(14 days)
INTEGRADWeb MPR/MIP™ by Dynamic Imaging, Inc. is a device that receives medical images (including mammograms) 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. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
INTEGRADWeb MPR/MIP ™ 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 MPR/MIP ™ 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 MPR/MIP ™ have been received from DICOM compliant modalities and/or systems.
This document is a 510(k) Summary of Safety and Effectiveness for the INTEGRADWeb MPR/MIP™ system by Dynamic Imaging, Inc., submitted to the FDA in 2004. It focuses on declaring substantial equivalence to a predicate device, rather than presenting a study for acceptance criteria.
Therefore, much of the requested information, such as acceptance criteria, specific performance metrics, sample sizes for test and training sets, ground truth establishment, expert qualifications, and details on standalone or MRMC studies, is not available in the provided text. The document is primarily a regulatory submission for market clearance.
However, based on the information provided, here's what can be inferred or explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance
Not available. The document does not specify quantitative acceptance criteria or report device performance against such criteria. It states that the submission "contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device." This indicates a qualitative comparison rather than a quantitative performance evaluation against pre-defined metrics within the document.
2. Sample Size Used for the Test Set and Data Provenance
Not available. The document does not describe a "test set" in the context of evaluating the device's performance against specific metrics. It indicates the device handles various medical images from different modalities (CT, MR, US, NM, CR, DR, DX, XA, PT), but no details on specific image datasets used for a performance study are provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable/Not available. As no specific performance study with a "test set" is described, there's no mention of experts establishing ground truth for such a set.
4. Adjudication Method for the Test Set
Not applicable/Not available. No test set or adjudication method is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No. The document does not mention an MRMC study or any comparison of human readers with and without AI assistance. The focus is on the device's functionality as a Picture Archiving Communications System (PACS) and its substantial equivalence to a predicate device.
6. If a Standalone (Algorithm Only) Performance Study Was Done
No. The document describes the INTEGRADWeb MPR/MIP™ as a software system for image management, processing, and display within a PACS environment, not as an AI algorithm providing diagnostic interpretations. Therefore, a standalone algorithm performance study is not relevant to the described device. The device "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."
7. The Type of Ground Truth Used
Not applicable/Not available. As no specific performance study that required ground truth for evaluation is described, the type of ground truth used is not mentioned.
8. The Sample Size for the Training Set
Not applicable/Not available. The device is a PACS, not a machine learning model that would require a dedicated training set in the typical sense. Its functionality revolves around accepting, transferring, displaying, storing, and digitally processing existing medical images.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not available. As there's no mention of a training set for a machine learning model, this information is not provided.
In summary, the provided document is a regulatory submission for a PACS device, attesting to its safety and substantial equivalence based on its functionalities and adherence to standards, rather than a detailed report of a clinical performance study with acceptance criteria.
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Image /page/0/Picture/1 description: The image shows the logo for DynamicImaging. The logo consists of a circular icon with a stylized "D" inside, followed by the word "DynamicImaging" in a bold, sans-serif font. The word "Dynamic" is in a larger font size than "Imaging", and the "i" in "Dynamic" is lowercase.
IntegradWe
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510(k) Summary of Safety and Effectiveness SEP = 9 2004
This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990.
Date Prepared: Auqust 1, 2004
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 MPR/MIP ™ by Dynamic Trade Name: Imaging, Inc. Picture Archiving Communications System Common Name: Device Classification: 892.2050 System, Image Processing Name:
System, Image Processing System, Image Processing Device Classification Name 892.2050 892.2050 Regulation Number 510(k) Number K031311 K040376 SECTRA IDS5 RADIOLOGY INTEGRADWEB BY Device Name WORKSTATION; SECTRA DYNAMIC IMAGING, INC MPR PAC Sectra-Imtec AB Applicant Dynamic Imaging Inc. LLZ LLZ Product Code 06/20/2003 05/04/2004 Decision Date
Predicate Device: 21 CFR 807. 92(a)(3)
Device Description: 21 CFR 807 92(a)(4)
I INTEGRADWeb MPR/MIP ™ 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 MPR/MIP ™ 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).
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Image /page/1/Picture/0 description: The image contains the logo for Dynamic Imaging. The logo consists of a stylized letter "D" inside a circle, followed by the words "Dynamic" and "Imaging" in a sans-serif font. The logo is black and white.
Image /page/1/Picture/1 description: The image shows the word "IntegradWeb" in a stylized font. The word "Integrad" is in bold, while the word "Web" is in a lighter font. There is a curved line above the word "Web" and below the word "Integrad", adding a design element to the logo.
The system does not produce any original medical images. All images located on INTEGRADWeb MPR/MIP ™ have been received from DICOM compliant modalities and/or systems.
Indications for Use: 21 CFR 807 92(a)(5)
INTEGRADWeb MPR/MIP™ by Dynamic Imaging, Inc. is a device that receives medical images (including mammograms) 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. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
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 MPR/MIP ™ 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 shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized representation of three human profiles facing right, arranged in a stacked, overlapping manner. The profiles are black and have a flowing, wave-like quality. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the top half of the logo.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 9 2004
Dynamic Imaging, Inc. % Mr. Ned Devine Responsible Third Party Official Entela, Inc. 3033 Madison Ave., SE GRAND RAPIDS MI 49548
Re: K042313
Trade/Device Name: INTEGRADWeb MPR/MIPTM Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II
Product Code: 90 LLZ Dated: August 24, 2004 Received: August 26, 2004
Dear Mr. Devine:
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 (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) I his letter will and you to ough finding of substantial equivalence of your device to a legally marketed predicated. The 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 It you desire specific advise to your 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 Other of Comphanes as ( ( 1 CFR Part 807.97) you may obtain. Other general of receise to premainted to promation of the Act may be obtained from the Division of Small miormation on your respond and Consumer Assistance at its toll-free number (800) 638-2041 or Mandlaoturors, Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brydon
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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K042313 510(k) Number:
Device Name: INTEGRADWeb MPR/MIP™
Indications for Use:
INTEGRADWeb MPR/MIP™ by Dynamic Imaging, Inc. is a device that receives medical images (including mammograms) 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.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
| Prescription Use | |
|---|---|
| (Part 21 CFR 801 Subpart D) |
AND/OR
| Over-The-Counter Use | |
|---|---|
| (21 CFR 807 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David le Segram
Division Sign-Off) Division of Reproductive, A 5 IO(K) Number
§ 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).