(175 days)
Not Found
No
The document does not mention AI, ML, or related terms like deep learning. The performance testing focuses on traditional MR system parameters and phantom studies.
No
The device is described as a "magnetic resonance diagnostic device" used to produce images and spectra for diagnosis, not for treating diseases or conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the systems are "magnetic resonance diagnostic devices (MRDD)" and that the information derived "may assist in diagnosis."
No
The device description explicitly states that the software includes "new software sequences, applications, coils and other hardware" and that "New scanners will be manufactured with this software version; existing scanners can be upgraded to this software version." This indicates the software is part of a larger hardware system (MR scanners) and is not a standalone software-only device. The performance studies also include testing of hardware components like coils and magnets.
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 head, body, or extremities. This is a description of an in vivo diagnostic device, meaning it is used to diagnose conditions within a living organism.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, outside of the body. This device does not perform tests on such samples.
- Input Modality: The input modality is Magnetic Resonance, which is an imaging technique applied directly to the patient, not to a sample.
Therefore, the device described is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that display 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 software syngo MR D13A is the latest software version for four Siemens MR scanners: MAGNETOM Aera (1.5T), Skyra (3T), Avanto (1.5T), and Verio (3T). New scanners will be manufactured with this software version; existing scanners can be upgraded to this software version. The new software version includes new software sequences, applications, coils and other hardware for the four MAGNETOM scanners. While some new features (hardware and software) are only available for certain scanners (of the four listed), the basic syngo MR D13A software will run on each of the four MAGNETOM systems.
Summary of New Features with syngo MR D13A:
Software
- . New sequences for all four systems for body, neurological, abdominal, orthopedic, and cardiac imaging, and for spectroscopy
- New or modified applications/software for all four systems: .
- Dot Engine improvements o
- Image processing and visualization improvements o
- o Mapping improvements
- Improved iPAT o
- Networked Scanner improvements 0
- Dot Engines now available for MAGNETOM Avanto & Verio (previously for . Aera & Skyra with software syngo MR D11)
- New Dot Engines for MAGNETOM Aera & Skyra .
- Multi Nuclear Option now available for MAGNETOM Skyra (previously for . Avanto & Verio with software syngo MR B17)
Hardware
- New coils for Aera & Skyra only: .
- o TxRx CP Head Coil
- o TxRx 15ch Knee Coil
- o 4 Channel Special Purpose Coil
- New coils for Avanto & Verio only: .
- Sentinelle Vanguard Breast 16ch Coil o
- o Sentinelle Endo Array coil
- . Modified Magnet, Skyra only
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
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 device:
- The coils were tested for SNR, image uniformity, and heating. .
- The magnet was tested for SNR, geometric distortion, image uniformity . and slice profile/thickness/spacing.
- Dedicated phantom testing was conducted on the MP2RAGE sequence. .
- The performance parameters of MNO Spectroscopy were phantom-. tested.
- syngo ASL 3D was tested using a dedicated phantom. .
- MR Elastography was tested using a dedicated phantom. .
- T1 mapping with B1 correction was phantom-tested. .
- All 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
There were not any 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.
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.
K111242, K082427, K083421, K092925, K082636, K091114, K103274, K112112
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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September 28, 2012
121434
510(k) Summary
This 510(k) summary is being submitted in accordance with 21 CFR § 807.92.
General Information
| Establishment | Siemens Medical Solutions USA, Inc.
51 Valley Stream Parkway
Mail Code D02
Malvern, PA 19355, USA
Registration Number 2240869 | NOV | 5 | 2012 |
|----------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----|---|------|
| Manufacturer | Siemens AG
Henkestrasse 127
D-91052 Erlangen, Germany
Registration Number 8010024 | | | |
| | 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. Michelle L. Byrne
Regulatory Affairs Technical Specialist
Siemens Medical Solutions USA, Inc.
51 Valley Stream Parkway
Mail Code D02
Malvern, PA 19355, USA
Phone: (610) 448-4293
Fax: (610) 448-1787
E-mail: Michelle.L.Byrne@siemens.com | | | |
| Device Name | Software syngo MR D13A for the
MAGNETOM systems Aera/Skyra/Avanto/Verio | | | |
| CFR Code | 21 CFR § 892.1000 | | | |
| Classification | Class II | | | |
| Product Codes | LNH, LNI, MOS | | | |
| | Classification NameMagnetic Resonance Diagnostic Device, MR
Spectroscopy, MR Coils | | | |
1
Information Supporting Substantial Equivalence
DEVICE DESCRIPTION
The software syngo MR D13A is the latest software version for four Siemens MR scanners: MAGNETOM Aera (1.5T), Skyra (3T), Avanto (1.5T), and Verio (3T). New scanners will be manufactured with this software version; existing scanners can be upgraded to this software version. The new software version includes new software sequences, applications, coils and other hardware for the four MAGNETOM scanners. While some new features (hardware and software) are only available for certain scanners (of the four listed), the basic syngo MR D13A software will run on each of the four MAGNETOM systems.
Summary of New Features with syngo MR D13A:
Software
- . New sequences for all four systems for body, neurological, abdominal, orthopedic, and cardiac imaging, and for spectroscopy
- New or modified applications/software for all four systems: .
- Dot Engine improvements o
- Image processing and visualization improvements o
- o Mapping improvements
- Improved iPAT o
- Networked Scanner improvements 0
- Dot Engines now available for MAGNETOM Avanto & Verio (previously for . Aera & Skyra with software syngo MR D11)
- New Dot Engines for MAGNETOM Aera & Skyra .
- Multi Nuclear Option now available for MAGNETOM Skyra (previously for . Avanto & Verio with software syngo MR B17)
Hardware
- New coils for Aera & Skyra only: .
- o TxRx CP Head Coil
- o TxRx 15ch Knee Coil
- o 4 Channel Special Purpose Coil
- New coils for Avanto & Verio only: .
- Sentinelle Vanguard Breast 16ch Coil o
- o Sentinelle Endo Array coil
- . Modified Magnet, Skyra only
2
INTENDED USE
The MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra, and that display 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.
NONCLINICAL TESTS
The following performance testing was conducted on the subject device:
- The coils were tested for SNR, image uniformity, and heating. .
- The magnet was tested for SNR, geometric distortion, image uniformity . and slice profile/thickness/spacing.
- Dedicated phantom testing was conducted on the MP2RAGE sequence. .
- The performance parameters of MNO Spectroscopy were phantom-. tested.
- syngo ASL 3D was tested using a dedicated phantom. .
- MR Elastography was tested using a dedicated phantom. .
- T1 mapping with B1 correction was phantom-tested. .
- All 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
There were not any 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.
SUBSTANTIAL EQUIVALENCE
Software syngo MR D13A for the MAGNETOM systems Aera/Skyra/Avanto/Verio is substantially equivalent to the following predicate devices:
3
September 28, 2012
| | Predicate Device Name | Manufacturer | 510(k)
Number | FDA Clearance
Date |
|---|-----------------------------------------------------------|-------------------------------------|------------------|-----------------------|
| 1 | MAGNETOM Aera &
MAGNETOM Skyra with
syngo® MR D11 | Siemens
Medical
Solutions | K111242 | November 23, 2011 |
| 2 | MAGNETOM Avanto &
MAGNETOM Verio with
syngo® MR.B17 | Siemens
Medical
Solutions | K082427 | November 7, 2008 |
| 3 | MR-Touch | GE Medical
Systems LLC | K083421 | July 24, 2009 |
| 4 | 3D ASL | GE Medical
Systems LLC. | K092925 | January 6, 2010 |
| 5 | TxRx 1.5T & 3T 15ch
Knee Coils | Quality
Electrodynamics
(QED) | K082636 | September 25,
2008 |
| 6 | TxRx 1.5T & 3T CP Head
Coils | Quality
Electrodynamics
(QED) | K091114 | May 1, 2009 |
| 7 | Sentinelle Endo Coil | Sentinelle
Medical Inc | K103274 | August 18, 2011 |
| 8 | Sentinelle 16ch Breast
Coil | Sentinelle
Medical Inc | K112112 | August 25, 2011 |
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 beginning early in the design cycle and continuing throughout the development of the product. Siemens Medical Solutions USA, Inc. and Siemens AG adhere to recognized and established industry standards, such as the IEC 60601-1 series, to minimize electrical and mechanical hazards.
The MAGNETOM systems Aera/Skyra/Avanto/Verio with software syngo MR D13A conform 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 CONCLUSION
There are no changes to the Indications for Use for the subject device, compared to that of the predicate MAGNETOM scanners with software syngo MR D11 and syngo MR B17. The differences between the subject device and the predicate
4
September 28, 2012
devices, which include the aforementioned new sequences, applications, coils, and hardware, give the systems greater capabilities than the predicate devices, but have the same technological characteristics as the predicate devices, are similar to the functionalities of the predicate devices, and do not introduce any new issues of safety or effectiveness.
Therefore, Siemens believes that the subject device, software version syngo MR D13A for MAGNETOM systems Aera, Skyra, Avanto, and Verio, is substantially equivalent to the predicate devices listed above.
5
Image /page/5/Picture/0 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal is circular and contains the department's name around the perimeter. In the center of the seal is a stylized caduceus, a symbol often associated with medicine and healthcare. The caduceus features a staff with a snake winding around it, and the overall design is simple and bold.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Ms. Michelle L. Byrne Regulatory Affairs Technical Specialist Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway, D-02 MALVERN PA 19355
Re: K121434
Trade/Device Name: Software syngo MR D13A for the MAGNETOM systems Aera/Skyra/Avanto/Verio
Regulation Number: 21 CFR 892.1000
Regulation Name: Magnetic resonance diagnostic device
Regulatory Class: II
Product Code: LNH, LNI, and MOS
Dated: October 10, 2012
Received: October 11, 2012
Dear Ms. Byrne:
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
6
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industrv/support/index.html.
Sincerely Yours,
Janine M. Morris
Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
Indications for Use Section 4 Statement
510(k) Number (if known)
Software syngo MR D13A for the Device Names: MAGNETOM systems Aera/Skyra/Avanto/Verio
Indications for Use
The MAGNETOM systems described above are indicated for use as magnetic resonance diagnostic devices (MRDD) that produce transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that display 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 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.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OVID)
Aland D. Oken
sion Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K121434
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Software syngo MR D13A for the MAGNETOM systems Aera/Skyra/Avanto/Verio
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