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 interreted by a trained physician, these images provide information that can be useful in determining a diagnosis.

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 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 following:

DWI pulse sequence and DWI image reconstruction
Image uniformity correction for all sequence types
Noise correction for all sequence types

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Swoop® Portable MR Imaging System™" and its substantial equivalence to a predicate device (Swoop System K223247). However, it does not contain the specific details about acceptance criteria, reported device performance, sample sizes for test or training sets, ground truth establishment methods, or information about multi-reader multi-case studies that you requested.

The document primarily focuses on:

Substantial Equivalence Discussion: Comparing the subject device's intended use, patient population, anatomical sites, environment of use, energy used, magnet characteristics, gradient characteristics, computer display, RF coils, patient weight capacity, operation temperature, warm-up time, temperature/humidity control, image reconstruction algorithms, and image post-processing to the predicate device.
Non-Clinical Performance Testing: Listing the types of verification and validation testing performed (Software Verification, Image Performance, Software Validation) and the standards applied. It also mentions leveraged testing from the predicate device (Biocompatibility, Cleaning/Disinfection, Safety, Performance, Cybersecurity).

Summary of What is Not Available in the Provided Text:

The document does not provide:

A table of acceptance criteria and reported device performance. It broadly states that "the subject device passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence," but no specific criteria or performance metrics are detailed.
Sample size used for the test set and data provenance.
Number of experts used to establish the ground truth for the test set and their qualifications.
Adjudication method for the test set.
Information on whether a multi-reader multi-case (MRMC) comparative effectiveness study was done, or any effect size of human reader improvement with AI assistance.
Information on whether a standalone (algorithm only without human-in-the-loop performance) study was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
The sample size for the training set.
How the ground truth for the training set was established.

The text indicates that the device utilizes deep learning for image reconstruction algorithms (specifically mentioning improvements for T1W, T2W, and FLAIR sequences in terms of noise and blurring reduction, and a Fast Iterative Shrinkage Thresholding Algorithm (FISTA) for DWI reconstruction). While this implies an AI component, the document does not elaborate on the specific AI performance characteristics or the studies evaluating them in the detail requested. The listed "Image Performance" testing refers to meeting "all image quality criteria" and applicable NEMA and ACR standards, which are general phantom-based image quality metrics for MR systems, not specific AI performance evaluations against a clinical ground truth for diagnostic accuracy.

Summary

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February 22, 2023

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

Re: K230208

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: January 25, 2023 Received: January 25, 2023

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

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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 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 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,

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) K230208

Device Name

Swoop® Portable MR Imaging System™

Indications for Use (Describe)

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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HYPERFINE

510(k) Summary Swoop® Portable MR Imaging System™ K230208

510(k) Submitter

Company Name:	Hyperfine, Inc.
Company Address:	351 New Whitfield StGuilford, CT 06437

CONTACT

Name:	Christine Kupchick
Telephone:	(203) 343-3404
Email:	ckupchick@hyperfine.io

Date Prepared: February 16, 2023

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 (K223247).

Device Description

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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 following:

DWI pulse sequence and DWI image reconstruction
Image uniformity correction for all sequence types
Noise correction for all sequence types

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.

Subject Swoop® Portable MRImaging System™	Subject Swoop® Portable MR ImagingSystem™	Predicate Swoop® Portable MRImaging System™ (K223247)
Intended Use/ Indications forUse:	The Swoop® Portable MR ImagingSystem™ is a bedside magneticresonance imaging device for producingimages that display the internalstructure of the head where fulldiagnostic examination is not clinicallypractical. When interpreted by a trainedphysician, these images provideinformation that can be useful indetermining 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 professionalhealth care facilities such as emergencyrooms, critical care units, hospital, orrehabilitation 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

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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
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
Noise Correction	Noise correction and line noisesuppression for all sequences	Same
T1W• T1-Standard• T1-Gray/White Contrast	Advanced Gridding	Same
T2W• T2• T2-Fast	Advanced Gridding	Same
FLAIR	Advanced Gridding	Same
DWI	Fast Iterative Shrinkage ThresholdingAlgorithm (FISTA)	Conjugate Gradient
Image Post-Processing	Advanced Denoising (applies toT1W, 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 Swoop System differs from the predicate in that it includes modifications to the following:

DWI pulse sequence and DWI image reconstruction
Image uniformity correction for all sequence types
. Noise correction for all sequence types

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

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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)
SoftwareVerification	Software verification testing in accordance withthe design requirements to ensure that thesoftware requirements were met.	• IEC 62304:2006• FDA Guidance, "Guidance for theContent of Premarket Submissions forSoftware Contained in MedicalDevices"
ImagePerformance	Testing to verify the subject device meets allimage quality criteria.	• NEMA MS 1-2008 (R2020)• NEMA MS 3-2008 (R2020)• NEMA MS 9-2008 (R2020)• NEMA MS 12-2016• American College of Radiology (ACR)Phantom Test Guidance for Use of theLarge MRI Phantom for the ACR MRIAccreditation Program• American College of Radiologystandards for named sequences
Software Validation	Validation to ensure the device meets user needsand performs as intended.	• FDA Guidance, "Guidance for theContent of Premarket Submissions forSoftware Contained in MedicalDevices"

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-contactingmaterials.	• ISO 10993-1:2018• ISO 10993-5:2009• ISO 10993-10:2010
Cleaning/Disinfection	Cleaning and disinfection validation of patient-contacting materials.	• FDA Guidance, "Reprocessing MedicalDevices in Health Care Settings:Validation Methods and Labeling"• ISO 17664:2017• ASTM F3208-17
Safety	Electrical Safety, EMC, and Essential Performancetesting.	• ANSI/AAMI ES 60601-1:2005/(R)2012• IEC 60601-1-2:2014• IEC 60601-1-6:2013
Performance	Characterization of the Specific Absorption Ratefor Magnetic Resonance Imaging Systems.	• NEMA MS 8-2016

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Cybersecurity	Testing to verify cybersecurity controls and management.	Cybersecurity as recommended in FDA guidance, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"
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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.

Regulation Number and Section

§ 892.1000 Magnetic resonance diagnostic device.

(a)
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).(b)
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.