(406 days)
Not Found
No
The document describes standard CT system functionality, image reconstruction, and pre-defined low-dose scan modes. There is no mention of AI, ML, or any related technologies in the device description or performance studies.
No
The device is used to generate images for diagnosis, not to treat a condition.
Yes
The system generates images that can be used by a trained physician "as an aid in diagnosis" and "for low dose lung cancer screening."
No
The device description explicitly states it is a "whole body X-ray computed tomography system" with a "continuously rotating tube-detector system," indicating it is a hardware device that includes software for control and processing.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that this is a computed tomography system that generates images of patients using X-ray transmission data. This is an in vivo imaging technique, meaning it is performed on a living patient, not on a sample outside the body.
- Intended Use: The intended use is to generate images that can be used by a physician as an aid in diagnosis. While diagnosis is a key aspect of healthcare, the method used by this device (imaging the patient directly) falls outside the scope of in vitro diagnostics.
Therefore, this device is a medical imaging device, not an IVD.
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 the system can be used by a trained physician as an aid in diagnosis. This CT system can be used for low dose lung cancer screening in high risk populations.* *As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
Product codes (comma separated list FDA assigned to the subject device)
JAK
Device Description
Siemens SOMATOM Computed Tomography System family scanners are whole body X-ray computed tomography systems which feature a continuously rotating tube-detector system and functions according to the fan beam principle. The SOMATOM Computed Tomography System family scanners vary in configurations from 6 to 192 slices, and are 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. 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 systems described in this submission provide pre-defined low dose scan modes similar to the modes used for The National Lung Screening Trial (NLST), and the features as recommend by the study. This allows use of these systems for screening in the same way the CT systems were used for NLST. The computer system delivered with the CT scanner is able to run 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
Non clinical tests (integration and functional) and phantom testing were conducted for the SOMATOM Computed Tomography System family during product development. 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 was also provided for the systems referenced in 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.
Performance Testing: Technical parameters utilized to test general CT use are also applicable for lung cancer screening. The following technical parameters have been compared for the subject devices and the Siemens devices used in NLST: CT number accuracy, CT number uniformity, Spatial resolution (MTF, maximum in-plane resolution), Slice thickness/sensitivity profile (minimum slice width), Noise properties (NPS, Image noise (standard deviation)), Contrast to Noise Ratio, (Maximum) scan speed, Minimum reconstructed slice interval. The test results demonstrate that the subject devices perform comparably or better than the older devices. Since the older devices have been identified as suitable for lung cancer screening within the NLST, the respective performance of the subject devices can be regarded as suitable for lung cancer screening as well.
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 Computed Tomography System family during product development. 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. Performance Testing: Technical parameters utilized to test general CT use are also applicable for lung cancer screening. The following technical parameters have been compared for the subject devices and the Siemens devices used in NLST: CT number accuracy, CT number uniformity, Spatial resolution (MTF, maximum in-plane resolution), Slice thickness/sensitivity profile (minimum slice width), Noise properties (NPS, Image noise (standard deviation)), Contrast to Noise Ratio, (Maximum) scan speed, Minimum reconstructed slice interval. The test results demonstrate that the subject devices perform comparably or better than the older devices. Since the older devices have been identified as suitable for lung cancer screening within the NLST, the respective performance of the subject devices can be regarded as suitable for lung cancer screening as well. Clinical literature, including the findings of the National Lung Screening Trial (NLST), and technical guidelines for general chest CT such as American College of Radiology (ACR) and National Comprehensive Cancer Network (NCCN) were also used to support the feasibility of the use of Siemens Computed Tomography scanners for low dose lung cancer screening.
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.
K133589, K121072, K120579, K081022, K122471, K130901, K133424, K133590, K113287, K140912, K982349
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.
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an emblem featuring a stylized depiction of three human profiles facing to the right, with the profiles overlapping to create a sense of depth and unity.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 24, 2015
Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Regulatory Affairs Technical Specialist 51 Valley Stream Parkway, Mail Code D02 MALVERN PA 19355
Re: K142955
Trade/Device Name: Somatom Force, Somatom Definition Flash, Somatom Definition Edge, Somatom Definition AS/AS+, Somatom Definition AS Open, Somatom Definition, Somatom Emotion 16, Somatom Perspective 64/128, Somatom Perspective 64/32, Somatom Scope/Scope Power, SOMATOM Plus 4WITH Volume Zoom CT Scanners Regulation Number: 21 CFR 892.1750
Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: October 30, 2015 Received: November 3, 2015
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
1
forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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/Resourcesfor You/Industry/default.htm. 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 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,
Robert Oals
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known) K142955
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 the system can be used by a trained physician as an aid in diagnosis.
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.
This CT system can be used for low dose lung cancer screening in high risk populations *
- As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
3
510(k) Number (if known) K142955
Device Name SOMATOM Definition AS/AS+
Indications for Use (Describe)
The Siemens SOMATOM Definition AS/ AS+(Project P46) systems are 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.
(*spiral planes: the axial planes resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)
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.
This CT system can be used for low dose lung cancer screening in high risk populations *
- As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
4
510(k) Number (if known) K142955
Device Name SOMATOM Definition AS Open
Indications for Use (Describe)
The Siemens SOMATOM Definition AS Open systems are 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.
(*spiral planes: the axial planes resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)
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.
This CT system can be used for low dose lung cancer screening in high risk populations *
*As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
5
510(k) Number (if known) K142955
Device Name SOMATOM Definition Flash
Indications for Use (Describe)
The Siemens SOMATOM Definition Flash 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 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 the simultaneous translation of the patient.)
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.
This CT system can be used for low dose lung cancer screening in high risk populations *
- As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
6
510(k) Number (if known) K142955
Device Name SOMATOM Definition Edge
Indications for Use (Describe)
The Siemens SOMATOM Definition Edge (Project P46F) systems are 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.
(*spiral planes: the axial planes resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)
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.
This CT system can be used for low dose lung cancer screening in high risk populations *
- As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
7
510(k) Number (if known) K142955
Device Name SOMATOM Definition
Indications for Use (Describe)
The SOMATOM P45 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.
(*spiral planes: the axial planes resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)
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.
This CT system can be used for low dose lung cancer screening in high risk populations *
- As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
8
510(k) Number (if known) K142955
Device Name SOMATOM Emotion 16
Indications for Use (Describe)
The SOMATOM Emotion 16 systems are 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.
(*spiral planes: the axial planes resulting from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)
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.
This CT system can be used for low dose lung cancer screening in high risk populations *
*As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
9
510(k) Number (if known) K142955
Device Name SOMATOM Perspective 64/128
Indications for Use (Describe)
The Siemens SOMATOM Perspective 64/128 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.)
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.
This CT system can be used for low dose lung cancer screening in high risk populations *
- As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
10
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
11
510(k) Number (if known) K142955
Device Name SOMATOM Perspective 16/32
Indications for Use (Describe)
The Siemens SOMATOM Perspective 16/32 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.)
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.
This CT system can be used for low dose lung cancer screening in high risk populations *
- As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
12
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
13
510(k) Number (if known) K142955
Device Name SOMATOM Scope/Scope Power
Indications for Use (Describe)
The SOMATOM Scope and the SOMATOM Scope Power are 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 angels or spiral planes* taken at different angles.
The images and results delivered by the SOMATOM Scope and the SOMATOM Scope Power 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.)
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.
This CT system can be used for low dose lung cancer screening in high risk populations *
- As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
| Type of Use (Select one or both, as applicable) | ||
|---|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
14
510(k) Number (if known) K142955
Device Name
SOMATOM Plus 4WITH Volume Zoom CT Scanners
Indications for Use (Describe)
The Somatom Plus 4 with Volume Zoom package 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 angels or spiral planes* taken at different angles.
(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)
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.
This CT system can be used for low dose lung cancer screening in high risk populations *
- As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
| Type of Use (Select one or both, as applicable) | |
|---|---|
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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Image /page/15/Picture/0 description: The image shows the word "SIEMENS" in a sans-serif font. The letters are all capitalized and are a light blue color. The background is white, which makes the word stand out.
510(K) SUMMARY FOR SOMATOM ( ) Computed Tomography System Family Scanners Submitted by: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Mail code 65-1A Malvern, PA 19355 Date Prepared: October 28, 2015
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. 40 Liberty Boulevard Mail code: 65-1A Malvern, PA 19355
Establishment Registration Number: 2240869
- General Information Importer/Distributor: Siemens Medical Solutions USA, Inc. 40 Liberty Boulevard Mail code: 65-1A Malvern, PA 19355
Manufacturing Site: SIEMENS AG, MEDICAL SOLUTIONS Siemensstrasse 1 91301 Forchheim, GERMANY
Establishment Registration Number: 3004977335
2. Contact Person:
Kimberly Mangum Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 40 Liberty Boulevard, Mail Code 65-1A Malvern, PA 19355 Phone: (610) 448-6477 Fax: (610) 640-4481 Email: kimberly.mangum@siemens.com
3. Device Name and Classification
| Product Name: | SOMATOM Force |
|---|---|
| Propriety Trade Name: | SOMATOM Force |
| Classification Name: | System, X-Ray, Tomography, Computed |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR § 892.1750 |
| Device Class: | II |
| Product Code: | 90 JAK |
16
Product Name: Propriety Trade Name: Classification Name: Classification Panel: Classification Requlation: Device Class: Product Code:
Product Name: Propriety Trade Name: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:
Product Name: Proprietv Trade Name: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:
Product Name: Propriety Trade Name: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:
Product Name: Propriety Trade Name: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:
Product Name: Propriety Trade Name: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:
Product Name: Propriety Trade Name: Classification Name: Classification Panel:
SOMATOM Definition AS/AS+ SOMATOM Definition AS/AS+ System, X-Ray, Tomography, Computed Radiology 21 CFR § 892.1750 . 90 JAK
SOMATOM Definition AS Open SOMATOM Definition AS Open System, X-Ray, Tomography, Computed Radiology 21 CFR § 892.1750 .
90 JAK
SOMATOM Definition Flash SOMATOM Definition Flash System, X-Ray, Tomography, Computed Radiology 21 CFR § 892.1750
90 JAK
SOMATOM Definition Edge SOMATOM Definition Edge System, X-Ray, Tomography, Computed Radiology 21 CFR § 892.1750 90 JAK
SOMATOM Definition SOMATOM Definition System, X-Ray, Tomography, Computed Radiology 21 CFR § 892.1750 . 90 JAK
SOMATOM Emotion 16 SOMATOM Emotion 16 Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II 90JAK
SOMATOM Perspective 64/128 SOMATOM Perspective Computed Tomography X-ray System Radiology
17
Classification Requlation: Device Class: Product Code:
Product Name: Propriety Trade Name: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:
Product Name: Propriety Trade Name: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:
21 CFR §892.1750 Class II 90JAK
SOMATOM Perspective 16/32 SOMATOM Perspective Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II 90JAK
SOMATOM Scope/Scope Power SOMATOM Scope/Scope Power Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II 90JAK
Product Name:
Propriety Trade Name:
Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:
SOMATOM Plus 4WITH Volume Zoom CT Scanners SOMATOM Plus 4WITH Volume Zoom CT Scanners Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II 90JAK
Legally Marketed Predicate Devices
Trade Name: 510(k)#: Clearance Date: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:
SOMATOM Definition Force K133589 April 17, 2014 System, X-Ray, Tomography, Computed Radiology 21 CFR § 892.1750 .
90 JAK
Trade Name: 510(k)#: K081022 Clearance Date: June 02, 2008 Classification Name: Classification Panel: Radiology Classification Regulation: Device Class: . Product Code: 90 JAK
SOMATOM Definition AS/AS+ System, X-Ray, Tomography, Computed 21 CFR § 892.1750
18
Trade Name: 510(k)#: Clearance Date: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:
Trade Name: 510(k)#: Clearance Date: Classification Name: Classification Panel: Classification Requlation: Device Class: Product Code:
Trade Name: 510(k)#: Clearance Date: Classification Name: Classification Panel: Classification Requlation: Device Class: Product Code:
Trade Name: 510(k)#: Clearance Date: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:
Trade Name: 510(k)#: Clearance Date: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:
Trade Name: 510(k)#: Clearance Date: Classification Name: Classification Panel: Classification Regulation: Device Class:
SOMATOM Definition AS Open K130901 January 02, 2014 System, X-Ray, Tomography, Computed Radiologv 21 CFR § 892.1750 ll 90 JAK
SOMATOM Definition Flash K121072 May 08, 2012 System, X-Ray, Tomography, Computed Radiology 21 CFR § 892.1750
90 JAK
SOMATOM Definition Edge K120579 May 23, 2012 System, X-Ray, Tomography, Computed Radiology 21 CFR § 892.1750 .
90 JAK
SOMATOM Definition K122471 September 11, 2012 System, X-Ray, Tomography, Computed Radiology 21 CFR § 892.1750 . 90 JAK
SOMATOM Emotion 16 CT System K133424 January 17, 2014 Computed Tomography X-ray System Radiologv 21 CFR §892.1750 Class II 90JAK
SOMATOM Perspective (128/64) K113287 May 23, 2012 Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II
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Image /page/19/Picture/0 description: The image contains the word "SIEMENS" in a large, sans-serif font. The text is a light teal color. The letters are evenly spaced and the word is horizontally oriented. The background is plain white.
Product Code:
Trade Name: 510(k)#: Clearance Date: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:
90JAK
SOMATOM Perspective (16/32) K133590 April 30, 2014 Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II 90JAK
Trade Name: 510(k)#: Clearance Date: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:
SOMATOM Scope/SOMATOM Scope Power K140912 September 15, 2014 Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II 90JAK
Trade Name:
510(k)#: Clearance Date: Classification Name: Classification Panel: Classification Regulation: Device Class: Product Code:
SOMATOM Plus 4WITH Volume Zoom CT Scanners K982349 September 30, 1998 Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II 90JAK
Substantial Equivalence: 4.
The subject devices are unmodified compared to their recent cleared versions. As such the cleared versions as listed in Table 1 below serve as the predicate devices:
| Predicate Devices | FDA Clearance
Number | FDA Clearance
Date |
|--------------------------------------|-------------------------|-----------------------|
| SOMATOM Force | K133589 | April 17, 2014 |
| SOMATOM Definition Flash | K121072 | May 08, 2012 |
| SOMATOM Definition Edge | K120579 | May 23, 2012 |
| SOMATOM Definition AS/AS+ | K081022 | June 02, 2008 |
| SOMATOM Definition | K122471 | September 11,
2012 |
| SOMATOM Definition AS Open | K130901 | January 02, 2014 |
| SOMATOM Emotion 16 CT System | K133424 | January 17, 2014 |
| SOMATOM Perspective (32) | K133590 | April 30, 2014 |
| SOMATOM Perspective (64) | K113287 | May 23, 2012 |
| SOMATOM Scope/SOMATOM
Scope Power | K140912 | September 15,
2014 |
| SOMATOM Plus 4WITH Volume | K982349 | September 30, 2014 |
Table 1: Predicate Device Comparable Properties
20
| Predicate Devices | FDA Clearance
Number | FDA Clearance
Date |
|-------------------|-------------------------|-----------------------|
| Zoom CT Scanners | | 1998 |
The following performance characteristics and image quality metrics relevant for low dose lung cancer screening were compared for the subject devices and the predicate devices, including predicate devices used as part of the NLST study.
- CT Number Accuracy ●
- CT Number Uniformity ●
- Spatial Resolution (MTF in-plane resolution) ●
- Slice Thickness/Sensitivity Profile (minimum slice width) ●
- Noise Properties
- Contrast to Noise Ratio .
- . Maximum Scan Speed
- Minimum Reconstructed Slice Interval ●
- . Scan parameters for low dose lung cancer screening (as defined by publically available information including the NLST study)
5. Device Description:
Siemens SOMATOM Computed Tomography System family scanners are whole body X-ray computed tomography systems which feature a continuously rotating tube-detector system and functions according to the fan beam principle. The SOMATOM Computed Tomography System family scanners vary in configurations from 6 to 192 slices, and are 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.
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 systems described in this submission provide pre-defined low dose scan modes similar to the modes used for The National Lung Screening Trial (NLST), and the features as recommend by the study. This allows use of these systems for screening in the same way the CT systems were used for NLST.
The computer system delivered with the CT scanner is able to run post processing applications optionally.
6. Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:
The SOMATOM Computed Tomography System family scanners referenced in this submission are comparable in indications for use, and are substantially equivalent in design, material, functionality, technology, energy source and are substantially equivalent to the predicate devices. No technical modifications have taken place to the subject device, and there are no technical differences between the predicate device and the subject device. The reason for this submission is to support the following additional Indications for Use:
This computed tomography system is intended to generate and process crosssectional images of patients by computer reconstruction of x-ray transmission data.
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The images delivered by the system can be used by a trained physician as an aid in diagnosis.
This CT system can be used for low dose lung cancer screening in high risk populations.*
*As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
This additional Indication for Use is based on the currently available technical parameters and software versions cleared for the predicate devices. The low dose lung cancer screening indication will be applicable for the Siemens qualified CT systems, and will not require any device modifications. Siemens predicate device systems included in this submission that received clearance after the Siemens system utilized as part of the NLST study have undergone modifications to improve performance, including but not limited to iterative reconstruction methods that support improved image quality and reduced dose. This indication will also be applicable for future qualified Siemens CT systems.
The intended use remains unchanged and the Indications for Use are similar. The technical parameters for general use CT such as minimum slice width, noise, Uniformity and mean value of CT numbers, maximum in-plane resolution of a non-UHR spiral scan mode, the minimum interval between two reconstructed images in axial direction and maximum scan speed are also applicable for lung cancer screening. A discussion of the specific image quality metrics assessed for the addition of this indication is provided in the performance testing section of this summary. The material, energy source, and fundamental scientific technology remain unchanged from the predicate devices; therefore Siemens believes that they are substantially equivalent to the predicate devices.
7. Nonclinical Testing:
The SOMATOM Computed Tomography System family scanners are designed to fulfill the requirements of following standards listed in Table 2 below:
| Recognition
Number | Product
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 |
| Recognition
Number | Product
Area | Title of Standard | Reference
Number and
Date | Publication
Date | Standards
Development
Organization |
| 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
requirements 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 |
| 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
2004) | 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 |
| Recognition
Number | Product
Area | Title of Standard | Reference
Number and
Date | Publication
Date | Standards
Development
Organization |
| 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
standard: Electromagnetic
compatibility - Requirements
and tests (Edition 3) | 60601-1-
2:2007 | 08/05/2013 | AAMI ANSI IEC |
Table 2: Conformance Standards
22
23
Non clinical tests (integration and functional) and phantom testing were conducted for the SOMATOM Computed Tomography System family during product development.
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 was also provided for the systems referenced in 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.
Performance Testing
Technical parameters utilized to test general CT use are also applicable for lung cancer screening. The following technical parameters have been compared for the subject devices and the Siemens devices used in NLST:
- . CT number accuracy
- CT number uniformity ●
- Spatial resolution (MTF, maximum in-plane resolution) ●
- Slice thickness/sensitivity profile (minimum slice width) .
- . Noise properties
- . NPS
- Image noise (standard deviation)
- Contrast to Noise Ratio .
- . (Maximum) scan speed
- Minimum reconstructed slice interval .
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The test results demonstrate that the subject devices perform comparably or better than the older devices. Since the older devices have been identified as suitable for lung cancer screening within the NLST, the respective performance of the subject devices can be regarded as suitable for lung cancer screening as well.
Reference Criteria and Clinical Literature
The evaluation criteria for lung cancer screening using Computed Tomography is a subset of the evaluation criteria for general chest CT. Table 3 below provides a listing of criteria for chest CT for screening purposes and the applicable organizations assessed in support of Siemens Computed Scanners for low dose lung cancer screening:
| General Chest CT | Chest CT for screening purpose | ||
|---|---|---|---|
| Topic | RSNA reporting | ||
| template(RSNA 2015) and | |||
| Fleischner criteria | Lung-RADs(Lung- | ||
| RADS 2014) | |||
| (criteria of ACR) | NCCN | ||
| guideline(NCCN 2015) | |||
| Lung and large | |||
| airways | e.g. pulmonary infiltrates, | ||
| emphysema, abnormalities | |||
| or the airways. | |||
| Evaluation of incidentally | |||
| found pulmonary nodules | |||
| explicitly outlined in the | |||
| Fleischner criteria | |||
| (MacMahon, Austin et al. |
- :
Nodules >4mm requiring
follow-up, smaller nodules
only in a high-risk patient | Only focusing on
pulmonary nodules.
New nodules >4mm
require actions
(shortened follow-up
period) | Focusing on pulmonary
nodules, new ground-
glass nodules > 5mm
require action
(shortened follow up) |
| Pleura | e.g. effusion, thickening | Not addressed | Not specifically
addressed |
| Heart and
pericardium | e.g. Size, pericardial
effusion | Not addressed | Not specifically
addressed |
| Mediastinum and
hila | e.g. tumors, lymph nodes | Not addressed | Not specifically
addressed |
| Chest wall and
lower neck | e.g. thyroid, soft tissues | Not addressed | Not specifically
addressed |
| Vessels | e.g. Atherosclerotic changes
in aorta and coronaries | Not addressed | Not specifically
addressed |
| Bones | e.g. fractures | Not addressed | Not specifically
addressed |
Table 3: Chest CT Scanning Recommendations
Clinical literature, including the findings of the National Lung Screening Trial (NLST), and technical quidelines for general chest CT such as American College of Radiology (ACR) and National Comprehensive Cancer Network (NCCN) were also used to support the feasibility of the use of Siemens Computed Tomography scanners for low dose lung cancer screening.
8. Intended Use Discussion:
In accordance with guidance document "Guidance for Industry. General/Specific Intended Use" issued November 4, 1998, and presentation "FDA/MITA Meeting on LDCT Lung Cancer Screening", the modified more specific indication for use does not alter the intended use for the legally marketed predicate devices with a general
25
indication for use, nor does it alter the intended diagnostic effect in comparison to the predicate devices.
The following decision making criteria included in document "Guidance for Industry. General/Specific Intended Use" issued November 4, 1998 were assessed as part of this submission:
- Risk
- Public Health Impact ●
- Knowledge Base
- Endpoints
- Tool or Treatment ●
- Adjunctive Therapy ●
- Design Changes .
Based on the results of the criteria above, Siemens computed tomography scanners are intended to produce cross sectional images of the body by computer reconstruction of x-ray transmission date. Lung cancer screening does not represent a new intended use
The more specific use of low dose lung cancer screening:
- Does not introduce new risk not normally associated with the general use of . the device
- . Does not impact public health to a significantly greater degree than the general diagnostic use of the device
- . There is an extensive body of publically available evidence that reflects understanding by the medical community that use of CT for lung cancer screening is a subset of the general use rather than a new intended use
- The performance or clinical endpoints used to evaluate general CT use can also be applied to the specific use of lung cancer screening
- . Does not perform any treatment functionality
- Does not require any other product not routinely needed for general CT to ● achieve the specific use safely or effectively
- Does not include any modifications to the general use CT device .
The more specific use of low dose lung cancer screening is a subset of the general use, rather than a new intended use. As such, Siemens is of the opinion that the Intended Use/Indications for use are substantially equivalent to the predicate devices.
9. Indications for Use:
This computed tomography system is intended to generate and process crosssectional 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.
This CT system can be used for low dose lung cancer screening in high risk populations. *
26
*As defined by professional medical societies. Please refer to clinical literature, including the results of the National Lung Screening Trial (N Engl J Med 2011; 365:395-409) and subsequent literature, for further information.
(See Indications for Use Statement for full Indications for Use Statements)
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 order to demonstrate substantial equivalence, the more specific indications for use low dose of lung cancer screening was assessed in accordance with guidance document "Guidance for Industry. General/Specific Intended Use" issued November 4, 1998, and presentation "FDA/MITA Meeting on LDCT Lung Cancer Screening", dated October 8, 2014. In accordance with these documents, it was determined that the modified more specific indication for use does not alter the intended use for the legally marketed predicate devices with a qeneral indication for use, nor does it alter the intended diagnostic effect in comparison to the predicate devices.
In accordance with guidance document "Guidance for Industry. General/Specific Intended Use" issued November 4, 1998, it was determined that:
-
The more specific indications for use of low dose lung cancer screening does not ● introduce risks not normally associated with the general use of the CT device, as the nature of CT, functionality, and performance has not been changed.
Based on Siemens evaluation of publically available information regarding the risk/benefits associated with the use of Computed tomography for lung cancer screening, Siemens is of the belief that the use of Siemens CT scanners for low dose lung cancer screening does not impact public health to a significantly greater degree than the general diagnostic use of the device, and falls within the general use of CT, as the criteria for low dose lung cancer screening is a subset of the criteria for general use CT. -
There is an extensive body of publically available evidence that reflects existing understanding by the medical community that the more specific use of CT for low dose lung cancer screening is a subset of the general use of CT, rather than a new intended use.
-
. Several general CT technical characteristics can also be used to define acceptable performance levels for use in lung cancer screening.
-
. The use of CT for low dose lung cancer screening is not intended to perform any treatment functions.
27
- . There is no product not routinely needed for general CT required for use to safely or effectively perform the task of low dose lung cancer screening with CT.
- . The use of CT for low dose lung cancer screening does not render the device less applicable to the diagnostic X-ray system tasks of general CT. The more specific use of low dose lung cancer screening is a subset of the general use, rather than a new intended use.
A comparison of the available protocol information for the Siemens CT predicate device utilized as part of the NLST study was also conducted, and the resulting information was provided within this submission to support the finding of substantial equivalence.
The predicate devices were cleared based on non-clinical supportive information and clinical images. The results of these tests demonstrate that the predicate devices are adequate for the intended use. The comparison of technological characteristics, nonclinical performance data, and software validation demonstrates that the subject device is as safe and effective when compared to the predicate devices that are currently marketed for the same intended use.