FDR AQRO (DR-XD 1000)

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 April 24, 2017 FUJIFILM Medical Systems U.S.A., Inc. Peter Altman Regulatory and Ouality Consultant 419 West Avenue Stamford, Connecticut 06902 Re: K170858 Trade/Device Name: FDR AORO (DR-XD 1000) Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL Dated: March 20, 2017 Received: March 22, 2017 Dear Peter Altman: 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 {1}------------------------------------------------ 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. 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/ResourcesforYou/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, Michael D.'Hara For Robert A. 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) K170858 Device Name FDR AQRO (DR-XD 1000) #### Indications for Use (Describe) The FDR AQRO (DR-XD 1000) is a digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams. The FDR AORO is not intended for mammography. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) ### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) 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." ## FDR AQRO(DR-XD 1000) {3}------------------------------------------------ # 510(k) Summary # FDR AQRO (DR-XD1000) Mobile X-ray System ## Date: March 20, 2017 ### Submitter's Information: FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, CT, 06902, USA ### Contact Persons: | Name: | Peter Altman | Dharaben Desai (alternate) | |------------|--------------------------------------|-----------------------------------| | Title: | Regulatory and Quality<br>Consultant | Sr. Regulatory Affairs Specialist | | Telephone: | (203) 602-3576 | (203) 276-3445 | | Facsimile: | (203) 602-3785 | (203) 602-3785 | ### ldentification of the Device: | Proprietary/Trade Name: | FDR AQRO (DR-XD1000) | |-------------------------|----------------------| | Classification Name: | Mobile X-ray system | | Regulations Number: | 21 CFR 892.1720 | | Product Codes: | IZL | | Device Class: | Class II | | Review Panel: | Radiology | | Common Name: | Mobile X-ray System | ### Identification of the Legally Marketed Predicate Device: | Sirius Starmobile Tiara, K143537 cleared 3/6/2015 | | |---------------------------------------------------|---------------------| | Classification Name: | Mobile X-ray system | | Regulations Number: | 21 CFR 892.1720 | | Product Codes: | IZL | | Device Class: | Class II | | Review Panel: | Radiology | | Common Name: | Mobile X-ray System | #### l. DEVICE DESCRIPTION FUJIFILM's FDR AQRO (DR-XD1000) is a compact, economical, lightweight, nonmotorized, low power (2.5 kW), mobile X-ray system designed to work with FUJIFILM's GOS and Csl scintillator FDR D-EVO2 (DR-ID 12XXSE) family of digital X-ray detectors coupled. The D-EVO2 detectors received clearance on 7/23/2014 via 510(k) K142003. The FDR AQRO includes a built-in operation console. The AQRO's console uses Version 10.0 of Fujifilm's FDX Console Software. This software received 510(k) {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the Fujifilm logo. The logo is black, except for a small red square with a white triangle cut out of it. Below the logo, the words "Value from Innovation" are written in a smaller, black font. clearance via K170451 on 3/16/2017. The console software includes Virtual Grid 2 (VG2) Image Processing functionality. The VG2 function allows using the mobile X-ray system without a physical grid, resulting in a dose reduction of up to 50% (when compared to using a physical grid). The Virtual Grid 2 Image Processing software received clearance on 4/8/2016 via K153464. The reduction in the external dimensions of FDR AQRO enables smooth movement in the hospital and at the bedside because of an integrated X-ray tube and high-voltage generator (mono-block) that eliminates the need for High Voltage cables and utilizes less space. A high performance Li-ion battery provides up to twelve (12) hours of continuous use (at ~20 exposures/hour) with a quick full charge in four hours. A quick charge of 15 minutes provides one hour of usage. Exposure may also be made when the AC power cord is plugged in. #### ll. INDICATIONS FOR USE The FDR AQRO (DR-XD1000) is a digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy. including adult, pediatric, and neonatal exams. The FDR AQRO is not intended for mammography. | Subject Device<br>FDR AQRO<br>(DR-XD1000) | Predicate Device K143537, cleared<br>Mar 6, 2015<br>Sirius Starmobile Tiara | | |--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------| | Indications for Use | | | | The FDR AQRO (DR-XD1000) is a digital mobile X-ray system intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams. The FDR AQRO is not intended for mammography. | The Mobile X-ray Unit Sirius Starmobile Tiara is a general radiography system and is composed of the X-ray high voltage generator, X-ray tube, support unit, and digital radiograph device (DR-ID 800) made by Fujifilm Corporation. This device is designed for pediatric and adult patients. It is intended for use in general radiography of the head, body, or extremities including pediatric exams. The device output can provide an aid to diagnosis when used by a qualified physician. | | | General Characteristics | | | | Weight | 90kg | 420kg | | Dimensions | 600x851x1460 mm | 575x1236x1780 mm | | Energy Source | Batteries charged by AC line | Batteries charged by AC line | | | Subject Device<br>FDR AQRO<br>(DR-XD1000) | Predicate Device K143537, cleared<br>Mar 6, 2015<br>Sirius Starmobile Tiara | | User Interface | Up-Down pushbuttons for kV<br>and mAs.<br>Software Driven Touch Panel<br>LCD. | Up-Down pushbuttons for kV and<br>mAs.<br>Software Driven Touch Panel LCD. | | X-ray Characteristics | | | | Radiography<br>ratings | 2.5kW | 32kW | | Tube voltage | 40 to 100 in 1kV steps | 40 to 130 in 1kV steps | | Maximum tube<br>current | 35mA<br>(automatically<br>set<br>according to tube voltage) | 400mA (automatically set according<br>to tube voltage) | | mAs | 0.25-25mAs | 0.5-320mAs | | X-ray tube focal<br>spot size | 1.7 x 2.4 mm | 0.9x1.3 mm:Small focus<br>1.7x2.4 mm:Large focus | | X-ray tube<br>maximum anode<br>heat capacity | 35kJ (50kHU) | 100kJ(140kHU) | | X-ray tube target<br>angle | 16 degree | 17 degrees | | X-ray tube<br>inherent filtration | 1.3 mmAl equivalent | 1.0 mmAl equivalent | | X-ray tube Added<br>filter | N/A | 0.3 mmAl equivalent | | X-ray beam<br>limiting device<br>illuminance of<br>light field | 200 Ix or over (Note: at SID<br>100cm) | 160 Ix or over (Note: at SID 100cm) | | X-ray beam<br>limiting device<br>timer for light<br>field | 30 seconds(This setting can<br>be changed to 60 sec., 90<br>sec, 120 sec.or 180 sec. in<br>the service setting) | 30 seconds | | X-ray beam<br>limiting device<br>inherent filtration | 1.2 mm Al equivalent | 1.2 mm Al equivalent | | Total filtration | 2.5 mm Al equivalent | 2.5 mm Al equivalent | | Maximum SID to<br>floor | 2000mm | 2010mm | | Tube arm reach | 1200mm | 1330mm | | Detector Characteristics | | | | Sizes | 24x30cm, 17x14in, 17x17in | 24x30cm, 17x14in, 17x17in | | Family | FUJIFILM Flat Panel Detector<br>"D-EVO2" (DR-ID12xxSE)<br>K142003 | FUJIFILM Flat Panel Detector "D-<br>EVO" (DR-ID6XXSE) included in the<br>DR-ID800 of the Sirius Starmobile<br>Tiara<br>K132509 | | | Subject Device<br>FDR AQRO<br>(DR-XD1000) | Predicate Device K143537, cleared<br>Mar 6, 2015<br>Sirius Starmobile Tiara | | Scintillator | GOS and CsI | GOS and CsI | | DQE (RQA5, 1<br>lp/mm, 1mR) –<br>detector alone,<br>without tabletop | 30% (GOS)<br>54% (CsI) | 29% (GOS)<br>53% (CsI) | | MTF (RQA5, 2<br>lp/mm) | 32% (GOS)<br>54% (CsI) | 32% (GOS)<br>52% (CsI) | #### SUMMARY OF TECHNOLOGICAL CHARACTERISTICS lll. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the Fujifilm logo. The logo consists of the word "FUJIFILM" in bold, black letters, with a red square above the "I". Below the company name is the slogan "Value from Innovation". The logo is simple and modern. {6}------------------------------------------------ Image /page/6/Picture/0 description: The image shows the Fujifilm logo. The logo consists of the word "FUJIFILM" in a bold, sans-serif font. The "I" in Fujifilm is red and has a small triangle cut out of the top right corner. Below the logo is the tagline "Value from Innovation" in a smaller font. Even though the subject device is small and compact, it still provides the ability to maneuver and perform all the typical functions required of a mobile x-ray system. The beam coverage of the subject device is equivalent to the predicate device because the focal spot size is the same as predicate. Anode heat capacity of the subiect device is less but the maximum mAs is also small so it will not impact the ability to perform exams. Acceptable image quality can be obtained with the FDR AQRO despite the smaller values of kV and mAs because of the highly sensitive detector system and the VG2 software. The D-EVO II and D-EVO detectors, DR-ID12xxSE and DR-ID6xxSE used in the FDR AQRO and Sirius Starmobile Tiara respectively, have the same Indications for Use. FDR D-EVO II detectors' scintillator materials (GOS or Csl), indirect conversion method (a-Si). Fuiifilm's unique ISS technology, readout properties. 150um pixel pitch, and 16 bit-depth remain the same as the D-EVO detectors. The MTF and DQE measurements are very similar between FDR D-EVO II and D-EVO detectors. While DR-ID12xxSE and DR-ID6xxSE are wireless detectors, the wireless feature in DR-ID12xxSE has been improved by expanding operating frequency options, and adding new wireless components. The active area size and pixel matrix of the DR-ID12xxSE detectors are only slightly different from the predicate device (K132509). . In general the detectors used with both systems have the same physical and technical characteristics and their performance is substantially equivalent (note that the FDR D-EVOII Flat Panel Detector System (DR-ID1200) received clearance using the FDR D-EVO Flat Panel Detector System (DR-ID600) as the predicate device). #### SUBSTANTIAL EQUIVALENCE IV. The FDR AQRO (DR-XD1000) is substantially equivalent to the following legally marketed device: | Legally Marketed Device | 510(k) # | Clearance Date | |-------------------------|----------|----------------| | Sirius Starmobile Tiara | K143537 | 3/6/2015 | Both systems, the subject device and the predicate (K143537), are intended for use in general purpose radiography for generating radiographic images. Both the subject device, FDR AQRO (DR-XD 1000), and the predicate device, Sirius Starmobile Tiara (K143537), are mobile X-ray systems and have similar Indications For Use, i.e., qeneral purpose radiography of adult and pediatric patients, although the FDR AQRO is also indicated for use with neonatal patients. The kev technological characteristics of the subject device and the predicate device are {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the Fujifilm logo. The logo is black, except for a small red square with a white triangle cut out of it. Below the logo is the text "Value from Innovation". similar and the differences do not affect the IFU. Both systems use detectors that are substantially equivalent. #### > SUMMARY OF STUDIES Non-clinical Performance Data: The FDR AQRO conformity includes the voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366, IEC 62494-1, DICOM 3.0, IEC 60601-2-54, IEC 60601-1-3, and IEC 60601-1-6. In addition the device complies with the requirements of 21 CFR Subchapter J, Electronic Product Radiation Control. As required by the risk analysis, all verification and validation activities for the FDR AQRO were performed and the results were satisfactory. The submission contains sample phantom images. Clinical Performance Data: The submission contains sample clinical images. #### VI. CONCLUSION Based upon the supporting data summarized above, we concluded the FDR AQRO is as safe and effective as the legally marketed device K143537 and does not raise different questions of safety and effectiveness than K143537.