When installed on an appropriate PC-based platform, VIEWSEND Medical software is intended to provide the medical professional with the capability to view, retrieve, store, import, process, collaborate, and/or transmit medical images in order to render a diagnosis. Options allow for teleradiology, telemedicine, videoconferencing, collaboration, DICOM 3.0, communications, viewer, customizable database, stand-alone or client/server or web-based, compression, or security. castommande and ass, suase, can be performed over wireless/wired LAN, ISDN, T1, ATM, satellite, and/or plain old telephone system (POTS). The DICOM 3.0 option allows for query, satchire, and, receive, print, or DICOM Dir actions with DICOM 3.0 compliant modalities or server.

Device Description

When integrated into an appropriate PC-based platform, VIEWSEND Medical imaging software contains several modules to enable the medical professional to view, retrieve, store, import, process, collaborate, and transmit medical images in order to render a diagnosis. VIEWSEND Medical software can include teleradiology, telemedicine, and videoconferencing in an open system that runs under the Microsoft Windows 98/2000/NT operating system.

VIEWSEND Medical software is modular and able to provide one or more of the VIEWSEND standard features to match clinical needs - teleradiology, telemedicine, videoconferencing, collaboration, DICOM 3.0, communications, viewer, customizable database, stand-alone or client/server or web-based, compression, or security.

Existing medical films can be digitized, scanned, and stored as DICOM 3.0 images. Communications between systems can be performed over wireless/wired LAN, ISDN, T1, ATM, satellite, or plain old telephone system (POTS). The DICOM option allows for query, retrieve, send, receive, print, or DICOM Dir actions with DICOM 3.0 compliant modalities or servers.

VIEWSEND Medical software allows medical professionals in remote locations to view, discuss and consult on the same images of a patient case file. This can be done with live cameras and scopes or by sending high-resolution files that have been scanned into the remotely located PC.

VIEWSEND Medical software allows images to be sent from the archive files of one machine, and be transported to a different server, so that images from previous examinations may be compared with new more up-to-date images. These stored images can be at the physician request, sent in advance to save time and bandwidth during crucial consultations. Communications between VIEWSEND systems can use industry standard 128-bit encryption, and/or JPEG or JPEG2000 compression.

AI/ML Overview

The provided text does not contain detailed information about acceptance criteria or a specific study that proves the device meets those criteria in a quantitative sense. The submission is for a software update to an existing device (VIEWSEND Medical Model 1200, K-962225) and focuses on demonstrating substantial equivalence to the original device.

Here's an analysis based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance:

No specific performance metrics or acceptance criteria (e.g., accuracy, sensitivity, specificity, processing speed targets) are mentioned for the VIEWSEND Medical software. The submission emphasizes that:

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence	The intended use for VIEWSEND Medical is the same as the original device.
	The technological characteristics have been described in sufficient detail to demonstrate that they are the same as the original device.
Software Quality Procedures	Testing of incremental software revisions followed KLT's normal procedures. A test plan was developed with relevant procedures. Test results were documented (what was tested, expected results, who performed, resources used).

2. Sample Size Used for the Test Set and Data Provenance:

No information is provided regarding a specific "test set" in the context of image analysis or diagnostic performance. The "testing" mentioned refers to internal software quality assurance procedures, not a clinical validation study with a defined dataset of patient images.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not applicable. No clinical expert-driven ground truth establishment is mentioned for this submission.

4. Adjudication Method for the Test Set:

Not applicable. No clinical test set or adjudication process is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC study was performed or mentioned. The submission is not focused on comparing human readers with and without AI assistance, but rather on the software's functional capabilities for image viewing, manipulation, and transmission.

6. Standalone Performance Study:

No standalone (algorithm-only) performance study was conducted or described in the provided text. The device is a "Picture Archiving and Communications System" (PACS) software designed to aid medical professionals, not to provide automated diagnoses independently.

7. Type of Ground Truth Used:

Not applicable. The submission does not detail any clinical ground truth (expert consensus, pathology, or outcomes data) being used for performance evaluation. The "ground truth" for the software testing would likely be the expected functional behavior of the software modules.

8. Sample Size for the Training Set:

Not applicable. The VIEWSEND Medical software described is a PACS system, not an AI or machine learning model that relies on a "training set" of images to learn diagnostic patterns.

9. How the Ground Truth for the Training Set Was Established:

Not applicable.

Summary of the Study (Based on Provided Text):

The submission describes a premarket notification (510(k)) for VIEWSEND Medical, which is an update to an existing software device. The "study" mentioned is not a clinical performance study in the typical sense of evaluating diagnostic accuracy. Instead, it refers to internal software development and testing procedures to demonstrate that the incremental revisions to the software maintain the same intended use and technological characteristics as the previously cleared predicate device (VIEWSEND Medical Model 1200, K-962225).

The core of the submission is to demonstrate substantial equivalence to the predicate device, not to prove new clinical performance metrics. The testing focused on:

Functional verification: Ensuring the software modules for viewing, retrieving, storing, importing, processing, collaborating, and transmitting medical images function as intended.
Adherence to quality procedures: Following KLT's established software development and testing protocols, including documenting test plans, expected results, and resources used.

The FDA's letter confirms that based on the provided information, the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market.

Summary

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K013994

Premarket Notification KLT Telecom Inc. VIEWSEND Medical August 24, 2001

Image /page/0/Picture/2 description: The image shows the logo for ViewSend. The logo is black and features the word "ViewSend" in a stylized font. There is a curved line above the word, and a small circle to the right of the word.

APPENDIX 4

FEB 01 2002 510(K) Summary

VIEWSEND Medical

Submitted By:	KLT Telecom, Inc.
	14080-A Sullyfield Circle
	Chantilly, VA 20151
	Tel. 703.502.1488

Ken Logsdon, Jr. Contact Person: Director of Programs 703.502.1840

Modified Device Trade Name:	VIEWSEND Medical
Unmodified Device Trade Name:	VIEWSEND Medical Model 1200 (K-962225)
Common Name:	VIEWSEND Medical
Classification:	Unclassified

DEVICE DESCRIPTION A.

Appendix 4-1

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Premarket Notification KLT Telecom Inc. VIEWSEND Medical August 24, 2001

Image /page/1/Picture/1 description: The image shows the logo for ViewSend. The logo is black and has a curved line above the text. The word "ViewSend" is written in a bold, sans-serif font, with a registered trademark symbol next to the "d".

INTENDED USE B.

When installed on an appropriate PC-based platform, VIEWSEND software is intended to provide the medical professional with the capability to manipulate, annotate, and/or transmit medical images in order to render a diagnosis. Options include teleradiology, telemedicine, videoconferencing, communications, viewer, customizable database, DICOM 3.0, stand-alone or client/server or web-based, compression, and/or security.

Communications between systems can be performed over wired LAN, ISDN, T1, ATM, satellite, and/or plain old telephone system (POTS). The DICOM 3.0 option allows for query, retrieve, send, receive, print, or DICOM Dir actions with DICOM 3.0 compliant modalities or servers.

C. TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the modified device are the original device. Incremental revisions to the software have been made.

D. TESTING

Testing of the incremental software revisions followed KLT's normal procedures. A test plan was developed containing a description of relevant test procedures. Test results were documented including what was tested, expected results, whom the test was performed by, which resources used (such as automated test tools).

E. CONCLUSIONS

In summary, KLT has demonstrated that the intended use for VIEWSEND Medical is the same as the original device. The technological characteristics have been described in sufficient detail to demonstrate that they are the same as the original device. Therefore, this premarket notification has demonstrated Substantial Equivalence as defined and understood in the Federal Food, Drug, & Cosmetic Act and its amendments.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles a bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 01 2002

Mr. Ken Logsdon, Jr. Director of Programs KLT Telecom, Inc. 14080-A Sullyfield Circle CHANTILLY VA 20151-1623 Re: K013994

Trade/Device Name: ViewSend Medical Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System

Regulatory Class: II Product Code: 90 LLZ Dated: January 10, 2002 Received: January 11, 2002

Dear Mr. Logsdon:

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 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 (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.

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This letter will allow you to begin marketing your device as described in your 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 this 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" (21 CFR Part 807.97). 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. Hogdon

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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Page 1 of I

K013994 510(k) Number (if known):

ViewSend Medical Device Name:

Indications For Use:

(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use

(Optional Format 3-10-98)

David h. Seymore

(Division Sign-Off) Division of Reproductive, and Radiological Devi 510(k) Number

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).