(25 days)
No
The summary focuses on hardware modifications and patient transfer capabilities, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML mentions.
No
The device is described as a "magnetic resonance diagnostic device" used to produce images and spectra for diagnosis, not for treatment.
Yes
The "Intended Use / Indications for Use" section states: "The MAGNETOM system is indicated for use as a magnetic resonance diagnostic device (MRDD)". It also mentions that the images and spectra "yield information that may assist in diagnosis."
No
The device description explicitly states "modified hardware" and details a "Nexaris Dockable Table" as a hardware component.
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)" that produces images and spectra of the internal structure and/or function of the body. It is used for imaging and assisting in diagnosis based on these images and derived parameters.
- 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 device description focuses on hardware modifications related to the MR system and patient table for imaging.
- Lack of Mention of Samples: There is no mention of the device being used to analyze samples taken from the body.
The MAGNETOM system 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 organism.
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 (comma separated list FDA assigned to the subject device)
LNH, LNI, MOS
Device Description
MAGNETOM Vida and MAGNETOM Sola with Nexaris Angio-MR include modified hardware compared to the predicate device, MAGNETOM Vida with software syngo MR XA31A (K203443). A high-level summary of the modified hardware is provided below:
Hardware
Modified Hardware
- The Nexaris Dockable Table is a variant of the MR patient table which is used for intraoperative or interventional imaging. It enables the patient transfer between OR/ARTIS tables and the MR system without repositioning on the MR patient table and vice versa during interventional procedures and surgeries. Additionally, it can be used for diagnostic imaging.
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)
The following performance testing was conducted on the subject devices.
| Performance Test | Tested Hardware or Software | Source/Rationale for test |
|---|---|---|
| Electrical, mechanical, structural, and related system safety test | modified features | AAMI / ANSI ES60601-1 |
| Verification and validation | modified features | 21 CFR §820.30 |
The results from each set of tests demonstrate that the devices perform as intended and are thus substantially equivalent to the predicate device to which it has been compared.
No additional clinical tests were conducted to support substantial equivalence for the subject devices.
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
March 11, 2022
Image /page/0/Picture/1 description: The image contains 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 FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Medical Solutions USA, Inc. % Alina Goodman Regulatory Affairs Professional 40 Liberty Boulevard MALVERN PA 19355
Re: K220425
Trade/Device Name: MAGNETOM Vida, MAGNETOM Sola Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: February 10, 2022 Received: February 14, 2022
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 (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/cfpmp/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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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,
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
Submission Number (if known)
K220425
Device Name
MAGNETOM Vida; MAGNETOM Sola
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)
e-Counter Use (21 CFR 801 Subpart C)
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3
510(k) Summary
K220425
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 ട്ട 807.92.
1. General Information
| Establishment: | Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard
Malvern, PA 19355, USA
Registration Number: 2240869 |
|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | February 10, 2022 |
| Manufacturer: | Siemens Healthcare GmbH
Henkestr. 127
91052 Erlangen
Germany
Registration Number: 3002808157 |
| Contract
Manufacturer: | Siemens Shenzhen Magnetic Resonance LTD
Siemens MRI Center
Hi-Tech Industrial park (middle)
Gaoxin C. Ave., 2nd
Shenzhen 518057
P.R. CHINA
Registration Number: 3004754211 |
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.ext@siemens-healthineers.com
3. Device Name and Classification
| Device/ Trade name: | MAGNETOM Vida, MAGNETOM Sola |
|---|---|
| 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 |
4
4. Legally Marketed Predicate Device
| Trade name: | MAGNETOM Vida |
|---|---|
| 510(k) Number: | K203443 |
| 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
The indications for use for the subject devices are 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 imaqes, 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 Vida and MAGNETOM Sola with Nexaris Angio-MR include modified hardware compared to the predicate device, MAGNETOM Vida with software syngo MR XA31A (K203443). A high-level summary of the modified hardware is provided below:
Hardware
Modified Hardware
- The Nexaris Dockable Table is a variant of the MR patient table which is used for intraoperative or interventional imaging. It enables the patient transfer between OR/ARTIS tables and the MR system without repositioning on the MR patient table and vice versa during interventional procedures and surgeries. Additionally, it can be used for diagnostic imaging.
7. Substantial Equivalence
MAGNETOM Vida and MAGNETOM Sola with Nexaris Angio-MR are substantially equivalent to the following predicate device:
| Predicate Device | FDA Clearance Number
and Date | Product
Code | Manufacturer |
|--------------------------------------|------------------------------------|-----------------|----------------------------|
| MAGNETOM Vida with
syngo MR XA31A | K203443, cleared March
31, 2021 | LNH
LNI, MOS | Siemens Healthcare
GmbH |
5
MAGNETOM Sola with Nexaris Angio-MR includes hardware already cleared on the following reference device.
| Predicate Device | FDA Clearance Number
and Date | Product
Code | Manufacturer |
|--------------------------------------|------------------------------------|-----------------|----------------------------|
| MAGNETOM Sola with
syngo MR XA31A | K203443, cleared March
31, 2021 | LNH
LNI, MOS | Siemens Healthcare
GmbH |
8. Technological Characteristics
The subject devices, MAGNETOM Vida and MAGNETOM Sola with Nexaris Angio-MR, are substantially equivalent to the predicate device with regard to the operational environment, programming language, operating system and performance.
The subject devices conform to the standard for medical device software (IEC 62304) and other relevant IEC and NEMA standards.
There are some differences in technological characteristics between the subject devices and predicate device, including modified hardware. These differences have been tested and the conclusion from the non-clinical data suggests that the features bear an equivalent safety and performance profile to that of the predicate device.
9. Nonclinical Tests
The following performance testing was conducted on the subject devices.
| Performance Test | Tested Hardware or Software | Source/Rationale for test |
|---|---|---|
| Electrical, mechanical, | ||
| structural, and related system | ||
| safety test | modified features | AAMI / ANSI ES60601-1 |
| Verification and validation | modified features | 21 CFR §820.30 |
The results from each set of tests demonstrate that the devices perform as intended and are thus substantially equivalent to the predicate device to which it has been compared.
10.Clinical Tests
No additional clinical tests were conducted to support substantial equivalence for the subject devices.
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.
6
MAGNETOM Vida and MAGNETOM Sola with Nexaris Angio-MR conform to the following FDA recognized and international IEC, ISO and NEMA standards:
| Recognition
Number | Product
Area | Title of Standard | Reference
Number and date | Standards
Development
Organization |
|-----------------------|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|------------------------------------------|
| 19-4 | General II
(ES/
EMC) | C1:2009/(R)2012 and
A2:2010/(R)2012 (Consolidated
Text) 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 | ANSI AAMI |
| 19-8 | General II
(ES/
EMC) | Medical electrical equipment -
Part 1-2: General requirements
for basic safety and essential
performance - Collateral
Standard: Electromagnetic
disturbances - Requirements
and tests | 60601-1-2 Edition
4.0 2014-02 | 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
b:2015 | IEC |
| 5-40 | General I
(QS/
RM) | Medical devices - Application of
risk management to medical
devices | 14971 Second
edition 2007-03-01 | ISO |
| 5-114 | General I
(QS/
RM) | Medical devices - Part 1:
Application of usability
engineering to medical devices | 62366-1:2015 | ANSI AAMI
IEC |
12.Conclusion as to Substantial Equivalence
MAGNETOM Vida and MAGNETOM Sola with Nexaris Angio-MR have the same intended use and same basic technological characteristics than the predicate device system, MAGNETOM Vida with syngo MR XA31A, with respect to the magnetic resonance features and functionalities. While there are some differences in technical features compared to the predicate device, the differences have been tested and the conclusions from all verification and validation data suggest that the features bear an equivalent safety and performance profile to that of the predicate and reference device.
Siemens believes that MAGNETOM Vida and MAGNETOM Sola with Nexaris Angio-MR are substantially equivalent to the currently marketed device MAGNETOM Vida with software syngo MR XA31A (K203443, cleared on March 31, 2021).