(198 days)
No
The document describes an iterative reconstruction algorithm (iTRIM) and standard CT system functions, but does not mention AI, ML, or related concepts like neural networks or deep learning.
No.
The device is described as an imaging system used to produce cross-sectional images for diagnostic aid, not for therapeutic purposes.
Yes
The device is described as producing images and results that "can be used by a trained physician as an aid in diagnosis," which clearly indicates its role in the diagnostic process.
No
The device description explicitly states it is a "Computed Tomography X-ray System" with a "continuously rotating tube-detector system," indicating it includes significant hardware components beyond just software.
Based on the provided text, the Siemens SOMATOM Perspective system is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- SOMATOM Perspective Function: The SOMATOM Perspective system is a Computed Tomography (CT) X-ray system. It produces images of the inside of the body by using X-rays and computer reconstruction. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it produces cross-sectional images of the body and provides analysis results based on these images. This is consistent with an in-vivo imaging device, not an in-vitro diagnostic device.
Therefore, the SOMATOM Perspective is an in-vivo imaging device, not an IVD.
N/A
Intended Use / Indications for 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.)
Product codes
90 JAK
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray transmission data
Anatomical Site
body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained physician
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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 Clearance
Number | FDA Clearance
Date |
|----------------------------|-------------------------|-----------------------|
| Siemens SOMATOM Emotion 16 | K050297 | 03/01/2005 |
1
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.
2
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
SOMATOM
Perspective | Predicate
SOMATOM Emotion
16 (P10) |
|--------------------------------------------|-----------------------------------|------------------------------------------|
| X-Ray Assembly
Tube
Max.Power | Dura 688-MV
55 kW | Dura 422-MV
50kW |
| Detector rows | 64 | 16 |
| Total number of detector
channels | 64x736 | 16x736 |
| Measuring channels | 64x1472 | 16x1472 |
| Spiral scan performance | | |
| - Pitch factor | up to 1.5
100 sec | up to 2.0
100 sec |
| - Max. uninterrupted scan
time | | |
| Software Image
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
3
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.
4
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
5
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
6
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