(36 days)
The 9900 Plus Mobile Fluoroscopy System is designed to provide fluoroscopic images of human anatomy during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The digital fluoroscopic imaging systems are intended to replace fluoroscopic system images obtained through image intensifier technology.
The 9900 Plus 3D option is a software option, which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to provide images that assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up. 9900 Pins 3D is intended for imaging bone and soft tissues as well as other internal body structures. 9900 Plus 3D is not intended for mammography applications.
The surgical Navigation feature is intended as an aid to the surgeon for locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from through of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone or vertebra visible on fluoroscopic images. The system may be used for other imaging applications at the physicians discretion.
The GE OEC 9900 Plus is a digital image intensified fluoroscopic mobile C-arm system. It consists of a C-arm that supports a high-voltage generator, X-ray tube, X-ray controls, flatpanel digital detector, and LCD monitors. The C-arm is designed to perform linear and rotational motions that allow the user to position the X-ray imaging components at various angles and distances with respect to the patient. The GE OEC Workstation is a mobile platform that provides image display screens, image processing, recording, and problem devices.
Interfaces are provided for optional peripheral devices such as thermal or laser printer, video recording devices, and display monitors. Video outputs are compatible with RS-170 format for domestic markets, CCIR format for international markets, and DIC WM . An auxillary connection is provided for an angiographic injector system to facilitate synchronization of angiographic images during contrast media injections.
This document is a 510(k) summary for the GE OEC 9900 Plus Mobile Digital C-Arm. It does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The document outlines:
- Submitter Information: GE OEC Medical Systems, Inc.
- Device Proprietary Name: GE OEC 9900 Plus
- Classification Name: Image Intensified Fluoroscopic X-ray System with Image Processing System / Mobile X-ray system.
- Common/Usual Names: Fluoroscopic Imaging System or Mobile C-arm.
- Substantial Equivalence: To the GE OEC 9900 Elite Mobile C-Arm (K041932) and GE OEC 9900 Elite™ Mobile C-Arm (K041931).
- Indications for Use: Provides fluoroscopic images of human anatomy during diagnostic, surgical, and interventional procedures. Specific applications listed include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care, and emergency room procedures. It also mentions a 3D option for reconstructing 3D volumes from Rotational Fluoroscopy and a surgical navigation feature to aid in locating anatomical structures.
- General Description: A digital image intensified fluoroscopic mobile C-arm system with a C-arm, high-voltage generator, X-ray tube, X-ray controls, flat-panel digital detector, LCD monitors, and a mobile workstation for image display, processing, and recording.
The FDA's letter (K061953) acknowledges the substantial equivalence determination but does not include details on performance criteria or validation studies beyond the general statement of substantial equivalence to predicate devices.
Therefore, I cannot provide the requested table or information regarding acceptance criteria and studies, as this specific document does not contain that level of detail. The FDA's 510(k) clearance process is based on demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical performance studies against specific acceptance criteria for every new submission, especially for established device types like C-arms.
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510(k) Notification
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Image /page/0/Picture/1 description: The image shows a handwritten text string that reads "K061953". The text is written in a bold, somewhat uneven style, giving it a distinct, hand-drawn appearance. The characters are closely spaced, and the overall impression is that of a quick, informal inscription.
510(k) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
| Date: | June 21, 2006 AUG 15 2006 |
|---|---|
| Name of Submitter: | GE OEC Medical Systems, Inc.384 Wright Brothers DriveSalt Lake City, UT 84116801-536-4525 (F) 801-328-4300 |
| Corresponding Official: | Greg L. HansenSafety & Regulatory Engineer |
| Device Proprietary Name: | GE OEC 9900 Plus |
| Classification Name: | Image Intensified Fluoroscopic X-ray System with ImageProcessing System / Mobile X-ray system. |
| Common/Usual Names: | Fluoroscopic Imaging System or Mobile C-arm. |
| Substantial Equivalence: | The GE OEC 9900 Plus Mobile Digital C-Arm is substantiallyequivalent to the:• GE OEC 9900 Elite Mobile C-Arm (K041932) marketed by GEOEC Medical Systems, Inc. |
- GE OEC 9900 Elite™ Mobile C-Arm (K041931) marketed by . GE OEC Medical Systems, Inc.
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Indications for Use
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The 9900 Plus Mobile Fluoroscopy System is designed to provide fluoroscopic images of human anatomy during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The digital fluoroscopic imaging systems are intended to replace fluoroscopic system images obtained through image intensifier technology.
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The 9900 Plus 3D option is a software option, which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to provide images that assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up. 9900 Pins 3D is intended for imaging bone and soft tissues as well as other internal body structures. 9900 Plus 3D is not intended for mammography applications.
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The surgical Navigation feature is intended as an aid to the surgeon for locating anatomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from through of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone or vertebra visible on fluoroscopic images. The system may be used for other imaging applications at the physicians discretion.
General Description
The GE OEC 9900 Plus is a digital image intensified fluoroscopic mobile C-arm system. It consists of a C-arm that supports a high-voltage generator, X-ray tube, X-ray controls, flatpanel digital detector, and LCD monitors. The C-arm is designed to perform linear and rotational motions that allow the user to position the X-ray imaging components at various angles and distances with respect to the patient. The GE OEC Workstation is a mobile platform that provides image display screens, image processing, recording, and problem devices.
Interfaces are provided for optional peripheral devices such as thermal or laser printer, video recording devices, and display monitors. Video outputs are compatible with RS-170 format for domestic markets, CCIR format for international markets, and DIC WM . An auxillary connection is provided for an angiographic injector system to facilitate synchronization of angiographic images during contrast media injections.
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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three stripes forming its body and wing. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around the circumference of the circle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Greg Hansen Safety & Regulatory Engineer GE OEC Medical Systems, Inc. 384 Write Brothers Drive SALT LAKE CITY UT 74116
JUL 30 2012
Re: K061953
Trade/Device Name: GE OEC 9900 Plus Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA and OXO Dated: June 21, 2006 Received: July 10, 2006
Dear Mr. Hansen
This letter corrects our substantially equivalent letter of August 15, 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 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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.
Sincerely Yours,
Janine M. Morris
Acting 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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510(k) Notification
Indications For Use Statement
Applicant:
Device name:
GE OEC Medical Systems. Inc.
510(k) No. (if known):
GE OEC 9900 Plus
Indications for use:
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The 9900 Plus Mobile Fluoroscopy System is designed to provide fluoroscopic images of human anatomy during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical-care and emergency room procedures. The digital fluoroscopic imaging systems are intended to replace fluoroscopic system images obtained through image intensifier technology.
-
The 9900 Plus 3D option is a software option, which reconstructs 3D volumes from Rotational Fluoroscopy acquisition to provide images that assist the physician in diagnosis, surgical planning, interventional procedures and treatment follow-up. 9900 Plus 3D is intended for imaging bone and soft tissues as well as other internal body structures. 9900 Plus 3D is not intended for mammography applications.
-
The surgical Navigation feature is intended as an aid to the surgeon for locating analomical structures anywhere on the human body during either open or percutaneous procedures. It is indicated for any medical condition that may benefit from the use of stereotactic surgery and which provides a reference to rigid anatomical structures such as sinus, skull, long bone or vertebra visible on fluoroscopic images. The system may be used for other imaging applications at the physicians discretion.
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Concurrence of CDRH Office of Device Evaluation (ODE) Unision Sigh-Off Division of Reproductive. Abdilis and Radiological Devices 510(k) Number _ Prescription Use OR Over-The-Counter (Per 21 CFR 801.109) (Optional Format 1-2-96)
§ 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.