(90 days)
Unknown
The description mentions "computer assisted detection of the heart boundaries of the left ventricle," which could potentially utilize AI/ML, but the summary does not explicitly state the use of these technologies.
No
The device processes MR images to provide quantitative and qualitative data for estimating cardiac function; it does not directly treat or alleviate a medical condition.
Yes
The device processes MR images of the heart to provide quantitative and qualitative data such as ejection fraction, stroke volume, and ventricular mass, which are used to estimate cardiac or cardiovascular function. This estimation of function based on imaging data is a diagnostic activity.
Yes
The device is described as a "Package" providing "off-line viewing and processing functions" for MR images on an "Easyvision Workstation". While it interacts with hardware (the workstation and MR scanner), the core functionality described is software-based image processing and analysis, with no mention of included hardware components.
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. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The MR Cardiac Analysis Package processes medical images (MR images of the heart) to provide quantitative and qualitative data about cardiac function. It does not analyze biological samples taken from the patient.
- Intended Use: The intended use clearly states it's for "processing cardiac or cardiovascular MR images."
- Device Description: The description details image processing functions, such as outlining heart boundaries and calculating parameters from images.
Therefore, because the device operates on medical images rather than biological samples, it falls outside the scope of an In Vitro Diagnostic device. It is a medical image analysis software.
N/A
Intended Use / Indications for Use
The MR Cardiac Analysis Package is intended for use in processing cardiac or cardiovascular MR images, resulting in quantitative and/or qualitative data that can be used to estimate cardiac or cardiovascular function.
The MR Cardiac Analysis Package is indicated for use in association with cardiac and cardiovascular examinations where it is useful or necessary to perform qualitative or quantitative analysis.
Product codes
90 LLZ
Device Description
The MR Cardiac Analysis Package provides off-line viewing and processing functions for cardiac and cardio-vascular examinations, acquired with Magnetic Resonance, to simplify the process.
Historically the user had to outline the end-systolic and end-diastolic ventricle areas in one or all slices. To reduce the time required for the analysis, the MR Cardiac Analysis Package provides a facility for computer assisted detection of the heart boundaries of the left ventricle. The user may edit the computer generated boundary and must always approve the selection. The right ventricle boundary must still be detected manually.
To use the MR Cardiac Analysis Package, MR images of the heart are acquired with dedicated MR sequences at multiple slices and different phases of the heart cycle and transferred to the Easyvision Workstation. Processing these images provides data that can be used to estimate various quantitative parameters, e.g., ejection fraction, stroke volume, diastolic and systolic volume, ventricular mass, and wall thickness. It can also provide a display of cardiac functional parameters and permits correction for errors caused by papillary muscle. . All quantitative results can be printed in a dedicated, user definable, print lavout for cardiac analysis, where analysis data (statistical and graphical) can be reported in combination with the image data.
The package will also provide viewing capabilities such as direct access to images, defined by slice location or heart phase, and synchronized movies for the different heart phases and/or slices.
Mentions image processing
The MR Cardiac Analysis Package is intended for use in processing cardiac or cardiovascular MR images, resulting in quantitative and/or qualitative data that can be used to estimate cardiac or cardiovascular function.
The MR Cardiac Analysis Package provides off-line viewing and processing functions for cardiac and cardio-vascular examinations, acquired with Magnetic Resonance, to simplify the process.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR images
Anatomical Site
cardiac or cardiovascular
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)
Philips Gyroview HR (K921219), GE Advantage Windows Review Workstation (K960613, K942120, and K913770)
Reference Device(s)
Philips Gyroscan Rel 2 MR Systems (K920578 and K920791)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 is a black and white logo for Philips. The logo is a shield shape with the word "PHILIPS" at the top. Inside the shield is a circle with two wavy lines and two four-pointed stars. The wavy lines are above and below the stars.
PHILIPS
K972103
SEP - 2 1997
510(k) Summary of Safety and Effectiveness
Philips Medical Systems North America Company Company Name: 710 Bridgeport Avenue Address: Shelton, CT 06484 Peter Altman Contact Person: 203-926-7031 Telephone Number: June 24, 1997 Prepared: Philips Easyvision Family Workstation Option Device Name: MR Cardiac Analysis Package Image Processing System Classification Name: (90 LLZ) Workstation Common/Usual Name: Philips Gyroview HR (K921219) Predicate Devices: GE Advantage Windows Review Workstation (K960613, K942120, and K913770). Philips Gyroscan Rel 2 MR Systems (K920578 and K920791)
Intended Use:
The MR Cardiac Analysis Package is intended for use in processing cardiac or cardiovascular MR images, resulting in quantitative and/or qualitative data that can be used to estimate cardiac or cardiovascular function.
Philips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, Connecticut 06484 Tel: (203) 926-767 Fax: (203) 929-609
1
System Description:
Quantitative analysis of MR Cardio exams is normally a tedious and time consuming procedure. The MR Cardiac Analysis Package provides off-line viewing and processing functions for cardiac and cardio-vascular examinations, acquired with Magnetic Resonance, to simplify the process.
Historically the user had to outline the end-systolic and end-diastolic ventricle areas in one or all slices. To reduce the time required for the analysis, the MR Cardiac Analysis Package provides a facility for computer assisted detection of the heart boundaries of the left ventricle. The user may edit the computer generated boundary and must always approve the selection. The right ventricle boundary must still be detected manually.
To use the MR Cardiac Analysis Package, MR images of the heart are acquired with dedicated MR sequences at multiple slices and different phases of the heart cycle and transferred to the Easyvision Workstation. Processing these images provides data that can be used to estimate various quantitative parameters, e.g., ejection fraction, stroke volume, diastolic and systolic volume, ventricular mass, and wall thickness. It can also provide a display of cardiac functional parameters and permits correction for errors caused by papillary muscle. . All quantitative results can be printed in a dedicated, user definable, print lavout for cardiac analysis, where analysis data (statistical and graphical) can be reported in combination with the image data.
The package will also provide viewing capabilities such as direct access to images, defined by slice location or heart phase, and synchronized movies for the different heart phases and/or slices.
2
Image /page/2/Picture/0 description: The image shows a logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The words "DEPARTMENT O. HEALTH &" are arranged vertically along the left side of the logo.
Food and Drug Administration. 9200 Corporate Boulevard Rockville MD 20850
Peter Altman Director of Regulatory Affairs Philips Medical Systems North America Company 710 Bridgeport Avenue P.O. Box 860 Shelton, CT 06484-0917
Re: K972103
EasyVision Family Workstation Option: MR Cardiac Analysis Software Package Dated: June 2, 1997 Received: June 4, 1997 Unclassified Procode: 90 LLZ
SEP - 2 1997
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 II (Special Controls) or 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 (QS) 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 marked 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 vitto diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation of the regulation of the regulation of the dr "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
h)liau Yin
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
3
Unknown- K972/03 510(k) Number (if known): __ Device Name : Philips Easy Vision Workstation MR Cardiac Analysis Option Indications For Use :
The MR Cardiac Analysis Package is indicated for use in association with cardiac and cardiovascular examinations where it is useful or necessary to perform qualitative or quantitative analysis.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Bergren
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Devices 510(k) Number
Prescription Use
( Per 21 CFR 801.109
OR
Over-The-Counter Use
(Optional Format 1-2-96)