The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Position Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images.

The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging.

These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

Device Description

The Biograph TruePoint Family of systems are combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanners. These systems are designed for whole body oncology, neurology and cardiology examinations. The Biograph TruePoint systems provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system (PET and CT). Additional components of the system include a patient handling system and acquisition and processing workstations with associated software.

Biograph TruePoint PET/CT Family software is a command based program used for patient manaqement, data management, scan control, image reconstruction and image archival and evaluation. All images conform to DICOM imaging format requirements.

The updates to the Biograph TruePoint systems software which are the subject of this application are considered substantially equivalent to the commercially available Biograph TruePoint software. Major modifications to the family of systems include:

. General
- Update of the operating system to Windows 7 for the ACS and PRS components O for improved sustainability
- Support for SolidCore implemented for chanqe protection and software O security.
- updates to address anomalies for CT and PET software o
synqo software upgrade .
- o Update of the synqo software to the latest revision (drivers, etc...)
. Somaris Software Update
- Upgrade to the latest revision Somaris Software (VB42) (K140232) O
- Inclusion of MITA Dose check features to be compliant with the MITA dose о requirements. Dose Notification and Dose Alert; Dose Logs; Access and CARE Analytics, CARE Dose 4D etc ...
- Improvements to scanning and reconstruction workflows o
PETsynqo software .
- Update of software to provide for improved consistency of features between all O TruePoint models
- Update to add Variable Bed Time O
- Update of the software scatter correction and bed removal O
- Update of the TrueD software O
- Improvements to the service tools O
- O Improvements to workflow

AI/ML Overview

This document describes the Biograph TruePoint PET/CT Family Software, focusing on its substantial equivalence to predicate devices and performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

The performance testing for the PET subsystem was conducted in accordance with NEMA NU2:2007 for two configurations: a 3-ring and a 4-ring version of the Biograph TruePoint systems.

Performance Criteria (Standard)	Acceptance Criteria	Reported Device Performance
Transverse Resolution FWHM @ 1 cm	<= 6.5 mm	Pass
Transverse Resolution FWHM @ 10 cm	<= 6.5 mm	Pass
Axial Resolution FWHM @ 1 cm	<= 6.0 mm	Pass
Axial Resolution FWHM @ 10 cm	<= 6.5 mm	Pass
Sensitivity @ 435 keV LLD	>= 4.0 cps/kBq (3R) >= 7.0 cps/kBq (4R)	Pass
Count Rate peak NECR	86 kcps @ 42 kBq/cc (3R) 148 kcps @ 42 kBq/cc (4R)	Pass
Count Rate peak trues	306 kcps @ 42 kBq/cc (3R) 467 kcps @ 42 kBq/cc (4R)	Pass
Count Rate bias (mean)	<= 7%	Pass
Scatter Fraction	< 38%	Pass

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

The document states that performance testing was conducted "on two different configurations of the Biograph TruePoint systems, a 3 ring version and a 4 ring version." It does not specify a sample size in terms of patient data or data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be based on physical measurements of the device's imaging capabilities according to a standard protocol (NEMA NU2:2007), rather than a clinical study with patient data.

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

Not applicable. The performance testing described is based on engineering specifications and measurements according to NEMA NU2:2007, not on expert-established ground truth from clinical images.

4. Adjudication Method for the Test Set

Not applicable. The described testing is a technical performance evaluation, not a clinical study requiring adjudication of image interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. This premarket notification describes the evaluation of software updates for a PET/CT system, focusing on its technical performance and substantial equivalence to existing devices. It does not mention an MRMC comparative effectiveness study involving human readers with and without AI assistance. The described "AI" would be the image reconstruction and processing algorithms inherent in the PET/CT software, not a separate AI application for interpretation.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in a sense. The performance testing outlined in the table is a standalone evaluation of the algorithm and hardware's capabilities to meet specified technical parameters (e.g., resolution, sensitivity, count rate) according to NEMA NU2:2007. This evaluation does not involve human interpretation or a "human-in-the-loop" component for the performance metrics listed.

7. The Type of Ground Truth Used

The ground truth for the performance testing is based on the objective measurements and standards defined by NEMA NU2:2007. This standard specifies phantoms and methods for measuring various performance characteristics of PET systems. Therefore, the "ground truth" is the physical reality represented by the phantom and measured by the device according to the NEMA protocol.

8. The Sample Size for the Training Set

Not applicable. This document describes a submission for software updates for an existing medical imaging system and its performance evaluation against a recognized standard (NEMA NU2:2007). It does not involve machine learning model training or a "training set" in that context. The software updates are described as general improvements to sustainability, security, and workflow, and upgrades to existing software components (e.g., operating system, Synqo, Somaris, PETsynqo).

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

Not applicable, as there is no mention of a machine learning training set in this submission.

Summary

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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

September 12, 2014

Siemens Medical Solutions USA, Inc. % Alaine Medio PET And PCS Regulatory Projects Manager 810 Innovation Drive KNOXVILLE TN 37932

Re: K141971

Trade/Device Name: Biograph TruePoint PET/CT Family Software Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS, JAK Dated: August 26, 2014 Received: August 27, 2014

Dear Alaine Medio:

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

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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/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,

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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K141971

Device Name

Biograph TruePoint PET/CT Family Software

Indications for Use (Describe)

The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging.

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)

_ Over-The-Counter Use (21 CFR 801 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 Radiological Health (CDRH) (Signature)

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510(k) Summary

as required by 21 CFR Part 807.87(h) and 807.92 (c)

Identification of the Submitter

Submitter:	M. Alaine Medio, RACPET and PCS Regulatory Projects ManagerSiemens Medical Solutions USA, Inc.Molecular Imaging810 Innovation DriveKnoxville, TN 37932
Telephone Number:	(865)218-2703
Fax Number:	(865)218-3019
Date of Submission:	September 3, 2014
Identification of the product
Device Proprietary Name:	Biograph TruePoint PET/CT Family Software
Common Name:	Positron Emission Tomography (PET) SystemComputed Tomography (CT) System
Classification Name:	Emission Computed Tomography System per21 CFR 892.1200Computed Tomography X-Ray System per 21CFR 892.1750
Product Code:	90 KPS and 90 JAK
Classification Panel:	Radiology
Device Class:	Class II
Marketed Devices to which Equivalence is claimed
Predicate	Device	Manufacturer	510(k) Number
Primary Predicate	Biograph mCT FamilyPET/CT scanner software	Siemens MedicalSolutions USA, Inc	K123737
Reference Predicate	Biograph TruePointPET/CT scanner software	Siemens MedicalSolutions USA, Inc	K083852

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Device Description:

. General
- Update of the operating system to Windows 7 for the ACS and PRS components O for improved sustainability
- Support for SolidCore implemented for chanqe protection and software O security.
- updates to address anomalies for CT and PET software o
synqo software upgrade .
- o Update of the synqo software to the latest revision (drivers, etc...)
. Somaris Software Update
- Upgrade to the latest revision Somaris Software (VB42) (K140232) O
- Inclusion of MITA Dose check features to be compliant with the MITA dose о requirements. Dose Notification and Dose Alert; Dose Logs; Access and CARE Analytics, CARE Dose 4D etc ...
- Improvements to scanning and reconstruction workflows o
PETsynqo software .
- Update of software to provide for improved consistency of features between all O TruePoint models
- Update to add Variable Bed Time O
- Update of the software scatter correction and bed removal O
- Update of the TrueD software O
- Improvements to the service tools O
- O Improvements to workflow

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Intended Use:

The Siemens Biograph TruePoint systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information.

The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging.

These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures.

Technological Characteristics

The Biograph TruePoint PET/CT Family software with modifications is based on the commercially available Biograph TruePoint and Biograph mCT Family software. There has been no introduction of features that are not already commercially available in the predicate systems introduced with these software modifications. All software has technological characteristics consistent with the predicate software.

Performance Testing / Safety and Effectiveness:

Performance testing for the CT subsystem was included in the original premarket notification for the CT subsystems and there have been no changes affecting this testing.

Performance Criteria (Standard)	Results	Acceptance
Transverse Resolution FWHM @ 1 cm	Pass	<= 6.5 mm
Transverse Resolution FWHM @ 10 cm	Pass	<= 6.5 mm
Axial Resolution FWHM @ 1 cm	Pass	<= 6.0 mm
Axial Resolution FWHM @ 10 cm	Pass	<= 6.5 mm
Sensitivity @435 keV LLD	Pass	>= 4.0 cps/kBq (3R)>= 7.0 cps/kBq (4R)
Count Rate peak NECR	Pass	86 kcps @ 42 kBq/cc (3R)148 kcps@ 42 kBq/cc (4R)
Count Rate peak trues	Pass	306 kcps @ 42 kBq/cc (3R)467 kcps @ 42 kBq/cc (4R)
Count Rate bias (mean)	Pass	<= 7%
Scatter Fraction	Pass	<38%

PET Testing in accordance with NEMA NU2:2007 was conducted on two different configurations of the Biograph TruePoint systems, a 3 ring version and a 4 ring version.

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All Performance testing met the predetermined acceptance values.

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 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. adheres to recognized and established industry standards such as IEC 60601-1 series and 21 CFR 1020.30 and 21 CFR 1020.33 to minimize electrical, mechanical and radiation hazards.

Verification and validation of Siemens systems is performed in accordance with documented procedures, design and code reviews, test plans and specifications. Traceability of the requirements specified in the requirement specifications and functional specifications is ensured during component integration, software validation and system testing.

Statement regarding Substantial Equivalence:

There have been no changes implemented in the modifications to the Biograph TruePoint PET/CT Family software that impact either the fundamental technology or the indications for use. The Biograph TruePoint software with the modifications outlined in this Premarket Notification is substantially equivalent to the currently commercially available predicate device.

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.