(90 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and provides no other indication of AI/ML technology.
No
The device is described as a magnetic resonance diagnostic device (MRDD) used for imaging and diagnosis, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the MAGNETOM system is "indicated for use as a magnetic resonance diagnostic device (MRDD)" and that the information it provides "may assist in diagnosis."
No
The device description explicitly states that the subject devices consist of "new and modified software and hardware". The performance studies also include electrical, mechanical, structural, and related system safety tests, which are indicative of hardware components.
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 to assist in diagnosis when interpreted by a trained physician.
- 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 the hardware and software of an MRI system, which is an imaging modality that does not involve testing samples taken from the body.
- Lack of IVD-related information: The document does not mention any analysis of biological samples, reagents, or laboratory procedures, which are characteristic of IVD devices.
Therefore, the MAGNETOM system, as described, is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
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
The subject devices, MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit with software syngo MR XA51A, consist of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Vida with syngo MR XA50A (K213693). A high-level summary of the new and modified hardware and software is provided below:
Hardware
- The myExam 3D Camera feature supports the radiographer and/or the technician with the positioning of the patient during the examination
Software
New Features and Applications
- myExam Autopilot is a simplified scan workflow designed for enabling less-MRI experience users to complete MRI routine Brain and Knee examinations successfully.
- Open Recon Framework interface allows to apply container-based reconstruction algorithms on the reconstruction systems. The Open Recon Framework only allows FDA cleared 3rd party algorithms to be imported for clinical use.
Modified Features and Applications
-
myExam Angio Advanced Assist for Test Bolus examinations supports the clinical user in planning and execution of peripheral angiography examinations.
The user is guided in the multi-station planning and the correct timing of the angiography measurement using the Angio Advanced Bolus Timing Addin. -
Beat Sensor Cardiac triggering is a physiological triggering technique based on the pilot tone technology that has been adapted in the subject devices to allow for cardiac triggering with a wide range of sequences typically used in MRI examinations of the heart and great vessels
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance
Anatomical Site
head, body, or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician, radiographer, technician, 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)
The following performance testing was conducted on the subject devices:
- Software verification and validation: Tested mainly new and modified software features based on Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices. Acceptance criteria: Verification and Validation tests are met. Overall Result: Passed.
- Electrical, mechanical, structural, and related system safety test: Tested complete system based on AAMI / ANSI ES60601-1 and IEC 60601-2-33. Acceptance criteria: Tests according to applicable standard are met/passed. Overall Result: Passed.
- Electrical safety and electromagnetic compatibility (EMC): Tested complete system based on IEC 60601-1-2. Acceptance criteria: EMC requirements are met/passed. Overall Result: Passed.
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; however, sample clinical images were provided.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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 for the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
September 13, 2022
Siemens Medical Solutions USA, Inc. % Alina Goodman Regulatory Affairs Professional 40 Liberty Boulevard MALVERN PA 19355
Re: K221733
Trade/Device Name: MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: June 9, 2022 Received: June 15, 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/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.
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 https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting
1
combination-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,
Daniel M. Krainak, Ph.D.
Assistant Director Magnetic Resonance and Nuclear Medicine Team 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
Enclosure
2
Indications for Use
Submission Number (if known)
K221733
Device Name
MAGNETOM Sola; MAGNETOM Altea; MAGNETOM Sola Fit
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)
type of Use (Select one or both, as applicable)
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
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: | June 9th, 2022 |
| Manufacturer: | Siemens Healthcare GmbH
Henkestr. 127
91052 Erlangen
Germany
Registration Number: 3002808157
Siemens Shenzhen Magnetic Resonance
Siemens MRI Center |
LTD. 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(317)371-8593 E-mail: alina.goodman@siemens-healthineers.com
3. Device Name and Classification
| Device/ Trade name: | MAGNETOM Sola, MAGNETOM Altea, MAGNETOM
Sola Fit with syngo MR XA51A |
|-----------------------|-------------------------------------------------------------------------|
| 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 with syngo MR XA50A |
|---|---|
| 510(k) Number: | K213693 |
| 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 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
The subject devices, MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit with software syngo MR XA51A, consist of new and modified software and hardware that is similar to what is currently offered on the predicate device, MAGNETOM Vida with syngo MR XA50A (K213693). A high-level summary of the new and modified hardware and software is provided below:
Hardware
New Features and Application
- The myExam 3D Camera feature supports the radiographer and/or the technician with the positioning of the patient during the examination
Software
New Features and Applications
- myExam Autopilot is a simplified scan workflow designed for enabling less-MRI experience users to complete MRI routine Brain and Knee examinations successfully.
- Open Recon Framework interface allows to apply container-based reconstruction algorithms on the reconstruction systems. The Open Recon Framework only allows FDA cleared 3rd party algorithms to be imported for clinical use.
Modified Features and Applications
- myExam Angio Advanced Assist for Test Bolus examinations supports the clinical user in planning and execution of peripheral angiography examinations.
5
The user is quided in the multi-station planning and the correct timing of the angiography measurement using the Angio Advanced Bolus Timing Addin.
- Beat Sensor Cardiac triggering is a physiological triggering technique based on the pilot tone technology that has been adapted in the subject devices to allow for cardiac triggering with a wide range of sequences typically used in MRI examinations of the heart and great vessels
7. Substantial Equivalence
MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit with software syngo MR XA51A is substantially equivalent to the following predicate device:
| Predicate Device | FDA Clearance Number
and Date | Product
Code | Manufacturer |
|--------------------|----------------------------------|-----------------|--------------------|
| MAGNETOM Vida with | K213693, cleared on | LNH | Siemens Healthcare |
| syngo MR XA50A | February 25, 2022 | LNI, MOS | GmbH |
8. Technological Characteristics
The subject devices, MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit with software synqo MR XA51A, 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 device and predicate device, including new and modified hardware/software. 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 | Acceptance
Criteria | Overall
Result | For Details
please refer to |
|--------------------------------------------------------------------------|----------------------------------------------------|---------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------|-------------------|-------------------------------------|
| Software verification
and validation | mainly new
and modified
software
features | Guidance for the
Content of
Premarket
Submissions for
Software
Contained in
Medical Devices | Verification
and
Validation
tests are met | Passed | V&V-List
see Attachment
10-4 |
| Electrical, mechanical,
structural, and related
system safety test | complete
system | - AAMI / ANSI
ES60601-1
- IEC 60601-2-33 | Tests
according to
applicable
standard are
met/passed | Passed | IEC testing
see Attachment
12 |
| Electrical safety and
electromagnetic
compatibility (EMC) | complete
system | IEC 60601-1-2 | EMC
requirements
are
met/passed | Passed | IEC testing
see Attachment
12 |
6
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 / Publications
No additional clinical tests were conducted to support substantial equivalence for the subject devices; however, as stated above, sample clinical images were provided. Furthermore, no additional clinical publications were needed referenced to provide information on the use of the following features and functions, since this was sufficiently done for the predicate 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 Sola, MAGNETOM Altea, MAGNETOM Sola Fit with software syngo MR XA51A conforms 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) | 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 |
| 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 |
| 13-79 | Software/
Informatics | Medical device software -
Software life cycle processes | 62304 Edition 1.1
2015-06
CONSOLIDATED
VERSION | IEC |
7
12.Conclusion as to Substantial Equivalence
MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit with software syngo MR XA51A has the same intended use and same basic technological characteristics than the predicate device system, MAGNETOM Vida with syngo MR XA50A, 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 device and reference devices.
Siemens believes that MAGNETOM Sola, MAGNETOM Altea, MAGNETOM Sola Fit with software syngo MR XA51A is substantially equivalent to the currently marketed device MAGNETOM Vida with software syngo MR XA50A (K213693, cleared on February 25, 2022).