(27 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 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 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
The provided text is a 510(k) Summary for the uMR 570 Magnetic Resonance Diagnostic Device. It focuses on demonstrating substantial equivalence to a predicate device, primarily due to the addition of a new pulse sequence called "gre_senc_spiral."
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics for the new pulse sequence. Instead, it focuses on qualitative comparisons and safety compliance. The claim is that the device "performs as expected" and is "substantially equivalent" to the predicate.
| Acceptance Criteria Category | Acceptance Criteria (Not explicitly stated quantitatively for the new feature, but implied by "substantial equivalence" and safety compliance) | Reported Device Performance (as stated or implied) |
|---|---|---|
| For new pulse sequence (gre_senc_spiral): | Intended use remains the same as predicate. | The modification (gre_senc_spiral) "does not affect the intended use nor alters the fundamental scientific technology of the device." Images are stored in DICOM format and suitable for 3rd party strain analysis. |
| Does not introduce new potential hazards or safety risks. | "It does not introduce new potential hazards or safety risks." Tested for Electrical Safety (Comply with ES60601-1), EMC (Comply with IEC60601-1-2), Max SAR (Comply with IEC 60601-2-33), Max dB/dt (Comply with IEC 60601-2-33), Biocompatibility (ISO 10993-5, ISO 10993-10). | |
| Overall Device: | Maintain technological characteristics similar to the predicate. | "has the same technological characteristics" as the predicate uMR 570 (K200024) in terms of magnet, gradient, RF system, coils, patient table, and safety, except for the new pulse sequence. |
| Performs as expected. | "The test results demonstrated that the device performs as expected." |
2. Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The "Performance Evaluation Report SENC A" is mentioned but no details about its contents or the number of cases/patients used are provided.
- Data Provenance: Not explicitly stated. Given it's a performance evaluation for a 510(k) submission, it's likely internal company data, but the country of origin and whether it was retrospective or prospective are not mentioned.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document. The statement mentions "images... when interpreted by a trained physician," implying physician involvement in diagnosis, but not specifically for establishing ground truth of a test set for the device's performance evaluation.
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:
- No MRMC comparative effectiveness study was done. The device itself is a Magnetic Resonance Diagnostic Device (MRDD), an imaging system, not an AI-based interpretation tool. The new pulse sequence (
gre_senc_spiral) is for acquiring SENC cardiac images, which are then "processed by 3rd party software for strain analysis and report." This submission is for the imaging device and the new acquisition sequence, not for the AI analysis of these images.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not done for this device as an AI algorithm. This submission is for an MRI system and a new pulse sequence. The "3rd party software for strain analysis" is separate and not part of this 510(k) submission.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- This information is not provided for the performance evaluation of the
gre_senc_spiralsequence. The purpose of this 510(k) is to demonstrate that the new sequence produces images that can be interpreted like those from an equivalent predicate, and that it's safe. It's not about evaluating diagnostic accuracy against a specific ground truth.
8. The sample size for the training set:
- Not applicable. This submission is for a hardware (MRI system) and a new pulse sequence (software component for acquisition). There is no mention of an AI algorithm being trained by the manufacturer for this device, nor a training set for the performance testing mentioned.
9. How the ground truth for the training set was established:
- Not applicable. As above, there is no mention of a training set or AI algorithm training within this submission.
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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
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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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Image /page/3/Picture/1 description: The image contains the logo for United Imaging. The words "UNITED 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.
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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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 DeviceuMR 570 | Predicate DeviceuMR 570 (K200024) | Remark | ||||
|---|---|---|---|---|---|---|---|
| Product Code | LNH | LNH | Same | ||||
| Regulation No. | 21 CFR 892.1000 | 21 CFR 892.1000 | Same | ||||
| Class | II | II | Same | ||||
| Indications ForUse | The uMR 570 system isindicated for use as a magneticresonance diagnostic device(MRDD) that produces sagittal,transverse, coronal, and obliquecross sectional images, andspectroscopic images, and thatdisplay internal anatomicalstructure and/or function of thehead, body and extremities.These images and the physicalparameters derived from theimages when interpreted by atrained physician yieldinformation that may assist thediagnosis. Contrast agents maybe used depending on theregion of interest of the scan. | The uMR 570 system is indicatedfor use as a magnetic resonancediagnostic device (MRDD) thatproduces sagittal, transverse,coronal, and oblique crosssectional images, andspectroscopic images, and thatdisplay internal anatomicalstructure and/or function of thehead, body and extremities.These images and the physicalparameters derived from theimages when interpreted by atrained physician yieldinformation that may assist thediagnosis. Contrast agents maybe used depending on the regionof interest of the scan. | Same | ||||
| Field Strength | 1.5 Tesla | 1.5 Tesla | Same | ||||
| Type of Magnet | ITEM | Superconducting | Proposed DeviceuMR 570 | Superconducting | Predicate DeviceuMR 570 (K200024) | Same | Remark |
| Patient-accessible boredimensions | width 700mm,height 530mm,length 1500mm | 0.240ppm @ 20cm DSV | width 700mm,height 530mm,length 1500mm | 0.240ppm @ 20cm DSV | Same | ||
| Type ofShielding | Actively shielded, OIStechnology | 0.040ppm @ 10cm DSV | Actively shielded, OIStechnology | 0.040ppm @ 10cm DSV | Same | ||
| MagnetHomogeneity | Gradient system | 1.4ppm @ 50cm DSV0.9ppm @ 45cm DSV0.72ppm @ 40cm DSV0.420ppm @ 30cm DSV | 1.4ppm @ 50cm DSV0.9ppm @ 45cm DSV0.72ppm @ 40cm DSV0.420ppm @ 30cm DSV | Same | |||
| Max gradientamplitude | 45mT/m | 45mT/m | Same | ||||
| Max slew rate | 200T/m/s | 200T/m/s | Same | ||||
| Shielding | active | active | Same | ||||
| Cooling | water | water | Same | ||||
| RF system | |||||||
| Resonantfrequencies | 63.87 MHz | 63.87 MHz | Same | ||||
| Number oftransmitchannels | 1 | 1 | Same | ||||
| Number ofreceive channels | Up to 48 | Up to 48 | Same | ||||
| Amplifier peakpower perchannel | 20 kW | 20 kW | Same | ||||
| RF Coils | |||||||
| Head & NeckCoil -16 | Yes | Yes | Same | ||||
| Body Array Coil- 6 | Yes | Yes | Same | ||||
| Body Array Coil- 12 | Yes | Yes | Same | ||||
| Breast Coil - 10 | Yes | Yes | Same | ||||
| Flex Coil Large- 4 | Yes | Yes | Same | ||||
| Flex Coil Small- 4 | Yes | Yes | Same | ||||
| Knee Coil - 12 | Yes | Yes | Same | ||||
| Lower ExtremityCoil - 24 | Yes | Yes | Same | ||||
| Shoulder Coil -12 | Yes | Yes | Same | ||||
| Small Loop Coil | Yes | Yes | Same | ||||
| Spine Coil - 24 | Yes | Yes | Same | ||||
| Wrist Coil - 12 | Yes | Yes | Same | ||||
| Cardiac Coil -24 | Yes | Yes | Same |
Table 1 Comparison of Hardware configuration
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| ITEM | Proposed DeviceuMR 570 | Predicate DeviceuMR 570 (K200024) | Remark |
|---|---|---|---|
| Foot & AnkleCoil - 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 |
| Maximumsupportedpatient weight | 250 kg | 250 kg | Same |
| Accessories | |||
| Vital SignalGating | ECG, Peripheral Pulse Gating,Respiratory Gating | ECG, Peripheral Pulse Gating,Respiratory Gating | Same |
| Safety | |||
| Electrical Safety | Comply with ES60601-1 | Comply with ES60601-1 | Same |
| EMC | Comply with IEC60601-1-2 | Comply with IEC60601-1-2 | Same |
| Max SAR forTransmit Coil | Comply with IEC 60601-2-33 | Comply with IEC 60601-2-33 | Same |
| Max dB/dt | Comply with IEC 60601-2-33 | Comply with IEC 60601-2-33 | Same |
| Biocompatibility | Patient Contact Materials weretested and demonstrated nocytotoxicity (ISO 10993-5), noevidence for irritation andsensitization (ISO 10993-10) | Patient Contact Materials weretested and demonstrated nocytotoxicity (ISO 10993-5), noevidence for irritation andsensitization (ISO 10993-10) | Same |
Table 2 provides the new application software features of the proposed device in comparison to the predicate device.
Table 2 Comparison of the new Application Software Features
| ITEM | Proposed DeviceuMR 570 | Reference DeviceIngenia and Ingenia CX, IngeniaElition, and Ingenia AmbitionMR 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.
§ 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.