(99 days)
Fujifilm's FDR Dual Energy Subtraction (DES) Option may be used with Fujifilm's DR X-ray Systems and is intended to be used by a qualified/trained doctor or technologist for acquiring dual energy subtraction images of human anatomy.
DES is intended to assist the physician through the visualization of anomalies by reducing the visibility of underlying / overlying anatomical structures.
This device is not intended for mammographic applications.
Dual Energy Subtraction (DES) is an advanced radiographic imaging application designed as an option to be used with our cleared FDR AcSelerate X-ray system, and will also be used in future FUJIFILM X-ray systems.
Two images are acquired at mulually different X-ray energies. These images are then subject to a weighted subtraction that can remove structures (e.g. soft tissue structures or bone structures) of a specific x-ray absorption characteristic. This results in a completed DES exam that typically consists of three processed images, (1) a standard radiographic image, (2) a soft-tissue image with the bone information removed, and (3) a bone image with the soft tissue information removed.
To suppress involuntary motion artifacts which are tvpical in dual-exposure energy subtraction, Fujifilm's DES option includes Multi-Stage Registration (MSR) which compensates for involuntary patient motion, such as the patient's heartbeat, that can produce slight differences in anatomic registration (seen as artifacts) between the first exposure (high energy image), and the second exposure (low energy image). MSR is added to suppress the motion artifacts seen in the DES image and maintains the image quality.
The Fujifilm FDR Dual Energy Subtraction (DES) Option is intended to assist physicians by visualizing anomalies through the reduction of underlying/overlying anatomical structures.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state quantitative acceptance criteria or corresponding reported device performance metrics in a readily digestible table format for the device's enhanced detection capabilities in humans. Instead, it refers to a qualitative assessment.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Improved DES detectability of lung nodules | "Multi-Stage Registration feature may improve DES detectability of lung nodules in the lower right lung." |
| Effective artifact reduction | "it has been confirmed by interviews with doctors that the artifact reduction was effective." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 20 subject images.
- Data Provenance: The studies were performed on the predicate device in Japan. This indicates the data is retrospective as it refers to past studies on an existing device.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Ten radiologists.
- Qualifications: The document only states "Ten radiologists" and does not provide further details on their experience or specific qualifications (e.g., number of years of experience, subspecialty).
4. Adjudication Method for the Test Set
The document does not specify an adjudication method like 2+1 or 3+1. It simply states that "Ten radiologists evaluated 20 subject images and concluded..." This implies a consensus or individual evaluation followed by a summary of findings rather than a structured adjudication process.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study comparing human readers with AI assistance versus without AI assistance was not explicitly detailed in the provided text for the proposed device. The study described involved radiologists evaluating images, but it doesn't clearly articulate a comparison of human performance with and without the new DES feature, nor does it quantify an effect size of improvement. It describes the feature itself as potentially improving detectability.
6. Standalone Performance Study
A standalone (algorithm-only without human-in-the-loop performance) study was not explicitly detailed for the proposed device. The information provided focuses on the perceived improvement in images as assessed by radiologists, implying a human-in-the-loop scenario. The "Multi-Stage Registration (MSR)" is a feature of the device, but its standalone performance (e.g., in artifact reduction metrics without human interpretation) is not separately detailed beyond visual demonstration.
7. Type of Ground Truth Used
The ground truth used was expert consensus/opinion from radiologists. The document states, "Ten radiologists evaluated 20 subject images and concluded that (1) Multi-Stage Registration feature may improve DES detectability of lung nodules in the lower right lung and (2) it has been confirmed by interviews with doctors that the artifact reduction was effective." While it implies "detectability of lung nodules," it doesn't specify if there was a definitive, external ground truth (like pathology or follow-up outcomes) for these nodules in the 20 cases. It relies on the radiologists' assessment.
8. Sample Size for the Training Set
The document does not specify a sample size for the training set. It refers to "System testing," "Software Verification, bench testing," "clinical image samples," and a "literature review," but no details on training data.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for any potential training set was established. It primarily discusses studies and evaluations of the device's output rather than the development or training process.
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Image /page/0/Picture/1 description: The image shows the Fujifilm Medical Systems, USA logo. The logo is in black and white. The word "FUJIFILM" is in large, bold letters, and the words "Fujifilm Medical Systems, USA" are in smaller letters below.
FUJIFILM FDR Dual Energy Subtraction (DES) Option 510(k) Summary
Date: August 10, 2012 Contact Person:
| Name: | Debbie Peacock |
|---|---|
| Title: | Regulatory Affairs Manager |
| Telephone: | (203) 602-3774 |
| Facsimile: | (203) 363-3813 |
ldentification of Device:
| Proprietary/Trade Name: | FDR Dual Energy Subtraction (DES) Option |
|---|---|
| Classification Name: | Stationary X-ray System w/Solid State Imager |
| Classification: | Panel: Radiology |
| CFR Section: | 21 CFR 892.1650, 21 CFR 892.1680 |
| Product Codes: | KPR/MQB |
| Common Name: | Stationary X-Ray System |
INDICATIONS FOR USE 1.
Fujifilm's FDR Dual Energy Subtraction (DES) Option may be used with Fujifilm's DR X-ray Systems and is intended to be used by a qualified/trained doctor or technologist for acquiring dual energy subtraction images of human anatomy.
DES is intended to assist the physician through the visualization of anomalies by reducing the visibility of underlying / overlying anatomical structures.
This device is not intended for mammographic applications.
II. DEVICE DESCRIPTION
Dual Energy Subtraction (DES) is an advanced radiographic imaging application designed as an option to be used with our cleared FDR AcSelerate X-ray system, and will also be used in future FUJFILM X-ray systems.
Two images are acquired at mulually different X-ray energies. These images are then subject to a weighted subtraction that can remove structures (e.g. soft tissue structures or bone structures) of a specific x-ray absorption characteristic. This results in a completed DES exam that typically consists of three processed images, (1) a standard radiographic image, (2) a soft-tissue image with the bone information removed, and (3) a bone image with the soft tissue information removed.
To suppress involuntary motion artifacts which are tvpical in dual-exposure energy subtraction, Fujifilm's DES option includes Multi-Stage Registration (MSR) which compensates for involuntary patient motion, such as the patient's heartbeat, that can
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Fuilfilm Medical Systems
produce slight differences in anatomic registration (seen as artifacts) between the first exposure (high energy image), and the second exposure (low energy image). MSR is added to suppress the motion artifacts seen in the DES image and maintains the image quality.
SUMMARY OF STUDIES 011.
System testing was performed and certified to the following International Standards:
- IEC 60601-1: Medical Electrical Equipment-Part 1: General requirements for A safety, 1988; Amendment 1, 1991-11, Amendment 2, 1995 (General)
-
UL 60601-1: Medical Electrical Equipment -Part 1: General requirements for safety. 2003
IEC 60601-1-2: Medical Electrical Equipment-Part 1-2. General requirements A for safety-Collateral standard: Electromagnetic compatibility-requirements and tests. 2007.
IEC 60601-1-3: Medical Electrical Equipment-Part 1, General requirements A for safety-3. Collateral standard: General requirements for radiation protection in diagnostic X-rav equipment. 1994.
A IEC 60601-1-4: Medical Electrical Equipment-Part 1-4; General requirements for safety-Collateral Standard: Programmable Electrical Medical systems. 1996 +A1, 1999.
A IEC 60601-2-7: Medical Electrical Equipment-Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators. 1998.
IEC 60601-2-28: Medical Electrical Equipment-Part 2: Particular A requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis. 1993.
- IEC 60601-2-32: Medical Electrical Equipment-Part 2: Particular requirements A for the safety of associated equipment of X-ray equipment. 1994.
- A IEC 60825: Safety of Laser Products-Part 1: Equipment classification and requirements. 2007.
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DICOM V3.0: Digital Imaging and Communications in Medicine (DICOM). 2007.
A literature review was submitted to discuss clinical and phantom studies performed on the outside US version of the proposed device. Studies were performed on the predicate device in Japan. A reading evaluation was performed. Ten radiologists evaluated 20 subject images and concluded that (1) Multi-Stage Registration feature may improve DES detectability of lung nodules in the lower right lung and (2) it has been confirmed by interviews with doctors that the artifact reduction was effective.
Three U.S. clinical DES reference images are included in this submission with and without MSR applied. These images are included to provide a visual demonstration of the effectiveness of Fujifilm's DES with MSR for artifact reduction.
Results of the Software Verification, bench testing, clinical image samples and literature review support a substantial equivalence determination.
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Image /page/2/Picture/0 description: The image contains the Fujifilm logo, followed by the text "Fujifilm Medical Systems, USA". Below that, the text "IV. SUBSTANTIAL EQUIVALENCE" is present. In the upper right corner, handwritten text reads "K122454 P. 3 of 3".
Fujifilm's FDR Dual Energy Subtraction (DES) Option is a modification to our currentlycleared FCR 9501ES (K952862) and is also substantially equivalent to General Electric's Dual Energy and Tissue Equalization Software Options for Digital Radiographic Systems (K013481).
A detailed Substantial Equivalence Comparison is provided in Section 12.
V. CONCLUSION
The proposed optional FDR Dual Energy Subtraction software tested with the currentlycleared FDR AcSelerate System has very similar Indications for Use, Functional and Technical requirements as the currently-cleared General Electric's Dual Energy and Tissue Equalization Software Options for Digital Radiographic Systems (K013481).
The Energy Subtraction algorithm is unchanged from our currently-cleared FCR 9501ES (K952862).
After analyzing bench and certified system test data, as well as literature review and the inclusion of confirmatory images with and without MSR applied, we feel that the proposed and predicate devices can be considered to be as safe and effective as the currently-cleared predicate devices.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular fashion around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
Ms. Debbie Peacock Regulatory Affairs Manager FUJIFILM Medical Systems, USA, Inc. 419 West Avenue STAMFORD CT 06902
December 5, 2012
Re: K122454
Trade/Device Name: FUJIFILM Dual Energy Subtraction (DES) software option Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: Class II Product Code: KPR Dated: October 26, 2012 Received: October 31, 2012
Dear Ms. Peacock:
This letter corrects our substantially equivalent letter of November 20, 2012.
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.
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
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostics and Radiological Health at (301) 796-5450. 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 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,
Michael D. O'Hara
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
FUJIFILM FDR Dual Energy Subtraction (DES) Option
510(k) Number (if known):
FUJIFILM FDR Dual Energy Subtraction (DES) Option Device Name:
Indications For Use:
Fujifilm's FDR Dual Energy Subtraction (DES) Option may be used with Fujifilm's DR X-ray Systems and is intended to be used by a qualified/trained doctor or technologist for acquiring dual energy subtraction images of human anatomy.
DES is intended to assist the physician through the visualization of anomalies by reducing the visibility of underlying / overlying anatomical structures.
This device is not intended for mammographic applications.
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Muhammad D. Khan
Page 1 of of
(Division Sign
Division of Radiological Health
of in Vitro Diegnostics and Ra
510(k) K122454
§ 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.