(73 days)
No
The document does not mention AI, ML, deep learning, or any related terms, nor does it describe features or performance metrics typically associated with AI/ML algorithms. The described software features are related to image processing and motion correction, which are not inherently AI/ML.
No
The device is described as a "magnetic resonance diagnostic device" used to produce images and spectra to assist in diagnosis, and it may be used for imaging during interventional procedures. It is not described as providing therapy.
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)". It further explains that the information derived from the images and/or spectra "may assist in diagnosis."
No
The device description explicitly states that the device includes both new and modified hardware components (Cover, EPC) in addition to software.
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 device 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 description details hardware and software modifications related to the MRI system itself, not to the analysis of biological samples.
- Lack of Mention of Biological Samples: There is no mention of the device interacting with or analyzing biological samples.
The device is an in-vivo diagnostic imaging system, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
Your 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 inages 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.
Your 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 Skyra Fit with software syngo MR XA50A includes new and modified hardware and software compared to the predicate device, MAGNETOM Vida with software syngo MR XA31A. A high level summary of the new and modified hardware and software is provided below:
Hardware
Modified Hardware
- Cover: The cover has been modified to bring the system up to the Siemens Healthineers Design incl. all BioMatrix components and interfaces.
- EPC (Electronic Cabinet and Measurement Control / Electronic Power Cabinet): upgrade of components to upgrade the EPC to the newest electronic cabinet series
Software
New Features and Applications
- TSE MoCo: TSE MoCo is an image-based motion correction in the averagedimension for the TSE pulse sequence type.
- Automatic fiducial detection: MR Breast Biopsy is improved with an automatic fiducial detection.
Modified Features and Applications
-
Fast GRE RefScan: A speed-optimized reference scan for GRAPPA and SMS kernel calibration for echo planar imaging pulse sequence types.
Other Modifications and / or Minor Changes -
The MAGNETOM Skyra Fit is a new MRI System which is the result of an upgrade from a MAGNETOM Verio.
Mentions image processing
Not Found
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
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 device.
| Performance Test | Tested Hardware or Software | Source/Rationale for test |
|---|---|---|
| Sample clinical images | coils, new and modified software features | Guidance for Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices |
| Image quality assessments by sample clinical images. In some cases a comparison of the image quality / quantitative data was made. | - new / modified pulse sequence types. - comparison images between the new / modified features and the predicate device features | Not mentioned |
| Performance bench test Software verification and validation | new and modified hardware new and modified software features | Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices |
| Electrical, mechanical, structural, and related system safety test | complete system | - AAMI / ANSI ES60601-1 - IEC 60601-2-33 |
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.
No additional clinical tests were conducted to support substantial equivalence for the subject device; however, as stated above, sample clinical images were provided. No clinical publications were referenced.
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.
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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Medical Solutions USA, Inc. % Martin Rajchel Senior Regulatory Affairs Manager 40 Liberty Boulevard, Mail Code 65-1A MALVERN PA 19355
Re: K220589
Trade/Device Name: MAGNETOM Skyra Fit Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: February 25, 2022 Received: March 1, 2022
Dear Martin Rajchel:
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
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,
Thalia T. Mills, Ph.D. Director DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name MAGNETOM Skyra Fit
Indications for Use (Describe)
Your 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 inages 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.
Your 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) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/1 description: The image shows the logo for Siemens Healthineers. The word "SIEMENS" is in teal, and the word "Healthineers" is in orange. To the right of the words is a graphic of orange dots arranged in a circular pattern.
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: May 3, 2022
- Manufacturer: Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen Germany Registration Number: 3002808157
2. Contact Information
Martin Rajchel Sr. Manager, Regulatory Affairs Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA Phone: +1 484-473-4209 Fax: (610) 448-1787 E-mail: martin.rajchel@siemens-healthineers.com
Device Name and Classification 3.
| Device/ Trade name: | MAGNETOM Skyra Fit |
|---|---|
| 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 Vida |
|---|---|
| 510(k) Number: | K203443 |
| Clearance Date: | March 31, 2021 |
| 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 device is the same as the predicate device:
Your 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.
Your 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 Skyra Fit with software syngo MR XA50A includes new and modified hardware and software compared to the predicate device, MAGNETOM Vida with software syngo MR XA31A. A high level summary of the new and modified hardware and software is provided below:
Hardware
Modified Hardware
- Cover: The cover has been modified to bring the system up to the Siemens Healthineers Design incl. all BioMatrix components and interfaces.
- EPC (Electronic Cabinet and Measurement Control / Electronic Power Cabinet): upgrade of components to upgrade the EPC to the newest electronic cabinet series
5
Software
New Features and Applications
- TSE MoCo: TSE MoCo is an image-based motion correction in the averagedimension for the TSE pulse sequence type.
- Automatic fiducial detection: MR Breast Biopsy is improved with an automatic fiducial detection.
Modified Features and Applications
-
Fast GRE RefScan: A speed-optimized reference scan for GRAPPA and SMS kernel calibration for echo planar imaging pulse sequence types.
Other Modifications and / or Minor Changes -
The MAGNETOM Skyra Fit is a new MRI System which is the result of an upgrade from a MAGNETOM Verio.
7. Substantial Equivalence
MAGNETOM Skyra Fit with software synqo MR XA50A is 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 |
MAGNETOM Skyra Fit with software syngo MR XA50A includes hardware and software already cleared on the following reference devices:
| Reference Devices | FDA Clearance Number
and Date | Product
Code | Manufacturer |
|-------------------------------------------------------|---------------------------------------|-----------------|----------------------------|
| MAGNETOM Verio with
software syngo MR E11D | K181613,
cleared November 6, 2018 | LNH
LNI, MOS | Siemens Healthcare
GmbH |
| MAGNETOM Skyrafit with
software syngo MR E11C-AP04 | K173592,
cleared February 13, 2018 | LNH
LNI, MOS | Siemens Healthcare
GmbH |
8. Comparison of technological Characteristics with the Predicate Device
The subject device, MAGNETOM Skyra Fit with software syngo MR XA50A, is substantially equivalent to the predicate device with reqard to the 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.
While there are some differences in technological characteristics between the subject device and predicate device, including new and modified hardware and software, these differences have been tested and the conclusions from the non
6
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 device.
| Performance Test | Tested Hardware or Software | Source/Rationale for test |
|---|---|---|
| Sample clinical images | coils, new and modified | |
| software features | Guidance for Submission of | |
| Premarket Notifications for | ||
| Magnetic Resonance | ||
| Diagnostic Devices | ||
| Image quality assessments by | ||
| sample clinical images. In | ||
| some cases a comparison of | ||
| the image quality / quantitative | ||
| data was made. | - new / modified pulse | |
| sequence types. |
- comparison images between
the new / modified features
and the predicate device
features | |
| Performance bench test
Software verification and
validation | new and modified hardware
new and modified software
features | Guidance for the Content of
Premarket Submissions for
Software Contained in Medical
Devices |
| Electrical, mechanical,
structural, and related system
safety test | complete system | - AAMI / ANSI ES60601-1 - IEC 60601-2-33 |
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 additional clinical tests were conducted to support substantial equivalence for the subject device; however, as stated above, sample clinical images were provided. No clinical publications were referenced.
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
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responsible for the acquisition and post processing of magnetic resonance images.
MAGNETOM Skyra Fit with software syngo MR XA50A 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
[Including CORRIGENDUM 1
(2016)] | 62366-1 Edition 1.0
2015-02 | IEC |
| 13-79 | Software/
Informatics | Medical device software -
Software life cycle processes | 62304 Edition 1.1
2015-06
CONSOLIDATED
VERSION | IEC |
| 12-232 | Radiology | Acoustic Noise Measurement
Procedure for Diagnosing
Magnetic Resonance Imaging
Devices | MS 4:2010 | NEMA |
| 12-300 | Radiology | Digital Imaging and
Communications in Medicine
(DICOM) Set | PS 3.1 - 3.20:2016 | NEMA |
12. Conclusion as to Substantial Equivalence
MAGNETOM Skyra Fit with software syngo MR XA50A has 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
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Image /page/8/Picture/1 description: The image shows 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.
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 Skyra Fit with software syngo MR XA50A is substantially equivalent to the currently marketed device MAGNETOM Vida with software syngo MR XA31A (K203443, cleared on March 31, 2021).