(20 days)
The Synq Software is indicated for use in conjunction with Synq, 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.
The Synq Software allows a user to configure and initiate a magnetic resonance scan of a subject. In doing so, the software coordinates the interactions of the magnetic field, gradients, radio frequency (RF) transmitter and receiver coil in Synq (Previously known as EVRY, K200327) to produce axial, sagittal, coronal, and oblique cross-sectional images that represent the spatial distribution of protons with spin. The Synq Software Version 1.3 upgrades the current software version in the Synq system to include additional imaging applications, functionality, and minor bug fixes. The Software should be used only by qualified medical professionals who are trained in magnetic resonance diagnostic devices.
This document describes the Synaptive Medical Inc. Syng Software Version 1.3, a magnetic resonance diagnostic device (MRDD). The 510(k) submission (K232981) asserts its substantial equivalence to the predicate device (Evry, K200327).
Acceptance Criteria and Reported Device Performance
The provided text does not contain a specific table detailing acceptance criteria alongside reported device performance. However, it states:
"As per Bench Testing document attached under Bench Testing the image performance testing and safety testing meet all predefined acceptance criteria. Together, with an attestation from a U.S. Board certified radiologist, demonstrate substantial equivalence to the predicate device (EVRY K200327) by conforming to FDA recognized standards and addressing all requirements in FDA MRDD Guidance."
This indicates that the acceptance criteria were based on FDA recognized standards (NEMA MS 1, 2, 3, 4, 5, 8, 9; IEC 62464-1, IEC-60601-2-33) and FDA MRDD Guidance, focusing on image performance and safety. The reported performance is that the device meets all these predefined acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion Category | Specific Criteria (Inferred from Text) | Reported Device Performance |
|---|---|---|
| Image Performance | Conformance to NEMA MS 1, 2, 3, 4, 5, 8, 9 standards | Met all predefined criteria |
| Conformance to IEC 62464-1 (Medical electrical equipment - Requirements for the safety of MR equipment for medical diagnosis) | Met all predefined criteria | |
| Compliance with FDA MRDD Guidance | Met all requirements | |
| Safety Testing | Conformance to IEC-60601-2-33 (Medical electrical equipment - Particular requirements for the basic safety and essential performance of magnetic resonance equipment for medical diagnosis) | Met all predefined criteria |
| Compliance with FDA MRDD Guidance | Met all requirements |
2. Sample Size Used for the Test Set and Data Provenance
The text states: "A small, representative subset of clinical images are provided along with this 510(k) submission, as per guidance document 'Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices' issued November 18, 2016."
- Sample Size: "A small, representative subset of clinical images." The exact number is not specified in the provided text.
- Data Provenance: The text does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "clinical images," which implies human subject data, but further details are absent.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The text mentions: "Together, with an attestation from a U.S. Board certified radiologist, demonstrate substantial equivalence to the predicate device (EVRY K200327) by conforming to FDA recognized standards and addressing all requirements in FDA MRDD Guidance."
- Number of Experts: At least one U.S. Board certified radiologist provided an attestation. It's unclear if more than one was involved for ground truth establishment.
- Qualifications: U.S. Board certified radiologist. The number of years of experience is not specified.
4. Adjudication Method for the Test Set
The document does not describe a formal adjudication method (like 2+1 or 3+1) for establishing the ground truth of the test set. It mentions an "attestation from a U.S. Board certified radiologist," suggesting a single expert's assessment was used, possibly against benchmarks.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and its Effect Size
No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Synq Software Version 1.3 did not require clinical tests since substantial equivalence to the legally marketed predicate device was proven with the verification and validation testing." Therefore, there is no effect size of human readers improving with AI vs. without AI assistance to report.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Yes, a standalone performance assessment was effectively conducted through "image performance testing and safety testing" against predefined acceptance criteria derived from FDA recognized standards. This implies the software's output (images) was evaluated independently as part of the verification and validation. The role of the radiologist was for "attestation" and interpretation of images, rather than as part of a human-in-the-loop performance study.
7. The Type of Ground Truth Used
The ground truth for the verification and validation testing appears to be based on conformance to established technical performance standards and safety requirements (NEMA MS and IEC standards, FDA MRDD Guidance). For the clinical images, the "attestation from a U.S. Board certified radiologist" suggests a form of expert consensus/opinion regarding the quality and diagnostic utility of the images produced by the device, likely assessed against expected clinical standards of MRI imaging. Pathology or outcomes data are not mentioned.
8. The Sample Size for the Training Set
The document does not provide information regarding a training set. The submission focuses on verification and validation testing for an updated software version (1.3) of an already cleared device, implying the device's core algorithms were likely developed and validated previously. This 510(k) is for updates and does not detail the original training data for the base software.
9. How the Ground Truth for the Training Set Was Established
Since no training set information is provided, there is no information on how its ground truth was established.
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October 11, 2023
Synaptive Medical Inc. % Prithul Bom Most Responsible Person Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114
Re: K232981
Trade/Device Name: Syng Software Version 1.3 Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH Dated: September 21, 2023 Received: September 21, 2023
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
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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 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,
Daniel M. Krainak, Ph.D. Assistant Director Magnetic Resonance and Nuclear Medicine Team DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Submission Number (if known)
Device Name
Syng Software Version 1.3
Indications for Use (Describe)
The Synq Software is indicated for use in conjunction with Syng, 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.
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) #: | K232981 | 510(k) Summary | Prepared on: 2023-09-28 | ||
|---|---|---|---|---|---|
| Contact Details | 21 CFR 807.92(a)(1) | ||||
| Applicant Name | Synaptive Medical Inc. | ||||
| Applicant Address | 555 Richmond St West, Suite 800 Toronto Ontario M5V 3B1 Canada | ||||
| Applicant Contact Telephone | +1-647-243-3334 | ||||
| Applicant Contact | Mr. Ahmed Hamed | ||||
| Applicant Contact Email | ahmed.hamed@synaptivemedical.com | ||||
| Device Name | 21 CFR 807.92(a)(2) | ||||
| Device Trade Name | Synq Software Version 1.3 | ||||
| Common Name | Magnetic resonance diagnostic device | ||||
| Classification Name | System, Nuclear Magnetic Resonance Imaging | ||||
| Regulation Number | 892.1000 | ||||
| Product Code | LNH | ||||
| Legally Marketed Predicate Devices | 21 CFR 807.92(a)(3) | ||||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code | |||
| K200327 | Evry | LNH | |||
| Device Description Summary | 21 CFR 807.92(a)(4) | ||||
| The Synq Software allows a user to configure and initiate a magnetic resonance scan of a subject. In doing so, the software coordinates the interactions of the magnetic field, gradients, radio frequency (RF) transmitter and receiver coil in Synq (Previously known as EVRY, K200327) to produce axial, sagittal, coronal, and oblique cross-sectional images that represent the spatial distribution of protons with spin. | |||||
| The Synq Software Version 1.3 upgrades the current software version in the Synq system to include additional imaging applications, functionality, and minor bug fixes. | |||||
| The Software should be used only by qualified medical professionals who are trained in magnetic resonance diagnostic devices. | |||||
| Intended Use/Indications for Use | 21 CFR 807.92(a)(5) | ||||
| The Synq Software is indicated for use in conjunction with Synq, 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. |
Indications for Use Comparison
The indications for use in the subject device is the same as the predicate device:
The Synq Software is indicated for use in conjunction with Synq, a magnetic resonance diagnostic device (MRDD) that produces axial,
21 CFR 807.92(a)(5)
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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 year may assist in diagnosis.
Technological Comparison
21 CFR 807.92(a)(6)
The Subject Device is an updated version of the Predicate Device and any differences are only additive and do not raise concerns on safety and effectiveness.
The substantive changes in the Subject Device are as follows:
· New pulse sequences, including: o 3D T1 CSE ME-GRE (3D Fat Sat T1) o 2D Spin Echo EPI o 2D T2 CSE Spin Echo (2D Fat Sat T2) o 3D T2 Spin Echo o 2D Spin Echo EPI FLAIR o 3D T2 FLAIR o Diffusion Tensor Imaging (DTI) o 3D T2* ME-GRE (3D SWI)
· Minor updates to existing protocols
· Updates to various SOUP/OTS packages
· Minor bug fixes
As such, functionality in the software of the Predicate Device remains substantially unchanged in the Subject Device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
As per Bench Testing document attached under Bench Testing the image performance testing and safety testing meet all predefined acceptance criteria. Together, with an attestation from a U.S. Board certified radiologist, demonstrate substantial equivalence to the predicate device (EVRY K200327) by conforming to FDA recognized standards and addressing all requirements in FDA MRDD Guidance. Applicable Standards and Guidance include: NEMA MS 1 NEMA MS 2 NEMA MS 3 NEMA MS 4 NEMA MS 5 NEMA MS 8 NEMA MS 9 IEC 62464-1 IEC-60601-2-33 Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices
A small, representative subset of clinical images are provided along with this 510(k) submission, as per quidance document "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices" issued November 18, 2016. Synq Software Version 1.3 did not require clinical tests since substantial equivalence to the legally marketed predicate device was proven with the verification and validation testing.
The conclusions drawn from the nonctrate that the device is as safe, as effective, and performs as intended, and therefore, substantially equivalent to the legally marketed device (Evry, K200327). Synq Software Version 1.3 did not require clinical tests since substantial equivalence to the legally marketed predicate device was proven with the verification and validation testing.
§ 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.