Lucy Point-of-Care Magnetic Resonance Imaging Device

K192002 · Hyperfine Research, Inc. · LNH · Feb 6, 2020 · Radiology

Device Facts

• Record ID: K192002
• Device Name: Lucy Point-of-Care Magnetic Resonance Imaging Device
• Applicant: Hyperfine Research, Inc.
• Product Code: LNH · Radiology
• Decision Date: Feb 6, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Lucy 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

Lucy is a portable, bedside MRI system for head imaging; enables visualization of internal head structures using standard MRI contrasts. System utilizes 64 mT permanent magnet; operates via user-supplied tablet interface for exam setup, execution, and image viewing. Data processed for quality control and cloud storage. Used in emergency rooms, critical care units, and hospital/rehabilitation rooms by clinicians. Physician interprets images to assist in diagnosis. Benefits include point-of-care access where traditional MRI is impractical.

Clinical Evidence

Bench testing only. Verification and validation activities performed per IEC and NEMA standards (e.g., IEC 60601-1, IEC 60601-2-33, NEMA MS 1, MS 3, MS 8, MS 9, MS 12). Clinical images provided to demonstrate adequate diagnostic quality for the intended use.

Technological Characteristics

64 mT permanent magnet; 16 mT/m gradient strength; 28 T/m/s slew rate. Form-fitting TX/RX head coil. Dimensions: 835 mm x 630 mm x 652 mm; weight 320 kg. Connectivity via user-supplied tablet and cloud storage. Complies with IEC 60601-1, IEC 60601-2-33, IEC 60601-1-2, IEC 60601-1-6, ISO 10993, ISO 14971, IEC 62304, and NEMA MS series standards.

Indications for Use

Indicated for adult and pediatric patients (above 2 years old) requiring MR images of the head 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

• Embrace Neonatal MRI System (K170978)

Submission Summary (Full Text)

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February 6, 2020

Hyperfine Research, Inc. % Mr. Brian Sawin Sr. Regulatory Affairs Manager 530 Old Whitfield Street GUILFORD CT 06437

Re: K192002

Trade/Device 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 Dated: January 7, 2020 Received: January 9, 2020

Dear Mr. Sawin:

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 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

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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 (OS) 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.

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)

#### K192002

Device Name

Lucy Point-of-Care Magnetic Resonance Imaging Device

Indications for Use (Describe)

The Lucy 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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Image /page/3/Picture/0 description: The image shows the word "HYPERFINE" in large, blue, sans-serif font. Below the word is the address "530 Old Whitfield Street, Guilford, CT 06437" followed by the phone number "[phone]". The address and phone number are in a smaller, black, sans-serif font. The image is likely a logo or contact information for a company called Hyperfine.

## 510(k) Summary of Safety and Effectiveness

K192002

## Submitter Information

## Submitter Name and Address

Hyperfine Research, Inc. 530 Old Whitfield St. Guilford, CT 06437 USA (tel.) 203.204.6900 (fax) 203.458.2514 www.hyperfine.io

#### Contact Person

Brian Sawin Sr. Regulatory Affairs Manager 203.204.6900 [e-mail]

## Date Prepared

February 6, 2020

## Subject Device - Proprietary/Trade Name

The Lucy Point-of-Care Magnetic Resonance Imaging Device

## Subject Device - Common Name

Magnetic Resonance Imaging (MRI)

#### Classification Name

| | Regulation 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:

K170978 - Embrace Neonatal MRI System, Aspect Imaging Ltd.

#### Device Summary:

Lucy is a magnetic resonance imaging (MRI) device. Its portability allows 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. Lucy 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 Lucy 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.

| Comparison of<br>Specifications | Embrace Neonatal MRI System<br>(K170978) | Lucy Point-of Care Magnetic<br>Resonance Imaging device |
|----------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended<br>Use/Indications for<br>Use | The Embrace Neonatal MRI System<br>is indicated for use as a magnetic<br>resonance imaging device for<br>producing axial, sagittal, coronal<br>and oblique images that displays<br>the internal structure of neonatal<br>head with a circumference of up to<br>38 cm and weight between 1Kg and<br>4.5 Kg. When interpreted by a<br>trained physician, these images<br>provide information that can be<br>useful in determining a diagnosis. | The Lucy Point-of-Care Magnetic<br>Resonance Imaging Device is a<br>bedside magnetic resonance<br>imaging device for producing<br>images that display the internal<br>structure of the head where full<br>diagnostic examination is not<br>clinically practical. When<br>interpreted by a trained<br>physician, these images provide<br>information that can be useful in<br>determining a diagnosis. |
| Patient Population | Patients requiring MR images of<br>the Neonatal Head | Adult and pediatric patients<br>(above 2 years old) |
| Anatomical Sites | Neonatal Head | Head |
| Environment of Use | Hospital setting | At the point of care in medical<br>facilities including emergency<br>rooms, critical care units,<br>hospital or rehabilitation rooms. |
| Energy Used and/or<br>delivered | Magnetic Resonance | Magnetic Resonance |
| Human Factors | The Embrace Neonatal MRI System<br>is designed similar to other<br>commercially available MRI<br>Systems and therefore is familiar<br>and easy for use for the user.<br>Furthermore, the device contains a<br>user-friendly software interface<br>through which the user may easily<br>access all device functions. | Lucy is designed similar to other<br>commercially available MRI<br>Systems and therefore is<br>familiar and easy to use for the<br>user. 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<br>Dimensions | 1710 mm x 1450 mm x 1810 mm | 835 mm x 630 mm x 652 mm |
| Bore Opening | 180 x 260 mm | 610 mm x 315 mm |
| Weight | 5500 (5680 with bed) Kg | 320 kg |
| Field Strength | 1 Tesla permanent magnet | 64 mT permanent magnet |
| Gradient: | | |
| Strength | 150 mT/m | 16 mT/m |
| Rise Time | 0.3 mSec | 0.5 ms |
| Slew Rate | 500 T/m/Sec | 28 T/m/s |
| Computer: | | |
| Display | 24" LED Display | User supplied tablet |
| RF Coils: | 1 Head Coil | 1 Head Coil |
| Coil Type | TX/RX | TX/RX |
| Coil Geometry | Cylindrical | Form-fitting |
| Inner Dimensions (mm) | 143mm Diameter | 205 mm x 240 mm |
| Coil Design | Linear Volume | Linear Volume |
| Target Population | Neonates with head circumference of<br>up to 38 cm and weight between 1Kg<br>and 4.5 Kg | Adult and pediatric patients<br>(above 2 years old) |
| Patient bed dimensions | 60.6cm W x 120cm H x 140cm L | n/a |
| Patient Weight Capacity | 4.5 Kg Max | 200 kg |
| Operation Temperature | 20.5°C - 36.5°C | 18-25 °C |
| Warm Up Time | 50 minutes | 3 minutes |
| Temperature Control | Air | No |
| Humidity Control | No | No |

## Comparison of Specifications:

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# Summary of Technological Characteristics

The Lucy Point-of-Care Magnetic Resonance Imaging Device has different technological characteristics from the predicate, including field strength and portability; however, 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 Lucy Point-of-Care Magnetic Resonance Imaging Device meets pre-determined performance specifications. Clinical images were provided and demonstrate adequate diagnostic quality for the intended use. The following standards in conjunction with inhouse protocols were used to determine appropriate methods for evaluating the performance of the device:

IEC 60601-1:2005, MOD. Medical Electrical Equipment - Part 1: General Requirements for Safety

IEC 60601-2-33: Edition 2.0 - 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: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests

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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 10993:2009 Biological Evaluation of Medical Devices. Part 1

ISO 14971: 2012 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 Maqnetic Resonance Imaging

NEMA MS 3-200 (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 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.