The Siemens Biograph HD 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 HD 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 HD 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 HD 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 Biograph HD systems which are the subject of this application are substantially equivalent to the commercially available Biograph 64/40 systems. Modifications include:

. Integration of system with the current Siemens Medical Solutions industrial design
. Improvement of performance characteristics of the PET and CT.

AI/ML Overview

This document is a 510(k) premarket notification for the "Biograph HD Systems" by Siemens Medical Solutions USA, Inc. This submission focuses on establishing substantial equivalence to a predicate device (Biograph 64, 40) for a combined PET/CT scanner. It does not contain a study comparing AI performance against acceptance criteria. The modifications described are related to industrial design and performance improvements of the PET and CT components, not the introduction of artificial intelligence functionality.

Therefore, most of the requested information regarding acceptance criteria and AI performance evaluation cannot be extracted from this document as it pertains to a traditional medical device (PET/CT scanner) submission rather than an AI/ML-enabled device.

However, based on the provided text, I can infer some general information about the device and its intended use.

Here's a breakdown of the requested information based on the provided text, with an emphasis on what is not applicable (N/A) due to the nature of the submission:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not specify acceptance criteria and reported device performance in the context of an AI study. The submission claims substantial equivalence to a predicate device due to "Improvement of performance characteristics of the PET and CT," but no specific metrics or targets are provided in the text for acceptance criteria.

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

N/A - This 510(k) submission is for a combined PET/CT scanner and does not present data from a test set for an AI algorithm.

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

N/A - This 510(k) submission is for a combined PET/CT scanner and does not present ground truth established by experts for an AI algorithm.

4. Adjudication Method for the Test Set

N/A - This 510(k) submission is for a combined PET/CT scanner and does not describe an adjudication method for an AI algorithm's test set.

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

N/A - This document is for a combined PET/CT scanner and does not describe an MRMC study related to AI assistance.

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

N/A - This document is for a combined PET/CT scanner and does not describe a standalone AI algorithm performance study.

7. The Type of Ground Truth Used

N/A - This document is for a combined PET/CT scanner and does not discuss ground truth in the context of validating an AI algorithm. The core functionality is to produce images; the "ground truth" for these images would be the physical reality of the patient's anatomy and physiology as depicted by a correctly functioning scanner.

8. The Sample Size for the Training Set

N/A - This document is for a combined PET/CT scanner and does not discuss a training set for an AI algorithm.

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

N/A - This document is for a combined PET/CT scanner and does not discuss how ground truth was established for an AI algorithm's training set.

Summary from the document:

Device Name: Biograph HD Systems
Device Type: Combined multi-slice X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) systems.
Purpose: Designed for whole body oncology, neurology, and cardiology examinations. Provides registration and fusion of high-resolution metabolic and anatomic information.
Modifications from Predicate: Integration with current Siemens Medical Solutions industrial design and improvement of performance characteristics of the PET and CT.
Safety and Effectiveness: Ensured via risk management (ISO 14971) and adherence to industry standards (IEC 60601-1 series, 21 CFR 1020.30, 21 CFR 1020.33) to minimize electrical, mechanical, and radiation hazards.
Intended Use: To be utilized by appropriately trained healthcare professionals to aid in detecting, localizing, diagnosing, staging, and restaging of lesions, tumors, disease, and organ function for evaluation of cardiovascular disease, neurological disorders, and cancer. Also for radiotherapy treatment planning and interventional radiology procedures.

Summary

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K081453
pg. 1 of 2

s required by 21 CFR Part 807.87(h)

		Identification of the Submitter- 4-4-4-4-4-4-4-4-4-4-48-44-48-44-44-44-44-4
------------------------------------------------------------------------------------------------------------------------------------------------------------------------------

JUN 2 3 2008

Submitter:	M. Alaine Medio, RACSr. Regulatory Affairs SpecialistSiemens Medical Solutions USA, Inc.Molecular Imaging810 Innovation DriveKnoxville, TN 37932
Telephone Number:	(865)218-2703
Fax Number:	(865)218-3019
Date of Submission:	May 16, 2008
Identification of the product
Device Proprietary Name:	Biograph HD 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

Marketed Devices to which Equivalence is claimed

Device	Manufacturer	510(k) Number
Biograph 64, 40	Siemens Medical Solutions USA,Inc	K060631

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K081453
pg. 2 of 2

Device Description:

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

The Biograph HD systems which are the subject of this application are substantially equivalent to the commercially available Biograph 64/40 systems. Modifications include:

. Inteqration of system with the current Siemens Medical Solutions industrial design
. Improvement of performance characteristics of the PET and CT.

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 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.

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 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.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. Inside the circle is a stylized graphic of three abstract shapes that resemble human profiles or flowing lines. The image is in black and white.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 2008

M. Alaine Medio, RAC Sr. Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. Molecular Imaging 810 Innovation Drive KNOXVILLE TN 37932

K081453 Re:

Trade/Device Name: Biograph HD Systems Regulation Number: 21 CFR §892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS and JAK Dated: May 22, 2008 Received: May 23, 2008

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.

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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); labcling (21 CFR Part 801); 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.

This letter will allow you to begin marketing your device as described in your Section 510/k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Nancy C. Brogdon

Nancy C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

1081453

Device Name: Biograph HD systems

Indications for Use:

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 anqles 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.

Prescription Use X (Part 21 CFR 801 Subpart D) OR

Over the Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Joani M. White

Page 1 of /

oductive. Abdominal, and 510(k) Number

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.