(208 days)
Not Found
No
The summary does not mention AI, ML, or any related terms in the device description, intended use, or performance studies. The focus is on standard MRI technology and image generation.
No.
The device is indicated for diagnostic purposes to assist medical diagnosis, not for treating or rehabilitating a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the "NEONA 1.5T MRI system is indicated for use as a magnetic resonance diagnostic device (MRDD)".
No
The device description explicitly lists multiple hardware components (Magnet, Magnet Enclosure, Patient Table, Gradient Coil, Transmission Coil, Receiver Coil, Client PC, and Imaging Cabinet) in addition to the software.
Based on the provided information, the NEONA 1.5T MRI system is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- NEONA MRI System Function: The NEONA MRI system is described as a device that produces images of the internal structure and/or function of the head, body, or extremities. It works by using magnetic fields and radio waves to create these images.
- Lack of Specimen Analysis: The description does not mention the analysis of any specimens taken from the body. The device directly interacts with the patient's body to generate images.
Therefore, the NEONA 1.5T MRI system falls under the category of an in vivo diagnostic device, as it performs diagnostic procedures directly on a living organism (the patient).
N/A
Intended Use / Indications for Use
NEONA 1.5T MRI system is indicated for use as a magnetic device (MRDD) which produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal struction of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by trained physician yield information that may assist medical diagnosis.
Product codes
LNH
Device Description
The NEONA 1.5T MRI System is a 1.5T superconducting magnet MRI system which produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. It is composed of Magnet, Magnet Enclosure, Patient Table, Gradient Coil, Transmission Coil, Receiver Coil, Client PC, and Imaging Cabinet. The system software, Prodiva, a Windows-based software, is an interactive program with user friendly interface. The device is conformed to IEC and DICOM standards.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Imaging
Anatomical Site
head, body, or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician / Not Found
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 Testing Summary: The performance testing results demonstrate the safety and performance as expected. Therefore, the filing device is substantially equivalent to the legally marketed predicate device.
Clinical Testing Summary: Sample clinical images are provided to verify the claim of filing device's capability in generating images for diagnostic purposes. Sample clinical image sets from filing device and predicate device on same pulse sequences are provided to demonstrate the substantial equivalence of filing device to legally marketed predicate device
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 in blue, with the words "U.S. FOOD & DRUG" stacked on top of the word "ADMINISTRATION".
February 21, 2023
Time Medical Limited % Nick Tse VP, Regulatory and Quality Systems Flat/Rm 301, 3/F 20E, 20 Science Park East Avenue Hong Kong Science Park Shatin, Hong Kong, HKSAR CHINA
Re: K222259
Trade/Device Name: NEONA 1.5T MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: January 12, 2023 Received: January 20, 2023
Dear Nick Tse:
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
1
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 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 medical devices and radiation-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,
FDA
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team 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
2
Indications for Use
510(k) Number (if known) K22259
Device Name NEONA 1.5T MRI System
Indications for Use (Describe)
NEONA 1.5T MRI system is indicated for use as a magnetic device (MRDD) which produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal struction of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images when interpreted by trained physician yield information that may assist medical diagnosis.
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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3
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS
This 510(k) Summary is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| Date of Submission: | |
|---|---|
| Sponsor: | Time Medical Limited |
| Unit 301, 20E, Science Park East Ave, Hong Kong Science Park, | |
| Shatin, New Territories, Hong Kong, China | |
| Contact Person: Nick Tse – VP, Regulatory and Quality System | |
| Telephone number: +852 21561711 (ext. 119) Fax.: +852 2156 0908 | |
| Correspondent: | Time Medical Limited |
| Unit 301, 20E, Science Park East Ave, Hong Kong Science Park, | |
| Shatin, New Territories, Hong Kong, China | |
| Contact Person: Nick Tse – VP, Regulatory and Quality System | |
| Telephone number: +852 21561711 (ext. 119) Fax.: +852 2156 0908 | |
| Filing Device: | NEONA 1.5T MRI System |
| Classification Name: | System. Nuclear Magnetic Resonance Imaging |
| Regulatory Description: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Class | Class II / LNH / 21 CFR 892. 1000 |
| Intended Use: | NEONA 1.5T MRI system is indicated for use as a magnetic resonance |
| diagnostic device (MRDD) which produces transverse, sagittal, coronal | |
| and oblique cross-sectional images, and those display the internal | |
| structure and/or function of the head, body, or extremities. Depending on | |
| the region of interest, contrast agents may be used. These images when | |
| interpreted by trained physician yield information that may assist medical | |
| diagnosis. | |
| Device Description: | The NEONA 1.5T MRI System is a 1.5T superconducting magnet MRI |
| system which produces transverse, sagittal, coronal and oblique cross- | |
| sectional images, and those display the internal structure and/or function | |
| of the head, body, or extremities. It is composed of Magnet, Magnet | |
| Enclosure, Patient Table, Gradient Coil, Transmission Coil, Receiver Coil, | |
| Client PC, and Imaging Cabinet. The system software, Prodiva, a | |
| Windows-based software, is an interactive program with user friendly | |
| interface. The device is conformed to IEC and DICOM standards. |
4
| General Comparison to Predicate Device: | |||
|---|---|---|---|
| -- | -- | ----------------------------------------- | -- |
| Comparison Element | Filing Device: | Predicate Device: |
|---|---|---|
| 510(k) Number | N.A. | K183621 |
| Model | 15000-02 | 15000-01 |
| Device Name | NEONA 1.5T MRI System | EMMA 1.5T MRI System |
| Applicant | Time Medical Limited | Time Medical Limited |
| Classification Name | System, Nuclear Magnetic | |
| Resonance Imaging | System, Nuclear Magnetic | |
| Resonance Imaging | ||
| Product Code | LNH | LNH |
| Regulation Number | 21 CFR 892.1000 | |
| Panel | Radiology | |
| Class | Class II | |
| Indications for Use | NEONA 1.5T MRI system is | |
| indicated for use as a magnetic | ||
| resonance diagnostic device | ||
| (MRDD) which produces | ||
| transverse, sagittal, coronal and | ||
| oblique cross-sectional images, and | ||
| those display the internal structure | ||
| and/or function of the head, body, | ||
| or extremities. Depending on the | ||
| region of interest, contrast agents | ||
| may be used. These images when | ||
| interpreted by trained physician | ||
| yield information that may assist | ||
| medical diagnosis. | The EMMA 1.5T MRI System is | |
| indicated for use as a magnetic | ||
| resonance diagnostic device | ||
| (MRDD) which produces | ||
| transverse, sagittal, coronal and | ||
| oblique cross-sectional images, and | ||
| those display the internal structure | ||
| and/or function of the head, body, | ||
| or extremities. Depending on the | ||
| region of interest, contrast agents | ||
| may be used. These images when | ||
| interpreted by trained physician | ||
| yield information that may assist | ||
| medical diagnosis. | ||
| The filing device has the same US FDA classification information including classification name, | ||
| product code, regulation number, panel, and class with the predicate device. |
The filing device has the same major indications for use as the predicate device: the device produces transverse, sagittal, coronal and oblique cross-sectional images, and those display the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be administrated according to physician's instructions. These images when interpreted by trained physician yield information that may assist medical diagnosis.
The minor differences in indications for use do not constitute any safety and effectiveness issue, as indicated in the performance data provided.
5
| Technological
| Characteristics | NEONA 1.5T MRI system is based on the principle that certain atomic nuclei present in the human body, when placed in a strong magnetic field and excited by a radio frequency signal at the precession frequency, will emit a relaxation signal. The emitted relaxation signals are acquired by signal receiving coils and are analyzed by the system. Human- interpretable images are reconstructed by and stored in the computer and displayed on the screen. |
|---|---|
| The principal components of NEONA 1.5T MRI system includes Superconducting magnet with corresponding cooling devices Gradient system RF transmission and receive system Cooling system for different components of the system Patient table and support components Spectrometer Server/Client PC and application software | |
| The superconducting magnet is made of coils of superconducting wires and is cooled to and maintained at low temperature. When energized, current flows continuously inside the superconducting wires as a closed loop; thus producing a constant magnetic field. This has the same major technological characteristics as the predicate device. | |
| The gradient system consists of a gradient coil and the gradient amplifier. The gradient coil produces varying linear gradient fields in the three orthogonal spatial axes with currents given by the gradient amplifier. The gradient coil can also produce various non-linear gradients fields to improve the homogeneity of the main magnetic field. This has the same major technological characteristics as the predicate device. | |
| The RF transmission and receive system consists of the RF amplifier, the RF transmission coil and various RF receiver coils for receiving the relaxation signals emitted from the subject after RF transmission. They are coils made of copper wires tuned to transmit and receive around the designed frequency corresponding to the magnetic field strength. This has the same major technological characteristics as the predicate device. | |
| The cooling system maintains suitable operating temperatures for amplifiers and other system devices. This has the same major technological characteristics as the predicate device. | |
| The patient table and support components provide a comfortable platform for the patient and allows the operator to easily position the patient to the location for imaging. This has the same major technological characteristics as the predicate device. | |
| The spectrometer controls the execution of the pulse sequence for RF transmit and receive and gradient output. This has the same major technological characteristics as the predicate device. | |
| The server/client PC and the application software provides the operator a platform to configure scans and manage scanned data. Raw data received from the spectrometer is also reconstructed here. This has the | |
| same major technological characteristics as the predicate device. | |
| Therefore, the same scientific technology theory is applied to both the | |
| NEONA 1.5T MRI system and predicate device. | |
| Any minor differences in physical attributes do not constitute any safety | |
| and effectiveness issue, as indicated in performance data provided. |
6
7
| The filing device is claimed to comply with the following cited FDA recognized standards: | |
|---|---|
| AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010(R)2012(Cons.Text) [Incl.AMD2:2021] - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance [Including Amendment 2 (2021)] IEC 60601-1-2:2020 Edition 4.1 - Medical Electrical Equipment - Part 1-2: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Electromagnetic Disturbances - Requirements and Tests [Including Amendment 1 (2021)] IEC 60601-2-33:2015 - Medical Electrical Equipment - Part 2-33: Particular Requirements for The Basic Safety and Essential Performance of Magnetic Resonance Equipment for Medical Diagnostic NEMA MS-1-2008 (R2020) - Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Images NEMA MS 2-2008 (R2020) - Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images NEMA MS 3-2008 (R2020) - Determination of Image Uniformity in Diagnostic Magnetic Resonance Images NEMA MS 4-2010 - Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices NEMA MS 5-2018 - Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging NEMA MS 6-2008 (R2014) - Determination of Signal-to-Noise Ratio and Image Uniformity for Single-Channel Non-Volume Coils in Diagnostic MR Imaging NEMA MS 8-2016 - Characterization of The Specific Absorption Rate For Magnetic Resonance Imaging Systems NEMA MS 9-2008 (R2020) - Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images NEMA MS 14-2019 - Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process ISO 10993-5:2009 Edition 3 - Biological Evaluation of Medical Devices - Part 5: Tests For In Vitro Cytotoxicity ISO 10993-10:2010 Edition 3 - Biological Evaluation of Medical Devices - Part 10: Tests For Irritation And Skin Sensitization Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices, dated November 18, 2016 Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices, dated May 11, 2005 Magnetic Resonance (MR) Receive-only Coil - Performance Criteria for Safety and Performance Based Pathway, dated December 11, 2020 | |
| Non-Clinical Testing Summary: | The performance testing results demonstrate the safety and performance as expected. Therefore, the filing device is substantially equivalent to the legally marketed predicate device. |
| Clinical Testing Summary: | Sample clinical images are provided to verify the claim of filing device's capability in generating images for diagnostic purposes. Sample clinical image sets from filing device and predicate device on same pulse sequences are provided to demonstrate the substantial equivalence of filing device to legally marketed predicate device |
8
| Conclusions Drawn
from Non-Clinical
Information and
Clinical Images: | The non-clinical information (safety and performance tests), combined
with clinical images (both from filing device and predicate device),
demonstrate that the filing device is as safe, as effective, and performs as
well as the predicate device. |
|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SE Conclusion: | The filing device has the same intended use as the predicate device. The
minor differences in indication for use do not constitute any safety and
effectiveness issue, as indicated in performance data provided.
The filing device utilizes same technologies as predicate device, and
gives consistent results (images) in medical diagnosis. Any minor
differences in physical attributes do not constitute any safety and
effectiveness issue, as indicated in performance data (non-
clinical/clinical) provided.
Therefore the filing device is demonstrated, for being substantially
equivalent to the legally marketed predicate device. |
9
510(K) SUMMARY OF SAFETY AND EFFECTIVENESS ADDITIONAL INFORMATION
| General | Filing Device | Predicate Device |
|---|---|---|
| Design | Cylindrical | Cylindrical |
| Materials | FRP, ABS | |
| Power Source | Isolated power supply | |
| Performance Data | Comply with: |
- NEMA MS standards
IEC standards: IEC 60601-1,
IEC60601-1-2,
IEC60601-2-33 |
| Magnet | Filing Device | Predicate Device |
| Type | | Superconducting |
| Field Strength | | 1.5T |
| Weight | 2,987 kg | 3,200 kg |
| Overall Dimensions | 1378 x 1736 x 2148 mm
(L x W x H) | 1497 x 1880 x 2421 mm
(L x W x H) |
| Cryogen Type | Liquid helium free magnet bore,
with 4K cryo-compressor | Liquid Helium |
| Spatial Homogeneity | 3.04 ppm (rms) at 40cm DSV | 1.45 ppm at 40 cm DSV |
| Fringe Field | 5 gauss line