(48 days)
Not Found
No
The description focuses on standard image processing and calculation of physiological parameters (CBF, CBV, MTT, etc.) based on contrast dynamics, without mentioning any AI or ML techniques.
No
The device is described as a post-processing software package that evaluates brain perfusion by calculating various parameters from CT data, and assists physicians in identifying areas of decreased perfusion or blood-brain barrier disturbances. It supports diagnosis and therapy monitoring but does not directly treat or provide therapy itself.
Yes
The device is designed to identify areas of decreased perfusion indicating acute stroke and to visualize permeability for differential diagnosis of brain tumors and therapy monitoring. These functions are directly related to diagnosing medical conditions.
Yes
The device is explicitly described as a "post-processing software package" that runs on a standard PC platform and processes images acquired from separate CT scanners. It does not include any hardware components of its own.
Based on the provided text, the Siemens syngo® Volume Perfusion-CT Neuro software package is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue. They are used to detect diseases, conditions, or infections.
- Device function: The syngo® Volume Perfusion-CT Neuro software processes images acquired from a CT scanner after the injection of contrast media. It analyzes the distribution and flow of the contrast media within the brain to provide information about perfusion and permeability. This is an in vivo process (occurring within the living body), not an in vitro process (occurring outside the body).
- Input: The input to the software is CT image data, not biological samples.
Therefore, the device falls under the category of medical imaging software or image processing software, not an IVD.
N/A
Intended Use / Indications for Use
The Siemens syngo® Volume Perfusion-CT Neuro software package has been designed to evaluate areas of brain perfusion. The software can calculate cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e. time to start, time to peak), mean transit time (MTT), and vascular permeability (blood brain barrier disturbances) from sets of images or volumes reconstructed from continuously acquired CT data after the injection of contrast media. The package also allows the calculation of mirrored regions or volumes of interest and the visual inspection of time attenuation curves.
One clinical application is to visualize the apparent blood perfusion in brain tissue affected by acute stroke. Areas of decreased perfusion, as is observed in acute cerebral infarcts. appear as areas of changed signal intensity (lower for CBF and CBV, higher for time to peak and MTT).
Syngo® Volume Perfusion-CT Neuro supports the physician in identifying areas of decreased perfusion which indicate the occurrence of acute stroke during the first 6 hours after onset of symptoms.
A second application is the visualization of the permeability. It is used for the modeling of extra-vascular leakage of blood into the interstitial space. This additional capability can display blood brain barrier disturbances and thus may improve the differential diagnosis of brain tumors and be helpful in therapy monitoring.
Product codes
JAK
Device Description
syngo® Volume Perfusion-CT Neuro 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 Neuro software package has been designed to evaluate areas of brain perfusion. The software can calculate cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e. time to start, time to peak), mean transit time (MTT), and vascular permeability (blood brain barrier disturbances) from sets of images or volumes reconstructed from continuously acquired CT data after the injection of contrast media. The package also allows the calculation of mirrored regions or volumes of interest and the visual inspection of time attenuation curves.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician
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
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.
1. GENERAL INFORMATION
1. Device Name and Classification
syngo® Volume Perfusion-CT Neuro Product Name: Classification Name: Accessory to Computed Tomography System Classification Panel: Radiology CFR Section: 21 CFR §892.1750 Device Class: Class II 90 JAK Product Code:
2. lmporter/Distributor Establishment: 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
Contact Person: 4.
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: Oct 12th 2007 5.
510(k)
2073238
Section 8
pg. 1 of 5
JAN - 3 2006
is being subr
1
Image /page/1/Picture/0 description: The image shows the word "SIEMENS" in a distressed, textured font. The letters are bold and appear to have a rough, almost eroded surface, giving the word a vintage or weathered look. The text is horizontally aligned and fills most of the frame, making it the central focus of the image. The overall effect is a strong, industrial aesthetic.
Image /page/1/Picture/1 description: This image contains handwritten text and numbers. The text includes "K073238" which is likely a reference or identification code. Below that, "PG. 2 of 3" indicates a page number within a document, specifically page 2 of a 3-page document. Finally, "510(k)" is present, which is a reference to a section of the Food, Drug, and Cosmetic Act in the United States.
ll. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL 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, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
7. Substantial Equivalence:
The syngo® Volume Perfusion-CT Neuro software package that is addressed in this premarket notification, is substantially equivalent to the following commercially available software package
| Manufacturer | Product | 510(k) | Clearance date |
|---|---|---|---|
| 1. Siemens | syngo Perfusion-CT | K033832 | 12/23/2003 |
| 2. Siemens | syngo Perf. CT Body | K050867 | 04/14/2005 |
| 3. General Electric | CT Perfusion 4 | K052839 | 03/10/2006 |
8. Device Description and Intended Use:
syngo® Volume Perfusion-CT Neuro 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 Neuro software package has been designed to evaluate areas of brain perfusion. The software can calculate cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e. time to start, time to peak), mean transit time (MTT), and vascular permeability (blood brain barrier disturbances) from sets of images or volumes reconstructed from continuously acquired CT data after the injection of contrast media. The package also allows the calculation of mirrored regions or volumes of interest and the visual inspection of time attenuation curves.
2
Image /page/2/Picture/0 description: The image shows the word "SIEMENS" in a bold, sans-serif font. The letters are textured with a grainy, speckled pattern, giving them a distressed or aged appearance. The word is presented in all capital letters and is horizontally aligned.
Image /page/2/Picture/1 description: The image shows a handwritten document with the text "K073238" at the top. Below a horizontal line, the text "Pg. 3 of 3" is written in a cursive style. The text "510(k)" is at the bottom of the image.
One clinical application is to visualize the apparent blood perfusion in brain tissue affected by acute stroke. Areas of decreased perfusion, as is observed in acute cerebral infarcts, appear as areas of changed signal intensity (lower for CBF and CBV, higher for time to peak and MTT).
Syngo® Volume Perfusion-CT Neuro supports the physician in identifying areas of decreased perfusion which indicate the occurrence of acute stroke during the first 6 hours after onset of symptoms.
A second application is the visualization of the permeability. It is used for the modeling of extra-vascular leakage of blood into the interstitial space. This additional capability can display blood brain barrier disturbances and thus may improve the differential diagnosis of brain tumors and be helpful in therapy monitoring.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract symbol that resembles three human profiles facing to the right, with flowing lines beneath them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 3 2008
Siemens AG Medical Solutions % Mr. Olaf Teichert Responsible Third Party Official TÜV SÜD America 1775 Old Hwy 8 NW. Ste 104 NEW BRIGHTON MN 55112-1891
Re: K073238
Trade/Device Name: syngo® Volume Perfusion-CT Neuro Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: December 10, 2007 Received: December 14, 2007
Dear Mr. Teichert:
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, 1796, 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.
4
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" (21CFR 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/cdrh/industry/support/index.html.
Sincerely yours,
Nancy Brogdon
Nancv C. Brogdon Director. Division of Reproductive. Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
5
Indication for use
510(k) Number (if known):
Device Name:
syngo® Volume Perfusion-CT Neuro
The Siemens syngo® Volume Perfusion-CT Neuro software package has been designed to evaluate areas of brain perfusion. The software can calculate cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e. time to start, time to peak), mean transit time (MTT), and vascular permeability (blood brain barrier disturbances) from sets of images or volumes reconstructed from continuously acquired CT data after the injection of contrast media. The package also allows the calculation of mirrored regions or volumes of interest and the visual inspection of time attenuation curves.
One clinical application is to visualize the apparent blood perfusion in brain tissue affected by acute stroke. Areas of decreased perfusion, as is observed in acute cerebral infarcts. appear as areas of changed signal intensity (lower for CBF and CBV, higher for time to peak and MTT).
Syngo® Volume Perfusion-CT Neuro supports the physician in identifying areas of decreased perfusion which indicate the occurrence of acute stroke during the first 6 hours after onset of symptoms.
A second application is the visualization of the permeability. It is used for the modeling of extra-vascular leakage of blood into the interstitial space. This additional capability can display blood brain barrier disturbances and thus may improve the differential diagnosis of brain tumors and be helpful in therapy monitoring.
Prescription Use × Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy Brogdon
Division Sign-Off
Division of Reproductive, Abdominal, and
Radiological Devices
510(k) Number K073238
Section 2