(23 days)
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the modifications and performance studies do not mention any AI/ML components or capabilities.
No.
The device is described as a "magnetic resonance diagnostic device" used to produce images and physical parameters to assist in diagnosis, not to treat a condition.
Yes
The text explicitly states "The uMR 680 system is indicated for use as a magnetic resonance diagnostic device (MRDD)" and mentions that the images and parameters "when interpreted by a trained physician yield information that may assist the diagnosis."
No
The device description explicitly lists numerous hardware components (magnet, RF power amplifier, RF coils, etc.) and the performance studies include testing of hardware aspects like surface heating, electrical/mechanical safety, and EMC.
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. 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 imaging device, not an in vitro diagnostic device.
- Device Description: The description details the components of an MRI system, which is used for imaging the inside of the body. IVD devices typically involve testing samples (like blood, urine, or tissue) outside the body.
- Performance Studies: The performance studies focus on aspects relevant to an MRI system, such as surface heating, electrical/mechanical safety, SNR, uniformity, biocompatibility, EMC, and clinical image quality of the generated images. These are not the types of performance studies conducted for IVD devices, which would focus on analytical and clinical performance related to the analysis of biological samples.
In summary, the uMR 680 system is an in vivo diagnostic imaging device, specifically an MRI system, and does not fit the definition of an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The uMR 680 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.
Product codes (comma separated list FDA assigned to the subject device)
LNH, MOS
Device Description
The uMR 680 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 680 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards. uMR 680 has been previously cleared by FDA via K222755. The modification performed on uMR 680 (K222755) in this submission is due to the addition of - Breast Coil -24 - epi_se_mre - MRE (Magnetic Resonance Elastography) The modification does not affect the intended use or alter the fundamental scientific technology of the device.
Mentions image processing
Not Found
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 uMR 680 and were provided in support of the substantial determination.
Breast Coil - 24
- Surface heating: Perform test according to NEMA MS 14. Acceptance Criteria: The maximum temperature of all temperature probes shall not exceed 41 °C. Results: Pass.
- General electrical/mechanical safety: Perform test according to ANSI/AAMI ES60601-1. Acceptance Criteria: Conform with ANSI/AAMI ES60601-1. Results: Pass.
- SNR and Uniformity: Perform test according to NEMA MS 1, NEMA MS 3, NEMA MS 6 and NEMA MS 9. Acceptance Criteria: SNR and Uniformity shall fulfill with the design specification. Results: Pass.
- Biocompatibility: Biocompatibility evaluation in agreement with recommendations in Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Acceptance Criteria: Materials of construction and manufacturing materials exempt from testing according to the Biocompatibility guidance (Attachment G), the 510(k) numbers for devices where these materials have been previously approved, or full biocompatibility report (assessment of sensitization, irritation and cytotoxicity risks) for components that have direct contact with the patient. Results: All the materials of patient-contacting components for the Breast Coil - 24 are identical to uMR Omega which was cleared in K230152 in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents).
- EMC-immunity, electrostatic discharge: Perform test according to IEC 60601-1-2 and IEC 60601-4-2. Acceptance Criteria: Conform with IEC 60601-1-2 and IEC 60601-4-2. Results: Pass.
- Clinical image quality: Evaluate the image generated by Breast Coil-24 with the same method as the predicate device. Acceptance Criteria: Image quality is sufficient for diagnostic use. Results: The U.S. Board Certified radiologist approves that image quality is sufficient for diagnostic use.
MRE/epi_se_mre
- General electrical/mechanical safety: Perform test according to ANSI/AAMI ES60601-1. Acceptance Criteria: Conform with ANSI/AAMI ES60601-1. Results: Pass.
- EMC: Perform test according to IEC 60601-1-2 and IEC 60601-4-2. Acceptance Criteria: Conform with IEC 60601-1-2 and IEC 60601-4-2. Results: Pass.
- Performance: Perform a phantom and volunteer test under the proposed device with MRE. Acceptance Criteria: Bias of accuracy, repeatability, reproducibility and parameter sensitivity shall fulfill with the design specification. Results: Pass.
- Clinical image quality: Evaluate the image generated by MRE. Acceptance Criteria: Image quality is sufficient for diagnostic use. Results: The U.S. Board Certified radiologist approves that image quality is sufficient for diagnostic use.
Key results: The test results demonstrated that the device performed as expected and thus, it is substantial equivalent to the predicate devices to which it has been compared.
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.
0
Image /page/0/Picture/0 description: The image shows 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in large, bold, blue letters, and the word "ADMINISTRATION" in smaller, blue letters below.
April 10, 2024
Shanghai United Imaging Healthcare Co., Ltd. % Xin Gao RA Manager No.2258 Chengbei Rd. Jiading District Shanghai, 201807 China
Re: K240744 Trade/Device Name: uMR 680 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, MOS Dated: March 18, 2024 Received: March 18, 2024
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 (the 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 available 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.
1
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
2
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,
Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
| Submission Number (if known) | K240744 |
|---|---|
| Device Name | uMR 680 |
| Indications for Use (Describe) | The uMR 680 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.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Image /page/4/Picture/2 description: The image contains the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" shape, which is also in a bold font. The logo is simple and modern.
510 (k) SUMMARY
1. Date of Prepared
March 18, 2024
Sponsor Identification 2.
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
Identification of Proposed Device(s) 3.
Trade Name: uMR 680 Common Name: Magnetic Resonance Diagnostic Device Model: uMR 680
Regulatory Information Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, MOS Review Panel: Radiology
4. Identification of Predicate Devices(s)
Predicate Device 510(k) Number: K222755 Model: uMR 680 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Review Panel: Radiology
Reference Device 510(k) Number: K230152 Model: uMR Omega
5
Image /page/5/Picture/1 description: The image shows the logo for United Imaging. The words "UNITED" and "IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the words is a stylized "U" shape, which is also in a bold font. The logo is simple and modern, and the colors are muted.
Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Review Panel: Radiology
5. Device Description
The uMR 680 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 680 Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.
uMR 680 has been previously cleared by FDA via K222755. The modification performed on uMR 680 (K222755) in this submission is due to the addition of
- Breast Coil -24
- epi_se_mre
- MRE (Magnetic Resonance Elastography)
The modification does not affect the intended use or alter the fundamental scientific technology of the device.
6. Indications for Use
The uMR 680 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. Comparison of Technological Characteristics with the Predicate Device
The differences from the predicate device are discussed in the comparison table in this submission as below.
| ITEM | Proposed Device
uMR 680 | Predicate Device
uMR 680 (K222755) | Remark |
|------------------------|--------------------------------------------------------------------|--------------------------------------------------------------------|--------|
| Indications
For Use | The uMR 680 system is indicated
for use as a magnetic resonance | The uMR 680 system is indicated
for use as a magnetic resonance | Same |
Table 1 Comparison to Predicate Device
6
Image /page/6/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" symbol, which is dark gray. The logo is simple and modern in design.
| ITEM | Proposed Device
uMR 680 | Predicate Device
uMR 680 (K222755) | Remark |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 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. | | 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. | |
| Breast
Coil - 24 | Yes | No | The intended use of
Breast coil -24 is
equivalent to previously
cleared Breast Coil-10.
The difference between
them is the number of
channels of the receiver
coil.
The difference did not
raise new safety and
effectiveness concerns. |
Table 2 Comparison to Reference Device
| ITEM | Proposed Device
uMR 680 | Predicate Device
uMR Omega (K230152) | Remark |
|------|----------------------------|-----------------------------------------|--------|
| MRE | Yes | Yes | Same |
Based on the comparison and analysis above, the proposed device has same intended use, similar performance, equivalence safety and effeteness in hardware and software as the predicate device. The differences above between the proposed device and predicate device do not affect the intended use, technology characteristics, safety and effectiveness. And no issues are raised regarding to safety and effectiveness.
Performance Data 8.
The following testing was conducted on uMR 680 and were provided in support of the substantial determination.
| Item | Verification/Validation Method(s) | Acceptance Criteria | Summary of Results | |
|---|---|---|---|---|
| Breast Coil - 24 | ||||
| Surface heating | Perform test according to NEMA MS 14 | The maximum temperature of all temperature probes shall not exceed 41 °C. | Pass | |
| General electrical/mechanical safety | Perform test according to ANSI/AAMI ES60601-1 | Conform with ANSI/AAMI ES60601-1 | Pass | |
| SNR and Uniformity | Perform test according to NEMA MS 1, NEMA MS 3, NEMA MS 6 and NEMA MS 9 | SNR and Uniformity shall fulfill with the design specification. | Pass | |
| Biocompatibility | Biocompatibility evaluation in agreement with recommendations in Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" | Materials of construction and manufacturing materials exempt from testing according to the Biocompatibility guidance (Attachment G), the 510(k) numbers for devices where these materials have been previously approved, or full biocompatibility report (assessment of sensitization, irritation and cytotoxicity risks) for components that have direct contact with the patient. | All the materials of patient- contacting components for the Breast Coil - 24 are identical to uMR Omega which was cleared in K230152 in formulation, processing, sterilization, and geometry, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents). | |
| EMC-immunity, electrostatic discharge | Perform test according to IEC 60601-1-2 and IEC 60601-4-2 | Conform with IEC 60601-1-2 and IEC 60601-4-2 | Pass | |
| Clinical image quality | Evaluate the image generated by Breast Coil-24 with the same method as the predicate device | Image quality is sufficient for diagnostic use. | The U.S. Board Certified radiologist approves that image quality is sufficient for diagnostic use. | |
| MRE/epi_se_mre | ||||
| General electrical/mechanical safety | Perform test according to ANSI/AAMI ES60601-1 | Conform with ANSI/AAMI ES60601-1 | Pass | |
| EMC | Perform test according to IEC 60601-1-2 and IEC 60601-4-2 | Conform with IEC 60601-1-2 and IEC 60601-4-2 | Pass | |
| Performance | Perform a phantom and volunteer test under the proposed device with MRE | Bias of accuracy, repeatability, reproducibility and parameter sensitivity shall fulfill with the design specification. | Pass | |
| Clinical | ||||
| quality | image | Evaluate the image generated by MRE | Image quality is sufficient | |
| for diagnostic use. | The U.S. Board Certified | |||
| radiologist approves that | ||||
| image quality is sufficient | ||||
| for diagnostic use. |
7
Image /page/7/Picture/1 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 "U" symbol, which is dark teal in color and has a vertical white line running through the center.
8
Image /page/8/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the word "UNITED" stacked on top of the word "IMAGING". To the right of the words is a stylized letter "U" that is dark gray. The logo is simple and modern.
The test results demonstrated that the device performed as expected and thus, it is substantial equivalent to the predicate devices to which it has been compared.
Conclusion 9.
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 680 Magnetic Resonance Diagnostic Device is substantially equivalent to the predicate device. It does not introduce new indications for use, and performance test results support that the technical characteristic change of the Breast Coil - 24 (i.e., the number of channels in the coil) and incorporating MRE/epi_se_mre do not introduce new potential hazards or safety risks.