(128 days)
No
The document describes a new imaging feature called "Compressed Sensing GRASP-VIBE" which is a software sequence for MR imaging. While compressed sensing is a signal processing technique that can be used in conjunction with AI/ML, the document does not mention any AI, ML, or deep learning components in the description of this feature or the device itself. The testing described focuses on software verification, validation, and performance tests related to MR imaging, not on the evaluation of AI/ML model performance.
No.
The device is a diagnostic imaging system (MRI) used to produce images and spectroscopic data to assist in diagnosis, not to treat conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the images, spectra, and derived physical parameters "when interpreted by a trained physician yield information that may assist in diagnosis." This indicates the device is used to produce information for diagnostic purposes.
No
The device description explicitly states that the MAGNETOM Vida system includes "software sequences, applications, coils and other hardware for the MAGNETOM scanner." While the filing focuses on a new software feature (Compressed Sensing GRASP-VIBE), the overall device being cleared is an MR system which is a hardware device with integrated software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions.
- Device Description: The text clearly describes the MAGNETOM system as a "magnetic device (MRDD)" that produces images and spectra of the internal structure and/or function of the body. It uses magnetic resonance technology.
- Intended Use: The intended use is to produce images and spectra that, when interpreted by a trained physician, "yield information that may assist in diagnosis." This is a description of an imaging device used for diagnostic purposes, not a test performed on a sample outside the body.
- Lack of Mention of Samples: There is no mention of analyzing blood, urine, tissue, or any other biological sample taken from the patient.
The device is a Magnetic Resonance (MR) system, which is a type of medical imaging device.
N/A
Intended Use / Indications for Use
Your MAGNETOM system is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Your MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
Compressed Sensing GRASP-VIBE is intended to be used in dynamic and/or non-contrast liver examinations to support patients who cannot reliably hold their breath for a conventional breath-hold measurement.
Product codes (comma separated list FDA assigned to the subject device)
LNH, LNI, MOS
Device Description
The subject device, MAGNETOM Vida, is an MR system. The software syngo MR XA10A is the latest software for the Siemens MAGNETOM Vida and includes software sequences, applications, coils and other hardware for the MAGNETOM scanner. The software sequences, applications, coils and other hardware were previously cleared with K170396.
MAGNETOM Vida will be offered ex-factory (new production) with software syngo MR XA10A and Compressed Sensing GRASP-VIBE. Installed MAGNETOM Vida systems can be updated by activating the blocked license.
This filing describes the new imaging feature intended to be used with the MAGNETOM Vida. Compressed Sensing GRASP-VIBE is intended to be used in dynamic and/or non-contrast liver examinations to support patients who cannot reliably hold their breath for a conventional breath-hold measurement.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
head, body, or extremities, liver
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician, healthcare professionals
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)
NONCLINICAL TESTS
- A comparison of the functionality was performed between the new feature and the reference device feature by detailed simulations with a numerical phantom.
- Software verification and validation testing was completed in accordance with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
- Performance tests were completed in accordance with the FDA guidance document, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices" dated November 18, 2016
- No testing in accordance with the applicable Performance Standards (NEMA) is needed due to the nature of the new imaging feature (software change only).
The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared.
CLINICAL TESTS
Sample clinical images, rather than a clinical study, were included in the determination of substantial equivalence.
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.
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 contains the logo of the U.S. Food and Drug Administration (FDA). The FDA logo is composed of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency, "U.S. Food & Drug Administration," on the right. The FDA acronym and the agency's name are in blue.
Siemens Medical Solutions USA, Inc. Cordell Fields Regulatory Specialist 65 Valley Stream Parkway Mailcode 65-1A Malvern, Pennsylvania 19533
March 30, 2018
Re: K173617
Trade/Device Name: MAGNETOM Vida with Compressed Sensing GRASP-VIBE Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: March 6, 2018 Received: March 7, 2018
Dear Cordell Fields:
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. 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
1
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Michael D. O'Hara For
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K173617
Device Name
MAGNETOM Vida with Compressed Sensing GRASP-VIBE
Indications for Use (Describe)
Your MAGNETOM system is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician yield information that may assist in diagnosis.
Your MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
Compressed Sensing GRASP-VIBE is intended to be used in dynamic and/or non-contrast liver examinations to support patients who cannot reliably hold their breath for a conventional breath-hold measurement.
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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3
Section 5 510(k) Summary
This 510(k) summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92.
5.1 General Information
| Establishment | Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Mail Code 65-1A
Malvern, PA 19355, USA
Registration Number: 2240869 |
|------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | November 21, 2017 |
| Manufacturer | Siemens Healthcare GmbH
Henkestrasse 127
Erlangen, Bayern, Germany 91052
Registration Number: 3002808157 |
| Contact Person | Cordell L. Fields, Esq
Regulatory Affairs Technical Specialist
Siemens Medical Solutions USA, Inc. |
| Device Name | MAGNETOM Vida with Compressed Sensing GRASP-VIBE |
| Trade Name | MAGNETOM Vida with Compressed Sensing GRASP-VIBE |
| Classification Name:
Classification Panel:
CFR Code:
Classification:
Product Code: | Magnetic Resonance Diagnostic Device (MRDD)
Radiology
21 CFR § 892.1000
Class II
Primary: LNH, Secondary: LNI, MOS |
4
Information Supporting Substantial 5.2 Equivalence
DEVICE DESCRIPTION
The subject device, MAGNETOM Vida, is an MR system. The software syngo MR XA10A is the latest software for the Siemens MAGNETOM Vida and includes software sequences, applications, coils and other hardware for the MAGNETOM scanner. The software sequences, applications, coils and other hardware were previously cleared with K170396.
MAGNETOM Vida will be offered ex-factory (new production) with software syngo MR XA10A and Compressed Sensing GRASP-VIBE. Installed MAGNETOM Vida systems can be updated by activating the blocked license.
This filing describes the new imaging feature intended to be used with the MAGNETOM Vida. Compressed Sensing GRASP-VIBE is intended to be used in dynamic and/or non-contrast liver examinations to support patients who cannot reliably hold their breath for a conventional breath-hold measurement.
INTENDED USE
Your MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/or spectra and the physical parameters derived from the images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.
Your MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
Compressed Sensing GRASP-VIBE is intended to be used in dynamic and/or noncontrast liver examinations to support patients who cannot reliably hold their breath for a conventional breath-hold measurement.
5
SIEMEN
Technological Characteristics
The MR system MAGNETOM Vida with Compressed Sensing GRASP-VIBE has one different technological characteristic (Compressed Sensing GRASP-VIBE) compared to the predicate device MAGNETOM Vida (K170396; cleared June 14, 2017). While there is a feature that varies with respect to the predicate device MR System, the conclusions from all verification and validation data suggest that the feature bears an equivalent safety and performance profile as that of the predicate device and the reference devices.
The subject device is substantially equivalent to the predicate device with regard to the software, hardware, operational environment, programming language, operating system and performance.
MAGNETOM Vida conforms to the standard for software medical devices (IEC 62304:2006) and IEC as well as NEMA standards.
NONCLINICAL TESTS
The following performance testing was conducted on the subject device:
- -A comparison of the functionality was performed between the new feature and the reference device feature by detailed simulations with a numerical phantom.
- -Software verification and validation testing was completed in accordance with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
- -Performance tests were completed in accordance with the FDA guidance document, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices" dated November 18, 2016
- No testing in accordance with the applicable Performance Standards (NEMA) is needed due to the nature of the new imaging feature (software change only).
The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared.
CLINICAL TESTS
Sample clinical images, rather than a clinical study, were included in the determination of substantial equivalence.
6
SUBSTANTIAL EQUIVALENCE
The MAGNETOM Vida with software syngo MR XA10A including the new imaging feature Compressed Sensing GRASP-VIBE is substantially equivalent to the following predicate device, described in Table 1.
Predicate and reference devices for MAGNETOM Vida with software Table 1: syngo MR XA10A including Compressed Sensing GRASP-VIBE
| Predicate Device | FDA
Clearance
Number | FDA
Clearance
Date | Main
Product
Code |
|------------------------------------------------------------|----------------------------|--------------------------|-------------------------|
| Software syngo MR XA10A for the
MR System MAGNETOM Vida | K170396 | June 14, 2017 | LNH, LNI,
MOS |
| Reference Devices | FDA
Clearance
Number | FDA
Clearance
Date | Main
Product
Code |
| syngo MR E11A for
MAGNETOM Skyra | K141977 | November
19, 2014 | LNH
LNI, MOS |
| syngo MR D13C for
MAGNETOM Skyra | K123510 | May 17, 2013 | LNH |
The subject device, MAGNETOM Vida, has been modified to include the new imaging feature, Compressed Sensing GRASP-VIBE. No other software modifications have been made, and there are no hardware changes.
SAFETY AND EFFECTIVENESS
The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.
Risk management is ensured via a risk analysis in compliance with ISO 14971:2007 to identify and provide mitigation of potential hazards in a risk analysis early in the design phase and continuously throughout the development of the product. These risks are controlled via measures realized in hardware and software development, testing and product labeling. To minimize risks, Siemens adheres to recognized and established industry practices and standards, such as the IEC 60601-1 series, to minimize electrical and mechanical risk. Furthermore, the operators are healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.
MAGNETOM Vida with software syngo MR XA10A conforms to the applicable FDA recognized and international IEC, ISO and NEMA standards with regards to performance and safety as recommended by the respective MR FDA Guidance Document as stated in the following table.
7
SIEM
| Recognition
Number | Product
Area | Title of Standard | Reference Number
and date | Standards
Development
Organization |
|-----------------------|----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------|------------------------------------------|
| 19-4 | General | Medical electrical equipment -
part 1: general requirements for
basic safety and essential
performance | ES60601-
1:2005/(R) 2012
and A1:2012 | AAMI / ANSI |
| 19-1 | General | Medical electrical equipment -
Part 1-2: General requirements
for basic safety and essential
performance - Collateral
standard: Electromagnetic
compatibility - Requirements and
tests | 60601-1-2 Edition
3:2007-03 | IEC |
| 12-271 | Radiology | Medical electrical equipment -
Part 2-33: Particular
requirements for the basic safety
and essential performance of
magnetic resonance equipment
for medical diagnosis | 60601-2-33 Ed.
3.1:2013 | IEC |
| 5-40 | General | Medical devices - Application of
risk management to medical
devices | 14971 Second
edition 2007-10 | ISO |
| 5-96 | General | Medical devices - Application of
usability engineering to medical
devices | 62366 Edition 1.0
2015 | AAMI
ANSI
IEC |
| 13-32 | Software | Medical device software -
Software life cycle processes | 62304:2006 | AAMI
ANSI
IEC |
| 12-232 | Radiology | Acoustic Noise Measurement
Procedure for Diagnosing
Magnetic Resonance Imaging
Devices | MS 4-2010 | NEMA |
| 12-288 | Radiology | Characterization of Phased
Array Coils for Diagnostic
Magnetic Resonance Images
(MRI) | MS 9-2008 | NEMA |
| 12-300 | Radiology | Digital Imaging and
Communications in Medicine
(DICOM) Set 03/16/2012
Radiology | PS 3.1 - 3.20
(2016) | NEMA |
| 2-156 | Biocompati
bility | biological evaluation of medical
devices -- part 1: evaluation and
testing within a risk management
process. (Biocompatibility) | 10993-1:2009/(R)
2013 | AAMI
ANSI
ISO |
8
SUBSTANTIAL EQUIVALENCE CONCLUSION
The MR system MAGNETOM Vida with software syngo MR XA10A with the new imaging feature Compressed Sensing GRASP-VIBE has the same intended use and one different technological characteristic compared to the predicate device system, MAGNETOM Vida with syngo MR XA10A, with respect to the magnetic resonance features and functionalities. While there is a feature that varies with respect to the predicate device MR System, the conclusions from all verification and validation data suggest that the feature bears an equivalent safety and performance profile as that of the predicate device and the reference devices. The new imaging feature offers the user additional possibilities to perform examinations. The modification aims to improve the user's workflow and reduces the complexity of the imaging procedure.
In summary, MAGNETOM Vida has the same functionalities as the predicate device and, based on the aforementioned information, does not introduce any new issues of safety or effectiveness. Therefore, Siemens is of the opinion that MAGNETOM Vida with software syngo MR XA10A with Compressed Sensing GRASP-VIBE does not raise new questions of safety or effectiveness and is substantially equivalent to the currently marketed device MAGNETOM Vida with software syngo MR XA10A (K170396 cleared on June 14, 2017).