Evry

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Synaptive Medical Inc. % Prithul Bom Responsible Third Party Official Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k SAINT PAUL MN 55114 Re: K200327 Trade/Device Name: Evry Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: April 20, 2020 Received: April 22, 2020 Dear Prithul Bom: 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/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. 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 April 29, 2020 {1}------------------------------------------------ devices or postmarketing safety reporting (21 CFR 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 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 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. 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) K200327 Device Name Evry Indications for Use (Describe) Evry is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces axial, sagittal, coronal, and oblique cross-sectional images and displays the internal structure and/or function of the region of interest, contrast agents may be used. These images when interpreted by a trained physician yield information that may assist in diagnosis. | Type of Use (Select one or both, as applicable) | |--------------------------------------------------------------------------------------| | <label><input type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D)</label> | | <label><input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C)</label> | ### 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}------------------------------------------------ ### 510(k) Summary [As required by 21 CFR 807.92(c)] | Manufacturer:<br>Address: | Synaptive Medical Inc.<br>555 Richmond Street West, Suite 800<br>Toronto, ON M5V 3B1<br>Canada | |-----------------------------|--------------------------------------------------------------------------------------------------| | Establishment Registration: | 3012075008 | | Primary Contact Person: | Andrew Gibson<br>Specialist, Regulatory Affairs<br>Phone: +1 647 243 3287<br>Fax: 1 888 650 5230 | | Secondary Contact Person: | Maham Ansari<br>Director, Requlatory Affairs<br>Phone: +1 647 925 3435<br>Fax: 1 888 650 5230 | | Date Prepared: | 27 November, 2019 | | Device Proprietary Name: | Evry™ | | Classification Name: | System, Nuclear Magnetic Resonance<br>Imaging | | Classification Panel: | Radiology | | Product Code: | LNH | | Regulation Number: | 21 CFR 892.1000 | | Regulation Class: | II | | Regulation Description: | Magnetic resonance diagnostic device | ## Predicate Devices: Substantial equivalence is claimed to the following device: | Trade name | Manufacturer | 510(k)<br>Number | Date Cleared | |----------------------------------------------------|-----------------------|------------------|--------------------| | 1.5T Signa HDx family and<br>3.0T Signa HDx family | GE Medical<br>Systems | K121676 | September 20, 2012 | | Device<br>Description | Evry is a magnetic resonance diagnostic device (MRDD) that<br>uses a superconducting magnet to produce axial, sagittal,<br>coronal, and oblique cross-sectional images, and displays | |-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Synaptive | | | | the internal structure and/or function of the head. The<br>system features various pulse sequences, imaging<br>techniques and conform to NEMA DICOM standards (Digital<br>Imaging and Communications in Medicine). | | Indications<br>for Use | Evry is indicated for use as a magnetic resonance diagnostic<br>device (MRDD) that produces axial, sagittal, coronal, and<br>oblique cross-sectional images and displays the internal<br>structure and/or function of the head. Depending on the<br>region of interest, contrast agents may be used. These<br>images when interpreted by a trained physician yield<br>information that may assist in diagnosis. | | Design<br>Features/<br>Fundamental<br>Scientific<br>Technology: | Evry is based on the fundamental principle that certain<br>atomic nuclei present in the human body can emit a weak<br>signal when placed in a strong magnetic field. To stimulate<br>this signal the nuclei must be excited by a radio signal at the<br>precession frequency of the nuclei. This resonant frequency<br>depends on the nuclei and the strength of the applied<br>magnetic field. Emitted signals are weak radio signals at this<br>resonant frequency which can be sampled using one or more<br>receiver antennas and digitized for processing.<br>Integrated into the Magnetic Resonance Imaging system are<br>a set of gradient coils which vary the strength of the applied<br>magnetic field as a function of position and time, and are<br>used to spatially encode the radio signals. Computed image<br>reconstruction algorithms are then able to convert the<br>encoded, digitized signals into images which can then be<br>displayed to the user.<br>As with the predicate device, Evry includes the following<br>technological components:<br>Magnet scanner unit, gradient system and RF transmit coilEquipment room containing the equipment needed to support the scanner unit functionalityPatient Transporter16-Channel Receive-Only Head CoilPatient Communication SystemOperator Console | {4}------------------------------------------------ # Synaptive {5}------------------------------------------------ Г | Summary of<br>Non-Clinical<br>Performance<br>Data | The subject device conforms with the following FDA-<br>recognized consensus standards and FDA guidance<br>documents: | |---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | • ISO 10993-1 Fourth edition 2009-10-15 | | | • ANSI AAMI ISO 14971:2007/(R)2010 | | | • ANSI AAMI ISO 15223-1:2016 | | | • ISO 17664 Second edition 2017-10 | | | • ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012,<br>C1:2009/(R)2012 and A2:2010/(R)2012 | | | • IEC 60601-1-2 Edition 4.0 2014-02 | | | • IEC 60601-1-6 Edition 3.1 2013-10 | | | • IEC 60601-2-33 Ed. 3.2 B:2015 | | | • IEC 62304 Edition 1.1 2015-06 | | | • ANSI AAMI IEC 62366-1:2015 | | | • IEEE Std 3333.2.1-2015 | | | • NEMA PS 3.1 – PS 3.20 (2016) | | | • NEMA MS-1-2008 (R2014) | | | • NEMA MS 2-2008 (R2014) | | | • NEMA MS 3-2008 (R2014) | | | • NEMA MS 4-2010 | | | • NEMA MS 5-2010 | | | • NEMA MS 8-2016 | | | • NEMA MS 9-2008 (R2014) | | | • "Guidance for the Submission of Premarket Notifications<br>for Magnetic Resonance Diagnostic Devices" Issued<br>November 18, 2016 | | | • "Guidance for Industry and FDA Staff – Guidance for the<br>Content of Premarket Submissions for Software Contained<br>in Medical Devices” Issued May 11, 2005 | | | • "Guidance for Industry and FDA Staff – Content of<br>Premarket Submissions for Management of Cybersecurity<br>in Medical Devices" – October 2, 2014 and Draft Guidance<br>Issued October 18, 2018 | | Synaptive | | | | | | | "Guidance for Industry and FDA Staff – Applying Human Factors and Usability Engineering to Medical Devices" Issued February 3, 2016 "Guidance for Industry and FDA Staff – Use of International Standard ISO 10993-1, “Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" Issued June 16, 2016 "Guidance for Industry and FDA Staff - Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-Powered Medical Devices" Issued July 11, 2016 "Reporting of Computational Modeling Studies in Medical Device Submissions" Issued September 21, 2016 Non-clinical verification and validation tests have been performed with regards to the intended use, technical claims, requirement specifications and risk management results.<br><br>Non-clinical testing included computational modeling of the integrated RF coil and gradient system demonstrating equivalence to the predicate device with respect to cardiac stimulation and RF energy deposition.<br><br>The verification and validation test results demonstrate that Evry conforms with the aforementioned FDA-recognized consensus standards and guidance documents and meets the acceptance criteria. Also, a representative set of clinical images of the proposed subject device have been reviewed by a U.S. Board Certified radiologist attesting that images produced by the device are of sufficient quality for diagnostic use.<br><br>Therefore, the safety and performance of Evry is substantially equivalent to the predicate device. | | Clinical<br>Testing | A direct determination peripheral nerve stimulation (PNS) volunteer study was conducted to characterize the stimulation thresholds for the purpose of deriving limits on PNS output, as outlined in IEC 60601-2-33 and "Guidance for the Submission of Premarket Notifications for Magnetic | | | Resonance Diagnostic Devices". Twenty subjects were<br>included in this study.<br>Data from this study were used to determine PNS limits that<br>were implemented on Evry to ensure equivalent safety<br>against PNS compared to the predicate device. | | Substantial<br>Equivalence | Evry and the legally marketed predicate device, 1.5T Signa<br>HDx family and 3.0T Signa HDx, family have equivalent<br>indications, design features, fundamental scientific<br>technology, performance and safety characteristics.<br>While there are differences in the technological<br>characteristics including the subject device being indicated<br>for a subset of the predicate device indications and a lower<br>magnetic field strength in the subject device, substantial<br>equivalence was demonstrated with nonclinical performance<br>(verification and validation) tests, which conformed with the<br>requirements specified in the international and FDA-<br>recognized consensus standards and device-specific<br>guidance. | | Conclusion | The results of the comparison of technological and safety<br>characteristics demonstrate that the subject device is as<br>safe and effective as the predicate and that any differences<br>do not raise any new concerns of safety or effectiveness. In<br>conclusion, Synaptive Medical Inc. considers the safety,<br>performance and effectiveness of Evry to be substantially<br>equivalent to the predicate device. | {6}------------------------------------------------ Synaptive {7}------------------------------------------------ # Synaptive