(116 days)
The NIDO Baby Magnetic Resonance Imaging System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coronal and oblique images that displays the internal structure of neonatal or infant head. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The NIDO Baby Magnetic Resonance Imaging System is applicable to neonatal or infant head with circumference of up to 50 cm and weight up to 15Kg.
The NIDO Baby Magnetic Resonance Imaging System, model LCM-MRI-3500-01A, is a specialized open-type MRI system designed for neonatal and infant head imaging. The system utilized a 0.35 Tesla (T) permanent magnet to acquire 2D single-slice, multi-slice, and 3D volume images of the brain.
Magnetic Resonance Imaging (MRI) is a non-invasive medical imaging technique that uses strong magnetic fields, radio waves, and a computer to produce detailed images of the internal structures of the body. Unlike X-rays or CT scans, MRI does not use ionizing radiation. Instead, it relies on the magnetic properties of atoms in the body, particularly hydrogen atoms, which are abundant in water and fat. When a patient is placed inside the MRI machine, the powerful magnets that create a strong magnetic field around the patient causes hydrogen atoms in the body to align with the field. Once the hydrogen atoms are aligned, radio waves are sent into the body. These waves temporarily disrupt the alignment of the hydrogen atoms. When the radio waves are turned off, the hydrogen atoms return to their original alignment, emitting signals in the process. These signals are detected by the MRI machine and converted into detailed images of the body's internal structures.
The NIDO Baby Magnetic Resonance Imaging System features a 0.35T permanent magnet with an open U-shaped structure, optimized for MR head imaging of neonatal and infant patients. Key components include the magnet system, gradient system, radio frequency (RF) system, spectrometer system, temperature control system and clinical imaging software. The system's gradient field strength is ≤32 mT/m with a slew rate of ≤107 T/m/s. Integrated transceive RF head coil also functions as a patient table, operating within a resonance frequency range of 14.6 MHz to 14.9 MHz is used to acquired MR images and to provide patient safety and comfort during scanning. The high-performance computer console is installed with clinical imaging software, which includes a variety of pulse sequences, such as Spin Echo, Fast Spin Echo, Fast Low Angle Shot Gradient Echo, Fluid-Attenuated Inversion Recovery and Diffusion-Weighted Imaging for Proton Density, T1 weighted, T2 weighted and Diffusion imaging.
The provided FDA 510(k) summary for the NIDO Baby Magnetic Resonance Imaging System focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria for an Artificial Intelligence/Machine Learning (AI/ML) enabled device.
The document details the device description, indications for use, and a comparison table with two predicate devices (Embrace Neonatal MRI System and Lucy Point-of-Care Magnetic Resonance Imaging Device). It also lists non-clinical tests performed, including software verification, image performance, and software validation. These tests primarily relate to the safety and basic functional performance of the MRI system itself, not specifically to an AI/ML component's diagnostic accuracy or interpretive capabilities.
Therefore, the requested information regarding AI/ML acceptance criteria and study details (such as sample size for test sets, expert ground truth establishment, adjudication methods, MRMC studies, standalone performance, and training set details) cannot be extracted from this document, as it does not describe an AI/ML component or its validation.
The document implicitly states that the "images provide information that can be useful in determining a diagnosis" when "interpreted by a trained physician" (Page 3, 6). This phrasing indicates that the device is an imaging tool requiring human interpretation, not an AI-powered diagnostic aide.
In summary, this document does not contain the information needed to answer your questions about AI/ML acceptance criteria and study proof because the device described is a standard Magnetic Resonance Imaging System, not an AI/ML-enabled diagnostic device.
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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, 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.
December 23, 2024
Jiangsu LiCi Medical Device Co., Ltd. % Rachel Yu Manager Zhihe Info-Tech (Suzhou) Co., Ltd. Room 616, Building 1, No. 1 Huayun Road, Industrial Park. Suzhou City Jiangsu, Suzhou 215134 China
Re: K242573
Trade/Device Name: NIDO Baby Magnetic Resonance Imaging System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: October 31, 2024 Received: October 31, 2024
Dear Rachel Yu:
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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Page
2
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.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
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.
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-regulatory
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assistance/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 Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
NIDO Baby Magnetic Resonance Imaging System
Indications for Use (Describe)
The NIDO Baby Magnetic Resonance Imaging System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coronal and oblique images that displays the internal structure of neonatal or infant head. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The NIDO Baby Magnetic Resonance Imaging System is applicable to neonatal or infant head with circumference of up to 50 cm and weight up to 15Kg.
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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510(k) summary
I. Submitter
| Device Submitter: | Jiangsu LiCi Medical Device Co., Ltd. |
|---|---|
| 277 Yuzhou South Road, Haizhou District, | |
| Lianyungang, Jiangsu, China |
| Contact Person: | Bing Keong Li |
|---|---|
| Title: General Manager | |
| E-mail: joeli@licimedical.com | |
| Date Prepared: | August 29, 2024 |
II Device
Trade Name of Device: NIDO Baby Magnetic Resonance Imaging System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Common Name: Magnetic Resonance Imaging System Regulatory Class: Class II Product code: LNH Review Panel: Radiology
III Predicate Device 1
| Trade Name: | Embrace Neonatal MRI System |
|---|---|
| Regulation Number: | 21 CFR 892.1000 |
| Regulation Name: | Magnetic Resonance Diagnostic Device |
| Regulatory Class: | Class II |
| Product Code: | LNH |
| Premarket Notification: | K170978 |
| Manufacturer: | Aspect Imaging Ltd. |
IV Predicate Device 2
| Trade Name: | Lucy Point-of-Care Magnetic Resonance Imaging Device |
|---|---|
| Regulation Number: | 21 CFR 892.1000 |
| Regulation Name: | Magnetic resonance diagnostic device |
| Regulatory Class: | Class II |
| Product Code: | LNH |
| Premarket Notification: | K192002 |
| Manufacturer: | Hyperfine Research, Inc. |
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V Device Description
The NIDO Baby Magnetic Resonance Imaging System, model LCM-MRI-3500-01A, is a specialized open-type MRI system designed for neonatal and infant head imaging. The system utilized a 0.35 Tesla (T) permanent magnet to acquire 2D single-slice, multi-slice, and 3D volume images of the brain.
Magnetic Resonance Imaging (MRI) is a non-invasive medical imaging technique that uses strong magnetic fields, radio waves, and a computer to produce detailed images of the internal structures of the body. Unlike X-rays or CT scans, MRI does not use ionizing radiation. Instead, it relies on the magnetic properties of atoms in the body, particularly hydrogen atoms, which are abundant in water and fat. When a patient is placed inside the MRI machine, the powerful magnets that create a strong magnetic field around the patient causes hydrogen atoms in the body to align with the field. Once the hydrogen atoms are aligned, radio waves are sent into the body. These waves temporarily disrupt the alignment of the hydrogen atoms. When the radio waves are turned off, the hydrogen atoms return to their original alignment, emitting signals in the process. These signals are detected by the MRI machine and converted into detailed images of the body's internal structures.
The NIDO Baby Magnetic Resonance Imaging System features a 0.35T permanent magnet with an open U-shaped structure, optimized for MR head imaging of neonatal and infant patients. Key components include the magnet system, gradient system, radio frequency (RF) system, spectrometer system, temperature control system and clinical imaging software. The system's gradient field strength is ≤32 mT/m with a slew rate of ≤107 T/m/s. Integrated transceive RF head coil also functions as a patient table, operating within a resonance frequency range of 14.6 MHz to 14.9 MHz is used to acquired MR images and to provide patient safety and comfort during scanning. The high-performance computer console is installed with clinical imaging software, which includes a variety of pulse sequences, such as Spin Echo, Fast Spin Echo, Fast Low Angle Shot Gradient Echo, Fluid-Attenuated Inversion Recovery and Diffusion-Weighted Imaging for Proton Density, T1 weighted, T2 weighted and Diffusion imaging.
VI Indications for Use
The NIDO Baby Magnetic Resonance Imaging System is indicated for use as a magnetic resonance imaging device for producing axial, sagittal, coronal and oblique images that displays the internal structure of neonatal or infant head. When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis. The NIDO Baby Magnetic Resonance Imaging System is applicable to neonatal or infant head with circumference
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of up to 50 cm and weight up to 15Kg.
VII Substantial Equivalence Discussion
| Items | Subject DeviceNIDO Baby MagneticResonance ImagingSystem | Predicate Device 1Embrace Neonatal MRISystem(K170978) | Predicate Device 2Lucy Point-of-CareMagnetic ResonanceImaging Device(K192002) | |
|---|---|---|---|---|
| Indications for Use | The NIDO BabyMagnetic ResonanceImaging System isindicated for use as amagnetic resonanceimaging device forproducing axial, sagittal,coronal and obliqueimages that displays theinternal structure ofneonatal or infant head.When interpreted by atrained physician, theseimages provideinformation that can beuseful in determining adiagnosis. The NIDOBaby MagneticResonance ImagingSystem is applicable toneonatal or infant headwith circumference of upto 50 cm and weight up to15Kg. | The Embrace NeonatalMRI System is indicatedfor use as a magneticresonance imaging devicefor producing axial,sagittal, coronal andoblique images thatdisplays the internalstructure of neonatal headwith a circumference ofup to 38 cm and weightbetween 1Kg and 4.5 Kg.When interpreted by atrained physician, theseimages provideinformation that can beuseful in determining adiagnosis. | The Lucy Point-of-CareMagnetic ResonanceImaging Device is a bedsidemagnetic resonance imagingdevice for producingimages that display theinternal structure of the headwhere full diagnosticexamination is not clinicallypractical. When interpretedby a trained physician, theseimages provide informationthat can be useful indetermining a diagnosis. | |
| Product Code | LNH | LNH | LNH | |
| Regulation Number | 21 CFR 892.1000 | 21 CFR 892.1000 | 21 CFR 892.1000 | |
| Class | CLASS II | CLASS II | CLASS II | |
| Environment of Use | At the point of care inmedical facilitiesincluding emergency | Hospital setting | At the point of care inmedical facilities includingemergency rooms, critical | |
| Items | Subject DeviceNIDO Baby MagneticResonance ImagingSystem | Predicate Device 1Embrace Neonatal MRISystem(K170978) | Predicate Device 2Lucy Point-of-CareMagnetic ResonanceImaging Device(K192002) | |
| Anatomical sites | rooms, critical care units, hospital. | care units, hospital or rehabilitation rooms. | ||
| Neonatal or infant head | Neonatal Head | Head | ||
| Energy Used and/orDelivered | Magnetic Resonance | Magnetic Resonance | Magnetic Resonance | |
| Patient Population | Neonatal or infant headwith circumference of upto 50 cm and weight up to15Kg. | Neonates with headcircumference of up to 38 cm and weight between1Kg and 4.5 Kg | Adult and pediatric patients(above 2 years old) | |
| Human Factors | The product is designedsimilar to othercommercially availableMRI systems andtherefore is familiar andeasy for use for the user.Furthermore, the devicecontains a user-friendlysoftware interface throughwhich the user may easilyaccess all devicefunctions. | The Embrace NeonatalMRI System is designedsimilar to othercommercially availableMRI Systems andtherefore is familiar andeasy for use for the user.Furthermore, the devicecontains a user-friendlysoftware interface throughwhich the user may easilyaccess all devicefunctions. | Lucy is designed similar toother commerciallyavailable MRI Systems andtherefore is familiar andeasy to use for the user.Furthermore, the devicecontains a user-friendlysoftware interface throughwhich the user may easilyaccess all device functions. | |
| Magnet | PhysicalDimensions | 109cm x 83cm x 138.5cm | 171cm x 145cm x 220cm | 835 mm x 630 mm x 652 mm |
| BoreOpening | 260mm Wide | 184x260mm | 610 mm x 315 mm | |
| Weight | 4500Kg | 5500(5680 with PB) Kg | 320 kg | |
| FieldStrength | 0.35Tesla PermanentMagnet | 1.0Tesla PermanentMagnet | 64 mT permanent magnet | |
| Gradient | Strength | 32mT/m | 150mT/m | 16 mT/m |
| Rise Time | 0.3mSec | 0.3mSec | 0.5 ms | |
| Slew Rate | 107T/m/Sec | 500T/m/Sec | 28 T/m/s | |
| Computer Display | 27" LED Display | 24" LED Display | User supplied tablet | |
| RF Coils | 1 head coil | 1 head coil | 1 head coil | |
| Coil Type | TX/RX | TX/RX | RX | |
| Items | Subject DeviceNIDO Baby MagneticResonance ImagingSystem | Predicate Device 1Embrace Neonatal MRISystem(K170978) | Predicate Device 2Lucy Point-of-CareMagnetic ResonanceImaging Device(K192002) | |
| Coil Geometry | Oval | Cylindrical | Form-fitting | |
| Coil Design | Linear Volume | Linear Volume | Linear Volume | |
| Patient TableDimensions | 139.5cm x 24.5cm x91.8cm | 140cm x 60.6cm x 120cm | N/A | |
| Patient WeightCapacity | 15kgs Max | 4.5kgs Max | 200 kg | |
| Electrical Safety | Evaluated according toIEC 60601-1 | Evaluated according toIEC 60601-1 | Evaluated according to IEC60601-1 | |
| EMC | Evaluated according toIEC 60601-1-2 | Evaluated according toIEC 60601-1-2 | Evaluated according to IEC60601-1-2 | |
| Max SAR for | Evaluated according to | Evaluated according to | Evaluated according to IEC | |
| Transmit Coil | IEC 60601-2-33, | IEC 60601-2-33, | 60601-2-33, | |
| Max dB/dt | Comply with IEC60601-2-33 | Comply with IEC60601-2-33 | Comply with IEC60601-2-33 | |
| Biocompatibility | Patient contact materialswere tested anddemonstrated nocytotoxicity (ISO10993-5), no evidence for(ISO 10993-10). | Patient contact materialswere tested anddemonstrated nocytotoxicity (ISO10993-5), no evidence forirritation and sensitization(ISO 10993-10). | Patient contact materialswere tested anddemonstrated nocytotoxicity (ISO 10993-5),no evidence for irritationand sensitization (ISO10993-10). |
Table VII-1 Substantial equivalence discussion
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The NIDO Baby Magnetic Resonance Imaging System have the same intended use, technology, design and performance specifications are either identical or substantially equivalent to existing legally marketed predicate devices. The differences between the NIDO Baby Magnetic Resonance Imaging System and predicate devices do not alter suitability of the proposed device for its intended use.
VIII Non-Clinical Tests
As part of demonstrating substantial equivalence to the predicate, a risk-based assessment was completed to identify the risks associated with the modifications. Based on the risk assessment, the following verification and validation testing was performed. The subject device passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence.
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| Test | Test Description | Applicable Standard(s) |
|---|---|---|
| SoftwareVerification | Software verification testing in accordance with the design requirements to ensure that the software requirements were met. | IEC 62304:2015 FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices |
| ImagePerformance | Testing to verify the subject device meets all image quality criteria. | NEMA MS-1-2008(R2020) NEMA MS-2-2008(R2020) NEMA MS-3-2008(R2020) NEMA MS-5-2018 NEMA MS-12-2016 |
| SoftwareValidation | Validation to ensure the subject device meets user needs and performs as intended. | FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices |
The following testing was leveraged from the predicate device. Test results from the predicate were used to support the subject device because the conditions were identical or the subject device modifications did not introduce a new worst-case configuration or scenario for testing.
| Test | Test Description | Applicable Standard(s) |
|---|---|---|
| Biocompatibility | Biocompatibility testing ofpatient-contacting materials. | ISO 10993-1:2018 ISO 10993-5:2009 ISO 10993-10:2021 ISO 10993-23:2021 |
| Safety | Electrical Safety, EMC, andEssential Performance testing. | IEC 60601-1: 2020 IEC 60601-1-2:2020 IEC 60601-1-6:2020 IEC 60601-2-33:2022 NEMA MS-4-2010 |
| Performance | Characterization of the SpecificAbsorption Rate or MagneticResonance Imaging Systems. | NEMA MS-8-2016 |
| Cybersecurity | Testing to verify cybersecuritycontrols and management. | Cybersecurity as recommended inFDA guidance, "Content ofPremarket Submissions forManagement of Cybersecurity inMedical Devices |
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IX Conclusion
Based on the intended use, technological characteristics, performance results, and comparison to the predicate, the subject NIDO Baby Magnetic Resonance Imaging System has been shown to be substantially equivalent to the predicate device identified in this submission and does not present any new issues of safety or effectiveness.
N/A