(121 days)
No
The document describes new software features and hardware modifications for an existing MR system. While it mentions image processing and analysis (LiverLab, MyoMaps), it does not explicitly mention or provide details about the use of AI, machine learning, deep learning, or related technologies in the device description, performance studies, or key metrics. The focus is on new applications for non-invasive evaluation and pixel map generation, which are not inherently AI/ML driven.
No
The Intended Use / Indications for Use clearly states that the device is a "magnetic resonance diagnostic device (MRDD)" used to produce images and/or spectra that "may assist in diagnosis." It does not mention any therapeutic function.
Yes
The "Intended Use / Indications for Use" section explicitly states that the MAGNETOM systems are "indicated for use as a magnetic resonance diagnostic device (MRDD)". It also mentions that the images and/or spectra and derived physical parameters "when interpreted by a trained physician yield information that may assist in diagnosis."
No
The device description explicitly states that in addition to software, "additional coils are offered and some hardware components have been modified." This indicates the submission includes hardware components, not just software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "magnetic resonance diagnostic device (MRDD)" that produces images and/or spectra of the internal structure and/or function of the body. It assists in diagnosis when interpreted by a trained physician. This describes an imaging device used for in-vivo diagnosis, not an in-vitro test performed on samples outside the body.
- Device Description: The description focuses on software applications for non-invasive evaluation (LiverLab, MyoMaps), workflows, sequences, coils, and hardware components of an MR system. These are all related to the operation and capabilities of an imaging device.
- No mention of in-vitro testing: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples outside the body, which is the defining characteristic of an IVD.
Therefore, the MAGNETOM systems described are imaging devices for in-vivo diagnosis, not in-vitro diagnostic devices.
N/A
Intended Use / Indications for Use
The MAGNETOM systems [MAGNETOM Aera and MAGNETOM Skyra] are 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 systems may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-Safe biopsy needles.
Product codes (comma separated list FDA assigned to the subject device)
LNH, LNI, MOS
Device Description
The subject device, software syngo MR E11A for MAGNETOM Aera and MAGNETOM Skyra offers two new applications, LiverLab (an application of non-invasive liver evaluation) and MyoMaps (an application designed to provide a means to generate pixel maps for myocardial MR relaxation times). In addition, software syngo MR E11A makes the Dot Cockpit available for the user to modify and create Siemens Dot Engine workflows in a very intuitive way which supplements some of the support of an application specialist. The software syngo MR E11A also includes new and modified sequences as well as minor modifications of already existing features. In additional coils are offered and some hardware components have been modified.
Siemens Medical Solutions, USA Inc., intends to market MAGNETOM Aera and MAGNETOM Skyra with new software, syngo MR E11A. While syngo MR E11A offers additional capabilities with respect to the predicate device, the MAGNETOM Aera and MAGNETOM Skyra have the same technological characteristics as the predicate device (K121434; Cleared November, 5, 2012).
Furthermore, Siemens Medical Solutions, USA Inc., intends to market a new configuration of the MAGNETOM Skyra with 24 receive channels with software syngo MR E11A.
The MAGNETOM Aera and MAGNETOM Skyra will be offered ex-factory (new production) as well as in-field upgrades for the currently installed MAGNETOM Aera and MAGNETOM Skyra systems. The new MAGNETOM Skyra configuration with 24 receive channels will be offered as an ex-factory option (new production).
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 / Not Found
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
MyoMaps was tested on volunteers after ECG's were applied. MyoMaps was compared to Thalassaemia Tools in a 100 person study
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- The coils were tested for SNR, image uniformity, and heating.
- Dedicated phantom testing was conducted on particular new sequences.
- Acoustic noise measurements were performed for quiet sequences
- Image quality assessments of all new/modified sequences and algorithms, were completed. In some cases a comparison of the image quality was made between the new/modified features and the predicate features.
- Features of LiverLab was validated with volunteer as well as phantom scans, and synthetic raw data
- MyoMaps was tested on volunteers after ECG's were applied. MyoMaps was compared to Thalassaemia Tools in a 100 person study
- All other software features were verified and validated.
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.
K073194, K121434, K123510, K132831, K133435, K073194, K121459, K090038, K140253, K121160, K132951, K140998
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/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus, with three human profiles forming the staff and a ribbon-like shape representing the snake.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 19, 2014
Siemens Medical Solutions USA, Inc. % Ms. Nadia Sookdeo Regulatory Affairs Technical Specialist 51 Valley Stream Parkway MALVERN PA 19355
Re: K141977
Trade/Device Name: Software syngo MR E11A for the MAGNETOM systems Aera/Skyra Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, LNI, MOS Dated: October 31, 2014 Received: November 3, 2014
Dear Ms. Sookdeo:
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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name MAGNETOM Aera and MAGNETOM Skyra
Indications for Use (Describe)
The MAGNETOM systems described above are indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional 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 systems described above may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-Safe biopsy needles.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/3/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are a light blue color, and there is a black line underneath the word. The word is likely a logo for the company Siemens.
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of Safe Medical Device Act 1990 and 21 CFR § 807.92.
- I. General Information
| Establishment | Siemens Medical Solutions USA. Inc.
51 Valley Stream Parkway
Mail Code D02
Malvern, PA 19355, USA |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Registration Number | 2240869 |
| Date Prepared | October 31, 2014 |
| Manufacturer | Siemens AG
Henkestrasse 127
D-91052 Erlangen, Germany
Registration Number: 3002808157 |
| 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 | |
| Contact Person | Ms. Nadia Sookdeo
Regulatory Affairs Technical Specialist
Siemens Healthcare
Siemens Medical Solutions USA, Inc.
Customer Solutions Group
51 Valley Stream Parkway
Mail Code D02
Malvern, PA 19355, USA
Phone: (610) 448-4918
Fax: (610) 448-1787 |
| Device Name | Software syngo MR E11A for the MAGNETOM systems Aera/Skyra |
| Trade Names: | MAGNETOM Aera
MAGNETOM Skyra |
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| Classification Name: |
|---|
| Classification Panel: |
| CFR Code: |
| Classification: |
| Product Code: |
Magnetic Resonance Diagnostic Device (MRDD) Radiology 21 CFR § 892.1000 Class II Primary: LNH, Secondary: LNI, MOS
Predicate Device
| Predicate Device Name | FDA
Number and Date | Clearance | Product
code | Manufacturer |
|------------------------------------------------------------------------|---------------------------------------|-----------|-----------------|--------------|
| syngo MR D13A for the
MAGNETOM systems
Aera/Skyra(/Avanto/Verio) | K121434, cleared
November 05, 2012 | | LNH
LNI,MOS | Siemens AG |
Reference Devices
Thalassaemia Tools cleared with K073194 on February 14, 2008
| Product | FDA
Clearance
Number and Date | Product
code | Manufacturer |
|------------------------------------------------------------------------------------|-----------------------------------------|-----------------|------------------------------------------------|
| syngo MR D13A for the
MAGNETOM systems
Aera/Skyra(/Avanto/Verio) | K121434, cleared
November 05, 2012 | LNH
LNI,MOS | Siemens AG |
| Tim TX True Shape and syngo
MR D13C for MAGNETOM
Skyra | K123510 cleared May
17, 2013 | LNH | Siemens AG |
| Software update syngo MR
D13A-AP-AA to syngo MR D13A
for MAGNETOM Aera/Skyra | K132831 cleared
November 01, 2013 | LNH
LNI,MOS | Siemens AG |
| MAGNETOM Aera/Skyra, syngo
MR D13A with additional local
coils | K133435 cleared
December 12, 2013 | LNH | Siemens AG |
| Thalassaemia Tools | K073194 cleared on
February 14, 2008 | LLZ | Cardiovascular
Imaging Solutions
Ltd. |
| syngo.MR Neurology | K121459 cleared June
22, 2012 | LLZ,
LNH | Siemens AG |
| syngo BreVis | K090038 cleared April
29, 2009 | LNH | Siemens AG |
| "MAGNETOM Artis Combi
Suite" for the MAGNETOM
systems Aera/Skyra | K140253 cleared
March 20, 2014 | LNH,
MOS | Siemens AG |
| MAGNETOM Spectra | K121160 cleared July
16, 2012 | LNH,
LNI,MOS | Siemens Shenzhen
Magnetic
Resonance Ltd. |
5
| Product | FDA
Number and Date | Product code | Manufacturer |
|------------------------------------------------------------------------------------------------------|--------------------------------------|--------------|--------------|
| MAGNETOM Aera with syngo
MR D13E | K132951 cleared
November 15, 2013 | LNH | Siemens AG |
| Pediatric 16, a 1.5T Tim Coil/
Pediatric 16 a 3T Tim Coil for
Aera/Skyra with syngo MR
E11A | K140998 cleared July
11, 2014 | MOS | QED |
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II. Safety and Effectiveness Information Supporting Substantial Equivalence
Intended Use
The MAGNETOM systems [MAGNETOM Aera and MAGNETOM Skyra] are 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 systems may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MR-Safe biopsy needles.
Device Description
The subject device, software syngo MR E11A for MAGNETOM Aera and MAGNETOM Skyra offers two new applications, LiverLab (an application of non-invasive liver evaluation) and MyoMaps (an application designed to provide a means to generate pixel maps for myocardial MR relaxation times). In addition, software syngo MR E11A makes the Dot Cockpit available for the user to modify and create Siemens Dot Engine workflows in a very intuitive way which supplements some of the support of an application specialist. The software syngo MR E11A also includes new and modified sequences as well as minor modifications of already existing features. In additional coils are offered and some hardware components have been modified.
Siemens Medical Solutions, USA Inc., intends to market MAGNETOM Aera and MAGNETOM Skyra with new software, syngo MR E11A. While syngo MR E11A offers additional capabilities with respect to the predicate device, the MAGNETOM Aera and MAGNETOM Skyra have the same technological characteristics as the predicate device (K121434; Cleared November, 5, 2012).
Furthermore, Siemens Medical Solutions, USA Inc., intends to market a new configuration of the MAGNETOM Skyra with 24 receive channels with software syngo MR E11A.
The MAGNETOM Aera and MAGNETOM Skyra will be offered ex-factory (new production) as well as in-field upgrades for the currently installed MAGNETOM Aera and MAGNETOM Skyra systems. The new MAGNETOM Skyra configuration with 24 receive channels will be offered as an ex-factory option (new production).
Technological Characteristics
MAGNETOM Aera/Skyra with syngo MR E11A and the predicate devices are substantially equivalent with regard to acquiring MR images steps/features.
MAGNETOM Aera/Skyra with syngo MR E11A and the predicate devices are substantially equivalent with regard to operational environment, programming language, operating system and performance
7
SIEMENS
MAGNETOM Aera/Skyra with syngo MR E11A and MAGNETOM Aera/Skyra with software syngo MR D13A, conform to the standard for software medical devices (IEC 62304:2006) and IEC as well as NEMA standards.
Nonclinical Tests
The following performance testing was conducted on the subject device:
- The coils were tested for SNR, image uniformity, and heating. .
- Dedicated phantom testing was conducted on particular new sequences. .
- . Acoustic noise measurements were performed for quiet sequences
- . Image quality assessments of all new/modified sequences and algorithms, were completed. In some cases a comparison of the image quality was made between the new/modified features and the predicate features.
- Features of LiverLab was validated with volunteer as well as phantom scans, and synthetic . raw data
- . MyoMaps was tested on volunteers after ECG's were applied. MyoMaps was compared to Thalassaemia Tools in a 100 person study
- All other software features were verified and validated. .
The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate devices to which it has been compared.
Clinical Tests
No clinical tests conducted to support the subject device and the substantial equivalence argument, however clinical images were provided to support the new coils as well as the new and modified software features of the subject device.
Safety and Effectiveness
The device labeling contains instructions for use and any necessary cautions and warnings, to provide for safe and effective use of the device.
Risk management is ensured via a risk analysis in compliance with ISO 14971:2007 to identify and provide mitigation to potential hazards in a risk analysis beginning early in the design phase and continuing throughout the development of the product. These risks are controlled via measures realized in software development, SW testing and product labeling. To minimize risks, Siemens adheres to recognized and established industry practices and standards, such as the IEC 60601-1 series, to minimize electrical and mechanical risk. Furthermore, the operators are healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.
The MAGNETOM Aera and MAGNETOM Skyra with software syngo MR E11A
conform to the applicable FDA recognized and international IEC, ISO and NEMA standards with reqards to performance and safety as recommended by the respective MR FDA Guidance Document.
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Image /page/8/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The word is in all capital letters and is a light blue color. There is a black line underneath the word.
Substantial Equivalence
MAGNETOM Aera and MAGNETOM Skyra with software syngo MR E11A are magnetic resonance diagnostic devices that include nearly all of the features of MAGNETOM Aera and MAGNETOM Skyra with syngo MR D13A.
| Predicate Device Name | FDA Clearance
Number and Date | Product
code | Manufacturer |
|-------------------------------------------------------------------------|---------------------------------------|-----------------|--------------|
| syngo MR D13A for the
MAGNETOM systems
Aera/Skyra(/Avanto/Verio) | K121434, cleared
November 05, 2012 | LNH
LNI, MOS | Siemens AG |
Conclusion as to Substantial Equivalence
MAGNETOM Aera and MAGNETOM Skyra with software syngo MR E11A have
the same intended use and the same basic technical characteristics as the
predecessor devices, MAGNETOM Aera and MAGNETOM Skyra with syngo MR D13A, with respect to the magnetic resonance features and functionalities. MAGNETOM Aera/Skyra with software syngo MR E11A will be used for acquiring MR imaqes (transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra). The predicate devices, MAGNETOM Aera/Skyra with software syngo MR D13A, are also capable of acquiring MR images (transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra).
The differences between the subject device and the predicate device, which include the aforementioned new and modified software and hardware features (mainly software), give the subject device greater capabilities than the predicate device. While there are some technological characteristics which vary with respect to the predicate device, the conclusions from the nonclinical data suggest that the features (of different technological characteristics with respect to the predicate device) bear an equivalent safety and performance profile as that of the predicate and reference devices.
MAGNETOM Aera/Skyra with software syngo MR E11A is similar to the functionalities of the predicate and reference devices, and does not introduce any new issues of safety or effectiveness. Therefore, Siemens is of the opinion that MAGNETOM Aera/Skyra with syngo MR E11A does not raise new questions of safety or effectiveness and is substantially equivalent to the currently marketed device MAGNETOM Aera/ Skyra with software syngo MR D13A (K121434 cleared on November 5, 2012).