(137 days)
The OEC® 9900 Elite Mobile Fluoroscopy System is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
The OEC® 9900 Elite Mobile Fluoroscopy System is an image intensified fluoroscopic system consisting of two mobile units: a Mainframe (C-Arm) and a Workstation. The Mainframe (C-Arm) is comprised of a high voltage generator, x-ray control, and a "C" shaped apparatus, which supports an X-ray tube and an image intensifier. The Mainframe 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 Workstation is a mobile platform that supports image display monitors, image processing and recording devices. Interfaces are provided for optional peripheral devices such as thermal or instant film printers.
Since the input pertains to a medical device's 510(k) summary, specific acceptance criteria and detailed study results like sample sizes, ground truth establishment, and MRMC studies are typically not explicitly detailed in the summary itself. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a comprehensive clinical trial report.
However, I can extract the information that is present and indicate where details are not provided in this specific document.
Here's an analysis based on the provided text:
1. A table of acceptance criteria and the reported device performance
The provided 510(k) summary for the OEC® 9900 Elite Mobile Fluoroscopy System does not explicitly state quantitative acceptance criteria or detailed performance metrics in the format of a table as typically seen in a clinical study report. Instead, the demonstration of substantial equivalence is based on a comparison of features to a predicate device and an assessment of non-clinical performance data.
The conclusion states: "Performance testing included within this 510(k) demonstrates that the OEC® 9900 Elite is safe, effective and performs in an equivalent manner to the predicate device, with improved reliability and in accordance with its labeling."
Without specific numerical criteria or performance results in this document, a table cannot be accurately constructed. The "performance" here refers to the device meeting the essential safety and effectiveness requirements by being equivalent to the predicate.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. The summary mentions "non-clinical performance data" without specifying the nature or origin of the test sets used. Given it's a fluoroscopy system, testing would likely involve technical performance characteristics rather than patient data in the context of substantial equivalence to a predicate.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
This information is not provided in the 510(k) summary. As noted above, the testing appears to be non-clinical performance data for the device itself, rather than diagnostic interpretation requiring expert ground truth establishment for a test set of images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided in the 510(k) summary. Given the non-clinical nature of the described performance testing, an adjudication method for a test set (which typically refers to human interpretation of images) would not be applicable here.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
An MRMC study was not conducted (or at least not mentioned) in this context. The OEC® 9900 Elite Mobile Fluoroscopy System is an imaging device, not an AI-powered diagnostic algorithm designed to assist human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" is not applicable to this device. The 510(k) is for the imaging system itself.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a mobile fluoroscopic imaging system, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Given that the device is a fluoroscopic imaging system and the testing reported is "non-clinical performance data" for demonstrating substantial equivalence, the "ground truth" would likely relate to objective measurements of the system's technical specifications and imaging capabilities (e.g., image resolution, dose, contrast, noise, geometric accuracy) against established industry standards or the predicate device's performance, rather than clinical ground truth like pathology or outcomes data. However, the specific type of "ground truth" used is not detailed in the summary.
8. The sample size for the training set
This is not applicable as the device is a hardware imaging system, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable as the device is a hardware imaging system, not a machine learning model.
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. 2 MAY - 2 2008
Section 5 510(k) Summary
.
Section 9 320(M Our Mr. J
The following information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Company Name: | GE Healthcare Surgery |
|---|---|
| Address: | 384 Wright Brothers DriveSalt Lake City, UT 84116 |
| Contact Person: | Maria C. FrameVice President Quality Assurance and Regulatory AffairsGE Healthcare SurgeryPhone: (801) 517 6440Fax: (801) 517 6566 |
| Preparation Date: | December 14, 2007 |
| Device (Trade Name): | OEC® 9900 Elite |
| Common/Usual Name: | Mobile Fluoroscopic Imaging System |
| Classification Names: | 21 CFR 892.1650 and 892.1720 (either) Image-intensified fluoroscopic x-ray system and Mobile x-ray system. Product Code: 90JAA and 90IZL. |
| Predicate Device: | K041932 OEC Olympus Fluoroscopic Imaging System |
| Device Description: | The OEC® 9900 Elite Mobile Fluoroscopy System is an image intensified fluoroscopic system consisting of two mobile units: a Mainframe (C-Arm) and a Workstation. The Mainframe (C-Arm) is comprised of a high voltage generator, x-ray control, and a "C" shaped apparatus, which supports an X-ray tube and an image intensifier. The Mainframe 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 Workstation is a mobile platform that supports image display monitors, image processing and recording devices.Interfaces are provided for optional peripheral devices such as thermal or instant film printers. |
| Intended Use: | The OEC® 9900 Elite Mobile Fluoroscopy System is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion. |
| Technology: | The OEC® 9900 Elite employs the same fundamental scientific technology as its predicate device. An uninterruptible power supply was added to provide additional safety to image and demographic data in the event of a power outage. |
| Determination of SubstantialEquivalence: | The demonstration of substantial equivalence is based on a comparison of features to the predicate device and an assessment of non-clinical performance data. Information is included with this 510(k) submission that supports this determination. |
| Conclusion: | Performance testing included within this 510(k) demonstrates that the OEC® 9900 Elite is safe, effective and performs in an equivalent manner to the predicate device, with improved reliability and in accordance with its labeling. |
2
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY - 2 2008
Ms. Maria C. Frame Vice President Ouality Assurance and Regulatory Affairs GE Healthcare Surgery (GE OEC Medical Systems, Inc.) 384 Write Brothers Drive SALT LAKE CITY UT 84116
Re: K073543
Trade/Device Name: OEC® 9900 Elite Regulation Number: 21 CFR 892.1650 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: JAA Dated: December 14, 2007 Received: December 17, 2007
Dear Ms. Frame:
We have reviewed vour 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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Page 2
Enclosure
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 nequirements 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 liating (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 100-1050.
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 logally 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 a 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, release contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 24/0276-3474. 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/cdrb/industry/support/index.html of
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
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Section 4 Indications For Use
Page 1 of 1
510(k) Number (if known):
OEC® 9900 Elite Device Name:
Indications for Use:
The OEC® 9900 Elite Mobile Fluoroscopy System is designed to provide fluoroscopic and spot-film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, critical care and emergency room procedures. The system may be used for other imaging applications at the physician's discretion.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _ (Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
ﻠﺴ
Tom Minter
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number
§ 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.