(21 days)
The OEC® 9900 Elite 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, vascular, cardiac, critical care and emergency room procedures.
The OEC® 9900 Elite is a system used to assist trained physicians. The system is used to provide X-Ray images while the physician performs a medical procedure. Images from the system help the physician to visualize the patients' anatomy. This visualization helps to localize surgical regions of interest and pathology. The images provide real-time visualization and records of pre-surgical anatomy, in vivo-surgical activity and post-surgical outcomes.
The proposed device will add an alternative supplier for the X-Ray Tube. The current tube and the proposed tube have the same specifications and will be interchangeable. Verification activities confirmed that the proposed tube meets the same specification as the current supplier's tube.
The proposed device will add an alternative supplier for the Radiological Imaging Unit (RIU) or Image Intensifier. The current RIU and the proposed RIU have the same specifications and will be interchangeable. Verification activities confirmed that the alternate RIU meets the same specification as the current supplier's RIU.
The proposed device will provide an optional wireless service platform to allow the user to connect to hospital intranet PACS system. The predicate product features a hard-wired connection. Verification testing confirmed that all specifications, including data security, were met.
Two printed circuit board assemblies have been combined into a single board in the proposed device. Both the proposed and predicate assemblies share common specifications as confirmed through verification testing.
The proposed device will provide an optional wireless foot switch and hand switch. The new option is equivalent to the predicate in that functionality is identical. The wireless option provides placement flexibility and reduced cable clutter.
The provided document is a 510(k) Premarket Notification Submission for the GE OEC 9900 Elite Mobile Fluoroscopic Imaging System. This submission describes modifications to an existing device rather than a new device requiring extensive clinical trials for performance validation. Therefore, the document discusses verification activities to confirm that the modifications meet the same specifications as the predicate device, rather than a study with specific acceptance criteria related to clinical performance metrics like sensitivity, specificity, or reader improvement.
Based on the provided text, here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance:
The acceptance criteria are implicitly that the proposed modifications (alternative X-Ray tube, alternative Radiological Imaging Unit (RIU), wireless service platform, combined printed circuit boards, and wireless foot/hand switch) meet the "same specifications" as the current/predicate components and demonstrate "equivalent functionality." The reported device performance is that these criteria were met through verification testing.
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Proposed X-Ray tube meets same specifications as current tube. | Verification activities confirmed that the proposed tube meets the same specification. |
| Proposed RIU meets same specifications as current RIU. | Verification activities confirmed that the alternate RIU meets the same specification. |
| Wireless service platform meets all specifications (including data security). | Verification testing confirmed that all specifications, including data security, were met. |
| Combined printed circuit board assemblies share common specifications with predicate. | Confirmed through verification testing. |
| Wireless foot switch and hand switch are equivalent in functionality to predicate. | Verification testing confirmed functionality is identical. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
The document does not specify a "test set" in the context of clinical performance evaluation with patient data. The "verification activities" mentioned are engineering and standards compliance testing, indicating a focus on hardware and software functionality and safety rather than a clinical dataset. Therefore, information about sample size, country of origin, or retrospective/prospective nature of patient data is not provided.
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 applicable to the type of study described. The verification testing focused on engineering specifications, not expert interpretation of medical images.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not applicable. There was no clinical test set requiring expert adjudication.
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:
No MRMC study was done. This submission is for modifications to a fluoroscopic imaging system, not an AI-powered diagnostic tool. The focus is on hardware and software equivalence, not human reader performance with or without AI assistance.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
No standalone algorithm performance was evaluated. The device is a "Mobile Fluoroscopic Imaging System," which is an imaging modality, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
The "ground truth" for this submission was based on engineering specifications and voluntary standards compliance. The verification activities confirmed that the modified components met the established technical requirements and safety standards, which are the "ground truth" for this type of medical device modification.
8. The sample size for the training set:
Not applicable. This submission concerns hardware and software modifications to an existing imaging system, not a machine learning model that requires a training set.
9. How the ground truth for the training set was established:
Not applicable, as there was no training set.
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AUG 16 2012
GE Healthcare 510(k) Premarket Notification Submission
510(k) Summary
In accordance with 21 CFR 807.92 the following summary of information is provided:
Date: August 3, 2012
Submitter:
GE Healthcare Surgery 384 Wright Brothers Drive Salt Lake City, UT 84116
Primary Contact Person:
Gerald Buss Director Regulatory Affairs GE Healthcare Surgery Phone: (801) 517-6591 Fax: (801) 517-6566
Secondary Contact Person:
Karen Russell Regulatory Affairs Leader GE Healthcare Surgery Phone: (801) 536-4930 Fax: (801) 517-6566
Device: (Trade Name): Common/Usual Name: Classification Names:
Mobile Fluoroscopic Imaging System
K120613 OEC® 9900 Elite
OEC® 9900 Elite
21 CFR 892.1650 Image-intensified fluoroscopic x-ray system
Product Code: 900XO, 90JAA, and OWB
Predicate Device(s):
Device Description:
The OEC® 9900 Elite is a system used to assist trained physicians. The system is used to provide X-Ray images while the physician performs a medical procedure. Images from the system help the physician to visualize the patients' anatomy. This visualization helps to localize surgical regions of interest and The images provide real-time visualization and pathology. records of pre-surgical anatomy, in vivo-surgical activity and post-surgical outcomes.
The proposed device will add an alternative supplier for the X-Ray The current tube and the proposed tube have the same Tube. specifications and will be interchangeable. Verification activities confirmed that the proposed tube meets the same specification as the current supplier's tube.
The proposed device will add an alternative supplier for the Radiological Imaging Unit (RIU) or Image Intensifier. The
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GE Healthcare
510(k) Premarket Notification Submission
current RIU and the proposed RIU have the same specifications and will be interchangeable. Verification activities confirmed that the alternate RIU meets the same specification as the current supplier's RIU.
The proposed device will provide an optional wireless service platform to allow the user to connect to hospital intranet PACS system. The predicate product features a hard-wired connection. Verification testing confirmed that all specifications, including data security, were met.
Two printed circuit board assemblies have been combined into a single board in the proposed device. Both the proposed and predicate assemblies share common specifications as confirmed through verification testing.
The proposed device will provide an optional wireless foot switch and hand switch. The new option is equivalent to the predicate in that functionality is identical. The wireless option provides placement flexibility and reduced cable clutter.
Intended Use:
Technology:
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, vascular, cardiac, critical care and emergency room procedures.
The OEC® 9900 Elite Mobile Fluoroscopy System is designed to
The modified OEC® 9900 Elite device employs the same fundamental scientific technology as the predicate device. The comparison chart reveals that functions performed by the predicate device are performed by the proposed device.
Verification testing has confirmed that the OEC® 9900 Elite and its application comply with voluntary standards as detailed in Section 9, of this premarket submission. The modifications from the predicate device OEC® 9900 Elite were completed in accordance with GE Healthcare Surgery's quality management system design controls. Engineering testing and standards compliance testing were successfully conducted and did not raise any new safety questions or concerns or identify new risks. Information is included with this 510(k) submission that supports this determination.
GE Healthcare considers the modified GE OEC® 9900 Elite to be Conclusion: as safe, as effective, and perform substantially equivalent to the predicate device OEC® 9900 Elite (K 120613).
Determination of Substantial Equivalence:
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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes extending from its wing, representing service to the people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
AUG 16 2012
Mr. Gerald Buss Director Regulatory Affairs GE Healthcare Surgery (GE OEC Medical Systems, Inc.) 384 Wright Brothers Drive SALT LAKE CITY UT 84116
Re: K122234
Trade/Device Name: GE OEC 9900 Elite Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB. OXO. and JAA Dated: July 20, 2012 Received: July 26, 2012
Dear Mr. Buss:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your Section >><(x) promation is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the Caclosure) to 1egarry mannet date of the Medical Device Amendments, or to commerce province to May 26, 1976, the encomment with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval application (PM and Cosment Act (Act) that to not require apple to the general controls provisions of the Act. The 1 ou may, merciole, market the device, ecolde requirements for annual registration, listing of general controls provisions of the rice 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 II your device is Classificu (sec above) into exase fr (sign your device can be found in Title 21, additional controls. Existing major regulations and to 895. In addition, FDA may publish further Code of Poderal Free ming your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuance of a subsidination with other requirements of the Act that FDA has made a dectrimation that your as receiner Federal agencies. You must of ally Federal statutes and regulations and limited to: registration and listing (21 Comply with an the 11et 5 requirements 801 and 809); medical device reporting (reporting of
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medical device-related adverse events) (21 CFR 803); and good manufacturing practices and Incurements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket witi anow you to oogin finding of substantial equivalence of your device to a legally marketed nouthoution. The FDF imally of fication 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 II you desire specific an rice for your ac-receive ex-res-evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket 9 150. Thise, process not 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 Tou may other belief one general management and Consumer Assistance at its toll-free number (800) 638-2041 of (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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Image /page/4/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined and enclosed within a circle. The letters and the circle are in black, contrasting with the white background.
GE Healthcare 510(k) Premarket Notification Submission
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: GE OEC 9900 Elite
Indications for Use:
The OEC® 9900 Elite 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, vascular, cardiac, critical care and emergency room procedures.
Prescription Use_ ✔ (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use_ (Part 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Radiological Devices
K122234
් පොකොට
§ 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.