(13 days)
Not Found
No
The description focuses on standard image processing techniques and calculations based on contrast media dynamics, with no mention of AI, ML, or related concepts.
No
The device is described as software for post-processing CT images to evaluate brain perfusion and assist in diagnosis (e.g., acute stroke, brain tumors). It processes data and provides information to clinicians but does not directly treat or provide therapy to patients.
Yes
The device is described as software that "evaluates areas of brain perfusion" and helps in "identifying the areas of decreased perfusion which indicates the occurrence of acute stroke." It also aims to "improve the differential diagnosis of brain tumors," all of which point to its use in diagnosing medical conditions.
Yes
The device is described as a "post-processing software package" that runs on a standard PC platform and processes images acquired from existing CT scanners. It does not include any hardware components of its own.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The Siemens syngo Perfusion-CT software processes imaging data (CT scans) acquired from within the patient's body after the injection of contrast media. It analyzes the distribution and flow of this contrast agent within the brain.
- Intended Use: The intended use is to evaluate brain perfusion and visualize areas of decreased perfusion or blood-brain barrier disturbances based on the analysis of these in-vivo images.
The device is a medical image processing software used for diagnostic purposes, but it operates on data acquired directly from the patient's body, not on in-vitro specimens.
N/A
Intended Use / Indications for Use
The Siemens syngo Perfusion-CT 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) and vascular permeability (blood brain barrier disturbances) from sets of images reconstructed from continuously acquired CT data after the injection of contrast media. The package also allows the calculation of mirrored regions of interest and the visual inspection of time density curves.
One potential 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).
Syngo Perfusion-CT is sensitive in identifying the areas of decreased perfusion which indicates the occurrence of acute stroke, during the first 6 hours after onset of symptoms.
A second potential application is the visualization of blood-brain-barrier disturbances in brain tumors. A modified Patlak approach is used for the modeling of extra-vascular leakage of blood into the interstitial space. This additional capability may improve the differential diagnosis of brain tumors and be helpful in therapy monitoring.
Product codes (comma separated list FDA assigned to the subject device)
90 JAK
Device Description
Syngo Perfusion-CT is a post-processing software package, which runs on an Intelbased PC platform designed to post-process images acquired with SOMATOM CT scanners, which meet certain minimal requirements (i.e. Siemens Sensation 16, Sensation 10, Sensation Cardiac, Sensation 4, Volume Zoom, Volume Access, Emotion 6, Emotion Duo, Emotion, SOMATOM Plus 4, SOMATOM AR.STAR, SOMATOM Classic). 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.
Syngo Perfusion-CT calculates the parameters related to brain perfusion and cerebral blood flow (CBF) using a simple linear relationship between the defected change of signal and the actual concentration of contrast media.
The Siemens syngo Perfusion-CT package has been designed to image cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e. time to start, time to peak) and vascular permeability from sets of images reconstructed from CT data that were continuously acquired after the injection of a bolus of contrast media. It also allows the calculation of mirrored regions of interest and the visual inspection of time density 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
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
DEC 2 3 2003
Ko33832
Attachment 8
510(k)
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 .
Device Name and Classification 1.
| Product Name: | syngo Perfusion-CT |
|---|---|
| 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
Contact Person: 4.
Mr. Rüdiger Körner Manager Regulatory Submissions Siemensstr.1; D-91301 Forchheim Phone: +49 9191 18-9355 +49 9191 18-9988 Fax:
Date of Preparation of Summary: Oct 15th 2003 5.
▪ 510(k) submission for SIEMENS 'syngo Perfusion-CT '
1
Image /page/1/Picture/0 description: The image shows the word "SIEMENS" written in a pixelated style. The letters are formed by small dots, giving the word a textured appearance. The overall effect is a digital or low-resolution representation of the brand name.
ll. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION
6. 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 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 Perfusion-CT 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 | K982536 | Nov. 24, 1998 |
| 2. General Electric | CT Perfusion 2 | K010042 | Jan. 30, 2001 |
8. Device Description and Intended Use:
Syngo Perfusion-CT is a post-processing software package, which runs on an Intelbased PC platform designed to post-process images acquired with SOMATOM CT scanners, which meet certain minimal requirements (i.e. Siemens Sensation 16, Sensation 10, Sensation Cardiac, Sensation 4, Volume Zoom, Volume Access, Emotion 6, Emotion Duo, Emotion, SOMATOM Plus 4, SOMATOM AR.STAR, SOMATOM Classic). 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.
Syngo Perfusion-CT calculates the parameters related to brain perfusion and cerebral blood flow (CBF) using a simple linear relationship between the defected change of signal and the actual concentration of contrast media.
The Siemens syngo Perfusion-CT package has been designed to image cerebral blood flow (CBF), cerebral blood volume (CBV), local bolus timing (i.e. time to start, time to peak) and vascular permeability from sets of images reconstructed from CT data that were continuously acquired after the injection of a bolus of contrast media. It also allows the calculation of mirrored regions of interest and the visual inspection of time density curves.
■ 510(k) submission for SIEMENS 'syngo Perfusion-CT '
2
One potential clinical application is to visualize the apparent brain perfusion in brain tissue affected by acute stroke. Areas of decreased perfusion, as is observed in acute cerebral infarcts, appear as areas of changed image intensity (lower for CBF and CBV, higher for time to peak).
Syngo Perfusion-CT is sensitive in identifying the occurrences of acute stroke during the first 6 hours after onset of symptoms.
A second potential application is the visualization of blood-brain-barrier disturbances in brain tumors. Assessing vascular permeability 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 features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 2003
Siemens Medical Solutions, Inc. % Mr. Stefan Preiss Responsible Third Party TÜV America, Inc. TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891 Re: K033832
Trade/Device Name: syngo Perfusion CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: December 5, 2003
Received: December 10, 2003
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 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.
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.
4
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 Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Bugden
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
SIEMENS
Attachment 2
Indication for use
510(k) Number (if known):
Device Name:
syngo Perfusion-CT
The Siemens syngo Perfusion-CT 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) and vascular permeability (blood brain barrier disturbances) from sets of images reconstructed from continuously acquired CT data after the injection of contrast media. The package also allows the calculation of mirrored regions of interest and the visual inspection of time density curves.
One potential 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).
Syngo Perfusion-CT is sensitive in identifying the areas of decreased perfusion which indicates the occurrence of acute stroke, during the first 6 hours after onset of symptoms.
A second potential application is the visualization of blood-brain-barrier disturbances in brain tumors. A modified Patlak approach is used for the modeling of extra-vascular leakage of blood into the interstitial space. This additional capability may improve the differential diagnosis of brain tumors and be helpful in therapy monitoring.
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Concurrence of the CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR §801.109)
OR Over-The-Counter Use
Daniel A. Larson
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________