(45 days)
XoranConnect is a medical imaging software system intended to display, edit, review, store, print and distribute images acquired from imaging devices such as Computed Tomography (CT), Magnetic Resonance (MR), Computed Radiography (CR), Ultrasound (US), Nuclear Medicine (NM), and other devices.
XoranConnect™ is a web-based service designed to complement point-of-care medical imaging systems by providing point-of-expertise viewing and interpretation tools. XoranConnect™ runs on standard offthe-shelf PC and networking hardware, all of which has been manufactured by third party reputable manufacturers.
The system performs these major functions.
- Off-site data storage allows user studies to be stored off-site. .
- Study viewer allows studies to be visualized and manipulated in 3D, multiplanar and other forms. .
To accommodate the major functions, the overall system architecture includes the following distinct components:
- XoranVault™ storage system (storage servers, dispatcher) .
- XoranConnect™ viewing system (study server, web server, web client) .
The storage (backup) system consists of one or more servers designed to store and serve stored imaging content on a RAID5 storage device. Imaging modality negotiates the connection and transfers study to the storage server.
Once stored, imaging data is ready to be served to the requesting clients. When a user logs into the system by visiting a XoranConnect web page, study server begins to serve the data, which in turn is displayed in the user's web browser window. Any storage server may simultaneously serve multiple requests for images.
It is the user's responsibility to ensure that the appropriate PC hardware and display device are used to run the XoranConnect™ software application. XoranConnect™ requires at all times an active Internet connection to operate. It is the user's responsibility to ensure that the connection that is being used provides the speed, stability and reliability required to utilize XoranConnect™ for any given purpose or application.
The provided text describes XoranConnect™, a web-based service for medical imaging, and its 510(k) premarket notification. However, the document does NOT contain information about specific acceptance criteria for device performance, nor does it detail any study that proves the device meets such criteria.
The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices (Visage PACS/CS and NovaPACS) based on similar functions and intended use, rather than presenting a performance study with defined acceptance criteria.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's a breakdown of what can be inferred from the document regarding a "study":
1. Table of acceptance criteria and reported device performance:
Not present in the document. The submission is based on substantial equivalence, not on head-to-head performance against specific criteria.
2. Sample size used for the test set and the data provenance:
Not applicable. No performance study with a test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No performance study with ground truth establishment is described.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable. No performance study is described.
5. Multi reader multi case (MRMC) comparative effectiveness study:
No, an MRMC comparative effectiveness study is not mentioned. The submission focuses on functional equivalence to predicate devices.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) study:
Not applicable. XoranConnect™ is a PACS system designed for human interpretation, and no standalone algorithmic performance study is described.
7. The type of ground truth used:
Not applicable. No performance study requiring ground truth is described.
8. The sample size for the training set:
Not applicable. XoranConnect™ is a PACS system, not an AI/ML algorithm that typically requires a training set.
9. How the ground truth for the training set was established:
Not applicable.
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Image /page/0/Picture/0 description: The image shows the logo for Xoran Technologies. The logo features a stylized "X" in a box-like shape, followed by the word "ORAN" in bold, sans-serif font. Below "ORAN" is the word "TECHNOLOGIES" in a smaller, lighter font.
K073306
pg 1 of 2
XoranConnect™ 510(k) Premarket Notification
9 510(k) Summary
9.1 Name and Address of Manufacturer
Xoran Technologies, Inc.
309 North First Street Ann Arbor, MI 48103
Phone: (734) 663 7194 (734) 663 8500 Fax:
9.2 Contact Information
Amy Kim Regulatory Affairs Manager
(734) 663 7194
Date of Submission: November 15, 2007
9.3 Product Identification
| Trade Name: | XoranConnect™ |
|---|---|
| Common Name: | PACS |
| Classification: | Class II, Product code LLZ (Image Processing System - PACS, Sec.892.2050). |
| Guidance Document: | Guidance for the Submission Of Premarket Notifications for Medical ImageManagement Devices (July 27, 2000) |
9.4 Substantially Equivalent (Predicate) Devices
XoranConnect™ software is substantially equivalent to the following predicate devices:
Visage PACS/CS (Mercury Computer Systems, Inc.), K072205
NovaPACS (NovaRad Corporation), K061920
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Image /page/1/Picture/0 description: The image shows the logo for Xoran Technologies. The logo features a stylized "X" with the word "XORAN" in bold, sans-serif font to the right of the "X". Below "XORAN" is the word "TECHNOLOGIES" in a smaller, sans-serif font. The logo has a simple, modern design.
XoranConnect™ 510(k) Premarket Notification
9.5 Device Description
XoranConnect™ is a web-based service designed to complement point-of-care medical imaging systems by providing point-of-expertise viewing and interpretation tools. XoranConnect™ runs on standard offthe-shelf PC and networking hardware, all of which has been manufactured by third party reputable manufacturers.
The system performs these major functions.
- Off-site data storage allows user studies to be stored off-site. .
- Study viewer allows studies to be visualized and manipulated in 3D, multiplanar and other forms. .
To accommodate the major functions, the overall system architecture includes the following distinct components:
- XoranVault™ storage system (storage servers, dispatcher) .
- XoranConnect™ viewing system (study server, web server, web client) .
The storage (backup) system consists of one or more servers designed to store and serve stored imaging content on a RAID5 storage device. Imaging modality negotiates the connection and transfers study to the storage server.
Once stored, imaging data is ready to be served to the requesting clients. When a user logs into the system by visiting a XoranConnect web page, study server begins to serve the data, which in turn is displayed in the user's web browser window. Any storage server may simultaneously serve multiple requests for images.
It is the user's responsibility to ensure that the appropriate PC hardware and display device are used to run the XoranConnect™ software application. XoranConnect™ requires at all times an active Internet connection to operate. It is the user's responsibility to ensure that the connection that is being used provides the speed, stability and reliability required to utilize XoranConnect™ for any given purpose or application.
9.6 Intended Use
XoranConnect™ is a web-based service designed to complement point-of-care medical imaging systems by providing point-of-expertise tools for viewing, interpretation, clinical review, analysis, distribution, processing and printing. Primary components include online multiplanar image viewing, offsite data storage, administrative reporting tools, and teleradiology workflow. It is intended as an extension to (but not limited to) the MiniCAT™ and xCAT™ CT imaging devices.
9.7 Comparison With the Predicate Devices
XoranConnect™ has the same indication for use as the predicate devices and they perform very similar functions. Apart from differences in menus, usability, specific tool implementations, appearance and price, all of XoranConnect™ functions can be found in at least one of the predicate devices (most likely both). All three devices perform similar functions, while the predicate devices have many additional features.
9.8 Conclusion
Functionality that XoranConnect™ provides is found on both predicate devices, and is therefore substantially similar to the predicate devices Visage PACS/CS (Mercury Computer Systems, Inc.), K072205, and NovaPACS (NovaRad Corporation), K061920. This design complies with 21 CFR 892.2050 and does not pose new safety risks.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
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JAN - 7 2008
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Amy S. Kim, DDS Regulatory Affairs Manager Xoran Technologies, Inc. 309 N First Street ANN ARBOR MI 48103
Re: K073306
Trade/Device Name: XoranConnect™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 21, 2007 Received: November 30, 2007
Dear Dr. Kim:
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.
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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 may 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 vours.
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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Indications for Use
510(k) Number (if known):
K07-3306
XoranConnect™ Device Name:
Indications for Use:
XoranConnect is a medical imaging software system intended to display, edit, review, store, print and distribute images acquired from imaging devices such as Computed Tomography (CT), Magnetic Resonance (MR), Computed Radiography (CR), Ultrasound (US), Nuclear Medicine (NM), and other devices.
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)
Vorquimthn
(División Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 073306 510(k) Number
Page 1 of 1
Division Sign-Off
510(k)
§ 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).