(15 days)
Not Found
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on standard imaging technology and image processing, not AI/ML capabilities.
No
The device is described as an "Imaging System" for "2D Fluoroscopic and 3D imaging for intraoperative applications." Its function is to provide visual information to guide surgical procedures, not to directly treat a condition or provide therapy.
Yes
The device aids in diagnosis by producing high-quality images (2D fluoroscopic and 3D) that allow for visualization of anatomical structures during orthopedic procedures. The performance study specifically mentions that a radiologist evaluated the images and determined their "equivalent diagnostic capability" to a predicate device.
No
The device description explicitly states it is a "mobile x-ray system" consisting of an "x-ray O-Arm™ Stand" and a "mobile view station," which are hardware components.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- O-Arm™ Function: The O-Arm™ Imaging System is an imaging system that uses X-rays to create images of the inside of the body in vivo (within the living organism). It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states "intraoperative applications in surgical theaters, particularly for orthopedic applications," which involves imaging the patient directly during surgery.
Therefore, based on its function and intended use, the O-Arm™ Imaging System is a medical imaging device, not an In Vitro Diagnostic.
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
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).
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
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)
A concurrence study was performed comparing images of the same anatomical structure made with a Siemens ISO-C C-Arm Imaging System and with the O-Arm™ Imaging System. The imaged subject was a cadaver allowing virtually identical sites to be imaged by both systems. Sites were selected to include common orthopedic procedure locations. Thirty one pairs of images, including 3-D and fluoroscopic images, were evaluated. The fluoroscopic images were evaluated "live". Both the O-Arm and the predicate device have a feature that freezes the last image of a fluoroscopic series. The 3-D images and the "frozen" last images last images were submitted with the 510(k).
A radiologist evaluated the images during the study. He determined that for all image pairs, the images from the O-Arm™ and the predicate device are of equivalent diagnostic capability.
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.
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MAY - 5 2005
510(k) Summary for the O-Arm™ Imaging System (4/01/05)
Submittal information:
Wolfgang Krull Breakaway Imaging, LLC 300 Foster Street Littleton, MA 01460
Phone: 978-952-2990
Device name and classification
| Proprietary Name: | O-Arm™ Imaging System |
|---|---|
| Classification Names: | Mobile X-ray System, Solid-state X-ray Imager |
| Classification Panel: | Radiology |
| CFR Sections: | 21 CFR 892.1720, 21 CFR 892.1650 |
| Class: | II |
| Product Codes: | OXO |
Substantial Equivalence
The O-Arm™ Imaging System is substantially equivalent to the Siemens SIREMOBIL Iso-C30, which was cleared in 510(k)'s K032280 and K003266.
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).
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.
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510(k) Summary for the O-Arm™ Imaging System (4/01/05) continued
Comparison with the Predicate Device
KOSO996
O-Arm™ Imaging System A portable system with separate Physical viewing station. The imaging configuration unit is full circle or "O-arm". 3-D imaging Imaging modes 2-D fluoroscopy Intraoperative imaging Intended use
SIREMOBIL Iso C3D A portable system with separate viewing station. The imaging unit is a 190ºC-arm.
3-D imaging 2-D fluoroscopy Intra-operative imaging.
Similarities and Differences
Both devices perform both 2-D fluoroscopy and 3-D volumetric imaging.
The mechanical configuration of both devices allows a lateral approach to the patient. The predicate device has a c-arm configuration, mounting the source and detector on distal ends of the 'C'. The O-Arm™ mounts the imaging components on a c-shaped rotor inside of an enclosed, full circle housing. The O-Arm™ housing is opened to approach the patient.
For 2-D imaging with the predicate device, the user manually orients the source and detector for the needed image trajectory. The O-arm™ utilizes high-precision robotics to orient the internal rotor to the proper trajectory. To return to a position, the Siemens user manually repositions the 'C'. With its robotic positioning, the O-arm™ automatically returns to positions "saved" by the user.
For 3-D imaging, the predicate device drives the 'C' in a circumferential movement through a 190° arc. The O-Arm™ drives the internal C-shaped rotor through a 360° arc inside the enclosed housing.
Both systems have two mobile, interconnected units: an X-ray stand and a mobile viewing station. Both units of the predicate device are moved manually. The O-Arm™ X-ray Stand has a power-assisted transport mechanism.
Both systems are configured with opposing x-ray source and x-ray detector. The sources are similar. The predicate device uses a circular image intensifier tube as the detector, while the O-Arm™ uses a rectangular flat panel digital detector. As a result, the images are displayed differently. In 2-D, the image intensifier displays a circular image, and the flat panel displays a rectangular image. In 3-D, the image intensifier reconstructs to a volumetric sphere, while the O-arm™ reconstructs to a volumetric cylinder. X-ray beam collimation, available in both systems, allow the user to select the area or volume to best fit the application.
Breakaway Imaging, LLC - - -
Q-Arm™ Imaging System 510(k)
Page 5
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510(k) Summary for the O-Arm™ Imaging System (4/01/05) continued
Koso996
Assessment of Performance Data
A concurrence study was performed comparing images of the same anatomical structure made with a Siemens ISO-C C-Arm Imaging System and with the O-Arm™ Imaging System. The imaged subject was a cadaver allowing virtually identical sites to be imaged by both systems. Sites were selected to include common orthopedic procedure locations. Thirty one pairs of images, including 3-D and fluoroscopic images, were evaluated. The fluoroscopic images were evaluated "live". Both the O-Arm and the predicate device have a feature that freezes the last image of a fluoroscopic series. The 3-D images and the "frozen" last images last images were submitted with the 510(k).
A radiologist evaluated the images during the study. He determined that for all image pairs, the images from the O-Arm™ and the predicate device are of equivalent diagnostic capability.
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's emblem, which consists of a stylized caduceus with three figures in profile facing right. The emblem is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA", which is arranged in a circular fashion around the emblem.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Breakaway Imaging, LLC % Mr. Jeff Rongero Senior Project Engineer/Program Reviewer Conformity Assessment Services Underwriters Laboratories, Inc. 1285 Walt Whitman Road MELVILLE NY 11747-3081
NOV 1 7 2011
Re: K050996
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: April 18, 2005 Received: April 20, 2005
Dear Mr. Rongero:
This letter corrects our substantially equivalent letter of May 5, 2005.
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 comply with all the Act's requirements, including, but not limited to: registration and listing (21
4
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,
Michael D O'Hern for
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
510(k) Number (if known): N/A_____________________________________________________________________________________________________________________________________________
Device Name: ____ O-Arm™ Imaging System_______________________________________________________________________________________________________________________________________
Indications for Use:
The O-Arm™ Imaging System is designed for 2D Fluoroscopic and 3D imaging for The O-Atin - Intagring of Stein is in surgical theaters, particularly for orthopedic mirations. The O-Arm™ Imaging System is compatible with certain Image Guided Surgical Systems.
ﯩﻴ
X 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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Syverson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _