FDR Cross (DR-XD 3000)

{0}------------------------------------------------ November 8, 2021 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below. FUJIFILM Corporation % Mr. Jeffrey Wan Manager, Regulatory Affairs FUJIFILM Medical Systems U.S.A. Inc. 81 Hartwell Avenue, Suite 300 LEXINGTON MA 02421 Re: K212956 Trade/Device Name: FDR CROSS (DR-XD 3000) Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA Dated: September 14, 2021 Received: September 16, 2021 Dear Mr. Wan: 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 Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K212956 Device Name FDR CROSS (DR-XD 3000) The DR-XD 3000 is a mobile C-arm system with detachable flat panel detector, which is intended for use in providing medical imaging for general populations including pediatrics. The device provides pulsed fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures and digital radiographic imaging. It is intended for use in procedures such as cholangiography, endoscopic, orthopedic, neurologic, peripheral vascular, critical care, emergency room procedures. This device does not support cardiac procedures and is not intended for use in performing mammography. 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) Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below. #### 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. 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}------------------------------------------------ ## FUJKFILM ## 510(k) Summary K212956 ## FDR CROSS (DR-XD 3000) #### Date: August 23, 2021 ## Submitter's Information: FUJIFILM Corporation 798 Miyanodai Kaisei-Machi, Ashigarakammi-Gun, Kanagawa, Japan ## Contact Person: Name: Jeffrey Wan Title: Manager, Requlatory Affairs (201) 675-8947 Telephone: E-Mail: Jeffrey.wan@fujifilm.com #### ldentification of the Device: | Proprietary/Trade Name: | FDR CROSS (DR-XD 3000) | |-------------------------|---------------------------------------------| | Classification Name: | Image-intensified fluoroscopic x-ray system | | Regulations Number: | 21 CFR 892.1650 | | Product Codes: | OWB, JAA | | Device Class: | Class II | | Review Panel: | Radiology | | Common Name: | Interventional Fluoroscopic X-Ray System | #### Identification of the Legally Marketed Device: | 1.Ziehm Vision FD, K193230 cleared 12/20/2019 | | |-----------------------------------------------|---------------------------------------------| | Classification Name: | Image-intensified fluoroscopic x-ray system | | Regulations Number: | 21 CFR 892.1650 | | Product Codes: | OWB, JAA | | Device Class: | Class II | | Review Panel: | Radiology | | Common Name: | Interventional Fluoroscopic X-Ray System | 2. FDR D-EVO III Flat Panel Detector System, K192932 cleared 11/12/2019 Classification Name: Stationary x-ray system Regulations Number: 21 CFR 892.1680 Product Codes: MQB Device Class: Class II Review Panel: Radiology Common Name: Solid State X-Ray Imager (Flat Panel/Digital Imager) #### l. DEVICE DESCRIPTION The FDR CROSS is mobile X-ray fluoroscopy equipment designed and manufactured by Fujifilm Corporation (FTYO) featuring high mobility arising from small size and light {4}------------------------------------------------ # FUJKFILM weight. The C-arm cart irradiates X-rays and detects X-rays by the flat panel sensor to perform X-ray fluoroscopy and radiography. A flat panel sensor has higher sensitivity than an image intensifier, which can result in dose reduction. The flat panel sensor is same as FDR D-EVO III Flat Panel Detector System (predicate device) cleared as radiography purpose. (K192932) The system contains the console software (DR-ID 340CL), control cabinet software (DR-ID 3000MC) and X-ray controller software (DR-ID 3000SX). The DR-ID 340CL and DR-ID 3000MC is modified to add fluoroscopic function based on the DR-ID 300CL and DR-ID 1200MC which are used in FDR D-EVO III Flat Panel Detector System cleared as radiography purpose (K192932). The software's Level of Concern is Moderate. #### II. INDICATIONS FOR USE The DR-XD 3000 is a mobile C-arm system with detachable flat panel detector, which is intended for use in providing medical imaging for general populations including pediatrics. The device provides pulsed fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures and digital radiographic imaging. It is intended for use in procedures such as cholangiography, endoscopic, urologic, orthopedic, neurologic, peripheral vascular, critical care, emergency room procedures. This device does not support cardiac procedures and is not intended for use in performing mammography. #### = SUBSTANTIAL EQUIVALENCE The FDR CROSS (DR-XD 3000) is substantially equivalent to the following legally marketed device. | Legally Marketed Device | 510(k) # | Clearance Date | |-------------------------|----------|----------------| | Ziehm Vision FD | K193230 | 20/12/2019 | Both systems, the subject device and the predicate (K193230), are intended for use in providing medical imaging for general populations. The device provides pulsed fluoroscopic imaging of patients during diagnostic, interventional and surgical procedures. The Indications for Use of the subject device are almost identical to the predicate device and representing identical indications for use and type of interventional and fluoroscopic procedures. The indications for use for of subject device are includes the statement that it has "detachable flat panel sensor" and "digital radiographic imaging". Further it includes the statement that it does not support cardiac procedures. These changes do not raise new safety or effectiveness concerns with regard to the predicate device. The key technological characteristics of the subject device and the predicate device are similar, and therefore the differences described below do not affect the Indications for Use. | | Subject Device<br>FDR CROSS<br>(DR-XD 3000) | Predicate Device<br>K193230 Dec,20,2019<br>Ziehm Vision FD | |-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | X-ray Generator | | | | Maximum<br>Parameter | max. 2.0 kW,<br>max. 110 kV,<br>max. 25 mA | max. 2.0 kW,<br>max. 110 kV,<br>max. 20 mA | | Pulsed<br>Fluoroscopy: | kV range: 40 - 110 kV<br>mA range: 0.8 - 20 mA | kV range: 40 - 110 kV<br>mA range: 0.2 - 16 mA | | Operating<br>values | | | | Pulsed<br>Fluoroscopy:<br>Pulse and<br>Duration | • pulse width:<br>18 - 60 ms<br>• pulse rate:<br>1, 2, 4, 8, 15 pulse/s<br>(Snapshot) | • pulse width:<br>10 - 40 ms (8" FPD Varex aSi)<br>• pulse rate:<br>1, 2, 5, 10, 15, 30 pulse/s | | Digital<br>Radiography /<br>Operating<br>Values | kV range: 40 - 110 kV<br>mA range: up to 20 mA<br>(Radiography)<br>kV range: 40 - 110 kV<br>mA range: up to 25 mA<br>mAs range: 0.25 - 25 mAs | (Snapshot)<br>kV range: 40 - 110 kV<br>mA range: up to 20 mA | | Image Detector | | | | Detector<br>Sizes | • Detachable Flat Panel Sensor<br>holder<br>• Detachable Flat Panel sensor<br>• Size:<br>(Fluoroscopy/Radiography)<br>247.2 mm x 297 mm<br>(DR-ID 1814SE)<br>350.4 mm x 425.4 mm<br>(DR-ID 1811SE)<br>424.8 mm x 425.4 mm<br>(DR-ID 1812SE)<br>(Radiography Only)<br>350.4 mm x 425.4 mm<br>(DR-ID 1831SE)<br>424.8 mm x 425.4 mm<br>(DR-ID 1832SE) | Size: 19.9 cm x 19.9 cm | | Electrical Requirements | | | | Electrical<br>Requirements | • Power supply:<br>100-240 VAC (± 10%), 50/60 Hz<br>Battery (Li-ion)<br>• Current consumption:<br>100 V: 12 A<br>240 V: 5 A<br>• Max. impedance:<br>$ \leq $ 0.2 Ω<br>• Class I equipment (when<br>operated by connecting the power<br>cable),<br>Internally powered equipment<br>(when operated with the<br>battery),<br>Type B | • Power supply:<br>100-240 VAC (± 10%), 50/60 Hz<br>• Current consumption:<br>100-120 V: 10 A<br>continuous, 22 A short time<br>200-240 V: 8 A<br>continuous, 16 A short time<br>• Max. impedance:<br>100-200 V: $ \leq $ 0.3 Ω<br>220-240 V: $ \leq $ 0.6 Ω<br>• Class I equipment,<br>Type B | | Mechanics | | | | Weight | C-arm Cart: max. 249kg | Mobile Stand: max. 337kg | | | Monitor Cart: max. 50kg | Monitor Cart: max. 233kg | | | Digital Image Processing | | | Real-Time<br>processing<br>functions | • Recursive filter: 4 levels<br>• Noise reduction filter(FNC2)<br>• Edge enhancement filter(MFP2):<br>4 levels<br>• Windowing<br>• Digital image rotation and<br>reversal without radiation<br>• Grayscale inversion<br>• Virtual collimators | • Recursive filter: 4 levels<br>• Edge enhancement filter: 5<br>levels<br>• Windowing and step windowing<br>• Digital image rotation and<br>reversal without radiation<br>• Grayscale inversion<br>• Virtual collimators | | Post-<br>Processing<br>Functions | (Fluoroscopy)<br>• Zoom: 1 level<br>• Windowing<br>(Radiography)<br>• Zoom<br>• Windowing<br>• Gradation conversion(GP)<br>• Standardization (EDR)<br>• Image enhancement<br>(frequency processing(RP),<br>dynamic range<br>compression(DRC), multi<br>frequency processing(MFP))<br>• Noise suppression (Granular<br>noise suppression(FNC2), Grid<br>moire removal(GPR), scattered<br>X-ray reduction(virtual grid)) | Edge enhancement: 5 levels<br>• Zoom: 3 levels<br>• Image rotation<br>• Windowing and step windowing<br>• Grayscale inversion<br>• Image cropping (digital<br>collimators)<br>• Digital measurement functions:<br>distance/angle (option) | {5}------------------------------------------------ # FUJIFILM {6}------------------------------------------------ # FUJKFILM The virtual grid function is the same as K153464. #### IV. SUMMARY OF STUDIES Non-clinical Performance Data: The FDR CROSS (DR-XD 3000) conforms to the voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 62304, IEC 62366-1, DICOM 3.0, IEC 60601-2-43, IEC 60601-2-54. In addition, the FDA's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices (issued on August 6, 1999) was followed to describe the detector characteristics, and Radio Frequency Wireless Technology in Medical Devices (issued August 14, 2013) was followed to test. As required by the risk analysis, necessary verification and validation activities were performed including software testing, and the results were satisfactory. #### CONCLUSION V. Based upon the supporting data summarized above, we concluded the FDR CROSS (DR-XD 3000) is as safe and effective as the legally marketed device Ziehm Vision FD (K193230) and does not raise different questions of safety and effectiveness than Ziehm Vision FD (K193230).