(176 days)
Not Found
No
The document describes image post-processing techniques for MR images, focusing on temporal analysis (ProPak) and diffusion-weighted imaging (ADC mapping). There is no mention of AI, ML, training sets, test sets, or performance metrics typically associated with AI/ML algorithms. The techniques described appear to be based on conventional image processing methods.
No
This device is for post-processing MR images to provide supplemental information or improved visualization, not for direct therapeutic intervention.
Yes
The device aids in visualizing and identifying acute stroke, which is a diagnostic function. It provides "supplemental information regarding contrast changes over time" and produces "parametric images with further contrast manipulation" to help identify areas of decreased diffusion, indicative of acute cerebral infarcts.
No
The device is described as post-processing techniques for MR images, implying it is software that operates on data generated by an MR system. However, the description refers to "Picker MR systems or workstations" and "Picker Diffusion-Weighted MR Imaging Package," suggesting it is integrated with or part of a larger hardware system (the MR scanner or workstation). The submission also mentions the indications for use for the "MR system remain unchanged," further linking the software to the hardware. A software-only medical device typically operates independently of specific hardware, receiving data from various sources.
Based on the provided text, 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 description clearly states that this device is for post-processing existing images obtained from MR systems. It manipulates and analyzes image data, not biological samples.
- Intended Use: The intended use is to provide supplemental information regarding contrast changes over time (ProPak) and to visualize and analyze the diffusive mobility of water molecules in tissues (ADC Mapping). These are image analysis functions, not diagnostic tests performed on biological specimens.
Therefore, while this device is used in a clinical setting and provides information relevant to diagnosis, it does not fit the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The intended use and indications for use for each of the types of Post-Processing Techniques described in this submission are described below.
ProPak Techniques
The ProPak Package for Picker MR systems or workstations provide supplemental information regarding contrast changes over time for those images extracted from MR temporal datasets. The indications for use for the MR system remain unchanged.
Apparent Diffusion Coefficient (ADC) Mapping
This submission adds the following sentence to the indications for use statement for Picker's Diffusion-Weighted MR Imaging Package.
Post-processing using ADC mapping produces parametric images with further contrast manipulation.
The Picker Diffusion-Weighted MR Imaging Package has been designed to image the diffusive mobility of water or other proton-containing molecules. One important clinical application is to visualize the apparent loss of mobility of water molecules in brain tissue affected by acute stroke. Areas of decreased diffusion, as is observed in acute cerebral infarcts, appear as areas of higher image intensity. Diffusion weighted MR pulse sequences are more accurate than conventional MRI pulse sequences in identifying the occurrence of acute stroke during the first 24 hours after onset of symptoms.
Product codes
LNH
Device Description
There are two basic types of post-processing techniques included in this submission. The first type is known as ProPak and is a set of techniques for processing temporally resolved image data sets and performing general perfusion analysis. The second type of technique is called ADC mapping and is for processing data from diffusion-weighted imaging sequences. All of the techniques included in this submission are for processing existing images that have already been reconstructed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
MR images
Single or multi-slice datasets with equally spaced time intervals (ProPak)
Diffusion-weighted images (ADC Mapping)
Anatomical Site
Brain and Body Imaging
brain tissue (specifically for ADC mapping related to acute stroke)
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
AUG 27 1998
K 980831
SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)
General Information 1.
| Classification: | Class II
Magnetic Resonance (MR) Diagnostic Device |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Common/Usual Name: | Magnetic Resonance (MR) Device Option |
| Proprietary Name: | Image Post-Processing Techniques |
| Establishment Registration: | Picker International, Inc.
World Headquarters
595 Miner Road
Highland Heights, Ohio 44143
FDA Owner Number: #1580240
FDA Registration Number: #1525965 |
| Performance Standards: | No applicable performance standards have been
issued under section 514 of the Food, Drug and
Cosmetic Act. |
Intended Uses 2.
)
The intended use and indications for use for each of the types of Post-Processing Techniques described in this submission are described below.
ProPak Techniques
The ProPak Package for Picker MR systems or workstations provide supplemental information regarding contrast changes over time for those images extracted from MR temporal datasets. The indications for use for the MR system remain unchanged.
Apparent Diffusion Coefficient (ADC) Mapping
This submission adds the following sentence to the indications for use statement for Picker's Diffusion-Weighted MR Imaging Package.
Post-processing using ADC mapping produces parametric images with further contrast manipulation.
1
Device Description 3.
There are two basic types of post-processing techniques included in this submission. The first type is known as ProPak and is a set of techniques for processing temporally resolved image data sets and performing general perfusion analysis. The second type of technique is called ADC mapping and is for processing data from diffusion-weighted imaging sequences. All of the techniques included in this submission are for processing existing images that have already been reconstructed.
Safety and Effectiveness 4.
The Post-Processing Techniques described in this submission are substantially equivalent in technological characteristics and intended use to the GE Functool Option, the Philips Quantitative Analysis Package and the Picker Diffusion-Weighted Imaging Package. The following table has been compiled in order to demonstrate this substantial equivalence.
| Parameter | Image Post-Processing
Techniques | Predicate Devices
GE FuncTool Option (K960265),
Philips Quantitative Anal. (K971965),
Diffusion Imaging (K974530), |
|---------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Compatibility | Same. | Available on Independent Workstations
or the MR System Operator's Console
(See K960265) |
| Inputs | • MR images
• Single or multi-slice datasets
with equally spaced time
intervals (ProPak)
• Diffusion-weighted images
(ADC Mapping) | • CT and MR images
• Single or multi-slice datasets with
equally spaced time intervals
(See K960265) |
| Features | • Semi-automated
• Color parametric images
(optional)
• Analysis on a pixel-by-pixel
basis or region of interest
• Time intensity information in
plot or tabular form | • Automated
• Color parametric images
• Overlay of parametric images on to
anatomical reference images
• Analysis on a pixel-by-pixel basis or
region of interest
• Time intensity information in plot or
tabular form
(See K960265 and K971965) |
SUBSTANTIAL EQUIVALENCE CHART
PICKER INTERNATIONAL, INC.
(POSTPRO)
3/3/98
2
| Parameter | Image Post-Processing
Techniques | Predicate Devices
GE FuncTool Option (K960265),
Philips Quantitative Anal. (K971965),
Diffusion Imaging (K974530), |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Filming and Archiving | Same. | Images can be filmed, stored in image
database or archived with rest of patient
exam. (See K960265) |
| Anatomy of Interest | Same. | Brain and Body Imaging
(See K960265) |
| Processing Algorithms | • Area Mapping
• Time to Peak Mapping
• ADC Mapping | • Negative Enhancement Integral
• Mean Time to Enhance
(See K960265) |
| Indications for Use | ProPak Techniques
The ProPak Package for Picker
MR systems or workstations
provide supplemental
information regarding contrast
changes over time for those
images extracted from MR
temporal datasets. The
indications for use for the MR
system remain unchanged. | FuncTools (K960265)
The FuncTool option to the Advantages
Windows workstation is a software
module that provides supplemental
information to those images extracted
from CT and MR temporal datasets.
Quantitative Analysis (K971965)
The CT/MR Quantitative Analysis
Package is intended for use where
visualization and analysis of CT and MR
dynamic studies, showing changes in
contrast over time, are useful or
necessary. |
ﺰ
/
, ジ
(POSTPRO)
3
| Parameter | Image Post-Processing
Techniques | Predicate Devices
GE FuncTool Option (K960265),
Philips Quantitative Anal. (K971965),
Diffusion Imaging (K974530), |
|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use
(cont.) | ADC Mapping
Same as Diffusion Imaging with
the addition of the following
sentence: Post-processing using
ADC mapping produces
parametric images with further
contrast manipulation. | Diffusion Imaging (K974530)
The Picker Diffusion-Weighted MR
Imaging Package has been designed to
image the diffusive mobility of water or
other proton-containing molecules. One
important clinical application is to
visualize the apparent loss of mobility of
water molecules in brain tissue affected
by acute stroke. Areas of decreased
diffusion, as is observed in acute
cerebral infarcts, appear as areas of
higher image intensity. Diffusion
weighted MR pulse sequences are more
accurate than conventional MRI pulse
sequences in identifying the occurrence
of acute stroke during the first 24 hours
after onset of symptoms. |
PICKER INTERNATIONAL, INC.
)
(POSTPRO)
3/3/98
I - 4
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. In the center of the circle is an abstract symbol that resembles a stylized caduceus or a series of flowing lines, possibly representing people or services.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 27 1998
Elaine K. Keeler, Ph.D. Manager, Clinical Science Picker International, Inc. 595 Miner Road Cleveland, OH 44143
K980831 Re:
Image Post-Processing Techniques (ProPak and Apparent Diffusion Coefficient Mapping) Dated: June 8, 1998 Received: June 9, 1998 Regulatory class: II 21 CFR 892.1000/Procode: 90 LNH
Dear Mr. Keeler:
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 Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 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 requirements, 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 542 of the Act for devices under the Electronic Product 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 questions on the promotion 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/cdch/dsmaldsmamain.html".
Sincerely yours,
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
5
K980831 510(k) Number (if known): _
Image Post-Processing Techniques Device Name:
Indications for Use:
The intended use and indications for use for each of the types of Post-Processing Techniques described in this submission are described below.
ProPak Techniques
The ProPak Package for Picker MR systems or workstations provide supplemental information regarding contrast changes over time for those images extracted from MR temporal datasets. The indications for use for the MR system remain unchanged.
Apparent Diffusion Coefficient Mapping
The Picker Diffusion-Weighted MR Imaging Package has been designed to image the diffusive mobility of water or other proton-containing molecules. One important clinical application is to visualize the apparent loss of mobility of water molecules in brain tissue affected by acute stroke. Areas of decreased diffusion, as is observed in acute cerebral infarcts, appear as areas of higher image intensity. Post-processing using ADC mapping produces parametric images with further contrast manipulation.
Diffusion weighted MR pulse sequences are more accurate than conventional MRI pulse sequences in identifying the occurrence of acute stroke during the first 24 hours after onset of symptoms.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K980831
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)