(21 days)
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.
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, 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.
The provided text is a 510(k) summary for a medical device called "Eloquence, Integrated Functional Imaging System." This document is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.
Crucially, a 510(k) submission for substantial equivalence generally does not involve new clinical studies with acceptance criteria and performance data in the same way a Premarket Approval (PMA) application would. Instead, it focuses on demonstrating that the new device is as safe and effective as devices already on the market through comparison to a predicate device.
Therefore, many of the requested elements (acceptance criteria, specific study details, sample sizes, ground truth establishment, MRMC studies, standalone performance) are not typically present or required in this type of submission unless the device introduces new technology or indications that necessitate new performance data.
Based on the provided text, here's what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as this is a 510(k) for substantial equivalence, not a performance study against predefined criteria for a new clinical claim.
- Reported Device Performance: Not reported in terms of specific metrics like sensitivity, specificity, etc., because actual performance data from a new study is not typically required to demonstrate substantial equivalence for this type of device and submission. The device is described in terms of its function (visualization and analysis of MRI studies based on BOLD contrast).
2. Sample Size for the Test Set and Data Provenance:
- Sample Size: Not applicable/not stated. No new clinical trials with test sets are described. The focus is on the device's functionality and its substantial equivalence to a predicate device, IFIS-SA.
- Data Provenance: Not applicable/not stated.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not applicable/not stated. No test set requiring ground truth establishment by experts is described in this submission.
- Qualifications: Not applicable/not stated. The text mentions that analyzed data "can be interpreted by a trained physician," implying expertise is needed for interpretation, but this is not about establishing ground truth for a device performance study.
4. Adjudication Method:
- Adjudication Method: Not applicable/not stated.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- MRMC Study: Not mentioned. Such studies are typically for devices claiming to improve human reader performance, which doesn't appear to be the primary claim or requirement for this 510(k). The device is a "stand-alone experiment presentation and post-processing workstation" for analysis and visualization.
- Effect Size of Improvement: Not applicable/not stated.
6. Standalone Performance Study (Algorithm Only):
- Standalone Study: Not mentioned as a separate performance study. The device itself is described as a "stand-alone experiment presentation and post-processing workstation." However, this refers to its functional independence, not a standalone performance evaluation in a clinical trial context.
7. Type of Ground Truth Used:
- Ground Truth: Not applicable/not stated. No performance study requiring ground truth is described.
8. Sample Size for the Training Set:
- Sample Size: Not applicable/not stated. The document describes a post-processing workstation that applies "standard statistical methods" to BOLD data. There is no indication of a machine learning model requiring a training set in the context of this 510(k).
9. How Ground Truth for the Training Set Was Established:
- Ground Truth Establishment: Not applicable/not stated.
Summary of what the document does provide:
- Device Name: Eloquence, Integrated Functional Imaging System
- Intended Use: To provide dedicated visualization and analysis of MRI studies based on Blood Oxygen Level Dependent (BOLD) contrast, useful for quantifying and visualizing small susceptibility changes in the human brain created by task execution.
- Indications for Use: To be used in conjunction with a Magnetic Resonance Scanner to analyze data acquired using BOLD contrast techniques, such analysis that can be interpreted by a trained physician.
- Predicate Device: IFIS-SA, Integrated Functional Imaging System (K003505 and K003899).
- Safety Information: "No new safety hazards are introduced by the use of Eloquence."
- Classification: Class II, Product Code 90 LNH (Magnetic resonance diagnostic device).
In essence, this 510(k) demonstrates the device is substantially equivalent to a predicate by showing it has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. It is not an document detailing the results of a primary clinical performance study with acceptance criteria.
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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
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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.
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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
§ 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.