(27 days)
Not Found
No
The summary describes standard image processing and display functionalities for ultrasound images on a PACS workstation, with no mention of AI, ML, or related concepts.
No.
The device is for image processing and analysis for clinical diagnosis, not for treating a disease or condition.
Yes
Explanation: The "Intended Use" section states that the use of a clinical application package by a qualified clinician "can add information to the study to be used for a clinical diagnosis." This indicates that the device assists in the diagnostic process.
Yes
The device is explicitly described as "software-only product" and its function is to process and display ultrasound images on a PACS workstation, which is a pre-existing hardware platform.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: IVDs are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The eSie Apps Suite software processes and analyzes ultrasound images. Ultrasound images are generated in vivo (within the living body) and are not samples taken from the body for laboratory testing.
- Intended Use: The intended use describes image processing, manipulation, and quantification of ultrasound images to add information for clinical diagnosis. This is consistent with medical imaging analysis, not in vitro testing.
The device's function and intended use clearly fall under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for 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. 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
Product codes (comma separated list FDA assigned to the subject device)
LLZ
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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 (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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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)
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5. 510(K) SUMMARY
| Submission Date | October 30, 2014 |
|---|---|
| Sponsor | Siemens Medical Solutions, Inc., |
| Ultrasound Division | |
| 685 East Middlefield Road | |
| Mountain View, California 94043 | |
| Contact Person | Nancy Burke |
| Telephone: (425) 295-8665 | |
| Fax: (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 Diagnostic | ||
| 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 /
Characteristic | eSie Apps Suite | eSie Apps Suite
(Primary Predicate) | ACUSON SC2000
Ultrasound 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 SC2000
Ultrasound System |
| Indications for
Use Statement | 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 | 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 | The SC2000 ultrasound
imaging system is
intended for the following
applications: Cardiac,
Neo-natal and Fetal
Cardiac, Pediatric,
Transesophageal, Adult
Cephalic, Peripheral
Vessel, Abdominal,
Intraoperative
Abdominal, Musculo-
skeletal Conventional,
and Musculo-skeletal
Superficial applications.
The system also
provides the ability to
measure anatomical
structures and
calculation packages that
provide information to the
clinician that may be
used adjunctively with
other medical data
obtained by a physician
for clinical diagnosis
purposes.
The system has Cardiac
Measurements and
Calculation Packages
that provide information
that may be used
adjunctively with other
medical data obtained by
a physician for clinical
diagnosis purposes. |
| Display, Measurement and Calculation Packages | | | |
| Viewing and
manipulation of
volume datasets | eSie Volume Viewer | eSie Volume Viewer | Yes |
| 2D quantitative
tool for
assessment of
global and
regional
myocardial
mechanics | N/A | N/A | eSie VVI |
| 3D Left Ventricle
volume
quantitative
analyses (Single +
Multibeat) | eSie LVA | eSie LVA | eSie LVA |
| Feature /
Characteristic | eSie Apps Suite | eSie Apps Suite
(Primary Predicate) | ACUSON SC2000
Ultrasound System |
| Quantification of
proximal
isovelocity surface
area | eSie PISA | eSie PISA | eSie PISA 3D semi
automatic |
| 2D Automated
tool to identify and
measure contours
of left ventricle
and atrium from
transthoracic
exams | N/A | N/A | eSie Left Heart |
| Visualize and
quantify mitral and
aortic valve
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.