K122205 · Exini Diagnostics AB · LLZ · Aug 15, 2012 · Radiology
Device Facts
Record ID
K122205
Device Name
EXINI
Applicant
Exini Diagnostics AB
Product Code
LLZ · Radiology
Decision Date
Aug 15, 2012
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 892.2050
Device Class
Class 2
Attributes
Software as a Medical Device, 3rd-Party Reviewed
Indications for Use
EXINI is intended to be used by trained healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear imaging (NM) and computed tomography (CT). The software provides general Picture Archiving and Communications System (PACS) tools and a clinical application for oncology including lesion marking and analysis.
Device Story
EXINI is a software-based PACS tool for digital medical images (NM and CT). It provides clinicians and researchers with capabilities for image storage, display, manipulation, and reporting. The device includes a clinical application for oncology, specifically for marking and analyzing bone lesions in bone scans. Operation involves semi-automatic processing where the software performs segmentation of skeletal regions, normalization, and hotspot contouring; a manual verification step is required where the user reviews and edits hotspot selections. Quantitative analysis is then performed based on 2D ROI measurements. The device runs on a standard PC with a Windows OS. By automating lesion identification and quantification, the device assists clinicians in oncology assessment and reporting, potentially improving workflow efficiency in bone scan analysis.
Clinical Evidence
No clinical data. Verification and validation (V&V) were performed via bench testing, including software unit, integration, and system testing to ensure functional requirements and user needs were met.
Technological Characteristics
Software-based PACS; DICOM 3 compliant; runs on standard PC with Microsoft Windows. Features include image processing for skeletal segmentation, normalization, and hotspot contouring/segmentation. Semi-automatic workflow requires manual hotspot verification. Quantitative analysis based on 2D ROI measurements.
Indications for Use
Indicated for trained healthcare professionals and researchers requiring acceptance, transfer, storage, display, manipulation, quantification, and reporting of NM and CT digital medical images, including oncology-related lesion marking and analysis.
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).
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510(k) Summary EXINI EXINI Diagnostics
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# 510(k) Summary
AUG 15 2012
# Submitter Information
| EXINI Diagnostics AB<br>Scheelevägen 19A<br>SE-223 70 Lund<br>Sweden | |
|----------------------------------------------------------------------|--------------------------------------------------------|
| Contact Person: | Allison Scott<br>317.569.9500<br>ascott@ansongroup.com |
| Date: | June 6, 2012 |
| Trade Name: | EXINI |
| Common Name: | Picture Archiving and Communications System (PACS) |
| Classification Name(s): | System, Image Processing, Radiological |
| Classification Number: | 21 CFR 892.2050, LLZ |
## Predicate Device(s)
| 510(k) Number | Device Name | Submitter Name |
|---------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| K111319 | IBIS Explorer and Markup Software<br>------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | Canadian Canada College of Children Comments of Children Come of<br>MEDQIA |
## Device Description
The EXINI software provides trained health-care professionals and researchers with a software tool set for acceptance, transfer, storage, image display, manipulation and quantification of digital medical images. The software is intended to be used with images acquired using nuclear imaging (NM) and computed tomography (CT) modalities. The software provides general Picture Archiving and Communications System (PACS) tools and a clinical application for markup and analysis of bone lesions in bone scans. The software complies with the Digital Imaging and Communications in Medicine (DICOM 3) standard.
The software runs on a standard PC with Microsoft Windows operating system.
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510(k) Summary EXINI EXINI Diagnostics
# Intended Use(s)
EXINI is intended to be used by trained healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear imaging (NM) and computed tomography (CT). The software provides general Picture Archiving and Communications System (PACS) tools and a clinical application for oncology including lesion marking and analysis.
# Technological Characteristics
EXINI and the IBIS Explorer and Markup Software have similar technological characteristics in that they are both software devices that provide general PACS functions with DICOM compatibility and image display. Both devices use image processing techniques for segmentation of skeletal regions, normalization and hotspot contouring/segmentation. Both devices are semi-automatic in that they require a manual step (hotspot verification step) where the user reviews and edits the selection of hotspots that are used as input for quantitative analysis. Both devices perform quantitative analysis based on 2D ROI (regions of interests) measurements in wholebody bone scans.
## Non-Clinical Performance Data
The verification and validation (V&V) plan including definition of test methods and acceptance criteria was designed to ensure equivalent performance with the predicate device. The verification included software unit testing, integration testing and software system testing with functional testing of all software requirements. The validation process was performed to ensure that the system meets the user needs specification. The V&V test results showed that EXINI meets its intended use, user needs and software requirements.
#### Clinical Performance Data
Clinical testing was not conducted to support this 510(k) submission.
#### Non-Clinical and Clinical Performance Data Conclusions
The non-clinical performance data concludes that the subject device has equal performance and raises no new questions of safety and effectiveness in comparison to the predicate device.
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# DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -- WO66-G609 Silver Spring, MD 20993-0002
AUG 15 2012
EXINI Diagnostics AB % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K122205
Trade/Device Name: EXINI Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 24, 2012 Received: July 25, 2012
Dear Mr. Job:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becally is to (1) person is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate Tot use stated in the encrosure) to regars) activent date of the Medical Device Amendments, or to commerce province to May 20, 1976, the encordance with the provisions of the Federal Food. Drug, de vices that nave been require approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not required to the general controls provisions of the Act. The T ou thay, therefore, thanket the Act include requirements for annual registration, listing of general controls provisions practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into class II (Special Controls), it may be subject to such II your device is classified (sec above) into enas frecting your device can be found in Title 21, additional controls. Existing major regerances and to 895. In addition, FDA may publish further Sode of recents concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination and any of the ot that FDA has made a determination that your device complies with other requirements of the Act that TDA has made a determination administered by other Federal agencies. You must of any Federal statutes and regulations and limited to: registration and listing (21 Comply with an the Fict 5 requirements 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requireneuls as set forut in the quality of come ( < >> ( = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = will anow you to begin marketing your averalence of your device to a legally marketed notification. The FDA imania of successification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and If you desire specific advice of In Vitro Diagnostic Device Eyaluation and Safety at (301) 796809), please contact the Office of In Vitro Diagnostic Device of to remarket 607), please connect the regulation entitled, "Misbranding by reference to premarket 5450. Also, prease note the regulation vialers, "For questions regarding of adverse events under the MDR regulation (21 CFR Part 803), please go to under the MDR regulation (21 CFR Pat 003), products good on 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 You may obtail other geleral mionmation on Jour Food Food and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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#### Indications for Use
#### 510(k) Number (if known):
Device Name: EXINI
#### Indications for Use:
EXINI is intended to be used by trained healthcare professionals and researchers for acceptance, transfer, storage, image display, manipulation, quantification and reporting of digital medical images. The system is intended to be used with images acquired using nuclear imaging (NM) and computed tomography (CT). The software provides general Picture Archiving and Communications System (PACS) tools and a clinical application for oncology including lesion marking and analysis.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
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Concurrence of CDRH, Office of In Vitro Diagnostics (OIVD)
Division Sign-Off Devices
Division of Radiological Devices
