INTEGRADWEB BY DYNAMIC IMAGING, INC. by DYNAMIC IMAGING INC.

INTEGRADWeb™ by Dynamic Imaging, Inc. is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations. Typical users of this system are trained professionals, as in physicians, nurses, and technicians.

Device Description

INTEGRADWeb™ is an Internet based software picture archiving and communications system that provides users with capabilities relating to the acceptance, transfer, display, storage, and digital processing of medical images. INTEGRADWeb™ includes features to access and manage medical imaging studies from cat-scan (CT), magnetic radiography (MR), ultrasound (US), nuclear medicine (NM), computerized radiography (CR), digital radiography (DR), digital x-ray (DX), x-ray angiography (XA), PET scan (PT), and other imaging modalities. INTEGRADWeb™ is designed to be deployed over conventional TCP/IP networking infrastructure available in most healthcare organizations, and utilizes commercially available computer platforms (Intel Pentium-based) and operating systems (Microsoft Windows 2000, Windows NT, and Windows 98). The system does not produce any original medical images. All images located on INTEGRADWeb™ have been received from DICOM compliant modalities and/or systems.

AI/ML Overview

The provided text is a 510(k) summary for INTEGRADWeb™ by Dynamic Imaging, Inc., a Picture Archiving Communications System. Based on the document, this device is a software system for managing and displaying medical images. It does not produce original medical images, nor does it make any diagnostic interpretations or claims about medical performance. As such, the document does not contain information about acceptance criteria or a study proving device performance in the way typically associated with AI/CADe devices that perform image analysis or diagnostic aid.

Here's why the direct questions cannot be answered from the provided text:

The device is a PACS system, primarily for image management, storage, communication, and display. It explicitly states, "The system does not produce any original medical images." and "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed." This indicates that the device supports human interpretation rather than performing automated diagnostic tasks.
The 510(k) application focuses on demonstrating "substantial equivalence" to a predicate PACS device (ISITE RADIOLOGY) by highlighting technological characteristics, indications for use, and a hazard analysis. It does not involve a performance study against a ground truth for diagnostic accuracy, sensitivity, or specificity.

Therefore, the following points are not applicable or cannot be extracted from the document:

A table of acceptance criteria and the reported device performance: Not applicable, as there are no diagnostic performance metrics for this type of device.
Sample sized used for the test set and the data provenance: Not applicable. No diagnostic test set is mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth establishment for diagnostic performance is mentioned.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 applicable. This is not an AI diagnostic aid device.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a system for image management, not autonomous algorithmic performance.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable. There is no mention of an AI algorithm requiring a training set.
How the ground truth for the training set was established: Not applicable.

In summary, the provided 510(k) document pertains to a Picture Archiving Communications System (PACS) that facilitates the handling and viewing of medical images, rather than performing automated analysis or diagnosis. Consequently, the performance criteria and study details requested are not relevant or present within this type of regulatory submission for this specific device. The 'study' mentioned is a hazard analysis and a comparison to a predicate device for substantial equivalence, not a clinical performance study.

Summary

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Image /page/0/Picture/0 description: The image contains a sequence of numbers and letters. The sequence is "K03/3//". The characters are written in a handwritten style.

JUN 2 0 2003

Dynamic Imaging, Inc.

Page 1

510(k) Summary of Safety and Effectiveness

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared: April 2, 2003

Submitter's Information: 21 CFR 807.92(a)(1) Dynamic Imaging, Inc. 110 Commerce Drive Allendale, NJ 07401

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) INTEGRADWeb™ by Dynamic Imaging, Inc. Trade Name: Common Name: Picture Archiving Communications System 892.2050 Device Classification: System, Image Processing Name:

Predicate Device: 21 CFR 807. 92(a)(3)

Device Classification Name SYSTEM, IMAGE SYSTEM, IMAGE PROCESSING,

Regulation Number	892.2050
510(k) Number	K013630
Device Name	ISITE RADIOLOGY
Applicant	STENTOR, INC.16303 PANORAMIC WAYSAN LEANDRO, CA 94578
Product Code	LLZ
Decision Date	12/05/2001

Device Description: 21 CFR 807 92(a)(4)

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Image /page/1/Picture/0 description: The image shows the logo for Dynamic Imaging, Inc. The logo features a stylized letter "D" with a black square above it. The text "Dynamic Imaging, Inc." is written in a simple, sans-serif font below the logo. The logo is black and white.

The system does not produce any original medical images. All images located on INTEGRADWeb™ have been received from DICOM compliant modalities and/or systems.

Indications for Use: 21 CFR 807 92(a)(5)

Technological Characteristics: 21 CFR 807 92(a)(6)

The device is medical device image software that is used with computer hardware in a picture archiving and communications system user environment. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed.

Conclusion: 21 CFR 807 92(b)(1)

The 510(k) Pre-Market Notification INTEGRADWeb™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. The system has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the potential hazards have been classified as Minor.

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Image /page/2/Picture/1 description: The image is a black and white logo. The logo features a stylized bird with three curved lines representing its body and wings. The bird is positioned within a circle, and the text "United States Environmental Protection Agency" is written around the circumference of the circle. The text is in a simple, sans-serif font and is arranged to follow the curve of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 0 2003

Dynamic Imaging, Inc. % Mr. Carl Alletto Consultant OTech, Inc. 1100 Lakeview Blvd. DENTEN TX 76208

Re: K031311

Trade/Device Name: INTEGRADWebTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communication system Regulatory Class: II Product Code: 90 LLZ Dated: March 19, 2003 Received: April 30, 2003

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.

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 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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15031311

Page 1 of -1

(Indications for Use Form)

510(k) Number:

Device Name:

INTEGRADWeb™ by Dynamic Imaging, Inc.

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

Over-The-Counter Use

(Per 21 CFR 801.109)

(Optional Format 1-2-96)

David B. Segmen

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).