(27 days)
No
The document describes a standard MRI system with a new pulse sequence. There is no mention of AI or ML in the device description, intended use, or performance studies. The image processing mentioned is performed by 3rd party software, not the core device itself, and is for strain analysis, which is a common post-processing technique, not necessarily indicative of AI/ML.
No
The device is a diagnostic device that produces images to assist diagnosis and does not provide therapeutic treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is a "magnetic resonance diagnostic device (MRDD)" and that the images it produces, when interpreted by a trained physician, "yield information that may assist the diagnosis." The "Device Description" also refers to it as a "magnetic resonance diagnostic device."
No
The device description explicitly lists numerous hardware components such as a magnet, RF coils, gradient coils, patient table, spectrometer, and computer, indicating it is a hardware-based medical device with associated software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
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. It is used to assist in diagnosis based on these images and derived physical parameters, interpreted by a trained physician. This describes an in vivo diagnostic process (examining the body directly), not an in vitro process (examining samples outside the body).
- Device Description: The description details components of an MRI system, which is used for imaging the body directly.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on such samples outside the body, which are hallmarks of IVD devices.
Therefore, the uMR 570 system, as described, is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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 images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of the scan.
Product codes (comma separated list FDA assigned to the subject device)
LNH
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 predicate device is uMR 570 (K200024) and the modification to the predicate device in this submission is the addition of a new pulse sequence, gre senc spiral which also exists in reference device of Philips Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (K183063) .
The modification performed on the predicate uMR 570 (K200024) in this submission is due to the addition of a new pulse sequence, gre_senc_spiral. The modification, which does not affect the intended use nor alters the fundamental scientific technology of the device, is as the following:
Introduce gre senc spiral as a new pulse sequence
Mentions image processing
The new sequence, gre_senc_spiral, is intended for acquisition of SENC(Strain ENCoding) cardiac images. The images are stored in DICOM format and processed by 3rd party software for strain analysis and report.
Mentions AI, DNN, or ML
Not Found
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
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following testing was conducted on the proposed devices: Performance Evaluation Report SENC A. 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. No clinical testing was conducted on the proposed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
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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 is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
Shanghai United Imaging Healthcare Co., Ltd. % Xin GAO Regulatory Affairs Specialist NO. 2258 Chengbei Road Shanghai, Shanghai 201807 CHINA
July 6, 2020
Re: K201540
Trade/Device Name: uMR570 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: June 5, 2020 Received: June 9, 2020
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 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
1
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 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.
For
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201540
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 images when interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region 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
June 5, 2020
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: 892.1000 Device Class: II
4. Identification of Predicate Devices(s)
Predicate Device #1 510(k) Number: K200024 Device Name: uMR 570 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH
Reference Device #1 510(k) Number: K183063 Device Name: Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR
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Systems
Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH
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 predicate device is uMR 570 (K200024) and the modification to the predicate device in this submission is the addition of a new pulse sequence, gre senc spiral which also exists in reference device of Philips Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (K183063) .
The modification performed on the predicate uMR 570 (K200024) in this submission is due to the addition of a new pulse sequence, gre_senc_spiral. The modification, which does not affect the intended use nor alters the fundamental scientific technology of the device, is as the following:
Introduce gre senc spiral as a new pulse sequence
6. Intended Use
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.
7. Technological Characteristic
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Image /page/5/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 also in bold. The color of the logo is a dark teal.
The differences from the predicate device are discussed in the comparison table in this submission is added below.
The new sequence, gre_senc_spiral, is intended for acquisition of SENC(Strain ENCoding) cardiac images. The images are stored in DICOM format and processed by 3rd party software for strain analysis and report.
| ITEM | Proposed Device
uMR 570 | Predicate Device
uMR 570 (K200024) | Remark | | | | |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|-------------------------------------------------------------------------------------|---------------------------------------|------|--------|
| 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 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 | | | | |
| Field Strength | 1.5 Tesla | 1.5 Tesla | Same | | | | |
| Type of Magnet | ITEM | Superconducting | Proposed Device
uMR 570 | Superconducting | Predicate Device
uMR 570 (K200024) | Same | Remark |
| Patient-
accessible bore
dimensions | | width 700mm,
height 530mm,
length 1500mm | 0.240ppm @ 20cm DSV | width 700mm,
height 530mm,
length 1500mm | 0.240ppm @ 20cm DSV | Same | |
| Type of
Shielding | | Actively shielded, OIS
technology | 0.040ppm @ 10cm DSV | Actively shielded, OIS
technology | 0.040ppm @ 10cm DSV | Same | |
| Magnet
Homogeneity | Gradient system | 1.4ppm @ 50cm DSV
0.9ppm @ 45cm DSV
0.72ppm @ 40cm DSV
0.420ppm @ 30cm DSV | | 1.4ppm @ 50cm DSV
0.9ppm @ 45cm DSV
0.72ppm @ 40cm DSV
0.420ppm @ 30cm DSV | | Same | |
| 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 | | | | |
| RF system | | | | | | | |
| Resonant
frequencies | 63.87 MHz | 63.87 MHz | Same | | | | |
| Number of
transmit
channels | 1 | 1 | Same | | | | |
| Number of
receive channels | Up to 48 | Up to 48 | Same | | | | |
| Amplifier peak
power 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 Extremity
Coil - 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 | | | | |
Table 1 Comparison of Hardware configuration
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| ITEM | Proposed Device
uMR 570 | Predicate Device
uMR 570 (K200024) | Remark |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|--------|
| 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 |
| Maximum
supported
patient weight | 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 for
Transmit 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 were
tested and demonstrated no
cytotoxicity (ISO 10993-5), no
evidence for irritation and
sensitization (ISO 10993-10) | Patient Contact Materials were
tested and demonstrated no
cytotoxicity (ISO 10993-5), no
evidence for irritation and
sensitization (ISO 10993-10) | Same |
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 Device
uMR 570 | Reference Device
Ingenia and Ingenia CX, Ingenia
Elition, and Ingenia Ambition
MR Systems (K183063) | Remark |
|------------------------|----------------------------|--------------------------------------------------------------------------------------------------------------|--------|
| Imaging Features | | | |
| Strain Encoding (SENC) | Yes | Yes | Same |
8. Non-Clinical Tests
The following testing was conducted on the proposed devices:
- Performance Evaluation Report SENC A
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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. Clinical Tests
No clinical testing was conducted on the proposed devices.
10. 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.