(25 days)
No
The summary focuses on hardware modifications and standard performance testing, with no mention of AI or ML in the intended use, device description, or performance studies.
No
The "Intended Use / Indications for Use" section states that the device is a "magnetic resonance diagnostic device (MRDD)" that produces images and/or spectra to "assist in diagnosis," not for treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD)". It also mentions that the images and/or spectra and derived physical parameters, "when interpreted by a trained physician yield information that may assist in diagnosis."
No
The device description explicitly states that the MAGNETOM Viato.Mobile with software syngo MR XA51A and XQ gradient system includes new hardware compared to the predicate device, specifically mentioning a modified Gradient Coil and Gradient Power Amplifier. This indicates it is a hardware device with accompanying software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the MAGNETOM system is a "magnetic resonance diagnostic device (MRDD)" used to produce images and spectra of the internal structure and/or function of the body. It assists in diagnosis when interpreted by a trained physician.
- IVD Definition: In vitro diagnostics (IVDs) 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 device description details hardware components related to a magnetic resonance imaging (MRI) system, not equipment used for analyzing biological samples.
- Input Imaging Modality: The input modality is Magnetic Resonance, which is an imaging technique, not a method for analyzing biological samples.
The device is an in vivo diagnostic device, meaning it performs diagnostic procedures directly on a living organism (the patient) rather than on samples taken from the patient.
N/A
Intended Use / Indications for Use
The 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 yield information that may assist in diagnosis.
The 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.
Product codes
LNH, LNI, MOS
Device Description
MAGNETOM Viato.Mobile with software syngo MR XA51A and XQ gradient system includes new hardware compared to the predicate device, MAGNETOM Viato.Mobile with software syngo MR XA51A and XJ gradient system. A high-level summary of the modified hardware is provided below:
Hardware
Modified Hardware
- Gradient Coil
- Gradient Power Amplifier
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
head, body, or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician; healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.
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)
Performance bench test was conducted on new hardware.
Verification and validation was conducted on new hardware.
Electrical safety and electromagnetic compatibility (EMC) was conducted on the complete system.
The results from each set of tests demonstrate that the subject device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
March 29, 2024
Siemens Medical Solutions USA, Inc. Alina Goodman Regulatory Affairs Professional 40 Liberty Boulevard Malvern, Pennsylvania 19355
Re: K240608
Trade/Device Name: MAGNETOM Viato.Mobile Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: February 29, 2024 Received: March 4, 2024
Dear Alina Goodman:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,
D. R. Katz
Daniel M. Krainak, Ph.D. Assistant Director 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
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Indications for Use
Submission Number (if known)
Device Name
MAGNETOM Viato.Mobile
Indications for Use (Describe)
The 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.
The 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.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act 1990 and 21 CFR § 807.92.
1. General Information
| Establishment: | Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355, USA
Registration Number: 2240869 |
|----------------|-----------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | February 29, 2024 |
| Manufacturer: | Siemens Healthcare GmbH
Henkestrasse 127
91052 Erlangen
Germany
Registration Number: 3002808157 |
2. Contact Information
Alina Goodman Regulatory Affairs Professional Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA Phone: +1 (224) 526-1404 E-mail: alina.goodman@siemens-healthineers.com
Device Name and Classification 3.
| Device/ Trade name: | MAGNETOM Viato.Mobile |
|---|---|
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | II |
| Product Code: | Primary: LNH |
| Secondary: LNI. MOS |
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Image /page/4/Picture/1 description: The image contains the logo for Siemens Healthineers. The word "SIEMENS" is written in teal, and the word "Healthineers" is written in orange below it. To the right of the words is a graphic of orange dots arranged in a circular pattern.
4. Legally Marketed Predicate Device
| Trade name: | MAGNETOM Viato.Mobile |
|---|---|
| 510(k) Number: | K232482 |
| Clearance Date: | September 6, 2023 |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | II |
| Product Code: | Primary: LNH |
| Secondary: LNI, MOS |
5. Intended Use / Indications for Use
The indications for use for the subject device is the same as the predicate device:
The 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 yield information that may assist in diagnosis.
The 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.
6. Device Description
MAGNETOM Viato.Mobile with software syngo MR XA51A and XQ gradient system includes new hardware compared to the predicate device, MAGNETOM Viato.Mobile with software syngo MR XA51A and XJ gradient system. A highlevel summary of the modified hardware is provided below:
Hardware
Modified Hardware
- Gradient Coil
- Gradient Power Amplifier
5
7. Substantial Equivalence
MAGNETOM Viato.Mobile with software syngo MR XA51A and XQ gradient system is substantially equivalent to the following predicate device:
| Predicate Device | FDA Clearance Number
and Date | Product Code | Manufacturer |
|----------------------------------------------|---------------------------------------|-----------------|----------------------------|
| MAGNETOM Viato.Mobile
with syngo MR XA51A | K232482,
cleared September 6, 2023 | LNH
LNI, MOS | Siemens Healthcare
GmbH |
MAGNETOM Viato.Mobile with software syngo MR XA51A and XQ gradient system includes hardware already cleared on the following reference device:
| Reference device | FDA Clearance Number
and Date | Product
Code | Manufacturer |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|-----------------|----------------------------|
| MAGNETOM Sola Fit with
software syngo MR XA51A | K221733,
cleared December 13, 2022 | LNH
LNI, MOS | Siemens Healthcare
GmbH |
| Please note: the XQ gradient
system, as part of MAGNETOM
Sola Fit with software syngo MR
XA51A, is the reference device
related to modifications performed
to provide a XQ gradient system
option. | | | |
Comparison of technological Characteristics with the Predicate Device 8.
The subject device, MAGNETOM Viato.Mobile with software syngo MR XA51A, and XQ gradient system is substantially equivalent to the predicate device with regard to the intended use, operational environment, programming language, operating system and performance.
The subject device conforms to the standard for medical device software (IEC 62304) and other relevant IEC and NEMA standards.
There are no differences in technological characteristics between the subject device and predicate device, but new hardware, these differences have been tested and the conclusion from the non-clinical data suggests that the system bears an equivalent safety and performance profile to that of the predicate device.
9. Nonclinical Tests
The following performance testing was conducted on the subject device.
| Performance Test | Tested Hardware or Software | Source/Rationale for test |
|---|---|---|
| Performance bench test | new hardware | Guidance for Submission of |
| Premarket Notifications for | ||
| Magnetic Resonance | ||
| Diagnostic Devices |
6
| Verification and validation | new hardware | Guidance for the Content of
Premarket Submissions for
Software Contained in Medical
Devices |
|-----------------------------------------------------------------|-----------------|------------------------------------------------------------------------------------------------------|
| Electrical safety and
electromagnetic compatibility
(EMC) | complete system | IEC 60601-1-2 |
The results from each set of tests demonstrate that the subject device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared.
10. Clinical Tests / Publications
No clinical study and no additional clinical tests were conducted to support substantial equivalence for the subject device.
11. Safety and Effectiveness
The device labeling contains instructions for use and any necessary cautions and warnings to ensure safe and effective use of the device.
Risk management is ensured via a risk analysis in compliance with ISO 14971, to identify and provide mitigation of potential hazards early in the design cycle and continuously throughout the development of the product. Siemens Healthcare GmbH adheres to recognized and established industry standards, such as the IEC 60601-1 series, to minimize electrical and mechanical hazards. Furthermore, the device is intended for healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.
MAGNETOM Viato.Mobile with software syngo MR XA51A and XQ gradient system conforms to the following FDA recognized and international IEC, ISO and NEMA standards:
| Recognition Product
Number | Area | Title of Standard | Reference
Number and date | Standards
Development
Organization |
|-------------------------------|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|------------------------------------------|
| 19-4 | General II
(ES/EMC) | Medical electrical equipment -
Part 1: General requirements for
basic safety and essential
performance (IEC 60601-
1:2005, MOD) | ES60601-
1:2005/(R)2012
and A1:2012,
C1:2009/(R)2012
and
A2:2010/(R)2012
(Consolidated Text) | ANSI AAMI |
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| 19-8 | General | Medical electrical equipment -
Part 1-2: General requirements
for basic safety and essential
performance - Collateral
Standard: Electromagnetic
disturbances - Requirements
and tests | 60601-1-2, Ed.
4.0:2014 | IEC |
|--------|-----------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|------|
| 12-295 | 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.
3.2:2015 | IEC |
| 5-125 | General I
(QS/ RM) | Medical devices - Application of
risk management to medical
devices | 14971 Third Edition
2019-12 | ISO |
| 12-232 | Radiology | Acoustic Noise Measurement
Procedure for Diagnosing
Magnetic Resonance Imaging
Devices | MS 4:2010 | NEMA |
12. Conclusion as to Substantial Equivalence
MAGNETOM Viato.Mobile with software syngo MR XA51A and XQ gradient system has the same intended use and same basic technological characteristics than the predicate device system, MAGNETOM Viato.Mobile with syngo MR XA51A and XJ gradient system, with respect to the magnetic resonance features and functionalities. There are no differences in technical features compared to the predicate device, but new hardware. The resulting differences have been tested and the conclusions from all verification and validation data suggest that the system bears an equivalent safety and performance profile to that of the predicate device and reference device.
Siemens believes that MAGNETOM Viato.Mobile with software syngo MR XA51A and XQ gradient system is substantially equivalent to the currently marketed device MAGNETOM Viato.Mobile with software syngo MR XA51A and XJ gradient system(K232482, cleared on September 6, 2023).