eSie Apps Suite

K143254 · Siemens Medical Solutions USA, Inc. · LLZ · Dec 10, 2014 · Radiology

Device Facts

• Record ID: K143254
• Device Name: eSie Apps Suite
• Applicant: Siemens Medical Solutions USA, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Dec 10, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, 3rd-Party Reviewed

Intended Use

eSie Apps Suite software is a software-only product to be run on a user's PACS (Picture Archiving and Communication System) workstation. It is intended to launch Siemens CAPs (Clinical Application Packages) for image processing, including the acceptance, transfer, display and digital processing of ultrasound images. Digital processing includes image manipulation and quantification on a workstation. Use of a clinical application package by a qualified clinician can add information to the study to be used for a clinical diagnosis. The software supports the following clinical application packages: eSie Volume Viewer eSie LVA eSie PISA eSie Valves

Device Story

eSie Apps Suite is a software-only PACS plug-in; hosts Clinical Application Packages (CAPs) for ultrasound image analysis. Input: ultrasound image data sets from PACS. Operation: launched via command line on PACS workstation; shares patient context; utilizes SC2000 renderer for volume display/manipulation. Output: processed images and quantification results appended to patient study. Used in clinical settings by clinicians. Benefits: enables advanced viewing, manipulation, and quantification of ultrasound data (e.g., volume, LVA, PISA, valves) within existing PACS workflow; supports clinical decision-making by providing quantitative anatomical information.

Clinical Evidence

No clinical data. Bench testing only; verification and validation performed per design control processes, including DICOM and IEC 62304 compliance.

Technological Characteristics

Software-only PACS plug-in; utilizes third-party application launching. Supports 2D and volume ultrasound image processing/quantification. Connectivity: DICOM. Software lifecycle: IEC 62304. Architecture: host for CAPs (eSie Volume Viewer, LVA, PISA, Valves).

Indications for Use

Indicated for use by qualified clinicians to perform image processing, manipulation, and quantification of ultrasound images on a PACS workstation to assist in clinical diagnosis.

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

• eSie Apps Suite (K141554)
• ACUSON SC2000 Diagnostic Ultrasound System Software (K142628)

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

Siemens Medical Solutions USA, Inc. % Mr. Mark Job Responsible Third Party Official 1394 25th Street, NW BUFFALO MN 55313

December 10, 2014

Re: K143254

Trade/Device Name: eSie Apps Suite Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 12, 2014 Received: November 13, 2014

Dear Mr. Job:

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

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

**Indications for**

510(k) Number (if known) K143254

Device Name eSie Apps Suite

Indications for Use (Describe)

eSie Apps Suite software is a software-only product to be run on a user's PACS (Picture Archiving and Communication System) workstation. It is intended to launch Siemens CAPs (Clinical Application Packages) for image processing, including the acceptance, transfer, display and digital processing of ultrasound images. Digital processing includes image manipulation and quantification. Use of a clinical application package by a qualified clinician can add information to the study to be used for a clinical diagnosis.

The software supports the following clinical application packages:

· eSie Volume Viewer

· eSie LVA

· eSie PISA

· eSie Valves

Type of Use (Select one or both, as applicable)

> Prescription Use {Part 21 CFR 801 Subpart D}

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

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### 5. 510(K) SUMMARY

| Submission Date | October 30, 2014 |
|-----------------|-------------------------------------------------------------------------------------------------------------------------|
| Sponsor | Siemens Medical Solutions, Inc.,<br>Ultrasound Division<br>685 East Middlefield Road<br>Mountain View, California 94043 |
| Contact Person | Nancy Burke<br>Telephone: [phone]<br>Fax: [phone] |
| Device Name | eSie Apps Suite. Note that for marketing purposes |

, the names eSie Apps Suite, syngo® US Apps Suite or syngo® Ultrasound Apps Suite may be used.

Common Name System, Image Processing, Radiological

#### Classification

Regulatory Class: Review Category: Tier II Classification Panel: Radiology

Picture Archiving and Communications System FR #892.2050 Product Code 90-LLZ

### Legally Marketed Predicate Devices

The eSie Apps Suite as described in this 510k is substantially equivalent to the company's current legally marketed devices shown below:

| Predicate Device | 510(k) Number | Clearance Date |
|--------------------------------------------------------|---------------|----------------|
| eSie Apps Suite | K141554 | 7/11/2014 |
| ACUSON SC2000 Diagnostic<br>Ultrasound System Software | K142628 | 10/10/2014 |

### 4. Device Description:

eSie Apps Suite is intended to be the Clinical Application Package (CAP) host for 2D and volume imaging applications on a PACS workstation. It is intended to maximize the reuse of the SC2000 renderer for volume display and manipulation. Additionally, the imaging applications from the SC2000 will be redeployed on a PACS workstation for the 2D and volume imaging analysis.

eSie Apps Suite is intended to have a simple basic configuration as a PACS plug-in by utilizing the third party launching capability of the host PACS. On the customer's workstation a command line will launch the eSie Apps Suite application - patient context will be shared between the PACS and eSie Apps Suite. Results created by the respective CAPs will be sent back to the PACS for appending to the patient study.

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The software level of concern for the eSie Apps Suite is considered moderate.

### 5. Intended Use

eSie Apps Suite software is a software-only product to be run on a user's PACS (Picture Archiving and Communication System) workstation. It is intended to launch Siemens CAPs (Clinical Application Packages) for image processing, including the acceptance, transfer, display and digital processing of ultrasound images. Digital processing includes image manipulation and quantification on a workstation. Use of a clinical application package by a qualified clinician can add information to the study to be used for a clinical diagnosis.

The software supports the following clinical application packages:

- . eSie Volume Viewer
- eSie LVA ●
- eSie PISA
- eSie Valves ●

### 6. Technological Characteristics as Compared to Predicate Devices

The eSie Apps Suite software in this submission is essentially equivalent to the cleared eSie Apps Suite software (K141554). eSie Apps Suite software is activated on a workstation connected to a cardiology PACS that includes a third-party application launcher. It is a graphical launch pad designed to provide viewing, manipulation and quantification functionality for ACUSON SC2000 ultrasound image data sets using Clinical Application Packages (CAPS).

The analysis packages included in this release of eSie Apps Suite are essentially the same as those available in the software on the ACUSON SC2000 Ultrasound System (K142628), except that the eSie Apps Suite CAPS are limited to eSie Volume Viewer, eSie LVA, eSie PISA, and with this submission, eSie Valves.

| Feature /<br>Characteristic | eSie Apps Suite | eSie Apps Suite<br>(Primary Predicate) | ACUSON SC2000<br>Ultrasound System |
|----------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Reference | This submission | K141554 | K142628 |
| Product Code(s) | LLZ | LLZ | IYN, IYO, ITX, OBJ |
| Feature /<br>Characteristic | eSie Apps Suite | eSie Apps Suite<br>(Primary Predicate) | ACUSON SC2000<br>Ultrasound System |
| Indications for<br>Use Statement | eSie Apps Suite software is<br>a software-only product to<br>be run on a user's PACS<br>(Picture Archiving and<br>Communication System)<br>workstation. It is intended<br>to launch Siemens CAPs<br>(Clinical Application<br>Packages) for image<br>processing, including the<br>acceptance, transfer,<br>display and digital<br>processing of ultrasound<br>images. Digital processing<br>includes image<br>manipulation and<br>quantification on a<br>workstation. Use of a<br>clinical application package<br>by a qualified clinician can<br>add information to the study<br>to be used for a clinical<br>diagnosis.<br>The software supports the<br>following clinical application<br>packages:<br>eSie Volume<br>Viewer eSie LVA eSie PISA eSie Valves | eSie Apps Suite software is<br>a software-only product to<br>be run on a user's PACS<br>(Picture Archiving and<br>Communication System)<br>workstation. It is intended<br>to launch Siemens CAPs<br>(Clinical Application<br>Packages) for image<br>processing, including the<br>acceptance, transfer,<br>display and digital<br>processing of ultrasound<br>images. Digital processing<br>includes image<br>manipulation and<br>quantification on a<br>workstation. Use of a<br>clinical application package<br>by a qualified clinician can<br>add information to the study<br>to be used for a clinical<br>diagnosis.<br>The software supports the<br>following clinical application<br>packages:<br>eSie Volume<br>Viewer eSie LVA eSie PISA | The SC2000 ultrasound<br>imaging system is<br>intended for the following<br>applications: Cardiac,<br>Neo-natal and Fetal<br>Cardiac, Pediatric,<br>Transesophageal, Adult<br>Cephalic, Peripheral<br>Vessel, Abdominal,<br>Intraoperative<br>Abdominal, Musculo-<br>skeletal Conventional,<br>and Musculo-skeletal<br>Superficial applications.<br>The system also<br>provides the ability to<br>measure anatomical<br>structures and<br>calculation packages that<br>provide information to the<br>clinician that may be<br>used adjunctively with<br>other medical data<br>obtained by a physician<br>for clinical diagnosis<br>purposes.<br>The system has Cardiac<br>Measurements and<br>Calculation Packages<br>that provide information<br>that may be used<br>adjunctively with other<br>medical data obtained by<br>a physician for clinical<br>diagnosis purposes. |
| Display, Measurement and Calculation Packages | | | |
| Viewing and<br>manipulation of<br>volume datasets | eSie Volume Viewer | eSie Volume Viewer | Yes |
| 2D quantitative<br>tool for<br>assessment of<br>global and<br>regional<br>myocardial<br>mechanics | N/A | N/A | eSie VVI |
| 3D Left Ventricle<br>volume<br>quantitative<br>analyses (Single +<br>Multibeat) | eSie LVA | eSie LVA | eSie LVA |
| Feature /<br>Characteristic | eSie Apps Suite | eSie Apps Suite<br>(Primary Predicate) | ACUSON SC2000<br>Ultrasound System |
| Quantification of<br>proximal<br>isovelocity surface<br>area | eSie PISA | eSie PISA | eSie PISA 3D semi<br>automatic |
| 2D Automated<br>tool to identify and<br>measure contours<br>of left ventricle<br>and atrium from<br>transthoracic<br>exams | N/A | N/A | eSie Left Heart |
| Visualize and<br>quantify mitral and<br>aortic valve<br>anatomy | eSie Valves | N/A | eSie Valves |

(Table continued on next page)

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# 7. A brief discussion of nonclinical tests submitted, referenced, or relied on in the 510(k) for a determination of substantial equivalence.

The eSie Apps Suite is designed, verified, and validated according to the company's design control process and has been subjected to extensive safety and performance testing before release. Final testing of the eSie Apps Suite included various safety and performance testing designed to ensure the device meets all of its specifications including:

- . DICOM (Digital Imaging and Communications in Medicine)
- . IEC 62304 Medical device software - Software Life Cycle Process

# 8. A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence.

Since the eSie Apps Suite in this submission use the same technology and principles as existing devices, clinical data is not required.

# 9. Conclusion

As shown by the device comparison table above, the modified eSie Apps Suite software has the same intended use as the predicate device, incorporates technological features of the predicate devices cleared through premarket notification and testing indicates that no new issues of safety or effectiveness are raised.