(106 days)
Syngo® Dual Energy is designed to operate with Siemens Dual Source CT scanners. CT images taken at the same time, using two different kV levels, of the same anatomical region of a patient are used. Depending on the region of interest, contrast agents may be used. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. The images are combined to visualize and analyze information about anatomical and pathological structures. The functionality of the syngo® Dual Energy has been extended with additional applications.
Syngo® Dual Energy is designed to operate with Siemens Dual Source CT scanners. CT images taken at the same time, using two different kV levels, of the same anatomical region of a patient are used. Depending on the region of interest, contrast agents may be used. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials. The images are combined to visualize and analyze information about anatomical and pathological structures. The functionality of the syngo® Dual Energy has been extended with additional applications.
The provided text is a 510(k) summary for a medical device called "syngo® Dual Energy with extended functionality". It contains details about the device's classification, contact information, and intended use. However, it does not contain any information regarding acceptance criteria, study design, or performance metrics.
Therefore, I cannot provide the requested information about acceptance criteria or a study proving the device meets them based on the given text.
The document discusses general safety and effectiveness concerns and states that "Risk management is ensured via a hazard analysis, which is used to identify potential hazards. These potential hazards are controlled via software development, verification and validation testing." However, it does not elaborate on specific acceptance criteria or the results of these verification and validation tests.
The listed predicate devices suggest this is a substantial equivalence submission, which typically focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, rather than performing a full clinical trial with defined acceptance criteria and performance studies for a novel device.
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Summary
Attachment 8
510(k) - Summary
1
SIEMENS
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.
I. GENERAL INFORMATION
FEB -7 --
1. Device Name and Classification
| Product Name: | syngo® Dual Energy with extended functionality |
|---|---|
| Classification Name: | Accessory to Computed Tomography System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 |
| Device Class: | Class II |
| Product Code: | 90 JAK |
Importer/Distributor Establishment: 2. Registration Number: 2240869
Siemens Medical Solutions, Inc. 51 Valley Stream Pkwy Malvern, PA 19355
3. Manufacturing Facility:
Siemens AG Medical Solutions Henkestrasse 127
D-91052 Erlangen, Germany
4. Contact Person:
Mrs. Corrine McLeod Siemens Medical Solutions USA Inc. 51 Valley Stream Parkway Malvern, PA 19355 (610) 448-1772 (610) 448-1787
5. Date of Preparation of Summary: September 10th 2007
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SIEMENS
SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL II. EQUIVALENCE DETERMINATION .
6. General Safety and Effectiveness Concerns:
The device Iabeling 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 via software development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
7. Substantial Equivalence:
The syngo® Dual Energy software package that is addressed in this premarket notification, is substantially equivalent to the following commercially available Siemens Medical Systems devices :
| Manufacturer | Product | 510(k) | Clearance date |
|---|---|---|---|
| 1. Siemens | syngo Dual Energy | K062351 | 10/05/2006 |
| 2. Siemens | syngo Circulation | K052029 | 08/09/2005 |
| 3. Siemens | syngo InSpace 4D | K071513 | 06/26/2007 |
| 4. Siemens | syngo InSpace 4D | K062673 | 09/22/2006 |
8. Device Description and Intended Use:
Syngo® Dual Energy is designed to operate with Siemens Dual Source CT scanners. CT images taken at the same time, using two different kV levels, of the same anatomical region of a patient are used. Depending on the region of interest, contrast agents may be used. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials.
The images are combined to visualize and analyze information about anatomical and pathological structures.
The functionality of the syngo® Dual Energy has been extended with additional applications.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
FEB - 7 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Corrine McLeod Regulatory Affairs Specialist Siemens Medical Solutions USA, Inc. Corporate Headquarters 51 Valley Stream Parkway MALVERN PA 19355
Re: K073003
Trade/Device Name: syngo® Dual Energy with Extended Functionality Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: January 11, 2008 Received: January 14, 2008
Dear Ms. McLeod:
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 either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2
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); 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.
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 Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrb/industry/support/index.html.
Sincerely vours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
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SIEMENS
Indications for use
Attachment 2
Indication for use
510(k) Number (if known):
Device Name:
syngo® Dual Energy with extended functionality
Syngo® Dual Energy is designed to operate with Siemens Dual Source CT scanners. CT images taken at the same time, using two different kV levels, of the same anatomical region of a patient are used. Depending on the region of interest, contrast agents may be used. The differences in the energy dependence of the attenuation coefficient of the different materials provide information about the chemical composition of body materials.
The images are combined to visualize and analyze information about anatomical and pathological structures.
The functionality of the syngo® Dual Energy has been extended with additional applications.
(Please do not write below this line - continue on another page if needed)
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Concurrence of the CDRH, Office of Device Evaluation (ODE)
Prescription Use ಹ (Per 21 CFR §801.109)
OR Over-The-Counter Use 그
Nguyễn Thị Nhạn
Division of Reproductive, Abdominal and Radiological Devic 510/k) Number
510(k) submission for SIEMENS 'syngo Dual Energy
§ 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.