(169 days)
Yes
The device description explicitly mentions "AI-assisted compressed sensing" as a new reconstruction method for certain sequences.
No.
The device is described as a "magnetic resonance diagnostic device (MRDD)" and its "Intended Use / Indications for Use" explicitly states it produces images "that may assist the diagnosis," not for 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 "may assist the diagnosis."
No
The device description explicitly lists numerous hardware components (magnet, RF coils, gradient coils, patient table, etc.) and describes it as a 3.0T superconducting magnetic resonance diagnostic device. The modifications described are additions and changes to pulse sequences and imaging processing methods, which are software components, but they are part of a larger hardware system.
Based on the provided information, 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. These images are then interpreted by a trained physician to assist in diagnosis. This describes an in vivo diagnostic process, where the device interacts directly with the patient's body to acquire data.
- Device Description: The description details the components of an MRI system, which is used for imaging the inside of a living body.
- Lack of IVD Characteristics: An IVD device is typically used to examine specimens (like blood, urine, tissue) taken from the body to provide information about a person's health. The provided information does not mention the analysis of any such specimens.
Therefore, the uMR 780 system, as described, is an in vivo diagnostic device, not an in vitro diagnostic device.
No
The letter explicitly states "Not Found" under the "Control Plan Authorized (PCCP) and relevant text" section, indicating no mention of PCCP approval or clearance.
Intended Use / 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 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
LNH
Device Description
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.
The modification performed on the uMR 780 (K191157) in this submission is due to the following changes that include:
-
- Addition and modification of pulse sequences
- New pulse sequences: gre_quick_wfi, hise, gre_quick_4dcemra, gre_ute, gre_maps.
- Broadened application scope of contrast characteristic for certain sequences: T1, T2, Pd.
- Added associated options for certain sequences: dark blood, navigator, multi-echo, reduced-FOV, computed DWI.
- Added reconstruction methods for certain sequences: compressed sensing, AI-assisted compressed sensing.
-
- 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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Magnetic Resonance (MR)
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)
Non-Clinical Tests:
The following testing was conducted on the proposed devices:
- Performance evaluation report for Spectroscopy, Computed DWI, AI-assisted compressed sensing.
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.
Clinical Tests:
No clinical testing was conducted on the proposed devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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.
Shanghai United Imaging Healthcare Co., Ltd. % Xin Gao Regulatory Affairs Specialist No. 2258 Chengbei Rd, Jiading District Shanghai, Shanghai 201807 CHINA
Re: K193176
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: April 10, 2020 Received: April 13, 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
May 5, 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
2
Indications for Use
510(k) Number (if known) K193176
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 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/2 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 words is a stylized "U" symbol, which is also in a bold font. The logo is simple and modern, and the use of bold fonts gives it a strong and confident look.
510 (k) SUMMARY
1. Date of Prepared
May 2, 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 780 Common Name: Magnetic Resonance Diagnostic Device Model(s): uMR 780 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH
4. Identification of Predicate Device(s)
Predicate Device 510(k) Number: K191157 Device Name: uMR 780/uMR 790 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: II Product Code: LNH
5. Device Description
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
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Image /page/4/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED IMAGING" are in bold, sans-serif font, stacked on top of each other. To the right of the words is a stylized "U" symbol, which is also in a dark, bold color. The logo appears to be for a company in the imaging industry.
standards.
uMR 780 has been previously cleared by FDA via K191157.
The modification performed on the uMR 780 (K191157) in this submission is due to the following changes that include:
-
- Addition and modification of pulse sequences
- New pulse sequences: gre_quick_wfi, hise, gre_quick_4dcemra, gre_ute, a) gre_maps.
- Broadened application scope of contrast characteristic for certain sequences: b) T1, T2, Pd.
- Added associated options for certain sequences: dark blood, navigator, multic) echo, reduced-FOV, computed DWI.
- d) Added reconstruction methods for certain sequences: compressed sensing, AI-assisted compressed sensing.
-
- 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).
The changes on uMR 780 don't affect the intended use or alter the fundamental scientific technology of the device.
3. 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.
4. Technological Characteristic
The updated uMR 780 system in this 510(k) submission has the same hardware configuration as the predicate device. The new/modified pulse sequences and imaging processing methods are software options which employs the same fundamental MRI scientific technology as the predicate device.
5. Non-Clinical Tests
The following testing was conducted on the proposed devices:
- Performance evaluation report for Spectroscopy, Computed DWI, AI-assisted A
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Image /page/5/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other in bold, sans-serif font. To the right of the text is a stylized, dark blue symbol that resembles a shield with a vertical white line running through the center.
compressed sensing.
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.
6. Clinical Tests
No clinical testing was conducted on the proposed devices.
7. 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 the updated uMR 780 Magnetic Resonance Diagnostic Device are substantially equivalent to the predicate devices. It does not introduce new indications for use, and has the same technological characteristics and does not introduce new potential hazards or safety risks.