(276 days)
Not Found
No
The document describes image reconstruction and manipulation techniques (MARIS, HD FoV Pro, t-MIP) which are standard image processing methods in CT, not explicitly AI/ML. There is no mention of AI, ML, deep learning, or any related terms.
No
The device is described as an X-ray Computed Tomography System intended to produce cross-sectional images for diagnostic purposes, not for direct treatment or therapy.
Yes
The "Intended Use / Indications for Use" section states that the device is "intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data," which are used for diagnostic purposes.
No
The device description clearly states it is a "whole body X-ray Computed Tomography System," which is a hardware device. The software described is a component of this hardware system, not a standalone software-only medical device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside of the body.
- Device Function: The description clearly states that the Siemens SOMATOM Definition AS Open system is an X-ray Computed Tomography System. It produces cross-sectional images of the body by using X-rays. This is an in vivo (within the living body) imaging technique, not an in vitro diagnostic test.
- Intended Use: The intended use is to produce images of the body for diagnostic purposes, not to analyze samples taken from the body.
Therefore, based on the provided information, the Siemens SOMATOM Definition AS Open is a medical imaging device, not an IVD.
N/A
Intended Use / Indications for Use
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 resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)
Product codes
JAK
Device Description
The Siemens SOMATOM Definition AS Open is a whole body X-ray Computed Tomography System. The SOMATOM Definition AS Open produces CT images in DICOM format, which can be used by post-processing 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, syngo® CT 2013B (SOMARIS/7 VA46A), supports the following features:
- MARIS (Metal Artifact Reduction in Image Space) A image . reconstruction mode designed to reduce image artifacts caused by metal
- HD FoV Pro (HD FoV 2.0) Designed to enable a more reliable . visualization of the skin line of human body parts located outside of the standard field of view
- t-MIP -- Image manipulation method for arithmetic operations which allows . the calculation of temporal Maximum or Minimum Intensity Projection (MIP) images from a set of series.
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
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Nonclinical tests (integration and functional) and phantom were conducted on the SOMATOM Definition AS Open configured with software version syngo® CT 2013B (SOMARIS/7 VA46A) during software development. Additionally, bench tests were performed to verify and validate the performance of the MARIS and HD FoV Pro (HD FoV 2.0) features.
Clinical test were performed using the SOMATOM Definition AS Open configured with software version syngo® CT 2013B (SOMARIS/7 VA46A) to validate the performance of the MARIS algorithm. These tests include testing of the metal artifact reduction capabilities of MARIS in different clinical scenarios.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1750 Computed tomography x-ray system.
(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
SIEMENS
JAN - 2 2014
510(K) Summary FOR
SOMATOM DEFINITION AS OPEN
Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
Date Prepared: December 4, 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
Establishment Registration Number: 2240869
Manufacturing Site: Siemens AG, Medical Solutions Siemensstrasse 1
Forchheim, Germany 91301
Establishment Registration Number: 3004977335
2. Contact Person:
Ms. Kimberly Mangum 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
3. Device Name and Classification
| Product Name: | SOMATOM Definition AS Open |
|---|---|
| Propriety Trade Name: | SOMATOM Definition AS Open |
| Classification Name: | Computed Tomography X-ray System |
1
Image /page/1/Picture/0 description: The image shows the word "SIEMENS" in a bold, outlined font. The letters are all capitalized and evenly spaced. The outline gives the word a distinct and modern appearance. The background is plain and white, which makes the word stand out.
Classification Panel: CFR Section: Device Class: Product Code:
Radiology 21 CFR §892.1750 Class II 90JAK
Legally Marketed Predicate Device
| Trade Name: | SOMATOM Definition AS Open |
|---|---|
| 510(k)#: | K103127 |
| Clearance Date: | March 04, 2011 |
| Classification Name: | Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| Classification Regulation: | 21 CFR §892.1750 . |
| Device Class: | II |
| Product Code: | JAK |
4. Device Description:
The Siemens SOMATOM Definition AS Open is a whole body X-ray Computed Tomography System. The SOMATOM Definition AS Open produces CT images in DICOM format, which can be used by post-processing 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, syngo® CT 2013B (SOMARIS/7 VA46A), supports the following features:
- MARIS (Metal Artifact Reduction in Image Space) A image . reconstruction mode designed to reduce image artifacts caused by metal
- HD FoV Pro (HD FoV 2.0) Designed to enable a more reliable . visualization of the skin line of human body parts located outside of the standard field of view
- t-MIP -- Image manipulation method for arithmetic operations which allows . the calculation of temporal Maximum or Minimum Intensity Projection (MIP) images from a set of series.
5. Indications for Use:
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 resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)
2
SIEMENS
6. Substantial Equivalence:
Siemens SOMATOM Definition AS Open configured with software version syngo® CT 2013B (Somaris/7 VA46A) is substantially equivalent to the following medical devices in commercial distribution:
| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|---|---|---|
| Siemens Definition AS Open | K103127 | 03/04/2011 |
| Siemens SOMATOM Definition | ||
| Edge | K120579 | 05/23/2012 |
7. Summary of Technical Characteristics of the Subject Device as Compared with the Predicate Device:
SOMATOM Definition AS Open configured with software version syngo® CT 2013B (SOMARIS/7 VA46A) is a further software development to the commercially available SOMATOM Definition AS Open CT system.
The SOMATOM Definition AS Open configured with software version syngo® CT 2013B (SOMARIS/7 VA46A) features the same indications for use, gantry, imaging and administrative functions as the predicate SOMATOM Definition AS Open. The image reconstruction and image manipulation are similar to the predicate device SOMATOM Definition AS Open.
The difference between the legally marketed predicate device SOMATOM Definition AS Open and the SOMATOM Definition AS Open configured with software version syngo® CT 2013B (SOMARIS/7 VA46A) is as follows:
| Property | SOMATOM Definition AS
Open
(configured with software
version syngo® CT 2013B
(SOMARIS/7 VA46A) | SOMATOM Definition
AS Open |
|----------------------------------------------------------|------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------|
| Image reconstruction
method for artifact
reduction | MARIS - Reduces metal
artifacts | Posterior Fossa
Optimization (PFO)
reduces beam
hardening artifacts |
| Reconstructed Field
of View | HD FoV Pro (HD FoV 2.0) –
Allows visualization of up to 80
cm | HD FoV – Allows
visualization of up to 78
cm |
| 3D display | tMIP – Allows calculation of
temporal maximum intensity
projection images | MIP - Allows calculation
of maximum intensity
projection images |
3
SIEMENS
The SOMATOM Definition AS Open configured with software version syngo® CT 2013B (SOMARIS/7 VA46A) 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; therefore Siemens believes that they are substantially equivalent to the predicate devices.
8. Nonclinical Testina:
SOMATOM Definition AS Open configured with software version syngo® CT 2013B (SOMARIS/7 VA46A) is designed to fulfill the requirements of following standards:
- · IEC 60601-1-4 : 2000; Medical electrical equipment Part 1-4: General requirements for basic safety and essential performance - Collateral Standard: Usability
- IEC 62304 Ed. 1.0, "Medical Device Software - Software Lifecycle Processes"
- I ISO 14971:2007; Medical Devices - Application of risk management to medical devices
- I DICOM (Digital Imaging and Communications in Medicine) Standard: NEMA PS 3.1 - 3.18 (2009)
- . IEC 60601-2-44:2009; Medical Electrical Equipment Part 2: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
- I IEC 61223-3-5:2004: Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests - Imaging performance of computed tomography X-ray equipment CORRIGENDUM 1
- I IEC 61223-2-6:2006; Evaluation and routine testing in medical imaging departments - Part 2 - 6: Constancy tests - Imaging performance of computed tomography X-ray equipment
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 were conducted on the SOMATOM Definition AS Open configured with software version syngo® CT 2013B (SOMARIS/7 VA46A) during software development. Additionally, bench tests were performed to verify and validate the performance of the MARIS and HD FoV Pro (HD FoV 2.0) features.
The risk analysis was completed and risk control implemented to mitiqate identified hazards. The testing supports that all 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.
4
Image /page/4/Picture/0 description: The image shows the word "SIEMENS" in all capital letters. The letters are outlined in black, giving them a hollow appearance. The font is sans-serif and appears to be a bold typeface.
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.
9. Clinical Testing
Clinical test were performed using the SOMATOM Definition AS Open configured with software version syngo® CT 2013B (SOMARIS/7 VA46A) to validate the performance of the MARIS algorithm. These tests include testing of the metal artifact reduction capabilities of MARIS in different clinical scenarios.
10. 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, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
11. Conclusion as to Substantial Equivalence
In summary, Siemens is of the opinion that the SOMATOM Definition AS open configured with software version synqo® CT 2013B (SOMARIS/7 VA46A) software package does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate devices.
5
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure embracing a globe, symbolizing the department's mission to protect the health of all Americans. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the emblem.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 2, 2014
Siemens Medical Solutions USA, Inc. % Ms. Kimberly Mangum Technical Specialist, Regulatory Submissions 51 Valley Stream Parkway, D02 MALVERN PA 19355
Re: K130901
Trade/Device Name: SOMATOM Definition AS Open Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: December 13, 2013 Received: December 23, 2013
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.
6
Page 2-Ms. Mangum
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resources/or You/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/MedicalDevices/Safety/ReportalProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industrv/default.htm.
Sincerely yours,
for
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
7
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K 1 3090 1
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 compuler 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 resulted from the continuous rotation of detectors and x-ray tube, and the simulaneous translation of the patient.)
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)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
Smh.p)
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
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