(28 days)
Not Found
No
The document describes standard CT imaging technology and software for image reconstruction and management. There is no mention of AI or ML algorithms for image analysis, diagnosis, or other functions. The "CARE" and "FAST" technologies appear to be related to dose reduction and workflow assistance, not AI/ML.
No
This device is an imaging system (CT scanner) used for diagnostic purposes (producing cross-sectional images), not for treating or curing a medical condition.
Yes
The device is described as producing "cross-sectional images of the body by computer reconstruction of x-ray transmission data," which provides information used for diagnosis.
No
The device description clearly states it is a "whole body X-ray Computed Tomography System" and mentions "two continuously rotating tube-detector systems," indicating it includes significant hardware components beyond just software.
Based on the provided information, the SOMATOM P45 is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for producing cross-sectional images of the body by computer reconstruction of x-ray transmission data. This is a diagnostic imaging device, not a device used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
- Device Description: The description confirms it's a whole body X-ray Computed Tomography System. CT scanners are imaging devices, not IVDs.
- Input Imaging Modality: The input is X-ray transmission data, which is used for imaging the body directly, not for analyzing biological samples.
IVD devices are specifically designed to perform tests on biological samples outside the body (in vitro). The SOMATOM P45 operates in vivo (within the body) to create images.
N/A
Intended Use / Indications for Use
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.)
Product codes (comma separated list FDA assigned to the subject device)
90JAK
Device Description
The Siemens SOMATOM P45 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 P45 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 new version of system software, SOMARIS/7 VA44, supports a Windows 7 operating system, additional scanning and evaluation techniques CARE (Combined Application to Reduce Exposure) and FAST (Fully Assisted Scanner Technology), and single click 3D reconstruction of Dual Energy Scans. The computer system delivered with the CT scanner is able to run the post processing applications optionally.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray Computed Tomography
Anatomical Site
body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
The modifications described in this premarket modification were supported with verification/validation as well as phantom testing. Non clinical tests are conducted for SOMATOM P45 configured with software version SOMARIS/7 VA 44 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.
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.
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
SIEMENS
Special 510(k) Submission: SOMATOM Definition CT System
SEP 1 1
2012
510(K) SUMMARY FOR SOMATOM P45
Submitted by:
Siemens Medical Solutions USA, Inc.
51 Valley Stream Parkway
Malvern, PA 19355
Date Prepared: August 10, 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:
Mrs. Kimberly Manqum Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Vallev Stream Parkwav D02 Malvern, PA 19355-1406 Phone: (610) 448-1772 Fax: (610) 448-1778 Email: kimberly.mangum@siemens.com
2. Device Name and Classification
SOMATOM P45 Product Name: Propriety Trade Name: SOMATOM Definition Classification Name: Computed Tomography X-ray System Classification Panel: Radiology 21 CFR §892.1750 CFR Section: Device Class: Class II Product Code: 90JAK
20
1
3. Substantial Equivalence:
SOMATOM P45 Computed Tomography Siemens X-ray systems. configured with software version SOMARIS/7 VA44 is substantially equivalent to the following medical devices in commercial distribution:
| Predicate Device Name | FDA Clearance
Number | FDA Clearance Date |
|------------------------------------|-------------------------|--------------------|
| Siemens SOMATOM P45 | K052216 | 09/08/2005 |
| Siemens SOMATOM Definition
Edge | K120579 | 05/23/2012 |
4. Device Description:
.
The Siemens SOMATOM P45 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 P45 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 new version of system software, SOMARIS/7 VA44, supports a Windows 7 operating system, additional scanning and evaluation techniques CARE (Combined Application to Reduce Exposure) and FAST (Fully Assisted Scanner Technology), and single click 3D reconstruction of Dual Energy Scans. The computer system delivered with the CT scanner is able to run the post processing applications optionally.
5. Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:
SOMATOM P45 configured with software version SOMARIS/7 VA44 does not have significant changes in materials, energy source, or technological characteristics when compared to the predicate devices. The intended use and fundamental scientific technology are similar to the predicate devices;
2
SIEMENS
therefore Siemens believes that they are substantially equivalent to the predicate devices.
6. Nonclinical Testing:
The modifications described in this premarket modification were supported with verification/validation as well as phantom testing. Non clinical tests are conducted for SOMATOM P45 configured with software version SOMARIS/7 VA 44 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.
7. Indications for Use:
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.)
8. 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.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the department's name arranged in a circular fashion around a symbol. The symbol is a stylized representation of an eagle or bird-like figure, with three curved lines forming the body and wings. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
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 Mangum Technical Specialist, Regulatory Affairs Siemens Medical Systems, Inc. 51 Valley Stream Parkway MALVERN PA 19355
Re: K122471
Trade/Device Name: SOMATOM P45 Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: August 10, 2012 Received: August 14, 2012
Dear Ms. Mangum:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your becaon of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the citerosule) to regarry manager date of the Medical Device American Comments, or to commerce prior to May 20, 1970, the chaoinen with the provisions of the Federal Food, Drug, devices may nave occh recuired in assess approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not require apple of the general controls provisions of the Act. The r ou may, dicierore, market the act include requirements for annual registration, listing of general controls provisions of the tice, 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 If your device is classified (see above) into exass ff (Specifice (an be found in Title 21, additional controls. Dations (CFR), Parts 800 to 895. In addition, FDA may publish further Out of Peachar Regarning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please or advised that I DA s issuation of a state complies with other requirements of the Act that FDA has made a decemmanon that your contribution we rederal agencies. You must or any Federal statutes and regulations adminities, but not limited to: registration and listing (21)
comply with all the Act's requirements, including, but not limited to: r Comply with an the Act s requirements, and 809); medical device reporting (reporting of
SEP 11 2012
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice mouitements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as bet form in are qu your device as described in your Section 510(k) premarket while a to began mading 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 11 you dosire specific ad reserved In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 5 150. Finds, prease note are of 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 r ou may other other general 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
Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):
Device Name: SOMATOM P45
Indications for Use:
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.)
Use Prescription - AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In vitro Diagnostic Device (OIVD)
Andrew D. Oja
of In Vitro Diagnostic Device