(25 days)
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.
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.
The provided text is a 510(k) Summary for a medical device (MAGNETOM Vida and MAGNETOM Sola with Nexaris Angio-MR). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific performance acceptance criteria through clinical studies for novel claims.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance are not directly available in this document. The submission relies on demonstrating that the modified hardware of the new device maintains the safety and performance profile of the predicate device.
Here's an analysis based on the information provided, highlighting what is present and what is absent:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not provide a table with specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) and corresponding reported device performance metrics for a novel diagnostic claim. Instead, the "acceptance criteria" are implied by compliance with recognized standards and successful verification and validation of modified hardware, demonstrating equivalent safety and performance to the predicate device.
The reported "performance" is that the device "perform[s] as intended" and "bear[s] an equivalent safety and performance profile to that of the predicate device."
| Criterion Type | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety & Performance | Equivalent to predicate device | "Perform as intended" and "bear an equivalent safety and performance profile to that of the predicate device." |
| Standard Compliance | AAMI / ANSI ES60601-1 compliant | Verified |
| Standard Compliance | 21 CFR §820.30 compliant | Verified |
| Standard Compliance | IEC 62304 compliant | Conforms |
| Standard Compliance | ISO 14971 compliant | Risk management ensured |
| Standard Compliance | IEC 60601-1 series compliant | Adheres to minimize hazards |
| Standard Compliance | Other listed standards | Conforms |
2. Sample Size Used for the Test Set and the Data Provenance
- Sample Size: Not applicable/not provided. The submission focuses on hardware modifications and compliance with standards, not on a clinical test set for diagnostic performance.
- Data Provenance: Not applicable/not provided for a clinical test set. The data provenance described is related to non-clinical performance testing of modified hardware against engineering and safety standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. As there was no clinical diagnostic test set evaluated for novel claims, there was no need for experts to establish ground truth in this context. The "truth" evaluated was compliance with engineering and safety standards.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
Not applicable. No adjudications were performed related to a diagnostic test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study was done, as this submission is for a Magnetic Resonance Diagnostic Device (MRDD) and not an AI-assisted diagnostic tool or software. The document explicitly states: "No additional clinical tests were conducted to support substantial equivalence for the subject devices."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No standalone performance study of an algorithm was done. This submission is for an MRDD system with modified hardware, not a standalone algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the nonclinical tests was based on engineering specifications, recognized safety standards (e.g., AAMI / ANSI ES60601-1, 21 CFR §820.30), and risk management principles (ISO 14971).
8. The Sample Size for the Training Set
Not applicable. This submission does not involve an AI algorithm that would require a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. This submission does not involve an AI algorithm or a training set.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets the "acceptance criteria" (which in this context are interpreted as demonstrating safe and equivalent performance to the predicate device) was a series of nonclinical performance tests focused on the modified hardware.
- Study Type: Nonclinical performance testing (verification and validation against established standards and engineering requirements).
- Focus: Evaluation of "modified hardware" (Nexaris Dockable Table) to ensure it performs as intended and maintains the safety and performance profile of the predicate device.
- Tests Conducted:
- Electrical, mechanical, structural, and related system safety tests (utilizing AAMI / ANSI ES60601-1).
- Verification and validation (in accordance with 21 CFR §820.30).
- Conclusion: The results of these nonclinical tests demonstrated that the modified features "bear an equivalent safety and performance profile to that of the predicate device." The device also conforms to various recognized standards including IEC 62304, ISO 14971, IEC 60601-1 series, and others listed in the document.
In essence, the "study" was a comprehensive engineering and regulatory compliance assessment of the hardware changes, leveraging industry standards and internal verification processes instead of clinical performance studies with diagnostic endpoints.
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March 11, 2022
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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
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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
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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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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 BoulevardMalvern, PA 19355, USARegistration Number: 2240869 |
|---|---|
| Date Prepared: | February 10, 2022 |
| Manufacturer: | Siemens Healthcare GmbHHenkestr. 12791052 ErlangenGermanyRegistration Number: 3002808157 |
| ContractManufacturer: | Siemens Shenzhen Magnetic Resonance LTDSiemens MRI CenterHi-Tech Industrial park (middle)Gaoxin C. Ave., 2ndShenzhen 518057P.R. CHINARegistration 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: LNHSecondary: LNI. MOS |
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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: LNHSecondary: 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 Numberand Date | ProductCode | Manufacturer |
|---|---|---|---|
| MAGNETOM Vida withsyngo MR XA31A | K203443, cleared March31, 2021 | LNHLNI, MOS | Siemens HealthcareGmbH |
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MAGNETOM Sola with Nexaris Angio-MR includes hardware already cleared on the following reference device.
| Predicate Device | FDA Clearance Numberand Date | ProductCode | Manufacturer |
|---|---|---|---|
| MAGNETOM Sola withsyngo MR XA31A | K203443, cleared March31, 2021 | LNHLNI, MOS | Siemens HealthcareGmbH |
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 systemsafety 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.
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MAGNETOM Vida and MAGNETOM Sola with Nexaris Angio-MR conform to the following FDA recognized and international IEC, ISO and NEMA standards:
| RecognitionNumber | ProductArea | Title of Standard | ReferenceNumber and date | StandardsDevelopmentOrganization |
|---|---|---|---|---|
| 19-4 | General II(ES/EMC) | C1:2009/(R)2012 andA2:2010/(R)2012 (ConsolidatedText) Medical electricalequipment - Part 1: Generalrequirements for basic safetyand essential performance (IEC60601-1:2005, MOD) | ES60601-1:2005/(R)2012and A1:2012 | ANSI AAMI |
| 19-8 | General II(ES/EMC) | Medical electrical equipment -Part 1-2: General requirementsfor basic safety and essentialperformance - CollateralStandard: Electromagneticdisturbances - Requirementsand tests | 60601-1-2 Edition4.0 2014-02 | IEC |
| 12-295 | Radiology | Medical electrical equipment -Part 2-33: Particularrequirements for the basicsafety and essentialperformance of magneticresonance equipment formedical diagnosis | 60601-2-33 Ed. 3.2b:2015 | IEC |
| 5-40 | General I(QS/RM) | Medical devices - Application ofrisk management to medicaldevices | 14971 Secondedition 2007-03-01 | ISO |
| 5-114 | General I(QS/RM) | Medical devices - Part 1:Application of usabilityengineering to medical devices | 62366-1:2015 | ANSI AAMIIEC |
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).
N/A