(123 days)
The OEC 9800 Plus is designed to provide fluoroscopic and spotfilm imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
The Series OEC® 9800 is a System used to assist trained Physicians. The system is used to provide X-Ray images while the Physician performs 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 system is composed of two primary physical elements. The first is referred to as the "C-Arm" because of its "C" shaped image gantry; the second referred to as the "Workstation" because this is the primary user interface to the system.
The system is used in different surgical procedures. Orthopedic Physicians may use the system to help perform hip replacements and reconstructions of badly fractured bones. Vascular Physicians may use the system to perform blood flow studies. Cardiologists may use the system to help see if there are blockages in some of the key arteries supplying blood to the heart. The procedures that these physicians perform are broadly referred to as "Clinical Applications". The system is controlled and run in a clinical environment.
The system employs X-Rays as its imaging technology. An X-Ray Generator located in the base of the C-Arm creates high voltage. High voltage is carried to the X-Ray tube across a set of cables. The X-Ray tube emits X-Rays that are directed toward the patient under the control of the operator. The Physician defines the desired view for the specific clinical procedure and directs the operator. The X-Rays pass through the patient and are captured by the image intensifier (II). Image intensifier images are captured by a camera and displayed on the image monitor located on the Workstation. The system operator and/or Physician view the images as they are displayed and they may choose to store the images for later review.
In order to perform these procedures different views of the human anatomy are required, so the system is designed with the ability to rotate and translate the C-Arm's image gantry to obtain different viewing angles. In addition since there is variation in thickness and density of the anatomy the operator has the ability to adjust the X-Ray Generator technique, image size and orientation to account for the anatomical differences.
This document, K111551, describes the GE Healthcare Surgery OEC® 9800 / OEC® 9800 Plus, which is a mobile fluoroscopic imaging system. The submission focuses on demonstrating substantial equivalence to a predicate device (K082781 OEC® 9900 Elite) rather than proving performance against specific acceptance criteria for an AI/algorithm-based device.
Therefore, many of the requested details, such as those related to AI algorithm performance testing, ground truth establishment, expert adjudication, and MRMC studies, are not applicable or not provided in this specific 510(k) summary. This is a conventional medical imaging device, not an AI/ML-driven one.
Here's a breakdown of the information available in the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not present performance in terms of specific, quantifiable acceptance criteria or reported device performance metrics in the way one would for an AI algorithm (e.g., sensitivity, specificity, AUC). Instead, it states:
| Criterion Type | Acceptance Criterion (Implied) | Reported Device Performance/Conclusion |
|---|---|---|
| Safety | Device is safe | "Performance testing included in Section 18 Performance Testing - Bench of this 510(k) demonstrates that the OEC® 9800 / OEC® 9800 Plus is safe." |
| Effectiveness | Device is effective | "...effective and performs in an equivalent manner to the predicate device and in accordance with its labeling." |
| Equivalence | Equivalent to predicate device | "The demonstration of substantial equivalence is based on a comparison of features to the predicate device and an assessment of non-clinical performance data." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Size: Not specified for any specific "test set" in the context of an algorithm. The submission mentions "non-clinical performance data" and "bench testing."
- Data Provenance: Not specified. The data would likely be from laboratory bench tests or phantom studies, as this is a hardware device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Not Applicable. This is a hardware imaging device, not an AI algorithm requiring expert ground truth for classification or detection.
4. Adjudication Method for the Test Set
- Not Applicable. No human-interpreted test set requiring adjudication is described.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is not mentioned. This type of study is typically done for AI-assisted diagnostic devices to measure human reader performance improvement.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is a hardware device, not a standalone algorithm.
7. The Type of Ground Truth Used
- Not Applicable in the context of ground truth for an AI algorithm. The "ground truth" for a fluoroscopic system would relate to its physical performance characteristics (e.g., image quality metrics, dose output, spatial resolution, contrast resolution), typically measured through bench testing with phantoms and calibrated instruments, rather than expert consensus or pathology.
8. The Sample Size for the Training Set
- Not Applicable. There is no AI algorithm being described, so there is no training set in this context.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set, there's no ground truth establishment for it.
Summary of what IS in the document:
- Device Type: Mobile Fluoroscopic Imaging System (OEC® 9800 / OEC® 9800 Plus).
- Intended Use: "to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures."
- Technology: Employs X-Rays and image intensifiers.
- Substantial Equivalence: Claimed based on comparison of features to predicate device (K082781 OEC® 9900 Elite) and assessment of non-clinical performance data (bench testing).
- Conclusion: "Performance testing... demonstrates that the OEC® 9800 / OEC® 9800 Plus is safe, effective and performs in an equivalent manner to the predicate device and in accordance with its labeling."
This document is a standard 510(k) submission for a conventional medical imaging device, demonstrating safety and effectiveness through substantial equivalence, not through AI/ML performance testing protocols.
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OCT - 4 2011
KIIISS
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Section 5 510(k) Summary
The following information is being submitted in accordance with the requirements of 21 CFR 807.92.
| Company Name: | GE Healthcare Surgery |
|---|---|
| 384 Wright Brothers Drive | |
| Address: | Salt Lake City, UT 84116 |
| Contact Person: | Gerald Buss |
| Director Regulatory Affairs | |
| GE Healthcare Surgery | |
| Phone: (801) 517.6591 Fax: (801) 517.6566 | |
| Preparation Date: | November 9, 2010 |
| Device (Trade Name): | OEC® 9800 / OEC® 9800 Plus |
| 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: | K082781 OEC® 9900 Elite |
| Device Description: | The Series OEC® 9800 is a System used to assist trained Physicians. Thesystem is used to provide X-Ray images while the Physician performsmedical 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 system is composed of two primary physical elements. The first is referred to as the "C-Arm" because of its "C" shaped image gantry; the second referred to as the "Workstation" because this is the primary user interface to the system.
The system is used in different surgical procedures. Orthopedic Physicians may use the system to help perform hip replacements and reconstructions of badly fractured bones. Vascular Physicians may use the system to perform blood flow studies. Cardiologists may use the system to help see if there are blockages in some of the key arteries supplying blood to the heart. The procedures that these physicians perform are broadly referred to as "Clinical Applications". The system is controlled and run in a clinical environment.
The system employs X-Rays as its imaging tcchnology. An X-Ray Generator located in the base of the C-Arm creates high voltage. High voltage is carried to the X-Ray tube across a set of cables. The X-Ray tube emits X-Rays that are directed toward the patient under the control of the operator. The Physician defines the desired view for the specific clinical procedure and directs the operator. The X-Rays pass through the patient and are captured by the image intensifier (II). Image intensifier images are
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K111551
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captured by a camera and displayed on the image monitor located on the Workstation. The system operator and/or Physician view the images as they are displayed and they may choose to store the images for later review.
In order to perform these procedures different views of the human anatomy are required, so the system is designed with the ability to rotate and translate the C-Arm's image gantry to obtain different viewing angles. In addition since there is variation in thickness and density of the anatomy the operator has the ability to adjust the X-Ray Generator technique, image size and orientation to account for the anatomical differences.
- Intended Use: The OEC 9800 Plus is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
The OEC® 9800 / OEC® 9800 Plus employs the same fundamental Technology: scientific technology as the predicate device.
Determination of Substantial Equivalence:
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.
Performance testing included in Section 18 Performance Testing - Bench of Conclusion: this 510(k) demonstrates that the OEC® 9800 / OEC® 9800 Plus is safe. effective and performs in an equivalent manner to the predicate device and in accordance with its labeling.
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Image /page/2/Picture/1 description: The image contains the logo for the U.S. Department of Health and Human Services. The logo features the department's emblem, which consists of a stylized caduceus-like symbol with three figures representing health, services, and human aspects. The emblem is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
MAY - 7 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: K111551
Trade/Device Name: OEC® 9800 / OEC® 9800 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: August 26, 2011 Received: August 29, 2011
Dear Mr. Buss:
This letter corrects our substantially equivalent letter of October 4, 2011.
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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Section 4 Indications For Use
510(k) Number (if known):
OEC® 9800 / OEC® 9800 Plus Device Name:
Indications for Use: The OEC 9800 Plus is designed to provide fluoroscopic and spotfilm imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
Prescription Use __ V __ V __ AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (Per 21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device (OIVD)
Mary S Patil
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K////55/
§ 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.