(49 days)
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.
The Point-Of-Care Magnetic Resonance Imaging (POC MRI) system is an MRI device that is portable allowing patient bedside imaging. It 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, used to operate the system, provide access to patient data, exam set-up, exam execution, and MRI image data viewing for quality control purposes as well as for cloud storage interactions. The POC MRI 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.
Based on the provided text, the device in question is the Hyperfine Point-Of-Care Magnetic Resonance Imaging Scanner System.
Here's an analysis of the acceptance criteria and the study information, extracting what's available in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not provide a specific table of quantitative acceptance criteria for image quality or diagnostic performance, nor does it report specific performance metrics for the device against such criteria. Instead, it refers to verification and validation activities conducted to demonstrate that the device meets "predetermined performance specifications" and several recognized standards.
2. Sample Size Used for the Test Set and Data Provenance
The document does not provide any details regarding the sample size used for a test set, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective) for any studies involving human subjects or patient data. The evaluation appears to be focused on technical standards and phantom testing as opposed to clinical study results presented in this 510(k) summary.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Given the lack of information on a clinical test set with human subjects, the document does not specify the number of experts used to establish ground truth or their qualifications. The "Indications for Use" section mentions that images, "When interpreted by a trained physician, these images provide information that can be useful in determining a diagnosis." However, this is a general statement about usage, not a description of a ground truth establishment process for a study.
4. Adjudication Method for the Test Set
As no test set with human subjects or expert assessment is described, there is no information on any 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
The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it mention any AI assistance or the effect size of such assistance on human readers. The summary focuses on the MRI system itself and its equivalence to a predicate device.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The document does not describe any standalone algorithm performance testing. The device is a diagnostic imaging system, and its output is intended for interpretation by a trained physician.
7. The Type of Ground Truth Used
The document does not specify the type of ground truth used for any clinical performance evaluation, as no such evaluation is detailed in this summary. The standards listed (e.g., NEMA standards for SNR, uniformity, geometric distortion) relate to technical performance characteristics typically evaluated using phantoms and standardized testing procedures, not clinical ground truth.
8. The Sample Size for the Training Set
The document does not provide any information about a training set or its sample size. This suggests the 510(k) summary does not involve a machine learning model that would require a distinct training set for diagnostic classification in the typical sense.
9. How the Ground Truth for the Training Set Was Established
Since no training set is mentioned, there is no information on how ground truth for a training set was established.
Summary of Information from the Document:
The provided 510(k) summary focuses on demonstrating substantial equivalence to a predicate device (K192002 - Lucy Point-of-Care Magnetic Resonance Imaging Device, Hyperfine Research, Inc.) based on technological characteristics, safety, and performance testing against recognized standards. It does not contain details about specific clinical performance studies involving patient data, expert interpretations, or AI-driven diagnostic capabilities. The performance evaluation primarily refers to adherence to engineering and safety standards using in-house protocols.
Standards cited for evaluating performance:
- ANSI AAMI 60601-1: 2005 (+ Amendment 1) Medical Electrical Equipment -Part 1: General Requirements for Safety
- IEC 60601-2-33: Edition 3.2 - 2015. Medical Electrical Equipment - Part 2-33: Particular Requirements for the Basic Safety and Essential Performance of Magnetic Resonance Equipment for Medical Diagnosis
- IEC 60601-1-2: Edition 4.0 - 2014, Medical Electrical Equipment- Part 1-2: General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
- IEC 60601-1-6: Edition 3.1 - 2013. Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Usability
- ISO 10993-1: Edition 5 - 2018 Biological Evaluation of Medical Devices, Part 1
- ISO 14971: 2007 (R)2010 Application of Risk Management to Medical Devices
- IEC 62304: 2006 (+ Amendment 1) Medical Device Software - Software Lifecycle Process
- 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 8-2008 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
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August 11, 2020
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Hyperfine Research, Inc. % Robert Fasciano, Ph.D. Head of Quality Assurance and Regulatory Affairs 530 Old Whitfield Street GUILFORD CT 06437
Re: K201722
Trade/Device Name: Hyperfine Point-Of-Care Magnetic Resonance Imaging Scanner System Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, MOS Dated: June 19, 2020 Received: June 23, 2020
Dear Dr. Fasciano:
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
510(k) Number (if known)
Device Name
Point-of-Care Magnetic Resonance Imaging Scanner System
Indications for Use (Describe)
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.
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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Section 5 - 510(k) Summary
P YPERFINE
530 Old Whitfield Street, Guilford, CT 06437 (203) 204-6900
510(k) Summary of Safety and Effectiveness
Submitter Information
Submitter Name and Address
Hyperfine Research, Inc. 530 Old Whitfield Street Guilford, CT 06437 USA (tel.) 203-204-6900 (fax) 203-458-2514 www.hyperfine.io
Contact Person
Robert Fasciano, PhD Head of Quality Assurance and Regulatory Affairs 617-425-9098 (cell) rfasciano@hyperfine.io
Date Prepared
June 19, 2020
Subject Device - Proprietary/Trade Name
Point-of-Care Magnetic Resonance Imaging Scanner System
Subject Device - Common Name
Magnetic Resonance Imaging (MRI)
| Classification Name | Requlation Number | Product Code |
|---|---|---|
| System, Nuclear Magnetic ResonanceImaging | 892.1000 | 90-LNH |
| Coil, Magnetic Resonance, Specialty | 892.1000 | 90-MOS |
Classification
Class II
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Predicate Device:
K192002 - Lucy Point-of-Care Magnetic Resonance Imaging Device, Hyperfine Research, Inc.
Device Summary:
The Point-Of-Care Magnetic Resonance Imaging (POC MRI) system is an MRI device that is portable allowing patient bedside imaging. It 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, used to operate the system, provide access to patient data, exam set-up, exam execution, and MRI image data viewing for quality control purposes as well as for cloud storage interactions. The POC MRI 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.
Indications for Use:
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.
Summary of Technological Characteristics
There are no technological characteristics, features or indications for use in this submission that are not previously evaluated and cleared in the predicate device. The technology meets the same intended use and performs the same actions.
Summary of Safety and Performance
Verification and validation activities were designed and performed to demonstrate that the POC MRI meets predetermined performance specifications. The following standards in conjunction with in-house protocols were used to determine appropriate methods for evaluating the performance of the device:
ANSI AAMI 60601-1: 2005 (+ Amendment 1) Medical Electrical Equipment -Part 1: General Requirements for Safety
IEC 60601-2-33: Edition 3.2 - 2015. Medical Electrical Equipment - Part 2-33: Particular Requirements for the Basic Safety and Essential Performance of Magnetic Resonance Equipment for Medical Diagnosis
IEC 60601-1-2: Edition 4.0 - 2014, Medical Electrical Equipment- Part 1-2:
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General Requirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests
IEC 60601-1-6: Edition 3.1 - 2013. Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Usability
ISO 10993-1: Edition 5 - 2018 Biological Evaluation of Medical Devices, Part 1
ISO 14971: 2007 (R)2010 Application of Risk Management to Medical Devices
IEC 62304: 2006 (+ Amendment 1) Medical Device Software - Software Lifecycle Process
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 8-2008 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
Summary of Substantial Equivalence:
Based on the indications for use, technological characteristics, and safety and performance testing, the subject device meets the requirements that are considered adequate for its intended use and is substantially equivalent in design, principles of operation and indications for use to the predicate device.
§ 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.