SOMATOM PERSPECTIVE

K113287 · Siemens Medical Solutions USA, Inc. · JAK · May 23, 2012 · Radiology

Device Facts

• Record ID: K113287
• Device Name: SOMATOM PERSPECTIVE
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: JAK · Radiology
• Decision Date: May 23, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The Siemens SOMATOM Perspective system 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 angles or spiral planes* taken at different angles. In addition the SOMATOM Perspective is able to produce additional image planes and analysis results by executing optional post-processing features, which operate on DICOM images. For cardiac imaging, which is an option on the system, a new reconstruction algorithm (iTRIM - Iterative Temporal Resolution Improvement Method) is used. iTRIM improves the temporal resolution of cardiac CT images compared to conventional cardiac CT image reconstruction. Actual results obtained with iTRIM can vary depending on the particular clinical situation. The images and results delivered by the SOMATOM Perspective can be used by a trained physician as an aid in diagnosis. (*spiral planes: the axial planes resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

Device Story

Computed Tomography (CT) system; utilizes continuously rotating tube-detector assembly; fan beam principle. Inputs: X-ray transmission data. Outputs: Cross-sectional DICOM images; analysis results. Operated by trained physicians/technicians in clinical settings. Features iTRIM (Iterative Temporal Resolution Improvement Method) for cardiac imaging to enhance temporal resolution; ECO Mode (eMode) for tube power management. System performs patient management, scan control, image reconstruction, and archiving. Output aids physician diagnosis; clinical decision-making supported by reconstructed images and post-processing analysis.

Clinical Evidence

Bench testing only. Verification and validation testing performed during product development. Phantom testing conducted. Risk analysis completed and hazards mitigated. Testing results met all software specifications and acceptance criteria.

Technological Characteristics

64-row CT system; Dura 688-MV X-ray tube (55 kW); 64x736 detector channels. Software: SOMARIS/5 (Windows XP-based). Features iTRIM reconstruction algorithm and eMode power management. Connectivity: DICOM standard. Energy source: X-ray.

Indications for Use

Indicated for patients requiring cross-sectional body imaging via CT. Used by trained physicians as an aid in diagnosis. Cardiac imaging option available for improved temporal resolution.

Regulatory Classification

Identification

A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Siemens SOMATOM Emotion 16 (K050297)

Submission Summary (Full Text)

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MAY 2 3 2012

### 510(k) Summary for SOMATOM Perspective

Company: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355

#### Date Prepared: May 21, 2012

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

#### 1 -Contact Person:

Kimberly Mangum Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway D-02 Malvern, PA 19355-1406 Email: [e-mail] Phone: [phone] Fax: [phone]

#### 2. Device Name and Classification:

| Product Name: | SOMATOM Project P68 |
|-----------------------|----------------------------------|
| Propriety Trade Name: | SOMATOM Perspective |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | 90 JAK |

#### 3. Substantial Equivalence:

Siemens SOMATOM Perspective Computed Tomography X-ray system, configured with software SOMARIS/5 is substantially equivalent to the following medical device in commercial distribution:

| Predicate Device Name | FDA Clearance<br>Number | FDA Clearance<br>Date |
|----------------------------|-------------------------|-----------------------|
| Siemens SOMATOM Emotion 16 | K050297 | 03/01/2005 |

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#### Device Description: 4.

Similar to the predicate device (Siemens SOMATOM Emotion 16 premarket notification K050297, clearance date 03/01/2005), Siemens SOMATOM Perspective is a Computed Tomography X- ray System, which features a continuously rotating tube-detector system and functions according to the fan beam principle. The system software is a command-based program used for patient management, data management, X-ray scan control, image reconstruction, and image archive/evaluation.

The SOMATOM Perspective system produces CT images in DICOM format, which can be used by post processing applications commercially distributed by Siemens and other vendors.

SOMATOM Perspective operates with software version SOMARIS/5 which is a Windows XP®1 based program used for patient management, data management. X-ray scan control, image reconstruction, and image archive/evaluation.

The key software new features for SOMATOM Perspective are iTRIM (Iterative Temporal Resolution Improvement Method) to improve the temporal resolution to a value of about 80% of that of conventionally reconstructed images, and ECO Mode (eMode) to increase the tube life by reducing the tube power.

The computer system delivered with the CT scanner is able to run such post processing applications optionally.

#### Indications for Use: 5.

The Siemens SOMATOM Perspective system 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 angles or spiral planes* taken at different angles.

In addition the SOMATOM Perspective is able to produce additional image planes and analysis results by executing optional postprocessing features, which operate on DICOM images.

For cardiac imaging, which is an option on the system, a new reconstruction algorithm (iTRIM - Iterative Temporal Resolution Improvement Method) is used. iTRIM improves the temporal resolution of cardiac CT images compared to conventional cardiac CT image reconstruction. Actual results obtained with iTRIM can vary depending on the particular clinical situation.

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The images and results delivered by the SOMATOM Perspective can be used by a trained physician as an aid in diagnosis.

(*spiral planes: the axial planes resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

#### 6. Substantial Equivalence:

Siemens believes that SOMATOM Perspective is substantially equivalent to SOMATOM Emotion 16 (premarket notification K050297, clearance date 03/01/2005).

The differences between SOMATOM Perspective and SOMATOM Emotion 16 are listed below:

| | Subject<br>SOMATOM<br>Perspective | Predicate<br>SOMATOM Emotion<br>16 (P10) |
|--------------------------------------------|-----------------------------------|------------------------------------------|
| X-Ray Assembly<br>Tube<br>Max.Power | Dura 688-MV<br>55 kW | Dura 422-MV<br>50kW |
| Detector rows | 64 | 16 |
| Total number of detector<br>channels | 64x736 | 16x736 |
| Measuring channels | 64x1472 | 16x1472 |
| Spiral scan performance | | |
| - Pitch factor | up to 1.5<br>100 sec | up to 2.0<br>100 sec |
| - Max. uninterrupted scan<br>time | | |
| Software Image<br>Reconstruction Algorithm | with iTRIM | without iTRIM |
| Software Scan Mode | with eMode | without eMode |

The mechanical structures of both systems are same. Except for detectors and tube, most components are reused or with minor modification to improve the performance matching the 64 rows detectors.

#### 7. Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:

SOMATOM Perspective does not have significant changes in materials, energy source, or technological characteristics when compared to the

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predicate device. The intended use and fundamental scientific technology are similar to the predicate device; therefore Siemens believes that they are substantially equivalent to this predicate device.

#### 8. Nonclinical Testing:

Non clinical tests are conducted for SOMATOM Perspective during product development. This includes verification and validation testing as well as phantom testing. The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria.

Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.

#### General Safety and Effectiveness Concerns: ഗ്

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 hazard analysis, which is used to identify potential hazards. These potential hazards are controlled during development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards. Siemens adheres to recognized and established industry practice and standards.

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized emblem featuring three abstract, wave-like shapes stacked vertically, resembling a human form.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

Ms. Kimberly Magnum Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway, G-01 MALVERN PA 19355-1406

MAY 2 3 2012

Re: K113287

Trade/Device Name: SOMATOM Perspective Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: April 20, 2012 Received: April 23, 2012

### Dear Ms. Magnum:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. 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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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## Attachment A Indications for Use

510(k) Number (if known): K113287

Device Name:

### SOMATOM Perspective

Indications for Use:

The Siemens SOMATOM Perspective system is intended to produce crosssectional 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.

In addition the SOMATOM Perspective is able to produce additional image planes and analysis results by executing optional post-processing features, which operate on DICOM images.

For cardiac imaging, which is an option on the system, a new reconstruction algorithm (iTRIM - Iterative Temporal Resolution Improvement Method) is used. iTRIM improves the temporal resolution of cardiac CT images compared to conventional cardiac CT image reconstruction. Actual results obtained with iTRIM can vary depending on the particular clinical situation.

The images and results delivered by the SOMATOM Perspective can be used by a trained physician as an aid in diagnosis.

(*spiral planes: the axial planes resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)

Prescription Use _____________________________________________________________________________________________________________(21 CFR 801 Subpa

(21 CFR 801 Subpart C)

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

Concurrence of CDRH. Office of In Vitro Diagnostic Devices (OIVD)

(Division Sign-Off)
Division of Radiological Devices

510K

Office of In Vitro Diagnostic Device Evaluatio