(84 days)
No
The document describes modifications to existing MR systems and software, focusing on new sequences and features for image acquisition and processing. There is no mention of AI, ML, or related concepts like deep learning, nor are there descriptions of training or test sets typically associated with AI/ML development.
No
The device is described as a "magnetic resonance diagnostic device" used for producing images and/or spectra to assist in diagnosis, not for therapeutic purposes.
Yes
The "Intended Use / Indications for Use" section explicitly states that the MAGNETOM systems are intended for use as a "magnetic resonance diagnostic device (MRDD)" and that the images and physical parameters, when interpreted by a trained physician, "yield information that may assist in diagnosis."
No
The device is described as a software application package ("syngo MR E11C - AP04") that is made available for existing MAGNETOM MR Systems. While the submission focuses on software modifications and features, the device's intended use and description clearly indicate it is software that operates on and enhances the functionality of physical MR imaging systems (hardware). The predicate devices are also described as software for specific MAGNETOM MR Systems.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the MAGNETOM systems are "magnetic resonance diagnostic devices (MRDD)" that produce images and/or spectra of the internal structure and/or function of the head, body, or extremities. This is a description of an imaging device used for in-vivo diagnosis.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. The MAGNETOM system does not perform tests on such samples.
- Device Description: The device description focuses on the software and hardware of an MRI system, not on reagents, calibrators, or other components typically associated with IVDs.
- Input Imaging Modality: The input is "Magnetic resonance," which is an imaging modality, not a biological sample.
The device is an imaging system used for diagnosis based on the interpretation of images and spectra by a trained physician. This falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The MAGNETOM systems 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 mages 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.
The indications for use for the subject device are the predicate devices and are as follows:
The MAGNETOM systems 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
LNH, LNI, MOS
Device Description
MAGNETOM Aera, MAGNETOM Skyra and MAGNETOM Prisma/Prisma" with syngo MR E11C software were cleared with K153343 and MAGNETOM Avanto" and MAGNETOM Skyrafff systems with syngo MR E11C software were cleared with K162102.
To address the new feature GOKnee3D and the modifications summarized in Section 3 and furthermore described in this Premarket Notification Siemens intends to make the software application package syngo MR E11C - AP04 available to the systems mentioned above.
The additional options for the synqo MR E11C software is being made available for the following MAGNETOM MR Systems:
- . MAGNETOM Aera,
- MAGNETOM Skyra / Skyraf" ●
- MAGNETOM Prisma / Prisma™ ●
- MAGNETOM Avantofit .
Those options include a new feature with a modified 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 Feature
GOKnee3D
GOKnee3D is a fast, push-button, clinically validated knee examination which comprises the AutoAlign knee localizer and two CAIPIRINHA SPACE sequences (PD and T2 fat suppression) to support fast high-resolution 3D exams of the knee
Modified Features
SPACE with CAIPIRINHA acquisition technique
The 3D SPACE pulse sequence (K153343 for Aera, Skyra, Prisma /Prismal"; K162102 for Avanto® and Skyra™) now offers the iPAT mode CAIPIRINHA (K153343 for Aera, Skyra, Prisma /Prisma"; K162102 for Avanto™ and Skyra ")
Dual Monitor support
To support the user with more efficient use of the Dot Cockpit and postprocessing parallel to the examination, a second monitor will be offered
Compressed Sensing Cardiac Cine (BEAT_CS Sequence)
With the syngo MR E11C - AP04 software, Compressed Sensing Cardiac Cine is made available for MAGNETOM Prisma and MAGNETOM Prismat". The Compressed Sensing Cardiac Cine was already described in K163312 for the syngo MR E11C - AP02 software and is used unchanged to this clearance
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
head, body, or extremities, knee, cardiac
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)
Nonclinical Tests:
The following performance testing was conducted on the subject devices for the modified sequence (CAIPIRINHA SPACE). 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 quidance 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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1000 Magnetic resonance diagnostic device.
(a)
Identification. A magnetic resonance diagnostic device is intended for general diagnostic use to present images which reflect the spatial distribution and/or magnetic resonance spectra which reflect frequency and distribution of nuclei exhibiting nuclear magnetic resonance. Other physical parameters derived from the images and/or spectra may also be produced. The device includes hydrogen-1 (proton) imaging, sodium-23 imaging, hydrogen-1 spectroscopy, phosphorus-31 spectroscopy, and chemical shift imaging (preserving simultaneous frequency and spatial information).(b)
Classification. Class II (special controls). A magnetic resonance imaging disposable kit intended for use with a magnetic resonance diagnostic device only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
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February 13, 2018
Siemens Medical Solutions USA, Inc. % Cordell Fields, Esq. Regulatory Affairs Technical Specialist 40 Liberty Boulevard, Mailcode 65-1A MALVERN PA 19355
Re: K173592
Trade/Device Name: MAGNETOM Aera, MAGNETOM Skyraft, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH, LNI, MOS Dated: November 20, 2017 Received: November 21, 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 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.
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 mediation-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,
Michael D. O'Hara For
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
Image /page/2/Picture/0 description: The image shows the word "SIEMENS" in a bold, sans-serif font. The color of the text is a bright teal. The letters are evenly spaced and the word is horizontally oriented. The background is plain white.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
510(k) Number (if known)
Device Name
MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prismafit, MAGNETOM Avantofit
Indications for Use (Describe)
The MAGNETOM systems 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 mages 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.
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)
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."
FORM FDA 3881 (7/17)
Page 1 of 1
PSC Publishing Services (301) 443-6740 EF
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 20, 2017 |
| Manufacturer | 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, MAGNETOM Skyra / Skyrafit,
MAGNETOM Prisma / Prismafit and MAGNETOM Avantofit |
with syngo MR E11C - AP04 software
4
| Trade Names | MAGNETOM Aera |
|---|---|
| MAGNETOM Skyra | |
| MAGNETOM Skyrafit | |
| MAGNETOM Avantofit | |
| MAGNETOM Prisma | |
| MAGNETOM Prismafit | |
| 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 |
II. Safety and Effectiveness Information Supporting Substantial Equivalence
Intended Use
The indications for use for the subject device are the predicate devices and are as follows:
The MAGNETOM systems 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
MAGNETOM Aera, MAGNETOM Skyra and MAGNETOM Prisma/Prisma" with syngo MR E11C software were cleared with K153343 and MAGNETOM Avanto" and MAGNETOM Skyrafff systems with syngo MR E11C software were cleared with K162102.
To address the new feature GOKnee3D and the modifications summarized in Section 3 and furthermore described in this Premarket Notification Siemens intends to make the software application package syngo MR E11C - AP04 available to the systems mentioned above.
The additional options for the synqo MR E11C software is being made available for the following MAGNETOM MR Systems:
- . MAGNETOM Aera,
- MAGNETOM Skyra / Skyraf" ●
5
- MAGNETOM Prisma / Prisma™ ●
- MAGNETOM Avantofit .
Those options include a new feature with a modified 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 Feature
। GOKnee3D2
GOKnee3D is a fast, push-button, clinically validated knee examination which comprises the AutoAlign knee localizer and two CAIPIRINHA SPACE sequences (PD and T2 fat suppression) to support fast high-resolution 3D exams of the knee
Modified Features
— SPACE with CAIPIRINHA acquisition technique
The 3D SPACE pulse sequence (K153343 for Aera, Skyra, Prisma /Prismal"; K162102 for Avanto® and Skyra™) now offers the iPAT mode CAIPIRINHA (K153343 for Aera, Skyra, Prisma /Prisma"; K162102 for Avanto™ and Skyra ")
। Dual Monitor support
To support the user with more efficient use of the Dot Cockpit and postprocessing parallel to the examination, a second monitor will be offered
| Compressed Sensing Cardiac Cine (BEAT_CS Sequence)
With the syngo MR E11C - AP04 software, Compressed Sensing Cardiac Cine is made available for MAGNETOM Prisma and MAGNETOM Prismat". The Compressed Sensing Cardiac Cine was already described in K163312 for the syngo MR E11C - AP02 software and is used unchanged to this clearance
Technological Characteristics
MAGNETOM Aera, MAGNETOM Skyra/Skyra®, MAGNETOM Prisma/Prisma™ and MAGNETOM Avanto® with syngo MR E11C - AP04 Software have the same technological characteristics as the predicate devices MR systems:
| Predicate Devices | FDA Clearance
Number | Product Code |
|-----------------------------------------------------------|------------------------------------------|------------------|
| Software syngo MR E11C_AP02 for MAGNETOM
Aera, Skyra | K163312, cleared
January 27, 2017 | LNH, LNI,
MOS |
| Software syngo MR E11C for MAGNETOM
Prisma/Prismafit | K153343, cleared
April 15, 2016 | LNH, LNI,
MOS |
| Software syngo MR E11C for MAGNETOM
Avantofit/Skyrafit | K162102, cleared
November 22,
2016 | LNH, LNI,
MOS |
Siemens 510(k) Traditional Premarket Notification
2 Available only for MAGNETOM Aera and MAGNETOM Skyra
6
SIEMENS
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 - AP04 software conforms to the standard for software medical devices (IEC 62304:2006) and IEC as well as NEMA standards.
syngo MR E11C - AP04 software includes new and modified features which are seen as substantially equivalent related to the predicate devices. Thus synqo MR E11C - AP04 for MAGNETOM Aera, MAGNETOM Skyra/Skyraf", MAGNETOM Prisma/Prisma/Prisma/" and MAGNETOM Avanto™ has the same technological characteristics as the predicate device systems.
Nonclinical Tests
- . The following performance testing was conducted on the subject devices for the modified sequence (CAIPIRINHA SPACE). 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 quidance 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.
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.
The syngo MR E11C - AP04 software for the MAGNETOM Aera, MAGNETOM Skyra/Skyraf", MAGNETOM Prisma/Prismat" and MAGNETOM Avanto™ 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.
7
Substantial Equivalence
syngo MR E11C - AP04 software for the MAGNETOM Aera, MAGNETOM Skyra/Skyra", MAGNETOM Prisma/Prismall and MAGNETOM Avanto™ includes new and modified features compared to the predicate devices shown below. Hardware is identical to the cleared MAGNETOM scanners in the predicate devices.
Predicate Devices Information
| Predicate Devices | FDA Clearance
Number | Product
Code | Manufacturer |
|------------------------------------------------------------------|------------------------------------------|------------------|----------------------------|
| Software syngo MR E11C_AP02
for MAGNETOM Aera, Skyra | K163312, cleared
January 27, 2017 | LNH, LNI,
MOS | Siemens
Healthcare GmbH |
| Software syngo MR E11C for
MAGNETOM Prisma/Prismafit | K153343, cleared
April 15, 2016 | LNH, LNI,
MOS | |
| Software syngo MR E11C for
MAGNETOM Avantofit/Skyrafit | K162102, cleared
November 22,
2016 | LNH, LNI,
MOS | |
Recall Information
The predicate device(s) have not been subject to design-related recalls.
Conclusion as to Substantial Equivalence
MAGNETOM Aera, MAGNETOM Skyra/Skyraf", MAGNETOM Prisma/Prismat" and MAGNETOM Avanto" with syngo MR E11C - AP04 software, have the same intended use and different technological characteristics as the predicate devices with respect to the magnetic resonance features and functionalities. 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.