(25 days)
The uMR Omega system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and obligue 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 vield information that may assist the diagnosis. Contrast agents may be used depending on the region of interest of the scan.
The uMR Omega is a 3.0T superconducting magnetic resonance diagnostic device with a 75cm 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 Omega Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.
uMR Omega has been previously cleared by FDA via K230152. The modification performed on uMR Omega (K230152) in this submission is due to the addition of Breast Coil -24.
The modification does not affect the intended use or alter the fundamental scientific technology of the device.
The provided text describes the regulatory clearance of the uMR Omega magnetic resonance diagnostic device, specifically focusing on the addition of a new Breast Coil - 24. The submission demonstrates substantial equivalence to a previously cleared predicate device (uMR Omega, K230152).
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. A table of acceptance criteria and the reported device performance
| Item | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Surface heating | The maximum temperature of all temperature probes shall not exceed 41℃. | Pass |
| General electrical/mechanical safety | Conform with ANSI/AAMI ES60601-1 | Pass |
| SNR and Uniformity | SNR and Uniformity shall fulfill the design specification. | Pass |
| Biocompatibility | Materials of construction and manufacturing materials exempt from testing according to the Biocompatibility guidance..., the 510(k) numbers for devices where these materials have been previously approved, or full biocompatibility report... 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. |
| EMC-immunity, electrostatic discharge | Conform with IEC 60601-1-2 and IEC 60601-4-2 | Pass |
| Clinical image quality | Image quality is sufficient for diagnostic use. | The U.S. Board Certified radiologist approves that image quality is sufficient for diagnostic use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not provide explicit details on the sample size for any of the tests, nor does it specify the data provenance (e.g., country of origin, retrospective or prospective) for the clinical image quality evaluation or any other performance tests.
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)
For the "Clinical image quality" test, the document states: "The U.S. Board Certified radiologist approves that image quality is sufficient for diagnostic use."
- Number of experts: Singular ("The U.S. Board Certified radiologist"), implying one expert.
- Qualifications of experts: "U.S. Board Certified radiologist." No information on years of experience is provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Based on the mention of "The U.S. Board Certified radiologist approves," the adjudication method for clinical image quality appears to be none, as a single expert's approval is noted. There is no indication of multiple reviewers or an adjudication process for disagreement.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study being done. This submission focuses on the performance of a medical device (uMR Omega with a new coil) rather than an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document refers to a Magnetic Resonance Diagnostic Device (MRDD), which produces images for interpretation by a trained physician. It does not describe an algorithm with standalone performance, but rather a hardware component (MRI system with a new coil). Therefore, a standalone (algorithm only) performance study is not applicable and was not done in the context described.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Clinical image quality" test, the ground truth is established by expert opinion/approval ("The U.S. Board Certified radiologist approves that image quality is sufficient for diagnostic use."). Other tests (Surface heating, electrical/mechanical safety, SNR and Uniformity, EMC) rely on defined physical and engineering standards/specifications. Biocompatibility refers to material identity with a previously approved device.
8. The sample size for the training set
This document does not mention a training set. The device is a Magnetic Resonance Diagnostic Device (hardware), not an algorithm that requires a training set in the conventional sense. The "training set" concept is typically relevant for machine learning or AI algorithms.
9. How the ground truth for the training set was established
As no training set is mentioned (see point 8), this information is not provided and is not applicable to the context of this device 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 a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 22, 2024
Shanghai United Imaging Healthcare Co., Ltd. % Xin Gao RA Manager No. 2258 Chengbei Rd. Jiading District Shanghai. 201807 China
Re: K240540
Trade/Device Name: uMR Omega Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, MOS Dated: February 24, 2024 Received: February 26, 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.
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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 (QS) 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.
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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,
D. Ryker
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
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Indications for Use
Submission Number (if known)
Device Name
uMR Omega
Indications for Use (Describe)
The uMR Omega system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces sagittal, transverse, coronal, and obligue 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 vield 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/4/Picture/1 description: The image shows the text "K240540" at the top. Below that is 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" shape, also in a bold font.
510 (k) SUMMARY
1. Date of Prepared
February 26, 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
3. Identification of Proposed Device(s)
Trade Name: uMR Omega Common Name: Magnetic Resonance Diagnostic Device Model: uMR Omega
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: K230152 Model: uMR Omega Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Review Panel: Radiology
Device Description 5.
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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 letter "U" that is also in a bold font. The logo is simple and modern.
The uMR Omega is a 3.0T superconducting magnetic resonance diagnostic device with a 75cm 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 Omega Magnetic Resonance Diagnostic Device is designed to conform to NEMA and DICOM standards.
uMR Omega has been previously cleared by FDA via K230152. The modification performed on uMR Omega (K230152) in this submission is due to the addition of Breast Coil -24.
The modification does not affect the intended use or alter the fundamental scientific technology of the device.
6. Indications for Use
The uMR Omega 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 DeviceuMR Omega | Predicate DeviceuMR Omega (K230152) | Remark |
|---|---|---|---|
| Indications ForUse | The uMR Omega system isindicated for use as a magneticresonance diagnostic device(MRDD) that produces sagittal,transverse, coronal, and obliquecross sectional images, andspectroscopic images, and thatdisplay internal anatomical structureand/or function of the head, bodyand extremities.These images and the physicalparameters derived from the imageswhen interpreted by a trainedphysician yield information that | The uMR Omega system isindicated for use as a magneticresonance diagnostic device(MRDD) that produces sagittal,transverse, coronal, and obliquecross sectional images, andspectroscopic images, and thatdisplay internal anatomical structureand/or function of the head, bodyand extremities.These images and the physicalparameters derived from the imageswhen interpreted by a trainedphysician yield information that | Same |
Table 1 Comparison of Modification
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| ITEM | Proposed DeviceuMR Omega | Predicate DeviceuMR Omega (K230152) | Remark |
|---|---|---|---|
| may assist the diagnosis. Contrastagents may be used depending onthe region of interest of the scan. | may assist the diagnosis. Contrastagents may be used depending onthe region of interest of the scan. | may assist the diagnosis. Contrastagents may be used depending onthe region of interest of the scan. | |
| Breast Coil - 24 | Yes | No | Note 1 |
The intended use of Breast coil -24 is equivalent to previously cleared Breast Coil-10. The difference Note between them is the number of channels of the receiver coil. 1 The difference did not raise new safety and effectiveness concerns.
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 Omega and were provided in support of the substantial determination.
| Item | Verification/ValidationMethod(s) | Acceptance Criteria | Summary of Results |
|---|---|---|---|
| Surface heating | Perform test according toNEMA MS 14 | The maximum temperatureof all temperature probesshall not exceed 41℃. | Pass |
| Generalelectrical/mechanicalsafety | Perform test according toANSI/AAMI ES60601-1 | Conform withANSI/AAMI ES60601-1 | Pass |
| SNR and Uniformity | Perform test according toNEMA MS 1, NEMA MS3, NEMA MS 6 andNEMA MS 9 | SNR and Uniformity shallfulfill the designspecification. | Pass |
| Biocompatibility | Biocompatibilityevaluation in agreementwith recommendations inUse of InternationalStandard ISO 10993-1,"Biological evaluation ofmedical devices - Part 1:Evaluation and testing | Materials of constructionand manufacturingmaterials exempt fromtesting according to theBiocompatibility guidance(Attachment G), the510(k) numbers fordevices where these | All the materials ofpatient-contactingcomponents for the BreastCoil - 24 are identical touMR Omega which wascleared in K230152 informulation, processing,sterilization, and |
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Image /page/7/Picture/1 description: The image shows 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 words is a stylized "U" shape, which is also in a bold font. The color of the logo is a dark teal.
| within a risk managementprocess" | materials have beenpreviously approved, orfull biocompatibility report(assessment ofsensitization, irritation andcytotoxicity risks) forcomponents that havedirect contact with thepatient. | geometry, and no otherchemicals have beenadded (e.g., plasticizers,fillers, additives, cleaningagents, mold releaseagents). | |
|---|---|---|---|
| EMC-immunity,electrostatic discharge | Perform test according toIEC 60601-1-2 and IEC60601-4-2 | Conform with IEC 60601-1-2 and IEC 60601-4-2 | Pass |
| Clinical image quality | Evaluate the imagegenerated by Breast Coil-24 with the same methodas the predicate device | Image quality is sufficientfor diagnostic use. | The U.S. Board Certifiedradiologist approves thatimage quality is sufficientfor diagnostic use. |
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.
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 conclude that the uMR Omega 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) 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.