(87 days)
The MRI-Q System is intended to provide additional processing of images for the analysis of multi-slice gradient echo MRI data sets of cardiac tissue to quantify the signal decay rate (R2*) and time (T2*).
The MRI-Q System is a software device that provides quantitative analysis of magnetic resonance image signal decay parameters in cardiac tissue. The device contains an image viewer for importing DICOM images, browsing through datasets and performing quantitative region of interest analysis. The software device has capability to measure the signal decay rate (R2*) and time (T2*) in heart tissue.
Stand alone software package used to facilitate the import, visualization and analysis of multi-slice gradient echo MRI data sets encompassing cardiac tissue, to quantify the signal decay rate (R2*) and time (T2*).
This document is a 510(k) summary for the MRI-Q System, a software device for analyzing cardiac MRI data. It does not contain the specific details about acceptance criteria, study design, or performance metrics that would typically be found in a study report. The document primarily focuses on establishing substantial equivalence to predicate devices for regulatory approval.
Therefore, I cannot provide a table of acceptance criteria and reported device performance or details about a study proving the device meets acceptance criteria based only on the provided text.
However, I can extract information related to the device description and intended use, which are foundational for any performance criteria:
Device Description and Intended Use:
- Function: Standalone software package used to facilitate the import, visualization, and analysis of multi-slice gradient echo MRI data sets encompassing cardiac tissue.
- Quantifies: Signal decay rate (R2*) and time (T2*).
- Operational Principle: Based on fitting signal decay curves to magnetic resonance image signal intensities acquired at different echo times on a voxel-by-voxel (3-D pixel) basis to determine R2* and T2*.
- Intended Use: To provide additional processing of images for the analysis of multi-slice gradient echo MRI data sets of cardiac tissue to quantify the signal decay rate (R2*) and time (T2*).
- Specific Capabilities: Image viewer for importing DICOM images, browsing datasets, and performing quantitative region of interest analysis.
To answer the specific questions about acceptance criteria and study details, more comprehensive information, typically found in a clinical study report or a more detailed section of the 510(k) submission, would be required. The provided text is a summary for regulatory approval, comparing the new device to existing predicate devices, rather than a detailed performance study report.
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Image /page/0/Picture/0 description: The image shows a handwritten text at the top, followed by the text "510(k) Submission: MRI-Q System" at the bottom. The handwritten text appears to be a sequence of characters, including what looks like the letter 'K' and the numbers '1' and '2'. The text at the bottom indicates that the image is related to a 510(k) submission for an MRI-Q system.
5. 510(K) SUMMARY
JUL 28 2011
| SUBMITTED BY: | Resonance Health Analysis Services Pty Ltd216 Stirling HighwayClaremont WA 6010Australia |
|---|---|
| Contact in Australia: | Mr Andrew BathgateQuality Assurance and Regulatory Affairs ManagerTel: +61 8 9286 5300Fax: +61 8 9286 1179 |
| Contact in the US:(Primary Contact) | Mr Greg HollandRegulatory Specialists Inc.3722 Ave. SausalitoIrvine, CA 92606Tel: 949-262-0411Fax: 949 552 2821 |
| DATE PREPARED: | April 21, 2011 |
| NAME OF DEVICE: | MRI-Q System |
CLASSIFICATION NAME: Picture Archiving and Communication System (PACS)
(21 CFR 892.2050)
| CLASSIFICATION NUMBER: | 90 LLZ |
|---|---|
| TRADE/PROPRIETARY NAME: | MRI-Q System |
Resonance Health Analysis Services Pty Ltd
Confidential
:
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PREDICATE DEVICE(S):
- K043271: Resonance Health Analysis Services R2-MRI Analysis System
- K073194 Cardiovascular Imaging Solutions Ltd. CMRtools and plug-in ThalassaemiaTools
DEVICE DESCRIPTION: Stand alone software package used to facilitate the import, visualization and analysis of multi-slice gradient echo MRI data sets encompassing cardiac tissue, to quantify the signal decay rate (R2*) and time (T2*).
- SCIENTIFIC CONCEPTS: The operational principle of the MRI-Q System is based on fitting signal decay curves to magnetic resonance image signal intensities acquired at different echo times on a voxel-by-voxel (3-D pixel) basis to determine the signal decay rate (R2*) and time (T2*).
INTENDED USE: The MRI-Q System is intended to provide additional processing of images for the analysis of multi-slice gradient echo MRI data sets of cardiac tissue to quantify the signal decay rate (R2*) and time (T2*).
SUBSTANTIAL EQUIVALENCE INFORMATION:
The device has been shown to be substantially equivalent to the Resonance Health Analysis Services R2-MRI Analysis System (K043271) and the Cardiovascular Imaging Solutions Ltd CMRtools and plug-in ThalassaemiaTools (K073194).
CONCLUSION:
The 510(k) premarket notification for the MRI-Q System contains adequate information and data to enable the FDA-CDRH to determine substantial equivalence to the predicate devices.
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three tail feathers, representing the department's mission to protect the health of all Americans and provide essential human services. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
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
Resonance Health Analysis Services PTY, Ltd. % Mr. Greg Holland Regulatory Specialist Regulatory Specialists, Inc. 3722 Ave Sausalito IRVINE CA 92606
JUL 28 2011
Re: K111222
Trade/Device Name: MRI-Q System Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 27, 2011 Received: May 2, 2011
Dear Mr. Holland:
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
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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 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 Parts 801 and 809), please 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 Division of Small 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,
Mary Patel
Mary S. Pastel, Sc.D. 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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4. INDICATIONS FOR USE STATEMENT
510(k) Number (if known): K11222
Device Name: MRI-Q System
Indications For Use: The MRI-Q System is a software device that provides quantitative analysis of magnetic resonance image signal decay parameters in cardiac tissue. The device contains an image viewer for importing DICOM images, browsing through datasets and performing quantitative region of interest analysis. The software device has capability to measure the signal decay rate (R2*) and time (T2*) in heart tissue.
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use __
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of In Vitro Diagnostic Device Evaluation & Safety (OIVD).
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Mh. D. Oth
(Division Sign-Off)
Division of Radiological Dev Office of In Vitro Diagnostic Device
510K K11222
Resonance Health Analysis Services Pty Ltd
Confidential
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).