(94 days)
Not Found
No
The description mentions a "post image processing algorithm called 'Virtual Grid Software'" which is a deterministic algorithm for improving image contrast. There is no mention of AI, ML, training data, or adaptive learning.
No
The device is used to capture and display radiographic images for diagnosis, not to provide therapy or treatment.
No
The device is described as capturing and displaying radiographic images for human anatomy, which are then used by a user to decide on image processing. It is not intended to provide a medical diagnosis on its own.
No
The device description clearly states it is a "Flat Panel Detector System" which is a hardware component used to acquire radiographic images. The "Virtual Grid Software" is described as a "design modification" added to this hardware system, indicating it is a software component of a larger hardware device, not a standalone software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for capturing and displaying radiographic images of human anatomy for general projection radiographic applications. This involves imaging the internal structure of the body using X-rays.
- Device Description: The description reinforces this by explaining it's a portable digital detector system that acquires and digitizes X-ray exposures.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. This device does not perform any such tests on biological samples.
The device is a medical imaging device used for diagnostic purposes, but it falls under the category of radiological imaging systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Wireless/Wired FDR D-EVO 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 is not intended for mammography, fluoroscopy, tomography, and angiography applications.
Product codes (comma separated list FDA assigned to the subject device)
MOB
Device Description
Fujifilm's FDR D-EVO Flat Panel Detector System (DR-ID600) is a portable digital detector system that interfaces with, and acquires and digitizes x-ray exposures, from standard radiographic systems. The FDR D-EVO 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 exams.
The design modification made to the FDR D-EVO is adding Fujifilm's new post image processing algorithm called 'Virtual Grid Software'. The Virtual Grid Software is designed to improve image contrast in general radiographic images by reducing the effects of scatter radiation, primarily for exams acquired without a grid. Based on the displayed image, the user can decide whether or not to apply the Virtual Grid image processing by turning it ON or OFF as they see fit.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
adults, pediatrics and neonates
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Performance Data: The modified FDR D-EVO FPD System (DR-ID600) conforms to the voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366, IEC 62494-1 and DICOM. As required by the risk analysis, all verification and validation activities for the Virtual Grid Software were performed and the results were satisfactory. Additionally the bench testing and image quality evaluation further demonstrated the Virtual Grid processing algorithm yields an improvement in image contrast and quality, for those images acquired without an antiscatter grid. The results of the bench testing and image evaluation are provided in the submission.
Clinical Performance Data: The design modification does not require clinical studies. The substantial equivalence has been demonstrated by non-clinical studies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a stylized eagle with its wings spread, facing right. The eagle is composed of three curved lines that suggest feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
October 3, 2014
Fujifilm Medical Systems U.S.A., Inc. % Ms. Katherine Y. Choi Regulatory Affairs Lead 419 West Avenue STAMFORD CT 06902
Re: K141765
Trade/Device Name: FDR D-EVO Flat Panel Detector System (DR-ID600) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MOB Dated: September 2, 2014 Received: September 3, 2014
Dear Ms. Choi:
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-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.
1
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/Resourcesfor You/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 yours.
Smh
for
Janine M. Morris 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)
Device Name
FDR D-EVO Flat Panel Detector System (DR-ID600)
Indications for Use (Describe)
The Wireless/Wired FDR D-EVO 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 is not intended for mammography, fluoroscopy, tomography, and angiography applications.
Type of Use (Select one or both, as applicable)
[四] 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)
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Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
3
Attachment B: K141765, 510(k) Summary
4
510(k) Summary
FDR D-EVO Flat Panel Detector System (DR-ID600)
Date: September 2, 2014
Submitter's Information:
FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, CT, 06902, USA
Contact Person:
| Name: | Katherine Y. Choi, RAC |
|---|---|
| Title: | Regulatory Affairs Lead |
| Telephone: | (203) 602-3568 |
| Facsimile: | (203) 602-3785 |
Identification of the Device:
| Proprietary/Trade Name: | FDR D-EVO Flat Panel Detector System (DR-ID600) |
|---|---|
| Classification Name: | Stationary x-ray system |
| Regulations Number: | 21 CFR 892.1680 |
| Product Codes: | 90 MQB |
| Device Class: | Class II |
| Review Panel: | Radiology |
| Common Name: | Flat Panel Digital Detector System |
Identification of the Legally Marketed Device:
FDR D-EVO Flat Panel Detector System (DR-ID600), K132509 cleared 11/25/2013
l. DEVICE DESCRIPTION
Fujifilm's FDR D-EVO Flat Panel Detector System (DR-ID600) is a portable digital detector system that interfaces with, and acquires and digitizes x-ray exposures, from standard radiographic systems. The FDR D-EVO 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 exams.
The design modification made to the FDR D-EVO is adding Fujifilm's new post image processing algorithm called 'Virtual Grid Software'. The Virtual Grid Software is designed to improve image contrast in general radiographic images by reducing the effects of scatter radiation, primarily for exams acquired without a grid. Based on the displayed image, the user can decide whether or not to apply the Virtual Grid image processing by turning it ON or OFF as they see fit.
5
Image /page/5/Picture/0 description: The image shows the Fujifilm Medical Systems, USA logo. The logo is black, except for a small red square above the letter 'I' in Fujifilm. The text 'Fujifilm Medical Systems, USA' is located below the main logo in a smaller font size.
The Virtual Grid Software will be available as option to be installed with the FDR D-EVO's acquisition workstation, FDX Console. This Software will also be made available with all other legally marketed Fuiifilm DR Systems that use the FDX Console as the acquisition workstation, since this post-processing algorithm does not depend on how the image is acquired, or with what acquisition device.
-INDICATIONS FOR USE
The Wireless/Wired FDR D-EVO 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 is not intended for mammography, fluoroscopy, tomography, and angiography applications,
. SUBSTANTIAL EQUIVALENCE
The modified FDR D-EVO FPD System (DR-ID600) is substantially equivalent to the following legally marketed device.
| Legally Marketed Device | 510(k) # | Clearance Date |
|---|---|---|
| FDR D-EVO Flat Panel Detector System (DR-ID600) | K132509 | 11/25/2013 |
Adding the Virtual Grid Software to FDR D-EVO (DR-ID600) does not affect the intended use or alter the fundamental scientific technology of the legally marketed device, K132509. The modified device's detector characteristics including Fujifilm's unique Irradiated Side Sampling (ISS) design delivering high image quality and wireless communication features remain unchanged, and the modified FDR D-EVO (DR-ID600) system virtually maintains the same functional and technical requirements as the currently-cleared predicate DR-ID600 system.
IV. SUMMARY OF STUDIES
Non-clinical Performance Data: The modified FDR D-EVO FPD System (DR-ID600) conforms to the voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366, IEC 62494-1 and DICOM. As required by the risk analysis, all verification and validation activities for the Virtual Grid Software were performed and the results were satisfactory. Additionally the bench testing and image quality evaluation further demonstrated the Virtual Grid processing algorithm yields an improvement in image contrast and quality, for those images acquired without an antiscatter grid. The results of the bench testing and image evaluation are provided in the submission.
Clinical Performance Data: The design modification does not require clinical studies. The substantial equivalence has been demonstrated by non-clinical studies.
V. CONCLUSION
Based upon the supporting data summarized above, we concluded the modified FDR D-EVO Flat Panel Detector System (DR-ID600) is as safe and effective as the legally marketed device K132509 and do not raise different questions of safety and effectiveness than K132509.