(46 days)
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.
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 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.
The subject Swoop System described in this submission includes software modifications related to the device pulse sequences; retrained advanced reconstruction models; service and support features; and adds an audible scanner startup tone.
The provided text describes the regulatory clearance of the Hyperfine Swoop® Portable MR Imaging System™ and mentions non-clinical performance testing. However, it does not contain the specific details required to complete all sections of your request, particularly a table of acceptance criteria and reported device performance based on a study, sample sizes, expert qualifications, or details of a multi-reader multi-case (MRMC) study.
The document indicates that the device's 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. It also states that the subject device includes retrained advanced reconstruction models. The non-clinical performance section states "Testing to verify the subject device meets all image quality criteria" and references various NEMA and ACR standards for image performance. It also mentions a "Validation study to ensure the device meets user needs and performs as intended."
Given the limitations of the provided text, I can only fill in the information that is explicitly stated or can be reasonably inferred. Many sections will be marked as "Not provided in the text".
Here's a summary of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions that "Testing to verify the subject device meets all image quality criteria" was performed against various NEMA and ACR standards. However, the specific quantitative acceptance criteria or the reported device performance metrics (e.g., specific SNR values, resolution, etc.) are not provided in the text.
2. Sample size used for the test set and the data provenance
Not provided in the text. The document mentions "non-clinical performance" and "verification and validation testing" but does not specify details about a clinical test set, sample size, or data provenance for these image quality assessments.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not provided in the text. The document mentions that the images, "When interpreted by a trained physician, ... provide information that can be useful in determining a diagnosis," but this refers to the intended use of the device, not the ground truth establishment for a specific test set within the regulatory submission.
4. Adjudication method for the test set
Not provided in the text.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not provided in the text. The document focuses on regulatory clearance based on substantial equivalence and non-clinical testing. While the device uses deep learning for image reconstruction, a MRMC study is not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Partially addressed: The text states, "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." This implies an algorithm-only component focusing on image quality improvement. The non-clinical performance section includes "Image Performance" testing against NEMA and ACR standards, which would primarily assess the standalone algorithm's output image quality. However, a standalone diagnostic performance study (e.g., sensitivity/specificity for detecting pathologies) is not explicitly detailed.
7. The type of ground truth used
Partially addressed / Inferred: For "Image Performance" testing (which includes assessments against NEMA and ACR standards), the ground truth is typically based on phantom measurements and known physical properties, not clinical outcomes or pathology directly. For the "Validation study to ensure the device meets user needs and performs as intended," the type of ground truth is not specified, but it would likely involve expert evaluation of image quality and usability, rather than a clinical ground truth like pathology.
8. The sample size for the training set
Not provided in the text. The document mentions "retrained advanced reconstruction models," indicating a training process, but no details about the training data size.
9. How the ground truth for the training set was established
Not provided in the text.
Summary Table of Available Information based on the Provided Text:
| Criteria | Information from Document |
|---|---|
| Acceptance Criteria & Reported Performance | The document states "Testing to verify the subject device meets all image quality criteria" against standards such as NEMA MS 1-2008 (R2020), NEMA MS 3-2008 (R2020), NEMA MS 9-2008 (R2020), NEMA MS 12-2016, and American College of Radiology (ACR) Phantom Test Guidance for Use of the Large MRI Phantom for the ACR MRI Accreditation Program, and ACR standards for named sequences. Specific quantitative acceptance criteria and reported device performance values are not provided in the text. |
| Sample size (Test Set) & Data Provenance | Not provided in the text. |
| Number & Qualifications of Experts (Test Set Ground Truth) | Not provided in the text. |
| Adjudication Method (Test Set) | Not provided in the text. |
| MRMC Comparative Effectiveness Study | Not provided in the text. |
| Standalone (Algorithm Only) Performance | Yes, implicitly. The document states, "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." This is an algorithm-only function. The "Image Performance" testing against NEMA and ACR standards would evaluate the standalone algorithm's output image quality. |
| Type of Ground Truth Used (Test Set) | For "Image Performance": Inferred to be based on phantom measurements and known physical characteristics as per NEMA and ACR phantom protocols. For "Software Validation" (user needs): Not specified, but likely expert evaluation of image quality and usability. |
| Sample Size for Training Set | Not provided in the text. |
| How Ground Truth for Training Set was Established | Not provided in the text. |
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December 6, 2022
Hyperfine, Inc. % Christine Kupchick Sr. Regulatory Specialist 351 New Whitfield St. GUILFORD CT 06437
Re: K223247
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: November 9, 2022 Received: November 9, 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
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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 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 mediation-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.G.K.
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team 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) K223247
Device Name
Swoop® Portable MR Imaging SystemTM
Indications for Use (Describe)
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 climically practical. When interpreted by a trained physician, these images provide information that can be useful in letermining a liagnosis.
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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K223247
Image /page/3/Picture/1 description: The image shows the word "HYPERFINE" in all caps. The letters are in a gradient of colors, starting with blue on the left and fading to orange on the right. The font is sans-serif and the letters are thick and rounded.
510(k) Summary Swoop® Portable MR Imaging System™ K223247
510(K) Submitter
| Company Name: | Hyperfine, Inc. |
|---|---|
| Company Address: | 351 New Whitfield StGuilford, CT 06437 |
Contact
| Name: | Christine Kupchick |
|---|---|
| Telephone: | (203) 343-3404 |
| Email: | ckupchick@hyperfine.io |
Date Prepared: November 9, 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 is substantially equivalent to the predicate Swoop System (K221923).
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 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
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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.
The subject Swoop System described in this submission includes software modifications related to the device pulse sequences; retrained advanced reconstruction models; service and support features; and adds an audible scanner startup tone.
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 ImagingSystem | Predicate Swoop Portable MR ImagingSystem (K221923) |
|---|---|---|
| Intended Use/ Indications forUse: | The Swoop® Portable MR ImagingSystem™ is a bedside magneticresonance imaging device for producingimages that display the internalstructure of the head where fulldiagnostic examination is not clinicallypractical. When interpreted by a trainedphysician, these images provideinformation that can be useful indetermining 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 professionalhealth care facilities such as emergencyrooms, critical care units, hospital, orrehabilitation 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 |
| Computer Display | Hyperfine-supplied tablet | Same |
| RF Coils: | ||
| Number of Coils | 1 head coil | Same |
| Coil Type | TX/RX | Same |
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| Specification | Subject Swoop Portable MR ImagingSystem | Predicate Swoop Portable MR ImagingSystem (K221923) |
|---|---|---|
| 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 | <3 minutes | Same |
| Temperature Control | No | Same |
| Humidity Control | No | Same |
| Image Reconstruction Algorithm | ||
| T1W- T1-Standard- T1-Gray/White Contrast | Advanced Gridding | Same |
| T2W- T2- T2-Fast | Advanced Gridding | Same |
| FLAIR | Advanced Gridding | Same |
| DWI | Conjugate Gradient | Same |
| Image Post-Processing | Advanced Denoising (applies to T1W, T2W, and FLAIR only) Image orientation transform Geometric distortion correction Receive coil intensity correction DICOM output | Same |
The subject device and the predicate device have the same intended use, operating principles, and similar technological characteristics. The subject device differs from the predicate in the following:
- Pulse sequences
- Retrained advanced reconstruction models
- Service/support features
- Audible scanner startup tone
These differences do not raise new questions of safety and efficacy as compared to the predicate.
Non-Clinical Performance
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 verification and validation testing was performed. The subject device passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence.
| Test | Test Description | Applicable Standard(s) |
|---|---|---|
| SoftwareVerification | Software verification testing in accordance withthe design requirements to ensure that thesoftware requirements were met. | - IEC 62304:2006- FDA Guidance, "Guidance for theContent of Premarket Submissionsfor Software Contained in MedicalDevices" |
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| ImagePerformance | Testing to verify the subject device meets allimage 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 ofthe Large MRI Phantom for the ACRMRI Accreditation Program- American College of Radiologystandards for named sequences |
|---|---|---|
| SoftwareValidation | Validation study to ensure the device meets userneeds and performs as intended. | - FDA Guidance, "Guidance for theContent of Premarket Submissionsfor Software Contained in MedicalDevices" |
The following testing was leveraged from the predicate device. 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-contactingmaterials. | - ISO 10993-1:2018- ISO 10993-5:2009- ISO 10993-10:2010 |
| Cleaning/Disinfection | Cleaning and disinfection validation of patient-contacting materials. | - FDA Guidance, "ReprocessingMedical Devices in Health CareSettings: Validation Methods andLabeling"- ISO 17664:2017- ASTM F3208-17 |
| Safety | Electrical Safety, EMC, and EssentialPerformance testing. | - ANSI/AAMI ES 60601-1:2005/(R)2012- IEC 60601-1-2:2014- IEC 60601-1-6:2013 |
| Performance | Characterization of the Specific Absorption Ratefor Magnetic Resonance Imaging Systems. | - NEMA MS 8-2016 |
| Cybersecurity | Testing to verify cybersecurity controls andmanagement. | - Cybersecurity as recommended inFDA guidance, "Content ofPremarket Submissions forManagement of Cybersecurity inMedical Devices" |
Conclusion
Based on the indications for use, technological characteristics, performance results, and comparison to the predicate, the subject Swoop Portable MR Imaging 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.
§ 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.