(58 days)
The EMMA 1.5T MR System is a magnetic resonance diagnostic device (MRDD) which produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by trained physician yield information that may assist medical diagnosis.
The EMMA 1.5T MRI System is a 1.5T superconducting magnet MRI system which produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. It is composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil, Transmission Coil, Receiver Coil, Client PC, and Imaging Cabinet. The system software, Prodiva, a Windows-based software, is an interactive program with user friendly interface. The device is conformed to IEC and DICOM standards.
The provided text is a 510(k) summary for the EMMA 1.5T MRI System. It details the device's characteristics and its substantial equivalence to a predicate device, focusing on non-clinical performance data and a comparison of clinical images.
Here's an analysis based on your request, highlighting the information available in the text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the EMMA 1.5T MRI System are largely based on compliance with various NEMA MS and IEC standards, demonstrating that its performance is equivalent to the predicate device. The text does not provide specific numerical acceptance criteria alongside numerical reported performance for each metric; instead, it states compliance with the standards.
| Acceptance Criteria Category | Standard/Requirement | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1 | Complies; evaluation conducted. |
| Electrical Safety & EMC | AAMI/ANSI ES60601-1, IEC 60601-2-33, IEC 60601-1-2:2014 Edition 4 | Complies; testing conducted. |
| Surface Heating of RF Receive Coils | AAMI/ANSI ES60601-1 (max 41°C) | Measured temperature never exceeds 41°C in either coil-plugged or coil-unplugged configurations. |
| Software Verification & Validation | FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." | Documentation provided; testing conducted. |
| Acoustic Testing | NEMA MS 4-2010 | Complies; testing conducted. |
| Performance Testing (Bench) | NEMA MS-1-2008 (R2014) (SNR) | Complies; demonstrates safety and performance as expected. |
| NEMA MS 2-2008 (R2014) (2D Geometric Distortion) | Complies; demonstrates safety and performance as expected. | |
| NEMA MS 3-2008 (R2014) (Image Uniformity) | Complies; demonstrates safety and performance as expected. | |
| NEMA MS 5-2010 (Slice Thickness) | Complies; demonstrates safety and performance as expected. | |
| NEMA MS 6-2008 (R2014) (SNR & Image Uniformity for Single-Channel Non-Volume Coils) | Complies; demonstrates safety and performance as expected. | |
| NEMA MS 8-2016 (SAR) | Complies; demonstrates safety and performance as expected. |
2. Sample Size Used for the Test Set and Data Provenance
The document mentions "Sample clinical images are provided to verify the claim of filing device's capability in generating images for diagnostic purposes." and "Sample clinical image sets from filing device and predicate device on same pulse sequences are provided to demonstrate the substantial equivalence."
- Sample size used for the test set: Not explicitly stated. The term "sample clinical images" suggests a limited set, but no number is given.
- Data provenance: Not explicitly stated. It is implied these are clinical images, but information on country of origin or whether they are retrospective or prospective is not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. The text states that the resulting images, "when interpreted by trained physician yield information that may assist medical diagnosis," but it does not detail an expert review process for a specific test set or the qualifications of any such experts.
4. Adjudication Method for the Test Set
This information is not provided in the document. There is no mention of an adjudication method like 2+1 or 3+1 for establishing ground truth on a test set.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study is not mentioned in the document. The study performed focuses on demonstrating substantial equivalence through non-clinical performance and a visual comparison of sample clinical images, not on quantifying human reader improvement with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
This is an MRI system, not an AI algorithm. Therefore, a standalone (algorithm only) performance study in the context of AI is not applicable/not performed as described for diagnostic algorithms. The performance studies are for the imaging system itself. The document mentions "Software Verification and Validation Testing," which is focused on the software's functionality and safety within the device, not its standalone diagnostic performance.
7. Type of Ground Truth Used
For the clinical image comparison, the ground truth is implicitly based on the visual interpretability of the images by a "trained physician" for diagnostic assistance. However, a formal "ground truth" (e.g., pathology, clinical follow-up) for a specific diagnostic outcome for these sample images is not explicitly stated or detailed. The comparison is about the quality and diagnostic utility of the images produced by the new device versus the predicate device.
8. Sample Size for the Training Set
This information is not applicable as the document describes an MRI system, not an AI algorithm that requires a training set in that conventional sense. The "software" in this context refers to the operating and image reconstruction software, which is traditionally developed and validated through engineering processes, not trained on radiological data like an AI model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as point 8.
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Image /page/0/Picture/0 description: The image contains two logos. The logo on the left is the Department of Health & Human Services - USA logo. The logo on the right is the FDA U.S. Food & Drug Administration logo. The FDA logo is blue.
Time Medical Limited % Mr. Nick Tse Compliance Manager G/F, Bio-Informatics Center No., 2 Science Park West Avenue Shatin, N.T., Hong Kong CHINA
February 22, 2019
Re: K183621
Trade/Device Name: EMMA 1.5T MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: December 12, 2018 Received: December 26, 2018
Dear Mr. Tse:
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 mav, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be avare that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael D. O'Hara
For
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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2.2 INDICATIONS FOR USE
FDA Indications for Use Form (FDA Form 3881) is shown below and at Annex K.
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use | Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below. |
|---|---|
| 510(k) Number (if known) | |
| K183621 | |
| Device Name |
EMMA 1.5T MRI System
Indications for Use (Describe)
The EMMA 1.5T MR System is a magnetic resonance diagnostic device (MRDD) which produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by trained physician yield information that may assist medical diagnosis.
| Type of Use (Select one or both, as applicable) | ||||
|---|---|---|---|---|
| 2 Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) | |||
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | ||||
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | ||||
| DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW . | ||||
| The burden time for this collection of information is estimated to average 79 hours per response, including thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to: | ||||
| Department of Health and Human ServicesFood and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff@fda.hhs.gov | ||||
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection ofinformation unless it displays a currently valid OMB number." |
FORM FDA 3881 (7/17)
Page 1 of 1
POC Fultidaing Services (301) 443-4345 EF
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2.1 510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Date of Submission: | February, 9, 2018 |
|---|---|
| Sponsor: | Time Medical LimitedG/F Bio-Informatics Centre, No. 2 Science Park West Avenue,Hong Kong Science Park, Shatin, New Territories, Hong Kong, ChinaContact Person: Nick Tse - Compliance ManagerTelephone number: +852 21561711 Fax.: +852 2156 0908 |
| Correspondent: | Time Medical LimitedG/F Bio-Informatics Centre, No. 2 Science Park West Avenue,Hong Kong Science Park, Shatin, New Territories, Hong Kong, ChinaContact Person: Nick Tse - Compliance ManagerTelephone number: +852 21561711 Fax.: +852 2156 0908 |
| Filing Device: | EMMA 1.5T MRI System |
| Classification Name: | System. Nuclear Magnetic Resonance Imaging |
| Regulatory Description: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Class | Class II / LNH / 21 CFR 892. 1000 |
| Intended Use: | The EMMA 1.5T MRI System is indicated for use as a magnetic resonancediagnostic device (MRDD) which produces transverse, sagittal, coronal andoblique cross-sectional images, and those display the internal structureand/or function of the head, body, or extremities. Depending on the region ofinterest, contrast agents may be used. These images when interpreted bytrained physician yield information that may assist medical diagnosis. |
| Device Description: | The EMMA 1.5T MRI System is a 1.5T superconducting magnet MRIsystem which produces transverse, sagittal, coronal and obliquecross-sectional images, and those display the internal structure and/orfunction of the head, body, or extremities. It is composed of Magnet, MagnetEnclosure, Patient Table, Gradient Coil, Transmission Coil, Receiver Coil,Client PC, and Imaging Cabinet. The system software, Prodiva, aWindows-based software, is an interactive program with user friendlyinterface. The device is conformed to IEC and DICOM standards. |
General Comparison to Predicate Device:
| Comparison Element | Filing Device: | Predicate Device: |
|---|---|---|
| 510(k) Number | N/A | K161567 |
| Model | 15000-01 | SIGNA Voyager 1.5T |
| Device Name | EMMA 1.5T MRI System | SIGNA Voyager |
| Applicant | Time Medical Limited | GE Healthcare |
| Applicant Address | Unit G01-G03, 05 & 08, G/F,Bio-Informatics Centre, Hong KongScience Park, Shatin, N.T | 3200 N. Grandview Blvd.Waukesha, WI 53188, USA |
| Classification Name | System, Nuclear MagneticResonance Imaging | Magnetic Resonance DiagnosticDevice |
| Product Code | LNH | LNH, MOS |
| Regulation Number | 21 CFR 892.1000 | |
| Panel | Radiology | |
| Class | Class II | |
| Indications for Use | The EMMA 1.5T MRI System isindicated for use as a magneticresonance diagnostic device(MRDD) which producestransverse, sagittal, coronal andoblique cross-sectional images,and those display the internalstructure and/or function of the | The SIGNA Voyager is a whole bodymagnetic resonance scannerdesigned to support high resolution,high signal-to-noise ratio, and shortscan time imaging. The SIGNAVoyager is indicated for use as adiagnostic imaging device to produceaxial, sagittal, coronal, and oblique |
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The filing device has the same US FDA classification including classification name, product code, regulation number, panel, and class with the predicate device.
The filing device has the same major indications for use as the predicate device produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by trained physician yield information that may assist medical diagnosis.
The minor differences in indications for use do not constitute any safety and effectiveness issue, as indicated in performance data provided.
| General | Filing Device | Predicate Device |
|---|---|---|
| Design | Cylindrical | Cylindrical |
| Materials | FRP, ABS | |
| Power Source | Isolated power supply | |
| Performance Data | Comply with:- NEMA MS standards- IEC standards: IEC 60601-1,IEC60601-1-2,IEC60601-2-33 | |
| Magnet | Filing Device | Predicate Device |
| Type | Superconducting | |
| Field Strength | 1.5T | |
| Weight | 3,200 kg | 3,900 kg |
| Overall Dimensions | 1497 x 1880 x 2421 mm(L x W x H) | 1730 x 2070 x 2360 mm(L x W x H) |
| Cryogen Type | Liquid Helium | |
| Spatial Homogeneity | 1.45 ppm at 40 cm DSV | 0.40 ppm at 40 cm DSV |
| Fringe Field | 5 gauss line < 2.5m radial x 4maxial | 2.5 m radial x 4.0 m axial |
| Magnet Room Lighting | For sufficient and even lighting, 16overhead lamps (100 lumen each)recommended | Available |
| Room Ventilation | HVAC is installed for ventilation. | |
| Gradient System | Filing Device | Predicate Device |
| Amplitude | 43.6 mT/m | 36 mT/m |
| Rise time | 0.17 ms | 0.24 ms |
| Slew rate | 257 T/m/s | 150 T/m/s |
| Patient Table | Filing Device | Predicate Device |
| Dimensions (L x W x H) | 92.1 x 24.6 x 34.0 inch(2340 x 624 x 864 mm) | 96.5 x 27.6 x 36.7 inch(2450 x 700 x 932 mm) |
| Patient positioning | Laser Localizer assisted automaticpatient table positioning.Manual Position mode | Laser Localizer Available |
| Max Patient Weight | 200kg | 250 kg |
| Patient-control roomcommunication | Microphones and speaker fortwo-way communication betweenpatient and radiologist | Magnacoustic Communication &Music System |
| Workstation | Filing Device | Predicate Device |
| Model | Multi-Processing, Multi-Core PCwith 24-inch monitor | Quad-Core Intel Xeon with 24-inchmonitor |
| Memory and Capacity | 64GB of RAM, 250GB SSD Storage | 32GB of RAM, 2 x 400 GB SSDStorage |
| Operating System | Microsoft Windows | Linux OS |
| Receive Coils | Filing Device | Predicate Device |
| Multi-Channel Head Coil | ✓ | ✓ |
| Multi-Channel Head andneck Coil | ✓ | ✓ |
| Multi-Channel ShoulderCoil | ✓ | ✓ |
| Multi-Channel Spine Coil | ✓ | ✓ |
| Multi-Channel Body Coil | ✓ | ✓ |
| Multi-Channel ClosedBreast Coil | ✓ | ✓ |
| Multi-Channel Knee Coil | ✓ | ✓ |
| Multi-Channel Ankle Coil | ✓ | ✓ |
| Multi-Channel Wrist Coil | ✓ | ✓ |
| Multi-ChannelMulti-purpose Coils | ✓ | ✓ |
| Pulse Sequences | Filing Device | Predicate Device |
| T1 Spin Echo | ✓ | ✓ |
| T1, T2 Fast Spin Echo,HASTE | ✓ | ✓ |
| T1, T2* Gradient Echo | ✓ | ✓ |
| FLAIR | ✓ | ✓ |
| TOF Angiography | ✓ | ✓ |
| Inversion Recovery | ✓ | ✓ |
| Fat-Water Separation | ✓ | ✓ |
| Chemical Fat Sat | ✓ | ✓ |
| MRCP | ✓ | ✓ |
| DWI EPI | ✓ | ✓ |
| CMGE | ✓ | ✓ |
| SWI | ✓ | ✓ |
| 2D Image ProcessingFeatures | Filing Device | Predicate Device |
| Image panning, zooming,windowing | ✓ | ✓ |
| Image flipping, invertingand rotation | ✓ | ✓ |
| Statistical Analysis | ✓ | ✓ |
| Geometric Measurement | ✓ | ✓ |
| Phase Image | ✓ | ✓ |
| CINE | ✓ | ✓ |
| Shutter | ✓ | ✓ |
| Image Filtering | ✓ | ✓ |
| Image Subtraction | ✓ | ✓ |
| Slice Profile | ✓ | ✓ |
| Histogram | ✓ | ✓ |
| 3D Image Processing(MPR/Max.IP) | Filing Device | Predicate Device |
| Image panning, zooming,windowing | ✓ | ✓ |
| Cutting Operation OutputStack | ✓ | ✓ |
| Image export | ✓ | ✓ |
| The filing device basically utilizes same technologies as predicate device, and can give consistentresults when using the images in medical diagnosis. The minor differences in technologicalcharacteristics do not constitute any safety and effectiveness issue, as indicated in performance dataprovided. |
Comparison of Technological Characteristics with the Predicate Device:
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| TechnologicalCharacteristic | EMMA 1.5T MRI system is based on the principle that certain atomic nucleipresent in the human body, when placed in a strong magnetic field andexcited by a radio frequency signal at the precession frequency, will emit arelaxation signal. The emitted relaxation signals are acquired by signalreceiving coils and are analyzed by the system. Human-interpretableimages are reconstructed by and stored in the computer and displayed onthe screen. |
|---|---|
| The principle components of EMMA 1.5T MRI system includes | |
| Superconducting magnet with corresponding cooling devices Gradient system RF transmission and receive system Cooling system for different components of the system Patient table and support components Spectrometer Server/Client PC and application software | |
| The superconducting magnet is made of coils of superconducting wiresand is cooled to and maintained at cryogenic temperature by an encloseddedicated cooling system. When energized, current flows continuouslyinside the superconducting wires as a closed loop; thus producing aconstant magnetic field. This has the same major technologicalcharacteristics as the predicate device. | |
| The gradient system consists of a gradient coil and the gradient amplifier.The gradient coil produces varying linear gradient fields in the threeorthogonal spatial axes with currents given by the gradient amplifier. Thegradient coil can also produce various non-linear gradients fields toimprove the homogeneity of the main magnetic field. This has the samemajor technological characteristics as the predicate device. | |
| The RF transmission and receive system consists of the RF amplifier, theRF transmission coil and various RF receiver coils for receiving therelaxation signals emitted from the subject after RF transmission. They arecoils made of copper wires tuned to transmit and receive around thedesigned frequency corresponding to the magnetic field strength. This hasthe same major technological characteristics as the predicate device. | |
| The cooling system maintains suitable operating temperatures foramplifiers and other system devices. This has the same majortechnological characteristics as the predicate device. | |
| The patient table and support components provide a comfortable platformfor the patient and allows the operator to easily position the patient to thelocation for imaging. This has the same major technological characteristicsas the predicate device. | |
| The spectrometer controls the execution of the pulse sequence for RFtransmit and receive and gradient output. This has the same majortechnological characteristics as the predicate device. | |
| The server/client PC and the application software provides the operator aplatform to configure scans and manage scanned data. Raw data receivedfrom the spectrometer is also reconstructed here. This has the same majortechnological characteristics as the predicate device. | |
| technological characteristics as the predicate device. | |
| Therefore, the same scientific technology theory is applied to both theEMMA 1.5T MRI system and predicate device. | |
| Any minor differences in physical attributes do not constitute any safety andeffectiveness issue, as indicated in performance data provided. |
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| Nonclinical TestingSummary: | Like the predicate device, the following performance data were provided insupport of the substantial equivalence determination. |
|---|---|
| Biocompatibility testingThe biocompatibility evaluation for the filing device was conducted inaccordance with ISO 10993-1 "Biological Evaluation of Medical Devices –Part 1: Evaluation and Testing Within a Risk Management Process" asrecognized by FDA. | |
| Electrical safety and electromagnetic compatibility (EMC)Electrical safety and EMC testing were conducted in accordance with AAMI/ ANSI ES60601-1:2005/(R)2012 And A1:2012 "Medical ElectricalEquipment - Part 1: General Requirements For Basic Safety And EssentialPerformance", IEC 60601-2-33:2010+A1:2013 "Medical ElectricalEquipment - Part 2-33: Particular Requirements For The Basic Safety AndEssential Performance Of Magnetic Resonance Equipment For MedicalDiagnostic for safety" and IEC 60601-1-2:2014 Edition 4 "Medical ElectricalEquipment - Part 1-2: General Requirements For Basic Safety AndEssential Performance - Collateral Standard: ElectromagneticDisturbances - Requirements And Tests" for EMC as recognized by FDA | |
| Surface Heating of RF Receive CoilsSurface heating was tested with both coil-plugged and coil-unpluggedconfigurations according to AAMI/ANSI ES60601-1. The measuredtemperature of the surface of the coil never exceeds the maximum limit of41°C in either configuration. | |
| Software Verification and Validation TestingSoftware verification and validation testing were conducted anddocumentation was provided as recommended by FDA's Guidance forIndustry and FDA Staff, "Guidance for the Content of PremarketSubmissions for Software Contained in Medical Devices." | |
| Acoustic testingAcoustic testing were conducted in accordance with NEMA MS 4-2010"Acoustic Noise Measurement Procedure for Diagnosing MagneticResonance Imaging Devices" | |
| Performance testing - BenchThe filing device complies with the following NEMA MS standard as does thepredicate device:• NEMA MS-1-2008 (R2014) - Determination of Signal-to-Noise Ratio(SNR) in Diagnostic Magnetic Resonance Images• NEMA MS 2-2008 (R2014) - Determination of Two-DimensionalGeometric Distortion in Diagnostic Magnetic Resonance Images• NEMA MS 3-2008 (R2014) - Determination of Image Uniformity inDiagnostic Magnetic Resonance Images• NEMA MS 5-2010 - Determination of Slice Thickness in DiagnosticMagnetic Resonance Imaging• NEMA MS 6-2008 (R2014) - Determination of Signal-to-Noise Ratioand Image Uniformity for Single-Channel Non-Volume Coils inDiagnostic MR Imaging• NEMA MS 8-2016 - Characterization Of The Specific AbsorptionRate For Magnetic Resonance Imaging SystemsThe performance testing results demonstrate the safety and performanceas expected. Therefore, the filing device is substantially equivalent to thelegally marketed predicate device. |
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| Clinical TestingSummary: | Sample clinical images are provided to verify the claim of filing device'scapability in generating images for diagnostic purposes. Sample clinicalimage sets from filing device and predicate device on same pulsesequences are provided to demonstrate the substantial equivalence of filingdevice to legally marketed predicate device. |
|---|---|
| Conclusions Drawnfrom Non-ClinicalInformation andClinical Images: | The non-clinical information (safety and performance tests), combined withclinical images (both from filing device and predicate device), demonstratethat the filing device is as safe, as effective, and performs as well as thepredicate device. |
| SE Conclusion: | The filing device has the same intended use as the predicate device. Theminor differences in indication for use do not constitute any safety andeffectiveness issue, as indicated in performance data provided. | |
|---|---|---|
| The filing device utilizes same technologies as predicate device, and givesconsistent results (images) in medical diagnosis. Any minor differences inphysical attributes do not constitute any safety and effectiveness issue, asindicated in performance data [non clinical/clinical] provided. | ||
| Therefore the filing device is demonstrated, for being substantiallyequivalent to the legally marketed predicate device. |
§ 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.