(87 days)
Not Found
No
The summary describes standard image processing and quantitative analysis techniques (quantifying R2* and T2* signal decay) without mentioning AI, ML, or related concepts like training/test sets, performance metrics typically associated with AI/ML models, or complex algorithms beyond standard signal processing.
No
The device is a software for quantitative analysis of MRI images to measure signal decay parameters, which is a diagnostic function, not a therapeutic one.
Yes
The device analyzes MRI data to quantify signal decay rates (R2* and T2*) in cardiac tissue, which are parameters used to assess the state or function of the tissue, indicating a diagnostic purpose.
Yes
The device description explicitly states it is a "Stand alone software package" and the intended use describes it as a "software device". There is no mention of accompanying hardware components.
Based on the provided information, the MRI-Q System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (in vitro). This typically involves blood, urine, tissue biopsies, etc.
- The MRI-Q System analyzes images of the human body (in vivo). It processes MRI data directly acquired from the patient's cardiac tissue.
The device description clearly states it's a "software device that provides quantitative analysis of magnetic resonance image signal decay parameters in cardiac tissue." This is image analysis, not analysis of a biological sample.
Therefore, the MRI-Q System falls under the category of medical devices that perform image processing and analysis, but not IVDs.
N/A
Intended Use / Indications for 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*).
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.
Product codes
LLZ
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*).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging (MRI)
Anatomical Site
Cardiac tissue / heart tissue
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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 Ltd
216 Stirling Highway
Claremont WA 6010
Australia |
|-----------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------|
| Contact in Australia: | Mr Andrew Bathgate
Quality Assurance and Regulatory Affairs Manager
Tel: +61 8 9286 5300
Fax: +61 8 9286 1179 |
| Contact in the US:
(Primary Contact) | Mr Greg Holland
Regulatory Specialists Inc.
3722 Ave. Sausalito
Irvine, CA 92606
Tel: 949-262-0411
Fax: 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.
2
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
3
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).
Page 1 of 1
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