QyScore Software

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December 13, 2019 Qynapse % Mr. Michael Daniel President Daniel & Daniel Consulting, LLC 340 Jones Lane GARDNERVILLE NV 89460 Re: K192531 Trade/Device Name: OyScore Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: November 29, 2019 Received: December 2, 2019 Dear Mr. Daniel: 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). 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Sincerely, 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) K192531 Device Name Qyscore Software #### Indications for Use (Describe) QyScore is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures and lesions from a set of MR images. Volumetric data may be compared to reference percentile data. QyScore is not intended for use in clinical scenarios that require evaluation of the white matter hyperintensities. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------| | <div> <span style="font-size: 10pt;">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span style="font-size: 10pt;">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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The word is centered and takes up most of the image. # Premarket Notification 510(k) Summary This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92. ## 510(k) Number: K192531 ## Applicant Information: | Date Prepared: | December 4, 2019 | |----------------|-------------------------------| | Name: | Qynapse | | | Address: 67 rue Saint Jacques | | | 75005 Paris, France | | Contact Person: | Michael A Daniel, Consultant<br>madaniel@clinregconsult.com | |-------------------|-------------------------------------------------------------| | Mobile Number: | (415) 407-0223 | | Office Number: | (775) 392-2970 | | Facsimile Number: | (610) 545-0799 | ## Device Information: | Trade Name: | QyScore Software | |---------------------------|---------------------------------------------| | Common Names: | Medical Image Processing Software | | Classification Name(s): | Picture archiving and communications system | | Product Code/ Regulation: | LLZ/21 CFR 892.2050 | | Classification: | Class II | ### Predicate Device: - NeuroQuant Medical Image Processing Software K170981 ● ### Device Description: QyScore automatically provides segmentations and measures of brain structures and lesions from a set of MR images for patients between the ages of 20 and 90. The software retrieves DICOM MRI data (3DT1 and T2FLAIR series) from a DICOM server and sends it to an analysis server for automatic segmentation of grey matter, white matter, hippocampus, amygdala and white matter hyperintensities. The outputs of the software include an electronic report and color overlays of the segmentation on the input images. The results are displayed in a dedicated graphical user interface, allowing the user to: - . Browse the segmentations and the measures, - Compare the results of segmented brain structures to a reference healthy population, ● - Read and edit a PDF report. {4}------------------------------------------------ QyScore integrates with leading RIS/PACS systems and can be operated with any MRI scan from 1.5T and 3T scanners for T1 MRI processing, and 3T scanners for T2FLAIR MRI processing. ## Indications for Use: QyScore is intended for automatic labeling, visualization and volumetric quantification of segmentable brain structures and lesions from a set of MR images. Volumetric data may be compared to reference percentile data. QyScore is not intended for use in clinical scenarios that require evaluation of the number of the white matter hyperintensities. | | Subject device | Predicate device | |------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | QyScore v1.7.0 | NeuroQuant v2.2 | | 510(k) number | N/A | K170981 | | Regulation<br>number | 21 CFR 892.2050 | 21 CFR 892.2050 | | Regulation<br>description | Picture archiving and<br>communications system | Picture archiving and<br>communications system | | Classification<br>name | System, Image Processing,<br>Radiological | System, Image Processing,<br>Radiological | | Classification | Class II | Class II | | Product Code | LLZ | LLZ | | Indications for<br>use | QyScore is intended for automatic<br>labeling, visualization and<br>volumetric quantification of<br>segmentable brain structures and<br>lesions from a set of MR images.<br>Volumetric data may be compared to<br>reference percentile data. QyScore is<br>not intended for use in clinical<br>scenarios that require evaluation of<br>the number of the white matter<br>hyperintensities. | NeuroQuant is intended for<br>automatic labeling, visualization and<br>volumetric quantification of<br>segmentable brain structures and<br>lesions from a set of MR images.<br>Volumetric measurements may be<br>compared to reference percentile<br>data. | | Design and<br>incorporated<br>technology | - Automated measurement of brain<br>tissue volumes and structures and<br>lesions<br>- Automatic segmentation and<br>quantification of brain structures<br>using a dynamic probabilistic<br>neuroanatomical atlas based on the<br>MR image intensity | - Automated measurement of brain<br>tissue volumes and structures and<br>lesions<br>- Automatic segmentation and<br>quantification of brain structures<br>using a dynamic probabilistic<br>neuroanatomical atlas, with age and<br>gender specificity, based on the MR<br>image intensity | | | - Results displayed through graphical user interface | | | Physical<br>characteristics | - Software package<br>- Operates on off-the-shelf hardware (multiple vendors) | - Software package<br>- Operates on off-the-shelf hardware (multiple vendors) | | Operating<br>system | Supports Linux | Supports Linux, Mac OS X and Windows | | Processing<br>architecture | Automated internal pipeline that performs:<br>- bias correction<br>- segmentation<br>- lesions quantification<br>- volume calculation<br>- report generation | Automated internal pipeline that performs:<br>- bias correction<br>- segmentation<br>- lesions quantification<br>- volume calculation<br>- report generation | | Data Source | MRI scanner: 3DT1 and FLAIR MRI scans acquired with specified protocols.<br>Supports DICOM format as input. | MRI scanner: 3DT1 and FLAIR MRI scans acquired with specified protocols.<br>Supports DICOM format as input. | | Output | - Provides volumetric measurements of brain structures and lesions<br>- Includes segmented color overlays and morphometric reports<br>- Automatically compares results to reference percentile data and to prior scans when available<br>- Supports DICOM format as output of results that can be displayed on DICOM workstations and Picture Archive and Communications Systems | - Provides volumetric measurements of brain structures and lesions<br>- Includes segmented color overlays and morphometric reports<br>- Automatically compares results to reference percentile data and to prior scans when available<br>- Supports DICOM format as output of results that can be displayed on DICOM workstations and Picture Archive and Communications Systems | | Safety | Automated quality control function:<br>scan protocol verification<br>Results must be reviewed by a trained physician | Automated quality control functions:<br>- Tissue contrast check<br>- Scan protocol verification<br>- Atlas alignment check<br>Results must be reviewed by a trained physician | ## Summary Comparison to Predicate: {5}------------------------------------------------ QyScore and the predicate device are software for automatically identifying and quantifying the volumes of brain structures, automatic labeling and visualization. The devices have the {6}------------------------------------------------ same intended use and operating principle. They take MR brain images as input and generate an electronic report with similar quantitative information. For both devices, output volumes are compared to a normative dataset of control subjects computed based on MRI data from normal control subjects. QyScore and NeuroQuant achieve their intended use based on a similar principle, since the quantification system relies on skull stripping (brain extraction), a brain segmentation based on a probabilistic atlas and image intensity information, and volume calculations of the segmented brain structures. Both devices normalize the volumes with the intracranial volume to allow for the statistical comparison with a normative dataset. Both devices are DICOM compatible and operate on off-the-shelf hardware. OyScore is used by medical personnel or neuroimaging trained personnel. NeuroQuant is used by physicians skilled in brain MR imaging. ## Summary of Performance Testing Testing performed on the OyScore software included: - Software verification testing . - Software validation testing - Human factors testing - Validation studies based on scientific literature - Evaluation of segmentation accuracy ● For the accuracy evaluation, QyScore segmentations were compared to expert manual segmentations for each segmented structure. Several acceptance criteria have been set in agreement with the literature, on both overlap metrics and volume difference metrics. The Dice coefficients exceed 85% on whole brain regions and are in the range of 75%-85% for subcortical brain structures segmented from 3DT1 MRI scans. The lesions segmentation, performed on (3DT1+T2FLAIR) paired sequences, was assessed on a broad validation population, with lesion loads ranging from 0.09mL to 87.65mL. The resulting mean absolute volume difference is 3.34mL. The performance testing demonstrated that the software meets its intended use, product specifications and user needs. ## Software Qynapse followed IEC 62304 and the FDA Guidance Document, "General Principles of Software Validation; Final Guidance for Industry and FDA Staff" (January, 2002) with respect to software development and validation. The QyScore software is classified as a "moderate level of concern" per the FDA guidance document. # Verification and validation testing was completed in compliance with the following standards and guidance documents: - · ISO 14971:2012. Medical devices application of risk management to medical devices - AAMI ANSI IEC 62304:2006, Medical device software Software life cycle processes ● {7}------------------------------------------------ - . General Principles of Software Validation; Final Guidance for Industry and FDA Staff" (January, 2002) - AAMI ANSI IEC 62366:2007, Medical devices Application of usability engineering . to medical devices Testing described in this 510(k) consists of verification of all design input requirements and product specifications. All clinical input requirements were validated. ## Conclusion Based upon the intended use, product technical information, performance evaluation, and standards compliance provided in this premarket notification, the QyScore software has been shown to be substantially equivalent to the legally marketed predicate device. The technological differences do not raise any new questions of safety and effectiveness.