SYNGO CT PULMO 3D

K123540 · Siemens Medical Systems, Inc. · JAK · Aug 29, 2013 · Radiology

Device Facts

• Record ID: K123540
• Device Name: SYNGO CT PULMO 3D
• Applicant: Siemens Medical Systems, Inc.
• Product Code: JAK · Radiology
• Decision Date: Aug 29, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1750
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended 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.

Device Story

syngo.CT Pulmo 3D is image analysis software for CT volume data sets; operates on syngo.via platform in clinical environments. Input: CT volume data. Processing: segments lungs and airways; calculates lung divisions (thirds, core/peel, lobes); identifies areas based on Hounsfield value thresholds; performs statistical analysis (histograms, percentiles). Output: lung volume computations, statistical displays, airway measurements, markers, and DICOM structured reports. Used by clinicians to evaluate lung parenchyma and airway disease effects. Facilitates reporting via key image creation. Benefits: provides quantitative assessment of lung tissue and airways to support clinical decision-making.

Clinical Evidence

Bench testing only. Verification and validation testing conducted during product development to confirm software specifications met acceptance criteria. Risk management and hazard analysis performed to mitigate identified risks.

Technological Characteristics

Software-only device; operates on syngo.via platform. Implements airway segmentation and lung lobe calculation algorithms. Complies with IEC 60601-1-6 (usability), IEC 62304 (software lifecycle), ISO 14971 (risk management), and DICOM 2008 standards.

Indications for Use

Indicated for analysis of CT volume data sets to evaluate lung parenchyma and airways in patients undergoing CT imaging. Provides lung volume computation, statistical analysis of Hounsfield values, and airway measurements.

Regulatory Classification

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.

Predicate Devices

• Siemens syngo® InSpace 4D (K071513)
• Vida Pulmonary Workstation 2 (PW 2) (K083227)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] Email: [e-mail]

**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 Clearance<br>Number | FDA Clearance Date |
|----------------------------------------|-------------------------|--------------------|
| Siemens syngo® InSpace 4D | K071513 | 06/26/2007 |
| Vida Pulmonary Workstation<br>2 (PW 2) | K083227 | 11/18/2008 |

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# SIEMENS

#### Device Description: 4.

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.

#### 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:

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.

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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

> 510(k) K123540

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