(65 days)
Not Found.
No
The document describes software updates for an existing MR system, focusing on new sequences and modified features, but does not mention AI or ML.
No
The device is described as a "magnetic resonance diagnostic device" used for producing images and information to "assist in diagnosis," not for treating or curing conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as a magnetic resonance diagnostic device (MRDD)" and that the output "when interpreted by a trained physician yield information that may assist in diagnosis."
No
The device is described as software (syngo MR E11C - AP02) that is an "Application Package" and "additional options" for existing MAGNETOM MR Systems (MAGNETOM Aera and MAGNETOM Skyra). The intended use and device description clearly indicate this software is an integral part of a physical MR system, not a standalone software-only device.
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 also mentions assisting in diagnosis when interpreted by a trained physician. This describes an imaging device used for in-vivo (within the living body) diagnosis.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases or other conditions. This device does not perform tests on such samples.
- Device Description: The description focuses on the software and hardware of an MR scanner, which is an imaging modality.
- Lack of IVD-related information: There is no mention of analyzing biological samples, reagents, or any other components typically associated with IVD devices.
Therefore, the MAGNETOM MR system described is an in-vivo diagnostic imaging device, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for Use
Your MAGNETOM MR 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. Your MAGNETOM MR 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 Aera and MAGNETOM Skyra with syngo MR E11C Software is cleared with K153343. To address the Compressed Sensing Cardiac Cine and the modified Software Features described in this Premarket Notification Siemens intends to make the Software Application Package syngo MR E11C - AP02 available to the MAGNETOM Aera and Skyra. The additional options for the synqo MR E11C software is being made available for the following MAGNETOM MR Systems:
. MAGNETOM Aera,
MAGNETOM Skyra .
The additional Options for the MR Scanner Software syngo MR E11C include a new feature with a new sequence and modified features for the above mentioned MR systems. A high level summary of sequences, features and improvements made available for the above systems is included below.
New Sequence
- Compressed Sensing Cardiac Cine (BEAT CS Sequence) Within MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C -AP02 Software, Compressed Sensing for Cardiac Cine is made available. To make this feature available a new sequence is introduced called BEAT_CS which is based on a TrueFISP Sequence.
New/Modified Features
. SMS EPI for Breast, Abdomen, and Pelvis
Simultaneous Multi Slice imaging several slices are ln excited simultaneously and separated during image reconstruction. The feature is intended for EPI diffusion and EPI BOLD imaging and now available for Breast, Abdomen and Pelvis.
GOBrain+ for Gadolinium Enhanced Imaging
The GOBrain protocols available with syngo MR E11C (K153343) are adapted to support protocols designed and developed for use with gadolinium contrast agent to enhanced imaging of the brain
Mentions image processing
Yes, the device produces images and spectra and other physical parameters derived from them used for interpretation. It also mentions "post processing of magnetic resonance images."
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
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
Not Found.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical Tests:
The following performance testing was conducted on the subject devices for the new sequence (BEAT_CS). Sample clinical images were taken for particular migrated modified sequence when determined to be necessary.
Image quality assessments of the new sequence and algorithms were completed.
Software verification and validation testing was completed in accordance with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
The results from each set of tests demonstrate that the devices perform as intended and are thus substantially equivalent to the predicate devices to which it has been compared.
Clinical Tests:
No clinical tests were conducted to support the subject devices and the substantial equivalence argument; however, clinical images and LV evaluation were provided to support the argumentation and documentation which demonstrate the clinical utility and technical capabilities of the method.
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.
Not Found.
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 U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized image of three human profiles. The profiles are arranged in a way that they appear to be connected or overlapping. The logo is simple and uses a monochromatic color scheme.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 27, 2017
Siemens Medical Solutions USA, Inc. % Cordell L. Fields, Esq. Regulatory Affairs Specialist 40 Liberty Boulevard, Mail Code 65-1A MALVERN PA 19355
Re: K163312
Trade/Device Name: MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, LNI, MOS Dated: January 20, 2017 Received: January 23, 2017
Dear Mr. Fields:
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'Hara
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
For
Enclosure
2
Indications for Use
510(k) Number (if known) K163312
Device Name MAGNETOM Aera & MAGNETOM Skyra
Indications for Use (Describe)
Your MAGNETOM MR 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 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 yield information that may assist in diagnosis.
Your MAGNETOM MR 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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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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"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
Section 5 510(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.
40 Liberty Boulevard
Mail Code 65-1A
Malvern, PA 19355, USA
Registration Number: 2240869 |
|----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | November 22, 2016 |
| Manufacturer | Siemens AG / Siemens Healthcare GmbH
Henkestr. 127
Erlangen Bayern, Germany 91052
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 | Mr. Cordell L. Fields, Esq.
Regulatory Affairs Technical Specialist
Siemens Healthcare
Siemens Medical Solutions USA, Inc.
Customer Solutions Group
40 Liberty Boulevard
Mail Code 65-1A
Malvern, PA 19355, USA
Phone: (610) 448-6469
Fax: (610) 640-4481 |
| Device Name | MAGNETOM Aera and MAGNETOM Skyra with syngo MR
E11C - AP02 Software |
| 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
II. Safety and Effectiveness Information Supporting Substantial Equivalence
Intended Use
The indications for use for the subject device are the same as the predicate device and are as follows:
Your MAGNETOM MR 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.
MAGNETOM MR system may also be used for imaging Your during interventional procedures when performed with MR compatible devices such as in-room displays and MR Safe biopsy needles.
Device Description
MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C Software is cleared with K153343. To address the Compressed Sensing Cardiac Cine and the modified Software Features described in this Premarket Notification Siemens intends to make the Software Application Package syngo MR E11C - AP02 available to the MAGNETOM Aera and Skyra.
The additional options for the synqo MR E11C software is being made available for the following MAGNETOM MR Systems:
- . MAGNETOM Aera,
- MAGNETOM Skyra .
The additional Options for the MR Scanner Software syngo MR E11C include a new feature with a new sequence and modified features for the above mentioned MR systems. A high level summary of sequences, features and improvements made available for the above systems is included below.
5
Image /page/5/Picture/1 description: The image shows the word "SIEMENS" in a bold, sans-serif font. The color of the text is a teal or cyan color. The background is white, providing a strong contrast to the text.
New Sequence
- Compressed Sensing Cardiac Cine (BEAT CS Sequence) Within MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C -AP02 Software, Compressed Sensing for Cardiac Cine is made available. To make this feature available a new sequence is introduced called BEAT_CS which is based on a TrueFISP Sequence.
New/Modified Features
. SMS EPI for Breast, Abdomen, and Pelvis
Simultaneous Multi Slice imaging several slices are ln excited simultaneously and separated during image reconstruction. The feature is intended for EPI diffusion and EPI BOLD imaging and now available for Breast, Abdomen and Pelvis.
GOBrain+ for Gadolinium Enhanced Imaging ●
The GOBrain protocols available with syngo MR E11C (K153343) are adapted to support protocols designed and developed for use with gadolinium contrast agent to enhanced imaging of the brain
Technological Characteristics
MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software has the same technological characteristics as the predicate device MR systems (K153343, cleared April 15, 2016).
The subject devices are substantially equivalent to the predicate devices with regard to the hardware, operational environment, programming language, operating system and performance.
syngo MR E11C - AP02 Software conforms to the standard for software medical devices (IEC 62304:2006) and IEC as well as NEMA standards.
syngo MR E11C - AP02 Software includes new features and a sequence which are seen as substantially equivalent related to the predicate devices. Thus syngo MR E11C - AP02 for Aera and Skyra has the same technological characteristics as the predicate device systems.
Nonclinical Tests
- . The following performance testing was conducted on the subject devices for the new sequence (BEAT_CS). Sample clinical images were taken for particular migrated modified sequence when determined to be necessary.
- . Image quality assessments of the new sequence and algorithms were completed.
- Software verification and validation testing was completed in accordance ● with the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"
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Image /page/6/Picture/1 description: The image shows the word "SIEMENS" in a sans-serif font. The word is written in a bright teal color. The background is white, which makes the word stand out.
The results from each set of tests demonstrate that the devices perform as intended and are thus substantially equivalent to the predicate devices to which it has been compared.
Clinical Tests
No clinical tests were conducted to support the subject devices and the substantial equivalence argument; however, clinical images and LV evaluation were provided to support the argumentation and documentation which demonstrate the clinical utility and technical capabilities of the method.
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 devices.
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.
syngo MR E11C - AP02 software for the MAGNETOM Aera and The MAGNETOM Skyra conforms to the applicable FDA recognized and international IEC, ISO and NEMA standards with regards to performance and safety as recommended by the respective MR FDA Guidance Document.
Substantial Equivalence
syngo MR E11C - AP02 software for the MAGNETOM Aera and MAGNETOM Skyra includes a new sequence and features compared to the predicate software syngo MR E11C. Hardware is identical to the cleared Aera and Skyra scanners in the predicate devices.
Predicate Devices Information
| Predicate Devices | FDA Clearance
Number and Date | Product
code | Manufacturer |
|----------------------------------------------------|------------------------------------|------------------|-----------------------------------------------|
| Software syngo MR E11C for
MAGNETOM Aera, Skyra | K153343, cleared
April 15, 2016 | LNH, LNI,
MOS | Siemens AG /
Siemens
Healthcare
GmbH |
MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software
7
Conclusion as to Substantial Equivalence
MAGNETOM Aera and MAGNETOM Skyra with syngo MR E11C - AP02 Software, has the same intended use and different technological characteristics as the predicate devices, syngo MR E11C software, with respect to the magnetic resonance features and functionalities. Further, the MR system hardware (i.e. scanner, coils, etc.) remains unchanged. The conclusions from the non-clinical data suggest that the features with different technological characteristics from the subject devices bear an equivalent safety and performance profile as that of the predicate devices. Therefore the subject devices are substantially equivalent to the predicate devices.