FDR D-EVO flat Panel Detector System

K153464 · Fujifilm Medical Systems U.S.A, Inc. · MQB · Apr 8, 2016 · Radiology

Device Facts

• Record ID: K153464
• Device Name: FDR D-EVO flat Panel Detector System
• Applicant: Fujifilm Medical Systems U.S.A, Inc.
• Product Code: MQB · Radiology
• Decision Date: Apr 8, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2
• Attributes: Pediatric

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. The FDR D-EVO can be used with Virtual Grid Software, which is optional image processing software installed on Fujifilm's FDX Console. Virtual Grid Software can be used in lieu of an anti-scatter grid to improve image contrast in general radiographic images by reducing the effects of scatter radiation.

Device Story

FDR D-EVO is a portable digital flat panel detector system capturing X-ray exposures for display. Used in general radiography (adults, pediatrics, neonates) in clinical environments; replaces conventional film/screen or CR systems. Detectors (GOS or CsI scintillators) interface with X-ray sources via wired/wireless connection or automatic X-ray detection (SmartSwitch). Optional 'Virtual Grid Software' on FDX Console processes images to improve contrast by reducing scatter radiation, allowing use without physical anti-scatter grids. Clinicians use the software to potentially reduce patient radiation dose by up to 50% while maintaining image quality comparable to hardware grids. Software is applied post-acquisition; users toggle processing ON/OFF based on visual assessment. Device supports upright (wall bucky) and recumbent (table bucky) exams.

Clinical Evidence

No clinical data. Substantial equivalence demonstrated via non-clinical bench testing and image quality evaluations. Testing confirmed Virtual Grid Software achieves image contrast equivalent to hardware grids with up to 50% dose reduction.

Technological Characteristics

Portable flat panel detector; GOS or CsI scintillators; 150µm pixel pitch; 16-bit resolution; Irradiated Side Sampling (ISS) technology. Connectivity: wireless/wired, automatic X-ray detection (SmartSwitch). Software: FDX Console v9.0+. Standards: AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366, IEC 62494-1, DICOM.

Indications for Use

Indicated for general projection radiographic imaging of human anatomy, including pediatric and neonatal patients. Not for mammography, fluoroscopy, tomography, or angiography.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• FDR D-EVO Flat Panel Detector System (DR-ID600) (K141765)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name in a circular arrangement around a symbol. The symbol consists of a stylized caduceus, which is a staff with two snakes entwined around it, representing medicine and healing. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 8, 2016

FUJIFILM Medical Systems U.S.A., Inc. % Mr. Peter Altman Regulatory and Quality Consultant 419 West Avenue STAMFORD CT 06902

Re: K153464

Trade/Device Name: FDR D-EVO Flat Panel Detector System (DR-ID600) with Improved Virtual Grid Software Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: March 11, 2016 Received: March 14, 2016

Dear Mr. 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-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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Michael D.'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | | Form Approved: OMB No. 0910-0120<br>Expiration Date: January 31, 2017<br>See PRA Statement below. |
|-------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------|
| <b>Indications for Use</b> | | |
| 510(k) Number (if known) | K153464 | |
| Device Name | FDR D-EVO Flat Panel Detector System (DR-ID600) with Improved Virtual Grid Software | |
| 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. The FDR D-EVO can be used with Virtual Grid Software, which is optional image processing software installed on Fujifilm's FDX Console. Virtual Grid Software can be used in lieu of an anti-scatter grid to improve image contrast in general radiographic images by reducing the effects of scatter radiation. | |
| Type of Use (Select one or both, as applicable) | ☐ 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
[e-mail]

"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."

FORM FDA 3881 (1/14)

Page 1 of 1

PSC Publishing Services [phone] EF

элемдог рисг гэтэй хэрэгтэй үүл (009Дг-ЯД) ОЛЭ-Д ЯДЭ

E-レ

{3}------------------------------------------------

Image /page/3/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, in a smaller font, is the text "Value from Innovation."

# 510(k) Summary

# FDR D-EVO Flat Panel Detector System (DR-ID600) With Improved Virtual Grid Software

# Date: April 7, 2016

# Submitter's Information:

FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, CT, 06902, USA

# Contact Person:

| Name: | Peter Altman |
|------------|-----------------------------------|
| Title: | Regulatory and Quality Consultant |
| Telephone: | [phone] |

# Identification of the Device:

| Proprietary/Trade Name: | FDR D-EVO Flat Panel Detector System (DR-ID600)<br>with Improved Virtual Grid Software |
|-------------------------|----------------------------------------------------------------------------------------|
| Classification Name: | Stationary X-ray system |
| Regulations Number: | 21 CFR 892.1680 |
| Product Codes: | 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), K141765 cleared 10/3/2014

| 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: | MQB |
| Device Class: | Class II |
| Review Panel: | Radiology |
| Common Name: | Flat Panel Digital Detector System |

#### 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

{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, which is located above the "I" in Fujifilm. Below the logo, the words "Value from Innovation" are written in a smaller, black font.

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 FDR D-EVO can be used with or without Virtual Grid Software, which is optional image processing software installed on Fujifilm's FDX Console. The Virtual Grid Software was originally designed to improve image contrast in general radiographic images by reducing the effects of scatter radiation, primarily for exams acquired without a grid. Initially, the anatomical regions of the software were for chests and abdomens only, where the effects of scatter radiation can be prominent if a grid is not used. The user can decide whether or not to apply the Virtual Grid image processing by turning it ON or OFF as they see fit based on the displayed image. The same software is also offered with other legally marketed Fujifilm DR Systems that use the same 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.

Since the K141765 clearance, however, several improvements have been made in order to expand the effectiveness of the Virtual Grid Software, which is the reason of the new submission. The improvements are 1) expansion of target body parts to cover the whole anatomy, 2) target image format to include images obtained by Fujifilm's CR systems, and 3) adding a new claim that Virtual Grid Software can be used in lieu of an antiscatter grid.

An additional benefit of using the Virtual Grid Software involves X-ray radiation dose. It is a well-known practice that exposure conditions should be increased when a hardware grid is used in order to compensate for the primary X-ray energy absorbed by the grid strips. On the other hand, since the Virtual Grid processing can be applied to images taken without a grid. Virtual Grid can achieve image contrast equivalent to that of a hardware grid, but at lower dose levels than are needed when using a hardware grid. Based on Fujifilm's performance testing and image quality evaluation results, a maximum dose reduction of 50% when using VG with Fuiifilm DR detectors can achieve comparable image quality when compared to using a real grid.

Virtual Grid Software comes with some limitations such as VG should not be applied to images that were acquired with a real grid. VG cannot be applied to images that were acquired prior to the VG software installation. VG can only be used for selected exposure menus listed in the manual. VG should not be used for images acquired with additional beam filtration.

Device Integration: The FDR D-EVO can be used with any legally-marketed and appropriately certified X-ray source. If FDR D-EVO is used with the optional Hand Switch Interface Box, a connection to the X-ray source/qenerator's timing signals (prep and exposure signals) is necessary. Even if such timing signals are not available, the

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the Fujifilm logo. The logo consists of the word "FUJIFILM" in a bold, sans-serif font, with the "I" in "FUJI" having a red square at the top. Below the logo is the tagline "Value from Innovation" in a smaller, sans-serif font.

FDR D-EVO can acquire an image using Automatic x-ray detection function (known as 'SmartSwitch' in the US), so the limitation is neqligible.

#### .. 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.

The FDR D-EVO can be used with Virtual Grid Software, which is optional image processing software installed on Fujifilm's FDX Console. Virtual Grid Software can be used in lieu of an anti-scatter grid to improve image contrast in general radiographic images by reducing the effects of scatter radiation.

#### = SUMMARY OF TECHNOLOGICAL CHARACTERISTICS

FDR D-EVO FPD System (DR-ID600) continues to offer 600 series detectors with two different scintillator materials - GOS (Gadolinium oxysulfide) or Csl (Cesium lodide) and various detector sizes to choose from. All detector characteristics including indirect conversion method using Fujifilm's unique Irradiated Side Sampling (ISS) technology, pixel pitch (150µm), resolution (16 bit), DQE (Detective Quantum Efficiency) measurements, MTF (Modulation Transfer Function) performance remains the same. The wireless communication feature, and automatic x-ray detection function (known as 'SmartSwitch' in the US) also stay unaffected by the changes. The same acquisition workstation, FDX Console will continue to support FDR D-EVO FPD System (DR-ID600), but FDX Console v9.0 or later will release the Improved Virtual Grid Software.

#### IV. SUBSTANTIAL EQUIVALENCE

The FDR D-EVO FPD System (DR-ID600) with Improved Virtual Grid Software 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) | K141765 | 10/3/2014 |

The Virtual Grid Software was cleared with FDR D-EVO in K141765 as optional software installed in the acquisition workstation, FDX Console. The FDR D-EVO's detector characteristics as well as other major features such as wireless communication and automatic x-ray detection function ('SmartSwitch') remain unchanged. The FDR D-EVO can be used with or without Virtual Grid Software, and the improvements made to the Virtual Grid Software do not affect the intended use or alter the fundamental scientific technology of the legally marketed device.

#### V. SUMMARY OF STUDIES

Non-clinical Performance Data: The conformity 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 remains unaffected. As required by the risk analysis, all verification and validation activities related to the improvements made to the Virtual Grid Software were performed and the results were satisfactory. Additionally the bench

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the Fujifilm logo. The logo is black, except for a red square with a white triangle cut out of the top right corner. Below the logo, the words "Value from Innovation" are written in black.

testing and image quality evaluation demonstrated that Virtual Grid Software can achieve image contrast equivalent to that of a hardware grid, but at lower dose levels than are needed when using a hardware grid. The results of the bench testing and image evaluation are provided in the submission.

Clinical Performance Data: The changes do not require clinical studies. The substantial equivalence has been demonstrated by non-clinical studies.

#### VI. CONCLUSION

Based upon the supporting data summarized above, we concluded the Improved Virtual Grid Software offered with FDR D-EVO Flat Panel Detector System (DR-ID600) is as safe and effective as the legally marketed device K141765 and do not raise different questions of safety and effectiveness than K141765.