(162 days)
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.
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.
The provided text is a 510(k) Summary for the neuro42 MRI System. It details the device's indications for use, description, classification, comparison to a predicate device, and a summary of testing. However, it does not contain information about acceptance criteria for device performance based on image quality or diagnostic accuracy, nor does it describe a specific study proving the device meets such criteria.
The text states: "No clinical trials were performed. Sample clinical images were provided to support substantial equivalence." This means there was no human diagnostic performance study (like an MRMC study) described within this document to establish diagnostic accuracy or compare human reader performance with and without AI.
Therefore, many of the requested items cannot be extracted from this document, as the FDA clearance was based on non-clinical performance and a comparison to a predicate device, rather than a clinical performance study with defined acceptance criteria for diagnostic output.
However, I can extract information regarding the technical performance and the type of testing conducted.
Here's what can be inferred and what is explicitly stated:
Information Not Available from the Provided Text:
- A table of acceptance criteria and the reported device performance regarding diagnostic accuracy or image interpretability by human readers. (No clinical trials or diagnostic performance studies are described.)
- Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective). (No described test set for diagnostic performance.)
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts. (Not applicable as no diagnostic performance study was conducted.)
- Adjudication method (e.g., 2+1, 3+1, none) for the test set. (Not applicable as no diagnostic performance study was conducted.)
- 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. (Explicitly stated: "No clinical trials were performed.")
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done. (Not specified, implies the device produces images for human interpretation, not an AI diagnostic algorithm.)
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.). (Not applicable as no diagnostic performance study was conducted.)
- The sample size for the training set. (Not applicable, as no AI model training is described for diagnostic purposes.)
- How the ground truth for the training set was established. (Not applicable, as no AI model training is described for diagnostic purposes.)
Information Available or Inferable from the Provided Text:
The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the technical and safety performance of the MRI system itself, based on recognized standards, rather than its diagnostic accuracy in a clinical setting with human readers.
1. A table of acceptance criteria and the reported device performance (based on technical standards):
The document lists several technical standards that the neuro42 MRI System has been "evaluated to demonstrate substantial equivalence related to medical electrical equipment, risk management, software verification and validation, and image quality." It states the device "has been found to conform" to these standards. The specific performance values against these standards are not detailed in a table format in the provided text.
| Acceptance Criteria (Standards Conformed To) | Reported Device Performance |
|---|---|
| IEC 60601-1 (Medical electrical equipment - General requirements for basic safety and essential performance) | Conformed |
| IEC 60601-2-33 (Medical electrical equipment - Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis) | Conformed |
| IEC 60601-1-2 (Medical electrical equipment - Electromagnetic disturbances) | Conformed |
| IEC 62304 (Medical device software – Software life cycle processes) | Conformed |
| AIM 7351731 Rev. 3.00 (Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers) | Conformed |
| NEMA MS 1 (Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging) | Conformed (Specific SNR value not provided, but assessed) |
| NEMA MS 2 (Determination of Two-Dimensional Geometric Distortion in Diagnostic Magnetic Resonance Images) | Conformed (Specific distortion values not provided, but assessed) |
| NEMA MS 3 (Determination of Image Uniformity in Diagnostic Magnetic Resonance Images) | Conformed (Specific uniformity values not provided, but assessed) |
| NEMA MS 4 (Acoustic Noise Measurement Procedure for Diagnosing Magnetic Resonance Imaging Devices) | Conformed (Specific noise levels not provided, but assessed) |
| NEMA MS 5 (Determination of Slice Thickness in Diagnostic Magnetic Resonance Imaging) | Conformed (Specific values not provided, but assessed) |
| NEMA MS 8 (Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems) | Conformed (Specific SAR values not provided, but assessed) |
| NEMA MS 12 (Quantification and Mapping of Geometric Distortion for Special Applications) | Conformed (Specific values not provided, but assessed) |
| NEMA MS 14 (Characterization of Radiofrequency (RF) Coil Heating in Magnetic Resonance Imaging Systems) | Conformed (Specific heating values not provided, but assessed) |
| ISO 10993-1 (Biological evaluation of medical devices Part 1: Evaluation and testing within a risk management process) - This implies material biocompatibility, not image performance. | Conformed |
2. Sample sized used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
- Sample Size: Not explicitly stated for the "sample clinical images" provided. These images were used to "support substantial equivalence," implying a qualitative assessment rather than a quantitative performance study with a defined sample size. These are likely images acquired during system development and testing, not a formal clinical trial dataset.
- Data Provenance: Not specified (country of origin, retrospective/prospective).
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):
- Not applicable for the type of testing described (which is technical compliance and qualitative image review, not diagnostic accuracy). The device produces images "interpreted by a trained physician," implying the human physician provides the diagnostic ground truth in clinical use, but this was not part of the clearance study.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable due to the absence of a diagnostic performance study.
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:
- No MRMC study was done. The document explicitly states: "No clinical trials were performed." The device does not appear to incorporate AI for image interpretation or diagnosis. It is an MRI system for image acquisition.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is an MRI device for image acquisition, not a diagnostic algorithm. Its output ("images") is intended to be interpreted by a human physician.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the technical performance aspects, the "ground truth" is adherence to the specified engineering and imaging standards (e.g., NEMA, IEC).
- For the "sample clinical images," no formal ground truth establishment process for diagnostic purposes is described, as these were provided for qualitative "substantial equivalence" support, not quantitative diagnostic performance.
8. The sample size for the training set:
- Not applicable. This document describes an MRI system, not an AI algorithm requiring a training set for diagnostic performance.
9. How the ground truth for the training set was established:
- Not applicable as no training set for an AI algorithm is mentioned.
{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. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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).
{1}------------------------------------------------
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
{2}------------------------------------------------
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)
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."
{3}------------------------------------------------
510(k) Summary
K232644
Submitter Information
Submitter name: neuro42, Inc Address: 2 Bryant St. Suite 240, San Francisco, CA 94105 Telephone Number: (480) 241-3211 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 ResonanceImaging | 892.1000 | LNH |
| Coil, Magnetic Resonance, Specialty | 892.1000 | MOS |
Predicate Device
The predicate device for neuro42 MRI system is:
{4}------------------------------------------------
| Trade Name | Common Name | Class | ProductCode | Manufacturer | K-number |
|---|---|---|---|---|---|
| Lucy Point-of-CareMRI System | MRI System | II | LNH, MOS | HyperfineResearch, Inc. | K192002 |
Comparison of Specifications
| Comparison ofSpecifications | Lucy Point-of Care MagneticResonance Imaging device(K192002) | neuro42 MRI System |
|---|---|---|
| Intended Use/Indicationsfor Use | The Lucy Point-of-CareMagnetic Resonance ImagingDevice is a bedside magneticresonance imaging device forproducing images that displaythe internal structure of thehead where full diagnosticexamination is not clinicallypractical. When interpreted bya trained physician, theseimages provide informationthat can be useful indetermining a diagnosis. | The neuro42 MagneticResonance Imaging is a bedsidemagnetic resonance imagingdevice for producing images thatdisplay the internal structure ofthe head where full diagnosticexamination is not clinicallypractical. When interpreted by atrained physician, the imagescan provide diagnostically usefulinformation. |
| Patient Population | Adult and pediatric patients(above 2 years old) | Adult patients (above 18 yearsold) |
| Anatomical Sites | Head | Head |
| Environment of Use | At the point of care in medicalfacilities including emergencyrooms, critical care units,hospital or rehabilitationrooms. | At the point of care in medicalfacilities including intensive care(ICU), emergency and urgentcare, stroke centers oroutpatient and ambulatory care |
| Energy Used and/orDelivered | Magnetic Resonance | Magnetic Resonance |
| Human Factors | Lucy is designed similar toother commercially availableMRI Systems and therefore isfamiliar and easy to use for theuser. Furthermore, the devicecontains a user-friendlysoftware interface throughwhich the user may easilyaccess all device functions | The neuro42 MRI System isdesigned similar to othercommercially available MRISystems and therefore is familiarand easy to use for the user.Furthermore, the devicecontains a user-friendly softwareinterface through which the usermay easily access all devicefunctions |
| Magnet: | ||
| Physical Dimensions | 83.5 cm x 63.0 cm x 65.2 cm | MRI Cart:72 cm x 74 cm x 120 cm |
| Electronic Cabinet: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 kgElectronic 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 onelectronic 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:19 cm x 21 cmn42-cl:21 cm x 24 cm |
| Coil Design | Linear Volume | Linear Volume |
| Target Population | Adult and pediatric patients(above 2 years old) | Adult patients (above 18 yearsold) |
| 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 |
{5}------------------------------------------------
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.
{6}------------------------------------------------
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
{7}------------------------------------------------
technological characteristics of the neuro42 MRI System with the predicate device demonstrates that neuro42 MRI System is substantially equivalent to the listed predicate.
N/A