The Siemens MR-PET system combines magnetic resonance diagnostic devices (MRDD) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information, acquired simultaneously and isocentrically. The combined system maintains independent functionality of the MR and PET devices, allowing for single modality MR and / or PET imaging.

These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders.

The MR is intended to produce transverse, sagittal, coronal and oblique crosssectional MR images, spectroscopic images and/or spectra, and displays the internal structure and/or function of the human body. Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, approved contrast agents may be used, as described in their labeling. This system may also be used for imaging during interventional procedures when performed with MR compatible devices, such as MR-safe biopsy needles.

The PET images and measures the distribution of PET radiopharmaceuticals in humans to aid the physician in determining various metabolic (molecular) and physiologic functions within the human body for evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer.

The combined system utilizes the MR for radiation-free attenuation correction maps for PET studies. The system provides inherent anatomical reference for the fused PET and MR images due to precisely aligned MR and PET image coordinate systems.

Device Description

The Biograph mMR systems are combined Maqnetic Resonance Imaging and Positron Emission Tomography scanners. The Biograph mMR systems provide registration and fusion of high-resolution metabolic, physiologic and anatomic information from the two major components of each system (PET and MR) acquired simultaneously and isocentrically.

Software syngo MR B20P is a new software version for the Siemens Biograph mMR systems that were previously cleared under K103429 (running software version syngo MR B18P).

New scanners will be manufactured with syngo MR B20P; existing scanners can be upgraded to this software version. The new software version includes new software features, coil modifications and other modified hardware for the Biograph mMR systems.

AI/ML Overview

This 510(k) submission (K133226) from Siemens for "Software syngo MR B20P for Biograph mMR" is a special 510(k), indicating modifications to an already cleared device. As such, the focus of the submission is on demonstrating that the new software and hardware features do not introduce new issues of safety or effectiveness and that the device remains substantially equivalent to its predicate.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly provide a table of quantitative acceptance criteria with corresponding performance metrics for the software changes in the way one might expect for a novel AI algorithm. Instead, the acceptance criteria are implicitly defined by standard engineering and regulatory practices for medical device modifications. The reported device performance is demonstrated through various tests designed to ensure the modified coils and software functions as intended and meet established standards.

Acceptance Criteria (Implicit)	Reported Device Performance
New Hardware (Coils):
- Maintain/improve image quality (SNR, uniformity)	- Coils were tested for SNR, image uniformity. (No specific quantitative values provided, but implied to be acceptable, demonstrating "performs as intended").
- Ensure user safety (heating)	- Coils were tested for heating. (Implied to be acceptable).
- Proper functionality in hybrid mode	- Coils were tested for hybrid mode. (Implied to be acceptable).
New Software Features:
- Correct implementation and functionality (Verification/Validation)	- All software features were verified and validated. (Implied to be bug-free and function as designed across all new additions: reconstruction improvements, usability improvements, quality control improvements, new sequences, Multi-Nuclear Spectroscopy).
- Accurate PET performance (NEMA NU:2 compliance)	- PET performance testing in accordance with NEMA NU:2. (This implies meeting established industry standards for PET image quality, quantification, and system performance).
- Accurate MNO Spectroscopy (phantom testing)	- The performance parameters of MNO Spectroscopy were phantom-tested. (Implied to be accurate and reliable when used with phantoms, indicating proper system calibration and data acquisition/processing for this specific application).
General Safety and Effectiveness:
- Compliance with regulatory standards	- Adherence to recognized and established industry standards, such as IEC 60601-1 series, ISO 14971:2007, and applicable FDA recognized and international IEC, ISO and NEMA standards as recommended by the respective MR FDA Guidance Document. (Demonstrates compliance with fundamental safety and performance benchmarks for medical devices).

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in the context of AI performance evaluation. The non-clinical tests involved:

Testing of coils (SNR, image uniformity, heating, hybrid mode).
Phantom testing for MNO Spectroscopy.
Verification and validation of all software features.
PET performance testing in accordance with NEMA NU:2.

The data provenance for these tests is implicitly from Siemens' internal testing environment and phantoms, as no patient data (retrospective or prospective) is mentioned as being used for the testing of the modified features to demonstrate conformance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. This submission does not describe a study involving expert-established ground truth on a test set (e.g., for diagnostic accuracy). The evaluation focuses on engineering performance and regulatory compliance for modified features.

4. Adjudication Method for the Test Set

Not applicable, as no expert adjudication of images or data to establish ground truth is described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of Human Readers Improve with AI vs. Without AI Assistance

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "There were not any clinical tests conducted to support the subject device and the substantial equivalence argument..." This is a software and hardware update, not a new diagnostic AI algorithm requiring such a study.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable in the typical sense for a diagnostic AI algorithm. The software features are enhancements to an existing imaging system, not a standalone diagnostic algorithm. The "standalone" performance here relates to the technical functionality of the new features (e.g., whether the new sequences produce images correctly, whether MNO spectroscopy works on phantoms). These functional tests were performed in a standalone manner (without a human interpreting findings for diagnostic purposes).

7. The Type of Ground Truth Used

The ground truth for the non-clinical tests was based on:

Physical measurements and engineering specifications: For coil performance (SNR, uniformity, heating, hybrid mode).
Phantom studies: For MNO Spectroscopy, where the phantom's known characteristics serve as the ground truth.
NEMA NU:2 standards: For PET performance, adherence to these published standards serves as the ground truth for system performance.
Software engineering requirements and specifications: For the verification and validation of all software features, ensuring they meet their design intent.

8. The Sample Size for the Training Set

Not applicable. This submission is for modifications to an existing MR-PET system software and hardware. The new software features described (e.g., reconstruction improvements, new sequences, usability improvements) are not typically "trained" in the machine learning sense from a large dataset but rather developed through traditional software engineering and signal processing methods.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no mention of a "training set" in the context of machine learning for this device modification.

Summary

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SIEMENS

Special 510(k) Submission

K13326
Page 1 of 5

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 ParkwayMail Code D02Malvern, PA 19355, USARegistration Number 2240869	NOV 1 2 2013
Manufacturer	Siemens AGHenkestrasse 127D-91052 Erlangen, GermanyRegistration Number 3002808157
	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 B20P for Biograph mMR
CFR Code	21 CFR § 892.1200
Classification	Class II
Product Codes	QUO
Classification Name	Magnetic Resonance Diagnostic Device (MRDD)

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SIEMENS

5.2 Information Supporting Substantial Equivalence

DEVICE DESCRIPTION

Software syngo MR B20P is a new software version for the Siemens Biograph mMR systems that were previously cleared under K103429 (running software version syngo MR B18P).

Summary of New Features with Biograph mMR Software syngo MR B20P:

Software

. New applications/software/sequences
- o Reconstruction improvements
- Usability improvements 0
- Quality control improvements 0
- New sequences (e.g. for joints and liver imaging) o
- Multi-Nuclear Spectroscopy 0

Hardware

. Modified coils:
- 4 Channel Special Purpose Coil o
- mMR Head/Neck Coil o
- mMR Breast Coil O

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INTENDED USE

These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders.

NONCLINICAL TESTS

The following performance testing was conducted on the subject device:

. The coils were tested for SNR, image uniformity, heating, and hybrid mode.
The performance parameters of MNO Spectroscopy were phantom-. : tested.
All software features were verified and validated. .
PET performance testing in accordance with NEMA NU:2 .

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

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SIEMENS

There were not any clinical tests conducted to support the subject device and the substantial equivalence argument, however clinical images are provided to better support the descriptions in Section 11 of the modified features of the subject device.

SUBSTANTIAL EQUIVALENCE

Biograph mMR System with software syngo MR B20P is substantially equivalent to the following predicate devices:

PrimaryPredicate Device	FDAClearanceNumber	FDA ClearanceDate	MainProductCode
Biograph mMR withsoftware syngo MR B18P	K103429	June 8, 2011	OUO

SupportingDevices forComponents	FDAClearanceNumber	FDA ClearanceDate	MainProductCode
syngo MR B19 forMAGNETOM Verio	K123938	February 12, 2013	LNH
Biograph mCT withsoftware PETsyngo VG50	K123737	January 29, 2013	90 KPSand 90 JAK

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 Biograph mMR System with software syngo MR B20P 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.

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SIEMENS

SUBSTANTIAL EQUIVALENCE CONCLUSION

There are no changes to the Indications for Use for the subject device, compared to that of the predicate Biograph mMR system with and the Biograph mMR System with software syngo MR B20P.

While the new hardware and software provides the user with additional capabilities compared to the subject system with the previous software version syngo MR B18P, it has the same technological characteristics as that of the predicate devices. The Biograph mMR is evolving with respect to the Biograph mCT with software PETsyngo VG50 (K123737) and the MAGNETOM Verio with syngo MR B19 (K123938). The new features on the Biograph mMR with syngo MR B20P 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.

The differences between the subject device and the predicate devices, include incorporation / adaptation of cleared features from the Biograph mCT with software PETsyngo VG50 (K123737), the MAGNETOM Verio with syngo MR B19 (K123938). and extensions of syngo MR B18P features (K103429). which give the Biograph mMR system similar capabilities with respect to the predicate devices, but have the same technological characteristics as the predicate devices, and do not introduce any new issues of safety or effectiveness. Therefore, Siemens believes that the subject device, Biograph mMR System with software syngo MR B20P is substantially equivalent to the predicate devices. Biograph mMR with syngo MR B18 and the MAGNETOM Verio with syngo MR B19.

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Image /page/5/Picture/0 description: The image shows a black and white logo for the Department of Health & Human Services, USA. 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 resembling an eagle or bird with three curved lines representing its wings or feathers.

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 12, 2013

SIEMENS MEDICAL SOLUTIONS USA, INC. NADIA SOOKDEO REGULATORY AFFAIRS TECHNICAL SPECIALIST 51 VALLEY STREAM PARKWAY MAILCODE D02 MALVERN PA 19355

Re: K133226

Trade/Device Name: Biograph mMR Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: OUO Dated: October 18, 2013 Received: October 21, 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. Ilisting 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.

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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 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/defaylt.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 hup://www.lda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Melvin M. Oza

for

JANINE 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

K133226 510(k) Number (if known) __

Software syngo MR B20P for Biograph mMR Device Name:

Indications for Use:

These systems are intended to be utilized by appropriately trained health care professionals to aid in the detection, localization, and diagnosis of diseases and disorders.

Prescription Use x (Part 21 CFR 801 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 Viro Diagnostics and Radiological Health (OIR) ・・・ . Haras ----------------------------------------------------------------------------------------------------------------------------------------------------------------------(Division Sign Off) "" Division of Radiological Health Office of In Fitro Diagnostic and Radiological Health 510(k) K133226 Page 1 of

Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.