Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

K201722 · Hyperfine Research, Inc. · LNH · Aug 11, 2020 · Radiology

Device Facts

• Record ID: K201722
• Device Name: Hyperfine Point-Of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
• Applicant: Hyperfine Research, Inc.
• Product Code: LNH · Radiology
• Decision Date: Aug 11, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2

Intended Use

The Point-of-Care Magnetic Resonance Imaging Device 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, these images provide information that can be useful in determining a diagnosis.

Device Story

Portable MRI system for bedside head imaging; enables visualization of internal head structures using standard MRI contrasts. System operated via commercial off-the-shelf interface for exam setup, execution, and image viewing. Data processed for quality control and cloud storage. Used by clinicians in point-of-care settings; provides images for interpretation by trained physicians to assist in diagnosis. Benefits patients by providing diagnostic information when conventional MRI is impractical.

Clinical Evidence

No clinical data. Verification and validation performed via bench testing using standards including ANSI AAMI 60601-1, IEC 60601-2-33, IEC 60601-1-2, IEC 60601-1-6, ISO 10993-1, ISO 14971, IEC 62304, and NEMA MS series (MS 1, MS 3, MS 8, MS 9, MS 12).

Technological Characteristics

Portable MRI scanner; bedside form factor. Operates via magnetic resonance imaging principles. Connectivity includes cloud storage interactions. Software lifecycle follows IEC 62304. Safety/performance testing per ANSI AAMI 60601-1, IEC 60601-2-33, IEC 60601-1-2, IEC 60601-1-6, ISO 10993-1, ISO 14971, and NEMA MS standards.

Indications for Use

Indicated for bedside MRI imaging of the head in patients where full diagnostic examination 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 Magnetic Resonance Imaging Device (K192002)

Submission Summary (Full Text)

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August 11, 2020

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Hyperfine Research, Inc. % Robert Fasciano, Ph.D. Head of Quality Assurance and Regulatory Affairs 530 Old Whitfield Street GUILFORD CT 06437

## Re: K201722

Trade/Device Name: Hyperfine Point-Of-Care Magnetic Resonance Imaging Scanner System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, MOS Dated: June 19, 2020 Received: June 23, 2020

Dear Dr. Fasciano:

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/cfpmp/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 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

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

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known)

K201722

Device Name

Point-of-Care Magnetic Resonance Imaging Scanner System

Indications for Use (Describe)

The Point-of-Care Magnetic Resonance Imaging Device 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, these images provide information that can be useful in determining a 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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## Section 5 - 510(k) Summary

#### P YPERFINE

530 Old Whitfield Street, Guilford, CT 06437 [phone]

## 510(k) Summary of Safety and Effectiveness

## Submitter Information

## Submitter Name and Address

Hyperfine Research, Inc. 530 Old Whitfield Street Guilford, CT 06437 USA (tel.) 203-204-6900 (fax) 203-458-2514 www.hyperfine.io

## Contact Person

Robert Fasciano, PhD Head of Quality Assurance and Regulatory Affairs 617-425-9098 (cell) [e-mail]

#### Date Prepared

June 19, 2020

## Subject Device - Proprietary/Trade Name

Point-of-Care Magnetic Resonance Imaging Scanner System

#### Subject Device - Common Name

Magnetic Resonance Imaging (MRI)

| Classification Name | Requlation Number | Product Code |
|-----------------------------------------------|-------------------|--------------|
| System, Nuclear Magnetic Resonance<br>Imaging | 892.1000 | 90-LNH |
| Coil, Magnetic Resonance, Specialty | 892.1000 | 90-MOS |

## Classification

Class II

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## Predicate Device:

K192002 - Lucy Point-of-Care Magnetic Resonance Imaging Device, Hyperfine Research, Inc.

## Device Summary:

The Point-Of-Care Magnetic Resonance Imaging (POC MRI) system is an MRI device that is portable allowing patient bedside imaging. It enables visualization of the internal structures of the head using standard magnetic resonance imaging contrasts. The main interface is a commercial off-the-shelf device, used to operate the system, provide access to patient data, exam set-up, exam execution, and MRI image data viewing for quality control purposes as well as for cloud storage interactions. The POC MRI system can generate MRI data sets with a broad range of contrasts.

The user interface includes touch screen menus, controls, indicators and navigation icons that allow the operator to control the system and to view imagery.

## Indications for Use:

The Point-of-Care Magnetic Resonance Imaging Device 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, these images provide information that can be useful in determining a diagnosis.

## Summary of Technological Characteristics

There are no technological characteristics, features or indications for use in this submission that are not previously evaluated and cleared in the predicate device. The technology meets the same intended use and performs the same actions.

# Summary of Safety and Performance

Verification and validation activities were designed and performed to demonstrate that the POC MRI meets predetermined performance specifications. The following standards in conjunction with in-house protocols were used to determine appropriate methods for evaluating the performance of the device:

ANSI AAMI 60601-1: 2005 (+ Amendment 1) Medical Electrical Equipment -Part 1: General Requirements for Safety

IEC 60601-2-33: Edition 3.2 - 2015. 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: Edition 4.0 - 2014, Medical Electrical Equipment- Part 1-2:

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General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests

IEC 60601-1-6: Edition 3.1 - 2013. Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Usability

ISO 10993-1: Edition 5 - 2018 Biological Evaluation of Medical Devices, Part 1

ISO 14971: 2007 (R)2010 Application of Risk Management to Medical Devices

IEC 62304: 2006 (+ Amendment 1) Medical Device Software - Software Lifecycle Process

NEMA MS 1-2008 (R2014) Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging

NEMA MS 3-2008 (R2014) Determination of Image Uniformity in Diagnostic Magnetic Resonance Images

NEMA MS 8-2008 Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems

NEMA MS 9-2008 (R2014) Characterization of Phased Array Coils for Diagnostic Magnetic Resonance Images

NEMA MS 12-2016 Quantification and Mapping of Geometric Distortion for Special Applications

# Summary of Substantial Equivalence:

Based on the indications for use, technological characteristics, and safety and performance testing, the subject device meets the requirements that are considered adequate for its intended use and is substantially equivalent in design, principles of operation and indications for use to the predicate device.