eSie Apps Suite software is intended for use as a PACS plug in utilizing the third party application launching feature of the PACS workstation. eSie Apps Suite software will provide the ability to launch Siemens CAPs (Clinical Application Packages) for image processing. Use of a CAP by a qualified clinician can add information to the study to be used for a clinical diagnosis. This initial release employs one CAP, the eSie Volume Viewer, which provides offline viewing and manipulation of the Acuson SC2000 system volume datasets.

The typical ultrasound user must be knowledgeable in the use of the ultrasound system in order to properly optimize and utilize the software. The eSie Apps Suite software is intended for use on a PACS workstation that must meet minimum system requirements to run optimally and also supports launching of third party applications.

Device Description

eSie Apps Suite is intended to be the 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. Other CAPs will be integrated as the market demands.

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.

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

AI/ML Overview

The Siemens eSie Apps Suite, as described in K132062, is a PACS plug-in designed to launch Siemens Clinical Application Packages (CAPs) for image processing. The initial release included the eSie Volume Viewer for offline viewing and manipulation of Acuson SC2000 system volume datasets.

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Design Control & Testing	Device meets all specifications.	"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."
Standards Compliance	Compliance with DICOM standards.	DICOM (Digital Imaging and Communications in Medicine)
Standards Compliance	Compliance with IEC 62304 for medical device software.	IEC 62304 Medical device software Software Life Cycle Process

2. Sample Size Used for the Test Set and Data Provenance

The provided 510(k) summary does not explicitly state the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the final testing performed on the eSie Apps Suite. It broadly mentions "various safety and performance testing."

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document does not specify the number of experts used to establish ground truth or their qualifications for the testing of the eSie Apps Suite. Given the nature of the device (a PACS plug-in for viewing and manipulation), the "ground truth" might pertain more to software functionality and rendering accuracy rather than diagnostic accuracy that would typically require expert consensus on clinical findings.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method used for a test set. This type of method (e.g., 2+1, 3+1) is typically employed in studies assessing diagnostic accuracy where multiple readers interpret cases and disagreements are resolved. As the device is primarily a viewing and manipulation tool, such an adjudication method might not be directly applicable or explicitly detailed in this type of submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not specifically mentioned or detailed in the provided submission. The submission focuses on the device's technical performance and equivalence to predicate devices, rather than an assessment of human reader improvement with AI assistance.

6. Standalone (Algorithm Only) Performance Study

The submission does not explicitly describe a standalone (algorithm only) performance study in terms of diagnostic accuracy or clinical decision-making. The device is presented as a tool within a PACS workstation to launch clinical applications, implying human interaction. The "performance testing" referenced is more related to software functionality and standards compliance.

7. Type of Ground Truth Used

Based on the information provided, the "ground truth" for the testing appears to be related to technical specifications, functional requirements, and compliance with industry standards (DICOM, IEC 62304). This implies that the device was evaluated against predefined technical correctness (e.g., proper image rendering, accurate manipulation, data transfer) rather than a clinical ground truth like pathology or outcomes data.

8. Sample Size for the Training Set

The document does not specify the sample size for a training set. This is likely because the eSie Apps Suite, particularly the eSie Volume Viewer, is described as a tool for viewing and manipulation, not as a device utilizing machine learning that typically requires a large training dataset for model development. The focus is on re-deploying existing rendering software and applications.

9. How Ground Truth for the Training Set Was Established

Since a training set and a machine learning model are not explicitly described, the document does not provide information on how ground truth for a training set was established.

Summary of Study that Proves Acceptance Criteria:

The provided 510(k) summary states that the eSie Apps Suite was "designed, verified, and validated according to the company's design control process" and subjected to "extensive safety and performance testing before release." This testing included ensuring the device meets its specifications and complies with DICOM standards and IEC 62304 for medical device software.

The specific details of these tests (e.g., number of test cases, specific metrics measured beyond general compliance, data used, human expert involvement) are not provided in this excerpt. The submission relies on demonstrating substantial equivalence to predicate devices (Siemens fourSight ViewTool, K052895, and the rendering software on the Acuson SC2000, K123622) in terms of intended use and technological characteristics, as outlined in the comparison table. This suggests that the primary "proof" of meeting acceptance criteria is through adherence to internal design controls and demonstrating that its functionality and performance are comparable to already-cleared devices within established standards.

Summary

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K 132062
page 1 06 3

Siemens Medical Solutions, Inc. Ultrasound Division

eSie Apps Suite 510(k) Submission

510(k) Summary Prepared March 19, 2013

JUL 2 3 2015

Sponsor:	Siemens Medical Solutions, Inc.,Ultrasound Division685 East Middlefield RoadMountain View, California 94043
Contact Person:	Patrick J. LynchTelephone: (650) 694-5658
Submission Date:	March 19, 2013
Device Name:	eSie Apps Suite

Common Name: System, Image Processing, Radiological

Classification:

Regulatory Class: 11 Review Category: Tier II Classification Panel: Radiology

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

A. Legally Marketed Predicate Devices

The eSie Apps Suite described in this 510k is substantially equivalent to Siemens fourSight ViewTool, K052895, and to the rendering software used on the Acuson SC2000, K123622.

B. Device Description:

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

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K132062
page 2 of 3

C. Intended Use

The typical ultrasound user must be knowledgeable in the ultrasound system in order to properly optimize and utilize the software. The eSie Apps Suite software is intended for use on a PACS workstation that must meet minimum system requirements to run optimally and also supports launching of third party applications.

D. Substantial Equivalence

The submission device is substantially equivalent to fourSight ViewTool, previously cleared in K052895, and Acuson SC2000 diagnostic ultrasound system (K123622) image rendering software with regard to both intended use and technological characteristics.

Description	AcusonSC2000TMK123622	fourSightViewToolK052895	eSie AppsSuiteK-TBD
System:
Medical device software - Software Life Cycle Process - IEC62304	X	X	X
Application packages:
syngo® Mitral Valve Assessment	X
syngo® auto Ejection Fraction technology	X
D†ART with syngo® fourSight™ TEE view	X	X
syngo® Quantitative Synch Tools™ technology (QST)	X
syngo® Velocity Vector Imaging™ technology (VVI) rotation	X
syngo® ACQ auto-tracking contrast quantification	X
Connectivity:
Wireless Network Connectivity	X		X
DICOM Print Service	X	X	X
DICOM Media Storage Service	X	X	X
DICOM Structured Reporting	X
Software Features:
Change the screen display format	X	X	X
SieShell animation displaying the volume as two halves	X		X
Rotate the volume on any axis	X	X	X
Free rotation of the reference plane around any axis	X	X	X
D'art point and click volume manipulation	X	X	X
Secondary clip dynamic or static clip capture to the PACS	X	X	X

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K132062
page 393

eSie Apps Suite 510(k) Submission

E. Performance Data

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

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES, USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird-like figure with three wing-like shapes.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 23, 2013

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

Re: K132062

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: July 01, 2013 Received: July 03, 2013

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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Page 2 - Mr. Job

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.fda.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/Safety/ReportalProblem/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,

ਿੰ

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): K132062

eSie Apps Suite Device Name:

Indications for Use:

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)

Smh.7)

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

510(k) _______________________________________________________________________________________________________________________________________________________________________

Page 1 of 1

Regulation Number and Section

§ 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).