(16 days)
syngo Circulation is a self-contained image analysis software package for evaluating cardiac and pulmonary CTA, PET and SPECT volume data sets.
syngo Circulation combines commercially available digital image processing and visualization tools (MIP thin/thick, MPR thin/thick, vessel aligned MPR, CPR, VRT, AngioView, hybrid visualization), evaluation tools (myocardial and volumetric analysis of the left ventricle, coronary tree segmentation, stenosis and plaque evaluation) and reporting tools (lesion and pulmonary embolism (PE) 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, in evaluation of the hearts functional parameters and/or in confirming the presence or absence of physician identified filling defects, e.g. emboli, in the pulmonary arteries in addition to documentation and follow-up of any lesions.
syngo Circulation is a self-contained image analysis software package for evaluating cardiac and pulmonary CTA, PET and SPECT volume data sets.
syngo Circulation combines commercially available digital image processing and visualization tools (MIP thin/thick, MPR thin/thick, vessel aligned MPR, CPR, VRT, AngioView, hybrid visualization), evaluation tools (myocardial and volumetric analysis of the left ventricle, coronary tree segmentation, stenosis and plaque evaluation) and reporting tools (lesion and pulmonary embolism (PE) 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, in evaluation of the hearts functional parameters and/or in confirming the presence or absence of physician identified filling defects, e.g. emboli, in the pulmonary arteries in addition to documentation and follow-up of any lesions.
The provided document is a 510(k) Summary for the Siemens syngo® Circulation Software Package with Extended Functionality. This document, primarily focused on establishing substantial equivalence to a predicate device, does not contain the detailed clinical study information about acceptance criteria and device performance that you requested.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for test sets or their data provenance.
- Number/qualifications of experts for ground truth establishment.
- Adjudication methods.
- Information on Multi-Reader Multi-Case (MRMC) comparative effectiveness studies.
- Information on standalone algorithm performance studies.
- The type of ground truth used (e.g., pathology, outcomes data).
- Sample size for training sets.
- How ground truth for training sets was established.
The document mainly focuses on:
- Identifying the device and its classification.
- Listing manufacturer and contact information.
- Stating the substantial equivalence to predicate devices (K052029, K010938, K022013).
- Describing the device's intended use and general safety/effectiveness concerns.
- Providing the FDA's clearance letter.
Therefore, I cannot fulfill your request for details on acceptance criteria and study results based on the provided text.
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Image /page/0/Picture/0 description: The image contains a sequence of alphanumeric characters. The sequence starts with the letters 'K0b', followed by the numbers '3762'. The characters are written in a bold, sans-serif font, and they appear to be handwritten or stylized.
Summary
JAN - 5 2007
SECTION 9
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.
1. Device Name and Classification
| Product Name: | syngo® Circulation | |
|---|---|---|
| Software Package with Extended Functionality | ||
| Classification Name: | Accessory to Computed Tomography System Classification | |
| Panel: | Radiology | |
| CFR Section: | 21 CFR §892.1750 | |
| Device Class: | Class II | |
| Product Code: | JAK |
2. Importer/Distributor Establishment:
Registration Number: 2240869
Siemens Medical Solutions, Inc. 51 Valley Stream Pkwy Malvern, PA 19355
3. Manufacturing Facility:
Siemens AG Wittelsbacherplatz 2 D-80333 Muenchen, Germany
4. Contact Person:
Dr. Kristin Frowein Regulatory Submissions Specialist Siemensstr.1; D-91301 Forchheim Phone: +49 9191 18-9638 Fax: +49 9191 18-9782
Date of Preparation of Summary: December 15, 2006 5.
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Summary
II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION
General Safety and Effectiveness Concerns ნ.
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 Circulation software package that is addressed in this premarket notification, is substantially equivalent to the following commercially available software packaqe:
| Manufacturer | Product | 510(k) | Clearance date |
|---|---|---|---|
| 1. Siemens AG | syngo Circulation | K052029 | 08/09/2005 |
| 2. Siemens AG | syngo MultimodalityWorkstation(feature: Image Fusion) | K010938 | 06/26/2001 |
| 3. Siemens AG | LungCARE CTSW Package | K022013 | 07/16/2002 |
8. Device Description and Intended Use:
syngo Circulation is a self-contained image analysis software package for evaluating cardiac and pulmonary CTA, PET and SPECT volume data sets.
syngo Circulation combines commercially available digital image processing and visualization tools (MIP thin/thick, MPR thin/thick, vessel aligned MPR, CPR, VRT, AngioView, hybrid visualization), evaluation tools (myocardial and volumetric analysis of the left ventricle, coronary tree segmentation, stenosis and plaque evaluation) and reporting tools (lesion and pulmonary embolism (PE) 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, in evaluation of the hearts functional parameters and/or in confirming the presence or absence of physician identified filling defects, e.g. emboli, in the pulmonary arteries in addition to documentation and follow-up of any lesions.
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Image /page/2/Picture/0 description: The image shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES" in a circular arrangement. The logo is simple and recognizable, and it is used to represent the U.S. Department of Health & Human Services.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
Siemens AG Medical Solutions % Mr. Stefan Preiss Responsible Third Party Official TÜV Product Service 1775 Old Highway 8 NW, Ste 104 NEW BRIGHTON MN 55112-1891
JAN - 5 2007
Re: K063762
Trade/Device Name: syngo® Circulation Software Package with Extended Functionality Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: December 11, 2006 Received: December 20, 2006
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, Drue, 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, T o on may 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.
Image /page/2/Picture/10 description: The image is a black and white circular logo. The logo has the letters "FDA" in a bold, stylized font in the center. Above the letters, there is the text "1906-2006". Below the letters, there is the word "Centennial" in a cursive font. There are three stars below the word "Centennial". The logo is surrounded by a dotted border.
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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 Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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 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/cdrl/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
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SEVENS
Indication for Use
SECTION 3
INDICATION FOR USE
510(k) Number (if known): K063762
Device Name:
syngo® Circulation
Software Package with Extended Functionality
Indications for Use:
syngo Circulation is a self-contained image analysis software package for evaluating cardiac and pulmonary CTA, PET and SPECT volume data sets.
syngo Circulation combines commercially available digital image processing and visualization tools (MIP thin/thick, MPR thin/thick, vessel aligned MPR, CPR, VRT, AngioView, hybrid visualization), evaluation tools (myocardial and volumetric analysis of the left ventricle, coronary tree segmentation, stenosis and plaque evaluation) and reporting tools (lesion and pulmonary embolism (PE) 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, in evaluation of the hearts functional parameters and/or in confirming the presence or absence of physician identified filling defects, e.g. emboli, in the pulmonary arteries in addition to documentation and follow-up of any lesions.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use _ (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 C. Broydon
n of Reproductive. Abde and Radiological Devices 510(k) Number
§ 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.