(133 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on hardware modifications and standard CT imaging principles.
No
The device is described as an imaging system (Computed Tomography X-ray Systems) used for producing cross-sectional images of the body for diagnostic purposes, not for treating diseases or conditions.
No
Explanation: The intended use states that the device is "intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data," which describes an imaging device, not a diagnostic device.
No
The device description explicitly states it is a "Computed Tomography X-ray System" with a "continuously rotating tube-detector system" and a "gantry bore," which are all hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "produce cross-sectional images of the body by computer reconstruction of x-ray transmission data." This describes an imaging device used for diagnostic purposes on the patient's body, not for testing samples in vitro (outside the body).
- Device Description: The description clearly identifies it as a "Computed Tomography X-ray System," which is an imaging modality.
- No mention of in vitro testing: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or performing tests on these samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used to image the body directly.
N/A
Intended Use / Indications for Use
The SOMATOM Definition AS Open 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 resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient.)
Product codes
90 JAK
Device Description
The Siemens SOMATOM Definition AS Open is a Computed Tomography X- ray Systems, which features a continuously rotating tube-detector system and functions according to the fan beam principle.
This system is a modified version of the cleared Somatom Definition AS/AS+ The modification features a larger gantry bore from the original (K081022). Definition AS, In addition, the gantry tilt accuracy is improved and a new HD FoV, will help provide an optimized solution for radiation treatment planning.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
body
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care professionals
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
Not Found
Key Metrics
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
510(k) Summary
For
SOMATOM Definition AS Open
MAR - 4 2011
Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
September 25, 2010
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.
1. General Information
Importer / Distributor
Siemens Medical Solutions, Inc. 51 Valley Stream Parkway, E-50 Malvern, PA 19355 Establishment Registration Number 2240869
Manufacturing Site
SIEMENS AG Sector Healthcare Siemens Straße 1 D-91301 Forchheim
2. Contact Person:
Mrs. Alicia Bustos-Juergensen Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway E-50 Malvern, PA 19355-1406 Phone:(610) 448-4056 Fax: (610) 448-1778
3. Device Name and Classification
SOMATOM Definition AS Product Name: Propriety Trade Name: SOMATOM Definition AS Open Classification Name: Computed Tomography X- ray System Radiology Classification Panel: 21 CFR §892.1750 CFR Section: Device Class: Class II Product Code: 90 JAK
1
SIEMENS
Device Description 4.
The Siemens SOMATOM Definition AS Open is a Computed Tomography X- ray Systems, which features a continuously rotating tube-detector system and functions according to the fan beam principle.
This system is a modified version of the cleared Somatom Definition AS/AS+ The modification features a larger gantry bore from the original (K081022). Definition AS, In addition, the gantry tilt accuracy is improved and a new HD FoV, will help provide an optimized solution for radiation treatment planning.
ડ. Intended Use
The SOMATOM Definition AS Open 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 resulted from the continuous rotation of detectors and x-ray tube, and the simultaneous translation of the patient. )
6. Substantial Equivalence:
Siemens SOMATOM Definition AS Open Computed Tomography X-ray system, configured with software version SOMARIS/7 is substantially equivalent to the following medical device in commercial distribution:
| Predicate Device Name | FDA Clearance Number | FDA Clearance Date |
|---|---|---|
| Siemens SOMATOM Definition AS/AS+ | K081022 | 06/05/2008 |
7. Summary of Technological Characteristics of the Principal Device as Compared with the Predicate Device
SOMATOM Definition AS Open is a modified SOMATOM Definition AS, which offers a larger gantry bore of 80 cm. It uses a modified tube collimator, adapted to the geometry of the 80 cm gantry bore
The Data Measurement System (DMS) of SOMATOM Definition AS Open is identical to the 32 row detector layout of SOMATOM Definition AS; UHR comb is not available for SOMATOM Definition AS Open.
SOMATOM Definition AS Open is designed with the mechanical accuracy necessary to provided data that can be used for Radiation Therapy Planning (RTP) by RTP systems.
2
General Safety and Effectiveness Concerns 8.
Instructions for use are included within the device labeling, and the information provided will enable the user to operate the device in a safe and effective manner. Several safety features including visual and audible warnings are incorporated into the system design. In addition the Somatom Definition AS Open is continually monitored, and if an error occurs, the system functions will be blocked and an error message will be displayed.
Furthermore the operators are health care professionals familiar with and responsible for the X-ray examinations to be performed. To minimize electrical, mechanical and radiation hazards, Siemens adheres to recognized and established industry practice, and all equipment is subject to final performance testing.
Conclusion as to Substantial Equivalence 9.
The Somatom Definition AS Open is intended for the same indications for use as the predicate Somatom Definition AS/AS+. The Somatom Definition AS Open is substantially equivalent to the Definition AS/AS+ with changes to the gantry opening, improved FoV and improvements to the mechanical accuracy of the gantry tilt system as required when used for Radiation Therapy Planning. The portfolios of accessories are the same as with the predicate Somatom Definition AS/AS+ to compliment the needs of the CT suite. It is Siemens opinion, that the Somatom Definition AS Open is substantially equivalent to the Somatom Definition AS/AS+.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird in flight, composed of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
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. Alicia Bustos-Juergensen Technical Specialist Regulatory Affairs Siemens Healthcare (Siemens Medical Solutions USA, Inc.) 51 Valley Stream Pkwy MALVERN PA 19355
Re: K103127
MAR - 4 2011
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: February 11, 2011 Received: February 14, 2011
Dear Ms. Bustos-Juergensen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of
4
medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office
of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours.
Mary S Postel
Mary Pastel. ScD. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
5
SIEMENS
510(k) Number (if known): K(03/27
Device Name:
Somatom Definition AS Open
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.)
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 ANOTHER PAGE OF NEEDED)
AND/OR
X
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Mary S Patel
Division Sign Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K103127
·
Siemens Medical Solutions, Inc. USA 510(k) for SOMATOM Definition AS Open CT System