(105 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 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 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 provided text describes a 510(k) premarket notification for the uMR 570 Magnetic Resonance Diagnostic Device. It details the device's technical specifications and compares it to a previously cleared predicate device (K180925). The focus of the submission is on modifications to the predicate device, including new RF coils, pulse sequences, and imaging processing methods.
However, the document does not describe, in detail, the acceptance criteria for specific performance metrics or the studies that prove the device meets those criteria with quantitative results. Instead, it generally 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." The testing listed is primarily technical and safety performance, as opposed to clinical or diagnostic performance with specific acceptance criteria.
Therefore, much of the requested information cannot be extracted from the provided text. I will populate the table and answer the questions based on the information available.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Image Signal to Noise Ratio | "Performs as expected" (not quantified) |
| Image Uniformity | "Performs as expected" (not quantified) |
| Performance testing for Spectroscopy | "Performs as expected" (not quantified) |
| Performance testing for Computed DWI | "Performs as expected" (not quantified) |
| Surface Heating of RF Receive | "Performs as expected" (not quantified) |
| ES 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance | "Comply with ES60601-1" |
| IEC 60601-1-2 Medical electrical equipment Part 1-2: General Requirements for basic safety and essential Performance | "Comply with IEC60601-1-2" |
| IEC 60601-2-33 Medical Electrical Equipment - Part 2-33: Particular Requirements For The Basic Safety And Essential Performance Of Magnetic Resonance Equipment For Medical Diagnostic | "Comply with IEC60601-2-33" |
| Clinical performance evaluation | "Performs as expected" (not quantified) |
| Biocompatibility | Patient Contact Materials were tested and demonstrated no cytotoxicity (ISO 10993-5), no evidence for irritation and sensitization (ISO 10993-10). |
| Performance testing for Inline T1/T2*Map | "Performs as expected" (not quantified) |
| Performance testing for SWI+ | "Performs as expected" (not quantified) |
| Performance testing for Easy-scan | "Performs as expected" (not quantified) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document mentions "Clinical performance evaluation" but does not detail the nature of this evaluation, the sample size, or data provenance.
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. While it states that images are "interpreted by a trained physician," there is no detail on the number or qualifications of experts for ground truth establishment during testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the document. This device is an MRI system, not explicitly a an AI/CAD device. The new features like Inline T1/T2*Map, PSIR, cDWI, and SWI+ are imaging processing methods, not AI assistance for human readers in the context of comparative effectiveness.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not provided in the document. The device itself is an MRDD that produces images to be interpreted by a trained physician; it does not describe a standalone algorithm for diagnostic output without human interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document primarily focuses on technical performance and equivalence to a predicate device. For the "Clinical performance evaluation," the type of ground truth used is not specified. For the general use of the device, images are "interpreted by a trained physician," implying clinical diagnosis as the ultimate ground for interpretation, but not in the context of establishing ground truth for a formal evaluation of the device's diagnostic accuracy.
8. The sample size for the training set
The document describes the device, its modifications, and performance testing for regulatory clearance. It does not mention any training set as this is not a submission for an AI/ML algorithm that typically requires a training set. The "new application software features" are described as "substantially equivalent" to conventional methods, not as machine learning models that require training.
9. How the ground truth for the training set was established
As no training set is mentioned (see point 8), this information is not applicable.
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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 acronym and full name on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out next to it.
Shanghai United Imaging Healthcare Co., Ltd. % Xin Gao Regulatory Affairs Specialist NO. 2258 Chengbei Road, Jiading District Shanghai, Shanghai 201807 CHINA
Re: K200024
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: April 3, 2020 Received: April 7, 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
April 20, 2020
{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)
Device Name uMR 570
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 imerpreted 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/2 description: The image contains the logo for United Imaging. The logo consists of the word "UNITED" stacked on top of the word "IMAGING", both in a bold, sans-serif font. To the right of the text is a stylized graphic element that resembles a shield or emblem. The emblem is divided vertically by a white line, and a horizontal white line crosses the vertical line near the top, creating a "T" shape within the shield.
510 (k) SUMMARY
1. Date of Prepared
April 03, 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 510(k) Number: K180925 Device Name: uMR 570 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
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standards.
uMR 570 has been previously cleared by FDA via K180925.
The modification performed on the uMR 570(K180925) in this submission is due to the following changes that include:
- Addition of Radio Frequency Coils: Head Coil-24, Head Coil-12, Carotid Coil-8 1.
- Addition and modification of pulse sequences 2.
- New sequences: gre quick wfi, hise, gre quick 4dcemra, gre ute, a) gre_maps
- b) Broadened application scope of Contrast characteristic for certain sequences: T1,T2, Pd, T2/T1
- Added certain sequences Associated options: dark blood, navigator, multic) echo , reduced-FOV, cDWI
- Added Reconstruction method for certain sequences: compressed sensing d)
-
- Addition of imaging processing methods: FACT(Fat Analysis and Calculation Technique), PSIR (Phase Sensitive Inversion Recovery), cDWI (Computed DWI), Inline T1/T2* Map, SWI+ (Susceptibility Weighted Imaging Plus)
These modifications do not affect the intended use or alter the fundamental scientific technology of the device.
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
The differences from the predicate device are discussed in the comparison table in this submission is added below.
| ITEM | Proposed DeviceuMR 570 | Predicate DeviceuMR 570 (K180925) | Remark |
|---|---|---|---|
| General | |||
| Product Code | LNH | LNH | Same |
| Regulation No. | 21 CFR 892.1000 | 21 CFR 892.1000 | Same |
| Class | II | II | Same |
| ITEM | Proposed DeviceuMR 570 | Predicate DeviceuMR 570 (K180925) | Remark |
| Indications For Use | The uMR 570 system isindicated for use as amagnetic resonancediagnostic device(MRDD) that producessagittal, transverse,coronal, and obliquecross sectional images,and spectroscopicimages, and that displayinternal anatomicalstructure and/or functionof the head, body andextremities.These images and thephysical parametersderived from the imageswhen interpreted by atrained physician yieldinformation that mayassist the diagnosis.Contrast agents may beused depending on theregion of interest of thescan. | The uMR 570 system isindicated for use as amagnetic resonancediagnostic device(MRDD) that producessagittal, transverse,coronal, and obliquecross sectional images,and spectroscopicimages, and that displayinternal anatomicalstructure and/or functionof the head, body andextremities.These images and thephysical parametersderived from theimages wheninterpreted by a trainedphysician yieldinformation that mayassist the diagnosis.Contrast agents may beused depending on theregion of interest of thescan. | Same |
| Magnet system | |||
| Field Strength | 1.5 Tesla | 1.5 Tesla | Same |
| Type of Magnet | Superconducting | Superconducting | Same |
| Patient-accessible boredimensions | width 700mm,height 530mm,length 1500mm | width 700mm,height 530mm,length 1500mm | Same |
| Type ofShielding | 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 Device uMR 570 | Predicate Device uMR 570 (K180925) | Remark |
| 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 |
| Foot & Ankle Coil - 24 | Yes | Yes | Same |
| Temporomandibular Joint Coil - 4 | Yes | Yes | Same |
| ITEM | Proposed DeviceuMR 570 | Predicate DeviceuMR 570 (K180925) | Remark |
| Head Coil - 24 | Yes | No | The intended use isequivalent topreviously clearedHead & Neck Coil -16for head scan. Morecoil elements in thenew coil allow betterimage quality andacceleration. |
| Head Coil - 12 | Yes | No | The intended use isequivalent topreviously clearedHead & Neck Coil -16for head scan. Morecoil elements in thenew coil allow betterimage quality andacceleration. |
| Carotid Coil - 8 | Yes | No | The intended use isequivalent topreviously clearedFlex Coil Small - 4 forneck scan. More coilelements in the newcoil allow better imagequality andacceleration. |
| Patient table | |||
| Dimensions | width 640mm, height880mm, length 2620mm | width 640mm, height880mm, length2620mm | Same |
| Maximumsupportedpatient weight | 250 kg | 250 kg | Same |
| Accessories | |||
| Vital SignalGating | ECG, Peripheral PulseGating, Respiratory Gating | ECG, Peripheral PulseGating, Respiratory Gating | Same |
| Safety | |||
| Electrical Safety | Comply with ES60601-1 | Comply with ES60601-1 | Same |
| EMC | Comply with IEC60601-1-2 | Comply withIEC60601-1-2 | Same |
| ITEM | Proposed DeviceuMR 570 | Predicate DeviceuMR 570 (K180925) | Remark |
| Max SAR forTransmit Coil | Comply with IEC60601-2-33 | Comply with IEC60601-2-33 | Same |
| Max dB/dt | Comply with IEC60601-2-33 | Comply with IEC60601-2-33 | Same |
| Biocompatibility | Patient Contact Materialswere tested anddemonstrated nocytotoxicity (ISO 10993-5), no evidence forirritation andsensitization (ISO10993-10). | Patient ContactMaterials were testedand demonstrated nocytotoxicity (ISO10993-5), no evidencefor irritation andsensitization (ISO10993-10). | Same |
Table 1 Comparison of Hardware configuration
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Image /page/5/Picture/1 description: The image contains 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 text is a stylized "U" shape, which is also in a dark color. The logo appears to be for a company in the imaging or medical technology field.
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Image /page/6/Picture/1 description: The image contains the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the words is a stylized logo that appears to be a letter "U" with a vertical line running through the center, creating a negative space "I" shape. The color of the text and logo is a dark teal or gray.
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Image /page/7/Picture/1 description: The image contains 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 text is a stylized "U" symbol, which is dark gray. The logo is simple and modern.
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Image /page/8/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 words is a stylized letter "U" that is also in a bold font. The logo is a dark teal color.
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 | ProposedDeviceuMR 570 | PredicateDeviceuMR 570(K180925) | Remark |
|---|---|---|---|
| Imaging Features | |||
| Inline T1/T2*Map | Yes | No | Inline T1/T2Map is significantlyequivalent to single-echo/multi-echo gradient-echo imaging. Quantitative T1 and T2 maps are generated from variable flip angle and multi-echo images, respectively. |
| Phase SensitiveInversion Recovery(PSIR) | Yes | No | PSIR is substantially equivalentto conventional inversion recovery (IR) and uses phase sensitive reconstruction to produce real imageinstead of magnitude image. |
| Computed DWI (cDWI) | Yes | No | cDWI calculates and outputsdiffusion-weighted images withuser-input b-values and issubstantially equivalent toconventional DWI. |
| Susceptibility WeightedImaging Plus (SWI+) | Yes | No | SWI+ is substantially equivalentto SWI and uses multi-echo inacquisition and reconstructioninstead of single echo. |
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Image /page/9/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 split in the middle by a vertical line. The logo is simple and modern, and the colors are muted.
| Easy Scan | Yes | No | Easy Scan feature allowsautomatic slice positioning forhead, cardiac, c-spine and kneeimaging. The positioning can alsobe adjusted manually from user.The final positioning effect isequivalent to manual operationwithout Easy Scan feature. |
|---|---|---|---|
| ----------- | ----- | ---- | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
8. Substantial Equivalence
The following testing was conducted on the proposed devices:
- A Image Signal to Noise Ratio
- A Image Uniformity
- A Performance testing for Spectroscopy, Computed DWI
- A Surface Heating of RF Receive
- A ES 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
- A IEC 60601-1-2 Medical electrical equipment Part 1-2: General Requirements for basic safety and essential Performance
-
IEC 60601-2-33 Medical Electrical Equipment - Part 2-33: Particular Requirements For The Basic Safety And Essential Performance Of Magnetic Resonance Equipment For Medical Diagnostic
- Clinical performance evaluation A
- A Biocompatibility
- A Performance testing for Inline T1/T2*Map
- A Performance testing for SWI+
-
Performance testing for Easy-scan
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 concludes 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.