Swoop® Portable MR Imaging® System

K240944 · Hyperfine, Inc. · LNH · Jul 16, 2024 · Radiology

Device Facts

• Record ID: K240944
• Device Name: Swoop® Portable MR Imaging® System
• Applicant: Hyperfine, Inc.
• Product Code: LNH · Radiology
• Decision Date: Jul 16, 2024
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1000
• Device Class: Class 2
• Attributes: AI/ML, Pediatric

Intended Use

The Swoop Portable MR Imaging System is a portable, ultra-low field 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

Swoop is a portable, ultra-low field (63.3 mT) MRI system for head imaging at the point of care (ER, ICU, rehabilitation centers). Operated by healthcare professionals, it uses a permanent magnet and RF head coil to acquire MRI data. The system interface, a tablet, manages exam setup, execution, and image viewing. An image reconstruction algorithm, utilizing deep learning and iterative methods (FISTA), processes raw data into T1W, T2W, FLAIR, and DWI sequences. Post-processing includes denoising, geometric distortion correction, and intensity correction. Output images are reviewed by physicians to assist in clinical diagnosis. The system is designed for environments where traditional high-field MRI is impractical, providing rapid, accessible diagnostic information.

Clinical Evidence

Bench testing only. Performance verified via software verification, image quality testing per NEMA MS standards (MS 1, 3, 9, 12), and cybersecurity assessment. Biocompatibility, cleaning/disinfection, electrical safety (ANSI/AAMI ES 60601-1), EMC, and SAR characterization (NEMA MS 8) were leveraged from the predicate device.

Technological Characteristics

Ultra-low field (63.3 mT) permanent magnet MRI. Dimensions: 835x630x652 mm; Weight: 320 kg. Includes one form-fitting linear volume head coil. Connectivity via tablet interface and cloud storage. Software includes deep learning-based reconstruction and FISTA algorithm. Complies with IEC 62304, NEMA MS series, and ISO 10993 biocompatibility standards.

Indications for Use

Indicated for adult and pediatric patients (≥ 0 years) requiring head imaging where full diagnostic MRI is not clinically practical. No specific contraindications listed.

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 (K232760)

Submission Summary (Full Text)

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July 16, 2024

Hyperfine, Inc. Christine Kupchick Sr. Manager, Global Regulatory 351 New Whitfield Street Guilford, Connecticut 06437

Re: K240944

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: April 5, 2024 Received: June 25, 2024

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 (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).

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

Sincerely,

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

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## Indications for Use

Submission Number (if known)

K240944

Device Name

Swoop® Portable MR Imaging® System

#### Indications for Use (Describe)

The Swoop Portable MR Imaging System is a portable, ultra-low field 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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# 510(k) Summary Swoop® Portable MR Imaging® System K240944

#### 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: June 25, 2024

#### 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 (K232760).

#### Device Description

The Swoop system is portable, ultra-low field MRI device that 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, FLAIR, and DWI sequences.

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The subject Swoop System described in this submission includes software modifications related to the pulse sequences and system quality control test features.

#### Indications for Use

The Swoop Portable MR Imaging System is a portable, ultra-low field 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 (K232760) |
|------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| Intended Use/ Indications for Use: | The Swoop Portable MR Imaging System<br>is a portable, ultra-low field 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, intensive/critical care units,<br>hospitals, outpatient, or rehabilitation<br>centers. | 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 |

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| 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 noise<br>suppression for all sequences | Same |
| 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 | Fast Iterative Shrinkage Thresholding<br>Algorithm (FISTA) | Same |
| Image Post-Processing | ● Advanced Denoising<br>● Image orientation transform<br>● Geometric distortion correction<br>● Receive coil intensity correction<br>● DICOM output | Same |

The subject device and the predicate device have the same intended use, operating principles, and similar technological characteristics. There are minor differences between the subject device and the predicate in pulse sequences and quality control test features. 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 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 Verification | Software verification testing in accordance with<br>the design requirements to ensure that the<br>software requirements were met. | • IEC 62304:2015<br>• FDA Guidance, "Content of Premarket<br>Submissions for Device Software<br>Functions" |

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| Image<br>Performance | Testing to verify the subject device meets all<br>image 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)<br>Phantom Test Guidance for Use of the<br>Large MRI Phantom for the ACR MRI<br>Accreditation Program American College of Radiology<br>standards for named sequences |
|----------------------|---------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Cybersecurity | Testing to verify cybersecurity controls and<br>management. | FDA Guidance, "Cybersecurity in<br>Medical Devices: Quality System<br>Considerations and Content of<br>Premarket Submissions" |
| Software Validation | Validation to ensure the subject device meets user<br>needs and performs as intended. | FDA Guidance, "Content of Premarket<br>Submissions for Device Software<br>Functions" |

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 Medical<br>Devices in Health Care Settings:<br>Validation Methods and Labeling"<br>• ISO 17664:2017<br>• ASTM F3208-17 |
| Safety | Electrical Safety, EMC, and Essential Performance<br>testing. | • ANSI/AAMI ES 60601-1:2005/(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 |

#### Conclusion

Based on the intended 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.