(47 days)
No
The summary describes standard image processing and user interface controls, with no mention of AI, ML, or related concepts.
No
The device is an imaging system designed for 2D fluoroscopic and 3D imaging during surgery; it does not provide therapy.
Yes
The "Intended Use / Indications for Use" states that "The O-arm™ Imaging System is designed for 2D fluoroscopic and 3D imaging for intraoperative applications in surgical theaters, particularly for orthopedic applications." Imaging for medical applications falls under the definition of a diagnostic device.
No
The device description clearly states it is a mobile x-ray system consisting of hardware components like an x-ray generator, detector, and view station, in addition to software for image processing and user interface.
Based on the provided information, the O-arm™ Imaging System is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for "2D fluoroscopic and 3D imaging for intraoperative applications in surgical theaters." This describes an imaging system used directly on a patient during surgery, not a device used to examine samples (like blood, tissue, or urine) outside of the body.
- Device Description: The description details an x-ray system that generates images of the patient's anatomy. This is consistent with an in-vivo imaging device, not an in-vitro diagnostic device.
- Lack of IVD Characteristics: The description does not mention any components or functions related to analyzing biological samples or providing diagnostic information based on such analysis.
IVD devices are specifically designed to perform tests on specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The O-arm™ Imaging System's function is to provide visual information about the patient's internal structures through imaging.
N/A
Intended Use / Indications for Use
The O-arm™ Imaging System is designed for 2D Fluoroscopic and 3D imaging for intraoperative applications in surgical theaters, particularly for orthopedic applications. The O-arm™ Imaging System is compatible with certain Image Guided Surgery Systems.
Product codes
Oxey, MQB, OXO
Device Description
The O-arm™ Imaging System is a mobile x-ray system which provides 3D imaging as well as 2D fluoroscopic imaging.
The system consists of two parts: the x-ray O-arm™ Stand (comprising x-ray generator, flat dynamic x-ray detector, and the x-ray control user interface) and the mobile view station (comprising the image processors, a user interface for image and patient handling, and viewing monitors).
The 1-D Display Control Mouse is an optional accessory. It is a sterile disposable limited-function wireless mouse. With the 1-D Mouse, a surgeon can remotely control and point at the O-arm™ image display. The 1-D mouse is similar to remote controls for controlling projectors during business presentations. The 1-D Mouse allows the surgeon to control what is displayed and to point out features on the image with a laser pointer. The sterile and wireless characteristics allow use by the surgeon without compromising the sterile field and without cluttering the surgical area with a mouse cable. No clinical information is transmitted by mouse, only display control commands.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Intraoperative applications in surgical theaters
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
MAR 2 9 2006
510(k) Summary O-arm™ Imaging System with 1-D Display Control Mouse (January 2005)
Submittal information:
Chas Burr Breakaway Imaging, LLC 300 Foster Street Littleton, MA 01460
Phone: 978-952-2646
Device name and classification
O-arm™ Imaging System Proprietary Name: Classification Names: Mobile X-ray System, Solid-state X-ray Imager Classification Panel: Radiology 21 CFR 892.1720, 21 CFR 892.1650 CFR Sections: Class: II Oxey, MQB Product Codes:
Substantial Equivalence
The O-arm™ Imaging System with the 1-D Display Control Mouse is substantially equivalent to the O-arm™ Imaging System, which was cleared in 510(k) K050996.
The display control functions provided by the optional sterile disposable wireless 1-D Control Mouse are also provided by console controls and by a non-sterile, hard-wired mouse on the standard O-arm™ Imaging System.
Device Description
The O-arm™ Imaging System is a mobile x-ray system which provides 3D imaging as well as 2D fluoroscopic imaging.
The system consists of two parts: the x-ray O-arm™ Stand (comprising x-ray generator, flat dynamic x-ray detector, and the x-ray control user interface) and the mobile view station (comprising the image processors, a user interface for image and patient handling, and viewing monitors).
The 1-D Display Control Mouse is an optional accessory. It is a sterile disposable limited-function wireless mouse. With the 1-D Mouse, a surgeon can remotely
1
control and point at the O-arm™ image display. The 1-D mouse is similar to remote controls for controlling projectors during business presentations. The 1-D Mouse allows the surgeon to control what is displayed and to point out features on the image with a laser pointer. The sterile and wireless characteristics allow use by the surgeon without compromising the sterile field and without cluttering the surgical area with a mouse cable. No clinical information is transmitted by mouse, only display control commands.
Intended Use
The O-arm™ Imaging System is designed for 2D Fluoroscopic and 3D imaging for intraoperative applications in surgical theaters, particularly for orthopedic applications. The O-arm™ Imaging System is compatible with certain Image Guided Surgery Systems.
| | O-arm™ Imaging System
with 1-D Mouse | O-arm™ Imaging System |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------|------------------------------------------|
| Physical
configuration | A portable system with separate viewing station. The imaging unit is
full circle or “O-arm”. | |
| Imaging modes | 3-D imaging and 2-D fluoroscopy | |
| Intended use | Intraoperative imaging | |
| Image display
control | Includes an optional sterile,
single-use, wireless, 1-D mouse
in addition to the standard
reusable, hardwired PC mouse | Standard reusable, hardwired
PC mouse |
Comparison with the Predicate Device
Similarities and Differences
The O-arm™ Imaging System with 1-D Mouse is virtually identical in safety and effectiveness to the previously cleared O-arm™ Imaging System. The only difference is that the hardwired PC mouse, which is used to control the display image, may be replaced by an optional sterile, single-use, wireless, 1-D mouse. The 1-D mouse provides simpler controls, reduced cable clutter, and greater assurance of maintaining the sterile field. The low power, unique communication protocol, and limited function of the 1-D Mouse ensure no co-existence, data latency and integrity, or security issues that might affect safety or effectiveness.
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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird-like figure with three distinct head profiles facing to the right. The bird is positioned within a circular border. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Mr. Rick Grant President and CEO Breakaway Imaging, LLC 300 Foster Street LITTLETON MA 01460
NOV 1 4 2011
Re: K060344
Trade/Device Name: O-arm™ Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system, mobile Regulatory Class: II Product Code: OXO Dated: February 9, 2006 Received: February 15, 2006
Dear Mr. Grant:
This letter corrects our substantially equivalent letter of March 29, 2006.
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 (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. Please Note: CDRH does not evaluate information related to contact liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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
3
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely Yours,
hDókh fo.
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
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Indications for Use
Kobo3444 510(k) Number (if known): N/A
O-arm™ Imaging System Device Name:
Indications for Use:
The O-arm™ Imaging System is designed for 2D fluoroscopic and 3D imaging for intraoperative applications in surgical theaters, particularly for orthopedic applications. The O-arm™ Imaging System is compatible with certain Image Guided Surgical Systems.
Prescription Use X (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancyc brogdon
(Division Sigh-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K060344