(8 days)
Not Found
No
The description focuses on standard image processing and calculation of perfusion parameters from CT data, with no mention of AI, ML, or related concepts.
No.
The device is a post-processing software that calculates perfusion parameters for diagnostic purposes (characterization of tumors, therapy monitoring) and does not directly provide therapy.
Yes
The software is designed to evaluate pathological conditions (perfusion of organs and tumors, characterization of tumors), and aids in therapy monitoring by analyzing perfusion parameters. These are clinical assessments contributing to diagnosis and treatment decisions.
Yes
The device is described as a "post-processing software package" that runs on a standard PC platform and processes images acquired from a separate CT scanner. It does not include any hardware components of its own.
Based on the provided information, the Siemens syngo Body Perfusion-CT software package is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The intended use and device description clearly state that this software processes images acquired from a CT scanner, which is an in vivo (within the living body) imaging modality. It analyzes data from the patient directly, not from a sample taken from the patient.
- The software performs image processing and analysis. While it provides quantitative data (blood flow, blood volume, permeability), this data is derived from the imaging information, not from a biochemical or biological analysis of a specimen.
The software is a post-processing tool for medical images, designed to aid in the evaluation of perfusion within the body. This falls under the category of medical imaging software, not IVDs.
N/A
Intended Use / Indications for Use
The Siemens syngo Body Perfusion-CT software package has been designed to evaluate perfusion of organs and tumors.
The software can calculate blood flow, blood volume 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 Body Perfusion-CT is a post-processing software package, which runs on an Intel-based PC platform designed to post-process images acquired with SOMATOM CT scanners,
The Siemens syngo Body Perfusion-CT software package has been designed to evaluate perfusion of organs and tumors.
The software can calculate blood flow, blood volume 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT
Anatomical Site
Organs and tumors (specifically mentioning hepatic perfusion as an example)
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
Image /page/0/Picture/0 description: The image shows the word "SIEMENS" in a stylized, slightly distressed font. The letters are evenly spaced and appear to be in all caps. The overall impression is of a logo or brand name, possibly from a printed document or advertisement.
Summary
APR 1 4 2005
Attachment 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.
| Product Name: | syngo Body 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
Manufacturing Facility: 3.
Siemens AG Medical Solutions Henkestrasse 127
D-91052 Erlangen, Germany
Contact Person: 4.
Mr. Rüdiger Körner Manager Regulatory Submissions Siemensstr.1; D-91301 Forchheim +49 9191 18-9355 Phone: +49 9191 18-9988 Fax:
Date of Preparation of Summary: Feb 20" 2005 5.
1
SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL 川. 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.
Substantial Equivalence: 7.
The syngo Body 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 | K033832 | Dec. 23, 2003 |
| 2. General Electric | CT Perfusion 2 | K010042 | Jan. 30, 2001 |
Device Description and Intended Use: 8.
Syngo Body Perfusion-CT is a post-processing software package, which runs on an Intel-based PC platform designed to post-process images acquired with SOMATOM CT scanners,
The Siemens syngo Body Perfusion-CT software package has been designed to evaluate perfusion of organs and tumors.
The software can calculate blood flow, blood volume 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/12 description: The image is a circular seal or logo. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the seal is a stylized image of an eagle or bird-like figure, with three curved lines representing its body and wings. The overall design is simple and monochromatic.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 4 2005
Siemens Medical Solutions, Inc. % Mr. Stefan Preiss Responsible Third Party Official TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891 Re: K050867
Trade/Device Name: syngo Body Perfusion-CT Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography Regulatory Class: II Product Code: JAK Dated: April 4, 2005 Received: April 6, 2005
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 (Premarket Approval), 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.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and in yourse and inding of substantial equivalence of your device to a legally prematice notification: "Thesalts 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 rr you dome 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 807.97). You may obtain other general information on your responsibilities under the Act from the 001:57). I Camal 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/industry/support/index.html.
Sincerely yours,
Nancy C. Hogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Image /page/4/Picture/20 description: The image shows the word "SIEMENS" in a slightly distressed or faded font. The letters are evenly spaced and appear to be in uppercase. The overall impression is of a logo or brand name, possibly from an older document or advertisement, given the worn appearance of the text.
Indications for use
Attachment 2
Indication for use
510(k) Number (if known):
Device Name:
syngo Body Perfusion-CT
The Siemens syngo Body Perfusion-CT software package has been designed to evaluate perfusion of organs and tumors.
The software can calculate blood flow, blood volume 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.
Nancy Brozdon
(Division Sign Off)()
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K050867
(Please do not write below this line - continue on another page if needed)
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and the image is blank.
Concurrence of the CDRH, Office of Device Evaluation (ODE)
×
Prescription Use
Over-The-Counter Use OR
(Per 21 CFR §801.109)