(57 days)
Not Found
No
The document does not mention AI, ML, or related terms, and the description focuses on hardware and software updates for image acquisition and processing, which are standard for MRI devices.
No.
The device's intended use is explicitly stated as a "magnetic resonance diagnostic device (MRDD)" to produce images and/or spectra for diagnostic purposes, not for therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated for use as a magnetic resonance diagnostic device (MRDD)" and that the information it yields "may assist in diagnosis."
No
The device description clearly states it is a 1.5T superconducting magnet system, which is a hardware component. The software update (syngo MR D13E) is part of a larger hardware system.
Based on the provided information, the MAGNETOM Aera with syngo MR D13E is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro) to provide information for diagnosis, monitoring, or screening.
- Device Function: The MAGNETOM Aera is a Magnetic Resonance (MR) device. It produces images and spectra of the internal structure and function of the body in vivo (within the living body). It does not analyze specimens taken from the body.
- Intended Use: The intended use clearly states it's a "magnetic resonance diagnostic device (MRDD)" that produces images and spectra of the head, body, or extremities. This is consistent with in vivo imaging, not in vitro analysis.
Therefore, the MAGNETOM Aera is an in vivo diagnostic imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The MAGNETOM Aera with syngo MR D13E 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.
The MAGNETOM Aera 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
Device Description
The MAGNETOM Aera is a 1.5T, utilizing a superconducting magnet design. The open bore, whole body scanner is designed for increased patient comfort The MAGNETOM Aera is being modified to include another configuration to the MAGNETOM portfolio to be available for Ex-factory (new) systems. The full modifications for the new MAGNETOM Aera configuration include 24 receive channels, modified Measurement and Reconstruction System (MaRS) and Syngo Acquisition Workplace (MRAWP)/Syngo MR Workplace(MRWP), an update to the software syngo MR D13E and the addition of three new coils to the existing MAGNETOM Aera Magnetic Resonance System.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Magnetic Resonance (MR)
Anatomical Site
head, body, or extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
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)
Not Found
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.
0
Special 510(k) Submission: MAGNETOM Aera 1.5T System
Section 5 510(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 1990 and 21 CFR § 807.92. The 510(k) Summary is provided on the next page and is suitable for publication on the FDA website.
I. General Information
SIEMENS
| Establishment | Siemens Medical Solutions USA. Inc.
51 Valley Stream Parkway
Mail Code D02
Malvern, PA 19355, USA
Registration Number 2240869 |
|---------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | January 31, 2013 |
| Registration Number | 2240869 |
| Manufacturers | Siemens AG
Henkestrasse 127
D-91052 Erlangen, Germany
Registration Number 3002808157
Siemens Shenzhen Magnetic Resonance Ltd.
Siemens MRI Center
Gaoxin C. Ave., 2nd
Hi-Tech Industrial Park,
Shenzhen 518057, P.R. China
Registration Number 3004754211 |
| Contact Person | Ms. Nadia Sookdeo
Regulatory Affairs Technical Specialist
Siemens Healthcare
Siemens Medical Solutions USA, Inc.
Customer Solutions Group
51 Valley Stream Parkway
Mail Code D02
Malvern, PA 19355, USA
Phone: (610) 448-4918
Fax: (610) 448-1787 |
| Device Name | Trade Names: MAGNETOM Aera
Classification Name: Magnetic Resonance Diagnostic Device
CFR Code: 21 CFR § 892.1000
Product Code: LNH
Classification: Class II |
1
SIEMENS
II. Safety and Effectiveness Information Supporting Substantial Equivalence
Intended Use
The intended use for the MAGNETOM Aera with syngo MR D13E is the same as MAGNETOM Aera with syngo MR D13A that is described in K121434 and cleared on November 05, 2012.
The MAGNETOM Aera with syngo MR D13E 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 atrained physician vield information that may assist in diagnosis.
The MAGNETOM Aera 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
The MAGNETOM Aera is a 1.5T, utilizing a superconducting magnet design. The open bore, whole body scanner is designed for increased patient comfort The MAGNETOM Aera is being modified to include another configuration to the MAGNETOM portfolio to be available for Ex-factory (new) systems. The full modifications for the new MAGNETOM Aera configuration include 24 receive channels, modified Measurement and Reconstruction System (MaRS) and Syngo Acquisition Workplace (MRAWP)/Syngo MR Workplace(MRWP), an update to the software syngo MR D13E and the addition of three new coils to the existing MAGNETOM Aera Magnetic Resonance System.
Substantial Equivalence
Siemens feels that the new system is substantially equivalent to the following predicate devices:
| Predicate Device Name-
System | FDA Clearance
Number | Product
Code | FDA
Clearance
Date |
|------------------------------------------------------|-------------------------|-----------------|--------------------------|
| Siemens MAGNETOM
Aera(1.5T) with syngo MR
D13A | K121434 | LNH | November
5, 2012 |
General Safety and Effectiveness Concerns:
The MAGNETOM Aera with software syngo MR D13E conforms to the applicable FDA recognized and international IEC, ISO and NEMA standards with regards to
2
Image /page/2/Picture/0 description: The image shows the word "SIEMENS" in bold, black letters. The letters are large and evenly spaced, with a thick black line underlining the entire word. The font appears to be sans-serif, giving the word a clean and modern look.
Special 510(k) Submission: MAGNETOM Aera 1.5T System
performance and safety as recommended by the respective MR FDA Guidance Document.
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 adheres to recognized and established industry standards, such as the IEC 60601-1 series, to minimize electrical and mechanical hazards.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, with three wavy lines representing snakes intertwined around a staff.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 15, 2013
Siemens Medical Solutions USA, Inc. % Ms. Nadia Sookdeo Technical Specialist, Regulatory Affairs 51 Valley Stream Parkway, D 02 MALVERN PA 19355
Re: K132951
Trade/Device Name: MAGNETOM Aera Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: October 23, 2013 Received: October 24, 2013
Dear Ms. Sookdeo:
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
Page 2-Ms. Sookdeo
... .
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
5
Special 510(k) Submission: MAGNETOM Aera 1.5T System
Section 4 Indications for Use Statement
510(k) Number (if known): K132951
Device Names: MAGNETOM Aera
Indications for Use:
The MAGNETOM Aera with syngo MR D13E 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.
The MAGNETOM Aera 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 x (Part 21 CFR 80) Subpart D) Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH. Office of In Vitro Diagnostics and Radiological Health (OIR) 12 - 11 - 1
-------------------- (Division Sign Off) Division of Radiological Health Office of In Firo Diagnostic and Radiological Health 510kk) K 13295 I
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