uMR 780
Device Facts
| Record ID | K181370 |
|---|---|
| Device Name | uMR 780 |
| Applicant | Shanghai United Imaging Healthcare Co., Ltd. |
| Product Code | LNH · Radiology |
| Decision Date | Oct 3, 2018 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 892.1000 |
| Device Class | Class 2 |
Indications for Use
The uMR 780 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.
Device Story
The uMR 780 is a 3.0T superconducting magnetic resonance imaging (MRI) system with a 65cm patient bore. It utilizes a magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, and computer system to acquire MR signals. The device transforms these signals into sagittal, transverse, coronal, and oblique cross-sectional and spectroscopic images. It is operated by trained medical professionals in a clinical environment. The resulting images and derived physical parameters are interpreted by a physician to assist in clinical diagnosis. The system supports the use of contrast agents depending on the scan region. The device conforms to NEMA and DICOM standards for image display and data handling.
Clinical Evidence
Bench testing included electrical safety (IEC 60601-1), electromagnetic compatibility (IEC 60601-1-2), MR-specific safety (IEC 60601-2-33), laser safety (IEC 60825-1), and biocompatibility (ISO 10993-5/10). Performance was validated via NEMA MS standards (MS 1-6, 8-9) for SNR, geometric distortion, uniformity, acoustic noise, slice thickness, and phased array characterization. Clinical evidence included a volunteer study to determine gradient-induced nerve stimulation safety limits and sample clinical images demonstrating diagnostic quality.
Technological Characteristics
3.0T superconducting MRI system; 65cm bore. Components: magnet, RF power amplifier, RF coils, gradient power amplifier, gradient coils, patient table, spectrometer, computer, equipment cabinets, power distribution, vital signal module. Conforms to NEMA and DICOM standards. Testing per IEC 60601-1, 60601-1-2, 60601-2-33, IEC 60825-1, ISO 10993-5/10, and NEMA MS 1-6, 8-9.
Indications for Use
Indicated for use as a magnetic resonance diagnostic device to produce cross-sectional and spectroscopic images of the head, body, and extremities to display internal anatomical structure and/or function for diagnostic assistance by a trained physician. Contrast agents may be used.
Regulatory Classification
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).
Special Controls
*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.
Predicate Devices
- MAGNETOM SKYRA (K123510)
Submission Summary (Full Text)
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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Shanghai United Imaging Healthcare Co., Ltd. Xin GAO Regulatory Affairs Specialist No. 2258 Chengbei Rd., Jiading Industrial District SHANGHAI, CHINA 201807
### Re: K181370
Trade/Device Name: uMR 780 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: May 21, 2018 Received: May 23, 2018
### 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
October 3, 2018
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Michael D. O'Hara
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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## Indications for Use
510(k) Number (if known) K181370
Device Name uMR 780
Indications for Use (Describe)
The uMR 780 system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and oblique cross sectional images, and that display internal anatomical structure and/or function of the head, body and extremities.
These images and the physical parameters derived from the interpreted by a trained physician yield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.
Type of Use (Select one or both, as applicable)
| <span style="font-size:100%;"><b></b></span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size:100%;"><b></b></span> 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 text "UNITED" is stacked on top of the text "IMAGING". To the right of the text is a stylized letter "U" that is dark teal in color. The logo is simple and modern.
## 510 (k) SUMMARY
K181370
- 1. Date Prepared [21 CFR 807.92(a)(1)] May 21, 2018
## 2. General Information [21 CFR 807.92(a)(1)]
| Manufacturer: | Shanghai United Imaging Healthcare Co., Ltd<br>2258 Chengbei Rd., Jiading District, Shanghai, 201807 |
|-----------------|------------------------------------------------------------------------------------------------------|
| Contact Person: | Xin GAO |
| | 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 780 |
|--------------------|--------------------------------------|
| Common Name: | Magnetic Resonance Diagnostic Device |
| Model: | uMR 780 |
| 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: SIEMENS AG Device Name: MAGNETOM SKYRA Product Code: LNH Device Class: II Regulation Number: 21 CFR 892.1000 FDA 510 (k) #: K123510
## 5. Device Description [21 CFR 807.92(a)(4)]
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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" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is made up of two vertical lines connected by a curved base. The logo is simple and modern, and the use of a bold font and a strong symbol gives it a sense of authority and trustworthiness.
The uMR 780 is a 3.0T superconducting magnetic resonance diagnostic device with a 65cm 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 780 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.
## 6. Intended Use [21 CFR 807.92(a)(5)]
The uMR 780 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 [21 CFR 807.92(a)(6)]
The uMR 780 has the same major technological characteristics as the predicate device. The differences from the predicate device including high order shimming configuration, interventional usage, RFPA power and external triggering function are discussed in the comparison table in this submission. The same scientific technology theory, similar physical design, same coil applications and functionalities are applied to both the uMR 780 and predicate device. The technical characteristic differences do not affect the safety and effectiveness of the uMR 780 for intended use.
## 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 780 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 3.0 2007-03, Medical Electrical Equipment - Part 1-2: General Requirements For Basic Safety And Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements And Tests
- A 60601-2-33 Ed. 3.1:2013, 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),
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Image /page/5/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 symbol that resembles a shield or a stylized letter U with a vertical line running through it. The logo has a modern and corporate feel.
Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]
- > ISO 10993-5 Third Edition 2009-06-01, Biological Evaluation Of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity
- ISO 10993-10 Third Edition 2010-08-01, Biological Evaluation Of Medical A Devices - Part 10: Tests For Irritation And Skin Sensitization
- > MS 1-2008(R2014), Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Images
- A MS 2-2008(R2014), Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images
- > MS 3-2008(R2014), Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
- > MS 4-2010, Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices
- A MS 5-2010, Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging
- A MS 6-2008(R2014), Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging
- > MS 8-2008, Characterization Of The Specific Absorption Rate For Magnetic Resonance Imaging Systems
- A MS 9-2008(R2014), Standards Publication Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images
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.
## Summary of Clinical Tests:
- A A volunteer study was used to determine the safety limits associated with gradient-induced nerve stimulation.
- Sample clinical images were provided to support the ability of uMR 780 to A generate diagnostic quality images in accordance with the MR guidance on premarket notification submissions.
## 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 780 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.
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