(391 days)
Not Found
No
The description focuses on conventional MR imaging techniques, post-processing, and spectral imaging, without mentioning AI or ML.
No
The device is described as an acquisition technique and post-processing software for MR systems that helps reduce artifacts and produce images for diagnostic purposes, not for treating a condition.
Yes
The text states, "When interpreted by a trained physician, images generated by MAVRIC SL provide information that can be useful in determining a diagnosis." This explicitly indicates its diagnostic utility.
No
The device is described as a software application that is an "option for GE MR scanners" and a "combination of an acquisition technique and post-processing software intended for use on GE 1.5T and 3.0T MR systems." While it includes software, it is intrinsically linked to and dependent on the hardware of the GE MR systems for image acquisition and processing, and is not a standalone software device.
Based on the provided text, 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.
- MAVRIC SL Function: MAVRIC SL is a software application for Magnetic Resonance (MR) systems. It's an imaging technique and post-processing tool used to improve the quality of MR images, particularly in the presence of metal implants. It works by acquiring and processing signals generated by the patient's body within the MR scanner.
- No Sample Analysis: The description of MAVRIC SL does not involve the analysis of any samples taken from the patient's body. It directly processes the signals acquired by the MR scanner.
Therefore, MAVRIC SL falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
MAVRIC SL is a combination of an acquisition technique and post-processing software intended for use on GE 1.5T and 3.0T MR systems. MAVRIC SL is suitable for use on all patients with passive MR Conditional orthopedics implants that are scanned according to the conditions of safe use for the specific MR Conditional implant being scanned. In addition, MAVRIC SL is suitable for use on patients without implants that are cleared for MR exams.
MAVRIC SL helps reduce artifacts caused by presence of metal in both in-plane and through-plane dimensions compared to conventional MR imaging techniques. Thus MAVRIC SL allows visualizing more tissue in the vicinity of MR Conditional implanted metal instrumentation.
When interpreted by a trained physician, images generated by MAVRIC SL provide information that can be useful in determining a diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
MAVRIC SL is a software application offered as an option for GE MR scanners. MAVRIC SL is based upon conventional 2D-FSE and then adds view-angle-tilting and additional phase-encoding in the slice-selective dimension. As a result, MAVRIC SL has reduced image artifacts and provides adequate spectral coverage in the presence of metal implants.
MAVRIC SL is a combination of an acquisition technique and post-processing software intended for use on GE 1.5T and 3.0T MR systems. MAVRIC SL is suitable for use on all patients cleared for MR exams.
MAVRIC SL helps reduce artifacts caused by presence of metal in both in-plane and through-plane dimensions compared to conventional MR imaging techniques. Thus MAVRIC SL allows visualizing tissue in the vicinity of implanted metal instrumentation.
When interpreted by a trained physician, images generated by MAVRIC SL provide information that can be useful in determining a diagnosis.
MAVRIC SL is an FSE-based, 3D Multi-Spectral Imaging technique. Individually encoded spectral images in the MAVRIC SL technique overlap in the frequency domain and together span a wide spectrum of spins located near metal implants. MAVRIC SL generates a final image by combining the individually encoded spectral images in a post-processing step. MAVRIC SL software option employs the same fundamental scientific technology as its predicate device.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
Not Found
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)
The following clinical testing has been performed to validate the MAVRIC SL technique:
- Application validation
- Clinical imaging
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
GE Healthcare
510(k) Premarket Notification Submission
510(k) Summary
DEC 1 1 2012
In accordance with 21 CFR 807.92 the following summary of information is provided:
November 09, 2011 .. Date:
Submitter:
GE Healthcare (GE Medical Systems, LLC 3200 N. Grandview Blvd. Waukesha, WI 53188 USA
Primary Contact Person:
Yuan Ma Regulatory Affairs Leader GE Healthcare (GE Medical Systems, LLC (262) 521-6223 (414) 908-9390fax
Secondary Contact Person:
Glen Sabin Regulatory Affairs Director GE Healthcare (GE Medical Systems, LLC (262) 521-6848 (262) 521-6439 fax
::
MAVRIC SL Trade Name: Device: Common/Usual Name:
. . .
Software Option for Magnetic Resonance Imaging System
Classification Names: 21 C.F.R. 892.1000 Magnetic Resonance Diagnostic Device
LNH Product Code:
Predicate Device(s):
PROPELLER Imaging Option for MRI, K031230
Device Description:
MAVRIC SL is a software application offered as an option for GE MR scanners. MAVRIC SL is based upon conventional 2D-FSE and then adds view-angle-tilting and additional phase-encoding in the slice-selective dimension. As a result, MAVRIC SL has reduced image artifacts and provides adequate spectral coverage in the presence of metal implants.
1
Image /page/1/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'G' and 'E' intertwined within a circular border. The letters and the border are in black, creating a strong contrast against the white background.
GE Healthcare
510(k) Premarket Notification Submission
MAVRIC SL is a combination of an acquisition technique and post-processing software intended for use on GE 1.5T and 3.0T MR systems. MAVRIC SL is suitable for use on all patients cleared for MR exams.
MAVRIC SL helps reduce artifacts caused by presence of metal in both in-plane and through-plane dimensions compared to conventional MR imaging techniques. Thus MAVRIC SL allows visualizing tissue in the vicinity of implanted metal instrumentation.
When interpreted by a trained physician, images generated by MAVRIC SL provide information that can be useful in determining a diagnosis.
Imaging technique. Individually encoded spectral images in the MAVRIC SL technique overlap in the frequency
MAVRIC SL is an FSE-based, 3D Multi-Spectral
Technology:
Intended Use:
final image by
spectral image
MAVRIC SL :
fundamental se
Determination of Substantial Equivalence:
domain and together span a wide spectrum of spins located near metal implants. MAVRIC SL generates a final image by combining the individually encoded spectral images in a post-processing step. MAVRIC SL software option employs the same
fundamental scientific technology as its predicate device.
Summary of Non-Clinical Tests:
The MAVRIC SL software option complies with voluntary standards as detailed in Section 9, 11, 16 and 18 of this premarket submission. The following quality assurance measures were applied to the development of the system:
- Risk Analysis
- Requirements Reviews
- Design Reviews .
- Design Verification
- Safety Testing
The following safety parameters were measured:
- Acoustic Noise
- dB/dt >
-
SAR
The non-clinical tests outlined above have been executed with acceptable results. Refer to Sections 9, 16, and 18 of this submission for testing results.
2
GE Healthcare
..
:
: : :
:: : : :
:: 1.:
: : :
. . . .
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4 of 4
510(k) Premarket Notification Submission
Summary of Clinical Tests:
·
The following clinical testing has been performed to validate the MAVRIC SL technique:
: : : .
- Application validation く
- Clinical imaging .
Conclusion:
GE Healthcare considers the MAVRIC SL software option to be as safe, as effective, and performance is substantially equivalent to the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized graphic of an abstract human figure with outstretched arms, accompanied by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the graphic. The text is in all caps and is evenly spaced around the circle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 11, 2012
GE Medical System, LLC C/O Mr. Yuan Ma Regualtory Affairs Leader, MR 3200 N. Grandview Blvd. W-828 WAUKESHA. WI 53188
Re: K113394
Trade/Device Name: MAVRIC SL Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 8, 2012 Received: November 9, 2012
Dear Mr. Ma:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
4
Page 2-Mr. Ma
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Janine M. Morris -S
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K113394
Device Name: MAVRIC SL
Indications for Use:
MAVRIC SL is a combination of an acquisition technique and post-processing software intended for use on GE 1.5T and 3.0T MR systems. MAVRIC SL is suitable for use on all patients with passive MR Conditional orthopedics implants that are scanned according to the conditions of safe use for the specific MR Conditional implant being scanned. In addition, MAVRIC SL is suitable for use on patients without implants that are cleared for MR exams.
MAVRIC SL helps reduce artifacts caused by presence of metal in both in-plane and through-plane dimensions compared to conventional MR imaging techniques. Thus MAVRIC SL allows visualizing more tissue in the vicinity of MR Conditional implanted metal instrumentation.
When interpreted by a trained physician, images generated by MAVRIC SL provide information that can be useful in determining a diagnosis.
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)
Janine M. Morris -5 2012.12.12 08:02:20 -05'00' (Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health
K113394 510(k)
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