(26 days)
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 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.
The purpose of this submission is to gain clearance for updates to the software to include automatic alignment and motion correction features.
The provided text describes a 510(k) summary for the Hyperfine Swoop™ Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System (K211818). However, it focuses primarily on demonstrating substantial equivalence to a predicate device (K201722) through non-clinical performance data and risk analysis of software updates (automatic alignment and motion correction, UI updates, security features).
Crucially, the provided document does NOT contain information about a clinical study that proves the device meets specific acceptance criteria based on human reader performance, nor does it detail a standalone AI performance study. The content explicitly states that the submission is for software updates and that performance testing was conducted "to evaluate the modifications" and demonstrates that the device "passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence." This refers to engineering and regulatory compliance testing rather than clinical performance evaluation against specific diagnostic accuracy metrics.
Therefore, I cannot fulfill all parts of your request with the provided information. I will address the parts that can be inferred or directly stated from the text, and clearly mark where the requested information is not available in the provided document.
Here's a breakdown based on the provided text, indicating where information is present and where it is absent:
Acceptance Criteria and Device Performance:
The document does not specify quantitative clinical acceptance criteria (e.g., minimum sensitivity, specificity, or reader agreement) for diagnostic performance or present a table of device performance against such criteria. The "performance testing" mentioned relates to non-clinical verification of software and hardware changes for safety and effectiveness in the context of substantial equivalence.
Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified for clinical diagnostic performance. The document states: "The subject device passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence." This primarily refers to: - Software Verification (IEC 62304) - Cybersecurity Information - Biocompatibility (ISO 10993-1) - Electrical Safety, EMC, Essential Performance (ANSI/AAMI ES 60601-1, IEC 60601-2-33, IEC 60601-1-2) - Usability (IEC 60601-1-6) - SNR (NEMA MS 1) - Image Uniformity (NEMA MS 3) - SAR (NEMA MS 8) - Phased Array Coils (NEMA MS 9) - Geometric Distortion (NEMA MS 12) | Not specified for clinical diagnostic performance. The document does not provide quantitative results for these non-clinical tests, only a statement that the device "passed all the testing." Specific values for SNR, uniformity, etc., are not reported in this summary. |
Missing Information Regarding Clinical Study:
The document does not describe a clinical study designed to demonstrate diagnostic performance of the device itself (or the AI functions if they were to assist human readers). Thus, the following information is not available from the provided text:
- Sample sizes used for the test set and the data provenance: Not available. The document refers to "testing" but not in the context of human reader performance or a clinical test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not available.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not available.
- 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 available. The document mentions "automatic alignment and motion correction features" as software updates, but it does not describe a study evaluating their impact on human reader performance. The device is described as "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." This implies the image quality is assessed, but no study details are provided.
- If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not available. The software updates are applied to the device, but there's no mention of an AI algorithm performing diagnostic tasks in a standalone manner.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not available.
- The sample size for the training set: Not applicable and not available. The document describes software updates to an existing device, not the development of a new AI model requiring a separate training set description. The "automatic alignment and motion correction features" are likely engineering solutions rather than AI models needing large image datasets for training in a diagnostic context.
- How the ground truth for the training set was established: Not applicable and not available.
Summary of what the document implies about "study that proves the device meets the acceptance criteria":
The "study" in this context refers to the non-clinical performance testing and risk analysis described in the 510(k) summary. These tests ensure the device, with its updated software features, continues to meet safety and technical standards for an MRI scanner intended for bedside use, consistent with its predicate. The "acceptance criteria" are the passing criteria for these engineering and regulatory tests, which are not listed specifically but are implied by the statement "passed all the testing." The document implies that by passing these tests and demonstrating substantial equivalence to a predicate, the device is considered to meet the necessary criteria for market clearance. It does not disclose a clinical study evaluating the device's diagnostic accuracy or the impact of its features on human diagnostic performance.
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July 7, 2021
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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
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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
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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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HYPERFINE
510(k) SUMMARY K211818
510(k) Submitter
| Company Name: | Hyperfine, Inc. |
|---|---|
| Company Address: | 530 Old Whitfield StGuilford, 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 ImagingCoil, 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.
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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 MagneticResonance Imaging Device is a bedsidemagnetic resonance imaging devicefor producing images that display theinternal structure of the head wherefull diagnostic examination is notclinically practical. When interpretedby a trained physician, these imagesprovide information that can be usefulin determining a diagnosis. | The Point-of-Care MagneticResonance Imaging Device is a bedsidemagnetic resonance imaging devicefor producing images that display theinternal structure of the head wherefull diagnostic examination is notclinically practical. When interpretedby a trained physician, these imagesprovide information that can be usefulin 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 |
| OperationTemperature | 15-30C | 15-30C |
| Warm Up Time | <3 min | <3 min |
| MAGNET | ||
| Physical Dimensions | 835 mm x 630 mm x 652 mm | 835 mm x 630 mm x 652 mm |
| Bore Opening | 610 mm x 315 mm | 610 mm x 315 mm |
| Weight | 320 kg | 320 kg |
| Field Strength | 63.3 mT permanent magnet | 63.3 mT permanent magnet |
| GRADIENT | ||
| Strength | 24 mT/m | 24 mT/m |
| Rise Time | 0.4 ms | 0.4 ms |
| Slew Rate | 22 T/m/s permanent magnet | 22 T/m/s permanent magnet |
| COMPUTER | ||
| Display | User supplied tablet | User supplied tablet |
| RF COIL | ||
| RF Coils | 1 Head Coil | 1 Head Coil |
| Coil Type | TX/RX | TX/RX |
| Coil Geometry | Form-Fitting | Form-Fitting |
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| Inner Dimensions | 205 mm x 240 mm | 205 mm x 240 mm |
|---|---|---|
| Coil Design | Linear Volume | Linear Volume |
The subject device and the predicate device have intended use, operating principles and similar technological characteristics. The subject device differs from the predicate in software features, which include automatic alignment and motion correction. Additionally, minor changes were made through letter-to-file to both the software and hardware of the minor changes to the software included updates to the user interface and enhanced security features, and the minor changes to the hardware included modifications to the RF shield and screen, gauss guard, and battery charger through. These differences do not raise new questions of safety and effectiveness as compared to the predicate.
Non-Clinical Performance
The subject device has similar technological characteristics as the predicate (K201722) and differs only in software, which includes automatic alignment and motion correction features, updates to the user interface, and enhanced security features. As part of demonstrating substantial equivalence to the predicate, a risk analysis was completed to identify the risks associated with the software modifications. Performance testing was conducted to evaluate the modifications. The subject device passed all the testing in accordance with internal requirements and applicable standards to support substantial equivalence.
- 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"
The following testing was leveraged from the predicate device (K201722). 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.
- 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
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- . 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 ● Resonance Images
- NEMA MS 12-2016 Quantification and Mapping of Geometric Distortion for Special . Applications
Conclusion
The results of the testing described above demonstrate that the subject Swoop POC MRI Scanner System is as safe and effective as the predicate and supports a determination of substantial equivalence.
§ 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.