(28 days)
No
The document describes software updates focused on image acquisition sequences and hardware updates, with no mention of AI, ML, or related concepts in the intended use, device description, or performance studies.
No
The device is described as a "magnetic resonance diagnostic device" used to produce images and spectroscopic images for diagnosis, not for therapy.
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 images and spectra it produces, "when interpreted by a trained physician yield information that may assist in diagnosis."
No
The device description explicitly lists hardware updates (Updated MRAWP/MRWP based on a new host platform and an Endorectal interface/adapter) in addition to the software modifications.
Based on the provided text, the 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 when interpreted by a trained physician.
- Device Description: The description details hardware and software components related to magnetic resonance imaging.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (such as blood, urine, or tissue) to provide information about a person's health. The provided text does not mention any interaction with biological samples or performing tests on them.
The device is a diagnostic imaging system, 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 that displays the internal structure and/or function of the head, body, or extremittes. 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
LNH, LNI, MOS
Device Description
The subject device, MAGNETOM Amira with syngo MR E11S, is a modification of the previously cleared predicate device, MAGNETOM Amira with syngo MR E11N (K152283). Software version syngo E11S for MAGNETOM Amira includes software applications migrated from the previously cleared MAGNETOM Aera systems with syngo MR E11C and E11C - AP02 (K153343 and K163312). Only minor adaptations were needed to support the system specific hardware and optimize the sequence/protocols. The following are the software applications migrated from previously cleared software to the subject device:
- . fast TSE
- o Improvements in BLADE Imaging
- SMS EPI .
- o Simultaneous Multi Slice Imaging
- Quiet DWI .
- o Noise reduced sequence for diffusion weighted imaging
- GOBrain ●
- o Supports brain examination in short acquisition time
- GOBrain+ ●
- o GOBrain adaptation to support protocols developed for contrast enhanced imaging of the brain
Listed below are the hardware updates to the MAGNETOM Amira with syngo MR E11S:
- Updated MRAWP/MRWP (Syngo Acquisition Workplace/ Syngo Workplace) . based on the new host platform-HP Z440.
- Endorectal interface and adapter to connect the Endorectal Coil (to be ordered . separately) to the MAGNETOM Amira systems.
The MAGNETOM Amira with software version syngo MR E11S will be offered ex-factory (new production) as well as in-field upgrades for the currently installed MAGNETOM Amira systems.
Mentions image processing
Yes, "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 / 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)
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", dated May 11, 2005. Performance testing was completed in accordance with the FDA guidance document, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices", dated November 18, 2016. The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared. No clinical tests were conducted to support the claim of substantial equivalence between the subject and predicate device. Sample clinical images have been provided in accordance with the FDA guidance document, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices," dated November 18, 2016.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found.
Predicate Device(s)
Reference Device(s)
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 contains two logos. The logo on the left is the Department of Health & Human Services logo. The logo on the right is the FDA logo, which includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Medical Solutions USA, Inc. Martin Rajchel Regulatory Affairs Specialist 40 Libertv Boulevard. Mail Code 65-1A Malvern, Pennsylvania 19355
Re: K173600
Trade/Device Name: MAGNETOM Amira Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: November 20, 2017 Received: November 21, 2017
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. 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
December 19, 2017
1
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.
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/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Robert Oals
Robert Ochs, Ph.D. 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) K173600
Device Name MAGNETOM Amira
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 extremittes. 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.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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 MAGNETOM Amira with software syngo MR E11S
Company: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA Establishment Registration Number: 2240869
Date Prepared November 20, 2017
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR § 807.92.
1. General Information
Importer/Distributor:
Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Malvern, PA 19355, USA Establishment Registration Number: 2240869
Manufacturing Sites:
Siemens Shenzhen Magnetic Resonance Ltd. Siemens MRI Center, Gaoxin C. Ave., 2nd Hi-Tech Industrial Park 518057 Shenzhen China Establishment Registration Number: 3004754211
Siemens Healthcare GmbH Henkestr. 127 91052 Erlangen Germany Establishment Registration Number: 3002808157
2. Contact Information
Martin Rajchel Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355, USA Phone: (610) 448-6545 Fax: (610) 640-4481 E-mail: martin.raichel@siemens-healthineers.com
4
SIEME
3. Device Name and Classification
| Trade Name | MAGNETOM Amira with software syngo MR E11S |
|---|---|
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | Class II |
| Product Code: | Primary: LNH |
| Secondary: LNI. MOS |
4. Legally Marketed Predicate Device
| Trade Name | MAGNETOM Amira with Software syngo MR E11N |
|---|---|
| 510(k) Number | K152283, Cleared December 24, 2015 |
| Classification Name: | Magnetic Resonance Diagnostic Device (MRDD) |
| Classification Panel: | Radiology |
| CFR Code: | 21 CFR § 892.1000 |
| Classification: | Class II |
| Product Code: | Primary: LNH |
| Secondary: LNI, MOS |
5. Device Description
The subject device, MAGNETOM Amira with syngo MR E11S, is a modification of the previously cleared predicate device, MAGNETOM Amira with syngo MR E11N (K152283). Software version syngo E11S for MAGNETOM Amira includes software applications migrated from the previously cleared MAGNETOM Aera systems with syngo MR E11C and E11C - AP02 (K153343 and K163312). Only minor adaptations were needed to support the system specific hardware and optimize the sequence/protocols. The following are the software applications migrated from previously cleared software to the subject device:
- . fast TSE
- o Improvements in BLADE Imaging
- SMS EPI .
- o Simultaneous Multi Slice Imaging
- Quiet DWI .
- o Noise reduced sequence for diffusion weighted imaging
- GOBrain ●
- o Supports brain examination in short acquisition time
- GOBrain+ ●
- o GOBrain adaptation to support protocols developed for contrast enhanced imaging of the brain
5
Listed below are the hardware updates to the MAGNETOM Amira with syngo MR E11S:
- Updated MRAWP/MRWP (Syngo Acquisition Workplace/ Syngo Workplace) . based on the new host platform-HP Z440.
- Endorectal interface and adapter to connect the Endorectal Coil (to be ordered . separately) to the MAGNETOM Amira systems.
The MAGNETOM Amira with software version syngo MR E11S will be offered ex-factory (new production) as well as in-field upgrades for the currently installed MAGNETOM Amira systems.
6. Indication for Use
The indications for use for the subject device is the same as the predicate device and is 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 vield 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.
7. Substantial Equivalence
The MAGNETOM Amira with syngo MR E11S is substantially equivalent to the following device:
| Predicate Device | FDA Clearance
Number | FDA
Clearance
Date | Product
Code |
|-------------------------------------------------------|-------------------------|--------------------------|-----------------|
| MAGNETOM Amira with software
version syngo MR E11N | K152283 | December 24, 2015 | LNH, LNI, MOS |
6
As described above, the MAGNETOM Amira with syngo MR E11S includes features already cleared on the following devices:
| Reference Device | FDA Clearance
Number | FDA
Clearance
Date | Product
Code |
|---------------------------------------------------------------------------|-------------------------|--------------------------|------------------|
| Software syngo MR E11C for the
MAGNETOM System Aera | K153343 | April 15, 2016 | LNH, LNI,
MOS |
| MAGNETOM Aera and
MAGNETOM Skyra with syngo
MR E11C - AP02 Software | K163312 | January 27,
2017 | LNH, LNI,
MOS |
8. Summary of Technological Characteristics of the Subject Device as Compared with the Predicate Device
The subject device MAGNETOM Amira with syngo E11S is substantially equivalent to the predicate device, MAGNETOM Amira with syngo MR E11N, with regard to the operational environment, programming language, operating system, and performance.
The subject device, MAGNETOM Amira with syngo MR E11S, conforms to the IEC 62304, Edition 1.1, 2015-06, standard for software medical devices 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 software applications and hardware additions, these differences have been tested and the conclusions from the non-clinical data suggests that the features bear an equivalent safety and performance profile as that of the predicate device.
9. Nonclinical Performance Testing
The following performance testing was conducted on the subject device:
- । Sample clinical images were taken for the endorectal coil.
- । 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", dated May 11, 2005.
- Performance testing was completed in accordance with the FDA quidance document, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices", dated November 18, 2016
The results from each set of tests demonstrate that the device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared.
MAGNETOM Amira with syngo E11S conforms to the following FDA recognized and international IEC and ISO standards:
7
| Recogniton
Number | Product
Area | Title of Standard | Reference
Number and
date | Standards
Development
Organization |
|----------------------|--------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------|------------------------------------------|
| 19-4 | General II
(ES/EMC) | C1:2009/(R)2012 and
A2:2010/(R)2012
(Consolidated Text) Medical
electrical equipment - Part 1:
General requirements for basic
safety and essential
performance (IEC 60601-
1:2005, MOD) | ES60601-
1:2005/(R)20
12 and
A1:2012, | AAMI ANSI |
| 19-1 | General II
(ES/EMC) | Medical electrical equipment -
Part 1-2: General
requirements for basic safety
and essential performance -
Collateral standard:
Electromagnetic compatibility -
Requirements and tests | 60601-1-2
Edition 3:
2007-03 | IEC |
| 12-271 | 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. 3.1:2013 | IEC |
| 5-40 | General I
(QS/RM) | Medical devices - Application
of risk management to medical
devices | 14971
Second
Edition 2007-
03-01 | ISO |
| 5-89 | General I
(QS/RM) | Medical electrical equipment -
Part 1-6: General
requirements for basic safety
and essential performance -
Collateral standard: Usability | 60601-1-6
Edition 3.1
2013-10 | IEC |
| 13-32 | Software/l
nformatics | Medical device software -
Software life cycle processes | IEC 62304
Edition 1.1
2015-06 | AAMI ANSI
IEC |
No clinical tests were conducted to support the claim of substantial equivalence between the subject and predicate device. Sample clinical images have been provided in accordance with the FDA guidance document, "Submission of Premarket Notifications for Magnetic Resonance Diagnostic Devices," dated November 18, 2016.
8
10. General Safety and Effectiveness Concerns
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 compliance with ISO 14971:2007 to identify and provide mitigation of potential hazards in a risk analysis early in the design phase and continuously throughout the development of the product. These risks are controlled via measures realized in hardware and software development, 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 device is intended for healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.
11.Conclusion as to Substantial Equivalence
There are no changes to the indications for use for the subject device as compared to that of the legally marketed predicate device, MAGNETOM Amira with software version syngo MR E11N (K152283).
While the new and modified software and hardware features provide additional capabilities compared to the predicate device, the additional capabilities are currently cleared features of the reference device MAGNETOM Aera with software syngo MR E11C and E11C – AP02 (K153343; K163312) and do not raise new questions of safety and effectiveness. All features have been verified and validated to support the claim of substantial equivalence to the predicate device.
Siemens believes that the subject device, MAGNETOM Amira with syngo MR E11S, is substantially equivalent to the predicate device, MAGNETOM Amira with syngo MR E11N.