(146 days)
No
The document describes standard CT image reconstruction and processing techniques (like iterative beam hardening correction) but does not mention AI, ML, or related concepts like neural networks or deep learning. The focus is on hardware and traditional software control and processing.
No
The device is a diagnostic imaging system intended to generate images for diagnosis, not to provide therapy.
Yes
The "Intended Use / Indications for Use" section explicitly states that the images delivered by the system "can be used by a trained physician as an aid in diagnosis." This directly indicates its role in the diagnostic process.
No
The device description clearly states it is a "whole body X-ray Computed Tomography System" and features "two continuously rotating tube-detector systems," indicating it is a hardware device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the system is for generating and processing cross-sectional images of patients using x-ray transmission data. These images are used by a physician as an aid in diagnosis. This describes an in vivo imaging system, where the device interacts directly with the patient's body.
- Device Description: The description details a whole body X-ray Computed Tomography System, which is a type of medical imaging equipment used on living patients.
- Input Imaging Modality: The input is X-ray, which is applied to the patient.
- Anatomical Site: The device is for the "whole body," indicating it's used on a living organism.
In Vitro Diagnostics (IVDs) are medical devices that are used to examine specimens, such as blood, urine, or tissue, that have been taken from the human body. They are used to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by a trained physician as an aid in diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
90JAK
Device Description
The SOMATOM Force is a whole body X-ray Computed Tomography System which features two continuously rotating tube-detector systems and functions according to the fan beam principle. The SOMATOM Force produces CT images in DICOM format, which can be used by postprocessing applications commercially distributed by Siemens and other vendors.
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 computer system delivered with the CT scanner is able to run the post processing applications optionally.
Mentions image processing
The SOMATOM Force produces CT images in DICOM format, which can be used by postprocessing applications commercially distributed by Siemens and other vendors.
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 Force is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission.
The SOMATOM Force also supports Iterative Beam Hardening Correction (IBHC). The Iterative Beam Hardening Correction (IBHC) feature is an extension of the Posterior Fossa Optimization (PFO) feature. The PFO feature was cleared as part of the SOMATOM Definition Flash (K082220, clearance date October 10, 2008) and part of the predicate device SOMATOM Definition Flash (K121072, clearance date May 08, 2012).
IBHC is a raw data based beam hardening correction method designed to improve image quality. IBHC uses 3D forward projection, and an additional two-compartment iodine/water model to reduce beam hardening artifacts while maintaining anatomical structures.
This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by a trained physician as an aid in diagnosis.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray transmission data
Anatomical Site
Whole 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 (integration and functional) and phantom testing were conducted for the SOMATOM Force during product development. The modifications described in this Premarket Notification were supported with verification/validation 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. EMC/electrical safety was evaluated according to the IEC Standards. Siemens certify conformance to Voluntary Standards covering Electrical and Mechanical Safety. In conclusion, the identified risk of electrical hazards was mitigated and is substantially equivalent to the predicate device in terms of safety and effectiveness. All testing and validation has been completed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
SIEMENS
APR 1 7 2014
510(K) SUMMARY FOR . SOMATOM Force
Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
Date Prepared: November 21, 2013
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.
-
- General Information
Importer/Distributor: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
- General Information
Establishment Registration Number: 2240869
Manufacturing Site: SIEMENS AG. MEDICAL SOLUTIONS Siemensstrasse 1 91301 Forchheim, GERMANY
Establishment Registration Number: 3004977335
2. Contact Person:
Mrs. Kimberly Manqum Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway D02 Malvern, PA 19355-1406 Phone: (610) 448-1772 Fax: (610) 448-1778 Email: kimberly mangum@siemens.com
Device Name and Classification 3.
SOMATOM Force Product Name: SOMATOM Force Propriety Trade Name: Computed Tomography X-ray System Classification Name: Radiology Classification Panel: 21 CFR §892.1750 CFR Section:
1
Device Class: Class II Product Code: 90JAK Legally Marketed Predicate Devices SOMATOM Definition Flash Trade Name: K21072 510(k)#: May 08, 2012 Clearance Date: System, X-Ray, Tomography, Computed Classification Name: Classification Panel: Radiology Classification Regulation:21 CFR § 892.1750 Device Class: 90 JAK Product Code:
4. Substantial Equivalence:
Siemens SOMATOM Force is substantially equivalent to the following medical devices in commercial distribution:
| Predicate Device Name | FDA Clearance
Number | FDA Clearance
Date |
|--------------------------|-------------------------|-----------------------|
| SOMATOM Definition Flash | K121072 | May 08, 2012 |
Device Description: 5.
The SOMATOM Force is a whole body X-ray Computed Tomography System which features two continuously rotating tube-detector systems and functions according to the fan beam principle. The SOMATOM Force produces CT images in DICOM format, which can be used by postprocessing applications commercially distributed by Siemens and other vendors.
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 computer system delivered with the CT scanner is able to run the post processing applications optionally.
- Summary of Technical Characteristics of the Subject Device as 6. Compared with the Predicate Device:
The SOMATOM Force is comparable in indications for use, design, material, functionality, technology, energy source and is considered substantially equivalent to the predicate device SOMATOM Definition Flash (K121072, clearance date May 08, 2012).
2
The differences between the legally marketed predicate device and the SOMATOM Force are as follows:
| Property | SOMATOM Force | SOMATOM Definition Flash |
|---|---|---|
| X-Ray Assembly Tube | 2 × Vectron | 2 × Straton MX P |
| Generator Power (max.) | 120 kW/120 kW | 100 kW/100 kW |
| Number of Detector Rows | 96/96 | 64/64 |
| Maximum Number of | ||
| slices/rotation | 192/192 | 128/128 |
| Number of measuring | ||
| channels in detector | 1840/1280 | 1472/960 |
| Beam Hardening | ||
| Correction | Iterative Beam | |
| Hardening Correction | ||
| (IBHC) | Posterior Fossa | |
| Optimization | ||
| (PFO) |
The SOMATOM Force is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission.
The SOMATOM Force also supports Iterative Beam Hardening Correction (IBHC). The Iterative Beam Hardening Correction (IBHC) feature is an extension of the Posterior Fossa Optimization (PFO) feature. The PFO feature was cleared as part of the SOMATOM Definition Flash (K082220, clearance date October 10, 2008) and part of the predicate device SOMATOM Definition Flash (K121072, clearance date May 08, 2012).
IBHC is a raw data based beam hardening correction method designed to improve image quality. IBHC uses 3D forward projection, and an additional two-compartment iodine/water model to reduce beam hardening artifacts while maintaining anatomical structures.
The intended use, materials, energy source, and fundamental scientific technology are similar to the predicate device; therefore Siemens believes that they are substantially equivalent to the predicate device.
3
7. Nonclinical Testing:
The SOMATOM Force is designed to fulfill the requirements of following safety and performance standards:
| Recognition Product
Number | Area | Title of Standard | Reference
Number and
Date | Publication
Date | Standards
Development
Organization |
|-------------------------------|-----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------|---------------------|------------------------------------------|
| 2-156 | Biocomp | Biological evaluation of
medical devices - Part 1:
Evaluation and testing within
a risk management process | 10993-1:2009 | 01/15/2013 | AAMI ANSI ISO |
| 12-120 | Radiology | Medical electrical equipment
- Part 2-44: Particular
requirements for the safety of
X-ray equipment for
computed tomography - Ed.
2.1 | 60601-2-44
(2002-11): | 09/09/2008 | IEC |
| 12-126 | Radiology | Medical electrical equipment -
Part 2-28: Particular
requirements for the safety of X-
ray source assemblies and X-ray
tube assemblies for medical
diagnosis - Ed. 1.0 | 60601-2-28:
1993 | 10/31/2005 | IEC |
| 12-127 | Radiology | Medical electrical equipment - Part 2-32: Particular
requirements for the safety
of associated equipment of
X-ray equipment - Ed. 1.0 | 60601-2-32:
1994 | 10/31/2005 | IEC |
| 12-199 | Radiology | Medical electrical equipment -
Part 1-3: General requirements
for basic safety 3. Collateral
Standard: General reguirements
for radiation protection in
diagnostic X-ray equipment | 60601-1-3 First
edition 1994-07 | 09/08/2009 | IEC |
| 12-204 | Radiology | Medical electrical equipment - Part 2-28: Particular
requirements for the basic
safety and essential
performance of X-ray tube
assemblies for medical
diagnosis | 60601-2-28
Edition 2.0
2010-03 | 08/05/2013 | IEC |
| 12-210 | Radiology | Medical electrical equipment -
Part 1-3: General requirements
for basic safety and essential
performance - Collateral
Standard: Radiation protection in
diagnostic X-ray equipment | 60601-1-3
Edition 2.0
2008-01 | 08/05/2013 | IEC |
| Recognition
Number | Product
Area | Title of Standard | Reference
Number and
Date | Publication
Date | Standards
Development
Organization |
| 12-223 | Radiology | Evaluation and routine
testing in medical imaging
departments - Part 3-5:
Acceptance tests - Imaging
performance of computed
tomography X-ray equipment
CORRIGENDUM 1 | 61223-3-5
(First edition
- | 03/18/2011 | IEC |
| 12-225 | Radiology | Computed Tomography Dose
Check | XR 25 | 03/18/2011 | NEMA |
| 12-226 | Radiology | Evaluation and routine testing in
medical imaging departments -
Part 2-6: Constancy tests -
Imaging performance of
computed tomography X-ray
equipment | 61223-2-6
Second Edition
2006-11 | 02/28/2011 | IEC |
| 12-238 | Radiology | Digital Imaging and
Communications in Medicine
(DICOM) Set | PS 3.1 - 3.18 | 03/16/2012 | NEMA |
| 13-8 | Software | Medical device software -
Software life cycle processes | 62304 First
edition 2006-05 | 08/20/2012 | IEC |
| 5-27 | General | Medical electrical equipment --
Part 1-1: General requirements
for safety - Collateral standard:
Safety requirements for medical
electrical systems | 60601-1-
1:2000 | 09/08/2009 | IEC |
| 5-4 | General | Medical Electrical Equipment -
Part 1: General Requirements
for Safety, 1988; Amendment 1,
1991-11, Amendment 2, 1995 | 60601-1 | 10/31/2005 | IEC |
| 5-40 | General | Medical devices - Application of
risk management to medical
devices | 14971 Second
Edition 2007-
03-01 | 08/20/2012 | ISO |
| 5-41 | General | Medical electrical equipment -
Part 1-4: General requirements
for safety --
Collateral standard:
Programmable electrical medical
systems, edition 1.1 | 60601-1-
4:2000 Consol.
Ed. 1.1 | 09/08/2009 | IEC |
| 5-54 | General | Medical electrical equipment -
Part 1-2: General requirements
for basic safety and essential
performance - Collateral
| 60601-1-
2:2007 | 08/05/2013 | AAMI ANSI IEC |
4
This submission contains performance data to demonstrate continued conformance with special controls for medical devices containing software. Non clinical tests (integration and functional) and phantom testing were conducted for the SOMATOM Force during product development. The modifications described in this Premarket Notification were supported with verification/validation testing.
5
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.
Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is also included as part of this submission.
EMC/electrical safety was evaluated according to the IEC Standards. Siemens certify conformance to Voluntary Standards covering Electrical and Mechanical Safety. In conclusion, the identified risk of electrical hazards was mitigated and is substantially equivalent to the predicate device in terms of safety and effectiveness. All testing and validation has been completed.
8. Indications for Use:
This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by the system can be used by a trained physician as an aid in diagnosis.
9. General Safety and Effectiveness Concerns:
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.
10. Conclusion as to Substantial Equivalence
In summary, Siemens is of the opinion that the SOMATOM Force does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate devices.
6
Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is a stylized symbol that resembles a person with outstretched arms, with three wavy lines extending from the person's arms.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 17, 2014
Siemens Medical Solutions USA, Inc. % Kimberly Mangum 51 Valley Stream Pkwy. MALVERN PA 19355
Re: K133589/S002
Trade/Device Name: SOMATOM Force Regulation Number: 21 CFR 892.1750 Regulation Name: System, X-Ray, Tomography, Computed Regulatory Class: II Product Code: JAK Dated: March 14, 2014 Received: March 18, 2014
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, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
7
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/McdicalDevices/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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
:
:
Sincerely yours,
Smh
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
8
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known)
Device Name SOMATOM Force
Indications for Use (Describe)
This computed tomography system is intended to generate and process cross-sectional images of patients by computer reconstruction of x-ray transmission data. The images delivered by a trained physician as an aid in diagnosis.
Type of Use (Select oner both, as applicable)
🇿 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
Image /page/8/Figure/12 description: The image shows a document with the heading "FOR FDA USE ONLY". Below the heading, there is a line that reads "Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)". An FDA logo is present, presumably indicating that the document is related to the Food and Drug Administration. The document appears to be an official form or record intended for internal use within the FDA.