Accuracy: ±(4% + 1 mA) | mA From 10 mA to 800 mA through the<br>following mA stations:<br>10, 12.5, 16, 20, 25, 32, 40, 50, 65, 80, 100,<br>125, 160, 200, 250, 320, 400, 500, 650, 800.<br>(Depending on the Generator model)<br>Accuracy: ±(4% + 1 mA) | | | mAs Product of mA x Time values from 0.1<br>mAs to 500 mAs (640 mAs on request)<br>Accuracy: ±(10% + 0.2 mAs | mAs Product of mA x Time values from 0.1<br>mAs to 650 mAs<br>Accuracy: ±(10% + 0.2 mAs | | Collimator | Ralco R 302/A DHHS (Manual Collimator) | Ralco R 225 DHHS (Manual Collimator)<br>(updated version of collimator) | | Power Source | Mains operated. | SAME | ## Substantial Equivalence Chart {6}------------------------------------------------ - 6) The technological characteristics, including design, materials, composition, and energy source, are substantially the same, so there are no issues impacting safety and effectiveness. Safety and Effectiveness, comparison to predicate device. The results of bench testing indicate that the new device is as safe and effective as the predicate devices. Proper system operation is fully verified upon installation. We verified that the modified combination of components worked properly and produced diagnostic quality images as good as our predicate generator/panel combination. - 7) Summary of non-clinical testing: Systems covering all generator/panel combinations were assembled and tested and found to be operating properly. Firmware was validated according to the FDA Guidance: Guidance for the Content of Premarket {7}------------------------------------------------ Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005. Because the system uses Wi-Fi and Ethernet, we observed the recommendations contained in the FDA Guidance Document: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff Document Issued on: October 2, 2014. Cybersecurity aspects are covered in the digital panel, cleared separately in K182688. The digital panel software employed was already reviewed by FDA in 510(k)s noted in "reference devices" above. Labeling was developed and information provided in accordance with this FDA Guidance Document: Pediatric Information for X-ray Imaging Device Premarket Notifications, Guidance for Industry and Food and Druq Administration Staff, November 2017. Labeling also includes reference to the Image Gently website (http://www.imagegently.org/). Because the device contains wireless technology, we consulted Radio Frequency Wireless Technology in Medical Devices - Guidance for Industry and FDA Staff, AUGUST 2013 and we incorporated those recommendations into our labeling. Wireless aspects pertain to the digital x-ray receptor panel cleared separately in K182688. The Radiographic System Proteus XR/f has been tested to be in compliance with the following International Standards: - a) 21 CFR 1020.30 Diagnostic x-ray systems and their major components and 21 CFR 1020.31 Radiographic equipment. A product report for the new SHFR generator series was previously submitted. The collimator is certified separately by the manufacturer Ralco. - b) IEC 60601-1:2005+A1:2012 (Edition 3.1) Medical Electrical Equipment, Part 1: General requirements for basic safety and essential performance. - c) IEC 60601-1-2:2014 (Edition 4.0) Medical electrical equipment Collateral Standard: Electromagnetic compatibility Requirements and tests. - d) IEC 60601-1-3:2008+A1:2013 (Edition 2.1) Medical electrical equipment Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment - e) IEC 60601-2-54:2009+A1:2015 (Edition 1.2) Particular Requirements For The Basic Safety And Essential Performance Of X-Ray Equipment for Radiography and Radioscopy. - 8) Summary of clinical testing: Clinical testing was not required to establish substantial equivalence because all digital x-ray receptor panels have had previous FDA clearance. - 9) Conclusion: After analyzing bench and clinical tests, it is the conclusion of Sedecal SA. that the new Radiographic Systems are as safe and effective as the predicate device, have few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.