The Siemens Biograph mCT 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 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 mCT and mCT Flow PET/CT Scanners 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 mCT 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 mCT 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 mCT systems which is the subject of this application is substantially equivalent to the commercially available Biograph mCT software. Modifications include:

Syngo software upgrade
Somaris Software (cleared in K143400, K143401))
Twin beam scanning feature for Biograph mCT-X and Biograph mCT Edge
HD Field of View Pro
Iterative Metal Artifact Reduction (iMAR)
Temporal minimum intensity projection and temporal maximum intensity projections (tMIP)
FAST 3D align / 3D Reconstruction
FAST DE Results
Repiratory Online mode
Enhancements to the Iterative Reconstruction software (ADMIRE)
PETsyngo software

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Biograph mCT and mCT Flow PET/CT Scanners, based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

The document provides a table summarizing performance criteria and results based on NEMA NU2:2012 testing for the PET subsystem.

Performance Criteria (Standard)	Reported Device Performance	Acceptance Criteria (from document)
Transverse Resolution FWHM @ 1 cm	Pass	<= 7.3 mm
Transverse Resolution FWHM @ 10 cm	Pass	<= 7.5 mm
Axial Resolution FWHM @ 1 cm	Pass	<= 6.0 mm
Axial Resolution FWHM @ 10 cm	Pass	<= 6.6 mm
Sensitivity @ 435 keV LLD	Pass	>= 5.0 cps/kBq (3R) >= 9.4 cps/kBq (4R)
Count Rate peak NECR	Pass	>= 95 kcps @ 30 kBq/cc (3R) >= 165 kcps @ 28 kBq/cc (4R)
Count Rate peak trues	Pass	>= 350 kcps @ 46 kBq/cc (3R) >= 575 kcps @ 40 kBq/cc (4R)
Count Rate bias (mean)	Pass	<= +/- 5%
Scatter Fraction	Pass	<= 37% (3R) <= 40% (4R)

Note: The "Reported Device Performance" column indicates "Pass" for all criteria, implying that the quantitative results met or exceeded the specified acceptance values. The document does not provide the exact numerical performance values here, only that they passed.

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

Sample Size: The document mentions that "PET Testing in accordance with NEMA NU2:2012 was conducted on two different configurations of the Biograph mCT systems, a 3 ring version and a 4 ring version." NEMA NU2 standards typically involve testing on phantom devices, not human patient data. Therefore, the "sample size" refers to the specific configurations of the physical device that were subjected to the NEMA tests. There is no mention of a "test set" in terms of patient data.
Data Provenance: The testing is described as being conducted on physical devices (3-ring and 4-ring versions of Biograph mCT systems). There is no mention of country of origin for the data or whether it was retrospective or prospective, as it's not a study based on patient data in this context.

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 and physics measurements using phantoms according to the NEMA NU2:2012 standard, not on human interpretation or ground truth established by experts.

4. Adjudication Method for the Test Set

Not applicable, as the testing involves objective physical measurements against a standard (NEMA NU2:2012), not subjective assessment requiring adjudication.

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

No. The document describes technical performance testing of the PET/CT scanner against an industry standard (NEMA NU2:2012), not a comparative effectiveness study involving human readers with or without AI assistance. The modifications listed are software upgrades and feature additions to the existing device, not an AI component intended to improve human reader performance in diagnostically significant ways requiring an MRMC study.

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

Yes, in a way. The performance testing against NEMA NU2:2012 is a standalone evaluation of the device's physical and technical performance parameters (e.g., resolution, sensitivity, count rates) as an imaging system, independent of human interpretation of images. The device itself (the PET/CT scanner) is the "algorithm" or system being tested in this context for its fundamental imaging capabilities.

7. The Type of Ground Truth Used

The ground truth used for these performance tests is defined by the NEMA NU2:2012 standard. This standard specifies phantoms (precisely engineered physical objects with known properties) and measurement methodologies to objectively quantify the performance characteristics of PET systems. Therefore, the "ground truth" is the known physical properties of the phantoms and the reproducible measurements defined by the standard.

8. The Sample Size for the Training Set

Not applicable. This document describes the clearance of a medical imaging device (PET/CT scanner) based on hardware and software upgrades, and its adherence to established performance standards. It does not involve a machine learning algorithm that requires a "training set" of data for development.

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

Not applicable (as above).

Summary

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Image /page/0/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" arranged around the perimeter. Inside the circle is a stylized design featuring three human profiles facing to the right, stacked on top of each other.

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

August 3, 2015

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

Re: K151486

Trade/Device Name: Biograph mCT and mCT Flow PET/CT Scanners Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS, JAK Dated: June 1, 2015 Received: June 2, 2015

Dear Ms. Medio:

This letter corrects our substantially equivalent letter of July 17, 2015.

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 (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/Resourcesfor You/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 yours,

Michael D'Hara For

Robert Ochs, Ph.D. Acting 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)

K151486

Device Name Biograph mCT and mCT Flow PET/CT Scanners

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)

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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
Manufacturers:	Siemens Medical Solutions USA, Inc.Molecular Imaging810 Innovation DriveKnoxville, TN 37932Siemens 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:	May 29th, 2015
Identification of the product
Device Proprietary Name:	Biograph mCT and mCT Flow PET/CT Scanners
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
Device Proprietary Name:	Biograph mCT and mCT Flow PET/CT Scanners
Manufacturer:	Siemens Medical Solutions USA, Inc.
Product Code:	90 KPS and 90 JAK
Device Class:	Class II
510(k) Number:	K123737
Reference Devices:
Device Name:	Somatom Definition AS/AS+
	Somatom Definition Edge
510(k) Numbers:	K143400 (Somatom Definition AS/AS+)
	K143401 (Somatom Definition Edge)

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Marketed Devices to which Equivalence is claimed

Predicate:

Device Description:

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

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

Syngo software upgrade
- o Update of the synqo software to the latest revision (drivers, etc...)
. Somaris Software (cleared in K143400, K143401))
- Upgrade to the latest revision of Somaris Software O
- Addition of new software features o
  - Scan Time, Respiratory Rate and Pitch adjustments to provide for Full 4D lung scans

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. Twin beam scanning feature for Biograph mCT-X and Biograph mCT Edge
. HD Field of View Pro
Iterative Metal Artifact Reduction (iMAR)
Temporal minimum intensity projection and temporal maximum intensity projections (tMIP)
FAST 3D align / 3D Reconstruction ■
FAST DE Results
Repiratory Online mode
Enhancements to the Iterative Reconstruction software (ADMIRE) o
PETsyngo software ●
- Update of the software to add stitched whole body and stitched HD-Chest O feature
- Update to add Multi-series CT for Attenuation Correction O
- Summed whole body dynamic O
- Update of the software corrections O
- Update of the TrueD software component o
  - = Address anomalies related to loading of PET images
  - Update to improve usability
- Improvements to workflow o
- Improvements to performance (faster reconstruction speeds) O

Intended Use:

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, diagnosinq, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to,

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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.

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 confiqurations of the Biograph mCT systems, a 3 rinq version and a 4 ring version.

Performance Criteria (Standard)	Results	Acceptance
Transverse Resolution FWHM @ 1 cm	Pass	<= 7.3 mm
Transverse Resolution FWHM @ 10 cm	Pass	<= 7.5 mm
Axial Resolution FWHM @ 1 cm	Pass	<= 6.0 mm
Axial Resolution FWHM @ 10 cm	Pass	<= 6.6 mm
Sensitivity @ 435 keV LLD	Pass	>= 5.0 cps/kBq (3R)>= 9.4 cps/kBq (4R)
Count Rate peak NECR	Pass	>= 95 kcps @ 30 kBq/cc (3R)>= 165 kcps @ 28 kBq/cc (4R)
Count Rate peak trues	Pass	>= 350 kcps @ 46 kBq/cc (3R)>= 575 kcps @ 40 kBq/cc (4R)
Count Rate bias (mean)	Pass	<=+/- 5%
Scatter Fraction	Pass	<= 37% (3R)<= 40% (4R)

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 mitiqation 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.

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Statement regarding Substantial Equivalence:

There have been no changes implemented in the modifications to the Biograph mCT that impact either the fundamental technology or the indications for use. The Biograph mCT 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.