(308 days)
Not Found
No
The description focuses on "iterative reconstruction," a traditional image processing technique, and does not mention AI, ML, or related terms. The testing described is also consistent with evaluating traditional image processing methods.
No
The device processes CT scan data to produce images for diagnosis, it does not directly treat or prevent a disease or condition.
Yes
The "Intended Use / Indications for Use" states that the resulting images are "to aid the physician in diagnosis."
Yes
The device is explicitly described as a "Software Application" and "software option" that processes raw data from a separate hardware device (a Philips CT Scanner) to produce images. The description focuses solely on the software's function and does not mention any accompanying hardware components or hardware-specific testing beyond its interaction with the CT scanner's raw data.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device function: The Philips IRT Software Application processes raw data from a CT scanner to produce images. It does not analyze biological samples from a patient.
- Intended Use: The intended use is to aid physicians in diagnosis by improving image quality, not by analyzing biological samples.
- Input: The input is raw data from a CT scanner, not a biological sample.
Therefore, the Philips IRT Software Application falls under the category of medical imaging software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The Philips IRT Software Application is intended to iteratively reconstruct raw data from a Philips CT Scanner to produce images containing noise levels less than or equal to images produced by standard Filtered Back Projection reconstruction. Resulting IRT images are to be used to supplement conventional Filtered Back Projection images to aid the physician in diagnosis; they are not to be used as the sole basis for diagnosis.
Product codes
90 JAK
Device Description
The Philips IRT Software Application is a software option used for the reduction of noise in an image. IRT iteratively reconstructs raw data from a Philips CT Scanner to produce images containing noise levels less than or equal to images produced by standard Filtered Back Projection (FBP) reconstruction. This feature will be used by radiologists as a supplementary method to reconstruct CT raw data, in addition to traditional FBP.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography X-Ray System
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists
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
Non-clinical testing was conducted with the IRT Software Application in the following manner: 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. Raw CT scan data using phantoms were reconstructed both with filtered backprojection and the IRT software application for comparison. Additionally, low contrast detectability (LCD) was evaluated via an observer study. In this study, a cohort of human subjects was required to identify a low contrast test object 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 IRT application. Clinical image raw data sets were reconstructed with filtered backprojection and then with the IRT software application to compare noise reduction. Resulting data confirmed that the IRT application provides equivalent or better noise reduction. In summary, the verification test evidence indicates that, under the conditions evaluated. IRT affords a reduction in noise and an improvement in LCD, with no degradation in high contrast spatial resolution, CT number accuracy, or CT number uniformity. Therefore, the IRT application provides equivalent or better noise reduction as compared to the filtered backprojection used in the Brilliance Volume CT.
Key Metrics
low contrast detectability (LCD) was evaluated via an observer study.
noise reduction.
high contrast spatial resolution, CT number accuracy, or CT number uniformity.
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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. Above the word "PHILIPS" is the number "K113483" written in a handwritten style. The number is smaller in size compared to the word "PHILIPS". The background of the image is white.
SEP 2 6 2012
Philips Medical Systems (Cleveland) Inc.
510(k) Summary
Philips Iterative Reconstruction Technique (IRT) Software Application
The summary of this 510(k) provides safety and effectiveness information submitted in accordance with the requirements of 21 CFR 807.92.
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- 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 21, 2011
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- Device Name and Classification
Philips IRT Software Application Device Name:
- Device Name and Classification
Computed Tomography X-Ray System. The FDA Device Classification: has classified the Computed Tomography X-Ray System and its accessories as Class II in 21 CFR 892.1750 (Product Code: 90 JAK)
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- Predicate Device Information
The Philips IRT Software Application is comparable in type and substantial equivalence to the legally marketed devices currently in commercial distribution, namely:
- Predicate Device Information
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a. Philips Brilliance Volume CT System K060937
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- Device Description
The Philips IRT Software Application is a software option used for the reduction
² Iterative Reconstruction Technique (IRT) is the current working descriptive name for the reconstruction process. During development the term iMR, a preliminary engineering name, was also used. Documentation in this 510(k) may use either the term Iterative Reconstruction Technique (IRT) or iMR. Both terms refer to the same process.
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Image /page/1/Picture/0 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The letters are black and appear to be slightly textured. The word is centered and takes up most of the frame.
Philips Medical Systems (Cleveland) Inc.
of noise in an image. IRT iteratively reconstructs raw data from a Philips CT Scanner to produce images containing noise levels less than or equal to images produced by standard Filtered Back Projection (FBP) reconstruction. This feature will be used by radiologists as a supplementary method to reconstruct CT raw data, in addition to traditional FBP.
-
- Indications for Use
The Philips IRT Software Application is intended to iteratively reconstruct raw data from a Philips CT Scanner to produce images containing noise levels less than or equal to images produced by standard Filtered Back Projection reconstruction. Resulting IRT images are to be used to supplement conventional Filtered Back Projection images to aid the physician in diagnosis; they are not to be used as the sole basis for diagnosis.
- Indications for Use
-
- Comparison to Predicate
In the opinion of Philips IRT Software Application is of a comparable type and substantially equivalent to the Philips Brilliance Volume CT System, the legally marketed device described in paragraph 3 above. IRT uses similar operating principles for the reconstruction of raw data from a CT scanner into viewable images. Most of the image reconstruction steps are identical to the FBP reconstruction except that IRT contains an iterative step in the preprocessing chain that reduces the noise and during the image post processing chain where there is an additional function that reduces pixel noise in the images while keeping the structures intact.
- Comparison to Predicate
| Predicate | 510(k) Number | Cleared |
|---|---|---|
| Brilliance Volume | K060937 | June 5, 2006 |
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- Safetv
The Philips IRT 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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- Performance Testing Summary
Non-clinical testing was conducted with the IRT Software Application in the following manner:
- Performance Testing Summary
2
Image /page/2/Picture/0 description: The image shows the word "PHILIPS" in large, bold, black letters. The font is sans-serif and the letters are closely spaced. The word is centered and takes up most of the frame. The background is plain white.
Philips Medical Systems (Cleveland) Inc.
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. Raw CT scan data using phantoms were reconstructed both with filtered backprojection and the IRT software application for comparison. Additionally, low contrast detectability (LCD) was evaluated via an observer study. In this study, a cohort of human subjects was required to identify a low contrast test object 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 IRT application.
Clinical image raw data sets were reconstructed with filtered backprojection and then with the IRT software application to compare noise reduction. Resulting data confirmed that the IRT application provides equivalent or better noise reduction.
In summary, the verification test evidence indicates that, under the conditions evaluated. IRT affords a reduction in noise and an improvement in LCD, with no degradation in high contrast spatial resolution, CT number accuracy, or CT number uniformity. Therefore, the IRT application provides equivalent or better noise reduction as compared to the filtered backprojection used in the Brilliance Volume CT.
Based on the above considerations, it is Philips's opinion that the results of the verification and validation testing and the results of the risk analysis demonstrates safety and effectiveness of the Philips IRT Software Application and that it is substantially equivalent to the predicate device documented above.
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the agency's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES "
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
SEP 26 2012
Ms. Christine Anderson Regulatory Affairs Specialist Philips Medical System (Cleveland) Inc. 595 Miner Road CLEVELAND OH 44183
Re: K113483
Trade/Device Name: Philips Iterative Reconstruction Technique Software Application Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: August 22, 2012 Received: August 23, 2012
Dear Ms. Anderson:
We have reviewed your Section 510(k) premarket notification of intent to maket the devices indication we nave reviewed your Section >10(k) promained is substantially equivalent (for the indications felerenced above and nave uctchillion the are as a see concess marketed in interstate for use stated in the enclosure) to regarly manatiment date of the Medical Device American Fred. Fred Drug commerce prior to May 26, 1976, the encordance with the provisions of the Federation (AMA) devices that have been reclassified in accession of a premarket approval application (PMA). and Cosment Act (Act) that do not require apple of a 12 general controls provisions of the Act. The Act. The Act. The Act. The You may, dierelove, market mo device, cauje requirements for annual registration, listing of general controls provisions of the fiel lieve and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such a title 21 If your device is classified (Scc above) into one it (Special in the found in Title 21, and in Title 21, and in Title 21, additional controls. Existing major regulations arouning your control.
Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further Code of Peachar Four device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualled of a substainle of the requirements of the Act .
that FDA has made a determination that your device complies with other requirements of that FDA has illiade a determination and your correct by other Federal agencies. You must of any Pederal Statures and regulations and udinated to: registration and listing (21
comply with all the Act's requirements, including, but not answering (scopying of comply with all the Act 3 requirements, incrueilig, on actively of the reporting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice modical device reated adverse ovelity systems (QS) regulation (21 CFR Part 820). This letter requirements as set form in the quality device as described in your Section 510(k) premarket with anow you to begin marketing your intial equivalence of your device to a legally marketed noticate 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 CFF Parts 801 and If you desire specific advice 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 under the MDA regulation (27 Of RT art 000), posses and .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 Tou may other belief general mornlations on Jon's 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,
Janine M. Morris
Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
PHILIPS
Philips Medical Systems (Cleveland) Inc.
510(k) Number (if known): K K K13483
Page 1 of 1
Philips Iterative Reconstruction Technique Software Application Device Name:
Indications for Use:
The Philips Iterative Reconstruction Technique (IRT) Software Application is intended to reconstruct raw data from a Philips CT Scanner to produce images containing noise levels less than or equal to images produced by standard Filtered Back Projection levels less than or oqual to integration is a migration of the supplement conventional rosoner astion. I toballang mages to aid the physician in diagnosis; they are not to be used as the sole basis for diagnosis.
Prescription Use _ (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use (Part 21CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER LINE IF NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Radiological Devices
ORYD
K113483