Who is the manufacturer of MAGNETOM Vida, MAGNETOM Sola?

Siemens Medical Solutions USA, Inc. filed the 510(k) submission for MAGNETOM Vida, MAGNETOM Sola (K220425).

What is the FDA product code for MAGNETOM Vida, MAGNETOM Sola?

LNH. It is classified under 21 CFR 892.1000 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for MAGNETOM Vida, MAGNETOM Sola?

510(k) clearance (submission type: Traditional).

What are the predicate devices for MAGNETOM Vida, MAGNETOM Sola?

MAGNETOM Vida with syngo MR XA31A (K203443).

Who can help prepare an FDA 510(k) submission like MAGNETOM Vida, MAGNETOM Sola?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

MAGNETOM Vida, MAGNETOM Sola

K220425 · Siemens Medical Solutions USA, Inc. · LNH · Mar 11, 2022 · Radiology

Device Facts

Record ID	K220425
Device Name	MAGNETOM Vida, MAGNETOM Sola
Applicant	Siemens Medical Solutions USA, Inc.
Product Code	LNH · Radiology
Decision Date	Mar 11, 2022
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 892.1000
Device Class	Class 2

Intended 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.

Device Story

MAGNETOM Vida and Sola are MR diagnostic systems; modified to include Nexaris Dockable Table for intraoperative/interventional imaging. Table enables patient transfer between OR/ARTIS tables and MR system without repositioning. System produces cross-sectional images, spectroscopic images, and derived physical parameters for head, body, and extremities. Operated by healthcare professionals in clinical/interventional settings. Physician interprets images/spectra to assist in diagnosis. Benefits include streamlined workflow for interventional procedures and reduced patient movement.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including electrical, mechanical, and structural safety verification and validation of modified hardware features.

Technological Characteristics

MR diagnostic system; includes Nexaris Dockable Table for patient transfer. Conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-2-33, ISO 14971, and IEC 62366-1. Software conforms to IEC 62304. System supports cross-sectional imaging and spectroscopy.

Indications for Use

Indicated for patients requiring diagnostic MR imaging of head, body, or extremities; includes interventional procedures using MR-compatible devices. No specific age or gender restrictions; contraindications include presence of non-MR-safe implants/devices.

Regulatory Classification

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).

Special Controls

*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.

Predicate Devices

MAGNETOM Vida with syngo MR XA31A (K203443)

Reference Devices

MAGNETOM Sola with syngo MR XA31A (K203443)

Related Devices

K142515 — MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Aera, MAGNETOM Combi Suite Neurosurgery for the MAGNETOM Skyra · Siemens Medical Solutions USA, Inc. · Oct 8, 2014
K012495 — OR TABLE AND HEADHOLDER/MAGNETOM HARMONY, SYMPHONY, SONATA SYSTEMS · Siemens Medical Solutions USA, Inc. · Oct 31, 2001
K013344 — INTERA I/T · Philips Medical Systems North America Co. · Dec 11, 2001
K043262 — GE SIGNA EXCITE MR SURGICAL OPTION · GE Healthcare · Jan 12, 2005
K140253 — MAGNETOM ARTIS COMBI SUITE FOR THE MAGNETOM AERA/SKYRA/SKYRA WITH TIMTX TRUESHAPE · Siemens Medical Solutions USA, Inc. · Mar 20, 2014

Submission Summary (Full Text)

{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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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).