(69 days)
No
The document describes standard PACS functionalities like image capture, storage, distribution, enhancement, manipulation, and networking. It mentions post-processing using Multi Planar Reconstruction (MPR), which is a traditional image processing technique, not AI/ML. There is no mention of AI, ML, deep learning, or any related terms or concepts in the provided text.
No
The device is described as a system that receives, processes, stores, and displays medical images and data. It does not directly treat or diagnose a disease or condition, which are characteristics of a therapeutic device.
No
The device is described as a system that receives, communicates, processes, manipulates, stores, and displays digital images and data from various sources (such as CT scanners, ultrasound systems). It is used for post-processing and viewing of medical images, but there is no mention of it performing any diagnostic analysis or interpretation on its own. While it supports interpretation by trained professionals, the device itself is a PACS (Picture Archiving and Communication System) for managing images, not a diagnostic tool.
Yes
The device description explicitly states that IntelePACS™ is "comprised of software modules" and describes its functions as software-based image handling and manipulation. While it interacts with hardware (imaging sources, monitors), the device itself is presented as a software system.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description of IntelePACS™ clearly states its function is to receive, process, manipulate, store, and display medical images from various imaging modalities (CT, ultrasound, etc.). It is a system for managing and viewing medical images, not for analyzing biological samples.
- Intended Use: The intended use describes the system's role in handling and displaying medical images for interpretation by trained professionals. It does not mention any analysis of biological specimens.
- Device Description: The device description focuses on software modules for image handling and networking. It does not mention any components or processes related to analyzing biological samples.
Therefore, IntelePACS™ falls under the category of medical imaging software/systems, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
IntelePACS™ is a device that receives digital images and data from various sources (such as, CT scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images and data can be communicated, processed, manipulated, stored, and displayed within the system and/or across computer networks at distributed locations. Post-processing of the images can be performed using Multi Planar Reconstruction (MPR).
Mammographic images may only be interpreted using an FDA cleared monitor that meets technical specifications reviewed and cleared by FDA. Typical users of this system are trained professionals, physicians, nurses, and technicians.
Contraindications: Lossy compressed images and digitized film screen images must not be reviewed for primary image interpretations.
Product codes
LLZ
Device Description
IntelePACS™ is comprised of software modules that provide image capture, storage, distribution, enhancement, manipulation, and networking of medical images at distributed locations.
In cases where DICOM images are not directly available to IntelePACS™, the system can acquire medical images using a DICOM image gateway, which generates DICOM-type files. For example, film digitizers obtain images from original film and convert them to meet DICOM standards. Stored files are transmitted using a network and can be viewed or manipulated using InteleViewer viewing software.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained professionals, physicians, nurses, and technicians.
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)
Nonclinical Testing:
The complete IntelePACS™ configuration has been assessed and tested at the factory and has passed all in-house testing criteria. The Verification Test Plan was designed to evaluate all input functions, output functions, and actions performed by the IntelePACS™ software in each operational mode and followed the process documented in the Validation Test Plan.
Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met. If the device is installed by INTELERAD MEDICAL SYSTEMS INCORPORATED, integration and installations verification tests are conducted against acceptance criteria prior to release to the client.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features three human profiles in silhouette, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is written in all capital letters.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 27, 2015
Intelerad Medical Systems Incorporated % Mr. Carl Alletto Consultant 8317 Belew Drive MCKINNEY TX 75071
Re: K150707 Trade/Device Name: IntelePACS™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 5, 2015 Received: May 14, 2015
Dear Mr. Alletto:
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
Robert Ochs. Ph.D. Acting 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)
Device Name IntelePACSTM
Indications for Use (Describe)
IntelePACS™ is a device that receives digital images and data from various sources (such as, CT scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images and data can be communicated, processed, manipulated, stored, and displayed within the system and/or across computer networks at distributed locations. Post-processing of the images can be performed using Multi Planar Reconstruction (MPR).
Mammographic images may only be interpreted using an FDA cleared monitor that meets technical specifications reviewed and cleared by FDA. Typical users of this system are trained professionals, physicians, nurses, and technicians.
Contraindications: Lossy compressed images and digitized film screen images must not be reviewed for primary image interpretations.
Type of Use (Select one or both, as applicable)
2 Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared:
April 25, 2015
Submitter's Information: 21 CFR 807.92(a)(1)
Ms. Luce Caron Quality Management System Manager Intelerad Medical Systems Incorporated 895 De La Gauchetière Street West, Suite 400 Montreal, Quebec, Canada H3B 4G1 Tel: 514.931.6222 #7307 Fax: 514.931.4653 Email: luce.caron@intelerad.com
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)
| Product Name: | IntelePACS™ |
|---|---|
| Common Name: | Picture, archive and communications system |
| Classification Name: | System, Image Processing, Radiological |
| Product Code: | LLZ |
Predicate Device: 21 CFR 807. 92(a)(3)
IntelePACS™ system is substantially equivalent to:
| Device Classification Name | system, image processing, radiological22 | ||
|---|---|---|---|
| 510(k) Number | K083520 | ||
| Device Name | INTELEPACS, MODEL VERSION 3.X.X | ||
| Original Applicant | INTELERAD MEDICAL SYSTEMS INCORPORATED | ||
| 895 de la Gauchetiere Street West, suite 400 | |||
| Montreal, QC, CA H3B 4G1 | |||
| Original Contact | Anibal Jodorcovsky | ||
| Regulation Number | 892.205023 | ||
| Classification Product Code | LLZ24 | ||
| Date Received | 11/26/2008 | ||
| Decision Date | 06/23/2009 | ||
| Decision | substantially equivalent (SESE) | ||
| Regulation Medical Specialty | Radiology | ||
| 510k Review Panel | Radiology | ||
| Type | Traditional | ||
| Reviewed by Third Party | No | ||
| Combination Product | No |
Device Description: 21 CFR 807 92(a)(4)
IntelePACS™ is comprised of software modules that provide image capture, storage, distribution, enhancement, manipulation, and networking of medical images at distributed locations.
In cases where DICOM images are not directly available to IntelePACS™, the system can acquire medical images using a DICOM image gateway, which generates DICOM-type files. For example, film digitizers obtain images from original film and convert them to meet DICOM
4
standards. Stored files are transmitted using a network and can be viewed or manipulated using InteleViewer viewing software.
InteleViewer™
InteleViewer is a medical image viewing system, providing access to all of the tools required for reviewing images. The searching capabilities allow the user find the studies and reports. InteleViewer features full DICOM support, including DICOM Query/Retrieve, Store, and Print. The software includes the complete range of InteleViewer functionality, including thumbnail display, real-time cine playback, linked stacking, MPR, annotations and measurements, and more. The web-enabled InteleViewer software uses JPEG 2000 compression and an advanced streaming protocol to provide lossless or lossy image viewing and manipulation. The user can examine multiple studies simultaneously and define customized image layouts. With a mouse click, the user can stack, rotate, zoom, take measurements, and view reports.
Key features of InteleViewer include:
- Seamless access to all studies for a selected patient
- Measuring regions of interest and calibrating measurements .
- . 3D cross-referencing tools
- . Creating complex layout protocols
- Saving key images and presentation states .
- Creating teaching cases and collections ●
- Viewing reports and impressions, and exporting reports to PDF files .
- . Exporting JPEG images
IntelePACS Administration
The IntelePACS administrator is responsible for diagnosing and maintaining the performance of the IntelePACS, managing user accounts, working with the InteleBrowser software, and keeping a vigilant eye out for issues that could impact the radiology workflow. This Administrator Guide contains procedures, definitions, and detailed information to complement your daily tasks. In the Administrator Guide, it will show how to:
- Connect to the IntelePACS.
- . Manage user roles and privileges.
- Understand and use the IntelePACS status tools to plan and troubleshoot network data . volumes.
- . Configure RIS prefetching, DICOM prefetching, and auto-routing rules.
- . Configure the Study Classifier to assign procedure attributes to procedures sent to your IntelePACS.
- . Create report distribution rules to distribute reports based on their status, referrers or other criteria.
- Get more help when needed, by either using the different Intelerad Help tools, such as . the Education and Support Center and Live Help, or by contacting the Intelerad Support Center.
InteleBrowser
InteleBrowser™ is a web-based interface for IntelePACS™, and provides access to the tools that are required in daily work. The user can search and find the studies and reports that are required. The web-based InteleBrowser™ software uses JPEG 2000 compression to provide lossy or lossless image viewing and manipulation, or the user can display compressed JPEG images directly in InteleBrowser.
Additional key features of InteleBrowser include:
- Viewing reports.
- . Validating studies.
- Moving studies to other workstations and modalities. ●
- . Granting study access to individual users.
- Correcting patient information.
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The main elements of the InteleBrowser interface are the main menu and the feature window. In the main menu, the user can choose among the key InteleBrowser functions. The selection from the main menu is then displayed in the feature window. The main menu is available on the left side of the browser window, reqardless of the user is using. The options available reflect the privileges assigned to the user specific account, and therefore may vary slightly depending on the user configuration.
The main menu options include the following:
- Dashboard a management tool that provides summarized information at a glance. The . information that appears on the Dashboard corresponds to the privileges that have been activated for the user account. For example, if the Validate Study privilege is activated for the user account, the Manual Study Validation area is shown, allowing the user to quickly see which servers have studies pending validation. The Dashboard also contains a quick patient search tool and links to other assigned features allowing the user to navigate to related pages quickly. Note: By default, the IntelePACS Monitor is hidden from the Dashboard.
- Patient Search - the user can search for patients to apply the most commonly-used functions for modifying and viewing patient information.
- InteleViewer launches the InteleViewer software, used for image viewing. ●
- . My Profile - customizes various aspects of the interface, changes passwords and contact information, and specifies the preferred delivery mode and template for report distribution.
- . Installers - Provides access to product installers and version information.
- . Help — Opens the online help in a separate browser window. The IntelePACS Help has links to the PDF documentation.
- Log Out ends the session. .
InteleViewer & Reporting Worklist Module Integration
The Reporting Worklist Module in InteleViewer is an integrated radiological worklist, designed to enhance reading workflow to assist user productivity. The Reporting Worklist Module has been designed with workflow interruptions in mind. The user can open and dictate multiple orders simultaneously and the image display will always stay in sync with the case that is being worked on, prevential dictation errors. The cases that appears in the work list are available for the user to dictate to. The filtering capabilities allows the user to refine the list to find the exams that are required. The user create customized filters, save them to use regularly, and combine them to further enhance the worklist view. The user interface provides streamlined interaction with information relevant to the case at hand and allows the user to choose a color scheme that is optimized for low-light environments. Integration with Intelerad's Dictation Module allows the user to create digital MP3 files and transmit them directly to the IntelePACS™ for transcription. The Reporting Worklist Module also works with third-party software to dictate reports.
Indications for Use: 21 CFR 807 92(a)(5)
IntelePACS™ is a device that receives digital images and data from various sources (such as, CT scanners, MR scanners, ultrasound systems, R/F units, computer and direct radiographic devices, secondary capture devices, scanners, imaging gateways, or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and/or across computer networks at distributed locations. Post-processing of the images can be performed using Multi Planar Reconstruction (MPR). Mammographic images may only be interpreted using an FDA cleared monitor that meets technical specifications reviewed and cleared by FDA. Typical users of this system are trained professionals, physicians, nurses, and technicians.
Contraindications: Lossy compressed images and digitized film screen images must not be reviewed for primary image interpretations.
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510(k) Summary of Safety
Technological Characteristics: 21 CFR 807 92(a)(6)
IntelePACS™ is a software product that handles and manipulates digital medical images. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human interprets images and information being displayed and printed. In general, a PACS (Picture Archiving and Communication System) is a medical imaging technology which provides storage of, and convenient access to, images from multiple modalities. Electronic images and reports are transmitted digitally via PACS; this eliminates the need to manually file, retrieve, or transport film jackets. The universal format for PACS image storage and transfer is DICOM 3.x (Digital Imaging and Communications in Medicine). Non-image data, such as scanned documents, may be incorporated using consumer industry standard formats like PDF (Portable Document Format), once encapsulated in DICOM. The subject device and predicate device are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The new device does not raise any new potential safety risks and is equivalent in performance to the existing legally marketed devices. Both systems have been developed to replace traditional film handling in radiology. The 2 devices are substantially equivalent in the areas of design, architecture, general function, application, and intended use. Any difference between the two devices does not affect safety or efficacy. The predicate device and the new device are compared below:
| Item | Functionality | INTELEPACS, MODEL
VERSION 3.X.X
(K083520) | INTELEPACS (Subject
Device) | If different, Impact
on Safety and or
Efficacy |
|------|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------|------------------------------------------------------|
| 1 | Workstation Operating
System | Windows XP Pro or
Windows 2000
Professional | Windows 7 64-bit
Professional | Difference - See
explanation in A. |
| 2 | Intended use | Acquiring, viewing, editing
and storing radiographs
and related patients
images | Same | No difference |
| 3 | Intended user | radiologist | radiologist | No difference |
| 4 | Network | 10/100/100 Ethernet | Same | No difference |
| 5 | Monitor | Above 19inch monitor
(Above 1280x900) | Same, Using
1280x1024 | No difference |
| 6 | User interaction/input | Mouse, keyboard, touch
monitor | Same | No difference |
| 7 | Multi-user | Available, but at a time,
only one user can use it | Same | No difference |
| 8 | Import / export images | Yes | Yes | No difference |
| 9 | Acquisition devices | C CT scanners, MR
scanners, ultrasound
systems, R/F units,
computer and direct
radiographic devices,
secondary capture
devices, scanners,
imaging gateways | Same | No difference |
| 10 | Imaging interfaces | Detector dependent | Detector dependent | No difference |
| 11 | Image organization | Yes. Patient ID, Name,
study instance UID | Same | No difference |
| 12 | Image search available | Yes | Yes | No difference |
| 13 | Image storage | Yes | Yes | No difference |
| 14 | Image viewing | Yes | Yes | No difference |
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510(k) Summary of Safety
| Item | Functionality | INTELEPACS, MODEL
VERSION 3.X.X
(K083520) | INTELEPACS (Subject
Device) | If different, Impact
on Safety and or
Efficacy |
|------|-------------------------------------|-----------------------------------------------------------------|-----------------------------------------------------------------|------------------------------------------------------|
| 15 | Image measurement | Yes | Yes | No difference |
| 16 | Image annotation | Yes | Yes | No difference |
| 17 | Image operations | Yes | Yes | No difference |
| 18 | Security | Yes (Priority by user) | Same | No difference |
| 19 | DICOM 3.0 compatibility | Yes | Yes | No difference |
| 20 | Generator Control | Yes | Yes | No difference |
| 21 | Generator Control
Protocol | Generator dependent | Generator dependent | No difference |
| 22 | RAW Image data
processing | Yes | Yes | No difference |
| 23 | Post image data
processing | Yes | Yes | No difference |
| 24 | Thumbnail viewing | Yes | Yes | No difference |
| 25 | Image reset | Yes | Yes | No difference |
| 26 | panning | Yes | Yes | No difference |
| 27 | Magnify glass | Yes | Yes | No difference |
| 28 | Fit image | Yes | Yes | No difference |
| 29 | Blackford Registration
(K142337) | No | Yes | Difference - See
explanation in B. |
| 30 | Server Operating System | Red Hat Enterprise Linux
4, latest Update, for 32-bit
×86 | Red Hat Enterprise
Linux 6, latest Update,
for 64-bit x86 | Difference - See
explanation in C. |
| 31 | Server Memory | 8 Gigabytes | 16 Gigabytes | Difference - See
explanation in D. |
| 32 | Server Database | Sybase | Sybase and
PostgreSQL | Difference - See
explanation in E |
| 33 | WorkStation Processor | Intel Core 2 Duo 2Ghz | Intel 6-core Xeon
Processor 3.2GHz | Difference - See
explanation in F. |
| 34 | Workstation Memory | 2 Gigabytes | 6 Gigabytes | Difference - See
explanation in G. |
- A. Workstation Operating System: The predicate was based upon the available Microsoft operating system for that time, Windows XP Pro or Windows 2000. These operating systems are no longer available or supported by Microsoft. Windows 2003 OS been replaced by Microsoft Windows 7. The system has been tested and validated with Windows 7 and the results of testing verified that there is no impact on safety or efficacy and that no additional risks have been identified.
- Blackford Registration (K142337): The difference is a user preference and does not B. directly affect the image or intended use. The system has been tested and validated and the results of the testing verified that there is no impact on safety or efficacy and that no additional risks have been identified. The Blackford Registration Product Family (cleared under K142337) consists of two components: 1. A Workflow Server that calculates DICOM registration objects from CT and MR modality data, and also PET/CT data via using the CT data for registration. 2. A localizer tool that works across studies, or series in the same study within a different frame of reference. The first intended clinical use, when reading studies of the above modalities, is to aid navigation through, and comparative interpretation of, a target series with respect to a source series. Normally,
8
the source series will be within a current study and the target series will be within a prior study. However they may also be within the same study but have a different frame of reference. Aiding navigation may include, but is not limited to, indicating corresponding anatomical locations, synchronized scrolling, matching orientations and/or reference lines in reformatted series and fusing two images from source and target series. The second clinical use is to aid presentation of change between cross-sectional radiographic studies to clinical colleagues and patients. Registration-aided interpretation of images should be carried out by a suitably qualified physician, who will base their diagnoses on training and protocols that do not necessarily rely on registration for navigation.
- C. Server Operating System: The predicate was based upon the available Red Hat operating system for that time, Enterprise Linux 4, which is no longer available or supported by Red Hat. Enterprise Linux 4, latest Update, for 32-bit x86 been replaced by Enterprise Linux 6, latest Update, for 64-bit x86. The system has been tested and validated with Enterprise Linux 6, latest Update, for 64-bit x86 and the results of testing verified that there is no impact on safety or efficacy and that no additional risks have been identified.
- D. Server Memory: Red Hat Enterprise Linux 6, 64-bit x86 require larger RAM for operating. The system has been tested and validated with Red Hat Enterprise Linux 6, 64-bit x86 and the results of testing verified that there is no impact on safety or efficacy and that no additional risks have been identified.
- ட் Server Database: PostgreSQL is an open source object-relational database system, It has more than 15 years of active development and a proven architecture that has earned it a strong reputation for reliability, data integrity, and correctness. It runs on all major operating systems, including Linux, UNIX (AIX, BSD, HP-UX, SGI IRIX, Mac OS X, Solaris, Tru64), and Windows. It is fully ACID compliant, has full support for foreign keys, joins, views, triggers, and stored procedures (in multiple languages). It includes most SQL: 2008 data types, including INTEGER, NUMERIC, BOOLEAN, CHAR, VARCHAR, DATE, INTERVAL, and TIMESTAMP. It also supports storage of binary large objects, including pictures, sounds, or video. It has native programming interfaces for C/C++, Java, .Net, Perl, Python, Ruby, Tcl, ODBC, among others. Both of these database systems use the Structured Query Language (SQL), but only PostgreSQL conforms to the standard set by the International Standards Organization (ISO). PostgreSQL is ACID (Atomicity, Consistency, Isolation, and Durability). The system has been tested and validated and the results of testing verified that there is no impact on safety or efficacy and that no additional risks have been identified.
- F. WorkStation Processor: The predicate was based upon the latest computer platform at the time of development. Intel Core 2 Duo 2Ghz processor are older technology and have been replaced with Intel Xeon processor or equivalent. The current system configuration with the Intel Xeon processor has been tested and validated and the results of testing verified that there is no impact on safety or efficacy and that no additional risks have been identified.
- G. Workstation Memory: Microsoft Windows 7 OS and Xeon Processor require a larger RAM for operating. The system has been tested and validated with Windows 7 and the results of testing verified that there is no impact on safety or efficacy and that no additional risks have been identified.
Nonclinical Testing:
The complete IntelePACS™ configuration has been assessed and tested at the factory and has passed all in-house testing criteria. The Verification Test Plan was designed to evaluate all input functions, output functions, and actions performed by the IntelePACS™ software in each operational mode and followed the process documented in the Validation Test Plan.
Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were
9
met. If the device is installed by INTELERAD MEDICAL SYSTEMS INCORPORATED, integration and installations verification tests are conducted against acceptance criteria prior to release to the client.
Conclusion: 21 CFR 807 92(b)(1)
The 510(k) Pre-Market Notification for IntelePACS™ contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device. The subject device will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The subject and predicate devices are substantially equivalent in the areas of technical characteristics, general function, application, and intended use. The modification to the subject device does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices. Nonclinical tests demonstrate that the device is as sffective, and performs as well as the predicate device. Therefore, IntelePACS™ is substantially equivalent to the predicate device.