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.

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.

AI/ML Overview

The provided text is a 510(k) Summary for the EchoConnex Communicator software. It primarily focuses on demonstrating substantial equivalence to a predicate device and software development processes, rather than presenting a performance study with detailed acceptance criteria and results. Therefore, much of the requested information is not available in the provided document.

Here's a breakdown of what can and cannot be answered based on the text:

Acceptance Criteria and Reported Device Performance

The document does not specify quantitative acceptance criteria or report specific performance metrics for the EchoConnex Communicator software beyond compliance with voluntary standards (ISO JPEG and DICOM 3.0) and general functionality description. It emphasizes substantial equivalence to a predicate device rather than independent performance validation against predefined criteria.

Acceptance Criteria	Reported Device Performance
No specific quantitative acceptance criteria are provided in the document. The device is designed to comply with ISO JPEG and DICOM Standard 3.0.	The device provides means for opening, displaying, transferring, retrieving, viewing, querying, creating graphic files (AVI, BMP, TIFF, JPG), and quantifying image data using standard measurement tools. It adheres to ISO JPEG and DICOM 3.0.

Study Information

Since no specific performance study against acceptance criteria is detailed in the document, most of the following information is not available:

Sample size used for the test set and the data provenance: Not mentioned. The document relies on substantial equivalence to a predicate device, not a new performance study.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. The EchoConnex Communicator is a PACS workstation, not an AI-assisted diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable/mentioned. This is a viewing and communication system, not a standalone diagnostic algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
The sample size for the training set: Not applicable/mentioned. This is not a machine learning model requiring a training set.
How the ground truth for the training set was established: Not applicable/mentioned.

Summary of available information:

The document describes the EchoConnex Communicator as a Picture Archiving and Communications Systems Workstation designed to view, quantify, transfer, and store image data acquired on medical imaging devices. It claims substantial equivalence to the CardioNow Cardiology Wide Area Network Archive and Retrieval System. The software development followed documented processes for design, verification, and validation, including a risk assessment. Compliance with ISO JPEG and DICOM Standard 3.0 is stated as a design goal. However, no specific performance study against defined acceptance criteria is presented in this 510(k) summary. The submission focuses on the device's functionality and adherence to established communication standards, rather than clinical performance metrics.

Summary

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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
Proprietary Name:	EchoConnex Communicator
Classification Name:	Picture Archiving and Communications System, Class II

3) Device Description

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✓

Regulation Number and Section

§ 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).