SIEMENS ENHANCED IMAGING SYSTEM

K041166 · Siemens Medical Solutions USA, Inc. · KPS · May 17, 2004 · Radiology

Device Facts

• Record ID: K041166
• Device Name: SIEMENS ENHANCED IMAGING SYSTEM
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: KPS · Radiology
• Decision Date: May 17, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Stand alone qamma camera and a gamma camera combined with an integral CT to be used for imaging of Nuclear Medicine scans, attenuation corrected images and fusion capabilities to assist in the registration and localization of emission images within the patient's anatomy. The proposed device is capable of performing both SPECT and CT protocols on the same machine.

Device Story

Hybrid imaging system combining gamma camera (SPECT) and CT scanner; enables SPECT and CT protocols on single instrument. SPECT component detects radioisotope tracer uptake; CT component reconstructs cross-sectional images from x-ray transmission data. System provides attenuation-corrected images and image fusion for anatomical/physiological registration. Used in clinical settings by healthcare professionals to identify regions of interest in patient anatomy. Upgraded electrical, computer, software, and mechanical components improve performance over predicate e.cam system. Output assists clinicians in localization and diagnostic decision-making.

Clinical Evidence

No clinical data. Evidence consists of bench and functional testing, software verification and validation, electrical safety, and environmental testing.

Technological Characteristics

Hybrid SPECT/CT system. SPECT: Gamma camera for radioisotope tracer detection. CT: X-ray transmission data acquisition for cross-sectional reconstruction. Includes upgraded electrical, computer, and mechanical components. Connectivity for data storage and display. Software-based image fusion and attenuation correction.

Indications for Use

Indicated for patients requiring SPECT radionuclide imaging (planar, whole body, tomographic up to 588keV) and/or CT cross-sectional imaging. Used for attenuation correction and registration/localization of anatomical and physiological images.

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

• Siemens, e.Cam Computer (K992731)
• Siemens, Ip 500 Nuclear Gamma Camera System (K952109)
• General Electric, Hawkeye Option for Dual-Head Variable Angle Gamma Camera (K991841)
• Siemens Somatom CT System (K023687)

Submission Summary (Full Text)

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# MAY 1 7 2004

## 510(k) Summary of Safety and Effectiveness

Submitted in accordance with 21 CFR 807.87(fr)

#### Proprietary Device Name

Siemens Enhanced Imaging System

## Establishment Name and Registration of Submitter

Siemens Medical Solutions USA, Inc. Nuclear Medicine Group 2501 N. Barrington Road Hoffman Estates, IL 60195 FDA Registration Number: 1423253 FDA Owner/Operator Number: 9010023

#### Date Prepared

March 30, 2004

#### Contact

Frank Pokrop Manager, Regulatory Affairs Phone: [phone] Fax: [phone] [e-mail]

#### Device Classification

Classification Code: Panel Identification: Classification Name:

Common Name: Device Classification:

KBS Radiology Emission Computed Tomography System, per 21 CFR 892.1200 Gamma Camera C Class II

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#### Reason for Submission

Modification of a legally marketed device

## Identification of Legally Marketed Equivalent Devices

| 510(k) Number | Date of Clearance | Device Name |
|---------------|-------------------|----------------------------------------------------------------------------------|
| K992731 | November 10, 1999 | Siemens, e.Cam Computer |
| K952109 | August 23, 1995 | Siemens, Ip 500 Nuclear Gamma Camera<br>System |
| K991841 | August 26, 1999 | General Electric, Hawkeye Option for<br>Dual-Head Variable Angle Gamma<br>Camera |
| K023687 | November 22, 2002 | Siemens Somatom CT System |

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#### 510/k) Summary of Safety and Effectiveness

Siemens Enhanced Imaging System Page 2 of 3

#### Proposed Device Description

The Siemens Enhanced Imaging System is an improved version of the e.cam gamma camera that now incorporates a CT.

The gamma camera is based on hardware and software features that generate nuclear medicine images based on the uptake of radioisotope tracers in a patient's body.

The CT system is designed 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 angles or spiral planes taken at different angles.

The Siemens Enhanced Imaging System is intended to allow healthcare facilities to carry out SPECT and CT studies using the same instrument.

### Description of Change or Modification

The Siemens Enhanced Imaging System has been modified to include upqraded electrical, computer, software and mechanical performance features that produce nuclear medicine images and CT-based attenuation corrected images in order to identify regions of interest in the patient's anatomy.

The device includes updated display equipment, data storage devices, patient and equipment supports and component parts and accessories.

#### Intended Use

Stand alone qamma camera and a gamma camera combined with an integral CT to be used for imaging of Nuclear Medicine scans, attenuation corrected images and fusion capabilities to assist in the registration and localization of emission images within the patient's anatomy. The proposed device is capable of performing both SPECT and CT protocols on the same machine.

#### Comparative Analysis

The Siemens Enhanced Imaging System has been demonstrated to be as safe and effective as the predicate devices for its intended use.

#### Summary of Studies

The Siemens Enhanced Imaging System has successfully undergone bench and functional testing as well as software verification and validation, electrical safety and environmental testing.

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## 510(k) Summary of Safety and Effectiveness

Siemens Enhanced Imaging System Page 3 of 3

## Discussions and Conclusions from Nonclinical Tests:

Data regarding the functional performance of the proposed device have been generated and reviewed. The results of testing conducted to validate and verify the design modifications demonstrate acceptable performance of the device. The test results do not raise any new or additional issues of safety or effectiveness.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms or extensions reaching upwards, symbolizing health, help, and well-being. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the figure.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# MAY 1 7 2004

Siemens Medical Solutions USA, Inc. % Mr. Ned Devine, Jr. Responsible Third Party Official Entela, Inc. 3033 Madison Ave. SE GRAND RAPIDS MI 49548

Re: K041166 Trade/Device Name: Siemens Enhanced Imaging System 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: 90 KPS and JAK Dated: March 30, 2004 Received: May 4, 2004

Dear Mr. Devine:

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.

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.

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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 promaticate 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 11 you doct of compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours,

Nancy C. Boyden

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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510(k) Number (if known): K041166

Device Name: Siemens Enhanced Imaging System

Indications for Use:

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

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

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

ﮯ Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Coneurrence of CDRH, Office of Device Evaluation (ODE)

David A. Legman

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