(104 days)
Yes
The device description explicitly states that the change to the image reconstruction algorithm "utilizes deep learning" to improve image quality. Deep learning is a subset of machine learning and artificial intelligence.
No
The device is described as a diagnostic imaging system ("produces images," "determining a diagnosis," "visualization of the internal structures") and does not mention treating or curing any medical condition.
Yes.
The "Intended Use / Indications for Use" section explicitly states that the device produces "images that display the internal structure of the head" and that "When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis." This clearly indicates its diagnostic purpose.
No
The device description clearly states it is a "portable MRI device" and a "bedside magnetic resonance imaging device," indicating it includes hardware components beyond just software. The software described is a change to the image reconstruction algorithm within this hardware system.
Based on the provided information, the Swoop Point-of-Care Magnetic Resonance Imaging System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Swoop System Function: The Swoop system is an imaging device that produces images of the internal structure of the head using magnetic resonance. It does not analyze biological specimens.
- Intended Use: The intended use is to produce images for interpretation by a physician to aid in diagnosis, not to perform tests on biological samples.
Therefore, the Swoop Point-of-Care Magnetic Resonance Imaging System falls under the category of medical imaging devices, not In Vitro Diagnostics.
No
The input explicitly states "Control Plan Authorized (PCCP) and relevant text: Not Found", meaning there is no mention of the FDA reviewing or clearing a PCCP for this device.
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.
Product codes
LNH, MOS
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 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).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Head
Indicated Patient Age Range
Adult and pediatric patients (>= 0 years)
Intended User / Care Setting
At the point of care in medical facilities, including emergency rooms, critical care units, hospital or rehabilitation rooms.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Advanced Reconstruction Verification:
- Testing to verify advanced reconstruction models do not alter image features or introduce artifacts.
- 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.
Advanced Reconstruction Validation:
- Validation studies to confirm that the device meets user needs and performs as intended.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
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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)
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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.
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| 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 |