(40 days)
The BrainAcquireRx™ / BrainProcessRx™ Data Suite is software 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.
The BrainAcquireRx software application 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 the BrainProcessRx application, which performs post-processing for quality control and subsequent viewing of fMRI and other MRI data. These applications can also be used to assist in scripted data acquisition and post-processing of anatomical, functional, and physiologic MR imagery including magnetic resonance spectroscopy (MRS) and MR diffusion. The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of brain pathology and the planning and monitoring of medical treatments.
The software provides support for functional MRI (fMRI) data acquisition and post-processing, as well as other anatomical, functional and physiologic MRI studies. BrainAcquireRx provides a scripted approach to performing fMRI and other functional, anatomical and physiologic MRI studies. BrainProcessRx performs post-processing of fMRI and other data sets. The processed data is ready for report generation utilizing the Kyron BrainViewRx™ Viewer.
The provided text states that "Software verification and validation was conducted to confirm proper function of the device's features," but it does not specify acceptance criteria, present performance metrics, or detail the study design elements typically found in a comprehensive performance study. Therefore, most of the requested information cannot be extracted from the given text.
Here is a summary of what can and cannot be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
Not available in the provided text. The document states "Software verification and validation was conducted to confirm proper function of the device's features," but it does not specify what those "proper functions" entail as measurable acceptance criteria, nor does it report any specific performance metrics.
2. Sample Size for the Test Set and Data Provenance
Not available in the provided text. No information is given about the size or origin of any test set used in the software verification and validation.
3. Number of Experts and their Qualifications for Ground Truth Establishment (Test Set)
Not available in the provided text. No mention of experts or their qualifications for establishing ground truth is made.
4. Adjudication Method (Test Set)
Not available in the provided text. There is no information regarding any adjudication methods.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not available in the provided text. The document makes no mention of an MRMC study or any comparison of human readers with and without AI assistance.
6. Standalone (Algorithm Only) Performance Study
The text indicates that "Software verification and validation was conducted to confirm proper function of the device's features." While this implies a standalone assessment of the algorithm's functionality, no specific quantitative or qualitative results from such a study are provided. The "performance study" section simply states that it was conducted but offers no details of its findings.
7. Type of Ground Truth Used
Not available in the provided text. The document does not specify the type of ground truth used for any validation or verification activities.
8. Sample Size for the Training Set
Not available in the provided text. The document does not mention a training set or its size.
9. How Ground Truth for the Training Set Was Established
Not available in the provided text. The document does not mention a training set or how its ground truth was established.
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Kob/255
Image /page/0/Picture/1 description: The image shows the logo for Kyron Clinical Imaging. The logo is black and features the word "kyron" in a stylized font, with a star above the "k". Below "kyron" are the words "CLINICAL IMAGING" in a smaller font. The logo has a curved line underneath the word "kyron".
5 510(k) Summary
JUN 1 3 2006 - BrainAcquireRx™ / BrainProcessRx™ Data Suite K
Contact Information 1.
- Contact Person Submitter James L. Reuss, Ph.D. (CTO) Kyron Clinical Imaging, Inc. 2457 N. Mayfair Rd., Suite 202 Phone 414-727-1930 414-727-1939 Wauwatosa, WI 53226 Fax
Date Summary Prepared: May 1st, 2006
2. Device Name and Classification
The proprietary name of the device to be introduced into interstate commerce is the BrainAcquireRx™ / BrainProcessRx™ Data Suite. It is image reconstruction and processing software running on a personal computer, classified under product code 90 LNH (regulation # 892.1000), "Radiology, Magnetic Resonance Diagnostic Device" as a class II medical device.
Identification of Legally Marketed Equivalent Predicate Devices 3.
| Predicate System | Manufacturer | Reg. Data |
|---|---|---|
| Eloquence IntegratedFunctional ImagingSystem | MRI Devices Corp.1515 Paramount Dr.Waukesha, WI 53186 | K023130SE 10/11/2002Product code LNHClass II |
| MindState™ FunctionalData Acquisition Device(fDAD™) | Neurognostics, Inc.10437 Innovation Dr., Suite 309Milwaukee, WI 53226 | K043290SE 1/28/2005Product code LNHClass II |
| Syngo® MultimodalityWorkstation | Siemens Medical Systems186 Wood Ave. SouthIselin, NJ 08830 | K010938SE 6/26/2001Product code LLZClass II |
| Diffusion tensor imagingoption for MRI | GE Medical SystemsP.O. Box 414, W-709Milwaukee, WI 53201 | K003573SE 1/23/2001Product code LNHClass II |
Description of Device 4.
The software provides support for functional MRI (fMRI) data acquisition and post-processing, as well as other anatomical, functional and physiologic MRI
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Image /page/1/Picture/1 description: The image shows the logo for Kyron Clinical Imaging. The logo is black and white and features the word "kyron" in a stylized font. The "k" is much larger than the other letters and has a curved line extending from the bottom of it. Below "kyron" are the words "CLINICAL IMAGING" in a smaller font.
studies. BrainAcquireRx provides a scripted approach to performing fMRI and other functional, anatomical and physiologic MRI studies. BrainProcessRx performs post-processing of fMRI and other data sets. The processed data is ready for report generation utilizing the Kyron BrainViewRx™ Viewer.
Statement of Intended Use 5.
"The BrainAcquireRx™ / BrainProcessRx™ Data Suite is software 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.
The BrainAcquireRx software application 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 the BrainProcessRx application, which performs post-processing for quality control and subsequent viewing of fMRI and other MRI data. These applications can also be used to assist in scripted data acquisition and post-processing of anatomical, functional, and physiologic MR imagery including magnetic resonance spectroscopy (MRS) and MR diffusion. The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of brain pathology and the planning and monitoring of medical treatments."
6. Predicate Device Comparison of Technological Characteristics
The BrainAcquireRx application contains fMRI stimulus, acquisition and postprocessing capabilities that are substantially equivalent to the software provided with the MRI Devices Eloquence and the Neurognostics MindState workstations. BrainProcessRx also performs post-processing of other MRI data sets substantially equivalent to the MRI data post-processed by the Siemens syngo software and GE DTI option.
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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Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
JUN 1 3 2006
James L. Reuss, Ph.D. Chief Technology Officer Kyron Clinical Imaging, Inc. 2457 N. Mayfair Rd., Suite 202 WAUWATOSA WI 53226
Re: K061255
Trade/Device Name: BrainAcquireRxTM / BrainProcessRxTM Data Suite Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: May 1, 2006 Received: May 4, 2006
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 either class II (Special Controls) or 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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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.
This letter will allow you to begin marketing your device as described in your Section 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:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150
or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely vours.
Nancy C. Hogdon
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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Indications For Use 4
510(k) Number (if known): K U
BrainAcquireRx™ / BrainProcessRx™ Data Suite Device Name:
INDICATIONS FOR USE:
The BrainAcquireRx™ / BrainProcessRx™ Data Suite is software used in conjunction The DramAcequirettx - 7 Drain 100000 and process blood oxygen level dependent (BOLD) functional magnetic resonance imaging (fMRI) and other MRI data sets.
The BrainAcquireRx software application 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 the I he patient's responses and image sportions post-processing for quality control and Drami rocesses upping 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 in scripted data acquisition and post nagnetic resonance spectroscopy (MRS) and MR diffusion. The integration of these data, when interpreted by a trained physician, yields information that may assist in the diagnosis of brain pathology and the planning and monitoring of medical treatments.
Over-the-Counter Use OR X Prescription Use (Per 21 CFR 801 Subpart C) (Per 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE - - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lappin
Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
Kyron™ Clinical Imaging, Inc.
Confidential
4-1
§ 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.