(27 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 that display the internal structure of the head and provides information for determining a diagnosis, rather than directly treating a disease or condition.
Yes
The "Intended Use / Indications for Use" section 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 role in the diagnostic process.
No
The device is described as a "portable MRI device" and a "bedside magnetic resonance imaging device," which are hardware components. While it utilizes software for operation, image processing, and reconstruction, it is fundamentally a hardware system that generates images.
Based on the provided information, the Swoop® Portable MR Imaging System™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health. This testing is performed outside of the body (in vitro).
- Swoop® Function: The Swoop® system is an imaging device that produces images of the internal structure of the head directly from the patient's body. It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's for producing images of the head to aid in diagnosis when interpreted by a physician. This is a function of medical imaging, not in vitro testing.
Therefore, the Swoop® Portable MR Imaging System™ falls under the category of a medical imaging device, not an In Vitro Diagnostic device.
No
The provided text does not contain any explicit statement that the FDA has reviewed, approved, or cleared a PCCP for this specific device.
Intended Use / 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.
Product codes
LNH, MOS
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 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
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)
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: Imaging Performance
Test Description: Testing to verify image performance 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
Test: Safety
Test Description: Testing to verify electrical safety and EMC meet the criteria.
Applicable Standard(s): ANSI/AAMI ES 60601-1:2005/(R)2012 IEC 60601-1-2:2014 IEC 60601-2-33:2015 NEMA MS 8-2016
The following testing was leveraged from the predicate to support the subject device because the conditions were identical or modifications did not introduce a new worst-case configuration or scenario for testing.
Test: Biocompatibility
Test Description: Biocompatibility testing of patient-contacting materials.
Applicable Standard(s): ISO 10993-1:2018 ISO 10993-5:2009 ISO 10993-10:2010
Test: Cleaning/Disinfection
Test Description: Cleaning and disinfection validation of patient-contacting materials.
Applicable Standard(s): FDA Guidance, “Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling” ISO 17664:2017 ASTM F3208-17
Test: Cybersecurity
Test Description: Testing to verify cybersecurity controls and management.
Applicable Standard(s): Cybersecurity as recommended in FDA guidance, “Content of Premarket Submissions for Management of Cybersecurity in Medical Devices”
Test: Software Verification
Test Description: Verification testing to ensure the design outputs meet the design input requirements.
Applicable Standard(s): IEC 62304:2006 FDA Guidance, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”
Test: Software Validation
Test Description: Validation studies to ensure the 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”
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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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
July 28, 2022
Hyperfine, Inc. % Christine Kupchick Sr. Regulatory Specialist 351 New Whitfield Street GUILFORD CT 06437
Re: K221923
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: June 30, 2022 Received: July 1, 2022
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
1
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 (QS) 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.
for
Michael D. O'Hara, Ph.D. Deputy 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
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
Device Name
Hyperfine Swoop® Portable MR Imaging System(TM)
Indications for Use (Describe)
Hyperfine Swoop® Portable MR Imaging System(TM) 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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HYPERFINE
510(k) Summary Swoop® Portable MR Imaging System™
510(к) 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: June 30, 2022
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™ (K201722/K221393).
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 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.
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The subject device in this submission includes modifications to the Swoop® system hardware components and minimum patient weight limit.
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.
| Specification | Subject Swoop® Portable MR Imaging System™ | Predicate Swoop® Portable MR Imaging System™ (K201722/K221393) |
|---|---|---|
| Intended Use/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. | 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 |
| Gradient: | ||
| Strength | X: 24 mT/m, Y: 23 mT/m, Z: 39 mT/m | 24 mT/m |
| Rise Time | X: 2.1 ms, Y: 2.0 ms, Z: 3.8 ms | 1.1 ms |
| Slew Rate | X: 24 T/m/s, Y: 22 T/m/s, Z: 21 T/m/s | 22 T/m/s |
| 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 |
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| Specification | Subject Swoop® Portable MR
Imaging System™ | Predicate Swoop® Portable MR
Imaging System™ (K201722/K221393) |
|-------------------------------------|---------------------------------------------------------------|-------------------------------------------------------------------|
| Coil Design | Linear Volume | Same |
| Patient Weight Capacity | 1.6kg-200 kg | 2.6kg-200 kg |
| Operation Temperature | 15-30 C | Same |
| Warm Up Time |