(34 days)
Not Found
No
The 510(k) summary focuses on the hardware (coils) and software updates for an existing MR system. There is no mention of AI, ML, or advanced image processing techniques that would typically indicate the presence of such technology. The performance testing is limited to hardware characteristics (SNR, uniformity, heating).
No
The device is described as a "magnetic resonance diagnostic device (MRDD)" and its "Intended Use / Indications for Use" state that it "yield[s] information that may assist in diagnosis," indicating it is for diagnostic purposes, not therapeutic.
Yes
The "Intended Use / Indications for Use" section explicitly states, "The MAGNETOM MR system [Aera / Skyra] is indicated for use as a magnetic resonance diagnostic device (MRDD)". It also mentions that the images and spectra, when interpreted by a trained physician, "yield information that may assist in diagnosis."
No
The device description explicitly states that the filing describes "additional local coils intended to be used with the MAGNETOM Aera and MAGNETOM Skyra," and lists specific new coils. This indicates the submission includes hardware components (the coils) in addition to software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The description clearly states that the MAGNETOM MR system produces images and spectra of the internal structure and/or function of the head, body, or extremities. This is direct imaging of the patient, not analysis of a sample taken from the patient.
- The intended use is for diagnostic imaging. The device is described as a "magnetic resonance diagnostic device (MRDD)" and its output is interpreted by a "trained physician" to "assist in diagnosis." This aligns with the purpose of medical imaging devices, not IVDs.
- There is no mention of analyzing biological samples. The description focuses on the hardware (MR system, coils) and software used to generate images and spectra from the patient's body.
Therefore, the MAGNETOM MR system described is a medical imaging device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The MAGNETOM MR system [Aera / Skyra] 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 MR system [Aera / Skyra] may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR-Safe biopsy needles.
Product codes (comma separated list FDA assigned to the subject device)
LNH
Device Description
The MAGNETOM MR system is a magnetic resonance device (MRDD) producing transverse, sagittal, coronal, and oblique sectional images, spectroscopic images and/or spectra, and displaying 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.
The MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR-safe biopsy needles.
The software syngo MR D13A is the latest software for the Siemens MAGNETOM scanners including software sequences, applications, coils and other hardware for the MAGNETOM scanners. This software was previously cleared under K121434.
New scanners are manufactured with syngo MR D13A: existing scanners can be upgraded to this software version.
This filing describes additional local coils intended to be used with the MAGNETOM Aera and MAGNETOM Skyra.
For MAGNETOM Skyra the Head/Neck 64, the Breast 18 and the Body 18 long are new coils. For MAGNETOM Aera the Breast 18 and the Body 18 long are new coils.
Mentions image processing
Not Found
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 / Not Found
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 coils were tested for SNR, image uniformity, and heating per applicable NEMA and IEC standards. The test results demonstrate that the device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared.
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
SIEMENS
K133435
Page 1 of 3
0(k) Submission
Special 510(k) Submission
Section 5 510(k) Summary
DEC 1222013
This 510(k) summary is being submitted in accordance with 21 CFR § 807.92.
5.1 General Information
| Establishment | Siemens Medical Solutions USA, Inc.
51 Valley Stream Parkway
Mail Code D02
Malvern, PA 19355, USA
Registration Number: 2240869 |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Siemens AG
Henkestrasse 127
D-91052 Erlangen, Germany
Registration Number: 3002808157 |
| Contact Person | Ms. Nadia Sookdeo
Regulatory Affairs Technical Specialist
Siemens Medical Solutions USA, Inc.
51 Valley Stream Parkway
Mail Code D02
Malvern, PA 19355, USA
Phone: (610) 448-4918
E-mail: Nadia.Sookdeo@siemens.com |
| Device Name | MAGNETOM Aera/Skyra |
| CFR Code | 21 CFR § 892.1200 |
| Classification | Class II |
| Product Codes | LNH |
| Classification Name | Magnetic Resonance Diagnostic Device (MRDD),
Emission Computed Tomography System, MR Coils |
1
5.2 Information Supporting Substantial Equivalence
DEVICE DESCRIPTION
The MAGNETOM MR system is a magnetic resonance device (MRDD) producing transverse, sagittal, coronal, and oblique sectional images, spectroscopic images and/or spectra, and displaying 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.
The MAGNETOM system may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR-safe biopsy needles.
The software syngo MR D13A is the latest software for the Siemens MAGNETOM scanners including software sequences, applications, coils and other hardware for the MAGNETOM scanners. This software was previously cleared under K121434.
New scanners are manufactured with syngo MR D13A: existing scanners can be upgraded to this software version.
This filing describes additional local coils intended to be used with the MAGNETOM Aera and MAGNETOM Skyra.
For MAGNETOM Skyra the Head/Neck 64, the Breast 18 and the Body 18 long are new coils. For MAGNETOM Aera the Breast 18 and the Body 18 long are new coils.
INTENDED USE
The MAGNETOM MR system [Aera / Skyra] 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 MR system [Aera / Skyra] may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room displays and MR-Safe biopsy needles.
2
NONCLINICAL TESTS
The following performance testing was conducted on the subject device:
- The coils were tested for SNR, image uniformity, and heating per . applicable NEMA and IEC standards.
The test results demonstrate that the device performs as intended and is thus substantially equivalent to the predicate device to which it has been compared.
CLINICAL TESTS
There were no clinical tests conducted to support the subject device and the substantial equivalence argument, however sample images of the now local coils of the subject devices are provided to support the descriptions in Section 11.
SUBSTANTIAL EQUIVALENCE
The MAGNETOM Aera/Skyra with software syngo MR D13A including the additional local coils Head/Neck 64, Breast 18 and Body 18 long is substantially equivalent to the following predicate device, described in Table 1.
Table 1: Predicate device for MAGNETOM Aera/Skyra
| Predicate Device Name | FDA
Clearance
Number | FDA Clearance
Date | Main
Product
Code |
|----------------------------------------------------------------------------------------|----------------------------|-----------------------|-------------------------|
| Software syngo MR D13A
for the MAGNETOM
Systems Aera / Skyra /
Avanto / Verio | K121434 | Nov 5, 2012 | LNH |
There is no system change and no software change. The only difference between the subject and the predicate device are the additional new local coils for the systems.
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.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image contains a logo and some text. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle. To the right of the logo is the letter "D" in a large font. The rest of the text is not clear enough to read.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 12, 2013
Siemens Medical Solutions USA, Inc. % Ms. Nadia Sookdeo Regulatory Affairs Technical Specialist 51 Valley Stream Parkway Mail Code D02 MALVERN PA 19355
Re: K133435
Trade/Device Name: MAGNETOM Aera/Skyra syngo MR D13A Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: November 7, 2013 Received: November 8, 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/Resources/orYou/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,
Smh.7)
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
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31. 2013 See PRA Statement on last page.
510(k) Number (if known) K133435
Device Name
MAGNETOM Aera Skyra syngo MR. D13A with additional local couls
Indications for Use (Describe)
The MAGNETOM SE system (Aera Skym) is indicated for use as a maggeour darice (MRDD) that produces transverse, segmal and oblique cross sections unsges. spectroscopic coasges and condition the manal structure and or function of the head. body, or extremines.
Other playical parameers darived from the spects may also be produced. Depending on the region of inzers. contast agent may be used. These unages and the physical paraneters derived from the mages and or spectar when internet by a trained physician yield information that may assist in diagnosis.
The MAGNETON MR system (Aen Skyrs) may also be used for imaging darner siben performed anti MR companible device: such as in-room displays and MR-Safe bropsy needles.
Type of Use (Select one or both. as applicable)
Prescription Use : Part 21 CFR 501 Subpan Di
Over-The-Counter Use (21 CFR 50) Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radictor car Health (CORH) (Signature)
Smh.7)
FORM FDA 3881 (9/13)
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