(60 days)
Not Found
No
The document describes a PACS and image viewer system with basic image processing capabilities, but there is no mention of AI, ML, or related concepts like training/test sets or performance metrics typically associated with AI/ML devices.
No.
This device is described as a system for archiving and viewing medical images, not for treating or diagnosing medical conditions.
No
The "Intended Use / Indications for Use" states that "CONi is not intended for diagnostic use on mobile devices." While it views and archives medical images, its primary purpose is stated as archiving and viewing, not diagnostic interpretation.
Yes
The device is described as a "secure cloud-based application" and a "software system comprised of a Picture Archiving and Communication System (CONiPACS) and an image viewer (CONiView)," with no mention of accompanying hardware components being part of the device itself.
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.
- CONi's function: CONi is described as a system for archiving and viewing medical images from various imaging modalities (CT, MR, X-ray, Ultrasound, Visible Light). It processes and manages image data, not biological samples.
- Intended Use: The intended use clearly states archiving and viewing of medical images. It does not mention any analysis of biological samples.
- Device Description: The description reinforces that it's a cloud-based application for viewing and archiving medical images.
- Lack of IVD characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information based on laboratory tests.
Therefore, CONi falls under the category of medical imaging software or a Picture Archiving and Communication System (PACS), not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
CONi provides for the archiving and viewing of medical images from the following DICOM modalities: Computed Tomography (CT), Magnetic Resonance (MR), X-ray (CR), Ultrasound (US), and Visible Light (External Camera (XC) and Other (OT)). Images and information can be viewed and stored via a secure Internet connection.
CONi is not intended for use in mammography.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
CONi (Capture Over Network Interface) is a secure cloud-based application for viewing and archiving medical images. The CONi software system is comprised of a Picture Archiving and Communication System (CONiPACS) and an image viewer (CONiView). CONi supports imaging studies from the following DICOM modalities: Computed Tomography (CT), Magnetic Resonance (MR), X-ray (CR), Ultrasound (US), and Visible Light (External Camera (XC) and Other (OT)). Images and information can be viewed and stored via a secure Internet connection.
Studies can be shared with a specialist at another facility quickly with a study-specific passcode. This facilitates remote consultation and expedites the study transfer process in emergency situations when a patient is being transported. No physical media such as CDs are needed because collaboration occurs entirely over an internet connection. Secondary over-triage can even be avoided.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Computed Tomography (CT), Magnetic Resonance (MR), X-ray (CR), Ultrasound (US), Visible Light (External Camera (XC) and Other (OT))
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained professionals, physicians, nurses, clinicians 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)
Not Found
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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K130624
Page 1 of 5
510(k) Summary GlobalMedia Group, LLC. CONi™
MAY 0 7 2013
Date Prepared: January 8, 2013
Submitter's Information:
GlobalMedia Group, LLC 15020 N. 74th St. Scottsdale, AZ 85260
| Contact: | Nicholas Campbell |
|---|---|
| Phone: | (480) 398-7430 |
| Fax: | (480) 922-1090 |
Trade Name, Common Name and Classification:
Trade Name: CONi®
Device Classification Regulation: 892.2050 ~ Picture Archiving Communication System Product Code: LLZ - System, Image Processing, Radiological
Predicate Device:
Trade Name: ALZ Web PACS (Version 1.0) Device Classification Regulation: 892.2050 – Picture Archiving Communication System Product Code: LLZ - System, Image Processing, Radiological Applicant: ALZ, Inc. 510(k) Number: K081304
Device Description:
CONi (Capture Over Network Interface) is a secure cloud-based application for viewing and archiving medical images. The CONi software system is comprised of a Picture Archiving and Communication System (CONiPACS) and an image viewer (CONiView). CONi supports imaging studies from the following DICOM modalities: Computed Tomography (CT), Magnetic Resonance (MR), X-ray (CR), Ultrasound (US), and Visible Light (External Camera (XC) and Other (OT)). Images and information can be viewed and stored via a secure Internet connection.
Studies can be shared with a specialist at another facility quickly with a study-specific passcode. This facilitates remote consultation and expedites the study transfer process in emergency situations when a patient is being transported. No physical media such as CDs are needed because collaboration occurs entirely over an internet connection. Secondary over-triage can even be avoided.
1
Intended Use:
CONi provides for the archiving and viewing of medical images from the following DICOM modalities: Computed Tomography (CT), Magnetic Resonance (MR), X-ray (CR), Ultrasound (US), and Visible Light (External Camera (XC) and Other (OT)). Images and information can be viewed and stored via a secure Internet connection.
CONi is not intended for use in mammography.
Technological Characteristics and Substantial Equivalence
The proposed and predicate devices provide a web-based system for the archiving and viewing of medical images. The proposed and predicate devices are to be used with general purpose computing hardware to acquire, transmit, or view the stored medical images. Equivalent with the predicate device, CONi consists of a software application that is installed in a hosted server environment that will communicate with the client's PCs via an internet connection. Communication between the CONi application and client's PCs utilizes DICOM protocols and encrypted browser communications. Both the proposed and predicate devices are hosted by HIPAA compliant facilities. File acquisition, sending functions, and image view and manipulation are included in the proposed and predicate devices.
| GlobalMedia Group | ALZ | |
|---|---|---|
| CONI | Web PACS (Version 1) | |
| Device | ||
| Description | CONI (Capture Over Network Interface) is | |
| a secure cloud-based application for | ||
| viewing and archiving medical images. The | ||
| CONI software system is comprised of a | ||
| Picture Archiving and Communication | ||
| System (CONIPACS) and an image viewer | ||
| (CONIView). Images and information can | ||
| be viewed and stored via a secure | ||
| Internet connection. | The ALZ Web PACS (Version 1.0) is | |
| designed for management, viewing, and | ||
| processing of DICOM images. The ALZ Web | ||
| PACS consists of the ALZ Web PACS | ||
| software application installed on a server | ||
| and the ALZ Web PACS viewer running on | ||
| client computers connecting to the server | ||
| via HTTPS protocol. | ||
| Regulation | ||
| Number | 892.2050 | 892.2050 |
| Product Code | LLZ | LLZ |
| Intended Use | CONI provides for the archiving and | |
| viewing of medical images from the | ||
| following DICOM modalities: Computed | ||
| Tomography (CT), Magnetic Resonance | ||
| (MR), X-ray (CR), Ultrasound (US), and | ||
| Visible Light (External Camera (XC) and | ||
| Other (OT)). Images and information can | ||
| be viewed and stored via a secure | ||
| Internet connection. |
CONI is not intended for use in | The ALZ Web PACS (Version 1.0) is an
imaging software system intended to be
used by trained healthcare professionals.
ALZ Web PACS is used with general
purpose computing hardware to acquire,
transmit, store, view, and process DICOM
images.
The device is not intended for
mammography. |
| | GlobalMedia Group
CONI
mammography. | ALZ
Web PACS (Version 1) |
| Technological
Characteristics
(Server) | Reliable hardware platform, preconfigured
and pretested
Multiple simultaneous DICOM associations
Multi-modality, multi-vendor functionality
and compatibility
RIS incorporated
Server monitored by GlobalMed and
hosting site (FireHost)
Shared archive
Studies are marked as reviewed after a
report is written | Reliable hardware platform, preconfigured
and pretested
Multiple simultaneous DICOM associations
Multi-modality, multi-vendor functionality
and compatibility
RIS incorporated
Server instance monitoring
Shared archive
Studies are marked as read after a DICOM
query (this feature is set if client requests) |
| Technological
Characteristics
(Communication) | Not a feature
DICOM Worklist Client
Automatic study routing based on
administrative routing rules
Compiles with DICOM standards
Email notification upon arrival of new
study or finished report | DICOM query/retrieve
DICOM Print client and DICOM Worklist
client
Auto forward of data sets
Complies with all HL7 and DICOM,
standards
Email notification upon arrival of new study |
| | Not a feature | Emailing images as JPEG |
| Technological
Characteristics
(Licensing) | Supports all modalities except
mammography | Available for all DICOM modalities |
| | Unlimited number of web users | Unlimited number of web users |
| Technological
Characteristics
(Web) | User-friendly web interface layout
Coherent overview of studies with search
and filter possibilities
Automatic browser logout
Unlimited number of users and concurrent
users
Display of all color/grayscale images
PDF reports
Transfer of images via web to DICOM
destinations | User-friendly web interface layout
Coherent overview of studies with search
and filter possibilities
Automatic browser logout
Unlimited number of users and concurrent
users
Display of all color/grayscale images
Display of structured reports
Transfer of images via web to DICOM
destinations |
| | Not a Feature | File attachments to images or studies |
| Technological
Characteristics
(Import) | Not a Feature
Not a Feature | Import of any DICOMDIR media
Directory registration of DICOM data |
| Technological
Characteristics
(Export) | Not a Feature | DICOM export function by burning the
DICOM images to a CD or by using a USB |
| Technological
Characteristics | Automatic synchronization with remote
servers | Automatic synchronization with remote
servers |
| | GlobalMedia Group
CONI | ALZ
Web PACS (Version 1) |
| (Database) | Not a Feature | Configurable overflow management (high
water/low water, study date, custom
settings) if setting is requested by client |
| Technological
Characteristics
(Data Access) | Admin user
Predefined privileges for physicians,
nurses, and technicians
User access control | Admin user
Privilege settings for each user/group are
customizable
User access control |
| Technological
Characteristics
(Service) | No client software updates required | Software updates/upgrades optional |
| Technological
Characteristics
(Languages) | English, Spanish, and Portuguese | English |
| Technological
Characteristics
(Web Viewer) | Available to an unlimited number of
viewers and concurrent viewers
Viewing of any kind of images and PDF
reports
Center/window | Available to an unlimited number of
viewers and concurrent viewers
Viewing of any kind of images and
structured reports
Center/window |
| | Not a feature | Comparison of multiple studies |
| | Stack mode/cine mode | Stack mode/cine mode |
| | Not a Feature | Measurements (distance, ROI, angle) |
| | Thumbnail preview | Thumbnail preview |
| | Background preload | Background preload |
| | Supports DICOM compressions. Server
does not compress DICOM files. | JPEG DICOM compressions vary per
modality |
| Typical User | Trained professionals, physicians, nurses,
clinicians and technicians. | Healthcare professionals |
| Software Level
of Concern | Moderate | Moderate |
Substantial Equivalence Table:
2
3
Summary of Non-Clinical Tests
The following quality assurance measures were applied to the development of the CONI system:
- . Establishment of Requirements
- Risk Analysis (software and system) .
- . DICOM Standard Conformance Statement
- . HIPAA Compliance Statement
- . Software Unit Testing
- . Software Integration Testing
- . Software System Testing
- Software Hazard Testing .
Safety and Effectiveness Summary
The CONi software application provides a safe and secure location for the archiving and
4
viewing of medical images. CONi does not diagnosis any medical condition and is intended to be used by trained individuals. The software utilizes DICOM communication protocols and has been designed and tested to meet HIPAA requirements. CONi does not control the function of any other medical device. GlobalMedia Group considers the CONi software application to be as safe and effective for use as the previous cleared predicate device.
Conclusion
The GlobalMedia Group CONi software application has similar functionality, intended use, technological characteristics, and typical users as the predicate device. As a result, the CapSure software application will fall under the same FDA classification number and product code as the predicate device. The GlobalMedia Group CONi software introduces no new issues or concerns of safety and effectiveness, and is substantially equivalent to the predicate device.
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Image /page/5/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 7, 2013
Globalmedia Group LLC % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313
Re: K130624
Trade/Device Name: CONi™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 23, 2013 Received: April 24, 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
6
Page 2 - Mr. Job
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.
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.
Smh7)
Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
for
Enclosure
7
Indications for Use
510(k) Number (if known): K130624
Device Name: CONi®
Indications for Use:
CONi provides for the archiving and viewing of medical images from the following DICOM modalities: Computed Tomography (CT). Magnetic Resonance (MR), X-ray (CR); Ultrasound (US), and Single Frame Visible Light Photography (External Camera (XC) and Other (OT)). Images and information can be viewed and stored via a secure Internet connection.
CONi is not intended for use in mammography.
CONi is not intended for diagnostic use on mobile devices
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
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