neuro42 MRI System

K232644 · Neuro42, Inc. · LNH · Feb 8, 2024 · Radiology

Device Facts

• Record ID: K232644
• Device Name: neuro42 MRI System
• Applicant: Neuro42, Inc.
• Product Code: LNH · Radiology
• Decision Date: Feb 8, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The neuro42 Magnetic Resonance Imaging System is a bedside magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, the images can provide diagnostically useful information.

Device Story

Bedside low-field MRI system; utilizes permanent Halbach magnet array (70 mT) for neuroimaging. System consists of mobile magnet cart and separate electronic cabinet. Input: magnetic resonance signals from head; output: diagnostic images of internal head structure. Used in ICU, emergency/urgent care, stroke centers, and ambulatory settings. Operated by trained clinicians. Physician interprets images on touch screen monitor to assist in clinical decision-making. Benefits include point-of-care access to imaging when standard MRI is impractical.

Clinical Evidence

Bench testing only. No clinical trials performed. Conformance demonstrated to IEC 60601-1, IEC 60601-2-33, IEC 60601-1-2, and NEMA MS series (SNR, geometric distortion, image uniformity, acoustic noise, slice thickness, SAR, RF coil heating). ISO 10993-1 biocompatibility testing performed. Sample clinical images provided to support substantial equivalence.

Technological Characteristics

Permanent Halbach magnet array (70 mT field strength); 13.07 mT/m gradient strength; 43.57 T/m/s slew rate. Two form-fitting linear volume head coils (TX/RX). Touch screen monitor interface. No external shielding required. Complies with IEC 60601-1, IEC 60601-2-33, NEMA MS 1-5, 8, 12, 14, and ISO 10993-1.

Indications for Use

Indicated for adult patients (above 18 years old) requiring head imaging where full diagnostic MRI is not clinically practical.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

• Lucy Point-of-Care MRI System (K192002)

Submission Summary (Full Text)

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February 8, 2024

Neuro42, Inc. Abhita Batra Chief Strategy Officer 2 Bryant Street. Suite 240 San Francisco, California 94105

Re: K232644

Trade/Device Name: neuro42 MRI System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, MOS Dated: August 30, 2023 Received: December 26, 2023

Dear Abhita Batra:

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.

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).

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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 OS 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.

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

D. R. K.

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

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# Indications for Use

Submission Number (if known)

Device Name

neuro42 MRI System

#### Indications for Use (Describe)

The neuro42 Magnetic Resonance Imaging System is a bedside magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, the images can provide diagnostically useful information.

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

# K232644

### Submitter Information

Submitter name: neuro42, Inc Address: 2 Bryant St. Suite 240, San Francisco, CA 94105 Telephone Number: [phone] Contact Person: Abhita Batra Date of Preparation: August 29, 2023

#### Name of Device

Trade/Device name: neuro42 MRI System Model Number/Name: n42-m

#### Indications for Use

The neuro42 Magnetic Resonance Imaging System is a bedside magnetic resonance imaging device for producing images that display the internal structure of the head where full diagnostic examination is not clinically practical. When interpreted by a trained physician, the images can provide diagnostically useful information.

### Device Description

neuro42 MRI System is a low-field MR system intended to be used for neuroimaging. The neuro42 Magnetic Resonance Imaging System is a bedside magnetic resonance imaging device intended to be used for producing images that display the internal structure of the head. The device is a low-field magnetic resonance system and includes a movable magnet cart on wheels connected to a separate electronic cabinet on wheels. The system utilizes a permanent Halbach magnet array and does not require any external shielding.

#### Classification Name

| | Regulation Number | Product Code |
|-----------------------------------------------|-------------------|--------------|
| System, Nuclear Magnetic Resonance<br>Imaging | 892.1000 | LNH |
| Coil, Magnetic Resonance, Specialty | 892.1000 | MOS |

#### Predicate Device

The predicate device for neuro42 MRI system is:

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| Trade Name | Common Name | Class | Product<br>Code | Manufacturer | K-number |
|----------------------------------|-------------|-------|-----------------|-----------------------------|----------|
| Lucy Point-of-Care<br>MRI System | MRI System | II | LNH, MOS | Hyperfine<br>Research, Inc. | K192002 |

## Comparison of Specifications

| Comparison of<br>Specifications | Lucy Point-of Care Magnetic<br>Resonance Imaging device<br>(K192002) | neuro42 MRI System |
|-------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use/Indications<br>for Use | The Lucy Point-of-Care<br>Magnetic Resonance Imaging<br>Device is a bedside magnetic<br>resonance imaging device for<br>producing images that display<br>the internal structure of the<br>head where full diagnostic<br>examination is not clinically<br>practical. When interpreted by<br>a trained physician, these<br>images provide information<br>that can be useful in<br>determining a diagnosis. | The neuro42 Magnetic<br>Resonance Imaging is a bedside<br>magnetic resonance imaging<br>device for producing images that<br>display the internal structure of<br>the head where full diagnostic<br>examination is not clinically<br>practical. When interpreted by a<br>trained physician, the images<br>can provide diagnostically useful<br>information. |
| Patient Population | Adult and pediatric patients<br>(above 2 years old) | Adult patients (above 18 years<br>old) |
| Anatomical Sites | Head | Head |
| Environment of Use | At the point of care in medical<br>facilities including emergency<br>rooms, critical care units,<br>hospital or rehabilitation<br>rooms. | At the point of care in medical<br>facilities including intensive care<br>(ICU), emergency and urgent<br>care, stroke centers or<br>outpatient and ambulatory care |
| Energy Used and/or<br>Delivered | Magnetic Resonance | Magnetic Resonance |
| Human Factors | Lucy is designed similar to<br>other commercially available<br>MRI Systems and therefore is<br>familiar and easy to use for the<br>user. Furthermore, the device<br>contains a user-friendly<br>software interface through<br>which the user may easily<br>access all device functions | The neuro42 MRI System is<br>designed similar to other<br>commercially available MRI<br>Systems and therefore is familiar<br>and easy to use for the user.<br>Furthermore, the device<br>contains a user-friendly software<br>interface through which the user<br>may easily access all device<br>functions |
| Magnet: | | |
| Physical Dimensions | 83.5 cm x 63.0 cm x 65.2 cm | MRI Cart:<br>72 cm x 74 cm x 120 cm |
| | | Electronic Cabinet:<br>60 cm x 100 cm x 152 cm |
| Bore Opening | 61 cm x 31.5 cm | 33.5 cm x 28.5 cm |
| Weight | 320 kg | MRI Cart: 200 kg<br>Electronic Cabinet: 380 kg |
| Field Strength | 64 mT permanent magnet | 70 mT permanent magnet |
| Gradient: | | |
| Strength | 16 mT/m | 13.07 mT/m |
| Rise Time | 0.5 ms | 0.3 ms |
| Slew Rate | 28 T/m/s | 43.57 T/m/s |
| Computer: | | |
| Display | User supplied tablet | Touch screen monitor on<br>electronic panel |
| RF Coils: | 1 Head Coil | 2 Head Coils |
| Coil Type | TX/RX | TX/RX |
| Coil Geometry | Form-fitting | Form-fitting |
| Inner Dimensions (mm) | 20.5 cm x 24 cm | n42-cm:<br>19 cm x 21 cm<br>n42-cl:<br>21 cm x 24 cm |
| Coil Design | Linear Volume | Linear Volume |
| Target Population | Adult and pediatric patients<br>(above 2 years old) | Adult patients (above 18 years<br>old) |
| Patient bed dimensions | n/a | n/a |
| Patient Weight Capacity | 200 kg | n/a |
| Operation Temperature | 18-25 °C | 15-25 °C |
| Warm Up Time | 3 minutes | < 3 minutes |
| Temperature Control | No | No |
| Humidity Control | No | No |

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## Technological Characteristics

There are some differences in technological characteristics between the subject device and the predicate device, including different hardware configuration and software. However, the technology meets the same intended use and performs the same actions.

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## Summary of Testing and Performance Data

neuro42 MRI System has been evaluated to demonstrate substantial equivalence related to medical electrical equipment, risk management, software verification and validation, and image quality and has been found to conform to the following medical device safety standards:

- -IEC 60601-1:2005 (3rd Edition) + CORR. 1:2006 + CORR. 2:2007 + A1:2012 + A2:2020 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
- -IEC 60601-2-33:2022 (4th Edition) Medical electrical equipment - Part 2-33: Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis
- -IEC 60601-1-2:2014/AMD1:2020 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
- -IEC 62304 Edition 1.1 2015-06 Consolidated Version
- -AIM 7351731 Rev. 3.00 (2021-06-04) – Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers
- -NEMA MS 1 – 2008 (R2020) Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging
- -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 8-2016 Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems
- -NEMA MS 12-2016 Quantification and Mapping of Geometric Distortion for Special Applications
- -NEMA MS 14-2019 Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems
- Other Standards -
- ISO 10993-1:2018 Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process.

No clinical trials were performed. Sample clinical images were provided to support substantial equivalence.

## Conclusion

Substantial equivalence comparison including intended use, function, specifications, and

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technological characteristics of the neuro42 MRI System with the predicate device demonstrates that neuro42 MRI System is substantially equivalent to the listed predicate.