(13 days)
Not Found
No
The description focuses on standard image processing and analysis tools, with no mention of AI, ML, or related concepts.
No
The device is described as image analysis software for evaluation and documentation of cardiac conditions, and does not provide any treatment or therapy.
Yes
The device is described as software that supports physicians in "confirming the presence or absence of physician identified coronary lesions and evaluation of the hearts functional parameter," which directly aligns with diagnostic purposes.
Yes
The device is described as a "self-contained image analysis software package" and its function is solely focused on processing and analyzing existing image data (cardiac CTA volume data sets). There is no mention of any hardware component being part of the device itself.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device function: syngo Circulation is a software package that analyzes cardiac CTA volume data sets. This data is generated from medical imaging (Computed Tomography Angiography), not from samples taken from the body.
- Intended Use: The intended use describes the software as supporting physicians in evaluating cardiac CTA data, confirming lesions, evaluating heart function, and documenting findings. This is all based on image analysis, not laboratory testing of biological samples.
Therefore, syngo Circulation falls under the category of medical imaging analysis software, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
syngo Circulation is a self-contained image analysis software package for evaluating cardiac CTA volume data sets.
syngo Circulation combines commercially available digital image processing and visualization tools (MIP thin/thick, MPR thin/thick, VRT, CPR), evaluation tools (volumetric analysis of the left ventricle, coronary tree segmentation and stenosis evaluation) and reporting tools (lesion location and characteristics) with a workflow including dedicated scanning protocols. The software package is designed to support the physician in confirming the presence or absence of physician identified coronary lesions and evaluation of the hearts functional parameter in addition to evaluation, documentation and follow-up of any such lesions.
These visualization/evaluation tools allow for volumetric analysis of the left ventricle and characterization of coronary lesions over time, helping the physician to assess the changes. It is also designed to help the physician classify conspicuous regions of tissue unambiguously, with respect to their size, dimensions, shape and position.
Product codes (comma separated list FDA assigned to the subject device)
90 JAK
Device Description
syngo Circulation is a self-contained image analysis software package for evaluating cardiac CTA volume data sets.
syngo Circulation combines commercially available digital image processing and visualization tools (MIP thin/thick, MPR thin/thick, VRT, CPR), evaluation tools (volumetric analysis of the left ventricle, coronary tree segmentation and stenosis evaluation) and reporting tools (lesion location and characteristics) with a workflow including dedicated scanning protocols. The software package is designed to support the physician in confirming the presence of physician identified coronary lesions and evaluation of the hearts functional parameter in addition to evaluation, documentation and follow-up of any such lesions.
These visualization/evaluation tools allow for volumetric analysis of the left ventricle and characterization of coronary lesions over time, helping the physician to assess the changes. It is also designed to help the physician classify conspicuous regions of tissue unambiguously, with respect to their size, dimensions, shape and position.
Mentions image processing
syngo Circulation combines commercially available digital image processing and visualization tools (MIP thin/thick, MPR thin/thick, VRT, CPR), evaluation tools (volumetric analysis of the left ventricle, coronary tree segmentation and stenosis evaluation) and reporting tools (lesion location and characteristics) with a workflow including dedicated scanning protocols.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
cardiac CTA volume data sets.
Anatomical Site
cardiac, coronary, left ventricle
Indicated Patient Age Range
Not Found
Intended User / Care Setting
physician / 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
Image /page/0/Picture/0 description: The image shows the word "Summary" in a simple, sans-serif font. The text is black against a white background. The word is presented in a straightforward manner, with no additional design elements or formatting.
Image /page/0/Picture/1 description: The image shows the date August 9, 2005. The month is abbreviated as AUG. The numbers are separated by a dash. The text is in a simple, sans-serif font.
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.
l. GENERAL INFORMATION
Device Name and Classification 1.
| Product Name: | syngo Circulation |
|---|---|
| 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:
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: May 06th 2005 5.
Attachment 8
1
Image /page/1/Picture/0 description: The image is a white background with several small, dark spots scattered across it. The spots are irregularly shaped and vary in size. They are distributed randomly throughout the image, with no apparent pattern or concentration in any particular area.
SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL 11. 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.
Substantial Equivalence: 7.
The syngo Circulation 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. General Electric | CardIQ Analysis III | K041267 | 05/27/2004 |
Device Description and Intended Use: 8.
syngo Circulation is a self-contained image analysis software package for evaluating cardiac CTA volume data sets.
syngo Circulation combines commercially available digital image processing and visualization tools (MIP thin/thick, MPR thin/thick, VRT, CPR), evaluation tools (volumetric analysis of the left ventricle, coronary tree segmentation and stenosis evaluation) and reporting tools (lesion location and characteristics) with a workflow including dedicated scanning protocols. The software package is designed to support the physician in confirming the presence of physician identified coronary lesions and evaluation of the hearts functional parameter in addition to evaluation, documentation and follow-up of any such lesions.
These visualization/evaluation tools allow for volumetric analysis of the left ventricle and characterization of coronary lesions over time, helping the physician to assess the changes. It is also designed to help the physician classify conspicuous regions of tissue unambiguously, with respect to their size, dimensions, shape and position.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 9 - 2005
Siemens AG Medical Solutions % Mr. Stefan Preiss Responsible Third Party Official TÜV America, Inc. TÜV Product Service 1775 Old Highway 8 NEW BRIGHTON MN 55112-1891 / Re: K052029 Trade/Device Name: syngo Circulation Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II
Product Code: JAK Dated: July 25, 2005 Received: July 27, 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) This letter will anow you to begin hantelling of substantial equivalence of your device to a legally prematication: The PDF maing of cassification 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 If you desire specific acrise for your 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 Also, phease note the regulation on your responsibilities under the Act from the 807.97). Tou may obtain other general meeting 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
S. STEVENS
Indications for use
Attachment 2
Indication for use
510(k) Number (if known):
2029
Device Name:
syngo Circulation
syngo Circulation is a self-contained image analysis software package for evaluating cardiac CTA volume data sets.
syngo Circulation combines commercially available digital image processing and visualization tools (MIP thin/thick, MPR thin/thick, VRT, CPR), evaluation tools (volumetric analysis of the left ventricle, coronary tree segmentation and stenosis evaluation) and reporting tools (lesion location and characteristics) with a workflow including dedicated scanning protocols. The software package is designed to support the physician in confirming the presence or absence of physician identified coronary lesions and evaluation of the hearts functional parameter in addition to evaluation, documentation and follow-up of any such lesions.
These visualization/evaluation tools allow for volumetric analysis of the left ventricle and characterization of coronary lesions over time, helping the physician to assess the changes. It is also designed to help the physician classify conspicuous regions of tissue unambiguously, with respect to their size, dimensions, shape and position.
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is the original image.
Concurrence of the CDRH, Office of Device Evaluation (ODE)
Prescription Use X (Per 21 CFR §801.109)
Over-the-Counter Use
sion Sinn-Of vision of Reproduc Dadiningical D