(14 days)
Not Found
Unknown
The summary mentions "automated segmentation" and "Polyp Enhanced Viewing" which could potentially utilize AI/ML, but the description lacks explicit mention of AI, ML, or related terms like deep learning or neural networks, and there is no information about training or test data sets which are typical for AI/ML devices.
No
The device is an image analysis and visualization software package designed to support physicians in evaluating CT and MR volume data sets for colon lesions; it does not directly treat or provide therapy to patients.
Yes
The device is designed to "support the physician in confirming the presence or absence of physician identified colon lesions (e.g. polyps)" and to "classify conspicuous regions of tissue unambiguously having determined their size, dimensions, shape, and position," which aligns with the definition of a diagnostic device.
Yes
The device is described as a "self-contained image analysis software package" and its function is to process and analyze existing CT and MR volume data sets. There is no mention of accompanying hardware or hardware components being part of the device itself.
Based on the provided text, this device 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, to detect diseases, conditions, or infections.
- Device Function: The syngo Colonography software analyzes medical images (CT and MR volume data sets) of the colon. It does not perform tests on biological samples.
- Intended Use: The intended use is to support physicians in evaluating and documenting colon lesions based on imaging data.
The device is a medical image analysis software, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
syngo Colonography - Software Package with Extended Functionality is a self-contained image analysis software package for evaluating CT volume data sets. This software package can also be utilized for evaluating suitable MR volume datasets. Combining enhanced commercially available digital image processing tools with an optimized workflow and reporting tools, the software is designed to support the physician in confirming the presence or absence of physician identified colon lesions (e.g. polyps) in addition to evaluation, documentation, and follow-up of any such lesions using standard or low-dose spiral CT or MR scanning.
The syngo Colonography - Software Package with Extended Functionality contains modifications for CT data only which support the user with a special workflow based on automated segmentation for the visual identification of possible lesions (Polyp Enhanced Viewing), Furthermore workflow improvements, like "segmentation in global view". "automatic size measurement", "synchronization of prone and supine" and "unseen areas" are included in this software package.
This visualization tool allows for volumetric analysis of colonic lesion size over time. helping the physician to assess the changes in its growth. It is also designed to help the physician to classify conspicuous regions of tissue unambiguously having determined their size, dimensions, shape, and position.
The syngo Colonography - Software Package with Extended Functionality is limited to CT volume data sets.
Product codes (comma separated list FDA assigned to the subject device)
LLZ, NWE
Device Description
This pre-market notification covers Siemens syngo Colonography - Software Package with Extended Functionality. It is based on Siemens syngo software platform.
syngo Colonography is a self-contained image analysis software package for evaluating CT volume data sets. This software package can also be utilized for evaluating suitable MR volume datasets. Combining enhanced commercially available digital image processing tools with an optimized workflow and reporting tools, the software is designed to support the physician in confirming the presence or absence of physician identified colon lesions (e.g. polyps) in addition to evaluation, documentation, and follow-up of any such lesions using standard or lowdose spiral CT or MR scanning.
The syngo Colonography Software Package with Extended Functionality contains modifications for CT data only which support the user with a special workflow based on Enhanced Viewing). Furthermore workflow improvements, like "segmentation in global view", "automatic size measurement", "synchronization of prone and supine" and "unseen areas" are included in this software package.
This visualization tool allows for volumetric analysis of colonic lesion size over time, helping the physician to assess the changes in its growth. It is also designed to help the physician to classify conspicuous regions of tissue unambiguously having determined their size, dimensions, shape, and position.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR
Anatomical Site
Colon
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): 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
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
Image /page/0/Picture/1 description: The image shows a handwritten string of characters, "K042605". The characters are written in a bold, somewhat uneven style, suggesting they were written quickly or with a thick marker. The characters are all connected, and the overall impression is that of a serial number or code.
510(k)
8 - 2004
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.
l. GENERAL INFORMATION
1. Device Name and Classification
| Product Name: | syngo Colonography - Software Package with
Extended Functionality |
|-----------------------|----------------------------------------------------------------------|
| Classification Name: | Accessory to Computed Tomography X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.2050 |
| Device Class: | Class II |
| Product Code: | LLZ |
2. Importer/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
4. Contact Person:
Mr. Rüdiger Körner Manager Regulatory Submissions Siemensstr.1; D-91301 Forchheim Phone: +49 9191 18-9355 Fax: +49 9191 18-9988
Date of Preparation of Summary: August 24, 2004 5.
1
II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING THE SUBSTANTIAL EQUIVALENCE DETERMINATION
1. 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, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.
2. Substantial Equivalence
The syngo Colonography - Software Package with Extended Functionality, addressed in this pre-market notification, is substantially equivalent to the following commercially available software package:
| Manufacturer | Product | 510(k) | Clearance date |
|---|---|---|---|
| 1. Siemens | syngo Colonography | ||
| Software Package | K030982 | April 08, 2003 |
In summary, Siemens is of the opinion that syngo Colonography Software Package with Extended Functionality does not introduce any new potential safety risks and is substantially equivalent to and performs as well as the predicate software components and the predicate device.
3. Device Description and Intended Use
This pre-market notification covers Siemens syngo Colonography - Software Package with Extended Functionality. It is based on Siemens syngo software platform.
syngo Colonography is a self-contained image analysis software package for evaluating CT volume data sets. This software package can also be utilized for evaluating suitable MR volume datasets. Combining enhanced commercially available digital image processing tools with an optimized workflow and reporting tools, the software is designed to support the physician in confirming the presence or absence of physician identified colon lesions (e.g. polyps) in addition to evaluation, documentation, and follow-up of any such lesions using standard or lowdose spiral CT or MR scanning.
The syngo colonography Software Package with Extended Functionality contains modifications for CT data only which support the user with a special workflow based
2
SIEMENS
Enhanced Viewing). Furthermore workflow improvements, like "segmentation in global view", "automatic size measurement", "synchronization of prone and supine" and "unseen areas" are included in this software package.
This visualization tool allows for volumetric analysis of colonic lesion size over time, helping the physician to assess the changes in its growth. It is also designed to help the physician to classify conspicuous regions of tissue unambiguously having determined their size, dimensions, shape, and position.
3
Image /page/3/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized abstract symbol resembling a bird or flowing fabric. The symbol is positioned to the right of a circular arrangement of text. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in all capital letters, encircling the symbol.
MAR 1 1 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
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: K042605
Trade/Device Name: syngo colonography-Software Package with Extended Functionality Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: NWE Dated: September 21, 2004 Received: September 24, 2004
Dear Mr. Preiss:
This letter corrects our substantially equivalent letter of October 8, 2004.
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.
4
Page 2
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 os 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 892.xxx | (Radiology) | (240) 276-0120 |
| Other | (240) 276-0100 |
Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometrics' (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 Manufactures. 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.suppot/index.html.
Sincerely yours.
Hecker leman
Geo. M. Meigs
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k)
SECTION 3
INDICATION FOR USE
510(k) Number (if known): _ /(