(72 days)
Not Found
No
The summary describes scripted data acquisition, post-processing, and visualization of MRI data. There is no mention of AI, ML, or any techniques that would typically fall under those categories. The processing described appears to be standard image processing and analysis techniques.
No.
The device is described as software used for acquiring, processing, and visualizing medical imaging data to assist in diagnosis and treatment planning, not to directly treat a medical condition.
Yes
The "Intended Use / Indications for Use" section states: "The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of central nervous system pathology and the planning and monitoring of medical treatments." This explicitly indicates its role in diagnosis.
Yes
The device description and intended use clearly state that the device is comprised of "software" (Prism Acquire®, Prism Process®, Prism View®, Prism Flow®) and is used "in conjunction with a Magnetic Resonance scanner". While it interacts with hardware (the MRI scanner), the device itself is described solely as software applications for data acquisition, processing, visualization, and communication. There is no mention of any proprietary hardware components being part of the device submission.
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 examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Prism software suite works in conjunction with an MRI scanner to acquire, process, and visualize imaging data from within the patient's body. It does not analyze specimens taken from the body.
- Intended Use: The intended use is to assist in the diagnosis of central nervous system pathology and the planning and monitoring of medical treatments based on in-vivo imaging data.
Therefore, the device falls under the category of medical imaging software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Prism Acquire® / Prism Process software is used in conjunction with a Magnetic Resonance scanner to acquire and process blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) and other MRI data sets. Prism View® software provides visualization of anatomical with functional and physiologic imaging data sets.
Prism Acquire presents a scripted series of synchronized visual and/or auditory stimuli and/or cognitive/motor tasks to the patient being scanned. The patient's responses and image data from the MRI scanner are stored for use by Prism Process, which performs post-processing for quality control and subsequent viewing of fMRI and other data. These applications can also be used to assist in scripted data acquisition and post-processing of other anatomical, functional and physiologic MR imagery including magnetic resonance spectroscopy (MRS), MR perfusion, and MR diffusion.
Prism View provides both analysis and viewing capabilities that promote the integration of anatomical with physiologic and functional imaging data sets including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), MR perfusion, and MR diffusion including diffusion tensor imaging (DTI).
The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of central nervous system pathology and the planning and monitoring of medical treatments.
Product codes
LNH, LLZ
Device Description
Prism Acquire provides a scripted approach to performing fMRI and other imaging studies. Prism Process performs post-processing and quality assurance of fMRI and other imaging data sets. The processed data is prepared for report generation utilizing the Prism View product, supporting the visualization and manipulation of clinical imagery of multiple kinds. It provides a flexible set of display, analysis, and export options for utilizing the imagery relationships. These applications may communicate in the healthcare IT environment via Prism Flow®, server-based software facilitating DICOM communications, authorization/authentication, audit logging, and other infrastructure functions.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR-fMRI, MRS, MR perfusion, MR diffusion including DTI), CT, PET
Anatomical Site
central nervous system
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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)
Software verification and validation was conducted to confirm proper function of the device’s features.
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.
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SEP 2 1 2012
Special 510(k) Summary б
- Prism Acquire®, Prism Process®, Prism View® K
1. Contact Information
Submitter Contact Person Prism Clinical Imaging, Inc. James L. Reuss, Ph.D. (CTO) 890 Elm Grove Rd. Ste. 215 Phone 262-754-3840 Elm Grove, WI 53122 Fax 262-754-3839
Date Summary Prepared: June 21, 2012
2. Device Name and Classification
| Trade Name | Classification Name | Class | Product Code |
|---|---|---|---|
| Prism Acquire | 892.1000, "Radiology, Magnetic | ||
| Resonance Diagnostic Device" | II | LNH | |
| Prism Process | 892.1000, "Radiology, Magnetic | ||
| Resonance Diagnostic Device" | II | LNH | |
| Prism View | 892.2050, "Picture archiving and | ||
| communications systems" | II | LLZ |
3. Identification of Legally Marketed Modified Predicate Device
| Predicate System | Manufacturer | Reg. Data |
|---|---|---|
| Prism Acquire®, | ||
| Prism Process®, | ||
| Prism View® | Prism Clinical Imaging, Inc. | |
| 890 Elm Grove Rd. Ste. 215 | ||
| Elm Grove, WI 53122 | ||
| (f/k/a Kyron Clinical Imaging) | K082964 | |
| SE 2/20/2009 | ||
| Product code LNH, LLZ | ||
| Class II |
4. Description of Device
Prism Acquire provides a scripted approach to performing fMRI and other imaging studies. Prism Process performs post-processing and quality assurance of fMRI and other imaging data sets. The processed data is prepared for report generation utilizing the Prism View product, supporting the visualization and manipulation of clinical imagery of multiple kinds. It provides a flexible set of display, analysis, and export options for utilizing the imagery relationships.
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These applications may communicate in the healthcare IT environment via Prism Flow®, server-based software facilitating DICOM communications, authorization/authentication, audit logging, and other infrastructure functions.
5. Statement of Intended Use
Prism Acquire® / Prism Process® software is used in conjunction with a Magnetic Resonance scanner to acquire and process blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) and other MRI data sets. Prism View® software provides visualization of anatomical with functional and physiologic imaging data sets.
Prism Acquire presents a scripted series of synchronized visual and/or auditory stimuli and/or cognitive/motor tasks to the patient being scanned. The patient's responses and image data from the MRI scanner are stored for use by Prism Process, which performs post-processing for quality control and subsequent viewing of fMRI and other data. These applications can also be used to assist in scripted data acquisition and post-processing of other anatomical, functional and physiologic MR imagery including magnetic resonance spectroscopy (MRS), MR perfusion, and MR diffusion.
Prism View provides both analysis and viewing capabilities that promote the integration of anatomical with physiologic and functional imaging data sets including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), MR perfusion, and MR diffusion including diffusion tensor imaging (DTI).
The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of central nervous system pathology and the planning and monitoring of medical treatments.
6. Predicate Device Comparison of Technological Characteristics
The intended uses and technological characteristics of Prism Acquire. Process and View are the same as the respective predicate devices. Incremental revisions to the software have been made, including the following:
-
- Expanded selection of fMRI paradigms, including additional natural languages;
-
- Improved tools for report workflow, including report creation and addition of image data to existing reports;
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-
- Expanded registration of MR, CT, and PET image combinations, including handling of scanner obliquity;
-
- Enhancement of DTI visualization to include additional parameter maps and diffusion tensor tractography (DTT);
-
- Addition of volume rendering and track markups to 3D visualization options:
-
- Support for MR Arterial-Spin Labeled (ASL) perfusion images in the MR perfusion visualization;
-
- Expanded selection of image markup tools.
None of these features represent fundamentally new scientific technology.
7. Performance Study
FDA has not established special controls or performance standards for this device. Software verification and validation was conducted to confirm proper function of the device's features.
8. Safety information
No new safety hazards are introduced by the use of the device in comparison to the software of the predicate devices.
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Image /page/3/Picture/0 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The seal is simple and monochromatic.
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. 21 2012
James L. Reuss, PhD Chief Technology Officer Prism Clinical Imaging, Inc. 890 Elm Grove Road. Suite 215 ELM GROVE WI 23122
Re: K122026
Trade/Device Name: Prism Acquire®, Prism Process®, Prism View® Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH and LLZ Dated: August 23, 2012 Received: August 29, 2012
Dear Dr. Reuss:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or uny 1 outlar statutes and including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as bet form in the your device as described in your Section 510(k) premarket while anow Jour to began mading of your device 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 Parts 801 and 11 you deen contact the Office 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.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 I va may of amall Manufacturers, International and 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
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5 Indications For Use
510(k) Number (if known): K
Device Name:
Prism Acquire®, Prism Process®, Prism View®
INDICATIONS FOR USE:
Prism Acquire® / Prism Process software is used in conjunction with a Magnetic Resonance scanner to acquire and process blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) and other MRI data sets. Prism View software provides visualization of anatomical with functional and physiologic imaging data sets.
Prism Acquire presents a scripted series of synchronized visual and/or auditory stimuli and/or cognitive/motor tasks to the patient being scanned. The patient's responses and image data from the MRJ scanner are stored for use by Prism Process, which performs post-processing for quality control and subsequent viewing of fMRI and other data. These applications can also be used to assist in scripted data acquisition and post-processing of other anatomical, functional and physiologic MR imagery including magnetic resonance spectroscopy (MRS), MR perfusion, and MR diffusion.
Prism View provides both analysis and viewing capabilities that promote the integration of anatomical with physiologic and functional imaging data sets including blood oxygen level dependent (BOLD) fMRI, magnetic resonance spectroscopy (MRS), MR perfusion, and MR diffusion tensor imaging (DT),
The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of central nervous system pathology and the planning and monitoring of medical treatments.
Prescription Use X (Per 21 CFR 801 Subpart D) OR
Over-the-Counter Use (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prism Clinical Imaging, Inc.
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