WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE

K111548 · Fujifilm Medical System U.S.A., Inc. · MQB · Aug 30, 2011 · Radiology

Device Facts

• Record ID: K111548
• Device Name: WIRELESS/WIRED FDR D-EVO FLAT PANCEL DETECTOR SYSTEM MODEL DR-ID600 W/DR-ID611SE
• Applicant: Fujifilm Medical System U.S.A., Inc.
• Product Code: MQB · Radiology
• Decision Date: Aug 30, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1680
• Device Class: Class 2

Intended 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 wherever conventional film/screen or CR systems may be used. The FDR D-EVO is not intended for mammography, fluoroscopy, tomography, and angiography applications.

Device Story

Portable digital flat panel detector system; acquires and digitizes x-ray exposures from standard radiographic systems. Input: x-ray radiation; Output: digital radiographic images for display. Uses Irradiated Side Sampling (ISS) design; Cesium Iodide (CsI) scintillator. Used in clinical environments; placed in wall bucky, table bucky, or used for non-grid exams. Operated by radiology staff. Output viewed by radiologists for diagnostic assessment; facilitates clinical decision-making by providing high-quality digital images equivalent to or better than predicate GOS-based detectors.

Clinical Evidence

Bench testing completed per IEC requirements and FDA guidance. Clinical image quality reader study performed on 30 image pairs comparing proposed CsI detector to predicate GOS detector. Three board-certified radiologists reviewed images; 100% deemed diagnostic. Consensus results indicated the proposed device provided equivalent or better diagnostic capability in 93.3% of cases.

Technological Characteristics

Portable 14x17" flat panel detector; Cesium Iodide (CsI) scintillator; Irradiated Side Sampling (ISS) design. Wireless and wired connectivity. Complies with IEC testing standards. Solid state x-ray imager.

Indications for Use

Indicated for general projection radiographic imaging of human anatomy in clinical settings where conventional film/screen or CR systems are used. Not indicated 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

• Wireless/Wired FDR D-EVO flat panel detector system (DR-ID600 w/DR-ID601SE) (K103596)
• Canon CXDI-70C Wireless (K102012)

Submission Summary (Full Text)

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

# KII1548

Image /page/0/Picture/1 description: The image shows the Fujifilm logo. The logo is in black and white and features the word "FUJIFILM" in large, bold letters. Below the main logo, there is the text "Fujifilm Medical Systems, USA" in a smaller font. The logo appears to be a company logo.

AUG 300 2011

# 510(k) Summary Wireless/Wired FDR D-EVO Flat Panel Detector System (DR-ID600 w/DR-ID611SE)

### Date: June 1, 2011

### 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 Specialist |
| Telephone: | [phone] |
| Facsimile: | [phone] |

## Identification of the Proposed Device:

Proprietary/Trade Name:

Classification Name: Regulations Number: Product Codes: Device Class: Review Panel: Common Name:

Wireless/Wired FDR D-EVO Flat Panel Detector System (DR-ID600 w/DR-ID611SE) Solid State X-ray Imager (Flat Panel/Digital Imager) 21 CFR 892.1650 90 MQB Class II Radiology Flat Panel Digital Detector

#### 1. 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 wherever conventional film/screen or CR systems may be used. The FDR D-EVO is not intended for mammography, fluoroscopy, tomography, and angiography applications.

#### ll. DEVICE DESCRIPTION

The proposed device, DR-ID600 w/DR-ID611SE is a modified version of our currentlycleared predicate device, Wired FDR D-EVO flat panel detector system (DR-ID600 w/DR-ID601SE), K103596. The predicate device includes the 14x17" fat panel detector model DR-ID601SE using GOS (Gadolinium Oxysulfide) scintillator whereas the proposed device introduces the 14x17" flat panel detector model DR-ID611SE using a different scintillator material, Csl (Cesium lodide).

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the logo for Fujifilm Medical Systems, USA. The word "FUJIFILM" is written in large, bold, black letters. Below the main logo, the words "Fujifilm Medical Systems, USA" are written in a smaller, sans-serif font, also in black.

FUJIFILM's unique Irradiated Side Sampling (ISS) design delivering high image quality, and wireless communication specifications remains unchanged in the proposed device.

The proposed DR-ID600 w/DR-ID611SE is a portable digital detector system that acquires and digitizes x-ray exposures from standard radiographic systems, which is the same as our legally marketed predicate device, DR-ID600 w/DR-ID601SE. The proposed device is designed to be used in any environment that would typically use a radiographic cassette. It 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. All of which are also the same as our legally marketed predicate device.

#### 1111. SUMMARY OF STUDIES

The proposed device, DR-ID600 w/DR-ID611SE successfully completed internal and international IEC testing requirements. In addition, the FDA 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.

FUJIFILM performed an image quality reader study on 30 image pairs comparing the images obtained between the proposed CsI detector (DR-ID611SE) and our legally marketed GOS detector (DR-ID601SE). Three board-certified radiologists reviewed the images and all images were deemed to be of diagnostic capability. In addition, the consensus results of the three radiologists shows that the proposed device provides images of equivalent or better diagnostic capability to those of our cleared predicate device (K103596) by 93.3%. Test protocol summary and analysis results are enclosed in the submission.

#### IV. SUBSTANTIAL EQUIVALENCE

The proposed device, DR-ID600 w/DR-ID611SE is substantially equivalent to the following legally marketed devices.

| Legally Marketed Device | 510(k)# |
|-----------------------------------------------------------------------------|---------|
| Wireless/Wired FDR D-EVO flat panel detector system (DR-ID600 w/DR-ID601SE) | K103596 |
| Canon CXDI-70C Wireless | K102012 |

The proposed DR-ID600 w/DR-ID611SE has the same Indications for Use and very similar functional and technical requirements as our currently-cleared predicate device, K103596. The proposed device's wireless communication specifications remain unchanged as K103596. In addition, the scintillator material used in the proposed device is the same material as the legally marketed device, K102012.

#### V. CONCLUSION

The proposed DR-ID600 w/DR-ID611SE is substantially equivalent to the legally marketed devices and conforms to applicable medical device safety standards.

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

Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings outstretched, symbolizing care and protection. The eagle is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.

Public Health Service

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

Ms. Katherine Y. Choi, RAC Regulatory Affairs Specialist Fuji Medical Systems U.S.A., Inc. 419 West Avenue STAMFORD CT 06902

AUG 23 2013

Re: K111548

Trade/Device Name: Wireless/Wired FDR D-EVO Flat Panel Detector System (DR-ID600 w/DR-ID611SE)

Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: July 26, 2011 Received: July 27, 2011

Dear Ms. Choi:

This letter corrects our substantially equivalent letter of August 30, 2011.

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 I va may , and controls of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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

medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirents as set form in the quality of evice as described in your Section 510(k) premarket whit anow you to begin marketing your arrance of your device to a legally marketed nouncation. The FDA imania of successification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFF Parts 801 and If you desire specific advice of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-007), product 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

under the MDK regulation (27 CFR Pat 003), products go the fault.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 Tour may of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

# Indications for Use

510(k) Number (if known): KIII548

## Device Name: Wired FDR D-EVO Flat Panel Detector System (DR-ID600 w/DR-ID611SE)

Indications for Use:

The Wireless:Wired FDR D-EVO flat panel detector system is intended to capture for display radiographic images of human analomy. It is intended for use in general projection radiographic applications wherever conventional film /screen or CR systems may be used. The FDR D-EVO is not intended for mammography, fluoroscopy, tomography, and angiography applications.

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

## (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Device (OIVD)

Michael O'Kane

7
(Division Sign-On)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K 111548

Page 39 of 711

r.