(206 days)
P030010, P030010/S
Not Found
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on hardware and standard image acquisition and processing.
No.
This device is for generating mammographic images for screening and diagnosis of breast cancer, which are diagnostic purposes, not therapeutic.
Yes
The device generates mammographic images that can be used for "screening and diagnosis of breast cancer," which clearly indicates a diagnostic purpose.
No
The device description clearly outlines numerous hardware components, including a gantry, X-ray tube, detector, operator console, and various paddles. This is a physical medical device system, not software-only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The Philips MammoDiagnost DR is an imaging system that uses X-rays to create images of the breast within the patient's body. It does not analyze samples taken from the body.
- Intended Use: The intended use is for generating mammographic images for screening and diagnosis of breast cancer, which is a form of medical imaging, not in vitro testing.
Therefore, based on the provided information, the Philips MammoDiagnost DR is a medical imaging device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MammoDiagnost DR is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The MammoDiagnost DR is intended to be used in the same clinical applications as traditional film/screen systems.
Product codes (comma separated list FDA assigned to the subject device)
MUE
Device Description
The Philips MammoDiagnost DR digital mammography system is designed to perform screening and diagnostic mammography procedures on standing, seated or recumbent patients. The system consists of a gantry with an operator console including the Eleva Workspot (EWS), consisting of an acquisition workstation (AWS) and a 19" touch screen monitor. The system's rotating X-ray tube (0.3 / 0.15 Focal Spot, Anode: Tungsten/Molybdenum) offers 4 anode tracks. The gantry provides motorized elevation, rapid rotation and compression via two foot switches. An operator radiation shield and a removable recessed patient face shield are included in the system as well as the following paddles: Compression paddles (7" x 9,5" x 12"), Axilla and Spot compression. The system is equipped with a solid state amorphous selenium detector, providing a matrix size of 3584 x 2816.
The acquisition workstation provides a high performance central processing unit with a minimum of 500GB hard disk, and a 4GB memory. A 19" flat panel touch screen color monitor on pivot mount allows the users a selectable viewing position. Acquired images are provided in DICOM MG format which allows its integration into a digital mammography environment including diagnostic review workstations, CAD Systems and PACS.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Breast
Indicated Patient Age Range
non-pregnant women over the age of 40
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Performance Testing:
- Sensitometric Response: Measured the sensitivity of the image acquisition system to different levels of x-ray exposures, showing a linear relationship between median LSB and detector entrance dose.
- Spatial Resolution: Measured image sharpness using modulation transfer function (MTF) according to IEC 62220-1-2.
- Noise Power Spectrum (NPS): Characterized noise distribution over spatial frequency at 8 dose levels, calculated according to IEC 62220-1-2.
- Signal-to-Noise Ratio (SNR): Measured the efficiency of SNR transfer using Detective Quantum Efficiency (DQE) as a function of spatial frequency, according to IEC 62220-1-2.
- Dynamic Range: Characterized by plotting DQE over dose at low and mid frequencies.
- Repeated Exposure Test: Measured lag behavior of the digital x-ray detector over 100 repetitions with one-minute intervals between images.
- Phantom Image Tests: Evaluated image quality using the American College of Radiology (ACR) accreditation phantom and the CDMAM contrast-detail mammography phantom. Scoring of the ACR phantom and analysis of CDMAM phantom images followed EUREF guidelines and published literature. Results for normal and high dose with a 4 mm thickness ACR MAP phantom demonstrated excellent detection capabilities.
- Automatic Exposure Control (AEC): Evaluated performance by acquiring data sets of varying breast equivalent thicknesses in normal and high dose modes. CNR in both normal and high dose contact modes changed by less than 10% per centimeter of PMMA thickness.
- Patient Radiation Dose: Tested phantom thicknesses of 2 cm, 4 cm, and 6 cm simulating fibroglandular/adipose tissue, using system AEC. Mean Glandular Dose results were provided.
Summary of Clinical Image Evaluation:
- Study Type: Image attribute review in accordance with the Class II Special Controls Guidance Document: Full-Field Digital Mammography System.
- Sample Size: 6 mammographic image cases (screening and diagnostic), each consisting of 4 standard views (RCC, RMLO, LCC, LMLO), including magnification or spot views from diagnostic cases.
- Data Source: Acquired from the Philips FFDM system, MammoDiagnost DR.
- Annotation Protocol: Reviewed by two expert Radiologist's meeting MQSA qualifications. Mammography cases were acquired from non-pregnant women over the age of 40. Women with breast implants were not included. Reviewers evaluated mammographic attributes, scored them from 1 (worse) to 5 (best), and determined an overall pass/fail for each case.
- Key Results: The two expert breast imaging subspecialist radiologists agreed that the six image sets from the Philips MammoDiagnost DR system are of sufficiently acceptable quality for clinical mammographic usage.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
P030010, P030010/S
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.
Not Found
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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Summary of Safety and Effectiveness
SEP 2 3 2011
510(k) Summary
In accordance with the requirements of the Safe Medical Device Act, Philips Medical Systems herewith submits a 510(k) Summary.
Name and Address of manufacturer:
Philips Medical Systems DMC GmbH Roentgenstrasse 24 22335 Hamburg Germany Establishment Registration No .: 3003768251 Owner/Operator Number: 1217116
Name, title and phone number of official correspondent:
Linda Jalbert Women's Health Care Philips Healthcare 3000 Minuteman Road Andover, MA 01810 Phone 978 659-7434
Device Identification:
Device Trade Name: Philips MammoDiagnost DR Common Name: Full Field Mammography System
Classification of the device:
Device Classification Name: Product Code: Device Classification No .: Panel: Regulatory Status:
Full Field Digital,System,X-ray,Mammographic MUE Part 892.1715 Radiology Class II
Device(s) Identification:
Device Trade Name: Common Name:
Philips MammoDiagnost DR Full Field Digital Mammography System
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| Predicate devices: | |
|---|---|
| Device Trade Name: | Siemens Mammomat Novation |
| Applicant: | Siemens Medical Solution |
| 510(k) No.: | P030010 |
| Device Trade Name: | Siemens Mammomat Inspiration |
| Applicant: | Siemens Medical Solution |
| 510(k) No.: | Supplement to P030010 (P030010/S |
The Philips MammoDiagnost DR Full Field Digital Mammography System is considered substantially equivalent to Siemens Mammomat Novation and Inspiration Full Field Digital Mammography Systems. There is no significant difference in intended use or technology.
Device Description:
The Philips MammoDiagnost DR digital mammography system is designed to perform screening and diagnostic mammography procedures on standing, seated or recumbent patients. The system consists of a gantry with an operator console including the Eleva Workspot (EWS), consisting of an acquisition workstation (AWS) and a 19" touch screen monitor. The system's rotating X-ray tube (0.3 / 0.15 Focal Spot, Anode: Tungsten/Molybdenum) offers 4 anode tracks. The gantry provides motorized elevation, rapid rotation and compression via two foot switches. An operator radiation shield and a removable recessed patient face shield are included in the system as well as the following paddles: Compression paddles (7" x 9,5" x 12"), Axilla and Spot compression. The system is equipped with a solid state amorphous selenium detector, providing a matrix size of 3584 x 2816.
The acquisition workstation provides a high performance central processing unit with a minimum of 500GB hard disk, and a 4GB memory. A 19" flat panel touch screen color monitor on pivot mount allows the users a selectable viewing position. Acquired images are provided in DICOM MG format which allows its integration into a digital mammography environment including diagnostic review workstations, CAD Systems and PACS.
Indications for Use:
The MammoDiagnost DR is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The MammoDiagnost DR is intended to be used in the same clinical applications as traditional film/screen systems.
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Summary of Non-Clinical Performance Testing:
Sensitometric Response:
Sensitometric Response is a measure of the sensitivity of the image acquisition system to different levels of x-ray exposures.
Image /page/2/Figure/6 description: This image is a graph that plots the median LSB against the detector entrance dose in micrograys. The x and y axes are on a logarithmic scale. The graph shows a linear relationship between the two variables, with the equation y = 3.5877x and an R-squared value of 1. The plot includes a scatter plot of the median and a line of best fit.
Spatial Resolution:
Image sharpness of an image detector can be quantified by its modulation transfer function (MTF). The spatial resolution was measured according to the IEC 62220-1-2.
Image /page/2/Figure/9 description: The image is a plot of Binned MTF vs Frequency. The x-axis is Frequency in LP/mm from 0 to 6. The y-axis is Binned MTF from 0 to 1.2. There are three lines plotted: Binned Vertical, Binned Horizontal, and Binned Average.
3
Noise Power Spectrum (NPS)
Noise power spectrum (NPS) is a characterization of the noise distribution over the spatial frequency which is an important factor contributing to image quality. The NPS (noise power spectra) was measured at 8 dose levels, and was calculated according to the IEC 62220-1-2.
510(K)
Image /page/3/Figure/4 description: The image contains two plots showing horizontal and vertical noise power spectrum (NPS) as a function of frequency. The top plot displays horizontal NPS, while the bottom plot displays vertical NPS, both measured in mm²LSB². Each plot contains multiple curves representing different exposure levels, ranging from 14.3 uGy to 836.7 uGy, with frequency on the x-axis in LP/mm, ranging from 0.1 to 10.
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Signal-to-Noise Ratio (SNR):
The efficiency of SNR transfer of the image acquisition system is measured by the DQE (detective quantum efficiency) as a function of spatial frequency. DQE provides a measure of the combined effect of the noise and contrast performance of an imaging system, expressed as a function of object detail. The DQE was measured according to the IEC 62220-1-2.
510(k)
Image /page/4/Figure/4 description: The image is a graph that shows the horizontal DQE (Detective Quantum Efficiency) as a function of frequency. The x-axis represents the frequency in LP/mm (line pairs per millimeter), ranging from 0 to 6. The y-axis represents the horizontal DQE, ranging from 0.0% to 80.0%. There are multiple lines on the graph, each representing a different xSpec value in uGy (microGray), including 14.3, 27.3, 53.9, 106.4, 212.1, 420, and 836.7.
Image /page/4/Figure/5 description: The image is a graph that shows the vertical DQE (detective quantum efficiency) as a function of frequency. The x-axis represents the frequency in LP/mm, ranging from 0 to 6. The y-axis represents the vertical DQE, ranging from 0.0% to 80.0%. There are multiple lines on the graph, each representing a different ySpec value, including 14.3uGy, 27.3uGy, 53.9uGy, 106.4uGy, 212.1uGy, 420uGy, and 836.7uGy.
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Dynamic Range
Dynamic range is a measure of the signal response of a detector exposed to x-rays. The dynamic range was characterized by plotting the DQE over dose at low and mid frequencies.
Image /page/5/Figure/5 description: The figure is a graph comparing xSpec and ySpec with respect to Entrance Dose in microGrays. The x-axis shows the Entrance Dose from 0 to 900 microGrays, and the y-axis shows DQE @ 3lp/mm from 0% to 70%. Both xSpec and ySpec increase as the Entrance Dose increases. At 800 microGrays, xSpec is at about 63% and ySpec is at about 56%.
Repeated Exposure Test
The purpose of this measurement is to qualify the lag behavior of the digital x-ray detector. The measurement was repeated 100 times, the time period between each image was set to one minute.
Image /page/5/Figure/8 description: The image is a graph that shows the ghost image factor over time. The x-axis represents time in minutes, ranging from 0 to 100. The y-axis represents the ghost image factor, ranging from 0.00 to 0.35. There are three lines on the graph: one representing the ghost image factor using the mean, one representing the ghost image factor using the average, and one representing the limitation, which is a straight line at 0.30.
Phantom Image Tests
ﮯ ﺩ
Image quality is also demonstrated by analysis of phantom images. Philips evaluated the visibility of various features of the American College of Radiology (ACR) accreditation phantom
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and the CDMAM contrast-detail mammography phantom. Scoring of the ACR phantom and analysis of the CDMAM phantom images were used to assess the MammoDiagnost DR image quality. CDMAM image acquisition and analysis were performed following EUREF guidelines (Bosmans H et al., 2009) and the published scientific literature (Young KC et al., 2008). The table below presents the results for normal and high dose using a 4 mm thickness ACR MAP phantom. Both phantom tests demonstrate the excellent detection capabilities of the MammoDiagnost DR System.
510(k)
| Softcopy | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| Mode | Fibers | Artifacts | Score | Speck | |||||
| Groups | Artifacts | Score | Masses | Artifacts | Score | ||||
| Normal | |||||||||
| Dose | 5.5 | 0 | 5.5 | 4.0 | 0 | 4.0 | 4.0 | 0 | 4.0 |
| High | |||||||||
| Dose | 6.0 | 0 | 6.0 | 4.0 | 0 | 4.0 | 4.0 | 0 | 4.0 |
| Hardcopy | |||||||||
| Mode | Fibers | Artifacts | Score | Speck | |||||
| Groups | Artifacts | Score | Masses | Artifacts | Score | ||||
| Normal | |||||||||
| Dose | 5.5 | 0 | 5.5 | 4.0 | 0 | 4.0 | 4.0 | 0 | 4.0 |
| High | |||||||||
| Dose | 6.0 | 0 | 6.0 | 4.0 | 0 | 4.0 | 4.0 | 0 | 4.0 |
Automatic Exposure Control (AEC)
Automatic exposure control (AEC) is a technology that is widely used in standard x-rav imaging and digital imaging systems. The objective of an AEC system is to optimize image quality while minimizing patient dose in an effort to produce consistent radiology images. The performance of the AEC was evaluated by acquiring data sets of varying breast equivalent thicknesses in both normal and high dose modes. An Aluminum target of 0.2 mm was used for the CNR measurement. CNR in both normal and high dose contact modes changed by less than 10% per centimeter of PMMA thickness.
Patient Radiation Dose
Breast equivalent phantom blocks were used to simulate fibroglandular/adipose tissue composition. Phantom thicknesses of 2 cm, 4 cm, and 6 cm were tested. For each phantom the system AEC was used to select x-ray exposure parameters. Results for the 50/50 fibroglandular/adipose tissue composition in contact mode are given in the table below.
| Thickness
(cm) | mAs | kV | Target | Filter | Entrance
exposure
(mR) | Mean
Glandular
Dose (mGy) |
|-------------------|-------|----|--------|--------|------------------------------|---------------------------------|
| 2 | 35.2 | 25 | W | Rh | 98.1 | 0.44 |
| 4 | 86.7 | 26 | W | Rh | 289.9 | 0.87 |
| 6 | 194.3 | 28 | W | Rh | 854.0 | 1.91 |
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/
.
Summary of Clinical Image Evaluation:
In accordance to the Class II Special Controls Guidance Document: Full-Field Digital Mammography System, an image attribute review was completed on 6 mammographic image cases that were acquired from the Philips FFDM system, MammoDiagnost DR. The purpose of the image attribute review was to determine if images from the Philips FFDM device had acceptable quality for mammographic screening and diagnostic usage and were substantially equivalent to a predicate device as determined by a MQSA review of the investigational FFDM images.
Six screening and diagnostic mammography cases consisting of 4 standard views (RCC. RMLO, LCC, LMLO) including magnification or spot views from the diagnostic cases were reviewed by two expert Radiologist's meeting the radiologists' qualifications specified in the Class II Special Controls Guidance Document: Full-Field Digital Mammography System. The mammography cases were acquired from non-pregnant women over the age of 40. Women with breast implants were not included in the study.
The image sets for this evaluation were reviewed in the same manner as clinical images submitted by a mammography facility for MQSA accreditation. The reviewers evaluated the mammographic attributes for each case, scored the attributes with a 1 (worse)-5 (best) score and determined an overall pass/fail for each case. The two expert breast imaging subspecialist radiologists agreed that the six image sets from the Philips MammoDiagnost DR system are of sufficiently acceptable quality for clinical mammographic usage.
Substantial Equivalence Discussion:
The Philips MammoDiagnost DR Full Field Digital Mammography System is considered substantially equivalent to Siemens Mammomat Novation and Inspiration Full Field Digital Mammography Systems. The MammoDiagnost DR has the same intended use and indications for use as the predicate devices. In addition there is no significant difference in technology. Like the predicate Inspiration System, the MammoDiagnost has an X-ray system with 0.3 / 0.15 Focal Spots and Tungsten/Molybdenum anodes, Rhodium//Molybdenum filters, Both systems use a solid state amorphous selenium detector with a matrix size of 3584 x 2816. The image quality performance characterized by DQE and MTF are very similar.
Conclusion:
Philips believes that the Philips MammoDiagnost DR Full Field Digital Mammography System is substantially equivalent to the currently legally marketed devices. It has the same intended use, does not introduce new indications for use, has the same technological characteristics and does not introduce new potential hazards or safety risks.
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Image /page/8/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles three abstract human figures or forms, stacked on top of each other. The figures are depicted with flowing, curved lines, giving the impression of movement or fluidity.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Ms. Linda Jalbert Director, Quality and Regulatory Philips Medical Systems 3000 Minuteman Road ANDOVER MA 01845
Re: K110572
Trade/Device Name: Philips MammoDiagnostic DR Regulation Number: 21 CFR 892.1715 Regulation Name: Full-field mammography system Regulatory Class: II Product Code: MUE Dated: August 15, 2011 Received: August 16, 2011
SEP 2 3 2011
Dear Ms. Jalbert:
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
9
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) 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 hitp://www.fda.gov/Medicall.Devices/Safety/ReportalProblem/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 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
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Indications for Use
510(k) number (if known):
Device Name:
Philips MammoDiagnost DR
Indications For Use:
The Philips MammoDiagnost DR is indicated for generating mammographic images that can be used for screening and diagnosis of breast cancer. The MammoDiagnost DR is intended to be used in the same clinical applications as traditional film/screen systems.
Prescription Use AND/OR Over-The-Counter Use X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
uly D. O'h
(Division Sign-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
510K K110572
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