Who is the manufacturer of Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System?

Hyperfine, Inc. filed the 510(k) submission for Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System (K212456).

What is the FDA product code for Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System?

LNH. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System?

Swoop POC MRI Scanner System (K201722/K211818).

Who can help prepare an FDA 510(k) submission like Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System

Q: Does Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System use AI or machine learning?

Yes. Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System (K212456) is flagged as an AI/ML-enabled medical device in the FDA's AI/ML device list.

Q: Can an AI/ML device like Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System get a guaranteed FDA 510(k) clearance?

Yes. Innolitics offers a guaranteed FDA 510(k) clearance engagement for AI/ML Software as a Medical Device — combining engineering and regulatory execution under one agreement with a guaranteed clearance outcome. Eligibility: the device must be an AI/ML Software as a Medical Device (SaMD), and its performance must meet the criteria Innolitics determines during an initial regulatory strategy engagement to be necessary for FDA clearance. See https://innolitics.com/services/end-to-end-samd/ or contact https://innolitics.com/contact.

K212456 · Hyperfine, Inc. · LNH · Nov 17, 2021 · Radiology

Device Facts

Record ID	K212456
Device Name	Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
Applicant	Hyperfine, Inc.
Product Code	LNH · Radiology
Decision Date	Nov 17, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2
Attributes	AI/ML, Pediatric

Intended Use

The Swoop Point-of-Care Magnetic Resonance 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. Inputs: magnetic resonance signals from head. Transformation: Advanced Gridding reconstruction and Advanced Denoising (deep learning-based) replace non-uniform FFT-gridding for T1W, T2W, and FLAIR sequences. Output: MRI image data displayed on commercial tablet. Used in emergency rooms, critical care units, and hospital/rehabilitation rooms; operated by clinicians. Benefits: enables rapid, point-of-care visualization of internal head structures when conventional MRI is impractical.

Clinical Evidence

Bench testing only. Verification and validation included Advanced Reconstruction performance analysis, image quality testing per NEMA MS standards (MS 1, 3, 9, 12), and ACR phantom testing. Cybersecurity and software functionality were verified per IEC 62304. Biocompatibility, electrical safety, and EMC testing were leveraged from the predicate device.

Technological Characteristics

Portable 63.3 mT permanent magnet MRI; 835x630x652 mm; 320 kg. Uses form-fitting linear volume head coil. Connectivity via tablet interface. Software includes deep learning-based image reconstruction (Advanced Gridding) and post-processing (Advanced Denoising). Standards: IEC 62304, NEMA MS 1/3/8/9/12, ISO 10993, ANSI/AAMI ES 60601-1.

Indications for Use

Indicated for adult and pediatric patients (≥ 0 years) requiring bedside head MRI imaging 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 POC MRI Scanner System (K201722/K211818)

Related Devices

K221923 — Swoop Portable MR Imaging System · Hyperfine, Inc. · Jul 28, 2022
K250236 — Swoop® Portable MR Imaging® System (V2) · Hyperfine, Inc. · May 30, 2025
K232760 — Swoop® Portable MR Imaging System® · Hyperfine, Inc. · Oct 6, 2023
K230208 — Swoop® Portable MR Imaging System · Hyperfine, Inc. · Feb 22, 2023
K223247 — Swoop Portable MR Imaging System · Hyperfine, Inc. · Dec 6, 2022

Submission Summary (Full Text)

{0}------------------------------------------------ November 17, 2021 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square are the words "U.S. FOOD & DRUG ADMINISTRATION" in blue. Hyperfine, Inc. % Christine Kupchick Sr. Regulatory Specialist 530 Old Whitfield Street GUILFORD CT 06437 Re: K212456 Trade/Device Name: Swoop" Point-of-Care Magnetic Resonance Imaging (POC MRI) System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, MOS Dated: October 20, 2021 Received: October 21, 2021 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 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 {1}------------------------------------------------ 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 (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Julie Sullivan -S 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K212456 Device Name Swoop™ Point-of-Care Magnetic Resonance Imaging System Indications for Use (Describe) The Swoop Point-of-Care Magnetic Resonance 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. 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW!* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." FORM FDA 3881 (6/20) PSC Publishing Services (301) 443-6740 EF {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "HYPERFINE" in all caps. The letters are a gradient of colors, starting with a dark purple on the left and transitioning to a bright orange on the right. The font is sans-serif and the letters are thick and bold. # 510(k) Summary Swoop™ Point-of-Care Magnetic Resonance Imaging (POC MRI) System K212456 #### SUBMITTER INFORMATION | Company Name: | Hyperfine, Inc. | |------------------|--------------------------------------------| | Company Address: | 530 Old Whitfield St Guilford. CT 06437 | #### CONTACT | Name: | Christine Kupchick | |------------|------------------------| | Telephone: | (203) 343-3404 | | Email: | ckupchick@hyperfine.io | Date Prepared: October 20, 2021 #### DEVICE IDENTIFICATION | Trade Name: | Swoop™ Point-of-Care Magnetic Resonance Imaging (POC MRI) 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™ POC MRI System is substantially equivalent to the predicate POC MRI Scanner System (K201722/K211818). #### DEVICE DESCRIPTION The Swoop™ Point-of-Care MRI 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 {4}------------------------------------------------ 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™ Point-of-Care MRI System user interface includes touchscreen menus, controls, indicators, and navigation icons that allow the operator to control the system and to view imagery. This subject device in this submission includes a change to the image reconstruction algorithm of the Swoop POC MRI device for the T1W, T2W, and FLAIR sequences. The image reconstruction change utilizes deep learning to provide improved image quality, specifically in terms of reductions in image noise and blurring. This change replaces the non-uniform FFT-gridding operation in the reconstruction pipeline with Advanced Gridding and adds an Advanced Denoising step in the image postprocessing stage. All other sections of the image reconstruction pipeline are unchanged with respect to those used in the previously cleared system (K201722/K211818). #### INDICATIONS FOR USE The Swoop™ Point-of-Care Magnetic Resonance 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 | Specification | Subject Swoop POC MRI System | Predicate Swoop POC MRI System (K201722/K211818) | |-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------| | Intended Use/Indications for Use: | The Swoop Point-of-Care Magnetic Resonance 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. | Same | | Patient Population: | Adult and pediatric patients (≥ 0 years) | Same | | Anatomical Sites: | Head | Same | | Environment of Use: | At the point of care in medical facilities, including emergency rooms, critical care units, hospital or 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 | The table below compares the subject device to the predicate. {5}------------------------------------------------ | Specification | Subject Swoop POC MRI System | Predicate Swoop POC MRI System (K201722/K211818) | |--------------------------------|-------------------------------------------------------------|-----------------------------------------------------| | Gradient: | | | | Strength | 24 mT/m | Same | | Rise Time | 1.1 ms | Same | | Slew Rate | 22 T/m/s | Same | | Computer Display | Hyperfine-supplied tablet | Same | | RF 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 | 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 | Advanced Gridding | Non-uniform FFT-griding | | T2W | Advanced Gridding | Non-uniform FFT-griding | | FLAR | Advanced Gridding | Non-uniform FFT-griding | | DWI | Conjugate Gradient | Same | | Image Post-Processing | Advanced Denoising (applies to T1W, T2W, and FLAIR only) | Image orientation transform | | | Image orientation transform | Geometric distortion correction | | | Geometric distortion correction | Receive coil intensity correction | | | Receive coil intensity correction | DICOM output | | | DICOM output | | | | | | The subject device and the predicate device have intended use, operating principles, and similar technological characteristics. The subject device differs from the predicate in that it utilizes deep learning for image reconstruction. These differences do not raise new questions of safety and effectiveness as compared to the predicate # NON-CLINICAL TESTING The subject device has similar technological characteristics as the predicate (K201722/K211818) and differs only in the utilization of deep learning for image reconstruction. As part of demonstrating substantial equivalence to the predicate, a risk analysis was completed to identify the risks associated with the software modification. The following verification and validation testing were conducted to evaluate the subject device as compared to the predicate. The subject device passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence. {6}------------------------------------------------ | Test | Test Description | Applicable Standard(s) | |-------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Advanced Reconstruction Verification | Testing to verify advanced reconstruction models do not alter image features or introduce artifacts. | • IEC 62304:2006 • FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | | | Testing to verify the ability for the expert-mode users to toggle between linear reconstruction and advanced reconstruction. | | | | Testing to verify that image quality with advanced reconstruction is acceptable, | | | | Testing to verify basic software functionality is unchanged between releases. | | | | NESSUS scan test to verify any vulnerabilities and serve as a security baseline. | | | Advanced Reconstruction Performance Analysis | Analysis of the verification completed to assess robustness, stability, and generalizability of the advanced reconstruction models. | | | Image Performance | Testing to verify image performance with advanced reconstruction meets all 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) Phantom Test Guidance for Use of the Large MRI Phantom for the ACR MRI Accreditation Program • American College of Radiology standards for named sequences | | Advanced Reconstruction Validation | Validation studies to confirm that the device meets user needs and performs as intended. | • FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" | The following testing was leveraged from the predicate device as provided in K201722. 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 materials. | ISO 10993-1:2018 ISO 10993-5:2009 ISO 10993-10:2010 | {7}------------------------------------------------ | Cleaning/ Disinfection | Cleaning and disinfection validation of patient- contacting materials. | FDA Guidance, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” ISO 17664:2017 ASTM F3208-17 | |---------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------| | Safety | Electrical Safety, EMC, and Essential Performance testing. | ANSI/AAMI ES 60601- 1:2005/(R)2012 IEC 60601-1-2:2014 IEC 60601-1-6:2013 | | 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” | | Performance | Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems. | NEMA MS 8-2016 | # CONCLUSION Based on the indications for use, technological characteristics, performance results, and comparison to the predicate, the subject Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) 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.