(28 days)
Not Found
Yes
The device description explicitly states that the image reconstruction algorithm utilizes deep learning, which is a subset of machine learning.
No
The device is used for producing images to assist in diagnosis, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section states that the images produced "provide information that can be useful in determining a diagnosis." This indicates its role in the diagnostic process.
No
The device description explicitly states it is a "portable, ultra-low field MRI device" and mentions hardware components like a "main interface" and the ability to "generate MRI data sets," indicating it is a hardware device with integrated software.
Based on the provided information, the Swoop Portable MR 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's 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 clearly states it's for producing images of the head, not for analyzing samples.
Therefore, the Swoop Portable MR Imaging System falls under the category of medical imaging devices, not IVDs.
No
The provided text does not explicitly state that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan (PCCP) for this specific device. The 'Control Plan Authorized (PCCP) and relevant text' section is marked as "Not Found".
Intended Use / 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.
Product codes
LNH, MOS
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, and FLAIR sequences, specifically in terms of reductions in image noise and blurring.
Mentions image processing
Yes
Mentions AI, DNN, or ML
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.
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 professional health care facilities such as 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)
Non-Clinical Performance:
- Software Verification: Software verification testing in accordance with the design requirements to ensure that the software requirements were met. Applicable Standard(s): IEC 62304:2015 FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
- Image Performance: Testing to verify the subject device meets all image quality criteria. Applicable Standard(s): 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
- Software Validation: Validation to ensure the subject device meets user needs and performs as intended. Applicable Standard(s): FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
The subject device passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence.
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.
0
Image /page/0/Picture/0 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 is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 6, 2023
Hyperfine, Inc. % Christine Kupchick Staff Regulatory Affairs Specialist 351 New Whitfield Street Guilford, CT 06437
Re: K232760
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: September 8, 2023 Received: September 8, 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 (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/cdrb/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.
1
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).
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.
2
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,
D. R. X
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
Enclosure
3
Indications for Use
510(k) Number (if known)
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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4
510(k) Summary Swoop® Portable MR Imaging System®
510(K) SUBMITTER
| Company Name: | Hyperfine, Inc. |
|---|---|
| Company Address: | 351 New Whitfield St |
| Guilford, CT 06437 |
CONTACT
| Name: | Christine Kupchick |
|---|---|
| Telephone: | (203) 343-3404 |
| Email: | ckupchick@hyperfine.io |
Date Prepared: September 8, 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 (K230208).
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, and FLAIR sequences, specifically in terms of reductions in image noise and blurring.
5
The subject Swoop System described in this submission includes software modifications related to the following:
- . Pulse sequence parameters (T1, T2, FLAIR, DWI)
- . Image reconstruction (T1, T2, FLAIR)
- 9 DWI image post-processing
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 System | Predicate Swoop Portable MR Imaging System (K230208) |
|---|---|---|
| Intended Use/ 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. | 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. |
| Patient Population: | Adult and pediatric patients (≥ 0 years) | Same |
| Anatomical Sites: | Head | Same |
| Environment of Use: | At the point of care in professional health care facilities such as 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 |
| 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 |
6
| 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 |