(63 days)
Not Found
No
The document describes hardware and software modifications to an existing MRI system to enable scanning of patients with implants by implementing fixed parameter limits and safety mechanisms. There is no mention of AI or ML algorithms for image processing, diagnosis, or any other function. The "prediction" mentioned is likely a deterministic look-ahead based on known pulse sequences and parameters, not an ML-based prediction.
No.
The device is used to produce images and/or spectra that, when interpreted by a trained physician, yield information that may assist in diagnosis. It is not intended for treatment or therapy.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the system "yields information that may assist in diagnosis." This directly indicates its role as a diagnostic device.
No
The device description explicitly lists several hardware modifications introduced with the application package, including additional control paths, supply-voltage supervisions, RF sensor data communication measures, a segregated TX- switch-off path, and new computer hardware. This indicates the device is not solely software.
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 system produces images and/or spectra of the internal structure and/or function of the head, body, or extremities. This is a description of an in vivo (within a living organism) diagnostic imaging device.
- 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 such tests.
- Device Description: The description focuses on the hardware and software modifications related to magnetic resonance imaging and patient safety during scanning, particularly for patients with implants. This aligns with an in vivo imaging system.
- Input Imaging Modality: The input modality is Magnetic Resonance, which is an in vivo imaging technique.
The device is a magnetic resonance imaging (MRI) system, which is a type of medical imaging device used for in vivo diagnosis.
N/A
Intended Use / Indications for Use
Your MAGNETOM system is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/ or spectra and the physical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.
Your MAGNETOM system 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 same as the predicate device:
Your MAGNETOM 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 system 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
The application package AP01, "Implant Suite" for MAGNETOM Aera, enables diagnostic imaging for patients with MR Conditional active and passive implants. Three different Fixed Parameter Options (FPO), Scan Limits 1, 2, and 3, provide conditional implant scan limitations as shown below:
Scan Limits 1: B1+ peak -, B1+ rms -, WB SAR ≤ 2 W/kg, dB/dt peak -, dB/dt rms -, Slew rate ≤ 200 T/m/s
Scan Limits 2: B1+ peak -, B1+ rms ≤ 2.0 μT, WB SAR ≤ 0.8 W/kg, dB/dt peak -, dB/dt rms -, Slew rate ≤ 200 T/m/s
Scan Limits 3: B1+ peak ≤ 30 μT, B1+ rms ≤ 2.0 μT, WB SAR ≤ 0.8 W/kg, dB/dt peak ≤ 50 T/s, dB/dt rms ≤ 56 T/s, Slew rate ≤ 125 T/m/s
Without a scan limitation selected, the subject device operates identically to the predicate device. The AP01 application package, "Implant Suite", is an optional feature.
With application package AP01, "Implant Suite" for MAGNETOM Aera, the following changes are introduced:
Hardware:
- Additional segregated control path to safely switch-off the gradient power in case the limits are reached during a scan
- Additional supply-voltage supervisions in the gradient amplifier
- Additional measures to ensure permanent active RF sensor data communication
- Additional segregated TX- switch-off path (TSO box)
- New computer hardware for MRAWP and MRWP due to obsolescence
Software:
- Implant Suite (syngo MR E11C-AP01)
Including:- New Online Patient Safety supervision (OPS) interface
- New safe reaction (switch-off) path for when implant related limits are exceeded
- Extended look-ahead functionality (prediction) to avoid starting sequences that could potentially exceed implant-related limits
- New internal supervision to detect latent failures in the control path
- New Implant Suite UI (IUI)
- New means to control coil usage
- Adapted pulse sequences with restricted operation mode
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance Diagnostic Device (MRDD)
Anatomical Site
head, body, or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.
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)
The following performance testing was conducted on the subject device:
- Image quality assessments of the modified measurement protocols
- Verification testing of the new Fixed Parameter Options (FPO) and respective limitations
- 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" (May 11, 2005)
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 substantial equivalence for the subject device: however, clinical images were provided to support the imaging performance of the device when using the limitations of the new "Implant Suite" feature.
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/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Siemens Medical Solutions USA Inc. Martin Rajchel Regulatory Affairs Specialist 40 Liberty Boulevard, Mail Code 65-IA Malvern, Pennsylvania 19355
October 26, 2018
Re: K182299
Trade/Device Name: MAGNETOM Aera Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH Dated: August 23, 2018 Received: August 24, 2018
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products, and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 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,
Image /page/1/Picture/5 description: The image shows the name "Michael D. O'hara -S" in large, bold font on the left side of the image. On the right side of the image, there is a digital signature from Michael D. O'hara, including the date 2018.10.26 08:34:51 -04'00'. The signature also includes information such as DN: c=US, o=U.S. Government, ou=HHS, ou=FDA, ou=People, and 0.9.2342.19200300.100.1.1=1300226 759, cn=Michael D. O'hara -S.
Robert A. Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
Device Name
MAGNETOM Aera
Indications for Use (Describe)
Your MAGNETOM system is indicated for use as a magnetic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These images and/ or spectra and the physical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.
Your MAGNETOM system 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)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary
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.
| Company: | Siemens Medical Solutions USA, Inc.
40 Liberty Boulevard, 65-1A
Malvern, PA 19355 |
| ---------- | ----------------------------------------------------------------------------------------- |
|---|
August 23, 2018 Date Prepared:
General Information 1.
lmporter/Distributor:
Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, Mail Code 65-1A Malvern, PA 19355, USA Establishment Registration Number: 2240869
Manufacturing Sites:
Siemens Healthcare GmbH Henkestrasse 127 91052 Erlangen. Germany Establishment 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 Establishment Registration Number: 3004754211
2. Contact Person:
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.rajchel@siemens-healthineers.com
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3. Device Name and Classification:
| Device Name | MAGNETOM Aera with syngo MR E11C-AP01
software |
|-------------------------|---------------------------------------------------|
| Trade Name | MAGNETOM Aera |
| Classification Name | Magnetic Resonance Diagnostic Device
(MRDD) |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR § 892.1000 |
| Device Class: | II |
| Primary Product Code: | LNH |
| Secondary Product Code: | LNI, MOS |
Legally Marketed Predicate Device: 4.
| Device Name | MAGNETOM Aera, MAGNETOM Skyra / Skyrafit,
MAGNETOM Prisma / Prismafit and MAGNETOM
Avantofit with syngo MR E11C - AP04 software |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Trade Names: | MAGNETOM Aera, MAGNETOM Skyra / Skyrafit,
MAGNETOM Prisma / Prismafit and MAGNETOM |
| 510(k) Number: | K173592, cleared February 13, 2018 |
| Classification Name | Magnetic Resonance Diagnostic Device
(MRDD) |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR § 892.1000 |
| Device Class: | II |
| Primary Product Code: | LNH |
| Secondary Product Code: | LNI, MOS |
5. Intended Use
The indications for use for the subject device are the same as the predicate device:
Your MAGNETOM 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 system 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.
5
Device Description: 6.
The application package AP01, "Implant Suite" for MAGNETOM Aera, enables diagnostic imaging for patients with MR Conditional active and passive implants. Three different Fixed Parameter Options (FPO), Scan Limits 1, 2, and 3, provide conditional implant scan limitations as shown below:
| Fixed Parameter
Options | B1+ peak | B1+ rms | WB SAR | dB/dt
peak | dB/dt rms | Slew rate |
|----------------------------|----------|----------|------------|---------------|-----------|----------------|
| Scan Limits 1 | - | - | ≤ 2 W/kg | - | - | ≤ 200
T/m/s |
| Scan Limits 2 | - | ≤ 2.0 μT | ≤ 0.8 W/kg | - | - | ≤ 200
T/m/s |
| Scan Limits 3 | ≤ 30 μT | ≤ 2.0 μT | ≤ 0.8 W/kg | ≤ 50 T/s | ≤ 56 T/s | ≤ 125
T/m/s |
Without a scan limitation selected, the subject device operates identically to the predicate device. The AP01 application package, "Implant Suite", is an optional feature.
With application package AP01, "Implant Suite" for MAGNETOM Aera, the following changes are introduced:
| Hardware | Modified
Hardware | - Additional segregated control path to safely
switch-off the gradient power in case the limits are
reached during a scan
- Additional supply-voltage supervisions in the
gradient amplifier - Additional measures to ensure permanent active
RF sensor data communication - Additional segregated TX- switch-off path (TSO
box) - New computer hardware for MRAWP and MRWP
due to obsolescence |
|----------|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Software | New Features
and Applications | - Implant Suite (syngo MR E11C-AP01)
Including: - New Online Patient Safety supervision (OPS)
interface - New safe reaction (switch-off) path for when
implant related limits are exceeded - Extended look-ahead functionality (prediction)
to avoid starting sequences that could
potentially exceed implant-related limits - New internal supervision to detect latent
failures in the control path - New Implant Suite UI (IUI)
- New means to control coil usage
- Adapted pulse sequences with restricted
operation mode |
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7. Technological Characteristics
The subject device, MAGNETOM Aera with syngo MR E11C-AP01, has the same fundamental technological characteristics as the predicate device, MAGNETOM Aera with syngo MR E11C-AP04, (K173592 cleared February 13. 2018) with regard to the operational environment, programming language, operating system, and performance.
The software was modified to implement a new user interface and limitations for scanning patients with MR Conditional implants. Additionally the hardware was modified to implement safe communication channels and a safe cut-off path for RF power.
The MAGNETOM Aera with syngo MR E11C-AP01 conforms to the standard for software medical devices (IEC 62304:2015) 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 to that of the predicate device.
8. Nonclinical Tests
The following performance testing was conducted on the subject device:
- Image quality assessments of the modified measurement protocols
- Verification testing of the new Fixed Parameter Options (FPO) and respective limitations
- 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" (May 11, 2005)
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.
Clinical Tests 9.
No clinical tests were conducted to support substantial equivalence for the subject device: however, clinical images were provided to support the imaging performance of the device when using the limitations of the new "Implant Suite" feature.
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10. Safety and Effectiveness
The device labeling contains instructions for use and any necessary cautions and warnings to ensure safe and effective use of the device.
Risk management is ensured via ISO 14971:2007 compliance 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 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. Software development is carried out according to the IEC 62304 standard for medical device software. Furthermore, the device is intended for healthcare professionals familiar with and responsible for the acquisition and post processing of magnetic resonance images.
The MAGNETOM Aera with syngo MR E11C-AP01 software conforms to the applicable FDA recognized and international IEC, ISO and NEMA.
| Recognition
Number | Product
Area | Title of Standard | Reference
Number and date | Standards
Development
Organization |
|-----------------------|-----------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------|------------------------------------------|
| 19-4 | General | 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)2012
and A1:2012 | AAMI ANSI |
| 19-8 | General | Medical electrical equipment - Part 1-2:
General requirements for basic safety
and essential performance - Collateral
Standard: Electromagnetic disturbances
- Requirements and tests | 60601-1-2
Edition 4.0
2014-02 | IEC |
| 12-295 | Radiology | Medical electrical equipment - Part 2-33:
Particular requirements for the basic
safety and essential performance of
magnetic resonance equipment for
medical diagnostic | 60601-2-33 Ed.
3.2 B:2015 | IEC |
| 5-40 | General | Medical devices - Application of risk
management to medical devices | 14971 Second
edition 2007-03-
01 | ISO |
| 5-89 | General | 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 |
| 5-96 | General | Medical devices - Application of usability
engineering to medical devices | 62366-1:2015 | AAMI ANSI
IEC |
| 13-79 | Software | Medical device software - Software life
cycle processes | 62304 Edition
1.1 2015-06 | IEC |
| 12-300 | Radiology | Digital Imaging and Communications in
Medicine (DICOM) Set 03/16/2012
Radiology | PS 3.1 - 3.20
(2016) | NEMA |
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11. Substantial Equivalence and Conclusion
The subject device, MAGNETOM Aera with syngo MR E11C-AP01, has the same intended use, indications for use, and fundamental technological characteristics as the predicate device, MAGNETOM Aera with syngo MR E11C-AP04, (K173592).
The software was modified to implement a user interface with selectable limitations for scanning patients with MR Conditional implants. Additionally the hardware was modified to implement safe communication channels and a safe cut-off path for RF power.
While there are 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 tests have shown that there were no additional questions of safety and effectiveness raised.
believes that the subiect device. MAGNETOM Aera with Siemens syngo MR E11C-AP01 is substantially equivalent to the predicate device, MAGNETOM Aera with syngo MR E11C-AP04.