(26 days)
Unknown
The description mentions "automatic alignment and motion correction features," which could potentially utilize AI/ML, but the document does not explicitly state this or provide details about the underlying technology.
No
The device is used for producing images to aid in diagnosis, not for treating a condition.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the images produced by the device "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 MRI device" and a "system" that includes a "main interface" and allows for "patient bedside imaging," indicating the presence of hardware components beyond just software. The submission is for software updates to an existing hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device function: The Swoop Point-of-Care Magnetic Resonance Imaging Device is an imaging device that produces images of the internal structure of the head. It does not analyze samples taken from the body.
- Intended Use: The intended use describes the device as producing images for diagnosis, which is consistent with an imaging device, not an IVD.
- Device Description: The description details a portable MRI scanner system, which is a medical imaging modality.
Therefore, the Swoop Point-of-Care Magnetic Resonance Imaging Device falls under the category of a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Swoop Point-of-Care Magnetic Resonance Imaging Device 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 POC MRI Scanner 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 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 POC MRI Scanner System user interface includes touchscreen menus, controls, indicators and navigation icons that allow the operator to control the system and to view imagery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
Head
Indicated Patient Age Range
Adult and pediatric (≥ 0 years)
Intended User / Care Setting
Trained physician / bedside
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)
Performance testing was conducted to evaluate the software modifications, including automatic alignment and motion correction features, updates to the user interface, and enhanced security features. The subject device passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence.
Testing included:
- Software Verification per IEC 62304:2006 and as recommended in the FDA Guidance, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
- Cybersecurity Information provided as recommended in FDA Guidance, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices"
Leveraged testing from predicate device (K201722) as conditions were identical or modifications did not introduce new worst-case scenarios:
- Biocompatibility per ISO 10993-1:2018
- Electrical Safety, EMC and Essential Performance per ANSI/AAMI ES 60601-1:2005/(R)2012, IEC 60601-2-33:2015, and IEC 60601-1-2:2014
- Electrical Safety Collateral Standard: Usability per IEC 60601-1-6:2013
- NEMA MS 1-2008 (R2014) - Determination of Signal-to-Noise Ratio (SNR) in Diagnostic Magnetic Resonance Imaging
- NEMA MS 3-2008 (R2014) - Determination of Image Uniformity in Diagnostic Magnetic Resonance Images
- NEMA MS 8-2016 - Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems
- NEMA MS 9-2008 (R2014) Characterization of Phased Array Coils for Diagnostic Magnetic Resistance Images
- NEMA MS 12-2016 Quantification and Mapping of Geometric Distortion for Special Applications
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
July 7, 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.
Hyperfine, Inc. % Ms. Christine Kupchick Sr. Regulatory Specialist 530 Old Whitfield Street Guilford, Connecticut 06437
Re: K211818
Trade/Device Name: Swoop™ Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, MOS Dated: June 10, 2021 Received: June 11, 2021
Dear Ms. 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/cfpmp/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 (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
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
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2023 See PRA Statement below.
510(k) Number (if known) K211818
Device Name
Swoop™ Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System
Indications for Use (Describe)
The Swoop Point-of-Care Magnetic Resonance Imaging Device 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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3
HYPERFINE
510(k) SUMMARY K211818
510(k) Submitter
| Company Name: | Hyperfine, Inc. |
|---|---|
| Company Address: | 530 Old Whitfield St |
| Guilford, CT 06437 |
Contact
| Name: | Christine Kupchick |
|---|---|
| Telephone: | (203) 343-3404 |
| Fax: | (203) 458-2514 |
| Email: | ckupchick@hyperfine.io |
July 2, 2021 Date Prepared:
Device Identification
| Trade Name: | Swoop™ Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner 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 Scanner System is substantially equivalent to the predicate POC MRI Scanner System (K201722).
The predicate device has not been subject to a design-related recall.
Device Description
The Swoop POC MRI Scanner 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 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 POC MRI Scanner System user interface includes touchscreen menus, controls, indicators and navigation icons that allow the operator to control the system and to view imagery.
4
The purpose of this submission is to gain clearance for updates to the software to include automatic alignment and motion correction features.
Indications for Use
The Swoop Point-of-Care Magnetic Resonance Imaging Device 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 MRI Device | Predicate POC MRI Device (K201722) |
|---|---|---|
| Indications for Use | The Swoop Point-of-Care Magnetic | |
| Resonance Imaging Device 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. | The Point-of-Care Magnetic | |
| Resonance Imaging Device 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 (≥ 0 years) | Adult and pediatric (≥ 0 years) |
| Anatomical Site | Head | Head |
| Patient Weight | 200 kg | 200 kg |
| Capacity | ||
| Energy Type | Magnetic Resonance | Magnetic Resonance |
| Operation | ||
| Temperature | 15-30C | 15-30C |
| Warm Up Time |