Swoop Portable MR Imaging System

K223247 · Hyperfine, Inc. · LNH · Dec 6, 2022 · Radiology

Device Facts

• Record ID: K223247
• Device Name: Swoop Portable MR Imaging System
• Applicant: Hyperfine, Inc.
• Product Code: LNH · Radiology
• Decision Date: Dec 6, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: AI/ML, Pediatric

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
MRI Image Quality (Noise and Blurring Reduction)	Deep learning-based image reconstruction models	—	—	—	—	—	—

Indications for Use

The Swoop® Portable MR 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, these images provide information that can be useful in determining a diagnosis.

Device Story

Portable bedside MRI system; produces head images for diagnostic support when standard MRI is impractical. Operates via 63.3 mT permanent magnet; utilizes form-fitting head coil. User interface (tablet) manages exam setup, execution, and image viewing. Reconstruction pipeline uses deep learning models to reduce noise and blurring in T1W, T2W, and FLAIR sequences. Used in professional healthcare facilities (ER, ICU, rehab) by trained clinicians. Output aids physician diagnosis. Modifications include updated pulse sequences, retrained reconstruction models, and service features.

Clinical Evidence

Bench testing only. Performance verified via NEMA MS standards (MS 1, 3, 9, 12) and ACR phantom guidance. Software verification and validation performed per IEC 62304 and FDA guidance. Biocompatibility, cleaning/disinfection, electrical safety, EMC, and SAR characterization leveraged from predicate device data.

Technological Characteristics

Permanent magnet (63.3 mT); 835x630x652 mm dimensions; 320 kg. Form-fitting TX/RX head coil. Tablet-based interface. Connectivity includes cloud storage interactions. Software includes deep learning-based image reconstruction for noise/blur reduction. Complies with NEMA MS standards, IEC 60601-1, and ISO 10993 biocompatibility standards.

Indications for Use

Indicated for adult and pediatric patients (≥ 0 years) requiring bedside magnetic resonance imaging 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

• Swoop System (K221923)

Submission Summary (Full Text)

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December 6, 2022

Hyperfine, Inc. % Christine Kupchick Sr. Regulatory Specialist 351 New Whitfield St. GUILFORD CT 06437

Re: K223247

Trade/Device Name: Swoop® Portable MR Imaging System™ Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, MOS Dated: November 9, 2022 Received: November 9, 2022

# Dear Christine Kupchick:

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

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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 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 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.G.K.

Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team 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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## DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K223247

## Device Name

Swoop® Portable MR Imaging SystemTM

#### Indications for Use (Describe)

The Swoop® Portable MR 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 climically practical. When interpreted by a trained physician, these images provide information that can be useful in letermining a liagnosis.

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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# K223247

Image /page/3/Picture/1 description: The image shows the word "HYPERFINE" in all caps. The letters are in a gradient of colors, starting with blue on the left and fading to orange on the right. The font is sans-serif and the letters are thick and rounded.

# 510(k) Summary Swoop® Portable MR Imaging System™ K223247

#### 510(K) Submitter

| Company Name: | Hyperfine, Inc. |
|------------------|--------------------------------------------|
| Company Address: | 351 New Whitfield St<br>Guilford, CT 06437 |

#### Contact

| Name: | Christine Kupchick |
|------------|------------------------|
| Telephone: | [phone] |
| Email: | [e-mail] |

Date Prepared: November 9, 2022

#### Device Identification

| Trade Name: | Swoop® Portable MR Imaging System™ |
|----------------------|---------------------------------------------------------------------|
| Common Name: | Magnetic Resonance Imaging |
| Regulation Number: | 21 CFR 892.1000 |
| Classification Name: | System, Nuclear Magnetic Resonance Imaging Coil, Magnetic Resonance |
| | Specialty |
| Product Code: | LNH; MOS |
| Regulatory Class: | Class II |

#### Predicate Device Information

The subject Swoop Portable MR Imaging System is substantially equivalent to the predicate Swoop System (K221923).

#### Device Description

The Swoop system is a portable MRI device that allows for patient bedside imaging. The system 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 that is used for operating the system, providing access to patient data, exam setup, exam execution, viewing MRI image data for quality control purposes, and cloud storage interactions. The system can generate MRI data sets with a broad range of contrasts. The Swoop system user interface includes touch screen menus, controls, indicators, and navigation icons that allow the operator to control the system and to view imagery. The Swoop

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System image reconstruction algorithm utilizes deep learning to provide improved image quality for T1W, T2W, and FLAIR sequences, specifically in terms of reductions in image noise and blurring.

The subject Swoop System described in this submission includes software modifications related to the device pulse sequences; retrained advanced reconstruction models; service and support features; and adds an audible scanner startup tone.

#### Indications for Use

The Swoop Portable MR 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, these images provide information that can be useful in determining a diagnosis.

#### Substantial Equivalence Discussion

The table below compares the subject device to the predicate.

| Specification | Subject Swoop Portable MR Imaging<br>System | Predicate Swoop Portable MR Imaging<br>System (K221923) |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Intended Use/ Indications for<br>Use: | The Swoop® Portable MR Imaging<br>System™ is a bedside magnetic<br>resonance imaging device for producing<br>images that display the internal<br>structure of the head where full<br>diagnostic examination is not clinically<br>practical. When interpreted by a trained<br>physician, these images provide<br>information that can be useful in<br>determining a diagnosis. | Same |
| Patient Population: | Adult and pediatric patients (≥ 0 years) | Same |
| Anatomical Sites: | Head | Same |
| Environment of Use: | At the point of care in professional<br>health care facilities such as emergency<br>rooms, critical care units, hospital, or<br>rehabilitation rooms. | Same |
| Energy Used and/or delivered: | Magnetic Resonance | Same |
| Magnet: | | |
| Physical Dimensions | 835 mm x 630 mm x 652 mm | Same |
| Bore Opening | 610 mm x 315 mm | Same |
| Weight | 320 kg | Same |
| Field Strength | 63.3 mT permanent magnet | Same |
| Gradient: | | |
| Strength | X: 24 mT/m, Y: 23 mT/m, Z: 39 mT/m | Same |
| Rise Time | X: 2.1 ms, Y: 2.0 ms, Z: 3.8 ms | Same |
| Slew Rate | X: 24 T/m/s, Y: 22 T/m/s, Z: 21 T/m/s | Same |
| Computer Display | Hyperfine-supplied tablet | Same |
| RF Coils: | | |
| Number of Coils | 1 head coil | Same |
| Coil Type | TX/RX | Same |

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| Specification | Subject Swoop Portable MR Imaging<br>System | Predicate Swoop Portable MR Imaging<br>System (K221923) |
|--------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Coil Geometry | Form-fitting | Same |
| Inner Dimensions (mm) | 205 mm x 240 mm | Same |
| Coil Design | Linear Volume | Same |
| Patient Weight Capacity | 1.6kg-200 kg | Same |
| Operation Temperature | 15-30 C | Same |
| Warm Up Time | <3 minutes | Same |
| Temperature Control | No | Same |
| Humidity Control | No | Same |
| Image Reconstruction Algorithm | | |
| T1W<br>- T1-Standard<br>- T1-Gray/White Contrast | Advanced Gridding | Same |
| T2W<br>- T2<br>- T2-Fast | Advanced Gridding | Same |
| FLAIR | Advanced Gridding | Same |
| DWI | Conjugate Gradient | Same |
| Image Post-Processing | Advanced Denoising (applies to T1W, T2W, and FLAIR only) Image orientation transform Geometric distortion correction Receive coil intensity correction DICOM output | Same |

The subject device and the predicate device have the same intended use, operating principles, and similar technological characteristics. The subject device differs from the predicate in the following:

- Pulse sequences
- Retrained advanced reconstruction models
- Service/support features
- Audible scanner startup tone

These differences do not raise new questions of safety and efficacy as compared to the predicate.

## Non-Clinical Performance

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.

| Test | Test Description | Applicable Standard(s) |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Software<br>Verification | Software verification testing in accordance with<br>the design requirements to ensure that the<br>software requirements were met. | - IEC 62304:2006<br>- FDA Guidance, "Guidance for the<br>Content of Premarket Submissions<br>for Software Contained in Medical<br>Devices" |

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| Image<br>Performance | Testing to verify the subject device meets all<br>image quality criteria. | - NEMA MS 1-2008 (R2020)<br>- NEMA MS 3-2008 (R2020)<br>- NEMA MS 9-2008 (R2020)<br>- NEMA MS 12-2016<br>- American College of Radiology (ACR)<br>Phantom Test Guidance for Use of<br>the Large MRI Phantom for the ACR<br>MRI Accreditation Program<br>- American College of Radiology<br>standards for named sequences |
|------------------------|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software<br>Validation | Validation study to ensure the device meets user<br>needs and performs as intended. | - FDA Guidance, "Guidance for the<br>Content of Premarket Submissions<br>for Software Contained in Medical<br>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 of patient-contacting<br>materials. | - ISO 10993-1:2018<br>- ISO 10993-5:2009<br>- ISO 10993-10:2010 |
| Cleaning/<br>Disinfection | Cleaning and disinfection validation of patient-<br>contacting materials. | - FDA Guidance, "Reprocessing<br>Medical Devices in Health Care<br>Settings: Validation Methods and<br>Labeling"<br>- ISO 17664:2017<br>- ASTM F3208-17 |
| Safety | Electrical Safety, EMC, and Essential<br>Performance testing. | - ANSI/AAMI ES 60601-<br>1:2005/(R)2012<br>- IEC 60601-1-2:2014<br>- IEC 60601-1-6:2013 |
| Performance | Characterization of the Specific Absorption Rate<br>for Magnetic Resonance Imaging Systems. | - NEMA MS 8-2016 |
| Cybersecurity | Testing to verify cybersecurity controls and<br>management. | - Cybersecurity as recommended in<br>FDA guidance, "Content of<br>Premarket Submissions for<br>Management of Cybersecurity in<br>Medical Devices" |

## Conclusion

Based on the indications for use, technological characteristics, performance results, and comparison to the predicate, the subject Swoop Portable MR 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.