The Siemens Biograph Horizon PET/CT systems are combined Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration 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.

This CT system can be used for low dose lung cancer screening in high risk populations *

As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

Device Description

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

The software for the Bioqraph Horizon systems which is the subject of this application is substantially equivalent to the commercially available Biograph Horizon software. Modifications include:

. Corrections to software anomalies and addition of new software features, including:
- Continuous Bed Motion O
- o HD·Chest (including Stitched HD Chest)
- Whole Body Gating O
HD FoV for Attenuation Correction о
Phased Matched Gating O
Low Dose CT Protocols for PET AC O
SMART Mobile Connect O
PET Dose Report O
Enhanced IT Security O
Scan Protocol Management o
TeamViewer O
Dual Topo O
True Stack O

Additionally, minor modifications have been made to the patient bed electronics due to obsolescence issues. These changes do not affect system performance characteristics and have no impact on safety or effectiveness.

AI/ML Overview

The provided text is a 510(k) Summary for the Siemens Biograph Horizon PET/CT system. It details the device, its intended use, and performance testing results. Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and the Reported Device Performance

Performance Criteria	Acceptance	Reported Device Performance
Resolution - Full Size
Transverse Resolution FWHM @ 1 cm	≤ 4.7 mm	Pass
Transverse Resolution FWHM @ 10 cm	≤ 5.5 mm	Pass
Transverse Resolution FWHM @ 20 cm	≤ 7.6 mm	Pass
Axial Resolution FWHM @ 1 cm	≤ 5.0 mm	Pass
Axial Resolution FWHM @ 10 cm	≤ 7.0 mm	Pass
Axial Resolution FWHM @ 20 cm	≤ 11.3 mm	Pass
Resolution - 256 x 256
Transverse Resolution FWHM @ 1 cm	≤ 7.3 mm	Pass
Transverse Resolution FWHM @ 10 cm	≤ 7.6 mm	Pass
Transverse Resolution FWHM @ 20 cm	≤ 8.9 mm	Pass
Axial Resolution FWHM @ 1 cm	≤ 6.1 mm	Pass
Axial Resolution FWHM @ 10 cm	≤ 7.3 mm	Pass
Axial Resolution FWHM @ 20 cm	≤ 11.9 mm	Pass
Count Rate / Scatter / Sensitivity
Sensitivity @435 keV LLD	≥ 5.8 cps/MBq≥ 10.9 cps/MBq (TrueV)	Pass
Count Rate peak NECR	≥ 78 kcps @ ≤ 26 kBq/cc≥ 135 kcps @ ≤ 26 kBq/cc (TrueV)	Pass
Count Rate peak trues	≥285 kcps @ ≤ 53 kBq/cc≥ 465 kcps @ ≤ 42 kBq/cc (TrueV)	Pass
Scatter Fraction at peak NECR	≤ 40%	Pass
Mean bias (%) at peak NEC	≤ 6%	Pass
Image Quality (4 to 1) - (% Contrast / Background Variability)
10mm sphere	≥ 10% / ≤ 10%	Pass
13mm sphere	≥ 25% / ≤ 10%	Pass
17mm sphere	≥ 40% / ≤ 10%	Pass
22mm sphere	≥ 55% / ≤ 10%	Pass
28mm sphere	≥ 55% / ≤ 10%	Pass
37mm sphere	≥ 60% / ≤ 10%	Pass

All performance testing met the predetermined acceptance values.

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

The document states that "PET Testing in accordance with NEMA NU2:2012 was conducted on two different configurations of the Biograph Horizon systems, a 3 ring version and a 4 ring version (TrueV)." NEMA NU2:2012 is a standard for the performance measurements of PET scanners, typically utilizing phantoms rather than human or clinical data. Therefore, the "test set" in this context refers to measurements taken on the physical systems using standardized phantoms. The document does not specify a separate sample size (e.g., number of patients or data points) beyond testing the two system configurations. The data provenance is derived from these physical system tests, not from a specific country of origin or clinical retrospective/prospective study.

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

Given that the performance testing was conducted according to NEMA NU2:2012, which involves standardized measurements using phantoms, the concept of "experts" establishing ground truth in a clinical sense (e.g., radiologists reviewing images) is not applicable here. The "ground truth" for this type of testing is established by the known physical properties and radioactive concentrations within the phantoms used, as measured against the NEMA standard.

4. Adjudication Method for the Test Set

As the performance testing against NEMA NU2:2012 involves direct physical measurements and calculations based on phantom acquisitions, there is no mention of a human adjudication method (like 2+1 or 3+1 consensus) in the document. The "Pass" results indicate that the measured values fell within the predefined acceptance ranges.

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

The provided document describes performance testing of a PET/CT scanner against technical standards (NEMA NU2:2012). It does not mention any multi-reader multi-case (MRMC) comparative effectiveness studies, nor any AI assistance to human readers. Therefore, no effect size for human reader improvement with/without AI can be determined from this document.

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

The document details the performance characteristics of the PET/CT hardware system. It refers to software modifications but these are for anomaly corrections and new features (e.g., Continuous Bed Motion, HD·Chest), not for an "algorithm only" standalone performance evaluation in a diagnostic context. The core performance testing focuses on the system's physical capabilities as measured by NEMA NU2:2012.

7. The Type of Ground Truth Used

The ground truth used for the performance testing was based on physical phantom measurements in accordance with the NEMA NU2:2012 standard. This standard defines precise methodologies for measuring metrics like resolution, sensitivity, and image quality using phantoms with known characteristics.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of machine learning or AI. The testing performed is related to the physical performance of the PET/CT system hardware, not a data-driven model that would require a training set.

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

As no training set is mentioned in the context of the device's performance evaluation in this document, the method for establishing its "ground truth" is not applicable or described.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 1, 2017

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

Re: K170904

Trade/Device Name: Biograph Horizon PET/CT Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS, JAK Dated: May 3, 2017 Received: May 4, 2017

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

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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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education 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,

Michael D. O'Hara
For

Robert Ochs, Ph.D. 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)

K170904

Device Name Biograph Horizon PET/CT

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.

This CT system can be used for low dose lung cancer screening in high risk populations *

As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

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)

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510(k) Summary

as required by 21 CFR Part 807.87(h)

Identification of the Submitter
Submitter:	M. Alaine Medio, RACPET and PCS Regulatory Projects ManagerSiemens Medical Solutions USA, Inc.Molecular Imaging810 Innovation DriveKnoxville, TN 37932
Manufacturer:	Siemens Medical Solutions USA, Inc.Molecular Imaging2501 North Barrington RoadHoffman Estates, IL 60192
Telephone Number:	(865)218-2703
Fax Number:	(865)218-3019
Date of Submission:	March 24, 2017
Identification of the product
Device Proprietary Name:	Biograph Horizon PET/CT Systems
Common Name:	Positron Emission Tomography (PET) SystemComputed Tomography (CT) System
Classification Name:	Emission Computed Tomography System per 21 CFR892.1200Computed Tomography X-Ray System per 21 CFR892.1750
Product Code:	90 KPS and 90 JAK
Classification Panel:	Radiology
Device Class:	Class II

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Marketed Devices to which Equivalence is claimed

Predicate:

Device Proprietary Name:	Biograph Horizon PET/CT Systems
Manufacturer:	Siemens Medical Solutions USA, Inc.
Product Code:	90 KPS and 90 JAK
Device Class:	Class II
510(k) Number:	K152880
Reference Devices:
Device Name:	Somatom Perspective CT
	Biograph mCT Family of PET/CT systems
	Biograph Horizon and Biograph mCT PET/CT SystemsUpdate to Indications
510(k) Numbers:	K151765 (Somatom Perspective CT)
	K151486 (Biograph mCT Family PET/CT)
	K162736 (Biograph Horizon and Biograph mCT PET/CTSystems Update to Indications)

Device Description:

The software for the Bioqraph Horizon systems which is the subject of this application is substantially equivalent to the commercially available Biograph Horizon software. Modifications include:

. Corrections to software anomalies and addition of new software features, including:
- Continuous Bed Motion O
- o HD·Chest (including Stitched HD Chest)
- Whole Body Gating O

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HD FoV for Attenuation Correction о
Phased Matched Gating O
Low Dose CT Protocols for PET AC O
SMART Mobile Connect O
PET Dose Report O
Enhanced IT Security O
Scan Protocol Management o
TeamViewer O
Dual Topo O
True Stack O

Intended Use:

The Siemens Biograph Horizon 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 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 anqles. 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 of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neuroloqical 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.

This CT system can be used for low dose lung cancer screening in high risk populations.*

As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.

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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.

PET Testing in accordance with NEMA NU2:2012 was conducted on two different configurations of the Biograph Horizon systems, a 3 ring version and a 4 ring version (TrueV).

Performance Criteria	Results	Acceptance
Resolution - Full Size
Transverse Resolution FWHM @ 1 cm	Pass	≤ 4.7 mm
Transverse Resolution FWHM @ 10 cm	Pass	≤ 5.5 mm
Transverse Resolution FWHM @ 20 cm	Pass	≤ 7.6 mm
Axial Resolution FWHM @ 1 cm	Pass	≤ 5.0 mm
Axial Resolution FWHM @ 10 cm	Pass	≤ 7.0 mm
Axial Resolution FWHM @ 20 cm	Pass	≤ 11.3 mm
Resolution - 256 x 256
Transverse Resolution FWHM @ 1 cm	Pass	≤ 7.3 mm
Transverse Resolution FWHM @ 10 cm	Pass	≤ 7.6 mm
Transverse Resolution FWHM @ 20 cm	Pass	≤ 8.9 mm
Axial Resolution FWHM @ 1 cm	Pass	≤ 6.1 mm
Axial Resolution FWHM @ 10 cm	Pass	≤ 7.3 mm
Axial Resolution FWHM @ 20 cm	Pass	≤ 11.9 mm
Count Rate / Scatter / Sensitivity
Sensitivity @435 keV LLD	Pass	≥ 5.8 cps/MBq≥ 10.9 cps/MBq (TrueV)
Count Rate peak NECR	Pass	≥ 78 kcps @ ≤ 26 kBq/cc≥ 135 kcps @ ≤ 26 kBq/cc (TrueV)
Count Rate peak trues	Pass	≥285 kcps @ ≤ 53 kBq/cc≥ 465 kcps @ ≤ 42 kBq/cc (TrueV)
Scatter Fraction at peak NECR	Pass	≤ 40%
Mean bias (%) at peak NEC	Pass	≤ 6%
Image Quality (4 to 1) - (% Contrast / Background Variability)
10mm sphere	Pass	≥ 10% / ≤ 10%
13mm sphere	Pass	≥ 25% / ≤ 10%
17mm sphere	Pass	≥ 40% / ≤ 10%
22mm sphere	Pass	≥ 55% / ≤ 10%
28mm sphere	Pass	≥ 55% / ≤ 10%
37mm sphere	Pass	≥ 60% / ≤ 10%

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.

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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 Horizon that impact either the fundamental technology or the indications for use. The Biograph Horizon 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.