(199 days)
Not Found
No
The description focuses on "iterative reconstruction techniques" and does not mention AI, ML, or related terms. The performance studies are based on phantom testing and physician evaluation of clinical images, not on training or testing AI/ML models.
No
The device is described as an image reconstruction feature for CT scanner data, intended to produce diagnostic images. It is used for diagnosis of clinical conditions, not for treatment or therapy.
No
The device is not a diagnostic device itself. It is a feature/software for CT scanners that processes CT scanner data to produce diagnostic images, meaning the images it helps create are used for diagnosis, but the software itself does not perform the diagnosis.
No
The device is described as a "feature" and "Software Application" that "will reside on any Philips CT System that meets minimum software platform and hardware requirements." This indicates it is software that runs on existing CT hardware, but it is not a standalone software device. It is an integral part of the CT system's functionality.
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.
- Device Function: The described device is a software feature for a CT scanner. It processes imaging data acquired from a patient's body using X-rays. It does not analyze biological samples.
- Intended Use: The intended use is to improve the quality of diagnostic images produced by a CT scanner, which are used by medical professionals for diagnosis. This is a function related to medical imaging, not in vitro testing.
Therefore, this device falls under the category of a medical imaging device component or software, not an IVD.
N/A
Intended Use / Indications for Use
The IMR reconstruction feature is intended as an alternative to standard reconstruction methods (filtered back projection) for the reconstruction of CT scanner data to produce diagnostic images. The IMR reconstruction feature is designed to reduce image noise, increase high-contrast spatial resolution, and improve low contrast detectability. IMR is designed to reduce dose required for diagnostic CT imaging. Image quality improvements and dose reduction depend on the clinical task, patient size, anatomical location, and clinical practice. IMR images will be used by a trained medical professional for diagnosis of clinical conditions in patients, including pediatrics and adults, who have been prescribed a CT scan as part of their clinical care.
Product codes (comma separated list FDA assigned to the subject device)
90 JAK
Device Description
The IMR reconstruction feature is intended as an alternative to standard reconstruction methods (filtered back projection) for the reconstruction of CT scanner data to produce diagnostic images. The IMR reconstruction feature is designed to reduce image noise, increase high-contrast spatial resolution, and improve low contrast detectability. IMR is designed to reduce dose required for diagnostic CT imaging. Image quality improvements and dose reduction depend on the clinical task, patient size, anatomical location, and clinical practice. The IMR Software Application will reside on any Philips CT System that meets minimum software platform and hardware requirements. IMR enables the user to apply iterative reconstruction techniques to reconstruct raw CT data to generate diagnostic CT images. The use of IMR to reconstruct images may be done prospectively or retrospectively.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanner data
Anatomical Site
Not Found
Indicated Patient Age Range
pediatrics and adults
Intended User / Care Setting
trained medical professional
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
Non-clinical Testing:
Objective image quality testing was conducted using phantoms and following the methodology in IEC 61223-3-5, Evaluation and routine testing in medical departments - Parts 3-5: Acceptance test - Imaging performance of computed tomography x-ray equipment for determining noise, CT number uniformity and high contrast spatial resolution. The CT scan data was reconstructed both with filtered backprojection and the IMR software application for comparison.
Additionally, a Four Alternative Force Choice (4-AFC) Detection human observer study was conducted with a four Low Contrast pin phantom for evaluating low contrast detectability (LCD). In this study, a cohort of human subjects was required to identify a low contrast pin in a panel of four images. In order to characterize the statistical nature of the detection of a low contrast object in an image with noise, the test was repeated multiple times for each test subject, and multiple test subjects were used.
Clinical Image Evaluation:
A total of 110 clinical image raw data sets were reconstructed with filtered backprojection and then with the IMR software application to compare image quality. The FBP and IMR images were evaluated image quality by a panel of eight physicians.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical Testing:
Objective image quality testing and 4-AFC Detection human observer study using phantoms. The resulting data confirmed the improved LCD using the IMR application.
Key results: IMR may simultaneously enable 60% - 80% lower radiation dose; and 43% - 80% low-contrast detectability improvement; and 70% - 83% less image noise, relative to filtered backprojection, as demonstrated through phantom-based tests. Low-contrast detectability was assessed using a reference abdomen protocol, based on a 4-AFC phantom test. IMR may alternatively enable 1.2x - 1.7x high-contrast spatial-resolution improvement; or 2.5x - 3.6x low-contrast detectability improvement; or up to 90% image noise reduction, relative to filtered backprojection, as demonstrated through phantom-based tests. Lower image noise assessed using a Reference Chest Protocol; Improved high-contrast spatial resolution using Reference Abdomen and Thorax Protocols: Improved low-contrast detectability using a Reference Abdomen Protocol. All metrics tested on phantoms.
Clinical Image Evaluation:
Study type: Image quality evaluation by a panel of eight physicians.
Sample size: 110 clinical image raw data sets.
Key results: The IMR software application provides diagnostic quality images and in majority of the cases, the physicians preferred the IMR images to standard (filter back projection) reconstruction.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Dose Reduction: 60%-80% lower dose
- Low-contrast detectability improvement: 43%-80%
- Image noise reduction: 70%-83% less image noise, or up to 90% image noise reduction
- High-contrast spatial resolution improvement: 1.2x-1.7x
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.
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
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
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Image /page/0/Picture/0 description: The image shows the word "PHILIPS" in large, bold, black letters. The font is a sans-serif typeface, and the letters are slightly distressed, giving them a textured appearance. The word is centered and takes up most of the frame.
510(k) Summarv
Philips IMR Software Application
The summary of this 510(k) provides safety and effectiveness information submitted in accordance with the requirements of 21 CFR 807.92.
-
- Submitter:
Philips Medical Systems (Cleveland), Inc. 595 Miner Road Cleveland, OH 44143
- Submitter:
Contact:
Christine Anderson Regulatory Affairs Specialist Tel.: (440) 483-7732 Fax: (440) 483-4918
Date of Summary: November 16, 2012
-
- Device Name and Classification
Philips IMR Software Application
- Device Name and Classification
Device Classification:
Device Name:
Computed Tomography X-Ray System. The FDA has classified the Computed Tomography X-Ray System and its accessories as Class II in 21 CFR 892.1750 (Product Code: 90 JAK)
3. Predicate Device Information
The Philips IMR Software Application is comparable in type and substantial equivalence to the legally marketed devices currently in commercial distribution, namely:
a. Philips IRT Software Application - K113483
- b. Philips Brilliance Volume CT System K060937
4. Device Description
The IMR reconstruction feature is intended as an alternative to standard reconstruction methods (filtered back projection) for the reconstruction of CT scanner data to produce diagnostic images. The IMR reconstruction feature is designed to reduce image noise, increase high-contrast spatial resolution, and improve low contrast detectability. IMR is designed to reduce dose required for diagnostic CT imaging. Image quality improvements and dose reduction depend on the clinical task, patient size, anatomical location, and clinical practice. The
JUN 7 2013
1
IMR Software Application will reside on any Philips CT System that meets minimum software platform and hardware requirements. IMR enables the user to apply iterative reconstruction techniques to reconstruct raw CT data to generate diagnostic CT images. The use of IMR to reconstruct images may be done prospectively or retrospectively.
-
- Indications for Use
The IMR reconstruction feature is intended as an alternative to standard reconstruction methods (filtered backprojection) for the reconstruction of CT scanner data to produce diagnostic images. The IMR reconstruction feature is designed to reduce image noise, increase high-contrast spatial resolution, and improve low contrast detectability. IMR is designed to reduce dose required for diagnostic CT imaging. Image quality improvements and dose reduction depend on the clinical task, patient size, anatomical location, and clinical practice. IMR images will be used by a trained medical professional for diagnosis of clinical conditions in patients, including pediatrics and adults, who have been prescribed a CT scan as part of their clinical care.
- Indications for Use
-
- Comparison to Predicate
In the opinion of Philips, the IMR Software Application is of a comparable type and substantially equivalent to the Philips Brilliance Volume CT System and the IRT Software Application, the legally marketed devices described in section 3 above. IRT reconstructs images from raw data based on iterative processing using the raw and image data. IMR is identical to IRT except for additional use cases and additional claims for image quality, as measured on a phantom, and dose reduction claims, as evaluated via a human observer study. Therefore, IMR expands on the capabilities of IRT.
- Comparison to Predicate
Predicate 510(k) Number Brilliance Volume K060937 Philips IRT Software K113483 Application
Cleared June 5, 2006 September 26, 2012
-
- Safetv
The Philips IMR software application is manufactured in accordance with the Quality System Requlation (QSR) 21 CFR 820 and to International Standards ISO 13485:2003. Potential hazards are identified in a hazard analysis and controlled in the following manner:
- Safetv
Software: Safety is assured by the company procedures that conform to accepted practices, including the FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
Instructions for Use are provided with the software application for the safe and effective operation of the application by the user.
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8. Performance Testing Summary
Non-clinical Testing
Obiective image quality testing was conducted using phantoms and following the methodology in IEC 61223-3-5, Evaluation and routine testing in medical departments - Parts 3-5: Acceptance test - Imaging performance of computed tomography x-ray equipment for determining noise, CT number uniformity and high contrast spatial resolution. The CT scan data was reconstructed both with filtered backproiection and the IMR software application for comparison. Additionally, a Four Alternative Force Choice (4-AFC) Detection human observer study was conducted with a four Low Contrast pin phantom for evaluating low contrast detectability (LCD). In this study, a cohort of human subjects was required to identify a low contrast pin in a panel of four images. In order to characterize the statistical nature of the detection of a low contrast object in an image with noise, the test was repeated multiple times for each test subject, and multiple test subjects were used. The resulting data confirmed the improved LCD using the IMR application.
IMR may simultaneously enable 60% - 80% lower radiation dose; and 43% -80% low-contrast detectability improvement; and 70% - 83% less image noise, relative to filtered backprojection, as demonstrated through phantom-based tests. Low-contrast detectability was assessed using a reference abdomen protocol, based on a 4-AFC phantom test.
IMR may alternatively enable 1.2x - 1.7x high-contrast spatial-resolution improvement; or 2.5x - 3.6x low-contrast detectability improvement; or up to.90% image noise reduction, relative to filtered backprojection, as demonstrated through phantom-based tests. Lower image noise assessed using a Reference Chest Protocol; Improved high-contrast spatial resolution using Reference Abdomen and Thorax Protocols: Improved low-contrast detectability using a Reference Abdomen Protocol. All metrics tested on phantoms.
Clinical Image Evaluation
A total of 110 clinical image raw data sets were reconstructed with filtered backprojection and then with the IMR software application to compare image quality. The FBP and IMR images were evaluated image quality by a panel of eight physicians. Resulting data confirmed that the IMR software application provides diagnostic quality images and in majority of the cases, the physicians preferred the IMR images to standard (filter back projection) reconstruction.
Conclusion
IMR may simultaneously enable:
- · 60% 80% lower radiation dose; and
- · 43% 80% low-contrast detectability improvement; and
- · 70% 83% less image noise.
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relative to filtered backprojection, as demonstrated through phantom-based tests (1).
IMR may alternatively enable:
- · 1.2x 1.7x high-contrast spatial-resolution improvement(1): or
- · 2.5x 3.6x low-contrast detectability improvement 13; or
- · Up to 90% image noise reduction(4),
relative to filtered backprojection, as demonstrated through phantom-based tests.
Note : In clinical practice, the use of IMR may reduce CT patient dose depending on the clinical task, patient size, anatomical location, and clinical practice. A consultation with a radiologist and a physicist should be made to determine the appropriate dose to obtain diagnostic image quality for the particular clinical task.
| IMR Image Quality
| Parameter | Results | Test Conditions |
|---|---|---|
| Dose Reduction: | ||
| 60%-80% lower | ||
| dose with | ||
| simultaneous | ||
| improved image | ||
| quality [1] | 60% lower radiation | |
| dose with a 43 % | ||
| improvement in low | ||
| contrast detectability | ||
| and 83% less image | ||
| noise | Lower (60%) limit as specified by: | |
| IMR settings: | ||
| • Reference Protocol1: Abdomen | ||
| • CTDIvol: 4 mGy | ||
| • Slice thickness: 0.8/0.4mm | ||
| • Clinical indication: Sharp | ||
| • Level: L3 | ||
| As compared to: | ||
| FBP settings | ||
| • Reference Protocol: Abdomen | ||
| • CTDIvol: 10mGy, | ||
| • Slice thickness: 0.8/0.4 mm, | ||
| • Standard filter: C | ||
| As tested on the MITA CT IQ | ||
| Phantom manufactured by Phantom | ||
| Laboratories, model CCTI83 and low | ||
| contrast detectability testing using | ||
| human observers. |
The table below represents the test conditions used to achieve the above performance parameters
4 Reference protocols refer to the standard factory reference protocols provided on the CT scanner
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Image /page/4/Picture/0 description: The image contains the word "PHILIPS" in all capital letters. The text is in a bold, sans-serif font. The letters are black and the background is white.
.
.
| 80% lower radiation
dose with a 80%
improvement in low
contrast detectability
and 70% less image
noise. | Upper limit (80%) as specified by
IMR settings:
• Reference protocol: Abdomen
• CTDIvol: 2mGy
• Slice thickness: 0.8/0.4mm
• Clinical indication: Smooth
• Level: L3
As compared to:
FBP settings
• Reference Protocol: Abdomen
• CTDIvol: 10mGy
• Slice thickness: 0.8/0.4 mm,
• Standard filter: B |
|------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | As tested on the MITA CT IQ
Phantom manufactured by Phantom
Laboratories, model CCT183 and low
contrast detectability testing using
human observers. |
:
and the same of the same
5
PHILIPS
/
Philips Medical Systems (Cleveland) Inc.
| High-contrast
spatial resolution
improvement [2] | 1.2x – 1.7x high-
contrast spatial-
resolution improvement | High-contrast spatial resolution (x-y)
and image noise.
Lower limit as specified by:
IMR settings Reference Protocol: Abdomen CTDIvol: 4mGy Slice thickness: 1.0/0.5 mm Clinical Indication: Sharp Level: L3. As compared to:
FBP Settings Reference Protocol: Abdomen CTDIvol: 4mGy Slice thickness: 1.0/0.5 mm, Standard filter: B Upper limit as specified by:
IMR settings Reference Protocol: Thorax/High
Res Helical Protocol CTDIvol: 20mGy Slice thickness: 1.0/0.5 mm Matrix: 512 matrix Clinical Indication: Sharp Level: L3 As compared to:
FBP Settings Reference Protocol: Abdomen CTDIvol: 20mGy Slice thickness: 1.0/0.5 mm, Standard filter: B Tested on the CatPhan 600 |
|--------------------------------------------------------|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Low-contrast
detectability
improvement [3] | 2.5x – 3.6x low-contrast
detectability
improvement | Lower limit as specified by:
IMR Settings:
• Reference Protocol: Abdomen
• CTDIvol: 10 mGy
• Slice thickness: 0.8/0.4 mm,
• Clinical Indication: Sharp
• Level: L3
As compared to:
FBP Settings
• Reference Protocol: Abdomen
• CTDIvol: 10mGy
• Slice thickness: 0.8/0.4 mm,
• Standard filter: C
Upper limit as specified by:
IMR Settings:
• Reference Protocol: Abdomen
• CTDIvol: 4 mGy
• Slice thickness: 0.8/0.4 mm,
• Clinical Indication: Smooth
• Level: L3
As compared to:
FBP Settings
• Reference Protocol: Abdomen
• CTDIvol: 4mGy
• Slice thickness: 0.8/0.4 mm,
Standard filter: B
As tested on the MITA CT IQ
Phantom manufactured by Phantom
Laboratories, model CCT183 and low
contrast detectability testing using
human observers |
| Noise reduction [4] | 90% image noise
reduction | IMR Settings:
• Reference Protocol: Chest
• CTDIvol: 20 mGy
• Slice thickness: 0.8/0.4 mm,
• Clinical Indication: Smooth
• Level: L3
As compared to:
FBP Settings:
• Reference Protocol: Chest
• CTDIvol: 20mGy
• Slice thickness: 0.67/0.34 mm,
• Standard filter: B
Tested on the CatPhan 600 with
cylindrical body ring |
:
:
:
6
PHILIPS
Philips Medical Systems (Cleveland) Inc.
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Image /page/7/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. To the right of the word, there is some handwritten text that reads "K123576 Page 8 of 8". The text is written in a cursive style.
Based on the above considerations, it is Philips' opinion that the results of the verification and validation testing and the results of the risk analysis demonstrates safety and effectiveness of the Philips IMR Software Application and that it is substantially equivalent to the predicate devices documented above.
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Image /page/8/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring. MD 20993-0002
June 7, 2013
Philips Medical System (Cleveland) Inc. % Ms. Christine Anderson Regulatory Affairs Specialist 595 Miner Road CLEVELAND OH 44143
Re: K123576
Trade/Device Name: IMR Software Application Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: Class II Product Code: JAK Dated: May 31, 2013 Received: June 04, 2013
Dear Ms. Anderson:
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. 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 vour 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 device-related adverse events) (21 CFR.803); good manufacturing practice requirements as set
9
Page 2 - Ms. Anderson
forth in the quality systems (OS) 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely vours.
Michael D. O'Hara
for
Janine M. Morris Director, Division of Radiological Health Office of in vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
10
Indications for Use
510(k) Number (if known):
Device Name:
IMR Software Application
Indications for Use:
The IMR reconstruction feature is intended as an alternative to standard reconstruction methods (filtered back projection) for the reconstruction of CT scanner data to produce diagnostic images. The IMR reconstruction feature is designed to reduce image noise, increase high-contrast spatial resolution, and improve low contrast detectability. IMR is designed to reduce dose required for diagnostic CT imaging, Image quality improvements and dose reduction depend on the clinical task, patient size, anatomical location, and clinical practice. IMR images will be used by a trained medical professional for diagnosis of clinical conditions in patients, including pediatrics and adults, who have been prescribed a CT scan as part of their clinical care
Prescription Use V (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE-DO-NOT-WRIFE-BELOW-THIS-LINE-EON-ANOTHER-PAGE-IF-NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Michael D. O'Hara
(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
K123576 510(k)
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