(157 days)
Not Found
Yes
The document explicitly mentions "Machine Learning Algorithm (DeepRecon)" and provides details about its training and testing data.
No
The device is described as a diagnostic device that produces images to assist in diagnosis, not to provide therapy or treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the system "produces... cross sectional images... [that] when interpreted by a trained physician yield information that may assist the diagnosis." The device is also referred to as a "magnetic resonance diagnostic device (MRDD)" multiple times.
No
The device description explicitly lists numerous hardware components such as a magnet, RF coils, gradient coils, patient table, spectrometer, computer, and equipment cabinets, indicating it is a physical medical device system, not software-only.
Based on the provided information, the uMR 680 system is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is a "magnetic resonance diagnostic device (MRDD)" that produces images of internal anatomical structure and/or function. These images are then interpreted by a trained physician to assist in diagnosis. This describes an in vivo diagnostic process, where the device interacts with the living body to obtain information.
- Device Description: The description details components of an MRI scanner, which is used for imaging the inside of the body.
- Input Imaging Modality: The input is Magnetic Resonance, which is an in vivo imaging technique.
- Anatomical Site: The device is used to image the head, body, and extremities, all of which are parts of the living organism.
In Vitro Diagnostics (IVDs) are devices used to examine specimens, such as blood, urine, or tissue, that have been taken from the human body. The uMR 680 system does not operate on such specimens.
No
The letter does not state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device.
Intended Use / Indications for Use
The uMR 680 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 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.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
The uMR 680 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 680 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Magnetic Resonance
Anatomical Site
head, body and extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
The training data of DeepRecon were collected from 264 volunteers. Each subject was scanned by UIH MRI systems for multiple body parts and clinical protocols, resulted in a total of 165.837 cases. In terms of the ground truth and input images in training dataset, the multiple-averaged images with high-resolution and high SNR were collected as the ground-truth images. The input images were generated from the ground-truth images by sequentially reducing the SNR and resolution of the groundtruth images. All data were manually quality controlled before included for training.
Description of the test set, sample size, data source, and annotation protocol
The DeepRecon has undergone performance testing on 68 US subjects with diverse demographic distributions covering various genders, age groups, ethnicities, and BMI groups (Table a). The independence of testing datasets were ensured by collecting testing data from various clinical sites and during separated time periods and on subjects different from the training data. Thus, the testing data have no overlap with the training data and are completely independent.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Tests:
The following testing was conducted on the uMR 680 Magnetic Resonance Diagnostic Device as the predicate device:
- A ES60601-1:2005/(R)2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- A IEC 60601-1-2 Edition 4.0 2014-02, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
- 60601-2-33 Ed. 3.2:2015 Medical Electrical Equipment - Part 2-33: Particular Requirements For The Basic Safety And Essential Performance Of Magnetic Resonance Equipment For Medical Diagnostic
- A IEC 60825-1 Edition 2.0 2007-03, Safety Of Laser Products - Part 1: Equipment Classification, And Requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
- A ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
- IEC 62464-1 Edition 2.0: 2018-12, Magnetic resonance equipment for medical imaging Part 1: Determination of essential image quality parameters.
- A MS 1-2008(R2020), Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Images
- MS 2-2008(R2020), Determination of Two-Dimensional Geometric Distortion in A Diagnostic Magnetic Resonance Images
- A MS 3-2008(R2020). Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
- A MS 4-2010, Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
- MS 5-2018, Determination of Slice Thickness in Diagnostic Magnetic A Resonance Imaging
- MS 6-2008(R2014), Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
- A MS 8-2016, Characterization Of The Specific Absorption Rate For Magnetic Resonance Imaging Systems
- A MS 9-2008(R2020), Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
- A MS 14-2019, Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems
Summary of Clinical Tests:
Sample clinical images were provided to support the ability of uMR 680 to generate diagnostic quality images in accordance with the MR guidance on premarket notification submissions.
Summary of the Machine Learning Algorithm (DeepRecon):
DeepRecon is a deep-learning based image processing algorithm for image de-noising and K-space-interpolation based image super-resolution.
The DeepRecon has undergone performance testing on 68 US subjects.
Test Results:
- Image SNR: DeepRecon: 186.87 versus NADR: 137.03 (PASS)
- Image Uniformity: 0.03% difference (PASS)
- Image Resolution: 15.57% higher for DeepRecon (PASS)
- Image Contrast: 1.0% intensity difference (PASS)
- Structure Measurement: 0% measurement difference (PASS)
DeepRecon images were evaluated by American Board of Radiologists certificated physicians, covering a range of protocols and body parts. The evaluation reports from radiologists verified that DeepRecon meets the requirements of clinical diagnosis. All DeepRecon images were rated with equivalent or higher scores in terms of diagnosis quality.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
- Image SNR
- Image Uniformity
- Image Resolution
- Image Contrast
- Structure Measurement
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
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
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 16, 2023
Shanghai United Imaging Intelligence Co., Ltd. % Xin GAO Regulatory Affairs Specialist No. 2258 Chengbei Road, Jiading District Shanghai, Shanghai 201807 CHINA
Re: K222755
Trade/Device Name: uMR 680 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: January 11, 2023 Received: January 17, 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
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 (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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-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,
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 Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K222755
Device Name uMR 680
Indications for Use (Describe)
The uMR 680 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 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.
| 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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Image /page/3/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is also in a bold, sans-serif font. The color of the logo is a dark teal.
510 (k) SUMMARY
-
- Date Prepared [21 CFR 807.92(a)(1)]
February 15, 2023
- Date Prepared [21 CFR 807.92(a)(1)]
2. General Information [21 CFR 807.92(a)(1)]
| Manufacturer: | Shanghai United Imaging Healthcare Co., Ltd | ||
|---|---|---|---|
| 2258 Chengbei Rd., Jiading District, Shanghai, 201807 |
Xin GAO Contact Person: Regulatory Affairs Specialist Tel: +86 (21) 67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com
3. Trade Name, Common Name, Classification [21 CFR 807.92(a)(2)]
| Trade Name: | uMR 680 |
|---|---|
| Common Name: | Magnetic Resonance Diagnostic Device |
| Model: | uMR 680 |
| Product Code: | LNH |
| Regulation Number: | 892.1000 |
| Device Class: | II |
4. Identification of Predicate Devices(s) [21 CFR 807.92(a)(3)]
The identification of predicates device within this submission is as follow:
Predicate Device Manufacturer: Shanghai United Imaging Healthcare Co., Ltd Magnetic Resonance Diagnostic Device Device Name: Product Code: LNH Device Class: II Regulation Number: 21 CFR 892.1000 FDA 510 (k) #: K201540
5. Device Description [21 CFR 807.92(a)(4)]
The uMR 680 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,
Page 1 of 11
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Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized symbol that resembles the letter "U" with a horizontal line through the middle. The color of the logo is a dark teal or gray.
spectrometer, computer, equipment cabinets, power distribution system, internal communication system, and vital signal module etc. The uMR 680 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.
6. Intended Use [21 CFR 807.92(a)(5)]
The uMR 680 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional imag es, and spectroscopic images, and that display internal anatomical structure and/or fu nction of the head, body and extremities.
These images and the physical parameters derived from the images when interpreted by a trained physician vield information that may assist the diagnosis. Contrast agen ts may be used depending on the region of interest of the scan.
7. Technological Characteristic [21 CFR 807.92(a)(6)]
The differences from the predicate device are discussed in the comparison table in this submission as below.
| ITEM | This submission
uMR 680 | Predicate Device
uMR 570 | 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 680 system is 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. | 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
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. | Same |
| Magnet system | | | |
| Field Strength | 1.5 Tesla | 1.5 Tesla | Same |
| ITEM | This submission
uMR 680 | Predicate Device
uMR 570 | Remark |
| Type of
Magnet | Superconducting | Superconducting | Same |
| Patient-
accessible
bore
dimensions | 70cm | 70cm | Same |
| Type of
Shielding | Actively shielded, OIS
technology | Actively shielded, OIS
technology | Same |
| Magnet
Homogeneity | 1.40ppm @ 50cm DSV
0.90ppm @ 45cm DSV
0.45ppm @ 40cm DSV
0.190ppm @ 30cm DSV
0.120ppm @ 20cm DSV
0.040ppm @ 10cm DSV | 1.40ppm @ 50cm DSV
0.90ppm @ 45cm DSV
0.72ppm @ 40cm DSV
0.420ppm @ 30cm DSV
0.240ppm @ 20cm DSV
0.040ppm @ 10cm DSV | Note 1 |
| Max gradient
amplitude | 45mT/m | 45mT/m | Same |
| Max slew rate | 200T/m/s | 200T/m/s | Same |
| Shielding | active | active | Same |
| Cooling | water | water | Same |
| Resonant
frequencies | 63.87 MHz | 63.87 MHz | Same |
| Number of
transmit
channels | 1 | 1 | Same |
| Number of
receive
channels | Up to 96 | Up to 48 | Note 2 |
| Amplifier
peak power
per channel | 18 kW | 20 kW | Note 3 |
| Head & Neck
Coil -16 | No | Yes | Note 4 |
| Head & Neck
Coil -24 | Yes | No | Note 5 |
| Spine Coil -
24 | No | Yes | Note 6 |
| Spine Coil -
32 | Yes | No | Note 7 |
| Body Array
Coil - 6 | No | Yes | Note 8 |
| Body Array
Coil - 12 | Yes | Yes | Same |
| Body Array
Coil - 24 | Yes | No | Note 8 |
| ITEM | This submission
uMR 680 | Predicate Device
uMR 570 | Remark |
| Breast Coil -
10 | Yes | Yes | Same |
| Knee Coil -
12 | Yes | Yes | Same |
| Lower
Extremity
Coil - 24 | Yes | Yes | Same |
| Shoulder Coil
- 12 | Yes | Yes | Same |
| Small Loop
Coil | Yes | Yes | Same |
| Wrist Coil -
12 | Yes | Yes | Same |
| Cardiac Coil -
24 | Yes | Yes | Same |
| Foot & Ankle
Coil - 24 | Yes | Yes | Same |
| Temporoman
dibular Joint
Coil - 4 | Yes | Yes | Same |
| Head Coil -
24 | No | Yes | Note 9 |
| Head Coil -
12 | No | Yes | Note 9 |
| Carotid Coil -
8 | Yes | Yes | Same |
| Flex Coil
Large - 4 | No | Yes | Note 10 |
| Flex Coil
Large - 8 | Yes | No | Note 10 |
| Flex Coil
Small - 4 | No | Yes | Note 11 |
| Flex Coil
Small - 8 | Yes | No | Note 11 |
| Infant Coil-24 | Yes | No | Note 12 |
| SuperFlex
Large - 12 | Yes | No | Note 13 |
| SuperFlex
Small - 12 | Yes | No | Note 14 |
| SuperFlex
Body - 24 | Yes | No | Note 15 |
| Patient table | Patient Table:
250 kg
Dockable Patient Table:
310kg | | Patient Table:
250 kg
No |
| Maximum
supported
patient weight | | | Same
Note 16 |
| ITEM | This submission
uMR 680 | Predicate Device
uMR 570 | Remark |
| Vital Signal
Gating | Support
ECG/Respiratory/Pulse signal triggering the scan | Support
ECG/Respiratory/Pulse signal triggering the scan | Same |
Table 1 Comparison of Hardware configuration
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Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, also in a bold font, with a white line running vertically and horizontally through the center of the "U".
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Image /page/7/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is formed by two vertical lines connected by a horizontal line in the middle. The logo is simple and modern in design.
| Note 1 | The homogeneity of the magnet is equal or better at typical DSVs thus the clinical
scanning of the proposed device is not limited compared to the predicate device. |
|---------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Note 2 | More receive channels allow the proposed device to use new high-channel count and
bigger coverage receive coils. |
| Note 3 | The RF Amplifier power is just one of the influence factors to affect the B1 field,
other influence factors such as efficiency of transmitting coil, damping of
transmitting chain, the distance between coil and target location will also affect the
intensity of B1 field, and the intensity of B1 field can be adjusted by different
sequences. Generally the target B1 field is achieved by system calibration
procedures and the required RF power is always less than the maximum RF
Amplifier power output, so this difference from predicate device will not affect the
system effectiveness, and the system safety is explained in device description and
verified by the third party safety report. |
| Note 4 | Compared to the predicate device, the proposed device removes Head & Neck Coil -
16 but adds Head & Neck Coil -24. The intended use of Head & Neck Coil -24 is
equivalent to previously cleared Head & Neck Coil -16. More coil elements in the
new coil allow larger coverage for bigger patient. |
| Note 5 | The intended use of Head & Neck Coil -24 is equivalent to previously cleared Head
& Neck Coil -16. More coil elements in the new coil allow larger coverage for
bigger patient. |
| Note 6 | Compared to the predicate device, the proposed device removes Spine Coil - 24 but
adds Spine Coil - 32. The intended use of Spine Coil - 32 is equivalent to previously
cleared Spine Coil - 24. More coil elements in the new coil allow larger coverage for
bigger patient. |
| Note 7 | The intended use of Spine Coil - 32 is equivalent to previously cleared Spine Coil -
24. More coil elements in the new coil allow larger coverage for bigger patient. |
| Note 8 | Compared to the predicate device, the proposed device removes Body Array Coil-6
but adds Body Array Coil-24. The intended use of Body Array Coil-24 is equivalent
to previously cleared Body Array Coil-6. More coil elements in the new coil allow
larger coverage for bigger patient. |
| Note 9 | Compared to the predicate device, the proposed device removes Head Coil – 12 and
Head Coil - 24. The intended use of Head Coil can be overridden by Head & Neck
Coil -24, so this difference from predicate device will not affect the system
effectiveness. |
| Note 10 | Compared to the predicate device, the proposed device removes Flex Coil Large - 4
but adds Flex Coil Large - 8. The intended use of Flex Coil Large - 8 is equivalent to
previously cleared Flex Coil Large - 4. More coil elements in the new coil allow
larger coverage for bigger patient. |
| Note 11 | Compared to the predicate device, the proposed device removes Flex Coil Small - 4
but adds Flex Coil Small - 8. The intended use of Flex Coil Small - 8 is equivalent to
previously cleared Flex Coil Small - 4. More coil elements in the new coil allow
larger coverage for bigger patient. |
| Note 12 | The proposed device adds Infant Coil-24 to facilitate the exam of infant. |
| Note 13 | The intended use of SuperFlex Large - 12 is essentially identical to previously
cleared Flex Coil Large - 8. The differences are the number of channels of the coil |
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| and the material used on the surface of the coil. More coil elements in the new coil | |
|---|---|
| can better cover the scanning parts and the flexible material is beneficial to wrap the | |
| scanning parts. | |
| Note 14 | The intended use of SuperFlex Small - 12 is essentially identical to previously |
| cleared Flex Coil Small - 8. The differences are the number of channels of the coil | |
| and the material used on the surface of the coil. More coil elements in the new coil | |
| can better cover the scanning parts and the flexible material is beneficial to wrap the | |
| scanning parts. | |
| Note 15 | The intended use of SuperFlex Body - 24 is essentially identical to previously |
| cleared Body Array Coil - 12. The differences are the number of channels of the coil | |
| and the material used on the surface of the coil. More coil elements in the new coil | |
| can better cover the scanning parts and the flexible material is beneficial to wrap the | |
| scanning parts. | |
| Note 16 | The proposed device adds Dockable Patient Table to facilitate patient transfer and |
| have a higher load capacity. |
Table 2 provides the new application software features of the proposed device in comparison to the predicate device.
| ITEM | This
submission
uMR 680 | Predicate
Device
uMR 570 | Remark |
|---------------------------------|-------------------------------|--------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Imaging Features | | | |
| Non-uniformity
Correction | Yes | Yes | Non-uniformity correction is used for
correcting image intensity non-
uniformity caused by transmit field or
receive field. |
| Distortion Correction | Yes | Yes | Distortion correction is used for
correcting the distortion caused by the
non-linear gradient field in image
domain. |
| Image Filter | Yes | Yes | Image filter is used for denoising,
enhancement and edge smoothness. |
| WFI | Yes | Yes | WFI is short for water fat imaging and
separates water and fat signal according
to chemical shift effect. |
| SWI | Yes | Yes | Susceptibility Weighted Imaging (SWI)
uses high-pass filter to generate local
phase map, then it is multiplied onto the
magnitude data to generate SWI image. |
| PC | Yes | Yes | PC combines two images with flow
encoding and without flow encoding to
achieve angiography imaging. |
| GETI | Yes | Yes | GETI is short for gradient echo train
imaging. It combines multi-echo images
by sum-of-square to generate hybrid
T2* contrast. |
| ADC | Yes | Yes | Apparent diffusion coefficient (ADC)
fits logarithm-linear least squares model
to represent water molecular diffusion
motion by DWI technique. |
| FACT | Yes | Yes | FACT is short for fat analysis and
calculation technique and substantially
equivalent to WFI. It not only separates
water and fat signal and quantifies fat
fraction and R2* mapping according to
chemical shift effect and T2* effect. |
| PSIR | Yes | Yes | PSIR is substantially equivalent to FFT
reconstruction and acquire real image
from two TI(time-inversion) images
which is benefit for more stable
contrast. |
| cDWI | Yes | Yes | cDWI is substantially equivalent to
DWI and generates fitting b-value from
multiple acquisition b values. |
| Inline T1/T2* Map | Yes | Yes | Inline T1/T2* Map is substantially
equivalent to T1/T2* Map processed by
post-processing module. The map result
displays inline without extra operation
by post-processing module. |
| Inline T2 Map | Yes | No | Inline T2 Map is substantially
equivalent to T2 Map processed by
post-processing module. The map result
displays inline without extra operation
by post-processing module. |
| SWI+ | Yes | Yes | SWI+ is substantially equivalent to SWI
and acquires multi-echo to achieve more
information than SWI. |
| Arterial Spin
Labeling (ASL) | Yes | Yes | ASL is substantially equivalent to FSE
and uses extra arterial spin labeling
preparation and imaging processing for
cerebral blood flow (CBF) imaging
without contrast agent. |
| Flow Quantification
(FQ) | Yes | No | FQ is substantially equivalent to GRE
and uses extra flow encoding and
imaging processing for flow
quantification. |
| Cardiac T1 Mapping | Yes | No | Cardiac T1 mapping is substantially
equivalent to GRE and uses multiple TI
acquisitions with IR preparation and
imaging processing for cardiac T1
mapping. |
| Cardiac T2 Mapping | Yes | No | Cardiac T2 mapping is substantially
equivalent to GRE and uses multiple
T2-prep duration preparation
acquisitions and imaging processing for
cardiac T2 mapping. |
| Cardiac T2*
Mapping | Yes | No | Cardiac T2* mapping is substantially
equivalent to GRE and uses multiple TE
acquisitions and imaging processing for
cardiac T2* mapping. |
| DeepRecon | Yes | No | DeepRecon is a deep-learning based
image processing algorithm for image |
| | | | |
| | Yes | No | de-noising and K-space-interpolation
based image super-resolution. |
| QScan | | | QScan is short for quiet scan. It doesn't
change the sequence mechanism and
only optimizes gradient waveform to
reduce MR scan acoustic noise. |
| Workflow Features | | | |
| EasyScan | Yes | No | EasyScan feature allows automatic slice
positioning for Head, cardiac, c-spine, t-
spine, l-spine, shoulder, abdomen and
knee imaging. The positioning can also
be adjusted manually by user. The final
positioning effect is equivalent to
manual operation without EasyScan
feature. |
| Function | | | |
| Remote Assistance | Yes | No | Remote Assistance intends for remote
support and service. |
| MR conditional
implant mode | Yes | No | In MR conditional implant mode, user
can set the safety conditions of the MR
conditional implant, and uMR 680
system ensure the scanning complies
with the conditions. |
| Spectroscopy Sequences | | | |
| Liver Spectroscopy | Yes | No | Liver spectroscopy is substantially
equivalent to Spectroscopy and uses
multi-echo acquisition and post-
processing instead of single echo for fat
quantification of liver. |
| Prostate
Spectroscopy | Yes | No | Prostate spectroscopy is substantially
equivalent to Spectroscopy and uses
characteristic metabolites detection post
processing for prostate spectroscopy. |
| Breast Spectroscopy | Yes | No | Breast spectroscopy is substantially
equivalent to Spectroscopy and uses
characteristic metabolites detection post
processing for breast spectroscopy. |
Table 2 Comparison of the new Application Software Features
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Image /page/10/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized symbol that resembles a shield or a letter "U" with a vertical line running through the center. The color of the text and the symbol is a dark teal or blue-gray.
8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]
Summary of Non-Clinical Tests:
The following testing was conducted on the uMR 680 Magnetic Resonance Diagnostic Device as the predicate device:
- A ES60601-1:2005/(R)2012, Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance
- A IEC 60601-1-2 Edition 4.0 2014-02, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
-
60601-2-33 Ed. 3.2:2015 Medical Electrical Equipment - Part 2-33: Particular
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Image /page/11/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is displayed in a bold, sans-serif font, stacked on two lines. To the right of the text is a stylized, geometric shape that resembles the letter "U" with a horizontal line across the top, creating a negative space in the shape of an "I".
Requirements For The Basic Safety And Essential Performance Of Magnetic Resonance Equipment For Medical Diagnostic
- A IEC 60825-1 Edition 2.0 2007-03, Safety Of Laser Products - Part 1: Equipment Classification, And Requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
- A ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- A ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization
-
IEC 62464-1 Edition 2.0: 2018-12, Magnetic resonance equipment for medical imaging Part 1: Determination of essential image quality parameters.
- A MS 1-2008(R2020), Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Images
- MS 2-2008(R2020), Determination of Two-Dimensional Geometric Distortion in A Diagnostic Magnetic Resonance Images
- A MS 3-2008(R2020). Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
- A MS 4-2010, Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
- MS 5-2018, Determination of Slice Thickness in Diagnostic Magnetic A Resonance Imaging
-
MS 6-2008(R2014), Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
- A MS 8-2016, Characterization Of The Specific Absorption Rate For Magnetic Resonance Imaging Systems
- A MS 9-2008(R2020), Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
- A MS 14-2019, Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems
Summary of Clinical Tests:
- Sample clinical images were provided to support the ability of uMR 680 to A generate diagnostic quality images in accordance with the MR guidance on premarket notification submissions.
Summary of the Machine Learning Algorithm (DeepRecon):
DeepRecon is a deep-learning based image processing algorithm for image de-noising and K-space-interpolation based image super-resolution.
The training data of DeepRecon were collected from 264 volunteers. Each subject was scanned by UIH MRI systems for multiple body parts and clinical protocols, resulted in a total of 165.837 cases. In terms of the ground truth and input images in training dataset, the multiple-averaged images with high-resolution and high SNR were collected as the ground-truth images. The input images were generated from the
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ground-truth images by sequentially reducing the SNR and resolution of the groundtruth images. All data were manually quality controlled before included for training.
The DeepRecon has undergone performance testing on 68 US subjects with diverse demographic distributions covering various genders, age groups, ethnicities, and BMI groups (Table a).
| Subjects' Characteristics | Total(N=68) |
|---|---|
| Gender | |
| Male | 24 |
| Female | 44 |
| Age | |
| 18-29 | 11 |
| 30-44 | 14 |
| 45-64 | 24 |
| >=65 | 19 |
| Ethnicity | |
| White | 26 |
| Black | 17 |
| Asian | 19 |
| Hispanic (of any race) | 6 |
| Body Mass Index (BMI) | |
| Underweight (=40) | 5 |
Table a. DeepRecon American Volunteers' Demographic Distribution
The independence of testing datasets were ensured by collecting testing data from various clinical sites and during separated time periods and on subjects different from the training data. Thus, the testing data have no overlap with the training data and are completely independent. The acceptance criteria for performance testing and the corresponding testing results can be found in Table b.
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Image /page/13/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other and are in a bold, sans-serif font. To the right of the words is a stylized "U" shape that is dark gray. The logo is simple and modern.
| Evaluation
| Item | Acceptance Criteria | Test Result | Results |
|---|---|---|---|
| Image SNR | DeepRecon images achieve higher | ||
| SNR compared to the images | |||
| without DeepRecon (NADR) | NADR: 137.03 | ||
| DeepRecon: | |||
| 186.87 | PASS | ||
| Image | |||
| Uniformity | Uniformity difference between | ||
| DeepRecon images and NADR | |||
| images under 5% | 0.03% | PASS | |
| Image | |||
| Resolution | DeepRecon images achieve 10% or | ||
| higher resolution compared to the | |||
| NADR images | 15.57% | PASS | |
| Image | |||
| Contrast | Intensity difference between | ||
| DeepRecon images and NADR | |||
| images under 5% | 1.0% | PASS | |
| Structure | |||
| Measurement | Measurements on NADR and | ||
| DeepRecon images of same | |||
| structures, measurement difference | |||
| under 5% | 0% | PASS |
| Table b. The performance evaluation report criteria of DeepRecon | |||||
|---|---|---|---|---|---|
The DeepRecon has been validated to provide image de-nosing and super-resolution processing using various ethnicities, age groups, BMIs, and pathological variations. In addition, DeepRecon images were evaluated by American Board of Radiologists certificated physicians, covering a range of protocols and body parts. The evaluation reports from radiologists verified that DeepRecon meets the requirements of clinical diagnosis. All DeepRecon images were rated with equivalent or higher scores in terms of diagnosis quality.
The test results demonstrated that the device performs as expected and thus, it is substantially equivalent to the predicate devices to which it has been compared.
9. Conclusion [21 CFR 807.92(b)(3)]
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 concludes that uMR 680 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.