BrainInsight

{0}------------------------------------------------ January 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 is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. Hyperfine Research, Inc. % Robert W. Fasciano, Ph.D. Head of Quality Assurance & Regulatory Affairs 530 Old Whitfield Street GUILFORD CT 06437 Re: K202414 Trade/Device Name: BrainInsight Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: December 4, 2020 Received: December 7, 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 {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 510(k) Number (if known) K202414 Device Name BrainInsight Indications for Use (Describe) BrainInsight is intended for automatic labeling, spatial measurement, and volumetric quantification of brain structures from a set of low-field MR images and returns annotated images, color overlays, and reports. | Type of Use (Select one or both, as applicable) | | |-------------------------------------------------|--| |-------------------------------------------------|--| X Prescription Use (Part 21 CFR 801 Subpart D) | | Over-The-Counter Use (21 CFR 801 Subpart C) ## CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ Page 1 of 4 Section 5 – 510(k) Summary K202414 | 510(k) Summary<br>(As required by 21 CFR 807.92) | | | |-----------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------| | Date Summary Prepared: | August 21, 2020 | | | Company Name:<br>As required by 807.92(a)(1) | Hyperfine Research, Inc. | | | Robert W. Fasciano, PhD | | | | Head of Quality Assurance & Regulatory Affairs | | | | | 530 Old Whitfield St. | | | | Guilford, CT 06437 | | | | (617) 435-9098 | | | | rfasciano@hyperfine-research.com | | | Device Name:<br>As required by 807.92(a)(2) | Device/Trade Name: | BrainInsight | | | Device Common Name: | System, Image Processing,<br>Radiological | | | Regulation Number: | 21 CFR 892.2050 | | | Regulation Name: | System, Image Processing,<br>Radiological | | | Regulation Description: | Picture archive and<br>communications system | | | Class: | II | | | Product Code: | LLZ | | Predicate Device(s):<br>As required by 807.92(a)(3) | NeuroQuant, K170981 | | | Device Description:<br>As required by 807.92(a)(4) | BrainInsight is a fully automated MR imaging post-<br>processing medical software that image alignment, whole<br>brain segmentation, ventricle segmentation, and midline<br>shift measurements of brain structures from a set of MR<br>images from patients aged 18 or older. The output annotated<br>and segmented images are provided in a standard image<br>format using segmented color overlays and reports that can<br>be displayed on third-party workstations and FDA cleared<br>Picture Archive and Communications Systems (PACS). The<br>high throughput capability makes the software suitable for<br>use in routine patient care as a support tool for clinicians ir<br>assessment of low-field (64mT) structural MRIs.<br>BrainInsight provides overlays and reports based on 64mT<br>3D MRI series of a T1 and T2-weighted sequence. The<br>outputs of the software are DICOM images which include | | {4}------------------------------------------------ volumes that have been annotated with color overlays, with each color representing a particular segmented region, spatial measurement of anatomical structures, and information reports computed from the image data, segmentations, and measurements. The BrainInsight processing architecture includes a proprietary automated internal pipeline that performs whole brain segmentation, ventricle segmentation, and midline shift measurements based on machine learning tools. Additionally, the system's automated safety measures include automated quality control functions, such as tissue contrast check and scan protocol verification. The system is installed on a standard computing platform, e.g. server that may be in the cloud, and is designed to support file transfer for input and output of results. Statement of Intended Use: BrainInsight is intended for automatic labeling, spatial As required by 807.92(a)(5) measurement, and volumetric quantification of brain structures from a set of low-field MR images and returns annotated and segmented images, color overlays, and reports. | Device | Proposed Device | Predicate Device | |----------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | BrainInsight | NeuroQuant, K170981 | | Classification | Class II, LLZ, 21 CFR 892.2050 | Class II, LLZ, 21 CFR 892.2050 | | Intended Use | Automatic labeling, spatial<br>measurement, and volumetric<br>quantification of brain structures<br>from a set of low-field MR<br>images and returns annotated<br>and segmented images, color<br>overlays, and reports. | Automatic labeling, visualization<br>and volumetric quantification of<br>segmentable brain structures and<br>lesions from a set of MR images.<br>Volumetric data may be<br>compared to reference percentile<br>data | | Target Anatomical Sites | Brain | Brain | | Technology | • Automated measurement of<br>brain tissue volumes and<br>structures<br>• Automatic segmentation and<br>quantification of brain structures<br>using machine learning | • Automated measurement of<br>brain tissue volumes and<br>structures and lesions<br>• Automatic segmentation and<br>quantification of brain structures<br>using a dynamic probabilistic<br>neuroanatomical atlas, with age<br>and gender specificity, based on<br>the MR image intensity | | Method of Use | MR images are automatically<br>sent to BrainInsight and<br>processed images are<br>automatically returned in<br>approximately 7 minutes. | User manually sends MR images<br>to NeuroQuant and processed<br>images are automatically<br>returned in approximately 7<br>minutes. | | Device | Proposed Device<br>BrainInsight | Predicate Device<br>NeuroQuant, K170981 | | User Interface / Physical<br>Characteristics | • No software required<br>• Operates in a serverless cloud environment<br>• User interface through PACS<br>(multiple vendors) | • Software package installed on<br>User hardware<br>• Operates on off-the-shelf<br>hardware (multiple vendors)<br>• User interface through the<br>software package | | Operating System | Supports Linux | Supports Linux, Mac OS X and<br>Windows | | Processing Architecture | Automated internal pipeline that<br>performs:<br>- segmentation<br>- volume calculation<br>- distance measurement<br>- numerical information display | Automated internal pipeline that<br>performs:<br>- artifact correction<br>- segmentation<br>- lesion quantification<br>- volume calculation<br>- report generation | | Data Source | • MRI scanner: Hyperfine FSE<br>MRI scans acquired with<br>specified protocols<br>• Supports DICOM format as<br>input | • MRI scanner: 3D T1 MRI<br>scans acquired with specified<br>protocols<br>• NeuroQuant Supports DICOM<br>format as input | | Output | Provides volumetric<br>measurements of brain structures<br>• Includes segmented color<br>overlays and morphometric<br>reports<br>• Supports DICOM format as<br>output of results that can be<br>displayed on DICOM<br>workstations and Picture<br>Archive and Communications<br>Systems | Provides volumetric<br>measurements of brain structures<br>and lesions<br>• Includes segmented color<br>overlays and morphometric<br>reports<br>• Automatically compares results<br>to reference percentile data and<br>to prior scans when available<br>• Supports DICOM format as<br>output of results that can be<br>displayed on DICOM<br>workstations and Picture<br>Archive and Communications<br>Systems | | Safety | Automated quality control<br>functions<br>• Tissue contrast check<br>• Scan protocol verification<br>• Atlas alignment check<br>• Results must be reviewed by a<br>trained physician | Automated quality control<br>functions<br>• Tissue contrast check<br>• Scan protocol verification<br>• Atlas alignment check<br>• Results must be reviewed by a<br>trained physician | ## Comparison of Technological Characteristics with Predicate Devices: As required by 807.92(a)(6) {5}------------------------------------------------ # Comparison of Technological Characteristics with Predicate Devices: As required by 807.92(a)(6) Performance data was limited to software evaluations to Non-clinical Performance Data: As required by 807.92(b)(1) confirm: - Cybersecurity and PHI protection • - . Midline shift - 3D Coordinates and alignment • - . Segmentation {6}------------------------------------------------ | Data Quality Control Audit trail User Manual information Software control Ventricle segmentation Midline shift measurement Skull stripping | |-------------------------------------------------------------------------------------------------------------------------------------------------------| | Assessment of Clinical Data: No clinical data was required to demonstrate substantial<br>As required by 807.92(b)(2) equivalence. | | Overall Conclusions: Based on the indications for use, technologic<br>As required by 807.92(b)(3) characteristics, and comparison to predicate device | ical ice, BrainInsight has been shown to be substantially equivalent to the predicate and is safe and effective for its intended use.