(11 days)
No
The summary describes standard image processing and calculation of physiological parameters from CT data, with no mention of AI, ML, or related concepts.
No
The device is a post-processing software package that evaluates perfusion parameters from CT data, which can be useful for tumor characterization and therapy monitoring, but it does not directly treat or provide therapy itself.
Yes
The device evaluates perfusion of organs and tumors, calculates various parameters (blood flow, blood volume, mean transit time, permeability), and characterizes tumors by analyzing differences in perfusion parameters, all of which are activities associated with diagnosis or assessment of a medical condition.
Yes
The device is described as a "software package" that runs on a standard PC platform and performs post-processing of images acquired from a separate CT scanner. It does not include any hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens derived from the human body. The description clearly states that this software processes images acquired from CT scanners, which are external imaging devices. It analyzes the perfusion of organs and tumors within the body, not samples taken from the body.
- The intended use is for evaluating perfusion parameters from imaging data. This is a diagnostic imaging post-processing tool, not a test performed on biological samples.
The device falls under the category of medical imaging software used for diagnostic purposes, but it does not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Siemens syngo Volume Perfusion-CT Body software package with extended functionality has been designed to evaluate perfusion of organs and tumors.
The software can calculate blood flow, blood volume, mean transit time and permeability from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media.
The package also allows the separate calculation of the arterial and portal venous component of hepatic perfusion. It supports evaluation of regions of interest and the visual inspection of time density curves.
A potential application is the characterization of tumors by analysing the differences of perfusion parameters to normal tissue. Determination of the change of perfusion parameters during the course of treatment may be helpful in therapy monitoring.
Product codes
90 JAK
Device Description
syngo® Volume Perfusion-CT Body software package with extended functionality is a post-processing software package, which runs on an Intel-based PC platform designed to post-process images acquired with SOMATOM CT scanners, which meet certain minimal requirements (i.e. Siemens Definition, Sensation 64, ....). It is a package containing evaluation software that supports the evaluation of Dynamic CT data gathered after the injection of a compact bolus of contrast media, where the contrast media acts as a pure intravascular tracer.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Body, organs, and tumors (specifically mentions hepatic perfusion)
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)
Not Found
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
JUL 1 7 2009
510(k)
1092013
Section 8
510(k) - Summary
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 l.
- Device Name and Classification 1,
syngo® Volume Perfusion-CT Body Product Name: Classification Name: Accessory to Computed Tomography System Classification Panel: Radiology 21 CFR §892.1750 CFR Section: Device Class: Class II Product Code: 90 JAK
2. Importer/Distributor Establishment: Registration Number: 2240869
Siemens Medical Solutions, Inc. 51 Valley Stream Pkwy Malvern, PA 19355
Manufacturing Facility: 3.
Siemens AG Medical Solutions Henkestrasse 127
D-91052 Erlangen, Germany
4. Contact Person:
Mr. Ralf Hofmann Regulatory Affairs Specialist Siemensstr.1; D-91301 Forchheim Phone: +49 9191 18-8170 Fax: +49 9191 18-9782
Date of Preparation of Summary: Jun. 19th 2009 5.
1
SIEMENS
SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL ll. EQUIVALENCE DETERMINATION
General Safety and Effectiveness Concerns: 6.
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 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® Volume Perfusion-CT Body software package with extended functionality that is addressed in this premarket notification, is substantially equivalent to the following commercially available software packages
| Manufacturer | Product | 510(k) | Clearance date |
|---|---|---|---|
| 1. Siemens AG | syngo Volume Perfusion CT Body | K073373 | Dec 18, 2007 |
| 2. Siemens AG | syngo Volume Perfusion CT Neuro | K073238 | Jan 03, 2008 |
Device Description and Intended Use: 8.
syngo® Volume Perfusion-CT Body software package with extended functionality is a post-processing software package, which runs on an Intel-based PC platform designed to post-process images acquired with SOMATOM CT scanners, which meet certain minimal requirements (i.e. Siemens Definition, Sensation 64, ....). It is a package containing evaluation software that supports the evaluation of Dynamic CT data gathered after the injection of a compact bolus of contrast media, where the contrast media acts as a pure intravascular tracer.
The Siemens syngo Volume Perfusion-CT Body software package with extended functionality has been designed to evaluate perfusion of organs and tumors.
The software can calculate blood flow, blood volume, mean transit time and permeability from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media.
The package also allows the separate calculation of the arterial and portal venous component of hepatic perfusion. It supports evaluation of regions of interest and the visual inspection of time density curves.
A potential application is the characterization of tumors by analysing the differences of perfusion parameters to normal tissue. Determination of the change of perfusion parameters during the course of treatment may be helpful in therapy monitoring.
2
Image /page/2/Picture/0 description: The image contains a logo for the U.S. Department of Health and Human Services. The logo features the department's seal, which includes an abstract caduceus symbol. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the seal. The seal and text are in black and white.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 7 2009
Siemens AG Medical Solutions % Mr. Stefan Preiss TÜV SÜD America 1775 Old Hwy 8 NW, Ste 104 NEW BRIGHTON MN 55112-1891
Re: K092013
Trade/Device Name: syngo® Volume Perfusion-CT Body Regulation Number: 21 CFR 892,1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: July 3, 2009 Received: July 6, 2009
Dear Mr. Preiss:
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 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
3
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/cdrl/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for use
510(k) Number (if known):
Device Name:
syngo® Volume Perfusion-CT Body
The Siemens syngo Volume Perfusion-CT Body software package with extended functionality has been designed to evaluate perfusion of organs and tumors.
The software can calculate blood flow, blood volume, mean transit time and permeability from sets of images reconstructed from dynamic CT data acquired after the injection of contrast media.
The package also allows the separate calculation of the arterial and portal venous component of hepatic perfusion. It supports evaluation of regions of interest and the visual inspection of time density curves.
A potential application is the characterization of tumors by analysing the differences of perfusion parameters to normal tissue. Determination of the change of perfusion parameters during the course of treatment may be helpful in therapy monitoring.
| Prescription Use
| (Part 21 CFR 801 Subpart D) | X |
|---|---|
| AND/OR | |
| Over-The-Counter Use | |
| (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
rrence of CDRH, Office of Device Evaluation (ODE)
Reproductive, Abdominal
Section 2