(53 days)
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.
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 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.
The provided text is a 510(k) Summary for a medical device (FDR CROSS (DR-XD 3000)), primarily focusing on demonstrating substantial equivalence to a predicate device. It details the device's characteristics and indicates what standards and guidance documents were followed for non-clinical performance data.
However, the document does not contain any information about an acceptance criteria table, device performance data against acceptance criteria, sample sizes for test or training sets, data provenance, expert ground truth establishment (number of experts, qualifications, adjudication), MRMC studies, or standalone algorithm performance.
The "SUMMARY OF STUDIES" section states: "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."
This indicates that the performance evaluation was based on conformance to voluntary standards and internal verification and validation activities, rather than a clinical study involving human readers or AI performance metrics against a clinical ground truth. The device listed (FDR CROSS (DR-XD 3000)) appears to be an X-ray imaging system, not an AI/CADe device that would typically have the kind of acceptance criteria and performance study described in your prompt.
Therefore, for your specific request:
- A table of acceptance criteria and the reported device performance: Not provided in the document. The performance evaluation focuses on conformance to general medical device standards for X-ray systems.
- Sample sized used for the test set and the data provenance: Not provided. The studies mentioned are non-clinical (conformance to standards, software testing).
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not provided. No human expert review to establish ground truth is described.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable/Not provided.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not done/Not applicable. This device is an imaging system, not an AI assistance tool.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The performance is assessed against engineering and regulatory standards for X-ray devices.
- The sample size for the training set: Not applicable/Not provided. This device is an X-ray system, not a machine learning model that requires a training set.
- How the ground truth for the training set was established: Not applicable.
In conclusion, the provided FDA 510(k) summary for the FDR CROSS (DR-XD 3000) does not contain the type of acceptance criteria and study information (e.g., clinical performance metrics, AI-specific studies) you are asking for. The clearance for this device is based on its substantial equivalence to a predicate X-ray system, demonstrated primarily through engineering safety and performance testing against recognized standards.
{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)
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 |
- 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 DeviceFDR CROSS(DR-XD 3000) | Predicate DeviceK193230 Dec,20,2019Ziehm Vision FD | |
|---|---|---|
| X-ray Generator | ||
| MaximumParameter | max. 2.0 kW,max. 110 kV,max. 25 mA | max. 2.0 kW,max. 110 kV,max. 20 mA |
| PulsedFluoroscopy: | kV range: 40 - 110 kVmA range: 0.8 - 20 mA | kV range: 40 - 110 kVmA range: 0.2 - 16 mA |
| Operatingvalues | ||
| PulsedFluoroscopy:Pulse andDuration | • pulse width:18 - 60 ms• pulse rate:1, 2, 4, 8, 15 pulse/s(Snapshot) | • pulse width:10 - 40 ms (8" FPD Varex aSi)• pulse rate:1, 2, 5, 10, 15, 30 pulse/s |
| DigitalRadiography /OperatingValues | kV range: 40 - 110 kVmA range: up to 20 mA(Radiography)kV range: 40 - 110 kVmA range: up to 25 mAmAs range: 0.25 - 25 mAs | (Snapshot)kV range: 40 - 110 kVmA range: up to 20 mA |
| Image Detector | ||
| DetectorSizes | • Detachable Flat Panel Sensorholder• Detachable Flat Panel sensor• Size:(Fluoroscopy/Radiography)247.2 mm x 297 mm(DR-ID 1814SE)350.4 mm x 425.4 mm(DR-ID 1811SE)424.8 mm x 425.4 mm(DR-ID 1812SE)(Radiography Only)350.4 mm x 425.4 mm(DR-ID 1831SE)424.8 mm x 425.4 mm(DR-ID 1832SE) | Size: 19.9 cm x 19.9 cm |
| Electrical Requirements | ||
| ElectricalRequirements | • Power supply:100-240 VAC (± 10%), 50/60 HzBattery (Li-ion)• Current consumption:100 V: 12 A240 V: 5 A• Max. impedance:$ \leq $ 0.2 Ω• Class I equipment (whenoperated by connecting the powercable),Internally powered equipment(when operated with thebattery),Type B | • Power supply:100-240 VAC (± 10%), 50/60 Hz• Current consumption:100-120 V: 10 Acontinuous, 22 A short time200-240 V: 8 Acontinuous, 16 A short time• Max. impedance:100-200 V: $ \leq $ 0.3 Ω220-240 V: $ \leq $ 0.6 Ω• Class I equipment,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-Timeprocessingfunctions | • Recursive filter: 4 levels• Noise reduction filter(FNC2)• Edge enhancement filter(MFP2):4 levels• Windowing• Digital image rotation andreversal without radiation• Grayscale inversion• Virtual collimators | • Recursive filter: 4 levels• Edge enhancement filter: 5levels• Windowing and step windowing• Digital image rotation andreversal without radiation• Grayscale inversion• Virtual collimators |
| Post-ProcessingFunctions | (Fluoroscopy)• Zoom: 1 level• Windowing(Radiography)• Zoom• Windowing• Gradation conversion(GP)• Standardization (EDR)• Image enhancement(frequency processing(RP),dynamic rangecompression(DRC), multifrequency processing(MFP))• Noise suppression (Granularnoise suppression(FNC2), Gridmoire removal(GPR), scatteredX-ray reduction(virtual grid)) | Edge enhancement: 5 levels• Zoom: 3 levels• Image rotation• Windowing and step windowing• Grayscale inversion• Image cropping (digitalcollimators)• Digital measurement functions: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).
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.