(79 days)
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.
Evry is a magnetic resonance diagnostic device (MRDD) that uses a superconducting magnet to produce axial, sagittal, coronal, and oblique cross-sectional images, and displays the internal structure and/or function of the head. The system features various pulse sequences, imaging techniques and conform to NEMA DICOM standards (Digital Imaging and Communications in Medicine).
Integrated into the Magnetic Resonance Imaging system are a set of gradient coils which vary the strength of the applied magnetic field as a function of position and time, and are used to spatially encode the radio signals. Computed image reconstruction algorithms are then able to convert the encoded, digitized signals into images which can then be displayed to the user.
As with the predicate device, Evry includes the following technological components: Magnet scanner unit, gradient system and RF transmit coil, Equipment room containing the equipment needed to support the scanner unit functionality, Patient Transporter, 16-Channel Receive-Only Head Coil, Patient Communication System, Operator Console.
The furnished document describes the FDA 510(k) premarket notification for Evry, a magnetic resonance diagnostic device (MRDD). However, the document does not contain the detailed acceptance criteria or results of a clinical study that proves the device meets specific performance criteria in terms of diagnostic accuracy or comparative effectiveness with human readers.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (GE Medical Systems' 1.5T Signa HDx and 3.0T Signa HDx families) primarily through non-clinical performance data and conformity to recognized standards.
Here's an analysis of the provided text in relation to your request, highlighting what is present and what is missing:
Summary based on the provided document:
The provided document describes the FDA 510(k) premarket notification for Synaptive Medical Inc.'s "Evry" Magnetic Resonance Diagnostic Device (MRDD). The submission aims to demonstrate substantial equivalence to a legally marketed predicate device (GE Medical, 1.5T Signa HDx and 3.0T Signa HDx families).
The document primarily outlines non-clinical performance data and adherence to recognized consensus standards and FDA guidance documents. It does not contain a detailed clinical study demonstrating the device's diagnostic performance against specific acceptance criteria in terms of metrics like sensitivity, specificity, or reader improvement with AI assistance.
Details from the document related to your questions:
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A table of acceptance criteria and the reported device performance:
- Not explicitly provided. The document states that "Non-clinical verification and validation tests have been performed with regards to the intended use, technical claims, requirement specifications and risk management results." It also notes that "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."
- However, specific quantitative acceptance criteria (e.g., minimum SNR, image quality metrics) and the exact reported values are not listed in a table format within this summary. It implicitly states that the device's performance is sufficient given its compliance with various engineering and safety standards (ISO, IEC, NEMA).
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Sample size used for the test set and the data provenance:
- No specific test set for diagnostic accuracy is described. The document mentions a "direct determination peripheral nerve stimulation (PNS) volunteer study" with 20 subjects to characterize stimulation thresholds for safety purposes. This is a safety study, not a diagnostic performance study.
- Data Provenance: The document does not specify the country of origin for the PNS study data or if it was retrospective or prospective, beyond stating it was a "volunteer study."
- It mentions that "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." This implies some form of qualitative assessment of imaging, but not a large-scale test set for diagnostic performance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the qualitative image review, it mentions one U.S. Board Certified radiologist. No specific details about the radiologist's years of experience are provided in this excerpt.
- For the PNS study, ground truth isn't applicable in the same diagnostic sense; it's about physiological response to stimulation.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not described for diagnostic performance, as no such study is detailed. For the single radiologist review, no adjudication method would be necessary.
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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:
- No MRMC or AI assistance study was conducted or described. This device is an MRDD (MRI scanner), not an AI-powered diagnostic algorithm. Its function is to produce images for interpretation by a physician, not to interpret or assist in the interpretation of those images. Therefore, questions regarding AI assistance or human reader improvement are not relevant to the scope of this particular device's submission as described.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. As stated above, this is an imaging device, not a diagnostic algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the limited "clinical images review," the "ground truth" was the attestation by a U.S. Board Certified radiologist regarding the diagnostic quality of the images produced by the device. This is a qualitative assessment of image quality, not a diagnostic accuracy assessment against a confirmed patient condition.
- For the PNS study, the "ground truth" was the direct observation of physiological responses (nerve stimulation) in volunteers.
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The sample size for the training set:
- Not applicable/Not described. This device is a hardware imaging system, not a machine learning algorithm that requires a training set in the typical sense.
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How the ground truth for the training set was established:
- Not applicable/Not described. (See point 8).
Conclusion:
The provided document describes a Class II MRI device (Evry) seeking 510(k) clearance by demonstrating substantial equivalence. The clearance is primarily based on non-clinical performance data, conformance to recognized engineering and safety standards (e.g., ISO, IEC, NEMA, FDA guidance), and qualitative review of image quality by a radiologist. A safety study (PNS) was conducted with 20 subjects.
The document does not contain information related to a clinical study on diagnostic accuracy, sensitivity, specificity, or the comparative effectiveness of human readers with or without AI assistance, because the device itself is an MR scanner, not an AI-driven diagnostic tool. Therefore, many of the questions asked are not addressed by the provided content.
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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size below that.
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
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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
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Indications for Use
510(k) Number (if known)
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) |
|---|
| Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
[As required by 21 CFR 807.92(c)]
| Manufacturer:Address: | Synaptive Medical Inc.555 Richmond Street West, Suite 800Toronto, ON M5V 3B1Canada |
|---|---|
| Establishment Registration: | 3012075008 |
| Primary Contact Person: | Andrew GibsonSpecialist, Regulatory AffairsPhone: +1 647 243 3287Fax: 1 888 650 5230 |
| Secondary Contact Person: | Maham AnsariDirector, Requlatory AffairsPhone: +1 647 925 3435Fax: 1 888 650 5230 |
| Date Prepared: | 27 November, 2019 |
| Device Proprietary Name: | Evry™ |
| Classification Name: | System, Nuclear Magnetic ResonanceImaging |
| 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)Number | Date Cleared |
|---|---|---|---|
| 1.5T Signa HDx family and3.0T Signa HDx family | GE MedicalSystems | K121676 | September 20, 2012 |
| DeviceDescription | Evry is a magnetic resonance diagnostic device (MRDD) thatuses a superconducting magnet to produce axial, sagittal,coronal, and oblique cross-sectional images, and displays |
|---|---|
| Synaptive | |
| the internal structure and/or function of the head. Thesystem features various pulse sequences, imagingtechniques and conform to NEMA DICOM standards (DigitalImaging and Communications in Medicine). | |
| Indicationsfor Use | Evry is indicated for use as a magnetic resonance diagnosticdevice (MRDD) that produces axial, sagittal, coronal, andoblique cross-sectional images and displays the internalstructure and/or function of the head. Depending on theregion of interest, contrast agents may be used. Theseimages when interpreted by a trained physician yieldinformation that may assist in diagnosis. |
| DesignFeatures/FundamentalScientificTechnology: | Evry is based on the fundamental principle that certainatomic nuclei present in the human body can emit a weaksignal when placed in a strong magnetic field. To stimulatethis signal the nuclei must be excited by a radio signal at theprecession frequency of the nuclei. This resonant frequencydepends on the nuclei and the strength of the appliedmagnetic field. Emitted signals are weak radio signals at thisresonant frequency which can be sampled using one or morereceiver antennas and digitized for processing.Integrated into the Magnetic Resonance Imaging system area set of gradient coils which vary the strength of the appliedmagnetic field as a function of position and time, and areused to spatially encode the radio signals. Computed imagereconstruction algorithms are then able to convert theencoded, digitized signals into images which can then bedisplayed to the user.As with the predicate device, Evry includes the followingtechnological components: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 |
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Synaptive
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| Summary ofNon-ClinicalPerformanceData | The subject device conforms with the following FDA-recognized consensus standards and FDA guidancedocuments: |
|---|---|
| • 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,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 Notificationsfor Magnetic Resonance Diagnostic Devices" IssuedNovember 18, 2016 | |
| • "Guidance for Industry and FDA Staff – Guidance for theContent of Premarket Submissions for Software Containedin Medical Devices” Issued May 11, 2005 | |
| • "Guidance for Industry and FDA Staff – Content ofPremarket Submissions for Management of Cybersecurityin Medical Devices" – October 2, 2014 and Draft GuidanceIssued 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.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.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.Therefore, the safety and performance of Evry is substantially equivalent to the predicate device. | |
| ClinicalTesting | 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 wereincluded in this study.Data from this study were used to determine PNS limits thatwere implemented on Evry to ensure equivalent safetyagainst PNS compared to the predicate device. | |
| SubstantialEquivalence | Evry and the legally marketed predicate device, 1.5T SignaHDx family and 3.0T Signa HDx, family have equivalentindications, design features, fundamental scientifictechnology, performance and safety characteristics.While there are differences in the technologicalcharacteristics including the subject device being indicatedfor a subset of the predicate device indications and a lowermagnetic field strength in the subject device, substantialequivalence was demonstrated with nonclinical performance(verification and validation) tests, which conformed with therequirements specified in the international and FDA-recognized consensus standards and device-specificguidance. |
| Conclusion | The results of the comparison of technological and safetycharacteristics demonstrate that the subject device is assafe and effective as the predicate and that any differencesdo not raise any new concerns of safety or effectiveness. Inconclusion, Synaptive Medical Inc. considers the safety,performance and effectiveness of Evry to be substantiallyequivalent to the predicate device. |
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Synaptive
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Synaptive
§ 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.