(88 days)
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.
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). 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.
The provided text describes a 510(k) premarket notification for a medical device, the Fujifilm Wireless/Wired FDR D-EVO Flat Panel Detector System (DR-ID600 w/DR-ID611SE). The submission aims to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implicit for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Diagnostic capability of images | All images from the proposed device were deemed of diagnostic capability by three board-certified radiologists. |
| Equivalence or superiority to predicate device images | Consensus results of three radiologists show the proposed device images were diagnostically equivalent or better than the cleared predicate device's images by 93.3%. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Sample size for test set: 30 image pairs.
- Data provenance: Not explicitly stated. The submission is from Fujifilm Medical Systems U.S.A., Inc., suggesting the study was likely conducted or overseen in the USA. It is a retrospective comparison of images, as it compares images already acquired by two different detector types.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Number of experts: Three.
- Qualifications of experts: Board-certified radiologists. Specific experience level beyond board certification is not mentioned.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Adjudication method: The text states "the consensus results of the three radiologists." This implies a form of consensus-based adjudication, but the exact mechanism (e.g., simple majority, all three agreement) is not specified.
5. 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
- MRMC study: Yes, a reader study was performed. It involved multiple readers (three radiologists) reviewing multiple cases (30 image pairs) comparatively.
- Effect size of human readers improving with AI vs without AI assistance: This study did not involve AI assistance. It was a comparison between two different types of flat panel detectors (CsI vs. GOS scintillator material), evaluating the diagnostic capability of the images produced by each. Therefore, an effect size related to AI improvement is not applicable here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone study: No. This study evaluated images produced by a medical device (an X-ray detector system) as interpreted by human radiologists. It does not describe an algorithm performing tasks without human input.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of ground truth: Expert consensus. The diagnostic capability was established by the agreement of three board-certified radiologists.
8. The sample size for the training set
- Sample size for training set: Not applicable/not mentioned. This device is an X-ray detector, not an AI/machine learning algorithm requiring a separate training set. The study concerns the quality of images produced by the detector itself.
9. How the ground truth for the training set was established
- How ground truth for training set was established: Not applicable, as there is no mention of a training set for an AI algorithm.
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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: | (203) 602-3568 |
| Facsimile: | (203) 363-3950 |
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).
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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.
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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
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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 (800) 638-2041 or (301) 796-7100 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
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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.
§ 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.