(54 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on new software sequences, coils, and hardware for existing MR systems. There is no mention of AI/ML in the intended use, device description, or performance studies.
No
The device is described as an imaging system that produces cross-sectional images to assist in diagnosis, not to provide therapy.
Yes
The "Intended Use" section states that the images and/or spectra and the physical parameters derived from them, "when interpreted by a trained physician, yield information that may assist in diagnosis." This explicitly indicates its role in the diagnostic process.
No
The device description explicitly states that the new software version includes "coils and other hardware" for the five MAGNETOM systems, indicating it 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. These images and derived parameters are interpreted by a trained physician to assist in diagnosis. This describes an in vivo imaging system, not a device that performs tests on biological samples outside the body (in vitro).
- Device Description: The description focuses on the software and hardware of a Magnetic Resonance (MR) system, which is a medical imaging modality used to visualize internal structures of the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or performing tests on these samples.
Therefore, the MAGNETOM systems with syngo MR B19 software are medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for Use
The MAGNETOM systems, Avanto, Espree, Symphony A Tim System, Trio A Tim System, and Verio with software syngo MR B19, 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, Avanto, Espree, Symphony A Tim System, Trio A Tim System, and Verio with software syngo MR B19, 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
Software syngo MR B19 is a new software version for five Siemens MR systems: MAGNETOM Avanto (1.5T), Espree (1.5T), Symphony A Tim System (1.5T), Trio A Tim System (3T), and Verio (3T). Systems that are already in clinical use and at customer sites (referred to as "field upgrades" throughout the rest of the submission) can be uparaded to this software version; some of the five MAGNETOM systems will be manufactured (referred to as "ex-factory systems" throughout the rest of this submission) with this software version (please see table below).
This new software version includes new software sequences, coils and other hardware for the five MAGNETOM systems. While some new features (hardware and software) are only available for certain systems (of the five listed), the basic syngo MR B19 software can run on each of the five MAGNETOM systems. Therefore, while five MAGNETOM systems are mentioned throughout this submission, the software version is the subject of this 510(k).
Summary of Features New with Software syngo MR B19 compared to predicate syngo MR B17:
Hardware
. Magnet: New shim sequence
. New coils:
o 4 Channel Special Purpose Coil
o Sentinelle Breast 16ch Coil
Sentinelle Breast 8ch Coil ୍
o Sentinelle Endo Array coil
Software
. New or modified sequences for all five systems for body, neurological, abdominal, and orthopedic imaging.
New software for all five systems: .
RTC (Rich Thin Client) hosting 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 SNR, image uniformity, and heating were 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 new coils as well as the new and 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
Traditional 510(k) Submission
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 8010024 |
| | 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 syngo MR B19 for MAGNETOM Avanto, Espree,
Symphony A Tim System, Trio A Tim System, and Verio |
| 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
Information Supporting Substantial Equivalence
DEVICE DESCRIPTION
Software syngo MR B19 is a new software version for five Siemens MR systems: MAGNETOM Avanto (1.5T), Espree (1.5T), Symphony A Tim System (1.5T), Trio A Tim System (3T), and Verio (3T). Systems that are already in clinical use and at customer sites (referred to as "field upgrades" throughout the rest of the submission) can be uparaded to this software version; some of the five MAGNETOM systems will be manufactured (referred to as "ex-factory systems" throughout the rest of this submission) with this software version (please see table below).
This new software version includes new software sequences, coils and other hardware for the five MAGNETOM systems. While some new features (hardware and software) are only available for certain systems (of the five listed), the basic syngo MR B19 software can run on each of the five MAGNETOM systems. Therefore, while five MAGNETOM systems are mentioned throughout this submission, the software version is the subject of this 510(k).
Summary of Features New with Software syngo MR B19 compared to predicate syngo MR B17:
Hardware
- . Magnet: New shim sequence
- . New coils:
- o 4 Channel Special Purpose Coil
- o Sentinelle Breast 16ch Coil
- Sentinelle Breast 8ch Coil ୍
- o Sentinelle Endo Array coil
- . New coils:
Software
- . New or modified sequences for all five systems for body, neurological, abdominal, and orthopedic imaging.
- New software for all five systems: .
- RTC (Rich Thin Client) hosting o
The above features have been previously cleared in the predicate, syngo MR D13A on November 5, 2012.
2
INTENDED USE
The MAGNETOM systems Avanto, Espree, Symphony A Tim System, Trio A Tim System, and Verio with software syngo MR B19 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 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.
NONCLINICAL TESTS
Performance testing such as SNR, image uniformity, and heating were 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 new coils as well as the new and modified software features of the subject device.
SUBSTANTIAL EQUIVALENCE
Software syngo MR B19 for MAGNETOM Avanto, Espree. Symphony A Tim System, Trio A Tim System, and Verio is substantially equivalent to the following predicate devices:
Table 1: Predicate device for syngo MR B19 for MAGNETOM Avanto, Espree, Symphony A Tim System, Trio A Tim System, and Verio
| Predicate Device Name | FDA
Clearance
Number | FDA Clearance
Date | Main
Product
Code |
|----------------------------------------------------------------------------------------------------------|----------------------------|-----------------------|-------------------------|
| MAGNETOM Avanto, Espree,
Symphony A Tim System, Trio A
Tim System, and Verio with
syngo® MR B17 | K082427 | November 7, 2008 | LNH |
3
| 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 |
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.
The MAGNETOM systems Avanto, Espree, Symphony A Tim System, Trio A Tim System, and Verio with software syngo MR B19 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 systems with software syngo MR B17 and syngo MR D13A.
While the new hardware and software provides the user with additional capabilities compared to the five subject MAGNETOM systems with the previous software version syngo MR B17. it has the same technological characteristics as that of the predicate devices. The new features from syngo MR D13A made available for the new software version, syngo MR B19, the subject of this premarket notification make the systems and software more user-friendly. These modifications improve the user's workflow and reduce the complexity of certain imaging procedures; providing additional output, information, and options to the user: and reduce image artifacts.
4
The differences between the subject device and the predicate devices, which include the aforementioned new sequences, coils, and hardware, give the systems the same (compared to syngo MR D13A) or enhanced (compared to syngo MR B17) capabilities with respect to 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, software version syngo MR B19 for MAGNETOM Avanto, Espree, Symphony A Tim System, Trio A Tim System, and Verio, is substantially equivalent to the predicate devices, syngo MR B17 and syngo MR D13A.
5
Image /page/5/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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized symbol that resembles a human figure with three arms or branches extending upwards.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 12, 2013
Ms. Nadia Sookdeo Regulatory Affairs Specialist Siemens Medical Solutions USA. Inc 51 Valley Stream Pkwy Mail Code D02 MALVERN PA 19355
Re: K123938
Trade/Device Name: Syngo MR B19 MAGNETOM Avanto (1.5T), Espree (1.5T), Symphony A Tim System (1.5T), Trio A Tim System (3T), and Verio (3T) MR systems Regulation Number: 21 CFR 892.1000 Regulation Name: Magnetic resonance diagnostic device Regulatory Class: II Product Code: LNH Dated: December 19, 2012 Received: December 20, 2012
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 Amendmonts, 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, l'isting 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 mioling.
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, EDA 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 not 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.
6
Page 2-Ms. Sookdeo
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please
r (2011) (2011) (2011) (11) (2011) (2020) (CDPH/CDPH/CDPH/CDPH/CDPH/CDPH/CD If you desire specific advice for your device of our nabeling in the mail offices/ucm I 1589.htm for the go to http://www.tda.gov/About/DACEmers/Dis) Office of Compliance. Also, please
the Center for Devices and Radiological Health's (CDRH)'s) Office of Criffication" (21CFR Par the Center for Devices and Radiological Transland of Contractor of Contractor of (21CR Part
note the regulation entitled, "Misbranding by reference to secures were the MDP re note the regulation entitled, "Misoranding by reference to premiers" CFR Part 803), please go to
CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/Reportalet/Suzusillence http://www.ida.govetrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the You may oftain other general information' your reoposumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address (800) 038-2041 01 (301) 770 1110 - 110 - 110 - 110 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 1
Sincerely yours,
Michael D. O'Hara
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
Indications for Use
510(k) Number (if known) _K123938
Software syngo MR B19 for MAGNETOM Avanto, Espree, Device Name: Symphony A Tim System, Trio A Tim System, and Verio
Indications for Use:
The MAGNETOM systems, Avanto, Espree, Symphony A Tim System, Trio A Tim The Mr ONE Verio with software syngo MR B19, are indicated for use as magnetic oyoten, and volto many man one (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, Avanto, Espree, Symphony A Tim System, Trio A Tim System, and Verio with software syngo MR B19, may also be used for imaging during interventional procedures when performed with MR compatible devices such as inroom display and MR-safe biopsy needles.
× Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 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)
ാസ്ട്രി of Radiological Health
Page 1 of 1
Office of In Vitro Diagnostics and Radiological Health
510(K) K123958
Software syngo MR B19 for MAGNETOM Systems