syngo.CT Lung CAD

K143196 · Siemens AG Medical Solutions · OEB · May 12, 2015 · Radiology

Device Facts

• Record ID: K143196
• Device Name: syngo.CT Lung CAD
• Applicant: Siemens AG Medical Solutions
• Product Code: OEB · Radiology
• Decision Date: May 12, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

AI Performance

Output	Algorithm	Acceptance	Observed	Dev DS	Dev Readers	Test DS	Test Readers
Lung Nodule Detection	—	—	—	—	—	—	—

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.

Device Story

syngo.CT Lung CAD is a software-based computer-aided detection (CAD) tool for thoracic CT examinations. It processes MDCT images (4+ detector rows) to identify solid pulmonary nodules (≥ 3 mm). The device functions as a second reader; it alerts radiologists to regions of interest (ROI) that may have been initially overlooked. It is operated by radiologists in a clinical setting. The device outputs CAD marks for suspected nodules, which are displayed via compatible visualization applications (e.g., syngo PET&CT Oncology). The radiologist evaluates these marks to inform clinical decision-making. The device does not alter original image data; it serves as an adjunctive tool to improve nodule detection sensitivity.

Clinical Evidence

Bench testing only. Performance evaluated via standalone testing comparing the subject device to the predicate. Metrics included sensitivity, false positive rates, and dismissibility of false positives. Verification and validation testing confirmed software specifications met acceptance criteria. No clinical prospective or retrospective studies were required.

Technological Characteristics

Software-based CAD tool for MDCT images. Operates on the syngo.via platform. Conforms to ISO 14971:2007 (risk management), IEC 62304:2006 (software lifecycle), and IEC 62366:2007 (usability). No patient-contacting materials. Designed for 4+ detector row CT scanners.

Indications for Use

Indicated for radiologists assisting in the detection of solid pulmonary nodules (≥ 3 mm, optimized for 3-10 mm) in MDCT chest examinations. Used as a second reader tool after initial radiologist review. Applicable to central/peripheral nodules and round/irregular contours; usable with or without contrast enhancement.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• syngo Lung CAD (K063877)

Reference Devices

• syngo PET&CT Oncology (K093621)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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) | |
|------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|
| <span style="text-decoration: overline;">X</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="text-decoration: overline;"> </span> 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: [phone] Fax: [phone] Email: [e-mail]

#### 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<br>510(k) (K063877) | syngo.CT Lung CAD<br>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<br>diagnostic chest CT exams | Solid pulmonary nodules in<br>diagnostic chest CT exams |
| Indications For Use | The syngo Lung CAD device<br>is a computer-aided detection<br>(CAD) tool designed to assist<br>radiologists in the detection of<br>solid pulmonary nodules during<br>review of multi-detector<br>computed tomography (MDCT)<br>examinations of the chest. The<br>software is an adjunctive tool to<br>alert the radiologist to regions<br>of interest (ROI) that may have<br>been initially overlooked.<br>The syngo Lung CAD device<br>is intended to be used as a<br>second reader after the<br>radiologist has completed<br>his/her initial read. | The syngo.CT Lung CAD device<br>is a computer-aided detection<br>(CAD) tool designed to assist<br>radiologists in the detection of<br>solid pulmonary nodules during<br>review of multi-detector<br>computed tomography (MDCT)<br>examinations of the chest. The<br>software is an adjunctive tool to<br>alert the radiologist to regions of<br>interest (ROI) that may have<br>been initially overlooked.<br>The syngo.CT Lung CAD device<br>is intended to be used as a<br>second reader after the<br>radiologist has completed<br>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.