(59 days)
The uMR 570 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and that display internal anatomical structure and/or function of the head, body and extremities.
These images and the physical parameters derived from the interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.
The uMR 570 is a 1.5T superconducting magnetic resonance diagnostic device with a 70cm size patient bore. It consists of components such as magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. The uMR 570 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.
The modification performed on the uMR 570 (K201540) in this submission is due to the following changes that include:
- (1) Addition and modification of pulse sequences
- (2) Addition of MR imaging processing methods: Inline T2 mapping, Cardiac T1 mapping, Cardiac T2 mapping, Cardiac T2* mapping, Flow Quantification, Arterial Spin Labeling (3D ASL).
- (3) Addition of Spectroscopy Sequences and Post Processing Features: SVS MRS (Liver), Prostate MRS, SVS MRS (Breast).
- (4) Addition of New function: Implant mode, Remote Assistance.
- (5) Addition of New Workflow Features: EasyScan.
This FDA 510(k) summary for the uMR 570 Magnetic Resonance Diagnostic Device details hardware and software modifications compared to a predicate device (K201540). The document asserts substantial equivalence without providing detailed acceptance criteria or study results for novel features.
Here's the breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state acceptance criteria in a quantitative manner for most of the new features. It generally confirms that the device "performs as expected" and is "substantially equivalent" to the predicate. For the specific item where a standard is mentioned:
| Acceptance Criteria (from predicate/standard alignment) | Reported Device Performance |
|---|---|
| NEMA MS 14-2019 (RF coil heating) | "perform as well as predicate devices." |
For other features, the acceptance criterion is implicitly that the features function as intended and yield diagnostically useful information, consistent with the foundational technology of MRI.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide information on the sample size used for the test set or the data provenance (country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The general statement is that "physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis."
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not specify any adjudication method for establishing ground truth or evaluating test results.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not mention any multi-reader multi-case (MRMC) comparative effectiveness study. The device itself is a diagnostic imaging system, not an AI-assisted interpretation tool, so this type of study would not be applicable in this context. The enhancements are primarily in imaging sequences and post-processing capabilities.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is an MRI system, not an AI algorithm for standalone diagnosis. Therefore, a standalone (algorithm only) performance study as typically understood for AI devices would not be relevant or performed. The performance evaluation is for the imaging capabilities and derived parameters.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not explicitly state the type of ground truth used. For an MRI system, the "ground truth" for image quality and quantitative parameter accuracy would typically involve phantom studies, comparison to established imaging techniques, and potentially correlation with other diagnostic findings or clinical outcomes, but this is not detailed. The phrase "physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis" implies clinical utility rather than a specific ground truth mechanism for validation.
8. The sample size for the training set
This information is not applicable as the device is an MRI diagnostic system and not an AI/ML model that would typically have a "training set" in the context of machine learning. The "training" for the system refers to its engineering and calibration.
9. How the ground truth for the training set was established
This information is not applicable for the reasons stated above (not an AI/ML model with a "training set").
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The provided 510(k) summary indicates that non-clinical testing and a clinical performance evaluation were conducted.
- Non-clinical testing: This included evaluation against NEMA MS 14-2019 for RF coil heating, which demonstrated the proposed device performs "as well as predicate devices."
- Clinical performance evaluation: This was done for new features such as Flow Quantification, 3D ASL, Inline T2 Mapping, Cardiac T1/T2/T2* Mapping, MARS+, MultiBand, QScan, and Silicon-Only Imaging.
- Performance testing for Spectroscopy: Specific tests were performed for Prostate MRS, SVS MRS (Breast), and SVS MRS (Liver).
- System Validation: Reports for Implant mode, Remote Assistance, and EasyScan were also provided.
The conclusion states that "The test results demonstrated that the device performs as expected and thus, it is substantial equivalent to the predicate devices to which it has been compared." This implies that the performance was deemed acceptable in comparison to the previously cleared predicate device, without detailing specific metrics or thresholds for acceptance for each new feature beyond the general statement of "as expected" and "substantial equivalence."
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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
May 18, 2023
Shanghai United Imaging Healthcare Co., Ltd. % Xin GAO Regulatory Affairs Specialist No. 2258 Chengbei Road, Jiading District Shanghai, Shanghai 201807 CHINA
Re: K230758
Trade/Device Name: uMR 570 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: March 20, 2023 Received: March 20, 2023
Dear Xin Gao:
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. Although this letter refers to your product as a device, please be aware 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
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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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
D.G.K.
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K230758
Device Name uMR 570
Indications for Use (Describe)
The uMR 570 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and that display internal anatomical structure and/or function of the head, body and extremities.
These images and the physical parameters derived from the interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510 (k) SUMMARY
1. Date of Prepared
March 20, 2023
2. Sponsor Identification
Shanghai United Imaging Healthcare Co., Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China
Contact Person: Xin GAO Position: Regulatory Affairs Specialist Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com
3. Identification of Proposed Device(s)
Trade Name: uMR 570 Common Name: Magnetic Resonance Diagnostic Device Model: uMR 570 Product Code: LNH Regulation Number: 21 CFR 892.1000 Device Class: II
4. Identification of Predicate Devices(s)
Predicate Device 510(k) Number: K201540 Device Name: uMR 570 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH
Reference Device 510(k) Number: K222755 Device Name: uMR 680 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH
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Image /page/4/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the words is a stylized letter "U" that is dark teal in color. The logo is simple and modern.
5. Device Description
The uMR 570 is a 1.5T superconducting magnetic resonance diagnostic device with a 70cm size patient bore. It consists of components such as magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. The uMR 570 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.
The modification performed on the uMR 570 (K201540) in this submission is due to the following changes that include:
- (1) Addition and modification of pulse sequences
- a) New sequences: fse_dwi, grase, asl_3d, fse_mars_sle, gre_fine, gre_fg, gre bssfp ucs. svs wfs. svs stme.
- b) Added associated options for certain sequences: se_me (Add Inline T2 mapping), fse (Add OScan, Silicon-Only Image), fse arms (Add QScan), fse_mx (Add QScan), fse_ssh (Add QScan, Silicon-Only Image), fse_wfi (Add QScan), se (Add QScan), epi_dwi (Add QScan, MultiBand), epi_bold (Add QScan, MultiBand), epi_dti (Add QScan, MultiBand), gre_swi (Add QScan), gre_fsp (Add QScan), gre_quick (Add QScan), gre (Add QScan), gre_fsp_c (Add Cardiac T2* mapping), gre_bssfp (Add Cardiac T1 mapping, Cardiac T2 mapping).
- c) Added additional accessory equipment required for certain sequences: gre_tof (Add respiratory, cardiac gating).
- (2) Addition of MR imaging processing methods: Inline T2 mapping, Cardiac T1 mapping, Cardiac T2 mapping, Cardiac T2* mapping, Flow Quantification, Arterial Spin Labeling (3D ASL).
- (3) Addition of Spectroscopy Sequences and Post Processing Features: SVS MRS (Liver), Prostate MRS, SVS MRS (Breast).
- (4) Addition of New function: Implant mode, Remote Assistance.
- (5) Addition of New Workflow Features: EasyScan.
These modifications do not affect the intended use or alter the fundamental scientific technology of the device.
6. Intended Use
The uMR 570 system system are indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and spectroscopic images, and that display internal anatomical structure and/or function of the head, body and extremities.
These images and the physical parameters derived from the images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.
7. Technological Characteristic
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The differences from the predicate device are discussed in the comparison table in this submission as below.
| ITEM | Proposed DeviceuMR 570 | Predicate DeviceuMR 570 (K201540) | Remark |
|---|---|---|---|
| General | |||
| Product Code | LNH | LNH | Same |
| Regulation No. | 21 CFR 892.1000 | 21 CFR 892.1000 | Same |
| Class | II | II | Same |
| Indications For Use | The uMR 570 system isindicated for use as a magneticresonance diagnostic device(MRDD) that produces sagittal,transverse, coronal, and obliquecross sectional images, andspectroscopic images, and thatdisplay internal anatomicalstructure and/or function of thehead, body and extremities.These images and the physicalparameters derived from theimages when interpreted by atrained physician yieldinformation that may assist thediagnosis. Contrast agents maybe used depending on the regionof interest of the scan. | The uMR 570 system isindicated for use as a magneticresonance diagnostic device(MRDD) that produces sagittal,transverse, coronal, and obliquecross sectional images, andspectroscopic images, and thatdisplay internal anatomicalstructure and/or function of thehead, body and extremities.These images and the physicalparameters derived from theimages when interpreted by atrained physician yieldinformation that may assist thediagnosis. Contrast agents maybe used depending on theregion of interest of the scan. | Same |
| Magnet system | |||
| Field Strength | 1.5 Tesla | 1.5 Tesla | Same |
| Type of Magnet | Superconducting | Superconducting | Same |
| Patient-accessiblebore dimensions | width 700mm,height 530mm,length 1500mm | width 700mm,height 530mm,length 1500mm | Same |
| Type of Shielding | Actively shielded, OIStechnology | Actively shielded, OIStechnology | Same |
| MagnetHomogeneity | 1.4ppm @ 50cm DSV0.9ppm @ 45cm DSV0.72ppm @ 40cm DSV0.420ppm @ 30cm DSV0.240ppm @ 20cm DSV0.040ppm @ 10cm DSV | 1.4ppm @ 50cm DSV0.9ppm @ 45cm DSV0.72ppm @ 40cm DSV0.420ppm @ 30cm DSV0.240ppm @ 20cm DSV0.040ppm @ 10cm DSV | Same |
| ITEM | Proposed DeviceuMR 570 | Predicate DeviceuMR 570 (K201540) | Remark |
| Max gradientamplitude | 45mT/m | 45mT/m | Same |
| Max slew rate | 200T/m/s | 200T/m/s | Same |
| Shielding | active | active | Same |
| Cooling | water | water | Same |
| RF system | |||
| Resonantfrequencies | 63.87 MHz | 63.87 MHz | Same |
| Number of transmitchannels | 1 | 1 | Same |
| Number of receivechannels | Up to 48 | Up to 48 | Same |
| Amplifier peakpower per channel | 20 kW | 20 kW | Same |
| RF Coils | |||
| Head & Neck Coil -16 | Yes | Yes | Same |
| Body Array Coil - 6 | Yes | Yes | Same |
| Body Array Coil -12 | Yes | Yes | Same |
| Breast Coil - 10 | Yes | Yes | Same |
| Flex Coil Large - 4 | Yes | Yes | Same |
| Flex Coil Small - 4 | Yes | Yes | Same |
| Knee Coil - 12 | Yes | Yes | Same |
| Lower ExtremityCoil - 24 | Yes | Yes | Same |
| Shoulder Coil - 12 | Yes | Yes | Same |
| Small Loop Coil | Yes | Yes | Same |
| Spine Coil - 24 | Yes | Yes | Same |
| Wrist Coil - 12 | Yes | Yes | Same |
| Cardiac Coil - 24 | Yes | Yes | Same |
| Foot & Ankle Coil- 24 | Yes | Yes | Same |
| Temporomandibular Joint Coil - 4 | Yes | Yes | Same |
| Head Coil - 24 | Yes | Yes | Same |
| Head Coil - 12 | Yes | Yes | Same |
| Carotid Coil - 8 | Yes | Yes | Same |
| Patient table | |||
| Dimensions | width 640mm,height 880mm,length 2620mm | width 640mm,height 880mm,length 2620mm | Same |
| ITEM | Proposed DeviceuMR 570 | Predicate DeviceuMR 570 (K201540) | Remark |
| Maximum supported patientweight | 250 kg | 250 kg | Same |
| Accessories | |||
| Vital Signal Gating | ECG, Peripheral Pulse Gating,Respiratory Gating | ECG, Peripheral Pulse Gating,Respiratory Gating | Same |
| Safety | |||
| Electrical Safety | Comply with ES60601-1 | Comply with ES60601-1 | Same |
| EMC | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 | Same |
| Max SAR forTransmit Coil | Comply with IEC 60601-2-33 | Comply with IEC 60601-2-33 | Same |
| Max dB/dt | Comply with IEC 60601-2-33 | Comply with IEC 60601-2-33 | Same |
| Biocompatibility | Patient Contact Materials weretested and demonstrated nocytotoxicity (ISO 10993-5), noevidence for irritation andsensitization (ISO 10993-10). | Patient Contact Materials weretested and demonstrated nocytotoxicity (ISO 10993-5), noevidence for irritation andsensitization (ISO 10993-10). | Same |
| Surface Heating | NEMA MS 14 | ES 60601-1 | Note 1 |
Table 1 Comparison of Hardware configuration
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Image /page/6/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other in bold, sans-serif font. To the right of the words is a stylized "U" symbol, which is dark gray in color. The logo is simple and modern in design.
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Image /page/7/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is divided vertically into two halves. The logo is simple and modern, with a focus on the company's name and a clean, geometric design.
| Note 1 | The NEMA standards publication MS 14-2019 describes the procedure for heating RF coil heating under worst-case normal operating conditions. The results for the surface heating test showed that proposed devices perform as well as predicate devices. |
|---|---|
| -------- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
Table 2 provides the new application software features of the proposed device in comparison to the predicate device.
Table 2 Comparison of the new Application Software Features
| ITEM | Proposed DeviceuMR 570 | Predicate DeviceuMR 570 (K201540) | Remark |
|---|---|---|---|
| Image Processing Features | |||
| Inline T2Mapping | Yes | No | Inline T2 Map is substantiallyequivalent to T2 Map processedby post-processing module. Themap result displays inline withoutextra operation by post-processing module. |
| Arterial SpinLabeling (3DASL) | Yes | No | 3D ASL is substantiallyequivalent to FSE and uses extraarterial spin labeling preparationand imaging processing forcerebral blood flow (CBF)imaging without contrast agent. |
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Image /page/8/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other in bold, sans-serif font. To the right of the words is a stylized "U" symbol, which is also in bold. The logo is simple and modern, and the colors are muted.
| FlowQuantification(FQ) | Yes | No | FQ is substantially equivalent toGRE and uses extra flowencoding and imaging processingfor flow quantification. |
|---|---|---|---|
| Cardiac T1Mapping | Yes | No | Cardiac T1 mapping issubstantially equivalent to GREand uses multiple TI acquisitionswith IR preparation and imagingprocessing for cardiac T1mapping. |
| Cardiac T2Mapping | Yes | No | Cardiac T2 mapping issubstantially equivalent to GREand uses multiple T2-prepduration preparation acquisitionsand imaging processing forcardiac T2 mapping. |
| Cardiac T2*Mapping | Yes | No | Cardiac T2* mapping issubstantially equivalent to GREand uses multiple TE acquisitionsand imaging processing forcardiac T2* mapping. |
| Spectroscopy Features | |||
| SVS MRS(Liver) | Yes | No | Liver spectroscopy issubstantially equivalent toSpectroscopy and uses multi-echoacquisition and post-processinginstead of single echo for fatquantification of liver. |
| Prostate MRS | Yes | No | Prostate spectroscopy issubstantially equivalent toSpectroscopy and usescharacteristic metabolitesdetection post processing forprostate spectroscopy. |
| SVS MRS(Breast) | Yes | No | Breast spectroscopy issubstantially equivalent toSpectroscopy and usescharacteristic metabolitesdetection post processing forbreast spectroscopy. |
Table 3 provides the new function and workflow features of the reference device in comparison to the predicate device.
Table 3 Comparison of the new function and workflow features
| ITEM | This Submission | Reference Device uMR 680(K222755) | Remark |
|---|---|---|---|
| Function |
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Image /page/9/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED IMAGING" are in bold, sans-serif font, stacked on top of each other. To the right of the words is a stylized "U" shape, which is also in bold. The logo is simple and modern.
| Implant Mode | Yes | Yes | Same |
|---|---|---|---|
| Remote Assistance | Yes | Yes | Same |
| Workflow Features | |||
| EasyScan | Yes | Yes | Same |
Based on the comparison and analysis above, the proposed device has same intended use, similar performance, equivalence safety and effeteness in hardware and software as the predicate device. The differences above between the proposed device and predicate device do not affect the intended use, technology characteristics, safety and effectiveness. And no issues are raised regarding to safety and effectiveness.
8. Performance Data
The following testing was performed as described in the guidance/standards:
-
A MS 14-2019, Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems
Non-clinical testing were conducted to verify the features described in this premarket submission. -
A Clinical performance evaluation
-
Performance evaluation report for Flow Quantification,3D ASL, Inline T2 A Mapping, Flow Quantification, Cardiac T1 Mapping, Cardiac T2 Mapping, Cardiac T2* Mapping, MARS+, MultiBand, QScan, Silicon-Only Imaging.
-
A Performance testing for Spectroscopy: Prostate MRS, SVS MRS (Breast), SVS MRS (Liver).
-
System Validation report: Implant mode, Remote Assistance, EasyScan.
The test results demonstrated that the device performs as expected and thus, it is substantial equivalent to the predicate devices to which it has been compared.
9. Conclusion
In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, we conclude that uMR 570 Magnetic Resonance Diagnostic Device is substantially equivalent to the predicate device. It does not introduce new indications for use, and has the same technological characteristics and does not introduce new potential hazards or safety risks.
§ 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.