(26 days)
The Wireless/Wired FDR D-EVO III flat panel detector system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. The FDR D-EVO III is not intended for mammography, fluoroscopy, tomography, and angiography applications.
The subject device FDR D-EVO III Flat Panel Detector System (DR-ID1800) is a portable digital detector system that interfaces with, and acquires and digitizes x-ray exposures from, standard radiographic systems. DR-ID1800 is designed to be used in any environment that would typically use a radiographic cassette for examinations of adults, pediatrics and neonates. The detector models support both wireless and wired/tethered data communication between the detector and the system. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid or free cassette exams. The software that supports the functions of the FDR D-EVO III Flat Panel Detector System is unchanged from the predicate device, cleared under K142003.
This document describes the FDR D-EVO III Flat Panel Detector System (DR-ID1800) and its substantial equivalence to the predicate device, FDR D-EVO II Flat Panel Detector System (DR-ID1200). The information provided heavily relies on a comparison between the two devices and non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. Acceptance Criteria and Reported Device Performance
The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail manner for each performance metric. Instead, it relies on demonstrating that the subject device's performance is substantially equivalent to or slightly improved over the predicate device, particularly in areas like DQE. The primary "acceptance criterion" appears to be equivalence through non-clinical testing.
| Metric (Comparison Item) | Acceptance Criteria (Implied by Predicate Performance) | Reported Device Performance (FDR D-EVO III) | Discussion/Conclusion from Document |
|---|---|---|---|
| Indications for Use | Same as predicate | Same as predicate | Same (Except device name) |
| Scintillator | GOS, CsI | GOS only | The subject device has only GOS based detector. No impact on safety or effectiveness of the device. |
| Dimensions | Same as predicate | Same as predicate | Same* |
| Number of Pixels | Same as predicate | Same as predicate | Same* |
| Pixel Size | 150 µm | 150 µm | Same |
| X-ray Conversion | Indirect conversion (a-Si) | Indirect conversion (a-Si) | Same |
| TFT sensor substrate | Glass-based TFT substrate | Film-based TFT substrate | Only the material of substrate is changed, there is no change in the mechanism. No impact on safety or effectiveness of the device. |
| DQE (RQA5, 1 lp/mm, 1mR) - detector alone, without tabletop | 31% (Measurement tolerance ±10%) | 33% (Measurement tolerance ±10%) | Slightly improved DQE by using Film-based TFT substrate. This difference of DQE does not impact clinical Image Quality. |
| MTF (RQA5, 1 lp/mm) | Two options: Normal 60%, High 75% | Two options: Normal 60%, High 75% | Same |
| Appearance | Rounded corners/curved edges, LED/button placement | More rounded shape, changed alignment of LEDs/Operation button that is easier to use | This difference of detector appearance does not impact on safety or effectiveness of the device. |
| Detector Weight | Approx. 2.3kg-3.0kg (14"x17", 17"x17") | Approx. 1.8kg-2.1kg (14"x17", 17"x17") | This difference of detector weight does not impact on safety or effectiveness of the device. |
| Workstation | FDX Console Version 8.0 and above | FDX Console Version 13.0 | This difference of the workstation is only to add this subject detector as the connectable Flat panel detector options. No impact on safety or effectiveness of the device. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: The document explicitly states "No clinical study has been performed." Therefore, there is no clinical test set for performance evaluation. Non-clinical studies were performed, but details about sample sizes for those specific tests (e.g., number of detectors tested for DQE) are not provided.
- Data Provenance: The studies are described as "Non-clinical Performance Data." There is no mention of country of origin for any data or whether it was retrospective or prospective, as no human subject data was involved in the substantial equivalence claim.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
As "No clinical study has been performed" and no human-reviewed test set is mentioned, this information is not applicable (N/A).
4. Adjudication Method for the Test Set
As "No clinical study has been performed" and no human-reviewed test set is mentioned, this information is not applicable (N/A).
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done
No. The document explicitly states: "No clinical study has been performed."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in essence. The evaluation focused on the device's technical specifications and imaging capabilities (e.g., DQE, MTF) without human interpretation as the primary endpoint for regulatory submission. The comparison is between the subject device and the predicate device's measured physical characteristics and image quality (as defined by objective metrics). The statement "the image quality evaluation confirmed that the image quality of the FDR D-EVO III Flat Panel Detector System (DR-ID1800) is substantially equivalent to that of the predicate device" refers to objective measurements, not human reader performance.
7. The Type of Ground Truth Used
The "ground truth" for the non-clinical studies was established by objective technical measurements and conformity to voluntary standards. This includes:
- Physical measurements of detector characteristics (dimensions, pixel size, weight).
- Quantifiable image quality metrics (DQE, MTF) measured using standardized phantom/test conditions (e.g., RQA5).
- Compliance with various international standards (AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 62304, IEC 62366-1, IEC 62494-1, DICOM).
- Following FDA guidance documents for solid-state X-ray imaging devices and wireless technology.
8. The Sample Size for the Training Set
Not applicable. This device is a hardware component (flat panel detector system), not an AI algorithm. Therefore, there is no training set in the context of machine learning. The "training" for such a device would refer to its design and engineering iterations, not a data-driven training process.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As explained above, this is a hardware device, not an AI algorithm requiring a training set.
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November 12, 2019
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG' in blue, and 'ADMINISTRATION' in a smaller font size below.
FUJIFILM Corporation % Ms. Kamila Sak Regulatory Affairs Specialist FUJIFILM Medical Systems U.S.A, Inc. 81 Hartwell Avenue, Suite 300 LEXINGTON MA 02421
Re: K192932
Trade/Device Name: FDR D-EVO III flat panel detector system Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: MQB Dated: October 16, 2019 Received: October 17, 2019
Dear Ms. Sak:
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 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-reporting-
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combination-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 medical devices and radiation-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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
FDR D-EVO III flat panel detector system
Indications for Use (Describe)
The Wireless/Wired FDR D-EVO III flat panel detector system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. The FDR D-EVO III is not intended for mammography, fluoroscopy, tomography, and angiography applications.
| 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) | ||
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510(k) Summary K192932
Date Prepared: November 05, 2019
Submitter's Information:
FUJIFILM Corporation 798 Miyanodai Kaisei-Machi Ashigarakami-Gun, Kanagawa, 258-8538, Japan FDA Establishment Registration Number: 3001722928
Contact Person:
Kamila Sak Specialist, Regulatory Affairs Telephone: (347) 577-2309 Email: kamila.sak@fujifilm.com
Device Name and Classification:
| Product Name: | FUJIFILM FDR D-EVO III Flat Panel Detector System |
|---|---|
| Model Number: | DR-ID 1800 |
| Classification Name: | Stationary x-ray system |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR 892.1680 |
| Device Class: | Class II |
| Product Code: | MQB |
Predicate Device:
| Product Name | FUJIFILM FDR D-EVO II Flat Panel Detector System(DR-ID 1200) |
|---|---|
| 510(k) Number | K142003 |
| Classification Name | Stationary x-ray system |
| Classification Panel | Radiology |
| CFR Section | 21 CFR 892.1680 |
| Device Class | Class II |
| Product Code | MQB |
The subject device FDR D-EVO III Flat Panel Detector System (DR-ID1800) is essentially a modified version of legally marketed FDR D-EVO II Flat Panel Detector System (DR-
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ID1200). The predicate device DR-ID 1200 had received 510(k) clearance via K142003 on October 21, 2014, and was documented internally several times after that.
Indications for Use:
The Wireless/Wired FDR D-EVO III flat panel detector system is intended to capture for display radiographic images of human anatomy. It is intended for use in general projection radiographic applications including pediatric and neonatal exams wherever conventional film/screen or CR systems may be used. The FDR D-EVO III is not intended for mammography, fluoroscopy, tomography, and angiography applications.
Description of the Device:
The subject device FDR D-EVO III Flat Panel Detector System (DR-ID1800) is a portable digital detector system that interfaces with, and acquires and digitizes x-ray exposures from, standard radiographic systems. DR-ID1800 is designed to be used in any environment that would typically use a radiographic cassette for examinations of adults, pediatrics and neonates. The detector models support both wireless and wired/tethered data communication between the detector and the system. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid or free cassette exams. The software that supports the functions of the FDR D-EVO III Flat Panel Detector System is unchanged from the predicate device, cleared under K142003.
Comparison of Technological Characteristics:
A comparison of the technological characteristics between the subject device and predicate device is provided below:
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| Comparison Item | Subject DeviceFDR D-EVO III FPD system (DR-ID1800) | Predicate DeviceFDR D-EVO II FPD system (DR-ID 1200) | Discussion&Conclusion |
|---|---|---|---|
| Indications forUse | The Wireless/Wired FDR D-EVO III flat paneldetector system is intended to capture for displayradiographic images of human anatomy. It isintended for use in general projectionradiographic applications including pediatric andneonatal exams wherever conventionalfilm/screen or CR systems may be used. TheFDR D-EVO III is not intended formammography, fluoroscopy, tomography, andangiography applications. | The Wireless/Wired FDR D-EVO II flat panel detectorsystem is intended to capture for display radiographicimages of human anatomy. It is intended for use ingeneral projection radiographic applications includingpediatric and neonatal exams wherever conventionalfilm /screen or CR systems may be used. The FDR D-EVO II is not intended for mammography, fluoroscopy,tomography, and angiography applications. | Same(Except device name) |
| Detector characteristics | |||
| Panel variation | DR-ID 1801SE (14" x 17")DR-ID 1802SE (17" x 17") | DR-ID 1201SE (14" x 17"),DR-ID 1202SE (17" x 17")DR-ID 1211SE (14" x 17"),DR-ID 1212SE (17" x 17")DR-ID 1213SE (9" x 11") | Described as below |
| Scintillator | GOS (Gadolinium oxysulfide) | GOS (Gadolinium oxysulfide);DR-ID 1201SE (14" x 17")DR-ID 1202SE (17" x 17")CsI(Secium Iodide);DR-ID 1211SE (14" x 17")DR-ID 1212SE (17" x 17")DR-ID 1213SE (9" x 11") | The subject device has onlyGOS based detector.No impact on safety oreffectiveness of the device. |
| Dimensions(Detector exterior) | DR-ID1801SE: 38.4 cm x 46 cm x 1.5 cmDR-ID1802SE: 46 cm x 46 cm x 1.5 cm | DR-ID1201SE, DR-ID1211SE: 38.4 cm x 46 cm x 1.5 cmDR-ID1202SE, DR-ID1212SE: 46 cm x 46 cm x 1.5 cmDR-ID1213SE: 26.8 cm x 32.8 cm x 1.5 cm | Same* |
| Number of Pixels | DR-ID1801SE: 2336 x 2836DR-ID1802SE: 2832 x 2836 | DR-ID1201SE, DR-ID1211SE: 2336 x 2836DR-ID1202SE, DR-ID1212SE: 2832 x 2836DR-ID1213SE:1920 x 1536 | Same* |
| Pixel Size | 150 μm | 150 μm | Same |
| Comparison Item | Subject DeviceFDR D-EVO III FPD system (DR-ID1800) | Predicate DeviceFDR D-EVO II FPD system (DR-ID 1200) | Discussion&Conclusion |
| X-ray Conversion | Indirect conversion (a-Si) | Indirect conversion (a-Si) | Same |
| TFT sensorsubstrate | Film-based TFT substrate | Glass-based TFT substrate | Only the material ofsubstrate is changed, thereis no change in themechanism. No impact onsafety or effectiveness ofthe device. |
| DQE (RQA5, 1lp/mm, 1mR) -detector alone,without tabletop | 33%Measurement tolerance (±10%) | 31%Measurement tolerance (±10%) | Slightly improved DQE byusing Film-based TFTsubstrateThis difference of DQEdoes not impact clinicalImage Quality. |
| MTF (RQA5, 1lp/mm) | Two options are available by setting.-Normal 60%-High 75% | Two options are available by setting.-Normal 60%-High 75% | Same |
| Appearancecharacteristics | - Adopt more rounded shape- Changed alighnment of LEDs/Operation buttonthat is easier to use | - Rounded corners and curved edges are adopted.- LEDs/Operation button is placed. | This difference of detectorappearance does notimpact on safety oreffectiveness of the device. |
| Detector Weight | DR-ID1801SE:: Approx. 1.8kg (without battery)DR-ID1802SE: Approx. 2.1kg (without battery) | DR-ID1201SE: Approx. 2.3kg (without battery)DR-ID1202SE: Approx. 2.9kg (without battery)DR-ID1211SE: Approx. 2.4kg (without battery)DR-ID1212SE: Approx. 3.0kg (without battery)DR-ID1213SE: Approx. 1.3kg (without battery) | This difference of detectorweight does not impact onsafety or effectiveness ofthe device. |
| Comparison Item | Subject DeviceFDR D-EVO III FPD system (DR-ID1800) | Predicate DeviceFDR D-EVO II FPD system (DR-ID 1200) | Discussion &Conclusion |
| Software Charactisctic | |||
| Workstation | FDX Console Version 13.0 | FDX Console Version 8.0 and above (Latest version:12.1) | This difference of theworkstation is only to addthis subject detector as theconnectable Flat paneldetector options. No impacton safety or effectiveness ofthe device. |
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*Note: Csl scintillator has not been adopted in DR-ID 1800 yet. Then, we discuss and conclude the substantial equivalence by excluding Csl scintillator.
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Substantial Equivalence:
Both the subject device and predicate device have the same Indication for Use. There are some differences, but the differences are minor and do not affect fundamental scientific technology, principles of operation, safety and effectiveness, and image quality. Therefore, the subject device FDR D-EVO III Flat Panel Detector System (DR-ID1800) can be considered to be substantially equivalent to the predicate device FDR D-EVO II Flat Panel Detector System (DR-ID1200) limited to the flat panel detector with GOS scintillator.
Summary Of Studies:
Non-clinical Performance Data: FDR D-EVO III Flat Panel Detector System (DR-ID1800) conforms to the voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-1-2, IEC 62304, IEC 62366-1, IEC 62494-1 and DICOM. In addition, the FDA's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices (September 1, 2016) was followed to describe the detector characteristics, and Radio Frequency Wireless Technology in Medical Devices (August 14, 2013) was followed to test wireless features. As required by the risk analysis, necessary verification and validation activities were performed including software testing, and the results were satisfactory. Furthermore, the image quality evaluation confirmed that the image quality of the FDR D-EVO III Flat Panel Detector System (DR-ID1800) is substantially equivalent to that of the predicate device.
Clinical Performance Data: No clinical study has been performed. The substantial equivalence has been demonstrated by non-clinical studies.
Conclusion:
This Special 510(k) premarket notification submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health. We conclude the subject device to be as safe and effective as the predicate device.
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.