(102 days)
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 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, FLAIR, and DWI sequences.
The provided document is a 510(k) Summary for the Hyperfine Swoop Portable MR Imaging System (K240944). It describes the device, its intended use, and compares it to a predicate device (K232760) to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and the study information based on the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly list "acceptance criteria" for the device, but rather describes the tests performed and the standards met for demonstrating substantial equivalence. The provided information focuses on engineering and software validation rather than clinical performance metrics such as sensitivity, specificity, or accuracy for a specific diagnostic task.
Here's a table summarizing the tests described and the reported outcome:
| Category | Test Description | Applicable Standard(s) | Reported Performance/Outcome |
|---|---|---|---|
| Non-Clinical Performance | |||
| Software Verification | Software verification testing in accordance with the design requirements to ensure that the software requirements were met. | • IEC 62304:2015• FDA Guidance, "Content of Premarket Submissions for Device Software Functions" | The subject device passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence. |
| Image Performance | Testing to verify the subject device meets all image 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 of the Large MRI Phantom for the ACR MRI Accreditation Program, American College of Radiology standards for named sequences | The subject device passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence. |
| Cybersecurity | Testing to verify cybersecurity controls and management. | FDA Guidance, "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions" | The subject device passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence. |
| Software Validation | Validation to ensure the subject device meets user needs and performs as intended. | FDA Guidance, "Content of Premarket Submissions for Device Software Functions" | The subject device passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence. |
| Leveraged from Predicate | |||
| Biocompatibility | Biocompatibility testing of patient-contacting materials. | • ISO 10993-1:2018• ISO 10993-5:2009• ISO 10993-10:2010 | 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. |
| Cleaning/Disinfection | Cleaning and disinfection validation of patient-contacting materials. | • FDA Guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling"• ISO 17664:2017• ASTM F3208-17 | 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. |
| Safety | Electrical Safety, EMC, and Essential Performance testing. | • ANSI/AAMI ES 60601-1:2005/(R)2012• IEC 60601-1-2:2014• IEC 60601-1-6:2013 | 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. |
| Performance | Characterization of the Specific Absorption Rate for Magnetic Resonance Imaging Systems. | • NEMA MS 8-2016 | 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. |
The document states that the "subject device passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence." This implies that the acceptance criteria were met, which were defined by the adherence to these standards and the internal requirements.
2. Sample Size Used for the Test Set and the Data Provenance
The document details testing for software verification, image performance (phantom-based), cybersecurity, and software validation. It does not describe a clinical test set involving patient data for the subject device to evaluate diagnostic performance. The image performance testing appears to be based on physical phantoms (NEMA, ACR). Therefore, information on sample size for a "test set" in the context of clinical images and data provenance (country of origin, retrospective/prospective) is not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Since no clinical test set evaluating diagnostic performance with patient images is described for the subject device in this document, there is no mention of experts establishing ground truth for such a set. The image performance testing refers to ACR Phantom Test Guidance and standards, which don't typically involve expert reading of collected patient images.
4. Adjudication Method for the Test Set
As no clinical test set for diagnostic performance is described, there is no information on an adjudication method.
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?
No MRMC comparative effectiveness study is mentioned in this document. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance and leveraging prior test results from the predicate, not on comparative clinical efficacy or improvement with AI assistance for human readers. The device does utilize deep learning for image reconstruction, but its impact on human reader performance is not evaluated in this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe a standalone performance study in the context of diagnostic accuracy for the AI component (deep learning for image reconstruction). The deep learning is part of an image reconstruction algorithm, and the "image performance" testing is done against established phantom standards, not against a ground truth for diagnostic accuracy.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
For the non-clinical tests described, the "ground truth" refers to:
- Software Verification/Validation: Adherence to design requirements and user needs.
- Image Performance: Adherence to image quality criteria as defined by NEMA and ACR phantom standards. The "ground truth" for these tests would be the known properties of the phantoms and the expected imaging parameters.
- Cybersecurity, Biocompatibility, Cleaning/Disinfection, Safety, Performance (SAR): Adherence to relevant regulatory standards (IEC, ISO, FDA Guidance, ANSI/AAMI, ASTM).
There is no mention of expert consensus, pathology, or outcomes data as ground truth because no clinical diagnostic accuracy study is presented.
8. The Sample Size for the Training Set
The document states that "The Swoop System image reconstruction algorithm utilizes deep learning to provide improved image quality for T1W, T2W, FLAIR, and DWI sequences." However, it does not provide any information regarding the sample size of the training set used for this deep learning algorithm.
9. How the Ground Truth for the Training Set was Established
Since the document does not provide details on the training set for the deep learning algorithm, it also does not specify how the ground truth for that training set was established. Given it's an image reconstruction algorithm, the "ground truth" for training would typically involve pairs of raw MRI data and high-quality reconstructed images (often from different acquisition parameters or iterative reconstruction methods) rather than diagnostic labels from experts.
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July 16, 2024
Hyperfine, Inc. Christine Kupchick Sr. Manager, Global Regulatory 351 New Whitfield Street Guilford, Connecticut 06437
Re: K240944
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: April 5, 2024 Received: June 25, 2024
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/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.
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).
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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.
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,
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
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Indications for Use
Submission 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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510(k) Summary Swoop® Portable MR Imaging® System K240944
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: June 25, 2024
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 (K232760).
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, FLAIR, and DWI sequences.
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The subject Swoop System described in this submission includes software modifications related to the pulse sequences and system quality control test features.
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 ImagingSystem | Predicate Swoop Portable MR ImagingSystem (K232760) |
|---|---|---|
| Intended Use/ Indications for Use: | The Swoop Portable MR Imaging Systemis a portable, ultra-low field 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, intensive/critical care units,hospitals, outpatient, or rehabilitationcenters. | 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 |
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| 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 | <3 minutes | Same |
| Temperature Control | No | Same |
| Humidity Control | No | Same |
| Image Reconstruction Algorithm: | ||
| Noise Correction | Noise correction and line noisesuppression for all sequences | Same |
| T1W● T1-Standard● T1-Gray/White Contrast | Advanced Gridding | Same |
| T2W● T2● T2-Fast | Advanced Gridding | Same |
| FLAIR | Advanced Gridding | Same |
| DWI | Fast Iterative Shrinkage ThresholdingAlgorithm (FISTA) | Same |
| Image Post-Processing | ● Advanced Denoising● 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. There are minor differences between the subject device and the predicate in pulse sequences and quality control test features. 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 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) |
|---|---|---|
| Software Verification | Software verification testing in accordance withthe design requirements to ensure that thesoftware requirements were met. | • IEC 62304:2015• FDA Guidance, "Content of PremarketSubmissions for Device SoftwareFunctions" |
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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 of theLarge MRI Phantom for the ACR MRIAccreditation Program American College of Radiologystandards for named sequences |
|---|---|---|
| Cybersecurity | Testing to verify cybersecurity controls andmanagement. | FDA Guidance, "Cybersecurity inMedical Devices: Quality SystemConsiderations and Content ofPremarket Submissions" |
| Software Validation | Validation to ensure the subject device meets userneeds and performs as intended. | FDA Guidance, "Content of PremarketSubmissions for Device SoftwareFunctions" |
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, "Reprocessing MedicalDevices in Health Care Settings:Validation Methods and Labeling"• ISO 17664:2017• ASTM F3208-17 |
| Safety | Electrical Safety, EMC, and Essential Performancetesting. | • 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 |
Conclusion
Based on the intended 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.