The Siemens PET/CT scanners are combined Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) scanners. The Biograph 6 is intended to be utilized by appropriately trained health care professionals to:

o Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and
Produce cross-sectional images of the body by computer reconstruction of o XRay transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.

The Biograph 6 PET/CT provides registration and fusion of high-resolution metabolic and anatomic information. The PET component utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for fused PET and CT images. Additionally, the system maintains independent functionality of the PET and CT devices, allowing for single modality CT and / or PET diagnostic imaging.

Device Description

The Biograph 6 TruePoint scanners are combined Positron Emission Tomography and X-Ray Computed Tomography scanners. These systems are designed for whole-body oncology, neurology, and cardiology examinations. They provide registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system, the Siemens LSO PET scanner and the Siemens Somatom Emotion 6 CT.

The combined PET/CT scanner is intended for use as a clinical, whole-body oncology machine with high-end spiral CT and PET performance. The CT component provides fast attenuation correction for PET studies as well as precise anatomical reference through fused PET and CT images. In addition, the PET / CT system maintains independent functionality of the PET and CT scanning systems, allowing for most standard stand-alone CT and PET clinical diagnostic protocols to be available as well.

The Biograph 6 system which is the subject of this application is substantially equivalent to the commercially available Biograph 6 (K060060) and the commercially available Biograph 64 and Biograph 40 (K060631). The notable changes incorporated in this application consist of the addition of a water-cooled gantry option and an optional computer.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Biograph 6 TruePoint device, based on the provided text:

Important Note: The provided 510(k) summary focuses heavily on establishing substantial equivalence to previously cleared devices rather than detailing the direct performance testing of the Biograph 6 TruePoint against specific numerical acceptance criteria. The text explicitly states, "The Biograph 6 system which is the subject of this application is substantially equivalent to the commercially available Biograph 6 (K060060) and the commercially available Biograph 64 and Biograph 40 (K060631)." This implies that the performance of the Biograph 6 TruePoint is considered acceptable because it is demonstrably similar to devices already on the market and cleared by the FDA for the same intended use. Therefore, the "acceptance criteria" are intrinsically tied to the performance characteristics of the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

As noted above, explicit numerical acceptance criteria for this specific device are not presented in the provided text. The "acceptance" is based on substantial equivalence to the predicate devices. However, we can infer the expected performance that formed the basis for this equivalence.

Performance Metric (Implied Acceptance Basis)	Reported Device Performance (as inferred from predicate equivalence)
Ability to Image and Measure Distribution of Injected Positron Emitting Radiopharmaceuticals for Metabolic/Physiologic Functions	Equivalent to Biograph 6 (K060060), Biograph 64 and Biograph 40 (K060631) in its ability to perform these functions effectively for whole-body oncology, neurology, and cardiology.
Ability to Produce Cross-Sectional Images by CT Reconstruction	Equivalent to Biograph 6 (K060060), Biograph 64 and Biograph 40 (K060631) in providing high-end spiral CT performance.
Registration and Fusion of Metabolic (PET) and Anatomic (CT) Information	Equivalent to Biograph 6 (K060060), Biograph 64 and Biograph 40 (K060631) in providing high-resolution registration and fusion.
CT for Fast Attenuation Correction Maps for PET Studies	Equivalent to Biograph 6 (K060060), Biograph 64 and Biograph 40 (K060631) in providing fast attenuation correction.
Precise Anatomical Reference for Fused PET and CT Images	Equivalent to Biograph 6 (K060060), Biograph 64 and Biograph 40 (K060631) in providing precise anatomical reference.
Independent Functionality of PET and CT Systems	Equivalent to Biograph 6 (K060060), Biograph 64 and Biograph 40 (K060631) in maintaining independent functionality for single modality imaging.

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

The provided text does not include information on a specific test set, its sample size, or data provenance for the Biograph 6 TruePoint itself. The submission relies on demonstrating substantial equivalence to pre-existing, cleared devices. Therefore, there's no mention of a separate test set used to independently validate the Biograph 6 TruePoint's performance in a clinical setting against acceptance criteria.

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

Since there is no mention of a specific test set or clinical study for the Biograph 6 TruePoint in the provided document, there is no information on the number or qualifications of experts used to establish ground truth.

4. Adjudication Method for the Test Set

As there is no mention of a test set, there is no information on an adjudication method.

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

The provided text does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The focus is on demonstrating substantial equivalence, not on comparing performance with or without AI assistance (as this is a medical imaging device, not an AI-driven interpretation tool in this context).

6. Standalone Performance Study

While the device operates "stand-alone" in the sense that it performs its imaging functions independently, the document does not describe a specific standalone performance study that rigorously evaluated its performance against predefined metrics, separate from the human-in-the-loop clinical use context. The substantial equivalence argument implicitly serves this purpose by referencing the proven performance of predicate devices.

7. Type of Ground Truth Used

Given the nature of a 510(k) submission focused on substantial equivalence for an imaging device, the "ground truth" for the predicate devices (and thus, implicitly for this device) would have been established through methodologies typical for medical imaging, likely involving:

Clinical correlation: Comparing imaging findings with other diagnostic tests, patient outcomes, or surgical/biopsy results.
Expert consensus: Interpretations by experienced radiologists or nuclear medicine physicians.
Physical phantom studies: For technical performance metrics like resolution, signal-to-noise ratio, etc.

However, the provided document does not explicitly state the specific type of ground truth used for the original predicate device clearances, nor for any new studies conducted for the Biograph 6 TruePoint.

8. Sample Size for the Training Set

This document describes a medical imaging device (PET/CT scanner), not typically an AI/machine learning algorithm requiring a "training set" in the conventional sense. Therefore, the concept of a training set sample size is not applicable to this submission.

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

Since the concept of a "training set" as understood in AI/machine learning is not applicable here, this information is not present in the document.

Summary

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K07/068

SIEMENS

510(k) Summary as required by 21 CFR Part 807.92

MAY 1 4 2007

Identification of the Submitter:

Submitter:	Cristin Wetherbee
Telephone Number:	865.218.2343
Fax Number:	865.218.3019
Date of Submission:	13 April 2007

Identification of the Product:

Device Proprietary Name: Biograph 6 TruePoint

Common Name:	Combination Positron Emission Tomography (PET)and Computed Tomography (CT) system
Classification Name:	Emission Computed Tomography System per 21CFR 892.1200, Computed Tomography X-Ray

System per 21 CFR 892.1750

Marketed Devices to which Equivalence is Claimed:

Device:	Manufacturer:	510(k) Number:
Biograph 6	Siemens Medical Solutions USA, Inc.Molecular Imaging	K060060
Biograph 64 andBiograph 40	Siemens Medical Solutions USA, Inc.Molecular Imaging	K060631

Device Description:

Siemens Medical Solutions USA, Inc.

Molecular Imaging

810 Innovation Drive Knoxville, TN 37932-2751 Tel: (865) 218-2000 www.siemens.com/medical

Page 13 of 490

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SIEMENS

information from the two major components of each system, the Siemens LSO PET scanner and the Siemens Somatom Emotion 6 CT.

Indications for Use:

o Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and
o Produce 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 Biograph 6 TruePoint PET/CT provides registration and fusion of highresolution metabolic and anatomic information. The PET component utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for fused PET and CT images. Additionally, the system maintains independent functionality of the PET and CT devices, allowing for single modality CT and / or PET diagnostic imaging.

Siemens Medical Solutions USA, Inc.

Molecular Imaging

810 Innovation Drive Knoxville, TN 37932-2751 Tel: (865) 218-2000 www.siemens.com/medical

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Mr. Cristin Wetherbee Regulatory Technology Specialist Siemens Medical Solutions USA, Inc. Molecular Imaging 810 Innovation Drive KNOXVILLE TN 37932

MAY 1 4 2007

Re: K071068

Trade/Device Name: Biograph 6 TruePoint Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: KPS and JAK Dated: April 13, 2007 Received: April 16, 2007

Dear Mr. Wetherbee:

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 (Premarket Approval), 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.

Image /page/2/Picture/10 description: The image is a circular logo or emblem. The text "1906-2006" is at the top of the logo. The letters "FDA" are in the center of the logo in a bold, sans-serif font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are at the bottom of the logo.

Protecting and Promoting Public Health

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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); labeling (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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. hogdon

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):

K071068

Device Name: Biograph 6 TruePoint

Indications for Use:

o Image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body; and
Produce cross-sectional images of the body by computer reconstruction of o XRay transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles.

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

Nancy C. Brogdon

on of Reproduct

Page 1 of 1

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.