(176 days)
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.
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.
The provided document is a 510(k) premarket notification for "Image Post-Processing Techniques" (ProPak and Apparent Diffusion Coefficient Mapping). This type of submission focuses on demonstrating substantial equivalence to legally marketed predicate devices, rather than establishing specific acceptance criteria and proving performance through a standalone clinical study with detailed metrics typically found in efficacy studies.
Therefore, the document does not contain the detailed information requested regarding specific acceptance criteria, a standalone study proving performance against those criteria, sample sizes for test/training sets, ground truth establishment, or multi-reader multi-case (MRMC) comparative effectiveness studies.
Instead, the submission relies on demonstrating that the new device has "similar technological characteristics and intended use" to existing predicate devices. The "Safety and Effectiveness" section explicitly states: "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."
Here's a breakdown of what can be extracted and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly defined or reported in the document. The implicit "acceptance criterion" for a 510(k) is substantial equivalence to predicate devices, meaning the new device is as safe and effective as existing legally marketed devices.
- Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, precision) are reported for the new device. The document describes the features and intended uses of the device and compares them to predicate devices, inferring similar performance.
| Parameter | Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (as described in comparison to predicates) |
|---|---|---|
| Compatibility | Must be compatible with existing MR systems/workstations like predicates. | "Same" as predicate (available on Independent Workstations or MR System Operator's Console). |
| Inputs | Must process MR images, single/multi-slice datasets (ProPak), and diffusion-weighted images (ADC Mapping). | "Same" as predicate (MR images, single/multi-slice datasets with equally spaced time intervals (ProPak), Diffusion-weighted images (ADC Mapping)). |
| Features | Must provide post-processing features comparable to predicates (e.g., semi-automated, color parametric images, pixel-by-pixel analysis, time intensity information). | "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." These are similar to predicate features (automated, color parametric images, overlay, pixel-by-pixel, time intensity info). |
| Filming and Archiving | Must allow filming, storage, and archiving similar to predicates. | "Same" as predicate (images can be filmed, stored, or archived). |
| Anatomy of Interest | Must apply to similar anatomical regions as predicates. | "Same" as predicate (Brain and Body Imaging). |
| Processing Algorithms | Must include algorithms comparable to predicates (e.g., Area Mapping, Time to Peak Mapping, ADC Mapping). | "Area Mapping," "Time to Peak Mapping," "ADC Mapping." These are algorithms identified for the device. Predicates have different but related algorithms like "Negative Enhancement Integral" and "Mean Time to Enhance." |
| Indications for Use (ProPak) | Must provide supplemental information regarding contrast changes over time for images from MR temporal datasets, with unchanged MR system indications. | "Provides 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." (Matches predicate's general description). |
| Indications for Use (ADC Mapping) | Must image diffusive mobility, visualize loss of mobility in acute stroke, and produce parametric images with further contrast manipulation. | "Designed to image the diffusive mobility of water or other proton-containing molecules... visualize the apparent loss of mobility of water molecules in brain tissue affected by acute stroke... produces parametric images with further contrast manipulation." (Adds the parametric image aspect to the predicate's description). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided. The document does not describe a specific "test set" or clinical study for the new device itself to establish performance metrics against acceptance criteria. The basis for safety and effectiveness is substantial equivalence to predicate devices, which implies that the predicate devices had already demonstrated effective performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not Applicable / Not Provided. As no specific "test set" with ground truth establishment for this device is described, there's no mention of experts for ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable / Not Provided. No test set or ground truth adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No, not done/described. This document does not describe an MRMC study or any study involving human readers' performance with or without the AI (post-processing) assistance. The device is a post-processing tool and its equivalence is based on its technical specifications.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not explicitly described as a standalone performance study. While the device itself is an algorithm (post-processing technique), the document doesn't detail a study specifically to measure its standalone performance (e.g., accuracy of mapping values against a gold standard). Its "performance" is implicitly assumed to be equivalent to the predicate devices based on its similar design and intended use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not Applicable / Not Provided. No ground truth is described for this device, as its premarket notification relies on substantial equivalence.
8. The sample size for the training set
- Not Applicable / Not Provided. This document does not refer to a "training set" as it's not describing a machine learning model's development in detail, but rather a software feature set that processes existing images.
9. How the ground truth for the training set was established
- Not Applicable / Not Provided. As no training set is mentioned, no ground truth establishment for it is described.
In summary, the provided K980831 document is a request for regulatory clearance based on substantial equivalence. It focuses on comparing the new device's technical characteristics and intended use to already cleared predicate devices. It does not contain the detailed clinical study information (like defined acceptance criteria, sample sizes, ground truth, or MRMC studies) that would be expected for a device proving novel efficacy or performance through a dedicated study.
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AUG 27 1998
K 980831
SUMMARY OF SAFETY AND EFFECTIVENESS (As required by 21 CFR 807.92)
General Information 1.
| Classification: | Class IIMagnetic Resonance (MR) Diagnostic Device |
|---|---|
| Common/Usual Name: | Magnetic Resonance (MR) Device Option |
| Proprietary Name: | Image Post-Processing Techniques |
| Establishment Registration: | Picker International, Inc.World Headquarters595 Miner RoadHighland Heights, Ohio 44143FDA Owner Number: #1580240FDA Registration Number: #1525965 |
| Performance Standards: | No applicable performance standards have beenissued under section 514 of the Food, Drug andCosmetic 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-ProcessingTechniques | Predicate DevicesGE FuncTool Option (K960265),Philips Quantitative Anal. (K971965),Diffusion Imaging (K974530), |
|---|---|---|
| Compatibility | Same. | Available on Independent Workstationsor the MR System Operator's Console(See K960265) |
| Inputs | • MR images• Single or multi-slice datasetswith equally spaced timeintervals (ProPak)• Diffusion-weighted images(ADC Mapping) | • CT and MR images• Single or multi-slice datasets withequally spaced time intervals(See K960265) |
| Features | • Semi-automated• Color parametric images(optional)• Analysis on a pixel-by-pixelbasis or region of interest• Time intensity information inplot or tabular form | • Automated• Color parametric images• Overlay of parametric images on toanatomical reference images• Analysis on a pixel-by-pixel basis orregion of interest• Time intensity information in plot ortabular form(See K960265 and K971965) |
SUBSTANTIAL EQUIVALENCE CHART
PICKER INTERNATIONAL, INC.
(POSTPRO)
3/3/98
{2}------------------------------------------------
| Parameter | Image Post-ProcessingTechniques | Predicate DevicesGE FuncTool Option (K960265),Philips Quantitative Anal. (K971965),Diffusion Imaging (K974530), |
|---|---|---|
| Filming and Archiving | Same. | Images can be filmed, stored in imagedatabase or archived with rest of patientexam. (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 TechniquesThe ProPak Package for PickerMR systems or workstationsprovide supplementalinformation regarding contrastchanges over time for thoseimages extracted from MRtemporal datasets. Theindications for use for the MRsystem remain unchanged. | FuncTools (K960265)The FuncTool option to the AdvantagesWindows workstation is a softwaremodule that provides supplementalinformation to those images extractedfrom CT and MR temporal datasets.Quantitative Analysis (K971965)The CT/MR Quantitative AnalysisPackage is intended for use wherevisualization and analysis of CT and MRdynamic studies, showing changes incontrast over time, are useful ornecessary. |
ﺰ
/
, ジ
(POSTPRO)
{3}------------------------------------------------
| Parameter | Image Post-ProcessingTechniques | Predicate DevicesGE FuncTool Option (K960265),Philips Quantitative Anal. (K971965),Diffusion Imaging (K974530), |
|---|---|---|
| Indications for Use(cont.) | ADC MappingSame as Diffusion Imaging withthe addition of the followingsentence: Post-processing usingADC mapping producesparametric images with furthercontrast manipulation. | Diffusion Imaging (K974530)The Picker Diffusion-Weighted MRImaging Package has been designed toimage the diffusive mobility of water orother proton-containing molecules. Oneimportant clinical application is tovisualize the apparent loss of mobility ofwater molecules in brain tissue affectedby acute stroke. Areas of decreaseddiffusion, as is observed in acutecerebral infarcts, appear as areas ofhigher image intensity. Diffusionweighted MR pulse sequences are moreaccurate than conventional MRI pulsesequences in identifying the occurrenceof acute stroke during the first 24 hoursafter onset of symptoms. |
PICKER INTERNATIONAL, INC.
)
(POSTPRO)
3/3/98
I - 4
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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
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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)
§ 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.