The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, 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.

SPECT: The SPECT component is intended to detect or image the distribution of radionuclides in the body or organ (physiology), using the following techniques: Planar imaging, whole body imaging for isotopes with energies up to 588 keV.

CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data (anatomy) from either the same axial plane taken at different angles or spiral planes take at different angles.

SPECT+CT: The SPECT and CT components used together acquire SPECT images can be corrected for attenuation with the CT images, and can be combined (image registration) to merge the patient's physiological (SPECT) and anatomical (CT) images.

Software: the syngo MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies in images produced from SPECT, PET, CT and other imaging modalities.

Device Description

The Siemens Symbia systems consist of Single Photon Emission Computed Tomography (SPECT) scanners and integrated hybrid X-Ray Computed Tomography (CT) and SPECT scanners. The SPECT subsystem images and measures the distribution of radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and integrates CT's anatomical detail for precise reference of the location of the metabolic activity. 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 system can be used as an integrated SPECT and CT modality while also enabling independent functionality of SPECT and CT as standalone diagnostic imaging devices.

For all systems, a new software version synqo MI Applications VB10A supports the upgrade to Windows® 7 Operating System, updates to 3rd party software, and optional LPHR collimator imaging are available.

AI/ML Overview

This document describes the Symbia 6.0, an Emission Computed Tomography (SPECT/CT) system. The information provided outlines the device's intended use, technological characteristics, and performance testing, primarily for the LPHR collimator and general system compliance. However, it does not contain detailed information about a study proving the device meets acceptance criteria in the context of AI/ML performance, human-in-the-loop studies, or specific clinical ground truths. It primarily focuses on hardware and software upgrades and compliance with regulatory standards.

Here's an analysis based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document provides acceptance criteria and test results specifically for the LPHR collimator component of the Symbia 6.0 system, according to NEMA NU-1:2007 standards.

LPHR Typical Values	Specification	Test Result
Intrinsic Spatial Resolution
FWHM in CFOV	$\le 3.84mm$	Pass
FWTM in CFOV	$\le 7.54mm$	Pass
FWHM in UFOV	$\le 3.94mm$	Pass
FWTM in UFOV	$\le 7.74mm$	Pass
Intrinsic Spatial Linearity
Differential in CFOV	$\le 0.24mm$	Pass
Absolute in CFOV	$\le 0.44mm$	Pass
Differential in UFOV	$\le 0.24mm$	Pass
Absolute in UFOV	$\le 0.69mm$	Pass

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Performance testing for the CT subsystem was included in the original premarket notification for the CT subsystems" and "IRIS Image Quality testing has been performed with Catphan® and water phantoms on the 6 and 16 slice SPECT/CT systems." However, specific sample sizes (number of patients or specific phantom scans) for these tests are not provided. Similarly, there is no information on the data provenance (e.g., country of origin, retrospective or prospective study design) as the testing appears to be primarily technical performance evaluation using phantoms rather than clinical studies with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. The performance testing described (for LPHR collimator and IRIS Image Quality) relies on physical phantom measurements and adherence to technical specifications (NEMA standards), not on expert clinical interpretation of images to establish ground truth.

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

Not applicable. As the testing involves physical measurements against technical specifications with phantoms, there is no clinical adjudication method described or required.

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, a multi-reader multi-case (MRMC) comparative effectiveness study focusing on human readers' improvement with or without AI assistance was not mentioned or implied in this document. The device is a SPECT/CT imaging system and its software, not an AI-driven diagnostic aid that would typically undergo such a study for clinical effectiveness.

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

The document describes the device as an imaging system and its associated display and analysis software. While the software ("syngo MI Applications") is intended to "aid the clinician in the assessment and quantification of pathologies," it is described as a display and analysis package rather than a standalone algorithm performing diagnostic tasks without human input. The performance testing focuses on the imaging hardware and basic image quality, not the autonomous diagnostic capability of an algorithm. Therefore, a standalone algorithm-only performance study in the context of AI performance (e.g., sensitivity/specificity for disease detection) was not detailed.

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

The ground truth for the described performance tests is based on:

Technical specifications and physical standards: For the LPHR collimator, performance is measured against NEMA NU-1:2007 standards and internal specifications (e.g., $\le 3.84mm$).
Phantom measurements: IRIS Image Quality testing was performed using Catphan® and water phantoms, which provide known physical properties and artifacts for image quality assessment.

8. The sample size for the training set

Not applicable. This document does not describe the development or testing of an AI/ML model that would require a training set in the conventional sense. The "syngo MI Applications" software mentioned is a display and analysis tool, and while it might incorporate algorithms, the document does not treat it as a machine learning product requiring a distinct training and test set with clinical ground truth.

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

Not applicable. As no training set for an AI/ML model is mentioned, there is no information on how its ground truth would have been established.

In summary, this 510(k) summary focuses on the technical performance and safety of a medical imaging device (SPECT/CT system) and its related software updates, rather than the clinical performance evaluation of an AI/ML-driven diagnostic or assistive tool. Therefore, many of the requested points related to AI/ML study design are not addressed in the provided text.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol representing the human form, depicted as three stylized profiles facing right, with flowing lines beneath them.

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

August 21, 2014

Siemens Medical Solutions USA, Inc. % Cynthia Busch Regulatory Technical Specialist 2501 North Barrington Rd. HOFFMAN ESTATES, ILLINOIS 60192

Re: K142006 Trade/Device Name: Symbia 6.0 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography Regulatory Class: II Product Code: KPS, JAK Dated: July 22, 2014 Received: July 23, 2014

Dear Ms. Busch:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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Page 2 - Ms. Busch

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 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 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

K142006

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name Symbia 6.0

Indications for Use (Describe)

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)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

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510(k) Summary

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

Identification of the Submitter

Submitter:	Cynthia BuschRegulatory Technical SpecialistSiemens Medical Solutions USA, Inc.2501 N. Barrington RoadHoffman Estates, IL 60192USA
Telephone Number:	(847) 304-7095
Fax Number:	(847) 304-6023
Name / Address of Manufacturer:	Siemens Medical Solutions USA, IncMolecular Imaging2501 N. Barrington RoadHoffman Estates, IL 60192USA
Date of Submission:	July 22, 2014
Identification of the product
Device Proprietary Name:	Symbia 6.0
Common/Classification Names:	Emission Computed Tomography per 21 CFR 892.1200Computed Tomography X-Ray System per 21 CFR 892.1750
Class:	II
Product Code:	KPS and JAK
Classification Panel:	Radiology
Marketed Devices to which Equivalence is claimed
Device	Manufacturer	510(k) Number
Symbia 5.0	Siemens Medical Solutions USA, Inc.	K131634

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Device Description:

Symbia 6.0 Family
SPECT only systems	e.cam	variable angle, dual detector gamma camera
	Symbia E Single	variable angle, single detector gamma camera
	Symbia E Dual	variable angle, dual detector gamma camera
	Symbia S	variable angle dual detector SPECT system
	Symbia Evo	variable angle dual detector SPECT system
	Symbia Evo Excel	variable angle dual detector SPECT system

SPECT/CT Systems	Symbia T series	a variable angle dual detector SPECT with a 2, 6, or 16-slice spiral CT
	Symbia Intevo Excel	SPECT/CT system with non-diagnostic CT support for only attenuation correction and anatomical localization
	Symbia Intevo Series	variable angle dual detector SPECT and 2, 6, or 16-slice spiral CT to give the system full functionality for all SPECT-only, xSPECT, or stand-alone CT diagnostic applications

Modifications in Symbia 6.0 include:

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Two new SPECT models: Evo and Evo Excel ●
Software upgrade to Windows® 7 Operating System and 3rd party software ● upgrades to support Windows® 7
o Implementation of commercially marketed CT software, IRIS (K133424, 'Synqo CT 2013A SOMARIS/5 VC20B')
. Hardware upgrades including modifications to the Dedicated Reconstruction System (DRS), rotate motor, and computer upgrade
o LPHR collimator

Indications for Use:

The Siemens Symbia series is intended for use by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and orqan 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.

SPECT: To detect or image the distribution of radionuclides in the body or organ, using the following techniques: planar imaging, whole body imaging, tomoqraphic imaging for isotopes with energies up to 588keV

CT: The CT component is intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from either the same axial plane taken at different anqles or spiral planes taken at different anqles.

SPECT+CT: Perform CT scans and nuclear imaging studies with the same instrument. To obtain attenuation corrected images and to provide registration of anatomical and physiological images within the patient's anatomy.

Software: The MI Applications software is a display and analysis package intended to aid the clinician in the assessment and quantification of pathologies taken from SPECT, PET, CT and other imaging modalities.

Technological Characteristics:

Symbia 6.0 systems are based on the commercially available Symbia 5.0 (K131634). The updates for the Evo Excel front bed, rotate motor and new optional LPHR collimator and software are based on the same fundamental technology of the predicate components. SPECT detector, existing collimators, and CT performance specifications do not change between the commercially available Symbia 5.0 systems and Symbia 6.0 systems The CT feature, IRIS, incorporated into the updated software, is a feature commercially available in 'syngo CT 2013A SOMARIS/5 VC20B' (K133424).

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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.

Symbia 6.0 is designed in accordance with the 60601-1 series including all relevant collateral standards general (IEC 60601-1, 1-2, 1-3, etc) and specific (IEC 60601-2-44). LPHR performance testing is conducted according to NEMA NU-1:2007. IRIS Image Quality testing has been performed with Catphan® and water phantoms on the 6 and 16 slice SPECT/CT systems. All Performance testing met the predetermined acceptance values.

LPHR Typical Values	3/8"
	Specification	Test Result
Intrinsic Spatial Resolution
FWHM in CFOV	$ \u2264 3.84mm $	Pass
FWTM in CFOV	$ \u2264 7.54mm $	Pass
FWHM in UFOV	$ \u2264 3.94mm $	Pass
FWTM in UFOV	$ \u2264 7.74mm $	Pass
Intrinsic Spatial Linearity		Pass
Differential in CFOV	$ \u2264 0.24mm $	Pass
Absolute in CFOV	$ \u2264 0.44mm $	Pass
Differential in UFOV	$ \u2264 0.24mm $	Pass
Absolute in UFOV	$ \u2264 0.69mm $	Pass

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.

Safety and Effectiveness:

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.

Symbia 6.0 conforms to applicable FDA recognized and international IEC, ISO and NEMA standards with reqards to performance and safety as required by the respective SPECT FDA Guidance Documents. SPECT detector and CT performance is conducted according to NEMA NU1:2007, and the performance does not change from the predicate device.

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Substantial Equivalence:

Symbia 6.0 has the same intended use and utilizes the same fundamental scientific technology as the predicate device. Siemens considers Symbia 6.0 to be as safe, as effective, and with performance substantially equivalent to the 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.