BIOGRAPH 16 TRUE POINT SYSTEMS

K083852 · Siemens Medical Solutions USA, Inc. · KPS · Mar 23, 2009 · Radiology

Device Facts

• Record ID: K083852
• Device Name: BIOGRAPH 16 TRUE POINT SYSTEMS
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: KPS · Radiology
• Decision Date: Mar 23, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2

Intended Use

The Siemens Biograph 16 True Point 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 Story

Biograph 16 True Point system combines X-Ray CT and PET scanners; provides registered/fused metabolic and anatomic images. Inputs: X-ray transmission data and PET radiopharmaceutical distribution. Operation: CT reconstructs cross-sectional images; PET measures radiopharmaceutical distribution; CT data used for PET attenuation correction. System includes patient handling, acquisition/processing workstations, and software. Used in clinical settings by trained healthcare professionals. Output: Fused PET/CT images for diagnosis, staging, and treatment planning. Benefits: Improved anatomical reference for metabolic data; enables single or dual-modality imaging.

Clinical Evidence

No clinical data provided. Safety and effectiveness supported by risk analysis, adherence to established industry standards (IEC 60601-1, 21 CFR 1020.30/33), and substantial equivalence to previously cleared predicate devices.

Technological Characteristics

Combined PET/CT scanner. CT component: X-ray transmission data reconstruction. PET component: Radiopharmaceutical distribution measurement. Connectivity: DICOM compliant. Software: Command-based for patient/data management, scan control, image reconstruction, and archival. Safety standards: ISO 14971, IEC 60601-1, 21 CFR 1020.30, 21 CFR 1020.33.

Indications for Use

Indicated for use in humans for diagnostic imaging of cardiovascular disease, neurological disorders, and cancer. Aids in detection, localization, diagnosis, staging, and restaging of lesions, tumors, and organ function. Used for radiotherapy treatment planning and interventional radiology procedures.

Regulatory Classification

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.

Predicate Devices

• Biograph 64, 40 (K060631)
• Biograph mCT systems (Biograph HD) (K081453)
• Somatom Project P10G (K050297)

Submission Summary (Full Text)

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Siemens Biograph True Point 510(k) Premarket Notification

K083852
Page 1 of 2

## 510(k) Summary

as required by 21 CFR Part 807.87(h)

·

:

### Identification of the Submitter

| Submitter: | M. Alaine Medio, RAC<br>Sr. Regulatory Affairs Specialist<br>Siemens Medical Solutions USA, Inc.<br>Molecular Imaging<br>810 Innovation Drive<br>Knoxville, TN 37932 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone Number: | [phone] |
| Fax Number: | [phone] |
| Date of Submission: | December 23, 2008 |
| Identification of the product | |
| Device Proprietary Name: | Biograph True Point System |
| Common Name: | Positron Emission Tomography (PET) System<br>Computed Tomography (CT) System |
| Classification Name: | Emission Computed Tomography System per 21 CFR<br>892.1200<br>Computed Tomography X-Ray System per 21 CFR<br>892.1750 |
| 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,<br>Inc. | K060631 |
| Biograph mCT systems<br>(Biograph HD) | Siemens Medical Solutions USA,<br>Inc. | K081453 |
| Somatom Project P10G | Siemens Medical Solutions USA,<br>Inc. | K050297 |

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K083852
Page 2 of 2

## Device Description:

The Biograph True Point 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 True Point 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 True Point 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 Biograph True Point systems which are the subject of this application are substantially equivalent to the commercially available Biograph mCT and Biograph True Point 64/40 systems and the Siemens Somatom CTs. Modifications include the integration of CT, PET and Patient Handling Systems to create an additional model to the Biograph True Point family of systems, and update of the system software.

#### 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.

### Indications for Use:

The Siemens Biograph True Point 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, turnors, 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 logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, overlaid on three human profiles. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the symbol.

#### Public Health Service

MAR 2 3 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

Re: K083852

Trade/Device Name: Biograph 16 True Point Systems Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS and JAK Dated: December 23, 2008 Received: December 24, 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); 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 os 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) | [phone] |
|----------------|----------------------------------|----------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | [phone] |
| 21 CFR 892.xxx | (Radiology) | [phone] |
| Other | | [phone] |

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (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 Manufactures, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry.suppor/index.html.

Sincerely yours,

Janine M. Morris

anine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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# Indications for Use

K083852

510(k) Number (if known):

Device Name: Biograph 16 True Point systems

Indications for Use:

The Siemens Biograph 16 True Point 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 I 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)

Over the Counter Use_ (21 CFR 801 Subpart C)

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

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)

Helens Reiner

Page 1 of

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number.