Predicate Devices

P080018, P050014

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a digital mammography system based on computed radiography (CR) technology. It focuses on the hardware components (reader, image plate, workstation) and image quality metrics (resolution, noise, DQE) typical of CR systems. There is no mention of AI, ML, deep learning, or any algorithms that would suggest the use of such technologies for image processing, analysis, or interpretation. The performance studies are based on standard preclinical and clinical image quality evaluations, not AI/ML model performance metrics.

Therapeutic

No
The device is indicated for generating mammographic images for screening and diagnosis of breast cancer, which serves a diagnostic purpose, not a therapeutic one.

Diagnostic

Yes

The "Intended Use / Indications for Use" section states that the device is indicated for "screening and diagnosis of breast cancer." The purpose of a diagnostic device is to assist in the diagnosis of a medical condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is composed of an image reader, image plate, and acquisition workstation, which are all hardware components.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
Device Function: The Aspire CR for Mammography System is a medical imaging system. It generates images of the breast using X-rays. This is an in vivo process (performed within the living body), not an in vitro process (performed outside the living body).
Intended Use: The intended use is for generating mammographic images for screening and diagnosis of breast cancer. This involves capturing images of the breast directly, not analyzing samples taken from the body.

Therefore, the Aspire CR for Mammography System falls under the category of medical imaging devices, not in vitro diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Aspire CR for Mammography (CRm) System is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The Fuji Aspire CRm System is intended to be used in the same clinical applications as traditional film/screen systems.

Product codes

MUE

Device Description

The FCR Aspire CRm is Fuji's newest reader to join our CR for mammography (FCRm) line of mammography readers (ClearView CSm and ClearView 1-m). The Aspire CRm system is composed of an Aspire CRm image reader, a new 50 micron HR VI single sided image plate (IP), and the same Fuji Flash Plus IIPm acquisition workstation as our approved FCRMS. In addition, any cleared dedicated mammographic x-ray machine may be used with the Aspire CRm system to generate digital mammographic images for screening and diagnosis of breast cancer. The mammographic images can be interpreted by a qualified physician using either hardcopy film or softcopy display at a 5 megapixel 510(k) cleared for mammography soft copy review station, and optionally printed on a 510(k) cleared for mammography printer.

The requirements for the dedicated mammographic x-ray machine are as follows:

An x-ray machine specifically designed and 510(k) cleared for mammography . should be used.
The X-ray tube should have as a minimum a molybdenum target and . molybdenum filter
(Mo/Mo) combination for calibration of the Aspire CRm image reader and . optionally any of the following anode target and filter combinations: molybdenum target with rhodium filter (Mo/Rh), rhodium target with rhodium filter (Rh/Rh), and tungsten target with rhodium filter (W/Rh).
The x-ray system should have both manual exposure control and automatic . exposure control (AEC). The AEC may be of the type controlling mAs only, or mAs and kVp, or mAs, kVp and filter, or mAs. kVp. filter, and target.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

Breast

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Qualified physician / 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 (study type, sample size, AUC, MRMC, standalone performance, key results)

Preclinical Studies:
The following Preclinical tests were performed in accordance with Section 8 of the Class II Special Controls Guidance Document: Full-Field Digital Mammography System Document issued on: November 5, 2010,

Sensitometric Response
Spatial resolution of Aspire CRm
Aspire CRm Noise Analysis
Aspire CRm Detective Quantum Efficiency
Dynamic Range-NEQ
Dynamic Range-DQE
Image Erasure and Fading Test for Aspire CRm
Image Fogging Test for Aspire CRm
ACR Phantom (2cm, 4.2cm, and 6cm). Scoring
CD MAM Scoring
Aspire CRm (HR-VI) / Kodak DirectViewCR (EHR-M2) MTF Comparison
Aspire CRm (HR-VI) / Kodak DirectViewCR (EHR-M2) DQE Comparison

The results of the tests demonstrate that our proposed device is substantially equivalent to our cleared predicate devices. The Aspire CRm system performed as well as the predicate devices in all relevant areas. As recommended by FFDM Guidance Document, and where appropriate, tests were performed in accordance with IEC 62220-1-2 and The Addendum on Digital Mammography: The European Protocol for the Quality Control of the physical and technical aspects of mammography screening, version 1.0, November 2003.

Clinical Images Studies:
An image attribute evaluation was conducted in accordance with the Class II Special Controls Guidance Document: Full-Field Digital Mammography System Guidance Document, dated November 5, 2010, which concluded that the images were of sufficiently acceptable quality for clinical mammographic usage.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

P080018, P050014

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.

Summary

0

K111646

DEC - 8 2011

Section 5

. . . . . . . .

510(k) Summary

Aspire CR for Mammography (CRm) FFDM System

This Section contains:

.. ...

,

510(k) Summary

.. .

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·

,

:

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KIII646

Image /page/2/Picture/1 description: The image shows the date December 8, 2011. The text is written in a simple, sans-serif font. The date is written in the format of month, day, and year. The text is black and the background is white.

510(k) Summarv Aspire CR for Mammography (CRm) FFDM System

Date: June 10, 2011

Submitter's Information:

FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, Connecticut, 06902, U.S.A.

Contact Person:

Name:	Debra Peacock
Title:	Regulatory Affairs Manager
Telephone:	(203) 602-3774
Facsimile:	(203) 363-3813

Identification of the Proposed Device:

Proprietary/Trade Name:	Aspire CR for Mammography (CRm) FFDM System
Classification Name:	Full Field Digital Mammography System
Regulations Number:	21 CFR 892.1715
Product Codes:	MUE
Device Class:	Class II
Review Panel:	Radiology
Common Name:	Full Field Digital Mammography System

1. INDICATIONS FOR USE

The Aspire CR for Mammography (CRm) System is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The Fuji Aspire CRm System is intended to be used in the same clinical applications as traditional film/screen systems.

2. DEVICE DESCRIPTION

The FCR Aspire CRm is Fuji's newest reader to join our CR for mammography (FCRm) line of mammography readers (ClearView CSm and ClearView 1-m). The Aspire CRm system is composed of an Aspire CRm image reader, a new 50 micron HR VI single sided image plate (IP), and the same Fuji Flash Plus IIPm acquisition workstation as our approved FCRMS. In addition, any cleared dedicated mammographic x-ray machine may be used with the Aspire CRm system to generate digital mammographic images for screening and diagnosis of breast cancer. The mammographic images can be interpreted by a qualified physician using either hardcopy film or softcopy display at a 5

3

Image /page/3/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, in a smaller font, it says "Fujifilm Medical Systems, USA".

megapixel 510(k) cleared for mammography soft copy review station, and optionally printed on a 510(k) cleared for mammography printer.

The requirements for the dedicated mammographic x-ray machine are as follows:

An x-ray machine specifically designed and 510(k) cleared for mammography . should be used.
The X-ray tube should have as a minimum a molybdenum target and . molybdenum filter
(Mo/Mo) combination for calibration of the Aspire CRm image reader and . optionally any of the following anode target and filter combinations: molybdenum target with rhodium filter (Mo/Rh), rhodium target with rhodium filter (Rh/Rh), and tungsten target with rhodium filter (W/Rh).
The x-ray system should have both manual exposure control and automatic . exposure control (AEC). The AEC may be of the type controlling mAs only, or mAs and kVp, or mAs, kVp and filter, or mAs. kVp. filter, and target.

| | Proposed Fujifilm
Aspire CRm | Predicate Kodak DirectView
CR Mammography System
(P080018) | Predicate Fuji CR for Mammography
System (FCRMS) (P050014) |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Detector-
only FFDM
System | Yes | Yes | Yes |
| Acquisition
Workstation | Fujifilm Flash Plus
IIPm (CR-IR348 CL)
Mammography
Workstation
specifically designed
for viewing and
storing images and
data. Fuji proprietary
software. | Yes. CARESTREAM
(KODAK)
Mammography
Workstation
specifically designed for
viewing and storing
images
and data. Carestream
(Kodak) proprietary
software. | Same. Fujifilm Flash Plus
IIPm (CR-IR348 CL)
Mammography Workstation
specifically designed for
viewing and storing images
and data. Fuji proprietary
software. |
| Image
Reader | Aspire CRm (CR-
IR359) single slot
reader can be used
for both
mammography and
general radiography. | Yes. Single slot
reader(s) can be used
for both mammography
and general
radiography. | ClearView CSm (CR-IR363)
multi slot reader and
ClearView-1m (CR-IR368)
single slot reader can be
used for both mammography
and general radiography. |
| Detector | Flexible, Single Sided
Imaging Plate (IP) | Rigid, Single Sided IP | Flexible, Dual Sided IP |

3. PREDICATE DEVICES

4

4. SUMMARY OF STUDIES

Preclinical Studies:

The following Preclinical tests were performed in accordance with Section 8 of the Class II Special Controls Guidance Document: Full-Field Digital Mammography System Document issued on: November 5, 2010,

� Sensitometric Response
. Spatial resolution of Aspire CRm
. Aspire CRm Noise Analysis
Aspire CRm Detective Quantum Efficiency .
. Dynamic Range-NEQ
Dynamic Range-DQE .
Image Erasure and Fading Test for Aspire CRm .
. Image Fogging Test for Aspire CRm
. ACR Phantom (2cm, 4.2cm, and 6cm). Scoring
CD MAM Scoring .
Aspire CRm (HR-VI) / Kodak DirectViewCR (EHR-M2) MTF Comparison .
Aspire CRm (HR-VI) / Kodak DirectViewCR (EHR-M2) DQE Comparison .

The results of the tests demonstrate that our proposed device is substantially equivalent to our cleared predicate devices. The Aspire CRm system performed as well as the predicate devices in all relevant areas. As recommended by FFDM Guidance Document, and where appropriate, tests were performed in accordance with IEC 62220-1-2 and The Addendum on Digital Mammography: The European Protocol for the Quality Control of the physical and technical aspects of mammography screening, version 1.0, November 2003.

Clinical Images Studies:

An image attribute evaluation was conducted in accordance with the Class II Special Controls Guidance Document: Full-Field Digital Mammography System Guidance Document, dated November 5, 2010, which concluded that the images were of sufficiently acceptable quality for clinical mammographic usage.

5. SUBSTANTIAL EQUIVALENCE

.

The Aspire CRm FFDM System is substantially equivalent to the predicate device, Kodak DirectView CR Mammography System (P080018) and our own Fuji CR for Mammography System (FCRMS). The Aspire CRm uses the same acquisition workstation as our currently approved FCRMS. Our FCRMS uses a dual sided 50 micron high resolution image plate. The Aspire CRm uses a new, single sided 50 micron, high resolution image plate (HR VI). Kodak's also uses a single sided 50 micron image plate. All systems are a detector-only FFDM (Computed Radiography for Mammography) system, using any cleared dedicated x-ray mammography system.

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Image /page/5/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. The logo appears to be a standard corporate branding element.

6. CONCLUSION

The Aspire CRm FFDM System is substantially equivalent to the predicate devices in respects to indication for use, technology, similar materials and image quality. All three systems are CR for mammography systems utilizing an imaging plate and CR image reader. All systems demonstrate comparable safety and effectiveness features, and are similar in design and construction.

All collected performance data demonstrate that the devices are substantially equivalent. Our conclusion is that the Aspire CRm FFDM System is as safe and effective as the legally marketed predicate devices.

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Image /page/6/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human profiles or abstract shapes, creating a sense of unity and connection.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

DEC - 8 2011

Ms. Debra A. Peacock Regulatory Affairs Manager FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue STAMFORD CT 06902

Re: K111646

Trade/Device Name: Aspire CR for Mammography (CRm) System Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE Dated: November 11, 2011 Received: November 14, 2011

Dear Ms. Peacock:

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 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

7

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 will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety 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.

Mary S Pastel

Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

8

Indications for Use

510(k) Number (if known):

Device Name: "Aspire CR for Mammography (CRm) System

Indications for Use:

The Aspire CR for Mammography (CRm) System is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The Fuji Aspire CRm System is intended to be used in the same clinical applications as traditional film/screen systems.

Prescription Use X (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)

ision Sign-Off)
Division of Radiological Devices Diagnostic Device Evaluation and Safety Office of In Vitro

510K. K111646