(132 days)
Omni-Vue™ System is a software device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Device options make possible reading (including mammography), telecommunications; fast demonstration; etc.; and teleconferencing. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images must 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.
The Omni-Vue device allows limited image processing capability: "sharpening preset" and window leveling function.
For image editing; the only an "L" or "R" marker can be added to the image but it must be already defined in the original image DICOM header as received by the system. "L" or "R" can not be added to the image if left & right is not defined in the original image.
The device provides scout line which is a reference line and is drawn on the AP image to display the location of the slice being viewed. In multi series images, whenever one image is clicked, scout line will be drawn on other series which is crossed direction.
Omni-Vue™ System makes possible the capturing, storage, distribution, manipulation, and networking of medical images at distributed locations. In cases where DICOM images are not directly available, the System can acquire medical images using a DICOM gateway, which generates DICOM-type files. For example, film digitizers obtain images from old film and convert them to meet DICOM standards and stored. Stored files are transmitted using a network and can be viewed or manipulated from an imaging workstation.
The provided text does not contain specific acceptance criteria or a detailed study proving the device meets them in the format requested. The document is a 510(k) summary indicating the device's substantial equivalence to a predicate device, Omni-Vue™ System, as a Picture Archiving Communications System (PACS).
Here's a breakdown of why the requested information cannot be fully provided based on the given text:
- Table of Acceptance Criteria and Reported Device Performance: This information is not present. The document focuses on demonstrating substantial equivalence to a predicate device, not on specific performance metrics against pre-defined acceptance criteria.
- Sample Size for Test Set and Data Provenance: Not mentioned.
- Number of Experts and Qualifications for Ground Truth: Not mentioned.
- Adjudication Method: Not mentioned.
- Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: Not mentioned. The document describes a software device for image management and viewing, not an AI-assisted diagnostic tool that would typically undergo such studies to show improvement in human reader performance.
- Standalone Performance Study: Not explicitly mentioned as a formal study with metrics. The "Technological Characteristics" section states that "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed," implying human oversight rather than an algorithm-only review.
- Type of Ground Truth Used: Not mentioned.
- Sample Size for Training Set: Not mentioned. This device is a PACS system, not a machine learning algorithm that typically requires a training set.
- How Ground Truth for Training Set Was Established: Not applicable as it's a PACS system.
Summary of available information related to performance/evaluation:
The core of the submission is to demonstrate substantial equivalence to the predicate device, PACSPartner™ (K042311). This typically involves showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness.
The document mentions:
- "The submission contains the results of a hazard analysis and the 'Level of Concern for potential hazards has been classified as 'Minor'."
- The device "will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey."
For a PACS system like Omni-Vue™, performance criteria would typically relate to:
- Image Quality: Maintaining the diagnostic quality of images.
- Speed and Efficiency: How quickly images can be acquired, stored, transmitted, and displayed.
- Security: Protection of patient data.
- Reliability: System uptime and data integrity.
- Functionality: Successful implementation of features like "sharpening preset," "window leveling," adding 'L'/'R' markers (when defined in DICOM header), and scout lines.
However, the provided text does not explicitly state how these types of performance criteria were measured or quantified for the Omni-Vue™ System in a formal study. The FDA's determination of "substantial equivalence" is based on the comparison to the predicate device, assuming similar performance for similar technology.
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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: October 6, 2007
Submitter's Information: 21 CFR 807.92(a)(1) Mr. Alain Tabares, Chief Technical Officer Genesis Digital Imaging, Inc. 12921 W. Washington Blvd. Los Angeles, CA 90066
MAR 1 0 2008
Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2) Omni-Vue™ System Trade Name: Common Name: Picture Archiving Communications System Device Classification: 892 2050 System, Image Processing Name:
Predicate Device: 21 CFR 807. 92(a)(3)
| Device Classification Name | system, image processing, radiological |
|---|---|
| 510(k) Number | K042311 |
| Regulation Number | 892.2050 Class II |
| Device Name | PACSPartner™ |
| Applicant | Medical Standard Co. Ltd., |
| Product Code | LLZ |
| Decision Date | 09/09/2004 |
| Decision | Substantially equivalent (SE) |
| Classification Advisory Committee | Radiology |
| Review Advisory Committee | Radiology |
| Type | Traditional |
Device Description: 21 CFR 807 92(a)(4)
Omni-Vue™ System makes possible the capturing, storage, distribution, manipulation, and networking of medical images at distributed locations. In cases where DICOM images are not directly available, the System can acquire medical images using a DICOM gateway, which generates DICOM-type files. For example, film digitizers obtain images from old film and convert them to meet DICOM standards and stored. Stored files are transmitted using a network and can be viewed or manipulated from an imaging workstation.
Indications for Use: 21 CFR 807 92(a)(5)
Omni-Vue™ System is a software device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer
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510(k) Summary of Safety and Effectiveness
networks at distributed locations. Device options make possible reading (including mammography), telecommunications; fast demonstration; etc.; and teleconferencing. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images must 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.
The Omni-Vue device allows limited image processing capability: "sharpening preset" and window leveling function.
For image editing; the only an "L" or "R" marker can be added to the image but it must be already defined in the original image DICOM header as received by the system. "L" or "R" can not be added to the image if left & right is not defined in the original image.
The device provides scout line which is a reference line and is drawn on the AP image to display the location of the slice being viewed. In multi series images, whenever one image is clicked, scout line will be drawn on other series which is crossed direction.
Technological Characteristics: 21 CFR 807 92(a)(6)
Omni-Vue™ System is a software product that handles and manipulates digital medical images. 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 for Omni-Vue™ System contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device.
Omni-Vue™ 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 "Level of Concern for potential hazards has been classified as "Minor".
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Image /page/2/Picture/0 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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a bird or a person with outstretched arms, composed of three curved lines. Below the symbol are two wavy lines.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
MAR 1 0 2008
Genesis Digital Imaging, Incorporated % Mr. Carl Alletto Consultant OTech, Incorporated 1600 Manchester Way CORINTH TX 76210
Re: K073062
Trade/Device Name: Omni-Vue™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 4, 2008 Received: February 6, 2008
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 (Premarket Approval), 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.
Image /page/2/Picture/10 description: The image shows a circular seal with the text "ISOE-2005 FDA Centennial". The seal also contains three stars at the bottom. The text is arranged in a circular fashion around the central FDA logo and the word "Centennial".
Protecting and Promoting Public Health
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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.
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.
| 21 CFR 876.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You max obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.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
inclosure
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510(k) Number:
Device Name:
Omni-Vue™
Indications for Use:
Omni-Vue™ System is a software device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Device options make possible reading (including mammography), telecommunications; fast demonstration; etc.; and teleconferencing. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images must 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.
The Omni-Vue device allows limited image processing capability: "sharpening preset" and window leveling function.
For image editing; the only an "L" or "R" marker can be added to the image but it must be already defined in the original image DICOM header as received by the system. "L" or "R" can not be added to the image if left & right is not defined in the original image.
The device provides scout line which is a reference line and is drawn on the AP image to display the location of the slice being viewed. In multi series images, whenever one image is clicked, scout line will be drawn on other series which is crossed direction.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Arnitk. War
(Division Sign Off)
Division of Reproductive, Abde 510(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).