(304 days)
Not Found
No
The summary describes modifications to existing components (X-ray tube, image intensifier, foot/hand switch, circuit boards, monitor, solid state drive, injector system) and mentions image processing, but there is no mention of AI, ML, or related concepts. The focus is on component equivalence and functional performance.
No
Explanation: The device is described as assisting surgeons by providing X-ray images for visualization and localization during procedures, not directly treating a disease or condition. While it aids in procedures that may be therapeutic, the device itself is for imaging and diagnostic purposes.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures." The "Device Description" also mentions that the images help the surgeon "to localize surgical regions of interest and pathology," which is a diagnostic activity.
No
The device description explicitly details multiple hardware components being part of the system, including an X-Ray Tube, Radiological Imaging Unit (Image Intensifier), foot switch, hand switch, printed circuit board assemblies, LCD monitor, solid state drive, and an OEM injector system. The submission describes modifications and alternative suppliers for these hardware components.
Based on the provided information, the OEC 9800 Plus is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures. This involves imaging the patient's anatomy directly.
- Device Description: The description reinforces that the system is used to provide X-Ray images while the Surgeon performs a medical procedure to visualize the patient's anatomy.
- Nature of IVD: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health.
The OEC 9800 Plus is an imaging device used in vivo (within the living body) to visualize internal structures using X-rays. This is fundamentally different from the function of an IVD.
N/A
Intended Use / Indications for Use
The Series OEC® 9800 Plus is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
Product codes (comma separated list FDA assigned to the subject device)
90OWB, 90OXO and 90JAA
Device Description
The OEC® 9800 Plus is a system used to assist trained Surgeons. The system is used to provide X-Ray images while the Surgeon performs a medical procedure. Images from the system help the Surgeon to visualize the patients' anatomy. This visualization helps to localize surgical regions of interest and pathology. The images provide realtime visualization and records of pre-surgical anatomy, in vivo-surgical activity and post surgical outcomes.
Mentions image processing
Yes, "image processing and presentation"
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic X-Ray, Spot-film X-Ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Surgeons / diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
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)
Non-Clinical Tests:
The following quality assurance measures were applied to the development of the proposed device: Risk Analysis, Requirements Reviews, Design Reviews and testing which included component, subsystem, and system.
Design verification methodology was hierarchal. When component development was completed, component level tests were executed. Upon completion of component testing, subsystem and system verification were also performed. The Design Verification of the OEC 9800 Plus confirms that design output meets design input requirements.
Functional testing was performed which included mechanical, electrical, and overall system tests. X-ray acquisition, X-ray control and indication, patient data management, imaging modes (basic and advanced), image quality acquisition and assessment, image processing and presentation, screen measurements, motorized system, and subsystem mechanical tests were performed. Performance testing included image quality, and subsystem performance.
Product Simulated Use Testing was used to evaluate whether the device meets user needs and intended uses by simulating a use environment, and having testing performed by users with relevant clinical experience. The functional requirements of image storage and recall capability were validated using the proposed device. The proposed device was also used to produce images that were evaluated to confirm the new monitor met user needs and intended use.
Safety testing was performed in laboratory settings by qualified technicians to confirm that the product met the requirements of the standards listed in Table 1.
Clinical Tests:
The OEC 9800 Plus is based on modifications to a cleared predicate device. There were no changes to the intended use. Clinical studies on living human patients were not necessary to support substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K111551 OEC® 9800 Plus
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
510(k) Summary
MAY 0 1 2014
In accordance with 21 CFR 807.92 the following summary of information is provided:
Date: November 20, 2013
GE Healthcare Surgery Submitter: 384 Wright Brothers Drive Salt Lake City, UT 84116
| Primary Contact Person: Karen Russell | |
|---|---|
| Regulatory Affairs Leader | |
| GE Healthcare Surgery | |
| Phone: (801) 536-4930 Fax: (801) 517-6566 | |
| Secondary Contact Person: Jeff Wagner | |
| Regulatory Affairs Manager | |
| GE Healthcare Surgery | |
| Phone: (801) 517-6415 Fax: (801) 517-6566 |
OEC® 9800 Plus Device: (Trade Name): Mobile Fluoroscopic Imaging System Common/Usual Name: 21 CFR 892.1650 Image-intensified fluoroscopic x-ray system Classification Names:
Product Code: 90OWB, 90OXO and 90JAA
K111551 OEC® 9800 Plus Predicate Device(s):
Device Description:
The OEC® 9800 Plus is a system used to assist trained The system is used to provide X-Ray images Surgeons. while the Surgeon performs a medical procedure. Images from the system help the Surgeon to visualize the patients' This visualization helps to localize surgical anatomy. regions of interest and pathology. The images provide realtime 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.
1
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 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.
Two printed circuit board assemblies have been combined into a single board in the proposed device due to parts obsolescence. Both the proposed and predicate assemblies common specifications as confirmed through share verification testing.
The proposed device will include a LCD monitor which replaces the obsolete CRT monitor. Both the proposed and predicate assemblies share common specifications as confirmed through verification testing.
The proposed device includes an alternative solid state drive. This drive provides a faster write speed. Both drives meet their specifications.
The proposed device will include a different model of an OEM injector system. Both the proposed and predicate OEM iniector systems share common specifications as confirmed through verification testing.
Intended Use:
The Series OEC® 9800 Plus is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical and interventional procedures. Clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
The modified OEC® 9800 Plus device employs the same Technology: fundamental scientific technology as the predicate device.
2
Determination of Substantial Equivalence:
Summary of Non-Clinical Tests
The following quality assurance measures were applied to the development of the proposed device: Risk Analysis, Requirements Reviews, Design Reviews and testing which included component, subsystem, and system.
Design verification methodology was hierarchal. When component development was completed, component level tests were executed. Upon completion of component testing, subsystem and system verification were also performed. The Design Verification of the OEC 9800 Plus confirms that design output meets design input requirements.
testing was performed which included Functional mechanical, electrical, and overall system tests. X-ray acquisition, X-ray control and indication, patient data management, imaging modes (basic and advanced), image quality acquisition and assessment, image processing and presentation, screen measurements, motorized system, and subsystem mechanical tests were performed. Performance testing included image quality, and subsystem performance.
Product Simulated Use Testing was used to evaluate whether the device meets user needs and intended uses by simulating a use environment, and having testing performed by users with relevant clinical experience. The functional requirements of image storage and recall capability were validated using the proposed device. The proposed device was also used to produce images that were evaluated to confirm the new monitor met user needs and intended use.
Safety testing was performed in laboratory settings by qualified technicians to confirm that the product met the requirements of the standards listed in Table 1 below.
The OEC® 9800 Plus complies with the voluntary and mandatory standards listed in Table 1 below.
3
Summary of Clinical Tests
The OEC 9800 Plus is based on modifications to a cleared predicate device. There were no changes to the intended use. Clinical studies on living human patients were not necessary to support substantial equivalence.
The verification and validation testing described above Conclusion: demonstrates that the OEC® 9800 Plus is safe, effective, and performs, for its intended use, in an equivalent manner to the predicate device and in accordance with its labeling. OEC® 9800 Plus is substantially equivalent in performance to the predicate OEC® 9800 Plus (K111551).
| Standards
No. | Standards
Organization | Standards Title | Version | Date |
|----------------------|---------------------------|---------------------------------------------------------------------------------------|-------------------------------|------------------------|
| 21 CFR
1020.30-32 | FDA | Federal Performance Standard for
Diagnostic X-ray Systems | 2012 | 2012 |
| 60601-1 | UL | Medical Electrical Equipment, Part 1:
General Requirements for Safety | 1st edition | 2003 |
| 60601-1 | IEC | Medical Electrical Equipment, Part 1:
General Requirements for Safety | A1 (1991)
and A2
(1995) | 1988,
1991,
1995 |
| 60601-1-2 | IEC | Collateral Std: Electromagnetic
Compatibility | 2.1 edition | 2004 |
| 60601-1-3 | IEC | Collateral Std: Radiation Protection in
Diagnostic X-ray Equipment | 1st edition | 1994 |
| 60601-1-4 | IEC | Collateral Std: Radiation Protection in
Diagnostic X-ray Equipment | 1.1 edition
(+A1) | 2000 |
| 60601-1-6 | IEC | Collateral Std: General Requirements
for Basic Safety and Essential
Performance | 2nd edition | 2006 |
| 60601-2-7 | IEC | Particular Std: Safety of H.V.
Diagnostic X-ray Generators | 2nd edition | 1998 |
| 60601-2-28 | IEC | Particular Std: Safety of X-ray Tube
and X-ray Source Assemblies | 1st edition | 1993 |
| 60601-2-32 | IEC | Particular Std: Safety of Associated
Equipment of X-ray Equipment | 1st edition | 1994 |
| NEPA 99 | NFPA | US National Electric Code Health
Care Facilities | 2005 | 2005 |
| DICOM | DICOM | US National Electric Code Health
Care Facilities | 2008 | 2008 |
Table 1 Product Standards Compliance
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center -WO66-G609 Silver Spring, MD 20993-0002
May 1. 2014
GE Healthcare Surgery Jeff Wagner Regulatory Affairs Manager 384 Wright Brothers Drive Salt Lake City, Utah 84116
K132027/S004 Re:
Trade/Device Name: OEC 9800 Plus Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II -Product Code: OWB, OXO, JAA Dated: February 27, 2014 Received: April 2, 2014
Dear Mr. Wagner:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into cither 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.
5
Page 2 - Mr. Wagner
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 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.
lf you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
6
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: December 31, 2013 See PRA Statement on last page.
510(k) Number (if known) K132027
Device Name GE OEC® 9800 Plus
Indications for Use (Describe)
Indications for Use: The OEC 9800 Plus is designed to provide fluoroscopic and spot-film imaging of the patient during diagnostic, margical and interventional procedures. Clinical application may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
Type of Use (Select one or both, as applicable)
[x] Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
FORM FDA 3881 (9/13)
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