(28 days)
No
The description details image processing algorithms (EDR2m and MFP2) that use statistical estimation and parameter optimization based on image analysis, but it does not mention or describe the use of AI or ML techniques such as neural networks, deep learning, or training on data sets. The methods described appear to be traditional image processing algorithms.
No.
The device is explicitly described as a system that generates or acquires diagnostic images for screening and diagnosis, not for treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device can be used for "screening and diagnosis of breast cancer."
No
The device is described as a software upgrade to an integrated FFDM system which includes hardware components like an X-ray system, detector, and acquisition workstation. While the submission focuses on the software upgrade, the device itself is not solely software.
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 system generates images for "screening and diagnosis of breast cancer" and is used in the "same clinical applications as traditional screen-film mammography systems." This describes a medical imaging device used for diagnostic purposes on the patient, not a device used to test samples in vitro (outside the body).
- Device Description: The description details an X-ray system, a detector, and a workstation for acquiring and processing images. This is consistent with a medical imaging system, not an IVD.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
The device is a medical imaging system used for diagnostic purposes, specifically mammography.
N/A
Intended Use / Indications for Use
The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
Product codes
MUE
Device Description
The ASPIRE Cristalle (K133972) (FDR MS-3500) is an integrated FFDM system combining an X-ray system made by Fujifilm with Fujifilm's a-Se detector and FDR-AWS3000 acquisition workstation (AWS). The system creates digital mammography images by direct capture of x-ray energy using a detector of Fujifilm design utilizing an a-Se photo-conversion layer with TFT readout circuitry to acquire image data and transfer images to the AWS for automated post processing, technologists' preview and QC, and subsequent transmission to hard copy printers, diagnostic workstations and archiving systems. The ASPIRE Cristalle provides powered compression and AEC modes.
The subject of this premarket notification is a software upgrade to the predicate device. The hardware is unchanged. The software is unchanged with the exception that the subject device incorporates improved grayscale and frequency processing software named Dynamic Visualization II for Mammography (DVIIm) in the FDR-AWS3000 image acquisition software.
DVIIm image processing consists of EDR2m and MFP2 image processing.
- . Exposure Data Recognition 2 for mammography (EDR2m) = the EDR2m algorithm analyzes image data and identifies various anatomic structures using a statistical estimation method as opposed to original EDR's histogram analysis method. EDR2m determines the parameters to optimize brightness and contrast of the image based on the analysis result.
- . Multi-Object Frequency Processing 2 (MFP2) - MFP2 optimizes the brightness, contrast and sharpness of the image using parameters determined by the EDR2m processing. MFP2 uses additional low frequency tables and a combination of automatic and preset dynamic range control operations.
DVIIm takes full advantage of the wide range of image data acquired with the high sensitivity of Fujifilm's advanced detector technologies. DVIIm provides improved contrast and density stability throughout the entire exposure region and achieves improved visibility across a wide range of breast compositions including the presence of implants.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Full-field digital mammography system
Anatomical Site
breast
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
Performance testing - bench: Applicable phantom testing results have been provided in accordance with the Phantom Testing in section 8. Physical Laboratory Testing of "Class II Special Controls Guidance Document: Full-Field Digital Mammography System" (March 27, 2012).
Performance testing - clinical: A clinical image attribute review was conducted by independent mammographic radiologists in accordance with the section 6 of "Class II Special Controls Guidance Document: Full-Field Digital Mammography System" (March 27, 2012) document. The mammographic attributes of six (6) image sets of screening and diagnostic cases were reviewed for all exposure modes concluding that the ASPIRE Cristalle provides sufficiently acceptable image quality for mammographic use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1715 Full-field digital mammography system.
(a)
Identification. A full-field digital mammography system is a device intended to produce planar digital x-ray images of the entire breast. This generic type of device may include digital mammography acquisition software, full-field digital image receptor, acquisition workstation, automatic exposure control, image processing and reconstruction programs, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). The special control for the device is FDA's guidance document entitled “Class II Special Controls Guidance Document: Full-Field Digital Mammography System.”See § 892.1(e) for the availability of this guidance document.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 27, 2017
FUJIFILM Medical Systems U.S.A., Inc. % Jyh-Shyan Lin Senior Manager, Regulatory, Quality and Clinical Affairs 419 West Avenue STAMFORD CT 06902
Re: K173132
Trade/Device Name: ASPIRE Cristalle Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE Dated: September 28, 2017 Received: September 29, 2017
Dear Jyh-Shyan Lin:
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. Isting 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions 531-542 of the Act); 21 CFR 1000-1050.
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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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/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 (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Robert Ochs, Ph.D. 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
510(k) Number (if known) K173132
Device Name ASPIRE Cristalle
Indications for Use (Describe)
The Fujifilm Digital Mammography System, ASPIRE Cristalle (FDR MS-3500) generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
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) |
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510(k) Summary
Date Prepared: October 27, 2017
Submitter's Information:
FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, Connecticut 06902, U.S.A. Telephone: (301) 251-1092 Contact: Jyh-Shyan Lin
Device Name and Classification:
| Product Name: | ASPIRE Cristalle |
|---|---|
| Model Number: | FDR MS-3500 |
| Classification Name: | Full-field digital mammography system |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR 892.1715 |
| Device Class: | Class II |
| Product Code: | MUE |
Description of the Device:
The ASPIRE Cristalle (K133972) (FDR MS-3500) is an integrated FFDM system combining an X-ray system made by Fujifilm with Fujifilm's a-Se detector and FDR-AWS3000 acquisition workstation (AWS). The system creates digital mammography images by direct capture of x-ray energy using a detector of Fujifilm design utilizing an a-Se photo-conversion layer with TFT readout circuitry to acquire image data and transfer images to the AWS for automated post processing, technologists' preview and QC, and subsequent transmission to hard copy printers, diagnostic workstations and archiving systems. The ASPIRE Cristalle provides powered compression and AEC modes.
The subject of this premarket notification is a software upgrade to the predicate device. The hardware is unchanged. The software is unchanged with the exception that the subject device incorporates improved grayscale and frequency processing software named Dynamic Visualization II for Mammography (DVIIm) in the FDR-AWS3000 image acquisition software.
DVIIm image processing consists of EDR2m and MFP2 image processing.
- . Exposure Data Recognition 2 for mammography (EDR2m) = the EDR2m algorithm analyzes image data and identifies various anatomic structures using a statistical estimation method as opposed to original EDR's histogram analysis method. EDR2m determines the parameters to optimize brightness and contrast of the image based on the analysis result.
- . Multi-Object Frequency Processing 2 (MFP2) - MFP2 optimizes the brightness, contrast and sharpness of the image using parameters determined by the EDR2m processing. MFP2 uses additional low frequency tables and a combination of automatic and preset dynamic range control operations.
DVIIm takes full advantage of the wide range of image data acquired with the high sensitivity of Fujifilm's advanced detector technologies. DVIIm provides improved contrast and density stability throughout the entire exposure region and achieves improved visibility across a wide range of breast compositions including the presence of implants.
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Image /page/4/Picture/0 description: The image shows the Fujifilm logo. The logo is black with a red square in the middle of the "I". Below the logo is the text "Value from Innovation".
Intended Use (Unchanged from the predicate):
The Fujifilm Digital Mammography System. ASPIRE Cristalle (FDR MS-3500) generates full-field digital mammography images that can, as other full-field digital mammography systems, be used for screening and diagnosis of breast cancer and is intended for use in the same clinical applications as traditional screen-film mammography systems.
Substantial Equivalence/Predicate Device:
FUJIFILM ASPIRE Cristalle (FDR MS-3500) (K133972)
The predicate and proposed devices have the same indications for use (IFU). Both devices generate digital mammographic images that are intended for screening and diagnosis of breast cancer and are intended for use in the same clinical applications as traditional screen-film mammography systems.
Testing and Performance Information:
Software: The development of DVIIm software includes the activities relating to the establishment of the software development plan (or plans) for definitely conducting software requirement analysis, architectural design, the detailed design, unit implementation, software integration and integration testing, software system test, software maintenance. Software verification and validation have been performed by the unit test, integration test, and system tests throughout the design verification phase and design validation phase. ASPIRE Cristalle maintains the confidentiality, integrity and availability in accordance with Section 6 of the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices; Guidance for Industry and Food and Drug Administration Staff (October 2, 2014).
Performance testing - bench: Applicable phantom testing results have been provided in accordance with the Phantom Testing in section 8. Physical Laboratory Testing of "Class II Special Controls Guidance Document: Full-Field Digital Mammography System" (March 27, 2012).
Performance testing - clinical: A clinical image attribute review was conducted by independent mammographic radiologists in accordance with the section 6 of "Class II Special Controls Guidance Document: Full-Field Digital Mammography System" (March 27, 2012) document. The mammographic attributes of six (6) image sets of screening and diagnostic cases were reviewed for all exposure modes concluding that the ASPIRE Cristalle provides sufficiently acceptable image quality for mammographic use.
Safety Information:
The ASPIRE Cristalle with DVIIm image processing introduces no new safety or efficacy issues other than those already identified with the predicate device. The Hazard Analysis combined with the appropriate preventive measures taken indicate that the device is of moderate concern as per the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (May 11, 2005) and is consistent with the level of concern indicated in the "Class II Special Controls Guidance Document: Full-Field Digital Mammography System" (March 27, 2012). The ASPIRE Cristalle meets the applicable basic safety and essential performance requirements for Medical Electrical Equipment, including IEC 60601-1, IEC 60601-1-2, , IEC 60601-1-3, IEC 60601-2-45, IEC 62304 and DICOM Version 3. The ASPIRE Cristalle labeling contains instructions for use and necessary cautions, warnings and notes to provide the safe and effective use of the device.
Conclusion:
This 510(k) premarket notification submission has demonstrated substantial equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health. We conclude the subject devices to be as safe and effective as the predicate device based upon the clinical and non-clinical data summarized above.