(21 days)
Not Found
No
The description explicitly states that the analysis is based on "standard statistical methods" and does not mention AI or ML.
No
The device is described as a "stand-alone experiment presentation and post-processing workstation" that analyzes data from an MRI scanner to assist in diagnosis when interpreted by a trained physician. It does not exert any direct therapeutic effect on the patient. Its function is to process and visualize data, which falls under diagnostic support.
Yes
The device is described as assisting in diagnosis and providing information that may assist in diagnosis when interpreted by a trained physician. It also processes BOLD data from MRI studies for visualization and analysis related to brain activity, which are characteristics of a diagnostic device.
Yes
The device is described as a "stand-alone experiment presentation and post-processing workstation" that supports the "visualization and analysis of MRI studies." It processes data acquired from a separate Magnetic Resonance Scanner. The description focuses on software functionalities like data processing, visualization, and analysis, without mentioning any proprietary hardware components included with the device itself. While it interacts with an MRI scanner (hardware), the device described in the summary appears to be solely the software/workstation for processing that data.
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.
- Device Function: Eloquence analyzes data acquired from a Magnetic Resonance Scanner, which is an imaging modality that does not involve testing samples taken from the body. It processes and visualizes imaging data of the body (specifically the human brain).
- Intended Use: The intended use is to analyze data acquired using BOLD contrast techniques from an MRI scanner to support the diagnostic process when interpreted by a trained physician. This is consistent with medical image analysis software, not IVD.
Therefore, Eloquence falls under the category of medical image processing and analysis software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The device. provides dedicated visualization and analysis of MRI studies based on Blood Oxygen Level Dependent (BOLD) contrast which are useful for quantifying and visualizing small susceptibility changes in the human brain, created by the execution of specific tasks. These susceptibility images can presentation of information to support the diagnostic process. These images, when interpreted by a trained physician, vield information that may assist in diagnosis. Eloquence may also be used as a patient entertainment system, via its ability to deliver high quality audio and video to the patient.
To be used in conjunction with a Magnetic Resonance Scanner to analyze data acquired using Blood Oxygen Level Dependent (BOLD) contrast techniques, such analysis that can be interpreted by a trained physician.
Product codes
LNH
Device Description
Eloquence is a stand-alone experiment presentation and post-processing workstation. The Eloquence package supports the visualization and analysis of MRI studies based on Blood Oxygen Level Dependent (BOLD) contrast. The image contrast differs between scans as a result of the variation of blood oxygenation through task performance by the subject (e.g., finger tapping). BOLD data can be processed with Eloquence to provide analysis based on standard statistical methods.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
human brain
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
IFIS-SA, Integrated Functional Imaging System K003505, IFIS-SA, Integrated Functional Imaging System - K003899
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
OCT 11 2002
510(K) Application. New Device, K003505 Model IFIS-SA Integrated Functional Imaging System,
Page- 28a 9/26/2002
Section M - Special 510(k) Summary
Special 510(K) Summary
This summary of this Special 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
- MRI Devices Corporation Company Name: 1515 Paramount Drive Waukesha, WI 53186
- Registration Number: 2184005
- William Jace Dinehart Contact Person: jace.dinehart@mridevices.com
- Telephone Number: 352.336.0010 X 154
- Prepared: September 26, 2002
- Eloquence, Integrated Functional Imaging System Device Name:
- Classification Name: Medical Specialty: Radiology,
- Class I (LNH) Classification:
- Functional Imaging System for Magnetic Resonance Imaging Common Name: System
- Predicate Devices: IFIS-SA, Integrated Functional Imaging System
- Device Description: Eloquence is a stand-alone experiment presentation and post-processing workstation. The Eloquence package supports the visualization and analysis of MRI studies based on Blood Oxygen Level Dependent (BOLD) contrast. The image contrast differs between scans as a result of the variation of blood oxygenation through task performance by the subject (e.g., finger tapping). BOLD data can be processed with Eloquence to provide analysis based on standard statistical methods.
- Eloquence, described in this submission, Intended Use: The device. provides dedicated visualization and analysis of MRI studies based on Blood Oxygen Level Dependent (BOLD) contrast which are useful for quantifying and visualizing small susceptibility changes in the human brain, created by the execution of specific tasks. These susceptibility images can
1
Page- 28b 9/26/2002
presentation of information to support the diagnostic process. These images, when interpreted by a trained physician, vield information that may assist in diagnosis.
Eloquence may also be used as a patient entertainment system, via its ability to deliver high quality audio and video to the patient.
Safety Information:
No new safety hazards are introduced by the use of Eloquence.
William J. Dinkelaker
Dihehart Manager, Functional Imaging Business September 26, 2002
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Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN" written around the top half of the circle. Inside the circle is a stylized image of an eagle with three curved lines representing its wings. The eagle is facing left and appears to be in flight.
OCT 1 1 2002
Food and Drug Administration, 9200 Corporate Boulevard Rockville MD 20850
Mr. William J. Dinehart Manager MRI Devices Corporation 1515 Paramount Drive WAUKESHA WI 53186
Re: K023130
Trade/Device Name: Eloquence, Integrated Functional Imaging System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II
Product Code: 90 LNH Dated: September 26, 2002 Received: October 1, 2002
Dear Mr. Dinehart:
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 adultcration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
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), please contact the Office of Compliance at one of the following numbers, based on the regulation . number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Nancy C. Snogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Special 510(K) Application, Device Modification Model Eloquence, Integrated Functional Imaging System, Page- 4 -09/18/02
Section C – Statement of Indications for Use:
This statement of Indications for use of this device is unchanged from that of the predicate device IFIS-SA, Integrated Functional Imaging System - K003899
MRI Devices Corporation Applicant: KO23130 510(k) number (if known):_ Eloquence, Integrated Functional Imaging System Device Name:
Indications for use:
:
To be used in conjunction with a Magnetic Resonance Scanner to analyze data acquired using Blood Oxygen Level Dependent (BOLD) contrast techniques, such analysis that can be interpreted by a trained physician.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ XX (Per 21 CFR 801.109)
or
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
David A. Bergman