SOMATOM DEFINITION FLASH

K113342 · Siemens Medical Systems, Inc. · JAK · Dec 29, 2011 · Radiology

Device Facts

• Record ID: K113342
• Device Name: SOMATOM DEFINITION FLASH
• Applicant: Siemens Medical Systems, Inc.
• Product Code: JAK · Radiology
• Decision Date: Dec 29, 2011
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2

Intended Use

The Siemens SOMATOM Definition Flash (with Stellar Detector) 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 Definition Flash (with Stellar Detector) 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 system 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 two continuously rotating tube-detector systems; operates on fan beam principle. Inputs: X-ray transmission data. Processing: Computer reconstruction of data into cross-sectional images; optional post-processing of DICOM images for analysis. Outputs: DICOM-format CT images and analysis results. Used in clinical settings by trained physicians. System aids in diagnosis by providing anatomical visualization and analysis. Benefits: Enables non-invasive cross-sectional body imaging for diagnostic purposes.

Clinical Evidence

No clinical data provided. Safety and effectiveness established through hazard analysis, verification, and validation testing.

Technological Characteristics

Dual-source CT system; fan beam geometry; Stellar Detector technology. Software: SOMARIS/7. Connectivity: DICOM-compliant. System includes computer for scan control, image reconstruction, and archiving. Adheres to recognized industry standards for electrical, mechanical, and radiation safety.

Indications for Use

Indicated for patients requiring cross-sectional imaging of the body via CT reconstruction. Used by trained physicians as an aid in diagnosis. No specific age or gender contraindications stated.

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 FLASH DS (K082220)

Submission Summary (Full Text)

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# TEM ENS

Section 5: 510(k) Summary

## 510(K) SUMMARY FOR SOMATOM DEFINITION Flash (with Stellar Detector)

DEC 2 9 2011

### Submitted by:

Siemens Medical Solutions USA, Inc.

51 Valley Stream Parkway

Malvern, PA 19355

Novemberr 9, 2011

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.

#### Contact Person: 1.

Mrs. Alicia Bustos-Juergensen Technical Specialist, Regulatory Affairs Submissions

Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway E-50 Malvern, PA 19355-1406 Phone:[phone] Fax: [phone]

#### 2. Device Name and Classification

| Product Name: | SOMATOM Definition Flash (with Stellar Detector) | |
|-----------------------|--------------------------------------------------|--|
| Propriety Trade Name: | SOMATOM Definition Flash | |
| Classification Name: | Computed Tomography X-ray System | |
| Classification Panel: | Radiology | |
| CFR Section: | 21 CFR §892.1750 | |
| Device Class: | Class II | |
| Product Code: | 90 JAK | |

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#### 3. Substantial Equivalence:

Siemens SOMATOM Definition Flash (with Stellar Detector) Computed Tomography Xray system, configured with software SOMARIS/7 is substantially equivalent to the following medical device in commercial distribution:

| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|--------------------------|----------------------|--------------------|
| Siemens SOMATOM FLASH DS | K082220 | 10/10/2008 |

#### 4. Device Description:

The Siemens SOMATOM Definition Flash (with Stellar Detector) is a Computed Tomography X- ray System, which features two continuously rotating tube-detector systems 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 Definition Flash (with Stellar Detector) 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.

#### 5. Indications for Use:

The Siemens SOMATOM Definition Flash (with Stellar Detector) 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 Definition Flash (with Stellar Detector) 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 system 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 xray tube, and the simultaneous translation of the patient.)

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#### 6. General Safety and Effectiveness Concerns:

EMENS

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/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services - USA. The seal features a circular design with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling a caduceus, a symbol often associated with healthcare. The emblem consists of a staff with a serpent entwined around it.

Public Health Service

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

DEC 2 9 2011

Ms. Kim Mangum Regulatory Affairs Technical Specialist Siemens Medical Solutions, USA Inc. 51 Valley Stream Parkway Mail Code D02 MALVERN PA 19355

Re: K113342

Trade/Device Name: SOMATOM Definition Flash (with Stellar Detector) Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: November 9, 2011 Received: November 14, 2011

Dear Ms. Mangum:

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. Ilsting 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.

Mary Pastel

Mary S. Pastel, Sc.D. 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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## SIEMENS

510(k) Number (if known):

Product Name:

SOMATOM Definition Flash (with Stellar Detector)

### Indications for Use:

The Siemens SOMATOM Definition Flash (with Stellar Detector) 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 Definition Flash (with Stellar Detector) 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 system 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 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 OF NEEDED)

AND/OR

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

Mary S. Postel

Division Sigr Office of In Vitro Diagnostic Device Evaluation

510(k) K113342