(283 days)
P050014
No
The summary describes a digital mammography system that replaces screen-film technology. It focuses on image acquisition, processing, and display, and the performance studies compare it to screen-film systems. There is no mention of AI, ML, or any features that would suggest the use of such technologies for image analysis, interpretation, or other functions. The "medical image processing workstation" mentioned is a standard component for handling digital medical images and does not inherently imply AI/ML.
No
Explanation: The device is used for screening and diagnosis of breast cancer, which are diagnostic purposes, not therapeutic. It produces images but does not directly treat any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The device is intended to be used for screening and diagnosis of breast cancer."
No
While the device is described as "software device," it is explicitly stated to be used "in conjunction with" and "activated" on specific Konica computed radiography systems (REGIUS Models 190 or 210 and REGIUS Console CS-3000), which are hardware components. The software processes images acquired by these hardware systems.
Based on the provided information, the Konica Minolta Xpress Digital Mammography System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Konica Minolta Xpress Digital Mammography System is a software device used in conjunction with imaging hardware (computed radiography system and mammography x-ray unit) to produce and process digital mammography images. It works with images generated from the human body using external energy (x-rays), not with specimens taken from the body.
- Intended Use: The intended use is for screening and diagnosis of breast cancer by interpreting mammographic images. This is a form of medical imaging, not in vitro testing.
Therefore, the device falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Konica Minolta Xpress Digital Mammography System is a software device that is used in conjunction with a specified Konica computed radiography system, REGIUS Model 190 or REGIUS Model 210 with REGIUS Cassette Plate CP1M200 and the REGIUS Console CS-3000, and a mammography x-ray unit, to produce full field digital mammography images. The Xpress Digital Mammography software with a specified Konica Minolta computed radiography system is designed to replace screen-film based systems for the production of mammographic images. The device is intended to be used for screening and diagnosis of breast cancer. The mammographic images can be interpreted by a qualified physician using either hard copy film or soft copy display at a workstation.
Product codes (comma separated list FDA assigned to the subject device)
MUE
Device Description
Konica Minolta's Xpress Digital Mammography is a software device that is used in conjunction with currently marketed Konica computed radiography systems to acquire Full Field Digital Mammography Images. Digital mammography can be performed with the specified Konica Minolta computed radiography systems including the activated Xpress Digital Mammography software using any mammography x-ray unit legally marketed in the U.S .. Konica Minolta does not specify a mammography x-ray unit for use with the specified Konica Minolta computed radiography system with the activated Xpress Digital Mammography software.
The components of the specified Konica Minolta computed radiography systems for digital mammography include either REGIUS Models 190 (K052095) or 210 (K092717) Direct Digitizers and the REGIUS Console CS-3000 medical image processing workstation (K051523) with optional bar code reader accessories.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Full Field Digital Mammography
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
Konica Minolta conducted a prospective, non-randomized, non-blinded clinical trial to acquire both standard screen-film mammograms and Xpress Digital mammograms at 11 clinical investigational centers. The final study cohort consisted of 210 subjects: 60 pathology proven cancers, 130 benign abnomal subjects (benign biopsy findings), and 20 negative subjects (confirmed by negative one year follow-up mammography). Both the screen-films images and the Xpress Digital images were acquired, randomized and evaluated.
Eleven radiologists who were blinded to the details of the subject histories, mammography films or results interpreted all 210 screen-film and Xpress Digital images. The radiologists scored each case with a BIRADS score of 0, 1, 2, 3, 4, or 5 and assigned a probability of malignancy to each case on a continuous scale from 0 - 100%.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Prospective, non-randomized, non-blinded clinical trial.
Sample Size: 210 subjects (60 pathology proven cancers, 130 benign abnormal subjects, 20 negative subjects).
AUC: The analysis of the AUC from the ROC curves indicated that the Xpress Digital Mammography System is non-inferior to Screen-Film Mammography. The observed difference in the areas was about 1% and the upper one-sided 95% confidence limits were less than 5%.
Key Results:
- The specificity for the Xpress System was non-inferior to the specificity of Screen-Film mammography. The difference in specificities was about 2% favoring the Xpress system and the upper one-sided confidence limit using GEE analysis which accounts for the subject image and reader correlations was less than 0.05. A supportive analysis of specificity using the ROC curve at a sensitivity of 46% also demonstrated the non-inferiority with an upper one-sided confidence limit less than 0.05.
- The sensitivity for the Xpress system was not non-inferior by GEE analysis, but an analysis using the ROC curve indicated that at a specificity of 90%, the upper one-sided confidence limit on the sensitivity of the Screen-Film minus the Xpress system was less than 0:10.
- The features analysis showed that the Xpress system was favored for visualization of the skin line, but all other features there was little evidence of a difference between the two systems. This indicates that the Xpress system does not lose detail that can be seen on Screen-Film images.
- Likewise, there did not appear to be a trend favoring hard image to soft image for the Xpress system.
- These results indicate that the Xpress Digital Mammography System provides images that are useful in the detection of cancer which are not inferior to those of conventional Screen-Film images.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Specificity: The specificity for the Xpress System was non-inferior to the specificity of Screen-Film mammography. The difference in specificities was about 2% favoring the Xpress system and the upper one-sided confidence limit using GEE analysis which accounts for the subject image and reader correlations was less than 0.05. A supportive analysis of specificity using the ROC curve at a sensitivity of 46% also demonstrated the non-inferiority with an upper one-sided confidence limit less than 0.05.
Sensitivity: The sensitivity for the Xpress system was not non-inferior by GEE analysis, but an analysis using the ROC curve indicated that at a specificity of 90%, the upper one-sided confidence limit on the sensitivity of the Screen-Film minus the Xpress system was less than 0:10.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
P050014
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Section 5: 510(k) Summary
| Submitter: | Konica Minolta Medical and Graphic |
|---|---|
| Shigeyuki Kojima | |
| Manager | |
| Regulations and Standards Section, Quality Assurance Center | |
| No. 1 Sakura-machi, Hino-shi, Tokyo 191-8511, Japan | |
| Contact Person: | Jillian M. Reed |
| Regulatory and Clinical Affairs Consultant | |
| Reed Technical Associates, LLC | |
| 25 Walnut Street | |
| Monroe, CT 06468 | |
| O: (203) 459-0659 | |
| F: (203) 538-3960 | |
| jillianreed@charter.net | |
| Date Prepared: | March 11, 2011 |
| Classification Name: | Full Field Digital Mammography System |
| Common Name: | Xpress Digital Mammography System |
| Proprietary Name: | Xpress Digital Mammography System |
| Predicate Devices: | P050014 |
| Fuji Computed Radiography Mammography Suite (FCRMS) |
Device Description:
Konica Minolta's Xpress Digital Mammography is a software device that is used in conjunction with currently marketed Konica computed radiography systems to acquire Full Field Digital Mammography Images. Digital mammography can be performed with the specified Konica Minolta computed radiography systems including the activated Xpress Digital Mammography software using any mammography x-ray unit legally marketed in the U.S .. Konica Minolta does not specify a mammography x-ray unit for use with the specified Konica Minolta computed radiography system with the activated Xpress Digital Mammography software.
The components of the specified Konica Minolta computed radiography systems for digital mammography include either REGIUS Models 190 (K052095) or 210 (K092717) Direct Digitizers and the REGIUS Console CS-3000 medical image processing workstation (K051523) with optional bar code reader accessories.
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Image /page/1/Picture/0 description: The image shows the Konica Minolta logo. The logo consists of a circular graphic above the company name. The graphic is a solid circle with three horizontal lines across the middle. The text "KONICA MINOLTA" is in a stylized font.
:
The x-ray images produced by the legally marketed x=ray unit:are captured on a REGIUS image plate and digitized using either REGIUS Model 190 or 210 Direct. Digitized images are imported into the REGIUS Console CS-3000 workstation. The REGIUS Console CS-3000 is identical to the REGIUS Console CS-3000 described in K051523, with the Xpress
Digital Manimography software activated. The Xpress Digital Mammography software prov a high resolution reading capability and display options specific to the review of mammographic image.
Soft. copy images can be transferred to any legally marketed diagnostic viewing station that accepts DICOM 3 input. Hard copy images can be generated using any printer legally marketed for use in digital mammography that supports DICOM basic grayscale print management service with a maximum 50 micrometer pixel pitch and film minimum optical density of at least 3.6.
Intended Use:
The Konica Minolta Xpress Digital Mammography System is a software device that is used in conjunction with a specified Konica. Minolta computed radiography system to produce full. field, digital mammography images. The Xpress Digital Mammography software with a specified. Konica Minolta computed radiography system is designed to replace screen-film based systems. for the production of mammographic images. The device is intended to be wised for screening and diagnosis of breast cancer.
Substantial Equivalence:
Results from the Non-Clinical and Clinical testing performed has shown that the Konica Minolta Xpress Digital Mammography System Software is substantially equivalent to the Fuji Computed Radiography Mammography Suite (FCRMS), #P050014 for its intended use.
Discussion of Non-Clinical Testing Performed:
In accordance with the FDA Guidance Document entitled "Class II Special Controls Guidance Document: Full Field Digital Mammography" dated November 5, 2010; Konica Minotta conducted the following physical performance tests required to demonstrate the substantial equivalence of the Xpress Digital Mammography System software used in conjunction with the Xpress CR-imaging system:
Sensitometric Response
Testing was conducted to evaluate the sensitometric response of the REGIUS image plate and exposed by the Senographe DMR x-ray unit.
A REGIUS image plate was inserted into the tholder and exposed under IEC62220-1-2 ROA-M2 conditions (28kV, Mo target and Mo: filter, 2 mm Aluminum filter).
The incident dose to the REGIUS image plate was measured using each of the plates and compared with the dose with no plate in the beam. Each exposed image plate was ready
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Image /page/2/Picture/0 description: The image shows the Konica Minolta logo. The logo consists of a circle with horizontal lines inside it, and the text "KONICA MINOLTA" is written below the circle. The text is in a sans-serif font and is slightly stylized. The image is in black and white.
with the REGIUS Model 190 Digitizer and the raw data was evaluated, to determine the average pixel value for the image area as a measure of the sensitometric response.
The relationship between the pixel value and radiation exposure is shown in Figure 5-1. The data shows that the linear relationship between pixel value and exposure was maintained for all exposure conditions.
Image /page/2/Figure/3 description: The figure shows a graph of pixel value versus exposure. The x-axis is exposure in mR, ranging from 1 to 1000, and the y-axis is pixel value, ranging from 0 to 4000. The graph shows a linear relationship between pixel value and exposure. The R-squared value is 1.00.
Image /page/2/Figure/4 description: The image shows the title of a figure. The title is "Figure 5-1: Sensitometric Response". The title is written in a clear, bold font.
Spatial Resolution
The modulation transfer function (MTF) of Xpress Digital Mammography was calculated to eyaluate the spatial resolution properties of the image acquisition system. Testing was, conducted under IEC62220-1-2 RQA-M2 conditions.
The presampling MTF was measured using the edge lechnique. An edge device made of tungsten (0.5 mm thickness) was placed on top of the x-ray unit breast support, table. Separate exposures were performed with the edge slightly tilted to the scan or sub-scan direction. A CP1M200 REGIUS image plate was inserted into the holder and exposed under RQA-M2 conditions for each scan direction.
Each exposed REGIUS image plate was read with the REGIUS Model 190 Digitizer at 43.75 um and the presampling MTF was measured from the image of the edge device in accordance with IEC62220-1-2. The presampling MTF is provided in Figure 5-2.
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Image /page/3/Figure/0 description: The figure is a graph from KONICA MINOLTA that shows MTF on the y-axis and spatial frequency (cycles/mm) on the x-axis. There are multiple data sets plotted on the graph, including 'scan', 'cross scan', 'FCRMS-scan', 'FCRMS-cross scan', and 'Screen-Film (Min-R EV / Min-R EV 150)'. The graph shows the relationship between MTF and spatial frequency for each of the data sets. The spatial frequency ranges from 0 to 10 cycles/mm.
Figure 5-2: Spatial resolution - Presampling MTF
Data extracted from the published Summary of Safety and Effectiveness Data for the MTF of unprocessed images generated using the Fuji Computed Radiography Mammography Suite (FCRMS) Fujifilm Medical System U.S.A., Inc.(P050014) is included in Figure 5-2 for a comparison. The data provided in Figure 5-2 demonstrates that the spatial resolution of the proposed Konica Minolta's Xpress Digital Mammography is equivalent or better than that of the Fuji. Computed Radiography Mammography Suite (FCRMS) Fujifilm Medical System U.S.A., Inc. (P050014).
Noise Analysis
Noise power spectrum (NPS) for the image acquisition system that constitutes the Xpress Digital Mammogitabhy was determined as a measure of noise analysis, at several different radiation exposures. Testing was conducted under IEC6220-1-2 RQA-M2 conditions.
Plots of the NPS as a function of spatial frequency (cycle/mm) in the scan and cross scan directions are provided in Figure 5-3 and 5-4.
1 http://www.fda.gov/cdrl/pdf5/p050014b.pdf
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Image /page/4/Picture/0 description: The image shows the Konica Minolta logo. The logo consists of a stylized globe with horizontal lines and the words "KONICA MINOLTA" written below it in a stylized font. The logo is black and white and appears to be a scanned image.
Image /page/4/Figure/1 description: The figure is a plot of NPS versus spatial frequency. The x-axis is spatial frequency in cycles/mm, ranging from 0 to 10. The y-axis is NPS, ranging from 1.0E-08 to 1.0E-04. There are 6 lines plotted, representing 2.4mR, 4.9mR, 9.9mR, 19.7mR, 38.8mR, and 77.7mR.
Figure 5-3: Noise Analysis - NPS:as a : funçtion of spatial frequency (čyclē/mm) in the scan direction .
Image /page/4/Figure/3 description: The image is a plot of NPS versus spatial frequency. The x-axis is spatial frequency in cycles/mm, ranging from 0 to 10. The y-axis is NPS, ranging from 1.0E-07 to 1.0E-04. There are six lines on the plot, representing different values of mR: 2.4mR, 4.9mR, 9.9mR, 19.7mR, 38.8mR, and 77.7mR.
Figure 5-4: Noise Analysis - NPS as a function of spatial frequency (cycle/mm) in the cross scan direction
Signal-to-Noise Ratio Transfer - DQE
DQE for the image acquisition system was measured at several different radiation DQE for the image acquisition system was and steam in Figures 5-5 and exposures and expressed as a fallouon or of 50-1-2 RQA-M2 conditions.
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Image /page/5/Figure/1 description: The figure is a plot of DQE(%) vs spatial frequency (cycles/mm) for different values of mR. The x-axis is spatial frequency from 0 to 10, and the y-axis is DQE(%) from 0 to 60. There are 6 different plots for 2.4mR, 4.9mR, 9.9mR, 19.7mR, 38.8mR, and 77.7mR.
Figure 5-5: Signal-to-Noise Ratio Transfer - DQE as a function of spatial frequency (cycle/mm) in the scan direction
Image /page/5/Figure/3 description: The image is a graph that shows the relationship between spatial frequency and DQE (%). The x-axis represents spatial frequency in cycles/mm, ranging from 0 to 10. The y-axis represents DQE (%) ranging from 0 to 60. There are six different lines on the graph, each representing a different value of mR: 2.4mR, 4.9mR, 9.9mR, 19.7mR, 38.8mR, and 77.7mR.
Image /page/5/Figure/4 description: This image is a figure titled "Figure 5-6: Signal-to-Noise Ratio Transfer - DQE as a function of spatial frequency (cycle/mm) in the cross scan direction". The figure describes the signal-to-noise ratio transfer. It also describes the DQE as a function of spatial frequency.
Dynamic Range
The dynamic range is indicated by using DQE as a function of radiation exposure level as shown in Figures 5-7, 5-8 and 5-9.
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Image /page/6/Picture/0 description: The image shows the Konica Minolta logo. The logo consists of a circular graphic above the company name. The graphic is a black circle with several horizontal white lines running through it. The text "KONICA MINOLTA" is written in a stylized font below the graphic.
The data provided in Figure 5-9 demonstrates that the average DQE of the proposed The Gala provided in Agare 3 > assimmography is equivalent or better than that of the Ruji Computed Radiography Mammography Suite (FCRMS) Fujifilm Medical System U.S.A., Inc. (P050014).
Image /page/6/Figure/2 description: The image is a graph that shows the relationship between exposure in mR and DQE in percentage. There are three lines on the graph, representing 0.5 cycles/mm, 4 cycles/mm, and 5 cycles/mm. The DQE decreases as the exposure increases for all three lines. The 0.5 cycles/mm line has the highest DQE, while the 5 cycles/mm line has the lowest DQE.
Figure 5-7: Dynamic Range -- DQE as a function of radiation exposure level in the scan direction
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Image /page/6/Figure/4 description: The image is a graph that shows the relationship between exposure in mR and DQE(%) for different cycles/mm. The graph includes three lines representing 0.5 cycles/mm, 4 cycles/mm, and 5 cycles/mm. The DQE(%) decreases as the exposure increases for all three cycles/mm. The 0.5 cycles/mm has a higher DQE(%) than the other two cycles/mm.
Figure 5-8: Dynamic Range - DQE as a function of radiation exposure level in the cross scan direction
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Image /page/7/Figure/0 description: The image is a graph that shows the relationship between exposure in mR and DQE(%). There are four lines on the graph, representing 0.5 cycles/mm, 4 cycles/mm, FCRMS-0.5 cycles/mm, and FCRMS-4 cycles/mm. The DQE(%) decreases as the exposure increases for all four lines. The 0.5 cycles/mm line has the highest DQE(%) at all exposure levels.
Figure 5-9: Dynamic Range - Average DQE as a function of radiation exposure level in comparison with a predicate device
Image Erasure and Fading
-
a. Image Erasure
Image erasure was assessed by reading an image after ensings. The previous interest was exposed under 28kV, Mo target and Mo filter, 32mAs, 2 mm Aluminum filter conditions. No residual signals were observed. -
b. Fading
The results of the image fading test at three different temperatures are provided in The results of the initial decline in luminescence intensity during 2 hours following the exposure was 20 % at 30 degrees Celsius.
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Image /page/8/Picture/0 description: The image shows the Konica Minolta logo. The logo consists of a circle with three horizontal lines in the middle, surrounded by a textured pattern. Below the circle, the text "KONICA MINOLTA" is written in a stylized font.
Image /page/8/Figure/1 description: The image shows a graph with three lines representing fading percentages over time at different temperatures. The x-axis represents time in minutes, ranging from 0 to 150. The y-axis represents the fading percentage, ranging from 0 to 120, with 100% labeled as '1min: 100%'. The three lines represent temperatures of 10°C, 23°C, and 30°C.
Image /page/8/Figure/2 description: The image shows the text "Figure 5-10: Fading". The text is in a bold, sans-serif font. The text is likely a figure caption from a book or article. The figure number is 5-10, and the figure is about fading.
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c. Image Retention
Image retention was assessed by repeating exposures and erasures at 100 times. The previous image was exposed under 28kV, Mo target and Mo filter, 32mAs, 2 mm Aluminum filter conditions. No signal was observed. -
d. Fogging after Exposure to Room Light
No signal fogging or depletion was observed after 5 minutes exposure to light of 7000. Ix luminance. The luminance is more than ten times greater than that of an ordinary room condition.
Repeated Exposure Test
After 100 cycles of exposures and erasures, the Lag value was calculated in accordance with IEC62220-1-2, Annex A.2.
The resultant lag value was 0.0047.
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Image /page/9/Picture/0 description: The image shows the Konica Minolta logo. The logo consists of a circle with horizontal lines and dots inside. Below the circle, the text "KONICA MINOLTA" is written in a bold, sans-serif font.
Phantom Testing
The performance of the Xpress Digital Mammography image acquisition system was The performinated of the contrast-detail mammography (CDMAM) phantom V3.4 and the Mammographic Accreditation (ACR) phantom NA18-220. The phantom images were Mannographic Acorechanon (1108) PAC. phantoms at standard climical conditions (28kV, Mo target and Mo filter). In each condition three images were acquired.
The phantom images were printed on dry films by using DR YPRO Model 793, #K042133, for a hard-copy display testing; and the films were observed on a lightbox. The lightbox luminance was greater than 7,000 cd/m² and the ambient illuminance was I ho mgnoox familiance on I ReadMammo (Merge Healthcare, K.040468) was used for a soft-copy display testing. The monitor luminance, was greater than 400 cd/m², and the ambient illuminance was less than 10 lx.
Three observers participated in the rating both the CDMAM phantom and the ACR phantom. Each observer rated all the images taken. Observer experience is listed in Table 5-1.
| Observer | Experience |
|---|---|
| A | Seven years' experience of the phantom scoring |
| B | Five years' experience of the phantom scoring |
| C | Five years' experience of the phantom scoring |
Table 5-1: Observer Experience
- The average scores of all three observers were calculated to create the contrast-detail. (C-D) The avolage softes of an ans generated from the CDMAM phantom images are provided in Figure 5-11, 5-12 and 5-13:
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Image /page/10/Figure/0 description: The image shows the Konica Minolta logo. The logo consists of a circular graphic above the company name. The graphic is a stylized representation of a globe or sphere with horizontal lines across it. The text "KONICA MINOLTA" is written in a bold, sans-serif font below the graphic.
Image /page/10/Figure/1 description: The figure shows a plot of threshold thickness in micrometers versus diameter in millimeters. The x-axis and y-axis are on a log scale. The threshold thickness decreases as the diameter increases. The data points are shown with error bars.
Figure 5-11: C-D diagram (hard-copy display, 2.94mGy)
Image /page/10/Figure/3 description: The figure is a plot of threshold thickness in micrometers versus diameter in millimeters. The x and y axes are on a log scale. The threshold thickness decreases as the diameter increases. The threshold thickness ranges from 0.01 to 10 micrometers, and the diameter ranges from 0.01 to 10 millimeters.
Image /page/10/Figure/4 description: The image shows the title of a figure, which is "Figure 5-12: C-D diagram (soft-copy display, 2.94mGy)". The title indicates that the figure is a C-D diagram. The diagram is a soft-copy display. The value 2.94mGy is also included in the title.
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Image /page/11/Figure/0 description: The image is a graph that plots threshold thickness in micrometers against diameter in millimeters. There are three data series plotted on the graph: 1.47mGy, 2.94mGy, and FCRMS. The threshold thickness decreases as the diameter increases for all three data series. The threshold thickness ranges from 0.01 to 10 micrometers, and the diameter ranges from 0.01 to 10 millimeters.
Figure 5-13: C-D diagram (average)
The image quality factor (IQF).is the sum of the products of the dismeters of each of the smallest I he image quality lacior (IQ) ).is me sam of the releveled at a diameter no larger than
scored objects and their relative contrast. The IQF: were calculared at 14 scored objects and dien rolarre connect than 2.5um and provided in Figure 5-14.
Image /page/11/Figure/3 description: This image is a bar graph comparing the Image Quality Factor (IQF) of different imaging methods. The y-axis represents the IQF, ranging from 0 to 1. The x-axis shows three categories: soft-copy, hard-copy, and FCRMS, each with two bars representing different radiation doses (1.47mGy and 2.94mGy). The hard-copy with 1.47mGy has the highest IQF, while the soft-copy with 2.94mGy has the lowest.
Image /page/11/Figure/4 description: The image shows the title of a figure. The title is "Figure 5-14: IQF results". The title is written in a bold, sans-serif font.
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Image /page/12/Picture/0 description: The image shows the logo for Konica Minolta. The logo consists of a circle with horizontal lines inside and a textured top portion. Below the circle, the words "KONICA MINOLTA" are written in a stylized font.
The average ACR phantom scores for fibers, specks, and masses are provided in Tables 5-2, 5-3, 5-4 and 5-5.
| Scoring
Criteria | ACR
Phantom* |
|---------------------|-----------------|
| Fibers | 5:7 |
| Specks | 4.0 |
| Masses | 4.4 |
Table 5-2: ACR phantom scores with hard-copy display
*Each value represents the average scores from 3 experienced readers
Table 5-3: ACR phantom scores with soft-copy display-
| Scoring
Criteria | ACR
Phantom* |
|---------------------|-----------------|
| Fibers | 5.4 |
| Specks | 4.1 |
| Masses, | 4.8 |
*Each value represents the average scores from 3 experienced readers
Table 5-4: ACR Phantom Scores of predicated device
| Scoring
Criteria | ACR
Phantom* |
|---------------------|-----------------|
| Fibers | 5.0 |
| Specks | 3.8 |
| Masses | 3.6 |
4 The predicated device is Fuji Computed Radiography Mammography:Suite (FCRMS):Fujifilm Medical System U.S.A., Inc. (P050014)
Table 5-5: ACR Phantom Scores of a-film-screen system
| Scoring
Criteria | ACR
Phantom* |
|---------------------|-----------------|
| Fibers | 4:9 |
| Specks | -3:8 |
| Masses | 4:0 |
· The film-screen system is Min-R EV/Min-R EV150. Each value represents the average scores from 3 experienced readers.
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Image /page/13/Picture/0 description: The image shows the Konica Minolta logo. The logo consists of a circular graphic above the company name. The graphic is a circle with horizontal lines and dots inside. The text "KONICA MINOLTA" is written in a sans-serif font below the graphic.
The data provided in Tables 5-2, 5-3, 5-4 and 5-5 demonstrates that the scores of ACR Phantom. of the proposed Konica Minolta's Xpress Digital Mammography is equivalent or better than or are proposed rechard Radiography Mammography Suite (FCRMS) Fujifilm Medical System U.S.A., Inc. (P050014) and the film-screen system (Min-R EV/Min-REV (20).
Discussion of Clinical Testing Performed:
Obiectives:
The purpose of the clinical study was to evaluate the safety and effectiveness of the Konica Minolta Medical Inaging Xpress Digital Mammography System (Xpress Digital) for screening and diagnosis of breast cancer. The trial design, as defined in this section, sought to compare the combined area under the curve (AUC), as well as sensitivity, specificity and features analyses of Xpress Digital to conventional screen-film mammography methods in detecting breast cancer.
Methods:
Konica Minolta conducted a prospective, non-randomized, non-blinded clinical trial to acquire both standard screen-film mammograms and Xpress Digital mammograms at 11 clinical investigational centers. The final study cohort consisted of 210 subjects: 60 pathology proven cancers, 130 benign abnomal subjects (benign biopsy findings), and 20 negative subjects (confirmed by negative one year follow-up mammography). Both the screen-films images and the Xpress Digital images were acquired, randomized and evaluated.
Eleven radiologists who were blinded to the details of the subject histories, mammography films or results interpreted all 210 screen-film and Xpress Digital images. The radiologists scored each case with a BIRADS score of 0, 1, 2, 3, 4, or 5 and assigned a probability of malignancy to each case on a continuous scale from 0 - 100%.
ROC curves were generated from the Xpress Digital and screen-film results and the areas under the curve were compared. Cases assigned a BIRADS score of 0: requiring further evaluation (i.e., magnification or spot manmography, ultrasound, MRI, biopsy, etc.) were classified as recalls. The sensitivity of each mammography modality was obtained by determining the radio of the number of correct positive readings to (assignment of a BIRADS score of 4 or 5) to the Specificity was obtained by determining the ratio of the total number of true posițive cases. number of true negative readings to the total number of the true negative cases (BIRADS score 1, 2, or 3):
Features analyses were then performed were half the readers comparing side-by-side comparisons of screen-film and Xpress Digital images of 100 cases (60 pathology proven cancers and 40 abnormal biopsy cases) and the other half comparing soft copy Xpress Digital images to hard-copy printed Xpress Digital images of 60 pathology provenicancers. In Drend mages to nare copy fraire pathology, several other characteristics of the images and anatomic features were compared.
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Image /page/14/Picture/0 description: The image shows the Konica Minolta logo. The logo consists of a circle with horizontal lines across the middle and a textured top and bottom. Below the circle, the words "KONICA MINOLTA" are written in a sans-serif font.
Results:
The analysis of the AUC from the ROC curves indicated that the Xpress Digital.Mammography System is non-inferior to Screen-Film Mammography. The observed difference in the areas was about 1% and the upper one-sided 95% confidence limits were less than 5%.
The specificity for the Xpress System was non-inferior to the specificity of Screen-Film mammography. The difference in specificities was about 2% favoring the Xpress system and the upper one-sided confidence limit using GEE analysis which accounts for the subject image and reader correlations was less than 0.05. A supportive analysis of specificity using the ROC curve at a sensitivity of 46% also demonstrated the non-inferiority with an upper one-sided confidence limit less than 0.05.
The sensitivity for the Xpress system was not non-inferior by GEE analysis, but an analysis using the ROC curve indicated that at a specificity of 90%, the upper one-sided confidence limit on the sensitivity of the Screen-Film minus the Xpress system was less than 0:10. The finding that the sensitivity of a Xpress system compared to Screen-Film is not surprising considering that the vast majority of subjects recruited into the trial were recommended for biopsy based on a suspicious Screen-Film examination. Unfortunately there were too few subjects in the screening sample in this trial to allow an adjustment method to be done for the associated bias.
The features analysis showed that the Xpress system was fayored for visualization of the skin line, but all other features there was little evidence of a difference between the two systems. This indicates that the Xpress system does not lose detail that can be seen on Screen-Film images. Likewise, there did not appear to be a trend favoring hard image to soft image for the Xpress system.
These results indicate that the Xpress Digital Mammography System provides images that are useful in the detection of cancer which are not inferior to those of conventional Screen-Film images.
Conclusion:
The Xpress Digital Mammography System is safe and effective for screening and diagnosis of breast cancer based on ROC analyses, sensitivity, specificity, recall rates, and features analyses.
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Image /page/15/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with flowing lines suggesting movement or progress.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Konica Minolta Medical and Graphic % Ms. Jillian M. Reed Regulatory and Clinical Affairs Consultant Reed Technical Associates, LLC 25 Walnut Street MONROE CT 06468
Re: K110717
Trade/Device Name: Konica Minolta Xpress Digital Mammography System Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field digital mammography system Regulatory Class: II Product Code: MUE Dated: December 20th, 2011 Received: December 21st, 2011
JAN 1 9 2012
Dear Ms. Reed:
This letter corrects our substantially equivalent letter of December 23d. 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 (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
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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 Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely Yours.
hmat Dó Xhum for
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
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Indications for Use
510(k) Number (if known) : K110717
Konica Minolta Xpress Digital Mammography System Device Name
Indications for Use:
The Konica Minolta Xpress Digital Mammography System is a software device that is used in conjunction with a specified Konica computed radiography system, REGIUS Model 190 or REGIUS Model 210 with REGIUS Cassette Plate CP1M200 and the REGIUS Console CS-3000, and a mammography x-ray unit, to produce full field digital mammography images. The Xpress Digital Mammography software with a specified Konica Minolta computed radiography system is designed to replace screen-film based systems for the production of mammographic images. The device is intended to be used for screening and diagnosis of breast cancer. The mammographic images can be interpreted by a qualified physician using either hard copy film or soft copy display at a workstation.
Prescription Use (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 Diagnostic Devices (OIVD)
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Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
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