SOMATOM PERSPECTIVE by SIEMENS MEDICAL SOLUTIONS USA, INC.

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 Description

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.

AI/ML Overview

The provided document is a 510(k) summary for the Siemens SOMATOM Perspective CT system. It does not contain acceptance criteria for device performance or the details of a study demonstrating that the device meets such criteria in terms of clinical output or diagnostic accuracy.

The summary focuses on demonstrating substantial equivalence to a predicate device (Siemens SOMATOM Emotion 16) based on technical characteristics and intended use. The "Nonclinical Testing" section mentions verification and validation testing, as well as phantom testing, but it does not provide specific acceptance criteria or detailed results from these tests in relation to clinical performance or diagnostic outcomes.

Therefore, for almost all of the requested information, the answer will be "Not provided in the document."

Here's a breakdown based on the information provided:

Acceptance Criteria and Device Performance Study for SOMATOM Perspective

The 510(k) summary provided does not detail specific acceptance criteria related to clinical performance (e.g., diagnostic accuracy, sensitivity, specificity) for the SOMATOM Perspective, nor does it present a study demonstrating the device meets such criteria for clinical or diagnostic endpoints.

The document primarily focuses on demonstrating substantial equivalence to a predicate device based on technical specifications and functionality, particularly for the new features like iTRIM and eMode. It mentions that "The testing results supports that all the software specifications have met the acceptance criteria," but these "software specifications" are not defined in terms of clinical outcomes or performance metrics in a way that would answer the specific questions below.

The "Nonclinical Testing" section refers to phantom testing and verification/validation, which are typical for medical device submissions, but no specific performance statistics are presented.

Therefore, the following information is largely not available from this document:

Table of Acceptance Criteria and Reported Device Performance: This information is not provided. The document states that "all the software specifications have met the acceptance criteria" but does not define these criteria or report specific performance metrics (like diagnostic accuracy, sensitivity, etc.) relevant to a clinical study.
Sample Size Used for the Test Set and Data Provenance: Not provided. The document mentions "nonclinical tests" including "phantom testing" but does not describe a test set based on patient data, its size, or provenance.
Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts: Not provided. Since a clinical test set with ground truth is not described, this information is not applicable here.
Adjudication Method for the Test Set: Not provided. As no clinical test set for diagnostic performance is described, no adjudication method is mentioned.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No MRMC comparative effectiveness study is mentioned in the provided text. The document refers to the iTRIM algorithm improving temporal resolution, stating that "Actual results obtained with iTRIM can vary depending on the particular clinical situation," but it doesn't quantify this improvement in terms of human reader performance or diagnostic effectiveness compared to a standard method.
Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study: No standalone diagnostic performance study (e.g., sensitivity, specificity, AUC) for the algorithm itself is presented. The document states that the images and results "can be used by a trained physician as an aid in diagnosis," implying human-in-the-loop operation, but no performance metrics for such use are provided.
Type of Ground Truth Used: Not provided. Since no clinical performance study is detailed, the type of ground truth is not mentioned.
Sample Size for the Training Set: Not provided. The document does not describe the development or training of an AI model with a training set.
How the Ground Truth for the Training Set was Established: Not provided. As no training set is described, this information is not applicable.

Summary

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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: Kimberly.mangum@siemens.com Phone: (610) 448-4912 Fax: (610) 448-1787

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 ClearanceNumber	FDA ClearanceDate
Siemens SOMATOM Emotion 16	K050297	03/01/2005

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Device Description: 4.

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.

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

Indications for Use: 5.

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.

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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:

	SubjectSOMATOMPerspective	PredicateSOMATOM Emotion16 (P10)
X-Ray AssemblyTubeMax.Power	Dura 688-MV55 kW	Dura 422-MV50kW
Detector rows	64	16
Total number of detectorchannels	64x736	16x736
Measuring channels	64x1472	16x1472
Spiral scan performance
- Pitch factor	up to 1.5100 sec	up to 2.0100 sec
- Max. uninterrupted scantime
Software ImageReconstruction 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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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 (301) 796-5450. 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 (800) 638-2041 or (301) 796-7100 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.

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

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
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.(b)
Classification. Class II.