(37 days)
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No
The description focuses on standard image viewing, transfer, storage, and basic measurement tools, with no mention of AI or ML technologies.
No
The device is a software application designed to view, quantify, transfer, and store image data acquired on medical imaging devices. It does not exert any therapeutic effect on a patient.
No
The device is described as software for viewing, quantifying, transferring, and storing medical image data. It does not state that it analyzes the data to diagnose a condition or disease.
Yes
The device is explicitly described as a "software application package" and its functions are solely related to viewing, quantifying, transferring, and storing image data through software means. There is no mention of accompanying hardware components that are part of the device itself.
Based on the provided information, the EchoConnex Communicator System is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended to be used in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality, or to determine the safety and compatibility with potential recipients, or to monitor therapeutic measures.
- EchoConnex Functionality: The EchoConnex Communicator System is described as software for viewing, quantifying, transferring, and storing image data acquired from medical imaging devices. It processes image data, not biological specimens.
- Intended Use: The intended use is focused on managing and analyzing medical images, not on analyzing biological samples for diagnostic information about a patient's condition.
The device is clearly focused on the management and analysis of medical images obtained from imaging modalities, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The EchoConnex Communicator System is a Windows 2000/Windows XP software application package. It is designed to view, quantify, transfer and store image data acquired on medical imaging devices.
Product codes (comma separated list FDA assigned to the subject device)
90 LLZ
Device Description
The EchoConnex Communicator software provides a means of opening and displaying image files. The EchoConnex Communicator software provides a means of transferring medical image files using a DICOM network method from the acquisition devices to the Connex Acquisition Server. The Connex Acquisition Server provides a means for transferring the acquired studies to the Connex Central Server using standard networking methods.
The EchoConnex Communicator software provides a means to retrieve and view image data located on one of the Connex server devices using a standard network connection. The EchoConnex Communicator software provides a means for querying and retrieving patient studies from a networked DICOM server device.
The EchoConnex Communicator software provides a means of creating AVI, BMP, TIFF and JPG graphic files from the image data displayed by the software. The EchoConnex Communicator software provides a means of quantifying the image data using standard measurement tools.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 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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NOV - 5 2003
510(k) Summary of Safety and Effectiveness
This summary of safety and effectiveness is provided as part of the Premarket Notification in compliance with 21CFR. Part 807, Subpart E, Section 807.92
1) Submitter's name, address, telephone number, contact person
Curtis LeBleu, President ConnexMD 8536 18th Ave NW Seattle, WA 98117 Telephone: (206) 850-5075 Facsimile: (206) 525-0633 E-mail: clebleu@connexmd.com
2) Name of the device, including the trade or proprietary name if applicable, the common or usual name, and the classification name, if known:
Common/Usual Name: | Picture Archiving and Communications Systems Workstation |
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Proprietary Name: | EchoConnex Communicator |
Classification Name: | Picture Archiving and Communications System, Class II |
3) Device Description
The EchoConnex Communicator software provides a means of opening and displaying image files. The EchoConnex Communicator software provides a means of transferring medical image files using a DICOM network method from the acquisition devices to the Connex Acquisition Server. The Connex Acquisition Server provides a means for transferring the acquired studies to the Connex Central Server using standard networking methods.
The EchoConnex Communicator software provides a means to retrieve and view image data located on one of the Connex server devices using a standard network connection. The EchoConnex Communicator software provides a means for querying and retrieving patient studies from a networked DICOM server device.
The EchoConnex Communicator software provides a means of creating AVI, BMP, TIFF and JPG graphic files from the image data displayed by the software. The EchoConnex Communicator software provides a means of quantifying the image data using standard measurement tools.
4) Performance Standards
No performance standards for PACS systems or components have been issued under the authority of Section 514. The EchoConnex Communicator software has been designed to comply with the following voluntary standards:
ISO Joint Photographic Experts Group (JPEG) Image Compression Standard DICOM Standard 3.0
5) General Safety and Effectiveness Concerns
The device labeling contains operating instructions for the safe and effective use of the EchoConnex Communicator software.
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6) Substantially Equivalent Devices
Connex MD believes that the capabilities of the EchoConnex Communicator software makes it substantially equivalent to other image display products commercially available, specifically the CardioNow Cardiology Wide Area Network Archive and Retrieval System.
7) Software
Software development for the EchoConnex Communicator software follows documented processes for software design, verification and validation testing. A risk assessment has been completed to identify potential design hazards that could cause an error or injury based on the use of the software. Appropriate steps have been taken to control all identified risks for this type of image display and communication product.
8) Conclusions
The EchoConnex Communicator software is designed and manufactured to meet United States and international standards for the display and transmission of images acquired on medical imaging devices. The system is designed to incorporate components common to all image viewing systems for the display, manipulation and image transmission within a clinical setting. The EchoConnex Communicator software incorporates features of predicate devices cleared through premarket notification and no new issues of safety or effectiveness are raised.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the body and wings, and the overall design is simple and clean.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 5 2003
Mr. Curtis LeBleu President ConnexMD, Inc. 8536 18th Ave. NW SEATTLE WA 98117 Re: K033093
Trade/Device Name: EchoConnex Communicator Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II
Product Code: 90 LLZ Dated: September 26, 2003 Received: September 29, 2003
Dear Mr. LeBleu:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (OS) 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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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
8xx. 1xxx | (301) 594-4591 |
---|---|
876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours.
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Appendix B
Indication for Use Form
510K Number (if known)_KC3 3 093
Device Name: EchoConnex Communicator Software
Indications for Use:
The EchoConnex Communicator System is a Windows 2000/Windows XP software application package. It is designed to view, quantify, transfer and store image data acquired on medical imaging devices.
Nancy C. Broadson
(Division Sign-Off) Division of Reproductive, Abde and Radiological Devices 510(k) Number
Yes, Prescription Device✓