(187 days)
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.
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.
The provided document, K143196 for syngo.CT Lung CAD, largely focuses on demonstrating substantial equivalence to a predicate device rather than presenting a detailed study proving performance against explicit acceptance criteria with specific metrics. The document states that "Non-clinical tests were conducted... The modifications described in this Premarket Notification were supported with verification and validation testing." However, it does not explicitly outline a table of acceptance criteria nor the corresponding reported device performance.
Nonetheless, based on the information provided, we can infer some aspects of the performance and the nature of the testing:
1. Table of Acceptance Criteria and the Reported Device Performance
The document does not provide a quantitative table of acceptance criteria or reported device performance metrics like sensitivity, specificity, or false positive rates. It generally states that "The results of these tests support the substantial equivalence of this device" and that "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." This implies that these metrics were assessed and found acceptable for substantial equivalence, but the actual numbers and predefined thresholds are not disclosed.
2. Sample Size Used for the Test Set and the Data Provenance
The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). It simply refers to "non-clinical tests" and "testing."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not provided in the document.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
The document mentions that the device is intended to be used as a "second reader after the radiologist has completed his/her initial read." It also states, "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." However, it does not explicitly describe an MRMC comparative effectiveness study that quantitatively assesses how much human readers improve with AI assistance versus without. The focus seems to be on the performance of the CAD system itself and its equivalence to a prior version.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone performance test was done. The document explicitly states: "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." This indicates that the algorithm's performance without direct human intervention was evaluated.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used (e.g., expert consensus, pathology, outcomes data). Given the context of detecting "solid pulmonary nodules," it is highly likely that the ground truth would have been established by a consensus of expert radiologists or possibly through follow-up imaging or pathology reports where available, but this is not explicitly detailed.
8. The Sample Size for the Training Set
The document does not provide any information regarding the sample size used for the training set.
9. How the Ground Truth for the Training Set Was Established
The document does not provide any information on how the ground truth for the training set was established.
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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 CAD510(k) (K063877) | syngo.CT Lung CADnew 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 indiagnostic chest CT exams | Solid pulmonary nodules indiagnostic chest CT exams |
| Indications For Use | The syngo Lung CAD deviceis a computer-aided detection(CAD) tool designed to assistradiologists in the detection ofsolid pulmonary nodules duringreview of multi-detectorcomputed tomography (MDCT)examinations of the chest. Thesoftware is an adjunctive tool toalert the radiologist to regionsof interest (ROI) that may havebeen initially overlooked.The syngo Lung CAD deviceis intended to be used as asecond reader after theradiologist has completedhis/her initial read. | The syngo.CT Lung CAD deviceis a computer-aided detection(CAD) tool designed to assistradiologists in the detection ofsolid pulmonary nodules duringreview of multi-detectorcomputed tomography (MDCT)examinations of the chest. Thesoftware is an adjunctive tool toalert the radiologist to regions ofinterest (ROI) that may havebeen initially overlooked.The syngo.CT Lung CAD deviceis intended to be used as asecond reader after theradiologist has completedhis/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.
§ 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).