(79 days)
Not Found
No
The document describes standard MRI image reconstruction algorithms and does not mention AI or ML.
No.
The device is a magnetic resonance diagnostic device (MRDD) indicated for producing images to assist in diagnosis, not for treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that Evry is "indicated for use as a magnetic resonance diagnostic device (MRDD)" and that the images produced "may assist in diagnosis." The "Device Description" also refers to it as a "magnetic resonance diagnostic device (MRDD)."
No
The device description explicitly lists multiple hardware components including a magnet scanner unit, gradient system, RF transmit coil, equipment room, patient transporter, head coil, patient communication system, and operator console. This indicates it is a hardware-based medical device with integrated software for image reconstruction and display.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that Evry is a "magnetic resonance diagnostic device (MRDD)" that produces images of the internal structure and/or function of the head. It uses a superconducting magnet, gradient coils, and radio signals.
- Intended Use: The intended use is to produce images that, when interpreted by a trained physician, "yield information that may assist in diagnosis." This is a description of an imaging device, not a test performed on a biological sample.
- Lack of Biological Sample Analysis: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) anywhere in the provided text.
Therefore, Evry is an imaging device used for diagnosis, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
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).
Evry is based on the fundamental principle that certain atomic nuclei present in the human body can emit a weak signal when placed in a strong magnetic field. To stimulate this signal the nuclei must be excited by a radio signal at the precession frequency of the nuclei. This resonant frequency depends on the nuclei and the strength of the applied magnetic field. Emitted signals are weak radio signals at this resonant frequency which can be sampled using one or more receiver antennas and digitized for processing. 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Diagnostic Device (MRDD)
Anatomical Site
Head, Region of interest
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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".
Sample Size: Twenty subjects were included in this study.
Key Results: Data from this study were used to determine PNS limits that were implemented on Evry to ensure equivalent safety against PNS compared to the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
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)
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 800
Toronto, ON M5V 3B1
Canada |
|-----------------------------|--------------------------------------------------------------------------------------------------|
| Establishment Registration: | 3012075008 |
| Primary Contact Person: | Andrew Gibson
Specialist, Regulatory Affairs
Phone: +1 647 243 3287
Fax: 1 888 650 5230 |
| Secondary Contact Person: | Maham Ansari
Director, Requlatory Affairs
Phone: +1 647 925 3435
Fax: 1 888 650 5230 |
| Date Prepared: | 27 November, 2019 |
| Device Proprietary Name: | Evry™ |
| Classification Name: | System, Nuclear Magnetic Resonance
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)
Number | Date Cleared |
|----------------------------------------------------|-----------------------|------------------|--------------------|
| 1.5T Signa HDx family and
3.0T Signa HDx family | GE Medical
Systems | K121676 | September 20, 2012 |
| Device
Description | 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 |
|-----------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Synaptive | |
| | 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). |
| Indications
for Use | 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 head. Depending on the
region of interest, contrast agents may be used. These
images when interpreted by a trained physician yield
information that may assist in diagnosis. |
| Design
Features/
Fundamental
Scientific
Technology: | Evry is based on the fundamental principle that certain
atomic nuclei present in the human body can emit a weak
signal when placed in a strong magnetic field. To stimulate
this signal the nuclei must be excited by a radio signal at the
precession frequency of the nuclei. This resonant frequency
depends on the nuclei and the strength of the applied
magnetic field. Emitted signals are weak radio signals at this
resonant frequency which can be sampled using one or more
receiver antennas and digitized for processing.
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 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
Non-Clinical
Performance
Data | The subject device conforms with the following FDA-
recognized consensus standards and FDA guidance
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,
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
for Magnetic Resonance Diagnostic Devices" Issued
November 18, 2016 |
| | • "Guidance for Industry and FDA Staff – Guidance for the
Content of Premarket Submissions for Software Contained
in Medical Devices” Issued May 11, 2005 |
| | • "Guidance for Industry and FDA Staff – Content of
Premarket Submissions for Management of Cybersecurity
in Medical Devices" – October 2, 2014 and Draft Guidance
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.
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. |
| Clinical
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
included in this study.
Data from this study were used to determine PNS limits that
were implemented on Evry to ensure equivalent safety
against PNS compared to the predicate device. |
| Substantial
Equivalence | Evry and the legally marketed predicate device, 1.5T Signa
HDx family and 3.0T Signa HDx, family have equivalent
indications, design features, fundamental scientific
technology, performance and safety characteristics.
While there are differences in the technological
characteristics including the subject device being indicated
for a subset of the predicate device indications and a lower
magnetic field strength in the subject device, substantial
equivalence was demonstrated with nonclinical performance
(verification and validation) tests, which conformed with the
requirements specified in the international and FDA-
recognized consensus standards and device-specific
guidance. |
| Conclusion | The results of the comparison of technological and safety
characteristics demonstrate that the subject device is as
safe and effective as the predicate and that any differences
do not raise any new concerns of safety or effectiveness. In
conclusion, Synaptive Medical Inc. considers the safety,
performance and effectiveness of Evry to be substantially
equivalent to the predicate device. |
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Synaptive
7