(52 days)
Not Found
No
The summary describes software updates to existing MR systems, focusing on modified sequences and performance testing. There is no mention of AI, ML, or related concepts.
No
The device is described as a "magnetic resonance diagnostic device" used to produce images and spectra for diagnosis, not for treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the systems are "indicated for use as magnetic resonance diagnostic devices (MRDD)" and that the information yielded "may assist in diagnosis."
No
The device is described as a software update for existing hardware (MAGNETOM Aera and Skyra MR systems). While the submission focuses on the software changes, the device itself is the combination of the hardware and the updated software, not the software in isolation.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the MAGNETOM systems are "magnetic resonance diagnostic devices (MRDD)" that produce images and spectra of the internal structure and/or function of the head, body, or extremities. This is a description of an in-vivo imaging device, not a device that performs tests on samples taken from the body (in vitro).
- Device Description: The description focuses on the software update for existing MR systems, which are imaging devices.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
The device is a medical imaging system used for diagnosis based on the interpretation of images and spectra by a trained physician.
N/A
Intended Use / Indications for Use
The MAGNETOM systems Aera and Skyra with the updated software syngo MR DI3A 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, vield information that may assist in diagnosis.
The MAGNETOM systems Aera and Skyra with the updated software syngo MR D13A 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 version syngo MR D13A is updated for two Siemens MR systems:
- o MAGNETOM Aera (1.5T)
- o MAGNETOM Skyra (3T)
Systems that are already in clinical use and at customer sites can be updated with this software update; both MAGNETOM systems can be manufactured with this software update.
This software update includes modified software sequences for MAGNETOM Aera and MAGNETOM Skyra.
MAGNETOM Aera and MAGNETOM Skyra with software syngo MR D13A were previously cleared under K121434 (November 5, 2012).
Summary of Features New with the Software Update compared to the commercially available Software Version syngo MR D13A:
Software
- Modified sequences: .
- Quiet sequences o
- VIBE sequence improvements o
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
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: Performance testing such as acoustic noise testing was conducted on the subject device. Additionally, all software features were verified and validated. The results from each set of tests demonstrate that the device performs as intended.
CLINICAL TESTS: There were not any clinical tests conducted to support the subject device and the substantial equivalence argument, however clinical images are provided to support the 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.
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
NOV 0 1 2013
Traditional 510(k) Submission
t; (;
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 |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Siemens AG
Henkestrasse 127
D-91052 Erlangen, Germany
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
Registration Number 3004754211 |
| 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 | Software update syngo MR D13A-AP-AA to the
commercially available software version syngo MR D13A
for MAGNETOM Aera and MAGNETOM Skyra |
| CFR Code | 21 CFR § 892.1000 |
| Classification | Class II |
| Product Codes | LNH, LNI, MOS |
| Classification Name | Magnetic Resonance Diagnostic Device,
MR Spectroscopy, MR Coils |
1
SIEMENS
K132831
page 2 of 4
Traditional 510(k) Submission
Information Supporting Substantial Equivalence
DEVICE DESCRIPTION
The software version syngo MR D13A is updated for two Siemens MR systems:
- o MAGNETOM Aera (1.5T)
- o MAGNETOM Skyra (3T)
Systems that are already in clinical use and at customer sites can be updated with this software update; both MAGNETOM systems can be manufactured with this software update.
This software update includes modified software sequences for MAGNETOM Aera and MAGNETOM Skyra.
MAGNETOM Aera and MAGNETOM Skyra with software syngo MR D13A were previously cleared under K121434 (November 5, 2012).
Summary of Features New with the Software Update compared to the commercially available Software Version syngo MR D13A:
Software
- Modified sequences: .
- Quiet sequences o
- VIBE sequence improvements o
INTENDED USE
The MAGNETOM systems Aera and Skyra with the updated 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 Aera and Skyra with the updated software syngo MR D13A may also be used for imaging during interventional procedures when performed with MR compatible devices such as in-room display and MRsafe biopsy needles.
NONCLINICAL TESTS
Software Update syngo MR D13A for MAGNETOM Aera/Skyra
2
K132831
page 3 of 4
SIEMENS
Performance testing such as acoustic noise testing was conducted on the subject device. Additionally, 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 are provided to support the modified software features of the subject device.
SUBSTANTIAL EQUIVALENCE
Software update to the commercially available software version syngo MR D13A for MAGNETOM Aera and MAGNETOM Skyra is substantially equivalent to the following predicate devices:
| Predicate Device Name | FDA
Clearance
Number | FDA Clearance
Date | Main
Product
Code |
|-------------------------------------------------------------------|----------------------------|-----------------------|-------------------------|
| MAGNETOM Aera, Skyra,
Avanto, and Verio with syngo®
MR D13A | K121434 | November 5, 2012 | LNH |
Predicate device for Software Update to the commercially available software version Table 1 syngo MR D13A for MAGNETOM Aera and MAGNETOM Skyra
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.
MAGNETOM systems Aera and Skyra with the updated 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 D13A.
3
SIEMENS
Traditional 510(k) Submission
While the updated software provides the user with additional capabilities compared to the two subject MAGNETOM systems with the previous software version syngo MR D13A, it has the same technological characteristics as that of the predicate devices. The modifications of the updated software version make the systems and software more user- and patient-friendly - providing imaging techniques with lower noise towards the patient: improving the user's workflow: providing additional information and options to the user.
The differences between the subject device and the predicate devices, which include the aforementioned modified sequences, 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, the updated software version syngo MR D13A for MAGNETOM systems Aera and Skyra is substantially equivalent to the predicate devices listed above.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 1. 2013
Siemens Medical Solutions USA, Inc. % Ms. Nadia Sookdeo Regulatory Affairs Technical Specialist 51 Valley Stream Parkway, MC D02 MALVERN PA 19355
Re: K132831
Trade/Device Name: Syngo MR D13A-AP-AA software update Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: September 25, 2013 Received: September 26, 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. Iisting 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
5
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
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" (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/ReportalProblem/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,
Michael D. O'Hara
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K132831
Device Name: Syngo MR D13A-AP-AA software update for MAGNETOM Aera and MAGNETOM Skyra
Indications for Use:
The MAGNETOM systems Aera and Skyra with the updated software syngo MR DI3A 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, vield information that may assist in diagnosis.
The MAGNETOM systems Aera and Skyra with the updated software syngo MR D13A 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 Diagnostics and Radiological Health (OIR)
Michael D. O'Hara
(Division Sign-Off Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health
210(k) K 13283 1
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