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

Updated 510(k) cleared CT. is used compared to the CT used in the predicate PET/CT system . (K113448);
· Updated gantry control buttons, and patient call button;
Updated computer hardware;
Updated software including:
- updated operating system; 0
- additional user configurable options and workflows
- cardiac gating updates to provide for improved gating characteristics :; o
- updated workflows for ease of use; and ಂ
- improvements in image quality. o

The new Biograph mCT capitalizes on list mode acquisition and positional information. Combined with the latest generation computer electronics it enables to continually take counts and reconstruct image data, providing a real-time display of the data flow as reconstructed.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Biograph mCT Family of PET/CT Systems:

1. Table of Acceptance Criteria and Reported Device Performance

Performance Criteria	Acceptance	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) >/= 8.5 cps/kBq (4R)	Pass
Count Rate peak NECR	86 kcps @ 36 kBq/cc (3R) 140 kcps@25 kBq/cc (4R)	Pass
Count Rate peak trues	280 kcps @ 42 kBq/cc (3R) 450 kcps @ 42 kBq/cc (4R)	Pass
Count Rate bias (mean)	<= 5%	Pass
Scatter Fraction	<40%	Pass

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

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

Sample Size for Test Set: The sample size is not explicitly stated in terms of number of cases or patients. Instead, the testing was performed on two physical configurations of the device (a 3-ring and a 4-ring version). NEMA NU2.2007 is a standard for and performance measurements of PET scanners, implying testing on phantoms or standardized objects rather than patient data.
Data Provenance: The document does not specify country of origin for data. Given it's a Siemens Medical Solutions USA, Inc. submission, the testing would likely have taken place in the US or at Siemens facilities. The testing appears to be prospective in nature, as it's a conformity assessment against a standard for a new or updated device.

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

This document describes a technical performance testing of a PET/CT scanner against established engineering and physics standards (NEMA NU2.2007). It does not involve clinical studies with human image interpretation or diagnostic accuracy assessment. Therefore, the concept of "experts used to establish ground truth for the test set" in the context of clinical interpretation is not applicable to this submission. The "ground truth" here is derived from objective physical measurements and comparisons to NEMA standards.

4. Adjudication Method for the Test Set

As this is technical performance testing against a standard and not a clinical study involving human interpretation, an adjudication method in the typical sense (e.g., 2+1, 3+1 for clinical consensus) is not applicable. The "adjudication" is inherent in the objective measurement and comparison to the NEMA NU2.2007 standard. If a measurement falls within the specified range (e.g., <= 6.5 mm for resolution), it "Passes."

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document does not describe an MRMC comparative effectiveness study comparing human readers with and without AI assistance. This submission focuses on the technical performance specifications of the PET/CT hardware and updated software.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, in a way. The "Performance Testing" section describes the device's technical performance in a standalone context, as objectively measured against NEMA NU2.2007 standards. The results (e.g., resolution, sensitivity, count rate) are measures of the algorithm and hardware's intrinsic performance, independent of a human operator's diagnostic interpretation.

7. Type of Ground Truth Used

The ground truth used for this performance testing is based on objective physical measurements against an established industry standard: NEMA NU2.2007. This standard defines precise methods and acceptable ranges for various performance metrics of PET scanners. It is not expert consensus, pathology, or outcomes data, but rather a technical benchmark.

8. Sample Size for the Training Set

The document does not mention a training set in the context of machine learning or AI. This submission is for an updated PET/CT system, and the "updated software" mentioned (including "improvements in image quality") are likely traditional image processing algorithms rather than deep learning models requiring large training datasets. Therefore, a "training set" as commonly understood in AI/ML is not applicable here.

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

Since no training set for AI/ML is mentioned, the method for establishing its ground truth is not applicable.

Summary

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510(k) Summary

as required by 21 CFR Part 807.87(h)

Identification of the Submitter

ನ 2013 JAN

:: M. Alaine Medio, RAC Submitter: PET and PCS Regulatory Projects Manager Siemens Medical Solutions USA, Inc. Molecular İmaging 810 Innovation Drive Knoxville, TN 37932

(865)218-2703 Telephone Number: : : : : ::::: (865)218-3019 Fax Number:

Date of Submission:

Identification of the product

.. .. Device Proprietary Name:

Biograph mCT. Family of PET/CT Systems

· Positron Emission Tomography (PET) System Common Name: Computed Tomography (CT) System

December 4, 2012

Classification Name:

: :

Emission Computed Tomography System per 21 CFR. 892.1200 Computed Tomography X-Ray System per 21 CFR 892.1750

: : : : : : : :

510(k) Number

. : . . . . :

90 KPS and 90 JAK Product Code: .

Classification Panel: Radiology Device Class: Class II

Marketed Devices to which Equivalence is claimed ...

. . . .

Manufacturer Device

Siemens Medical Solutions USA, Biograph mCT-X and lnc mCT · S

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Device Description:

Updated 510(k) cleared CT. is used compared to the CT used in the predicate PET/CT system . (K113448);
· Updated gantry control buttons, and patient call button;
Updated computer hardware;
Updated software including:
- updated operating system; 0
- additional user configurable options and workflows
- cardiac gating updates to provide for improved gating characteristics :; o
- updated workflows for ease of use; and ಂ
- improvements in image quality. o

Performance Testing:

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 NU2.2007 was conducted on two different configurations of the Biograph mCT systems, a 3 rinq version and a 4 ring version.

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Performance Criteria	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)>/= 8.5 cps/kBq (4R)
Count Rate peak NECR	Pass	86 kcps @ 36 kBq/cc (3R)140 kcps@25 kBq/cc (4R)
Count Rate peak trues	Pass	280 kcps @ 42 kBq/cc (3R)450 kcps @ 42 kBq/cc (4R)
Count Rate bias (mean)	Pass	<= 5%
Scatter Fraction	Pass	<40%

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.

Indications for 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, diagnosing, staging and restaging of lesions, tumors, disease

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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.

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. .......

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Image /page/4/Picture/0 description: The image shows the 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 image of an eagle or bird-like figure with three curved lines representing its wings or body.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

JAN 2 9 2013

Ms. Alaine Medio, RAC Official Correspondent Siemens Medical Solutions USA, Inc - Molecular Imaging 810 Innovation Drive KNOXVILLE TN 37932

Re: K123737

Trade/Device Name: Biograph mCT Family Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS and JAK Dated: January 9, 2013 Received: January 10, 2013

Dear Ms. 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/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/Resourcesfor You/Industry/default.htm.

Sincerely yours,

Michael D. O'Hara

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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Indications for Use

510(k) Number (if known): K123737

Device Name: Biograph mCT Family

Indications for Use:

The Siemens Biograph mCT systems are combined X-Ray Computed Tomography (CT) and The Sitemens Diography (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 The CT component produces cross sociesame axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET taken at urrerent allgies: "The PLP cabs purpose of determining various metabolic (molecular) radiopharmaceated.runctions within the human body and utilizes the CT for fast attenuation and prysiologic 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.

Prescription Use X -

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael D. O'Hara
2013.01.29
18:22:16 -05'00'

(Division Sign Off) Division of Radiological Health Office of In Vitro Diagnostic and Radiological Health

K123737 510(k)

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.