(17 days)
Your MAGNETOM system is indicated for use as a magnetic 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.
The mobile configuration for MAGNETOM scanners enables customers to relocate the MRI System to different locations and therefore provide imaging services to hospitals or locations where fixed installations are not possible or feasible.
For MAGNETOM Aera a mobile configuration is already available on the market with a fixed patient table. Within this premarket notification the Tim Dockable Table is being made available for the MAGNETOM Aera - Mobile Solution to enable customers to use the mobile MR Tim Dockable Table as an extension to their MRI fleet.
In order to support the addition of the Tim Dockable Table a hardware modification is necessary. A support bracket will be modified to secure the Tim Dockable Table during repositioning of the Trailer. For this modifications for the trailer manufacturers, which need to underqo certification, are adapted.
The MAGNETOM Aera - Mobile Solution with Tim Dockable Table described within this submission does not contain any software modifications.
- Workflow Release of Tim Dockable Table to the MAGNETOM Aera - Mobile Solution to enable customers to use the mobile MR table as an extension to their MRI fleet
- Modification of an existing support bracket to secure the Tim Dockable Hardware Table during repositioning of the Trailer
- The MAGNETOM Aera Mobile Solution with Tim Dockable Table Software described within this submission does not contain any software modification compared to the predicate device.
The provided text describes a 510(k) submission for a device called "MAGNETOM Aera - Mobile Solution with Tim Dockable Table." However, it is not an AI/ML medical device submission. This submission is for a hardware modification to an existing Magnetic Resonance Diagnostic Device (MRDD). The key modification is the addition of a "Tim Dockable Table" to a mobile MRI unit and a complementary support bracket to secure it during transport.
Therefore, the document does not contain the information requested regarding acceptance criteria and performance studies for an AI/ML medical device. Specifically, it lacks:
- A table of acceptance criteria and reported device performance (for an AI/ML algorithm).
- Details on sample sizes for test sets, data provenance, or ground truth establishment for AI/ML.
- Information on expert reviewers, adjudication methods, or MRMC studies.
- Mention of standalone algorithm performance or training set details for an AI/ML model.
Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (MAGNETOM Aera with syngo MR E11C-AP01) through:
- Nonclinical Tests: General Performance Testing, Acoustic Noise Testing, and Environmental Testing (Weather Influences).
- Safety and Effectiveness: Compliance with standards like ISO 14971 (risk management), IEC 60601-1 series (electrical/mechanical risk), IEC 62304 (software development, though it explicitly states no software modifications), and NEMA DICOM standards.
The document explicitly states: "No clinical tests were conducted to support substantial equivalence for the subject device." and "The MAGNETOM Aera - Mobile Solution with Tim Dockable Table described within this submission does not contain any software modifications." It goes on to clarify this again: "The MAGNETOM Aera Mobile Solution with Tim Dockable Table Software described within this submission does not contain any software modification compared to the predicate device."
Since this is a submission for a hardware modification to a conventional medical device, and not an AI/ML device, the requested information cannot be extracted from this document.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image contains 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font below.
February 15, 2019
Siemens Medical Solutions USA, Inc. % Cordell L. Fields, Esq. Regulatory Affairs Specialist 40 Liberty Boulevard, Mailcode 65-1A MALVERN PA 19355
Re: K190138
Trade/Device Name: MAGNETOM Aera Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic Resonance Diagnostic Device Regulatory Class: Class II Product Code: LNH, LNI, MOS Dated: January 28, 2019 Received: January 29, 2019
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. 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
{1}------------------------------------------------
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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.
Hol 2. Nils
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}------------------------------------------------
| DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug AdministrationIndications for Use | Form Approved: OMB No. 0910-0120Expiration Date: 06/30/2020See PRA Statement below. |
|---|---|
| 510(k) Number (if known) | K190138 |
| 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, 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.
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}------------------------------------------------
510(k) Summary
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Device Act of 1990 and 21 CFR § 807.92.
| Company: | Siemens Medical Solutions USA, Inc.40 Liberty Boulevard, 65-1AMalvern, PA 19355 |
|---|---|
| ---------- | ----------------------------------------------------------------------------------------- |
Date Prepared: January 28, 2019
General Information 1.
Importer/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:
Cordell L. Fields, Esq. Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard, 65-1A Malvern, PA 19355, USA Phone: (610) 448-6469 Fax: (610) 640-4481 E-mail: Cordell.Fields@siemens-healthineers.com
{4}------------------------------------------------
3. Device Name and Classification:
| Device Name | MAGNETOM Aera - Mobile Solution with TimDockable Table |
|---|---|
| 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 |
4. Legally Marketed Predicate Device:
| Device Name | MAGNETOM Aera with syngo MR E11C - AP01software |
|---|---|
| Trade Names: | MAGNETOM Aera |
| 510(k) Number: | K182299, cleared October 26, 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}------------------------------------------------
6. Device Description:
The mobile configuration for MAGNETOM scanners enables customers to relocate the MRI System to different locations and therefore provide imaging services to hospitals or locations where fixed installations are not possible or feasible.
For MAGNETOM Aera a mobile configuration is already available on the market with a fixed patient table. Within this premarket notification the Tim Dockable Table is being made available for the MAGNETOM Aera - Mobile Solution to enable customers to use the mobile MR Tim Dockable Table as an extension to their MRI fleet.
In order to support the addition of the Tim Dockable Table a hardware modification is necessary. A support bracket will be modified to secure the Tim Dockable Table during repositioning of the Trailer. For this modifications for the trailer manufacturers, which need to underqo certification, are adapted.
The MAGNETOM Aera - Mobile Solution with Tim Dockable Table described within this submission does not contain any software modifications.
- Workflow Release of Tim Dockable Table to the MAGNETOM Aera - Mobile Solution to enable customers to use the mobile MR table as an extension to their MRI fleet
- Modification of an existing support bracket to secure the Tim Dockable Hardware Table during repositioning of the Trailer
- The MAGNETOM Aera Mobile Solution with Tim Dockable Table Software described within this submission does not contain any software modification compared to the predicate device.
7. Technological Characteristics
The subiect device. MAGNETOM Aera - Mobile Solution with Tim Dockable Table, has the same technological characteristics as the predicate device, MAGNETOM Aera with synqo MR E11C-AP01. (K182299, cleared October 26. 2018) with regard to the operational environment, programming language, operating system, and performance.
The hardware was modified to introduce a support bracket to secure the Tim Dockable Table during repositioning of the Trailer. Furthermore the Requirements to the Trailer Manufacturer need to consider the dockable table.
The MAGNETOM Aera - Mobile Solution with Tim Dockable Table conforms to the standard for software medical devices (IEC 62304:2015) and other relevant IEC and NEMA standards.
While there is a hardware difference between the subject device and predicate device, in this case only hardware modification of a bracket which impacts the overall workflow, the MAGNETOM Aera system itself is not changed. This
{6}------------------------------------------------
hardware modification which impacts the overall workflow has been tested for safety and effectiveness; it is safe and effective.
8. Nonclinical Tests
The following performance testing was conducted on the subject device:
- General Performance Testing
- Acoustic Noise Testing
- Environmental Testing (Weather Influences)
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.
9. Clinical Tests
No clinical tests were conducted to support substantial equivalence for the subject device.
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 - Mobile Solution with Tim Dockable Table conforms to the applicable FDA recognized and international IEC, ISO and NEMA.
| RecognitionNumber | Product Area | Title of Standard | ReferenceNumber and date | StandardsDevelopmentOrganization |
|---|---|---|---|---|
| 19-4 | General | C1:2009/(R)2012 andA2:2010/(R)2012 (Consolidated Text)Medical electrical equipment - Part 1:General requirements for basic safetyand essential performance (IEC60601-1:2005, MOD) | ES60601-1:2005/(R)2012and A1:2012 | AAMI ANSI |
{7}------------------------------------------------
| RecognitionNumber | Product Area | Title of Standard | ReferenceNumber and date | StandardsDevelopmentOrganization |
|---|---|---|---|---|
| 19-8 | General | Medical electrical equipment - Part 1-2: General requirements for basicsafety and essential performance -Collateral Standard: Electromagneticdisturbances - Requirements andtests | 60601-1-2Edition 4.02014-02 | IEC |
| 12-295 | Radiology | Medical electrical equipment - Part 2-33: Particular requirements for thebasic safety and essentialperformance of magnetic resonanceequipment for medical diagnostic | 60601-2-33 Ed.3.2 B:2015 | IEC |
| 5-40 | General | Medical devices - Application of riskmanagement to medical devices | 14971 Secondedition 2007-03-01 | ISO |
| 5-89 | General | Medical electrical equipment - Part 1-6: General requirements for basicsafety and essential performance -Collateral standard: Usability | 60601-1-6Edition 3.12013-10 | IEC |
| 5-96 | General | Medical devices - Application ofusability engineering to medicaldevices | 62366-1:2015 | AAMI ANSIIEC |
| 13-79 | Software | Medical device software - Softwarelife cycle processes | 62304 Edition1.1 2015-06 | IEC |
| 12-300 | Radiology | Digital Imaging and Communicationsin Medicine (DICOM) Set 03/16/2012Radiology | PS 3.1 - 3.20(2016) | NEMA |
11. Substantial Equivalence and Conclusion
The subject device, MAGNETOM Aera - Mobile Solution with Tim Dockable Table, has the same intended use, indications for use, and technological characteristics as the predicate device, MAGNETOM Aera with syngo MR E11C-AP01, (K182299).
The hardware was modified to introduce a support bracket to secure the Tim Dockable Table during repositioning of the Trailer.
While there is a hardware difference between the subject device and predicate device, in this case only hardware modification of a bracket which impacts the overall workflow, the MAGNETOM Aera system itself is not changed. This hardware modification which impacts the overall workflow has been tested for safety and effectiveness; it is safe and effective.
Siemens believes that the subject device, MAGNETOM Aera - Mobile Solution with Tim Dockable Table is substantially equivalent to the predicate device, MAGNETOM Aera with syngo MR E11C-AP01.
§ 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.