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 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.

AI/ML Overview

This document is a 510(k) summary for the Siemens Medical Solutions USA, Inc. eSie Apps Suite. It outlines the device, its intended use, and its substantial equivalence to previously cleared predicate devices. However, it does not contain a study designed to prove the device meets specific acceptance criteria in terms of performance metrics like sensitivity, specificity, or reader agreement.

The document focuses on demonstrating substantial equivalence based on technological characteristics and intended use, stating that "clinical data is not required" because the device uses the same technology and principles as existing devices. Therefore, the requested information about acceptance criteria, device performance, sample sizes, ground truth establishment, and MRMC studies is not available within this document.

Here's a breakdown of the explicitly stated information from the document related to your request:

A table of acceptance criteria and the reported device performance:
- Not provided. The document states that the device was subject to "extensive safety and performance testing" to ensure it "meets all of its specifications." However, it does not list specific acceptance criteria (e.g., minimum sensitivity, specificity, or agreement rates) or quantitative performance results against such criteria.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not provided. No clinical performance test set or data provenance is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. Since no clinical performance study or test set is described, there's no mention of experts establishing ground truth for such a set.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No MRMC study was done or reported. The document explicitly states, "clinical data is not required."
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No standalone performance study for the algorithm is reported. The validation mentioned focuses on DICOM compliance and software lifecycle processes, not clinical performance metrics. The software is described as being for "image manipulation and quantification on a workstation" with "use of a clinical application package by a qualified clinician."
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable / Not provided.
The sample size for the training set:
- Not provided. As no machine learning or AI model with distinct training and test sets are described in terms of clinical performance, no training set size is mentioned.
How the ground truth for the training set was established:
- Not applicable / Not provided.

Summary of Nonclinical Tests:

The document briefly mentions nonclinical tests:

DICOM (Digital Imaging and Communications in Medicine) compliance.
IEC 62304 Medical device software - Software Life Cycle Process compliance.
These tests ensure the software's technical functionality and adherence to medical device software standards, but they do not provide clinical performance data.

Conclusion from the document:

The conclusion is that the device is substantially equivalent to predicate devices based on intended use and technological characteristics, and that "testing indicates that no new issues of safety or effectiveness are raised." This statement refers to the nonclinical (technical) testing, not clinical performance studies comparing the device's output to a ground truth established by experts or pathology.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol featuring three human profiles facing to the right, arranged in a cascading manner.

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.

{1}------------------------------------------------

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 (800) 638 2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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

{2}------------------------------------------------

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

5. 510(K) SUMMARY

Submission Date	October 30, 2014
Sponsor	Siemens Medical Solutions, Inc.,Ultrasound Division685 East Middlefield RoadMountain View, California 94043
Contact Person	Nancy BurkeTelephone: (425) 295-8665Fax: (425) 391-9161
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 DiagnosticUltrasound System Software	K142628	10/10/2014

4. Device Description:

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.

{4}------------------------------------------------

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

5. Intended Use

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 /Characteristic	eSie Apps Suite	eSie Apps Suite(Primary Predicate)	ACUSON SC2000Ultrasound System
510(k) Reference	This submission	K141554	K142628
Product Code(s)	LLZ	LLZ	IYN, IYO, ITX, OBJ
Feature /Characteristic	eSie Apps Suite	eSie Apps Suite(Primary Predicate)	ACUSON SC2000Ultrasound System
Indications forUse Statement	eSie Apps Suite software isa software-only product tobe run on a user's PACS(Picture Archiving andCommunication System)workstation. It is intendedto launch Siemens CAPs(Clinical ApplicationPackages) for imageprocessing, including theacceptance, transfer,display and digitalprocessing of ultrasoundimages. Digital processingincludes imagemanipulation andquantification on aworkstation. Use of aclinical application packageby a qualified clinician canadd information to the studyto be used for a clinicaldiagnosis.The software supports thefollowing clinical applicationpackages:eSie VolumeViewer eSie LVA eSie PISA eSie Valves	eSie Apps Suite software isa software-only product tobe run on a user's PACS(Picture Archiving andCommunication System)workstation. It is intendedto launch Siemens CAPs(Clinical ApplicationPackages) for imageprocessing, including theacceptance, transfer,display and digitalprocessing of ultrasoundimages. Digital processingincludes imagemanipulation andquantification on aworkstation. Use of aclinical application packageby a qualified clinician canadd information to the studyto be used for a clinicaldiagnosis.The software supports thefollowing clinical applicationpackages:eSie VolumeViewer eSie LVA eSie PISA	The SC2000 ultrasoundimaging system isintended for the followingapplications: Cardiac,Neo-natal and FetalCardiac, Pediatric,Transesophageal, AdultCephalic, PeripheralVessel, Abdominal,IntraoperativeAbdominal, Musculo-skeletal Conventional,and Musculo-skeletalSuperficial applications.The system alsoprovides the ability tomeasure anatomicalstructures andcalculation packages thatprovide information to theclinician that may beused adjunctively withother medical dataobtained by a physicianfor clinical diagnosispurposes.The system has CardiacMeasurements andCalculation Packagesthat provide informationthat may be usedadjunctively with othermedical data obtained bya physician for clinicaldiagnosis purposes.
Display, Measurement and Calculation Packages
Viewing andmanipulation ofvolume datasets	eSie Volume Viewer	eSie Volume Viewer	Yes
2D quantitativetool forassessment ofglobal andregionalmyocardialmechanics	N/A	N/A	eSie VVI
3D Left Ventriclevolumequantitativeanalyses (Single +Multibeat)	eSie LVA	eSie LVA	eSie LVA
Feature /Characteristic	eSie Apps Suite	eSie Apps Suite(Primary Predicate)	ACUSON SC2000Ultrasound System
Quantification ofproximalisovelocity surfacearea	eSie PISA	eSie PISA	eSie PISA 3D semiautomatic
2D Automatedtool to identify andmeasure contoursof left ventricleand atrium fromtransthoracicexams	N/A	N/A	eSie Left Heart
Visualize andquantify mitral andaortic valveanatomy	eSie Valves	N/A	eSie Valves

(Table continued on next page)

{5}------------------------------------------------

{6}------------------------------------------------

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.

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).