(11 days)
No
The description focuses on standard image processing tools, workflow optimization, and reporting, without mentioning AI or ML capabilities.
No
The device is described as an "image analysis software package" and "evaluation tool" designed to "support the physician in studying" and "facilitates the detection, evaluation, documentation and follow-up" of colonic lesions. It does not perform any treatment or therapy.
Yes
The device is an "image analysis software package" designed to "support the physician" in "evaluating CT volume data sets" and "MR volume datasets" of the colon to "facilitate the detection of colonic lesions (eg. Polyps) in addition to the evaluation, documentation and follow-up of any such lesions." It also allows for "volumetric analysis of colonic polyps or lesion size over time, helping the Physician to assess the changes in their growth" and to "classify conspicuous regions of tissue unambiguously, with respect to their size, dimensions, shape and position." These functions clearly fall under the definition of a diagnostic device.
Yes
The device is explicitly described as a "self-contained image analysis software package" and the description focuses solely on its software functionalities for image processing and analysis of existing CT and MR datasets. There is no mention of accompanying hardware components developed or included as part of this specific device submission.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body (in vitro). This device analyzes medical images (CT and MR volume data sets) of the colon, which are generated from the body but are not biological samples themselves.
- The intended use is image analysis and visualization. The software is designed to help physicians evaluate the colon's structure and identify lesions based on imaging data. This is distinct from analyzing biological fluids or tissues to diagnose or monitor conditions.
The device falls under the category of medical image analysis software, which is a different type of medical device than an IVD.
N/A
Intended Use / Indications for Use
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 optimized workflow and reporting tools, the software is designed to support the physician in studying the inside (intra-lumenal view), the wall and the outside (extra-lumenal view) of the colon. With the functionality to view datasets from both the prone and supine positions, it facilitates the detection of colonic lesions (eg. Polyps) in addition to the evaluation, documentation and follow-up of any such lesions using standard spiral CT or MR scanning. This evaluation tool allows for volumetric analysis of colonic polyps or lesion size over time, helping the Physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue unambiguously, with respect to their size, dimensions. shape and position.
Due to all these capabilities the syngo Colonography software has the advantage of non-invasive evaluation of colonic lesions as compared to conventional colonoscopy.
Product codes (comma separated list FDA assigned to the subject device)
90 JAK, 90 LLZ
Device Description
This premarket notification covers Siemens Syngo Colonography software package. 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 optimized workflow and reporting tools, the software is designed to support the physician in studying the inside (intra-lumenal view), the wall and the outside (extra-lumenal view) of the colon. With the functionality to view datasets from both the prone and supine positions, it facilitates the detection of colonic lesions (eg. Polyps) in addition to the evaluation, documentation and follow-up of any such lesions using standard spiral CT or MR scanning. This evaluation tool allows for volumetric analysis of colonic polyps or lesion size over time, helping the Physician to assess the changes in their growth. 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
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.
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
510(k) Summary of Safety and Effectiveness
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.
I. GENERAL INFORMATION
Device Name and Classification
| Product Name: | Syngo Colonography software package |
|---|---|
| Common Name | 3D Reconstruction Software |
| Classification Name: | Accessory to Computed Tomography System |
| Classification Panel: | Radiology |
| CFR Section: | 21 CFR §892.1750 2050 |
| Device Class: | Class II |
| Product Code: | 90 JAK LLZ |
Establishment:
Importer/Distributor:
Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355
Registration Number: 2240869
Manufacturing Facility:
Siemens AG Medical Solutions Henkestrasse 127 D-91052 Erlangen, Germany syngo is a registered trademark of Siemens AG
Contact Person: Mr. Jamie Yieh Senior Technical Specialist Telephone: (610) 448-1785 Fax: (610) 448-1787
Date of Preparation of Summary: November 26th 2002
II. SAFETY AND EFFECTIVENESS INFORMATION SUPPORTING SUBSTANTIAL THE EQUIVALENCE DETERMINATION
Device Description and Intended Use:
This premarket notification covers Siemens Syngo Colonography software package. 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
1
with optimized workflow and reporting tools, the software is designed to support the physician in studying the inside (intra-lumenal view), the wall and the outside (extra-lumenal view) of the colon. With the functionality to view datasets from both the prone and supine positions, it facilitates the detection of colonic lesions (eg. Polyps) in addition to the evaluation, documentation and follow-up of any such lesions using standard spiral CT or MR scanning. This evaluation tool allows for volumetric analysis of colonic polyps or lesion size over time, helping the Physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue unambiguously, with respect to their size, dimensions, shape and position.
Due to all these capabilities the syngo Colonography software has the advantage of noninvasive evaluation of colonic lesions as compared to conventional colonoscopy.
General Safety and Effectiveness Concerns:
The device labeling contains instructions for use and any necessary cautions and warning, 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:
The Syngo Colonography software package, addressed in this premarket notification, is substantially equivalent to the following commercially available software package:
| Predicate Device Name | FDA Clearance
Number | FDA Clearance
Date |
|-------------------------------------------------------------|-------------------------|-----------------------|
| GE CT Colonography/Navigator 2
Workstation | K012313 | 08/07/01 |
| Siemens Fly Through | K971717 | 09/03/97 |
| Siemens RealTime 3D Diagnostic
Workstation (3D Virtuoso) | K973010 | 11/10/97 |
The Syngo Colonography software package described in this 510(k) has the same intended use and similar technical characteristics as the commercially available software listed above.
In addition, many of the image processing, display and evaluation components of syngo Colonography are currently available on software options like the Volume Rendering Technique option, K923524/S2, cleared on May 17th 1994 and workstations like the syngo Multimodality Workstation, K010938 cleared on 26th June 2001 wherein the Fly Thorough software algorithms were transferred over to the syngo software platform. syngo Colonography packages these image processing and image display components in an optimized workflow palette.
In summary, Siemens is of the opinion that Syngo Colonography software package 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.
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 stylized caduceus symbol, which features three parallel lines that curve upwards and resemble wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 0 8 2003
Siemens Medical Solutions, Inc. % Mr. Heinz Joerg Steneberg Division Manager, Medical Division TUV Rheinland of North America 12 Commerce Road NEWTON CT 06470
Re: K030982
Trade/Device Name: Syngo Colongraphy Software Package Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: March 26, 2003 Received: March 28, 2003
Dear Mr. Steneberg:
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 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) 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. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indication for use
KO30982 510(k) Number (if known):
Device Name:
syngo Colonography Software Package
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 optimized workflow and reporting tools, the software is designed to support the physician in studying the inside (intra-lumenal view), the wall and the outside (extra-lumenal view) of the colon. With the functionality to view datasets from both the prone and supine positions, it facilitates the detection of colonic lesions (eg. Polyps) in addition to the evaluation, documentation and follow-up of any such lesions using standard spiral CT or MR scanning. This evaluation tool allows for volumetric analysis of colonic polyps or lesion size over time, helping the Physician to assess the changes in their growth. It is also designed to help the physician classify conspicuous regions of tissue unambiguously, with respect to their size, dimensions. shape and position.
Due to all these capabilities the syngo Colonography software has the advantage of non-invasive evaluation of colonic lesions as compared to conventional colonoscopy.
(Please do not write below this line - continue on another page if needed)
Concurrence of the CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
| 510(k) Number | K030982 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | OR Over-The-Counter Use |
|---|---|
| --------------------------------------- | ------------------------- |