(33 days)
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.
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) 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.
This document describes the 510(k) premarket notification for the Fujifilm FDR AQRO (DR-XD1000) Mobile X-ray System. As such, it primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed clinical study with specific acceptance criteria, comprehensive performance metrics, and a full statistical plan often found in PMA applications or de novo submissions for novel AI/ML devices.
Therefore, many of the typical elements requested in your prompt regarding acceptance criteria and performance studies (e.g., number of experts for ground truth, adjudication methods, MRMC studies, effect sizes, training set details) are not explicitly provided or applicable in this 510(k) summary for a mobile X-ray system. The performance is assessed primarily through non-clinical (phantom images, compliance with standards) and limited clinical data (sample clinical images) to demonstrate that the device is as safe and effective as the predicate.
However, I can extract the information that is present and explain why certain details are missing based on the nature of this submission.
Here's the breakdown based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The document does not present "acceptance criteria" in the sense of specific quantitative thresholds for clinical performance (e.g., sensitivity, specificity, AUC) that a novel diagnostic AI algorithm would typically undergo. Instead, the "performance" is demonstrated through:
- Compliance with recognized standards: This serves as a primary form of "acceptance criteria" for safety and basic performance of X-ray systems.
- Comparison to a predicate device: The core argument is substantial equivalence, meaning the new device performs "as safe and effective as" the legally marketed predicate.
- Image Quality: Assessed via sample phantom and clinical images, which are qualitatively evaluated rather than against quantitative metrics in this summary.
- Technical Specifications: Comparison of technical specs to the predicate.
| Acceptance Critera (Implied via Standards Compliance / Equivalence) | Reported Device Performance (FDR AQRO) |
|---|---|
| Safety and Electrical Standards Compliance | Complies with AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366, IEC 60601-2-54, IEC 60601-1-3, and IEC 60601-1-6. Also complies with 21 CFR Subchapter J, Electronic Product Radiation Control. |
| Image Quality (General Radiography) | "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." Submission contains sample phantom images and sample clinical images (specific metrics not provided). DQE (GOS): 30% (Predicate: 29%), DQE (CsI): 54% (Predicate: 53%). MTF (GOS): 32% (Predicate: 32%), MTF (CsI): 54% (Predicate: 52%). These values are very similar to the predicate. |
| Functional Equivalence to Predicate | "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." "Tube arm reach" and "Maximum SID to floor" are comparable to predicate. |
| Software Performance (FDX Console Software) | Fujifilm's FDX Console Software Version 10.0 and Virtual Grid 2 (VG2) Image Processing functionality previously received 510(k) clearance (K170451 for console, K153464 for VG2). VG2 function enables use without a physical grid, potentially reducing dose up to 50%. The associated D-EVO2 detectors were also previously cleared (K142003) and described as having similar MTF and DQE to the D-EVO detectors used with the predicate. |
| Risk Analysis | "As required by the risk analysis, all verification and validation activities for the FDR AQRO were performed and the results were satisfactory." |
| Intended Use | Intended for use in general purpose radiography for generating radiographic images of human anatomy, including adult, pediatric, and neonatal exams. Not intended for mammography. (Predicate had similar indications, albeit without explicit mention of neonatal patients, which the document states does not affect substantial equivalence given the similar technological characteristics). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify a quantitative "test set" sample size in terms of number of cases for a clinical performance study. The evaluation appears to involve "sample phantom images" and "sample clinical images" for qualitative assessment. This is typical for a 510(k) for an X-ray system, which focuses on device safety and basic image generation capabilities, rather than a diagnostic algorithm that analyzes images for specific findings.
- Data Provenance: Not specified within this summary. It's likely general radiography data, but no country of origin or whether it's retrospective/prospective is mentioned.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable/Not Specified: For a 510(k) submission of an X-ray system, the "ground truth" is typically the physical output and image quality of the device (compared to a predicate and standards), not a diagnostic finding that requires expert interpretation to establish a gold standard. Without a diagnostic study quantifying performance against a true disease state, there's no mention of experts establishing ground truth for a test set.
4. Adjudication Method for the Test Set
- Not Applicable/Not Specified: As there isn't a stated clinical study with a test set requiring interpretation for specific findings, there is no adjudication method described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No: The document does not mention an MRMC study comparing human readers with and without AI assistance. This device is an X-ray system, not an AI software for diagnosis. While it includes "Virtual Grid 2" software, its clearance (K153464) and functionality relate to image processing affecting dose and image appearance, not to diagnostic AI assistance for readers that would warrant an MRMC study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- No: This is a physical X-ray system. While it contains software components (FDX Console Software and Virtual Grid 2), the "standalone performance" refers to the system as a whole in generating images, not an AI algorithm analyzing images independently. The performance data is primarily demonstrated through technical specifications, compliance with standards, and visual assessment of sample images.
7. The Type of Ground Truth Used
- Technical Specifications & Compliance Standards/Predicate Comparison: The "ground truth" used for this device is effectively its ability to generate radiographic images safely and effectively, achieving comparable technical performance metrics (e.g., DQE, MTF, tube characteristics, radiation control) to a legally marketed predicate device, and compliance with relevant industry and medical device standards. Qualitative visual assessment of sample phantom and clinical images also contributes.
8. The Sample Size for the Training Set
- Not Applicable/Not Specified: This is not an AI/ML device that learns from a "training set" of images in the conventional sense. It's an X-ray system. The software components like FDX Console and Virtual Grid 2 would have been developed and tested through software validation processes (IEC 62304 compliance is noted), but this does not involve a "training set" of patient images in the way an AI diagnostic algorithm would.
9. How the Ground Truth for the Training Set Was Established
- Not Applicable/Not Specified: Since there is no "training set" for an AI/ML model described, there is no ground truth established in this context. Device performance is evaluated against engineering specifications, safety standards, and equivalence to a predicate.
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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
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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
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Indications for Use
510(k) Number (if known)
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)
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FDR AQRO(DR-XD 1000)
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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 QualityConsultant | 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)
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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 DeviceFDR AQRO(DR-XD1000) | Predicate Device K143537, clearedMar 6, 2015Sirius 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 DeviceFDR AQRO(DR-XD1000) | Predicate Device K143537, clearedMar 6, 2015Sirius Starmobile Tiara | |
| User Interface | Up-Down pushbuttons for kVand mAs.Software Driven Touch PanelLCD. | Up-Down pushbuttons for kV andmAs.Software Driven Touch Panel LCD. |
| X-ray Characteristics | ||
| Radiographyratings | 2.5kW | 32kW |
| Tube voltage | 40 to 100 in 1kV steps | 40 to 130 in 1kV steps |
| Maximum tubecurrent | 35mA(automaticallysetaccording to tube voltage) | 400mA (automatically set accordingto tube voltage) |
| mAs | 0.25-25mAs | 0.5-320mAs |
| X-ray tube focalspot size | 1.7 x 2.4 mm | 0.9x1.3 mm:Small focus1.7x2.4 mm:Large focus |
| X-ray tubemaximum anodeheat capacity | 35kJ (50kHU) | 100kJ(140kHU) |
| X-ray tube targetangle | 16 degree | 17 degrees |
| X-ray tubeinherent filtration | 1.3 mmAl equivalent | 1.0 mmAl equivalent |
| X-ray tube Addedfilter | N/A | 0.3 mmAl equivalent |
| X-ray beamlimiting deviceilluminance oflight field | 200 Ix or over (Note: at SID100cm) | 160 Ix or over (Note: at SID 100cm) |
| X-ray beamlimiting devicetimer for lightfield | 30 seconds(This setting canbe changed to 60 sec., 90sec, 120 sec.or 180 sec. inthe service setting) | 30 seconds |
| X-ray beamlimiting deviceinherent 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 tofloor | 2000mm | 2010mm |
| Tube arm reach | 1200mm | 1330mm |
| Detector Characteristics | ||
| Sizes | 24x30cm, 17x14in, 17x17in | 24x30cm, 17x14in, 17x17in |
| Family | FUJIFILM Flat Panel Detector"D-EVO2" (DR-ID12xxSE)K142003 | FUJIFILM Flat Panel Detector "D-EVO" (DR-ID6XXSE) included in theDR-ID800 of the Sirius StarmobileTiaraK132509 |
| Subject DeviceFDR AQRO(DR-XD1000) | Predicate Device K143537, clearedMar 6, 2015Sirius Starmobile Tiara | |
| Scintillator | GOS and CsI | GOS and CsI |
| DQE (RQA5, 1lp/mm, 1mR) –detector alone,without tabletop | 30% (GOS)54% (CsI) | 29% (GOS)53% (CsI) |
| MTF (RQA5, 2lp/mm) | 32% (GOS)54% (CsI) | 32% (GOS)52% (CsI) |
SUMMARY OF TECHNOLOGICAL CHARACTERISTICS lll.
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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.
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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
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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.
§ 892.1720 Mobile x-ray system.
(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.