syngo.CT Pulmo 3D is an image analysis software for CT volume data sets. It analyses the lunq, either completely or in parts, identifying areas with lower or higher Hounsfield values in comparison to a predefined threshold. These areas are evaluated using statistical methods such as histograms and percentiles.

Using syngo.CT Pulmo 3D, you can examine the lung parenchyma and the airways of the lung.

The following evaluation tools are provided:

Computation of lung volumes .
Display of statistics related to the lung .
Setting of markers .
Airway measurements .

syngo.CT Pulmo 3D facilitates the reporting by using of appropriate reporting tools, for example, key image creation.

You can use syngo.CT Pulmo 3D to create a DiCOM Structured Report.

Device Description

syngo.CT Pulmo 3D allows the evaluation of lung tissue and airways. In contrast to lung function tests, CT evaluations can show the effect of a disease on the parenchyma and the airways. The lungs as well as the airways are segmented in the preprocessing, and divisions of the lungs like thirds, core/peel, and lung lobes are calculated.

AI/ML Overview

The provided text does not contain details of specific acceptance criteria or an explicit study that proves the device meets them in the format requested.

The document is a 510(k) Summary for the SIEMENS syngo.CT Pulmo 3D device, which focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed performance validation studies with specific acceptance criteria.

However, based on the non-clinical testing section, we can infer some general information:

Inferred Information from the Document:

Acceptance Criteria & Device Performance: The document generally states that "The testing results supports that all the software specifications have met the acceptance criteria." However, it does not provide a table specifying these criteria or the reported performance metrics. The criteria are likely tied to the software's functional specifications, such as accurate lung and airway segmentation, volume computation, and statistical analysis as described in the "Device Description" and "Indications for Use" sections.
Sample Size and Data Provenance: Not mentioned for any test sets.
Number of Experts and Qualifications: Not mentioned.
Adjudication Method: Not mentioned.
Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned. The focus is on the software's functionality, not comparative effectiveness with human readers.
Standalone Performance: The testing mentioned in Section 6 ("Nonclinical Testing") refers to verification and validation of the device's software package to ensure it fulfills requirements and specifications. This implies standalone (algorithm-only) testing.
Type of Ground Truth: Not explicitly stated, but for software functionality like segmentation and measurement, the ground truth would typically be established by expert radiologists or phantoms, though this is not confirmed in the document.
Training Set Sample Size: Not mentioned.
Ground Truth for Training Set: Not mentioned.

Summary of what is present and what is missing:

Information Type	Details from the Document
1. Acceptance Criteria & Reported Device Performance	Acceptance Criteria: Not explicitly listed in a table. Inferred to be related to software specifications for lung and airway segmentation, volume computation, and statistical analysis. Reported Device Performance: Document states: "The testing results supports that all the software specifications have met the acceptance criteria." No specific performance metrics or values are provided.
2. Sample Size (Test Set) & Data Provenance (e.g., country, retrospective/prospective)	Not mentioned.
3. Number & Qualifications of Experts for Ground Truth (Test Set)	Not mentioned.
4. Adjudication Method (Test Set)	Not mentioned.
5. MRMC Comparative Effectiveness Study	No. (No mention of human reader improvement with AI assistance).
6. Standalone Performance Study	Yes, inferred. Non-clinical testing for verification and validation of the software package was conducted "to support the claims of substantial equivalence," implying standalone functional and performance testing of the algorithm.
7. Type of Ground Truth Used	Not explicitly stated. Likely expert consensus or phantom-based for functionalities like segmentation and measurements.
8. Sample Size for Training Set	Not mentioned.
9. How Ground Truth for Training Set Was Established	Not mentioned.

This 510(k) summary focuses more on demonstrating regulatory compliance and substantial equivalence through adherence to standards (IEC, ISO, DICOM) and risk management, rather than detailed clinical or performance validation studies with explicit quantitative acceptance criteria.

Summary

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SIEMENS

K123540
Page 1 of 3

510(K) SUMMARY FOR SYNGO.CT PULMO 3D

Submitted by: Siemens Medical Solutions USA, Inc. 51 Valley Stream Parkway Malvern, PA 19355

Date Prepared: August 16, 2013

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.

1. Contact Person:

Mrs. Kimberly Manqum Technical Specialist, Regulatory Affairs Submissions Siemens Medical Solutions, Inc. USA 51 Valley Stream Parkway D02 Malvern, PA 19355-1406 Phone: (610) 448-1772 Fax: (610) 448-1778 Email: kimberly.manqum@siemens.com

AUG 29 2013

2. Device Name and Classification

Product Name: Propriety Trade Name: Classification Name: Classification Panel: CFR Section: Device Class: Product Code:

syngo.CT Pulmo 3D syngo. CT Pulmo 3D Computed Tomography X-ray System Radiology 21 CFR §892.1750 Class II 90JAK

3. Substantial Equivalence:

Siemens syngo.CT Pulmo 3D post processing software package is substantially equivalent to the following medical devices in commercial distribution:

Predicate Device Name	FDA ClearanceNumber	FDA Clearance Date
Siemens syngo® InSpace 4D	K071513	06/26/2007
Vida Pulmonary Workstation2 (PW 2)	K083227	11/18/2008

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SIEMENS

Device Description: 4.

Summary of Technical Characteristics of the Subject Device as Compared 5. with the Predicate Device:

syngo.CT Pulmo 3D software package has similar intended use as the predicate synqo® Inspace4D (K071513, clearance date 06/26/2007). syngo.CT Pulmo 3D is designed to be operated on syngo.via platform in a single or multi user environment.

Airway segmentation and lung lobe calculation tools are provided with this software version.

6. Nonclinical Testing:

syngo.CT Pulmo 3D is designed to fulfill the requirements of following standards:

IEC 60601-1-6 : 2006; Medical electrical equipment Part 1-6: General . requirements for basic safety and essential performance - Collateral Standard: Usability
IEC 62304 Ed. 1.0. "Medical Device Software Software Lifecycle . Processes"
ISO 14971:2007; Medical devices Application of risk management to . medical devices
DICOM (Digital Imaging and Communications in Medicine) Standard: 2008 DICOM conformity is fully covered by syngo.via implementations.

Non clinical tests were conducted for synao.CT Pulmo 3D software package during product development. The Risk analysis was completed and risk control implemented to mitigate identified hazards. The testing results supports that all the software specifications have met the acceptance criteria.

Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence.

7. Indications for Use:

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Image /page/2/Picture/0 description: The image shows the word "SIEMENS" in a bold, outlined font. The letters are evenly spaced and the word is centered. The outline of the letters gives the word a textured appearance. The background is plain and white.

K123540
Page 3 of 3

Using syngo.CT Pulmo 3D, you can examine the lung parenchyma and the airways of the lung.

The following evaluation tools are provided:

Computation of lung volumes .
Display of statistics related to the lung .
Setting of markers .
Airway measurements .

syngo.CT Pulmo 3D facilitates the reporting by using of appropriate reporting tools, for example, key image creation.

You can use syngo.CT Pulmo 3D to create a DiCOM Structured Report.

8. 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 during development, verification and validation testing. To minimize electrical, mechanical, and radiation hazards, Siemens adheres to recognized and established industry practice and standards.

9. Conclusion as to Substantial Equivalence

In summary. Siemens is of the opinion that the syngo.CT Pulmo 3D software package does not introduce any new potential safety risk and is substantially equivalent to and performs as well as the predicate devices.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, consisting of a staff with two snakes coiled around it. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.

Poblic Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

August 29. 2013

Siemens Medical Solution USA, Inc. % Ms. Kimberly Mangum Technical Specialist, Regulatory Submissions 51 Valley Stream Parkway, D02 MALVERN PA 19355-1406

Rc: K123540

Trade/Device Name: syngo.CT Pulmo 3D Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: August 16. 2013 Received: August 19. 2012

Dear Ms. Mangum:

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 enaciment 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 upplication (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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2-Ms. Mangum

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.lda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Safetv/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 Small Manufacturers, International and Consumer Assistance 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,

for

Janine M. Morris 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): K123540

Device Name: syngo.CT Pulmo 3D

Indications for Use:

syngo.CT Pulmo 3D is an image analysis software for CT volume data sets. It analyses the lung, either completely or in parts, identifying areas with lower or higher Hounsfield values in comparison to a predefined threshold. These areas are evaluated using statistical methods such as histograms and percentiles.

Using syngo.CT Pulmo 3D, you can examine the lung parenchyma and the airways of the lung.

The following evaluation tools are provided:

Computation of lung volumes .
Display of statistics related to the lung ●
Setting of markers .
. Airway measurements

syngo.CT Pulmo 3D facilitates the reporting by using of appropriate reporting tools, for example, key image creation.

You can use syngo.CT Pulmo 3D to create a DICOM Structured Report.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

$m.7)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

510(k) K123540

Page 1 of 1

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.