The Siemens Biograph Horizon PET/CT 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 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 re 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.

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 Biograph 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:

OncoFreeze
OncoFreeze AI (Data Driven Gating)
CardioFreeze
FlowMotion Multi-Parametric PET AI ●
PET FAST Planning (FlowMotion Al)
FAST PET Workflow
QualityGuard
. Updates to HD FoV
Updates to PET DICOM dose Report
Whole Body Scatter Correction

Additionally, minor modifications have been made to the computers due to obsolescence issues and to the controllers of the PHS for cost improvement. These changes do not affect system performance characteristics and have no impact on safety or effectiveness.

AI/ML Overview

The Siemens Biograph Horizon PET/CT system (K193178) underwent performance testing against NEMA NU2-2018 standards for its PET subsystem. The device also had specific evaluations for new software features: OncoFreeze AI, OncoFreeze/CardioFreeze, FlowMotion Multi-Parametric PET AI, FlowMotion AI (PET FAST Planning), QualityGuard, and Whole Body Scatter Correction.

Here's the breakdown of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

Performance Criteria	Acceptance	Reported Device Performance	Study Performed For
Resolution - Full Size			PET (NEMA NU2-2018)
Transverse Resolution FWHM @ 1 cm	≤ 4.7 mm	Pass	PET (NEMA NU2-2018)
Transverse Resolution FWHM @ 10 cm	≤ 5.5 mm	Pass	PET (NEMA NU2-2018)
Transverse Resolution FWHM @ 20 cm	≤ 7.6 mm	Pass	PET (NEMA NU2-2018)
Axial Resolution FWHM @ 1 cm	≤ 5.0 mm	Pass	PET (NEMA NU2-2018)
Axial Resolution FWHM @ 10 cm	≤ 7.0 mm	Pass	PET (NEMA NU2-2018)
Axial Resolution FWHM @ 20 cm	≤ 11.3 mm	Pass	PET (NEMA NU2-2018)
Resolution - 256 x 256			PET (NEMA NU2-2018)
Transverse Resolution FWHM @ 1 cm	≤ 7.3 mm	Pass	PET (NEMA NU2-2018)
Transverse Resolution FWHM @ 10 cm	≤ 7.6 mm	Pass	PET (NEMA NU2-2018)
Transverse Resolution FWHM @ 20 cm	≤ 8.9 mm	Pass	PET (NEMA NU2-2018)
Axial Resolution FWHM @ 1 cm	≤ 6.1 mm	Pass	PET (NEMA NU2-2018)
Axial Resolution FWHM @ 10 cm	≤ 7.3 mm	Pass	PET (NEMA NU2-2018)
Axial Resolution FWHM @ 20 cm	≤ 11.9 mm	Pass	PET (NEMA NU2-2018)
Count Rate / Scatter / Sensitivity			PET (NEMA NU2-2018)
Sensitivity @435 keV LLD	≥ 5.8 cps/kBq (≥ 10.9 cps/kBq for TrueV)	Pass	PET (NEMA NU2-2018)
Count Rate peak NECR	≥ 78 kcps @ ≤ 26 kBq/cc (≥ 135 kcps @ ≤ 26 kBq/cc for TrueV)	Pass	PET (NEMA NU2-2018)
Count Rate peak trues	≥285 kcps @ ≤ 53 kBq/cc (≥ 465 kcps @ ≤ 42 kBq/cc for TrueV)	Pass	PET (NEMA NU2-2018)
Scatter Fraction at peak NECR	≤ 40%	Pass	PET (NEMA NU2-2018)
Mean bias (%) at peak NEC	≤ +/- 6%	Pass	PET (NEMA NU2-2018)
Image Quality (4 to 1) - (% Contrast / Background Variability)			PET (NEMA NU2-2018)
10mm sphere	≥ 10% / ≤ 10%	Pass	PET (NEMA NU2-2018)
13mm sphere	≥ 25% / ≤ 10%	Pass	PET (NEMA NU2-2018)
17mm sphere	≥ 40% / ≤ 10%	Pass	PET (NEMA NU2-2018)
22mm sphere	≥ 55% / ≤ 10%	Pass	PET (NEMA NU2-2018)
28mm sphere	≥ 60% / ≤ 10%	Pass	PET (NEMA NU2-2018)
37mm sphere	≥ 65% / ≤ 10%	Pass	PET (NEMA NU2-2018)
Co-Registration Accuracy			System Performance
Max Error	≤ 5 mm	Pass	System Performance
OncoFreeze AI (Data Driven Gating)	Change in SUVmax / SUVmean / Volume similar to Anzai-based gating	Pass	Comparison of motion-corrected images
ΔSUVmax (relative to static)	N/A (compared to Anzai)	27% ± 22% (vs. 29% ± 22%)	OncoFreeze AI vs. Anzai-based OncoFreeze
ΔSUVmean (relative to static)	N/A (compared to Anzai)	26% ± 22% (vs. 27% ± 22%)	OncoFreeze AI vs. Anzai-based OncoFreeze
ΔVolume (relative to static)	N/A (compared to Anzai)	-31% ± 19% (vs. -34% ± 23%)	OncoFreeze AI vs. Anzai-based OncoFreeze
FlowMotion AI (PET FAST Planning)	Successful identification of bed ranges at high percentage	87.1% to 100%	Evaluation of accuracy in defining bed ranges
QualityGuard	Time savings and reduction in staff exposure	Up to 30 mins/day savings, 98% exposure reduction	Evaluation of time and exposure reduction
Whole Body Scatter Correction	Reduced difference from ground truth in ROI measurements compared to Single Bed Scatter Correction	Pass	Simulation study of phantom ROIs (ground truth)
Representative ROI close to phantom (high signal)	N/A (compared to Single Bed)	-2% (vs. +87%)	Whole Body Scatter Correction vs. Single Bed Scatter Correction
Representative ROI close to phantom (low signal)	N/A (compared to Single Bed)	-3% (vs. -42%)	Whole Body Scatter Correction vs. Single Bed Scatter Correction
Representative ROI inside phantom	N/A (compared to Single Bed)	-0.4% (vs. +0.5%)	Whole Body Scatter Correction vs. Single Bed Scatter Correction

2. Sample size used for the test set and the data provenance:

PET Testing (NEMA NU2-2018): The document implies physical phantom testing which is standard for NEMA NU2-2018. The number of samples (scans or measurements) from the phantom is not explicitly stated, but these tests are typically performed on two different configurations: a 3-ring version and a 4-ring version (TrueV). Data provenance is from physical phantom measurements on the device itself.
OncoFreeze AI (Data Driven Gating): The document mentions "motion-corrected (OncoFreeze) images comparing Anzai based gating and deviceless gating." It does not specify the number of patient images or specific phantom studies. The provenance isn't explicitly stated as retrospective or prospective, nor a country of origin.
FlowMotion AI (PET FAST Planning): No specific sample size (i.e., number of cases or scans) is given. The study evaluated "configuration set" effectiveness. The provenance is not explicitly stated.
Whole Body Scatter Correction: This was a "simulation study of phantom." The sample size (number of ROIs or simulation runs) is not specified. Provenance is simulation data based on a phantom.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

For the NEMA NU2-2018 PET testing, the ground truth for performance metrics (resolution, sensitivity, scatter fraction, image quality) is established by the known physical properties and activity concentrations of the NEMA phantom according to the standard. No human experts are involved in establishing this ground truth.
For OncoFreeze AI, the "ground truth" for motion correction comparison is implicitly the static image or the Anzai-based gated images acting as a reference for comparison of SUV and Volume changes. No explicit expert involvement for ground truth is mentioned.
For FlowMotion Multi-Parametric PET AI, the "ground truth" for improved noise characteristics and delineation is a comparison against the Patlak transformation performed during reconstruction without the automatic feature. This implies qualitative assessment, but no expert details are given.
For FlowMotion AI (PET FAST Planning), the "ground truth" for correctly defined bed ranges would be based on the known or intended bed ranges. No expert involvement in establishing this ground truth is mentioned.
For QualityGuard, the "ground truth" for time savings and exposure reduction would be direct measurement or comparison to previous workflows. No expert involvement for ground truth is mentioned.
For Whole Body Scatter Correction, "ground truth" was established by a "simulation study of phantom," implying that the true values for activity in different regions of interest were known from the simulation setup. No human experts are involved in establishing this ground truth; it's inherent to the simulation.

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

No adjudication method for expert review of images or data is mentioned for any of the tests described. The tests are primarily technical performance evaluations (NEMA standards, quantitative comparisons, simulation studies) or workflow efficiency observations.

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 multi-reader multi-case (MRMC) comparative effectiveness study evaluating human reader improvement with AI assistance is mentioned in the provided text. The AI features mentioned (OncoFreeze AI, FlowMotion Multi-Parametric PET AI, FlowMotion AI (PET FAST Planning)) are related to image processing and workflow automation rather than direct diagnostic assistance for human readers in a comparative effectiveness setting.

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

The device itself is a diagnostic imaging system (PET/CT), not an AI algorithm that provides a diagnostic output to a human. The AI features described within the device, such as OncoFreeze AI and FlowMotion AI, are designed to improve image quality, correct for motion, or automate planning. The performance metrics focus on the output of these features (e.g., changes in SUV, bed range identification accuracy, scatter correction accuracy) as part of the overall imaging system's functionality. Therefore, these features are evaluated in a standalone manner within the machine's operation, without explicit human-in-the-loop performance studies described here.

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

NEMA NU2-2018 PET testing: Physical phantom with known activity concentrations and physical dimensions.
OncoFreeze AI: Comparison to static images and Anzai-based gating, which implicitly serve as a reference or "ground truth" for the motion-corrected measurements.
FlowMotion Multi-Parametric PET AI: Comparison to non-automated Patlak transformation results.
FlowMotion AI (PET FAST Planning): Known or intended bed ranges from the configuration setup.
QualityGuard: Measured time and staff exposure.
Whole Body Scatter Correction: Known values from a "simulation study of phantom."

In summary, the ground truth types are primarily known physical properties of phantoms (or simulated phantoms), comparative measurements against established methods, or direct measurements of efficiency/safety.

8. The sample size for the training set:

The document does not provide any information about the training set size for the AI features (OncoFreeze AI, FlowMotion AI).

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

Since no information on training sets is provided, there is also no information on how ground truth for any training sets was established.

Summary

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February 12, 2020

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the image is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Siemens Medical Solution USA, Inc. % Alaine Medio Regulatory Affairs Professional 810 Innovation Drive KNOXVILLE TN 37932

Re: K193178

Trade/Device Name: Biograph Horizon PET/CT Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS, JAK Dated: January 16, 2020 Received: Janu 17, 2020

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)

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regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
See PRA Statement below.
510(k) Number (if known)	K193178
Device Name	Biograph Horizon PET/CT
Indications for Use (Describe)	The Siemens Biograph Horizon PET/CT 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 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 re 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.
	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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EZOO

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510(k) Summary - K193178

as required by 21 CFR Part 807.87(h)

Identification of the Submitter

Submitter:	M. Alaine Medio, RACRegulatory AffairsSiemens Medical Solutions USA, Inc.Molecular Imaging810 Innovation DriveKnoxville, TN 37932
Alternative Contact:	Tabitha EstesRegulatory Affairs
Manufacturer:	Siemens Medical Solutions USA, Inc.Molecular Imaging2501 North Barrington RoadHoffman Estates, IL 60192
Telephone Number:	(865)206-0337
Fax Number:	(865)218-3019
Date of Submission:	November 12, 2019
Identification of the product
Device ProprietaryName:	Biograph Horizon PET/CT
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 CFR 892.1750
Product Code:	KPS and JAK
Classification Panel:	Radiology
Device Class:	Class II

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Marketed Devices to which Equivalence is claimed

Predicate:

Device ProprietaryName:	Biograph Horizon PET/CT Systems
Manufacturer:	Siemens Medical Solutions USA, Inc.
Product Code:	KPS and JAK
Device Class:	Class II
510(k) Number:	K170904
Reference Devices:
Device Name and 510(k)numbers:	Biograph mCT PET/CT systems	K173578
	Biograph Vision PET/CT systems	K190900
	SOMATOM Perspective CT	K183548

Device Description:

OncoFreeze
OncoFreeze AI (Data Driven Gating)
CardioFreeze
FlowMotion Multi-Parametric PET AI ●

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PET FAST Planning (FlowMotion Al)
FAST PET Workflow
QualityGuard
. Updates to HD FoV
Updates to PET DICOM dose Report
Whole Body Scatter Correction

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 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.

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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 NU2-2018 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/kBq≥ 10.9 cps/kBq (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	≥ 60% / ≤ 10%
37mm sphere	Pass	≥ 65% / ≤ 10%
Co-Registration Accuracy
Max Error	Pass	≤ 5 mm

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All features (including the new features listed in device description) were tested during Verification and Validation testing and met the predetermined acceptance criteria.

Further, the changes below had additional scientific evaluations performed. A brief description of testing activities is provided.

OncoFreeze AI (Data Driven Gating) - An evaluation of change in SUVmax, SUVmean and Volume measurement has been performed in motion-corrected (OncoFreeze) images comparing Anzai based gating and deviceless gating.

	Anzai-based OncoFreeze	Deviceless OncoFreeze
ΔSUVmax (relative to static)	+29% ± 22%	+27% ± 22%
ΔSUVmean (relative to static)	+27% ± 22%	+26% ± 22%
ΔVolume (relative to static)	-34% ± 23%	-31% ± 19%

OncoFreeze / CardioFreeze These features were shown to enable each individual ● gate to be reconstructed using 100% of the counts – 24x more in each individual gate than conventional dual gating (assuming 8 cardiac gates and a duty cycle of 35%).
FlowMotion Multi-Parametric PET Al – Comparison of Patlak transformation on a series of dynamic PET images on a voxel by voxel basis in image space versus performing the Patlak transformation during reconstruction using the automatic feature showed improved noise characteristics and better delineation of organs and tumors when using the Patlak during reconstruction.
. FlowMotion AI (PET FAST Planning) – Testing was performed to evaluate the accuracy with which FlowMotion Al correctly defined the bed ranges. Successful identification of all ranges in a FlowMotion Al configuration ranged from 87.1% to 100%, dependent on the configuration set.
. QualityGuard – Use of Quality Guard demonstrated a time savings of up to 30 minutes / day as well as reducing staff exposure to calibration sources by up to 98%.
Whole Body Scatter Correction - An evaluation was performed to evaluate ROIs using Single Bed Scatter compared to whole body scatter correction.

Difference from ground truthIn simulation study of phantom	Single Bed ScatterCorrection	Whole BodyScatter correction
Representative region of interest close tophantom exhibiting high signal	+87%	-2%
Representative region of interest close tophantom exhibiting low signal	-42%	-3%
Representative region of interest insidephantom	+0.5%	-0.4%

The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.

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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.

Siemens claims compliance with the following product standards for the Biograph Horizon:

IEC 60601-1: 2005+ A1:2012
IEC 60601-1-2: 2014
IEC 60601-1-3: 2013
IEC 60601-1-6:2010 +A1:2013
IEC 60601-2-28:2010
IEC 60601-2-44: 2009 + A1:2012
IEC 62366-1:2015
IEC 61223-2-6:2006
IEC 61223-3-5:2004
NEMA XR 25: 2010
NEMA XR 28: 2013
NEMA XR 29: 2013 ●
NEMA PS3.1-3.20

Additionally, the Biograph Horizon has been developed in accordance with the requirements of the following standards:

. IEC 62304:2006 +A1:2015
ISO 14971:2012 (ISO 14971:2007)

The device labeling contains instructions for use and any necessary cautions and warnings to provide for safe and effective use of the device.

Cybersecurity information in accordance with FDA Guidance documents issued October 2, 2014 has been provided. The Biograph Horizon software has specific cybersecurity controls to prevent unauthorized access, modifications, misuse or denial of use. Additionally, controls are enabled to prevent the unauthorized use of information that is stored, accessed or transferred between the Biograph Horizon and external devices.

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.

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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.