(20 days)
No
The document describes image processing and viewing software that integrates with a PACS system. There is no mention of AI, ML, or related concepts like deep learning, training sets, or performance metrics typically associated with AI/ML devices.
No.
The device is described as software for image processing and viewing, intended to assist clinicians with diagnosis, rather than directly treating a disease or condition.
No
Explanation: The device is described as software that launches Clinical Application Packages (CAPs) for image processing and viewing. While the use of a CAP by a qualified clinician can add information to the study to be used for a clinical diagnosis, the software itself is not directly performing the diagnosis or providing diagnostic information. It is a tool for enabling the viewing and manipulation of medical images, which can then be used by a clinician as part of their diagnostic process.
Yes
The device is described as "eSie Apps Suite software" and its function is to provide image processing and viewing capabilities as a PACS plug-in. The description focuses entirely on the software's functionality and integration with existing hardware (PACS workstation), without mentioning any accompanying or required hardware components provided by the manufacturer.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The text explicitly states the device is for "offline viewing and manipulation of the Acuson SC2000 system volume datasets," which are ultrasound images. Ultrasound is an imaging modality that visualizes structures within the body, not a method for analyzing biological specimens.
- The intended use is image processing and viewing. The primary function described is launching applications for "image processing" and "offline viewing and manipulation" of ultrasound data. This aligns with medical imaging software, not IVDs.
- The device is a PACS plug-in. PACS (Picture Archiving and Communication System) is a system for storing, retrieving, presenting, and sharing medical images. A plug-in for a PACS is inherently related to image management and viewing, not laboratory testing of specimens.
The device's function is clearly focused on the manipulation and viewing of medical images obtained from an ultrasound system, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
LLZ
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified clinician / PACS workstation
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
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
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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K 132062
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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 Division
685 East Middlefield Road
Mountain View, California 94043 |
|------------------|-------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Patrick J. Lynch
Telephone: (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:
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.
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K132062
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C. Intended Use
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 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 | Acuson
SC2000TM
K123622 | fourSight
ViewTool
K052895 | eSie Apps
Suite
K-TBD |
|----------------------------------------------------------------------|-------------------------------|----------------------------------|-----------------------------|
| System: | | | |
| Medical device software - Software Life Cycle Process - IEC
62304 | 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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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
3
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
5
Indications for Use
510(k) Number (if known): K132062
eSie Apps Suite Device Name:
Indications for Use:
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.
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) _______________________________________________________________________________________________________________________________________________________________________
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