(187 days)
Unknown
The document describes a Computer-Aided Detection (CAD) tool for image processing, which could utilize AI/ML, but the summary does not explicitly mention these technologies or provide details about training/test sets typically associated with AI/ML development.
No.
Explanation: A therapeutic device is designed to treat, cure, or mitigate a disease or condition. This device is a diagnostic tool used to assist radiologists in the detection of pulmonary nodules. It does not provide any treatment or therapy.
Yes
The device is a computer-aided detection (CAD) tool designed to assist radiologists in the detection of solid pulmonary nodules, which is a diagnostic function. It identifies regions of interest that may indicate a medical condition.
Yes
The device is described as software that processes images from a CT scanner and provides output for display on other software. It does not mention any hardware components included with 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.CT Lung CAD device processes medical images (CT scans) to assist radiologists in identifying potential lung nodules. It does not analyze biological samples from the patient.
- Intended Use: The intended use clearly states it's a "computer-aided detection (CAD) tool designed to assist radiologists in the detection of solid pulmonary nodules during review of multi-detector computed tomography (MDCT) examinations of the chest." This is image analysis, not in vitro testing.
Therefore, the syngo.CT Lung CAD device falls under the category of medical imaging software or a medical device that processes imaging data, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The syngo.CT Lung CAD device is a computer-aided detection (CAD) tool designed to assist radiologists in the detection of solid pulmonary nodules during review of multi-detector computed tomography (MDCT) examinations of the chest. The software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may have been initially overlooked. The syngo. CT Lung CAD device is intended to be used as a second reader after the radiologist has completed his/her initial read.
Product codes
OEB
Device Description
syngo.CT Lung CAD is a medical device that is designed to perform CAD processing in thoracic CT examinations for the detection of solid pulmonary nodules ≥ 3 mm in size. The device processes images acquired with Siemens multi-detector CT scanners with 4 or more detector rows.
The syngo.CT Lung CAD device supports the full range of nodule locations (central, peripheral) and contours (round, irregular). The detection performance of the syngo.CT Lung CAD device is optimized for nodules between 3 mm and 10 mm in size. Additionally, the syngo.CT Lung CAD device can be used in scans with or without contrast enhancement.
The device receives images via an input data interface, performs CAD processing and provides locations of suspected nodules as an output. Specific visualizations, such as the syngo PET&CT Oncology application (K093621) or equivalent Siemens products, should be used (but are not part of this clearance) to display the CAD marks. The syngo.CT Lung CAD device is intended to be used as a second reader only after the initial read is completed.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
multi-detector computed tomography (MDCT)
Anatomical Site
chest / pulmonary
Indicated Patient Age Range
Not Found
Intended User / Care Setting
radiologists
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)
Non-clinical tests were conducted for the device syngo.CT Lunq CAD during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.
Testing, including standalone performance testing, were conducted to assess the new syngo.CT Lung CAD device and compare it to the predicate device with respect to false positives, sensitivity, and the dismissibility of false positives. The results of these tests support the substantial equivalence of this device.
The Risk Analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.
Performance tests were conducted to test the functionality of the device syngo.CT Lung CAD. Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
false positives, sensitivity, and the dismissibility of false positives
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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Image /page/0/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 is a staff with two snakes coiled around it, overlaid on a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the top half of the circle. The logo is black and white.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 12, 2015
Siemens AG Medical Solutions % James Kuhn Jr. Senior Regulatory Submissions Manager 20 Valley Stream Parkway MALVERN PA 19355
Re: K143196
Trade/Device Name: syngo.CT Lung CAD Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: OEB Dated: April 20, 2015 Received: April 22, 2015
Dear Mr. Kuhn:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Robert A. Ochs
Robert Ochs. Ph.D. Acting Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143196
Device Name syngo.CT Lung CAD
Indications for Use (Describe)
The syngo.CT Lung CAD device is a computer-aided detection (CAD) tool designed to assist radiologists in the detection of solid pulmonary nodules during review of multi-detector computed tomography (MDCT) examinations of the chest. The software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may have been initially overlooked. The syngo. CT Lung CAD device is intended to be used as a second reader after the radiologist has completed his/her initial read.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) Summary
This summary of 510(k) safety and effectiveness is provided in accordance with the requirements of SMDA 1990 and 21 CFR §807.92
Date Prepared: May 11tt, 2015
General Information
Legal Manufacturer
Siemens AG Medical Solutions Henkestrasse 127 91052 Erlangen Germany
Manufacturing Location
Siemens Medical Solutions USA, Inc. 20 Valley Stream Parkway Malvern PA. 19355
Establishment Registration Number: 3002808157
Contact Person
James E. Kuhn Jr. Senior Regulatory Submissions Manager Phone: (610) 448-3006 Fax: (610) 448-4274 Email: james.kuhn@siemens.com
Device Name and Classification
Trade Name: syngo.CT Lung CAD Classification Name: Lung computed tomography system, computer-aided detection 21 CFR §892. 2050 CFR Section: Device Class: Class II Product Code: OEB
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Safety and Effectiveness Information Supporting the Substantial Equivalence Determination
Device Description
syngo.CT Lung CAD is a medical device that is designed to perform CAD processing in thoracic CT examinations for the detection of solid pulmonary nodules ≥ 3 mm in size. The device processes images acquired with Siemens multi-detector CT scanners with 4 or more detector rows.
The syngo.CT Lung CAD device supports the full range of nodule locations (central, peripheral) and contours (round, irregular). The detection performance of the syngo.CT Lung CAD device is optimized for nodules between 3 mm and 10 mm in size. Additionally, the syngo.CT Lung CAD device can be used in scans with or without contrast enhancement.
The device receives images via an input data interface, performs CAD processing and provides locations of suspected nodules as an output. Specific visualizations, such as the syngo PET&CT Oncology application (K093621) or equivalent Siemens products, should be used (but are not part of this clearance) to display the CAD marks. The syngo.CT Lung CAD device is intended to be used as a second reader only after the initial read is completed.
Intended Use
The syngo.CT Lung CAD device is a computer-aided detection (CAD) tool designed to assist radiologists in the detection of solid pulmonary nodules during review of multi-detector computed tomography (MDCT) examinations of the software is an adjunctive tool to alert the radiologist to regions of interest (ROI) that may have been initially overlooked. The syngo.CT Lung CAD device is intended to be used as a second reader after the radiologist has completed his/her initial read.
Safety and Effectiveness Information
Software design description, hazard analysis, and technical and safety information have also been completed and provided in support of this device. Risk management is ensured via the hazard analysis, which is used to identify potential hazards. These potential hazards are controlled during the development, verification/validation testing, and adherence to recognized and established industry practices and standards.
The device has no patient contacting materials and is utilized only by trained professionals. The output of the device is evaluated by trained professionals as a second reader. Use of this device does not impact the quality or status of the original acquired data.
Substantial Equivalence
The syngo.CT Lung CAD is substantially equivalent, both in intended use and technical characteristics to the following device:
| Company | Product - Trade Name | 510(k) # |
|---|---|---|
| Siemens | syngo Lung CAD | K063877 |
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In summary, Siemens is of the opinion that the syngo.CT Lung CAD software, as described within this document, does not pose any unmitigated potential safety risks and is substantially equivalent to and performs as well as the predicate device.
The difference between the predicate device syngo Lung CAD and syngo.CT Lung CAD are minor in nature and both devices have the same characteristics and functionalities. The comparison table below summarizes the differences and similarities between the two devices.
| Subject Device | syngo Lung CAD
510(k) (K063877) | syngo.CT Lung CAD
new version |
|---------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Differences | | |
| Device name | syngo Lung CAD | syngo.CT Lung CAD |
| Platform | syngo classic | syngo.via |
| Similarities | | |
| Workflow | Second reader tool | Second reader tool |
| Detection target | Solid pulmonary nodules in
diagnostic chest CT exams | Solid pulmonary nodules in
diagnostic chest CT exams |
| Indications For Use | The syngo Lung CAD device
is a computer-aided detection
(CAD) tool designed to assist
radiologists in the detection of
solid pulmonary nodules during
review of multi-detector
computed tomography (MDCT)
examinations of the chest. The
software is an adjunctive tool to
alert the radiologist to regions
of interest (ROI) that may have
been initially overlooked.
The syngo Lung CAD device
is intended to be used as a
second reader after the
radiologist has completed
his/her initial read. | The syngo.CT Lung CAD device
is a computer-aided detection
(CAD) tool designed to assist
radiologists in the detection of
solid pulmonary nodules during
review of multi-detector
computed tomography (MDCT)
examinations of the chest. The
software is an adjunctive tool to
alert the radiologist to regions of
interest (ROI) that may have
been initially overlooked.
The syngo.CT Lung CAD device
is intended to be used as a
second reader after the
radiologist has completed
his/her initial read. |
Non-clinical Performance Testing Summary
Non-clinical tests were conducted for the device syngo.CT Lunq CAD during product development. The modifications described in this Premarket Notification were supported with verification and validation testing.
Siemens claims conformance to the following standards:
- ISO 14971:2007: Medical Devices Application of risk assessment to medical devices.
- IEC 62304:2006: Medical Device Software life cycle processes.
- IEC 62366:2007: Application of usability engineering to medical devices.
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Software Verification and Validation
Testing, including standalone performance testing, were conducted to assess the new syngo.CT Lung CAD device and compare it to the predicate device with respect to false positives, sensitivity, and the dismissibility of false positives. The results of these tests support the substantial equivalence of this device.
The Risk Analysis was completed and risk control implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.
Software documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 is included as part of this submission. The performance data demonstrates that the subject device conforms to the special controls for medical devices containing software.
Summary
Performance tests were conducted to test the functionality of the device syngo.CT Lung CAD. Results of all conducted testing were found acceptable in supporting the claim of substantial equivalence.