(183 days)
No
The description mentions "image processing" for reconstruction, but there is no mention of AI, ML, or related terms like deep learning or neural networks. The process described is a standard tomosynthesis reconstruction technique.
No
The device is described as an advanced radiographic application used to acquire tomographic images for diagnostic purposes, not for treating or preventing disease.
Yes
The device acquires tomographic images that are then processed to produce "slice" images for an anatomical region of interest. The "Summary of Performance Studies" section also mentions "diagnostic image quality" in relation to the device's performance, indicating its role in providing diagnostic information.
No
The device is described as an "advanced radiographic application" that works with Fujifilm's DR X-ray systems to acquire and process images. While it involves image processing (software), it is intrinsically linked to and dependent on the hardware (DR X-ray systems and the X-ray tube sweep/rotation) for image acquisition. The description and performance studies mention bench testing and software verification/validation, but the core function relies on hardware interaction.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for acquiring tomographic images of human anatomy using X-rays and synthesizing tomographic slices. This is a diagnostic imaging process performed on the patient's body, not on samples taken from the body.
- Device Description: The description details the process of acquiring X-ray images and processing them to create tomographic slices. This is consistent with medical imaging equipment used for in-vivo diagnosis.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting specific analytes, or providing information about a patient's health status based on laboratory tests.
IVD devices are specifically designed to be used in vitro (outside the living body) to examine specimens derived from the human body to provide information for diagnostic purposes. This device operates in vivo (within the living body) using X-rays.
N/A
Intended Use / Indications for Use
Fujifilm's Tomosynthesis option is intended to acquire tomographic images of human anatomy and to be used with Fujifilm's DR X-ray systems. Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. It is not intended for mammographic applications.
Product codes
KPR, MQB, IZF
Device Description
Tomosynthesis is an advanced radiographic application that produces individual coronal "slice" images through an anatomical region of interest (ROI). To produce these slices, multiple projection radiographic images are acquired in rapid succession as the X-ray tube sweeps and rotates across the ROI. Once acquired, these projection images are subject to image processing that registers and reconstructs them into individual tomographic slices.
Tomosynthesis provides visualization of human anatomy by
-
- Removing overlying anatomical structures, which could otherwise obscure a structure of interest by superimposition in a 2 dimensional presentation, and
- Producing a number of slice images throughout the entire volume of the anatomy.
Tomosynthesis will be available as an option to the legally marketed FDR AcSelerate Stationary X-ray System (K093427) with some modifications. To support Tomosynthesis application, the new Tomosynthesis software and new system component called Pre-Processing Unit (PPU) are required along with the upgraded version of the FDX Console. The new 17x17" Csl (cesium iodide) built-in detector, which replaced the previous a-Se (amorphous selenium) 17x17" FPD, will be used for Tomosynthesis.
Mentions image processing
Once acquired, these projection images are subject to image processing that registers and reconstructs them into individual tomographic slices.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
Not Found
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
Various bench testing in addition to software verification and validation testing to evaluate the Tomosynthesis performance were completed and the results were satisfactory. Additionally the image quality evaluation demonstrated the proposed Tomosynthesis' diagnostic image quality is substantially equivalent to the legally marketed devices, including the existing linear tomography capability of the AcSelerate system. The supporting documents are enclosed in the submission along with sample images.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1740 Tomographic x-ray system.
(a)
Identification. A tomographic x-ray system is an x-ray device intended to be used to produce radiologic images of a specific cross-sectional plane of the body by blurring or eliminating detail from other planes. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the logo for Fujifilm Medical Systems, USA. The logo is in black and white, with the word "FUJIFILM" in large, bold letters. Below the company name is the text "Fujifilm Medical Systems, USA" in a smaller font. The logo is simple and modern, and it is likely used on the company's website, marketing materials, and products.
510(k) Summary
Date: October 29, 2012
Submitter's Information:
FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, CT, 06902, USA
NOV 2 0 2012
Contact Person:
| Name: | Katherine Y. Choi, RAC |
|---|---|
| Title: | Regulatory Affairs Specialist |
| Telephone: | (203) 602-3568 |
| Facsimile: | (203) 602-3785 |
Identification of the Proposed Device:
Proprietary/Trade Name:
Common Name: Device Class: Review Panel:
FUJIFILM Tomosynthesis option for FDR AcSelerate Stationary X-ray System Stationary X-ray System Class II Radiology
Classification Information:
| Classification Name | CFR Section | Product Codes |
|---|---|---|
| Stationary X-ray System | 21 CFR 892.1680 | KPR |
| Solid State X-ray Imager (Flat Panel/Digital | ||
| Imager) | 21 CFR 892.1650 | MQB |
| Tomographic X-ray System | 21 CFR 892.1740 | IZF |
l. INDICATIONS FOR USE
Fujifilm's Tomosynthesis option is intended to acquire tomographic images of human anatomy and to be used with Fujifilm's DR X-ray systems. Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. It is not intended for mammographic applications.
II. DEVICE DESCRIPTION
Tomosynthesis is an advanced radiographic application that produces individual coronal "slice" images through an anatomical region of interest (ROI). To produce these slices, multiple projection radiographic images are acquired in rapid succession as the X-ray tube sweeps and rotates across the ROI. Once acquired, these projection images are subject to image processing that registers and reconstructs them into individual tomographic slices.
1
Image /page/1/Picture/0 description: The image shows the logo for Fujifilm Medical Systems, USA. The logo is in black and white, with the word "FUJIFILM" in large, bold letters. Below the word "FUJIFILM" is the text "Fujifilm Medical Systems, USA" in a smaller font. The logo is simple and clean, and it is likely used on the company's products and marketing materials.
Tomosynthesis provides visualization of human anatomy by
-
- Removing overlying anatomical structures, which could otherwise obscure a structure of interest by superimposition in a 2 dimensional presentation, and
- Producing a number of slice images throughout the entire volume of the anatomy.
Tomosynthesis will be available as an option to the legally marketed FDR AcSelerate Stationary X-ray System (K093427) with some modifications. To support Tomosynthesis application, the new Tomosynthesis software and new system component called Pre-Processing Unit (PPU) are required along with the upgraded version of the FDX Console. The new 17x17" Csl (cesium iodide) built-in detector, which replaced the previous a-Se (amorphous selenium) 17x17" FPD, will be used for Tomosynthesis.
lll. SUMMARY OF STUDIES
The proposed device conforms to the following voluntary standards as applicable to the system.
| IEC 60601-1 | Medical electrical equipment - Part 1: General requirements for safety |
|---|---|
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2: General requirements for safety |
- Collateral standard: Electromagnetic compatibility – Requirements and tests |
| IEC 60601-1-3 | Medical electrical equipment - Part 1-3: General requirements for safety - Collateral standard: General requirements for radiation protection in diagnostic X-ray equipment |
| IEC 60601-1-4 | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable Electrical Medical systems |
| IEC 60601-2-7 | Medical electrical equipment - Part 2-7: Particular requirements for the safety of high-voltage generators of diagnostic X-ray generators |
| IEC 60601-2-28 | Medical electrical equipment - Part 2-28: Particular requirements for the safety of X-ray source assemblies and X-ray tube assemblies for medical diagnosis |
| IEC 60601-2-32 | Medical electrical equipment - Part 2-32: Particular requirements for the safety of associated equipment of X-ray equipment |
| IEC 60825-1 | Safety of laser products - Part 1: Equipment classification and requirements |
| UL 60601-1 | Medical electrical equipment - Part 1: General requirements for safety |
| DICOM | Digital Imaging and Communications in Medicine (DICOM) |
Various bench testing in addition to software verification and validation testing to evaluate the Tomosynthesis performance were completed and the results were satisfactory. Additionally the image quality evaluation demonstrated the proposed Tomosynthesis' diagnostic image quality is substantially equivalent to the legally marketed devices, including the existing linear tomography capability of the AcSelerate system. The supporting documents are enclosed in the submission along with sample images.
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Image /page/2/Picture/0 description: The image shows the logo for Fujifilm Medical Systems, USA. The logo is in black and white, with the word "FUJIFILM" in large, bold letters. Below the word "FUJIFILM" is the text "Fujifilm Medical Systems, USA" in a smaller font. The logo is simple and clean, and it is likely used on the company's products and marketing materials.
IV. SUBSTANTIAL EQUIVALENCE
The proposed device, FUJIFILM Tomosynthesis option for FDR AcSelerate Stationary X-ray System is substantially equivalent to the following legally marketed devices.
| Legally Marketed Device | 510(k) # |
|---|---|
| Revolutionary XR/d with Tomosynthesis | K051967 |
| FDR AcSelerate Stationary X-ray System | K093427 |
The proposed device has the very similar Indications for Use, functional and technical requirements as the predicate device, K051967. In addition, most X-ray system and Xray generator specifications remain the same as the previously-cleared FDR AcSelerate System in K093427.
V. CONCLUSION
We concluded the proposed FUJIFILM Tomosynthesis option for FDR AcSelerate Stationary X-ray System is as safe and effective as the legally marketed devices based upon the studies summarized above.
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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services-USA. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined strands representing the department's various services. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the caduceus. The overall design is simple and professional, reflecting the department's role in public health and welfare.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO-66 Silver Spring, MD 20993-002
November 20, 2012
Ms. Katherine Choi Regulatory Affairs Specialist FUJIFILM Medical Systems USA, Inc. 419 West Avenue STAMFORD CT 06902
Re: K121499
Trade/Device Name: FUJIFILM Tomosynthesis option for FDR AcSelerate Stationary X-ray System Regulation Number: 21 CFR 892.1740
Regulation Name: Tomographic x-ray system Regulatory Class: II Product Code: IZF Dated: October 29, 2012 Received: November 1, 2012
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.
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
4
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,
Janine M. Morris -S
Janine M. Morris 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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510(k) Number (if known): K121499
Device Name: FUJIFILM Tomosynthesis for FDR AcSelerate Stationary X-ray System
Indications for Use:
Fujifilm's Tomosynthesis option is intended to acquire tomographic images of human anatomy and to be used with Fujifilm's DR X-ray systems. Tomosynthesis is used to synthesize tomographic slices from a single tomographic sweep. It is not intended for mammographic applications. .
Prescription Use X (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)
Janine M. Morris -S 2012.11.20 15:28:15 -05'00'
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
K121499 510(k) =
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