(90 days)
Philips Integris, Siemens
Not Found
No
The description focuses on standard image processing techniques like subtraction, landmarking, and pixel shifting, which are not inherently AI/ML. While "AutoWarp" is mentioned as a means of adapting regions, the description does not provide enough detail to suggest it uses AI/ML algorithms rather than traditional image registration methods. There is no mention of AI, ML, training data, or performance metrics typically associated with AI/ML devices.
No.
The device is described as a software package for off-line image processing and manipulation of diagnostic images (DSA) to aid in diagnosis, not to directly treat or mitigate a disease or condition.
Yes
The device supports postprocessing of Digital Subtraction Angiography (DSA) images "done to perform diagnosis" and allows for "optimizing images" to make "vascular anatomy/pathology" visible. This indicates its role in aiding the diagnostic process.
Yes
The device description focuses entirely on software functionalities for image processing and manipulation of existing digital datasets. There is no mention of any hardware components being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
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 Vascular Analysis Package is described as a software package for off-line image processing and manipulation of digitally acquired datasets from Integris systems. These datasets are images obtained from Digital Subtraction Angiography (DSA), which is an imaging technique performed on the patient's body.
- No Specimen Handling: The device does not involve the collection, preparation, or examination of any specimens taken from the human body. It operates on images of the human body.
- Image Processing, Not Specimen Analysis: The core function is image processing (subtraction, landmarking, pixel shift, AutoWarp) to enhance the visualization of vascular structures within the acquired images. This is distinct from analyzing biological or chemical components of a specimen.
In summary, the Vascular Analysis Package is a medical device used for post-processing medical images acquired from a patient, not for analyzing specimens taken from a patient. Therefore, it falls outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Vascular Analysis package allows for off-line image processing and manipulation of digitally acquired datasets from Integris systems The use of the Vascular Analysis package is comparable with that on the Integris operator console (the algorithms used with the Easyvision are identical to those already used on the Intetgris systems, although the user interface is different).
With the Vascular Analysis package the user can optimize images and perceived image quality for vascular application specific purposes.
Product codes (comma separated list FDA assigned to the subject device)
90 LZZ
Device Description
The vascular analysis package supports the postprocessing on Digital Subtraction Angiography (DSA) images done to perform diagnosis. In a vascular study series of images are acquired either with or without contrast media. These contrast media can be iodine or CO2, and they make the vasculature visible in the image. The features in the vascular package allow for optimizing these images in the following way. Subtraction is a common used technique in DSA . Two images representing the same part of the anatomy (one with contrast media and one without contrast media) are subtracted from each other. The resulting image is an image that displays the vascular anatomy/pathology only, due to the fact that all equal anatomical structures in the two images are subtracted from each other. Thereby leaving only visible the vascular structures filled with contrast media. Run subtraction is identical to subtraction but now the subtraction process is applied to two series of images wherein image 1 of series 1 correlates w.r.t anatomy/position to image 1 in series 2.
Landmarking will allow to bring back some of the anatomical structure back into the image as to relate vascular pathology to anatomical position. Sometimes there can be a mismatch between two images that are subtracted from each other due to patient movement. To correct for this movement pixel shift is applied to the image pair, where the mask image (image without the contrast) is shifted in horizontal and/or vertical axis compared to the contrast image. This will enhance the visibility of the vascular structure only.
This can either be done:
- Manually, the user shifts in a Region Of Interest (ROI) to have an optimal result. The . shift result in the ROI will be applied to the whole image.
- Split Screen, to allow different shifts in one subtracted pair. The image is either divided . by a horizontal or vertical line into two areas. In each of those two areas different values of shift can be applied.
- . AutoWarp, a means of enhancing a pair of subtracted images by adapting regions in the mask image to regions in the contrast image.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Digital Subtraction Angiography (DSA)
Anatomical Site
vascular anatomy/pathology
Indicated Patient Age Range
Not Found
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)
Not Found
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.
Philips Integris, Siemens
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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/0 description: The image shows the Philips logo. The logo consists of a shield shape with the word "PHILIPS" at the top. Inside the shield, there is a circular design with two stars and two wavy lines.
Image /page/0/Picture/1 description: The image shows the word "PHILIPS" in a bold, sans-serif font. The text is black and appears to have a slightly distressed or textured effect, as if it were printed with a worn-out stamp. The background is plain white, providing a stark contrast to the dark lettering.
Philips Medical Systems
ﻨﻤﺴﻴﺴﺎ
")
510 (k) Summary of Safety and Effectiveness
K 97 38-5
JAN - 6 1998
| Company Name: | Philips Medical Systems North America Company |
|---|---|
| Address: | 710 Bridgeport Avenue |
| Shelton, CT 06484 | |
| Contact Person | Peter Altman |
| Telephone Number: | 203-926-7031 |
| Prepared (date): | July 11, 1997 |
| Device Name: | Philips Easy Vision Family Workstation Option |
| Vascular Analysis | |
| Classification Name: | Image Processing System |
| (90 LLZ) | |
| Common/Usual Name: | Workstation |
| Predicate Devices: | Philips Integris, |
| Siemens |
1
919(K) Summary
Intended Use:
The Vascular Analysis package allows for off-line image processing and manipulation of digitally acquired datasets from Integris systems The use of the Vascular Analysis package is comparable with that on the Integris operator console (the algorithms used with the Easyvision are identical to those already used on the Intetgris systems, although the user interface is different).
With the Vascular Analysis package the user can optimize images and perceived image quality for vascular application specific purposes.
System Description.
The vascular analysis package supports the postprocessing on Digital Subtraction Angiography (DSA) images done to perform diagnosis. In a vascular study series of images are acquired either with or without contrast media. These contrast media can be iodine or CO2, and they make the vasculature visible in the image. The features in the vascular package allow for optimizing these images in the following way. Subtraction is a common used technique in DSA . Two images representing the same part of the anatomy (one with contrast media and one without contrast media) are subtracted from each other. The resulting image is an image that displays the vascular anatomy/pathology only, due to the fact that all equal anatomical structures in the two images are subtracted from each other. Thereby leaving only visible the vascular structures filled with contrast media. Run subtraction is identical to subtraction but now the subtraction process is applied to two series of images wherein image 1 of series 1 correlates w.r.t anatomy/position to image 1 in series 2.
Landmarking will allow to bring back some of the anatomical structure back into the image as to relate vascular pathology to anatomical position. Sometimes there can be a mismatch between two images that are subtracted from each other due to patient movement. To correct for this movement pixel shift is applied to the image pair, where the mask image (image without the contrast) is shifted in horizontal and/or vertical axis compared to the contrast image. This will enhance the visibility of the vascular structure only.
This can either be done:
- Manually, the user shifts in a Region Of Interest (ROI) to have an optimal result. The . shift result in the ROI will be applied to the whole image.
- Split Screen, to allow different shifts in one subtracted pair. The image is either divided . by a horizontal or vertical line into two areas. In each of those two areas different values of shift can be applied.
- . AutoWarp, a means of enhancing a pair of subtracted images by adapting regions in the mask image to regions in the contrast image.
2
Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three wavy lines representing its feathers.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 6 1998
Peter Altman Director of Regulatory Affairs Philips Medical Systems, Inc. North America Company 710 Bridgeport Avenue Shelton, CT 06484-0917
Re:
K973835 Easyvision Workstation, Vascular Analysis Package Addition Dated: October 7, 1997 Received: October 8, 1997 Regulatory class: Unclassified Procode: 90 LZZ
Dear Mr. Altman:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html": '
Sincerely yours,
hT Tiau Yi
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Unknown K973835 510(k) Number (if known):
Philips Easy Vision Workstation Vascular Analysis Option Device Name :
Indications For Use :
The Vascular Analysis Package is intended for off-line image processing and manipulation of digitally acquired datasets from Integris systems. The use of the Vascular Analysis package is comparable with that on the Integris operator console (the algorithms used with the Easyvision are identical to those already used on the Integris systems, although the user interface is different).
With the Vascular Analysis package the user can optimize images and perceived image quality for vascular application specific purposes.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Elnil G. begnon
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices
OR
510(k) Number K973833
Prescription Use
( Per 21 CFR 801.109
Over-The-Counter Use
(Optional Format 1-2-96)