SYNGO MR B19 FOR MAGNETOM AVANTO, SYNGO MR B19 FOR MAGNETOM ESPREE, SYNGO MR B19 FOR MAGNETOM SYMPHONY A TIM SYSTEM, SYN by SIEMENS MEDICAL SOLUTIONS USA, INC.

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.

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).

AI/ML Overview

The Siemens Medical Solutions USA, Inc. 510(k) submission for "Software syngo MR B19 for MAGNETOM Avanto, Espree, Symphony A Tim System, Trio A Tim System, and Verio" provides information about device performance validation, but does not include acceptance criteria as a table, nor does it detail a study proving the device meets specific acceptance criteria in the manner typically associated with clinical performance studies for AI/CAD devices.

This submission is for a software upgrade (syngo MR B19) to existing Magnetic Resonance Diagnostic Devices (MRDDs). The focus of the submission is on demonstrating substantial equivalence to previously cleared predicate devices (syngo MR B17 and syngo MR D13A), rather than proving net new clinical performance characteristics through comparative studies against quantitative acceptance thresholds.

Here's a breakdown of the requested information based on the provided text, highlighting what is present and what is not:

1. A table of acceptance criteria and the reported device performance

Not present in the form requested. The submission focuses on demonstrating substantial equivalence by comparing the new software's features and performance to existing predicate devices. It states:
- "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."
- "Performance testing such as SNR, image uniformity, and heating were conducted on the subject device. Additionally, all software features were verified and validated."
- The new features "do not introduce any new issues of safety or effectiveness."
- The document implies that the "acceptance criteria" are the standards of performance (SNR, uniformity, heating) met by the predicate devices, and the new software meets or exceeds these. However, no specific numerical thresholds or a table like:

Metric	Acceptance Criteria	syngo MR B19 Performance
SNR	> X% of predicate	Met/Exceeded
Image Uniformity	< Y% deviation from predicate	Met/Exceeded
Heating	Within Z safety limits	Met/Exceeded
etc.

...is provided.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not explicitly detailed in the provided text for "test sets" in a clinical performance sense. The document states:
- "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."
- This indicates that while some clinical images were "provided," a formal clinical study with a defined test set sample size and provenance (like retrospective/prospective, country of origin) was not performed for this 510(k) submission. The performance testing mentioned (SNR, uniformity, heating) would involve phantom or controlled tests, not necessarily human subject data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Not present. Since no formal clinical performance test set (as would be used for AI/CAD) was conducted or presented in this submission, there is no mention of experts establishing ground truth for such a set. The "trained physician" mentioned in the Indications for Use refers to the end-users of the device for diagnosis, not experts establishing ground truth for a study.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not present. No clinical test set requiring adjudication was performed as part of this submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No (Not for this submission). This is a submission for a general MR system software update, not specifically for an AI/CAD product. Therefore, an MRMC study comparing human reader performance with and without AI assistance was not conducted or presented.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is an MR diagnostic device software, which always operates with human interpretation ("when interpreted by a trained physician"). It is not a standalone algorithm providing diagnostic outputs without human involvement. The "performance testing" on SNR, uniformity, etc., can be considered an "algorithm only" or device-only performance assessment, but not in the context of diagnostic accuracy.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

No external ground truth for clinical diagnostic performance was established for the purpose of this submission. The device's performance was validated against engineering and technical standards (e.g., SNR, image uniformity, heating) and its equivalence to predicate devices was the primary argument.

8. The sample size for the training set

Not applicable / Not present. This submission does not describe a machine learning algorithm or AI model that requires a training set. It's a software upgrade for an imaging system.

9. How the ground truth for the training set was established

Not applicable / Not present. As there's no mention of an AI/ML training set, there's no discussion of establishing ground truth for one.

Summary of Device Performance and Acceptance Criteria (as implied by the document):

The acceptance criteria for this software upgrade are implicitly tied to maintaining or improving the recognized performance characteristics (e.g., SNR, image uniformity, heating) and safety of the predicate MR systems, and ensuring the new features integrate without introducing new safety or effectiveness concerns. The study described is non-clinical performance testing and verification/validation of software features, rather than a clinical performance study with defined ground truth and statistical endpoints against clinical acceptance criteria. The "proof" is the demonstration of substantial equivalence through these engineering performance tests and the claim that the device performs "as intended" and "does not introduce any new issues of safety or effectiveness."

Summary

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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 ParkwayMail Code D02Malvern, PA 19355, USARegistration Number 2240869
Manufacturer	Siemens AGHenkestrasse 127D-91052 Erlangen, GermanyRegistration Number 8010024
	SIEMENS SHENZHEN MAGNETIC RESONANCE LTD.Siemens MRI CenterHi-Tech Industrial park (middle)Gaoxin C. Ave., 2ndShenzhen 518057, P.R. CHINARegistration Number 3004754211
Contact Person	Ms. Nadia SookdeoRegulatory Affairs Technical SpecialistSiemens Medical Solutions USA, Inc.51 Valley Stream ParkwayMail Code D02Malvern, PA 19355, USAPhone: (610) 448-4918E-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

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Information Supporting Substantial Equivalence

DEVICE DESCRIPTION

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

The above features have been previously cleared in the predicate, syngo MR D13A on November 5, 2012.

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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	FDAClearanceNumber	FDA ClearanceDate	MainProductCode
MAGNETOM Avanto, Espree,Symphony A Tim System, Trio ATim System, and Verio withsyngo® MR B17	K082427	November 7, 2008	LNH

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Predicate Device Name	FDAClearanceNumber	FDA ClearanceDate	MainProductCode
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.

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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.

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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.

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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

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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:

× 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

Regulation Number and Section

§ 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.