(26 days)
No
The primary technology change described is the addition of an optional wireless footswitch. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies summary. The image processing mentioned is standard for fluoroscopic systems and does not imply AI/ML.
Yes
The device is described as being intended to aid physicians and surgeons during "therapeutic treatment/surgical procedures."
Yes
The "Intended Use / Indications for Use" states that the device is "intended to aid physicians and surgeons during diagnostic or therapeutic treatment/surgical procedures." The "Device Description" also mentions it provides "fluoroscopic images of patients of all ages during diagnostic, treatment, and surgical procedures."
No
The device description clearly outlines a physical C-arm system with an X-ray source, detector, and workstation, indicating it is a hardware device with integrated software for image processing and control.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The OEC Elite™ MiniView™ is a mobile mini C-Arm that uses fluoroscopic X-ray imaging to visualize the internal structures of the body in real-time. It is used during diagnostic or therapeutic procedures, not to analyze samples outside the body.
- Intended Use: The intended use clearly states it's for "real time general fluoroscopic visualization of patients" and to "aid physicians and surgeons during diagnostic or therapeutic treatment/surgical procedures." This involves direct imaging of the patient, not testing of biological samples.
- Device Description: The description focuses on the hardware components for generating and detecting X-rays and processing the resulting images. There is no mention of handling or analyzing biological samples.
Therefore, the OEC Elite™ MiniView™ is a medical imaging device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The OEC Elite™ MiniView (mobile mini C-Arm) is designed to provide physicians with real time general fluoroscopic visualization of patients of all ages. It is intended to aid physicians and surgeons during diagnostic or therapeutic treatment/surgical procedures of the limbs/extremities and shoulders including, but not limited to, orthopedics and emergency medicine.
Product codes
OXO, JAA
Device Description
The OEC Elite™ MiniView™ is a mobile fluoroscopic mini C- arm system that provides fluoroscopic images of patients of all ages during diagnostic, treatment, and surgical procedures of the shoulders, limbs, and extremities. The system consists of a C-arm attached to an image processing workstation. A CsI(TI) -CMOS flat panel detector and the identical X-ray source monoblock are used for image acquisition.
The C-arm supports the high-voltage generator, X-ray tube, X-ray controls, collimator, and the FPD. The C-arm is capable of performing linear (vertical, horizontal, orbital) and rotational motions that allow the user to position the X-Ray imaging components at various angles and distances with respect to the patient extremity anatomy to be imaged. The C and support arm are mechanically balanced allowing for ease of movement and capable of being "locked" in place using an electronically controlled braking system. The workstation is a stable mobile platform that supports the C-arm, image display monitor(s), image processing equipment/software, recording devices, data input/output devices and power control systems.
The primary technology change for the subject device compared to the unmodified predicate OEC Elite MiniView, was to add an optional wireless footswitch which provides identical functionalities as the wired footswitch to control X-ray on and off.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Fluoroscopic X-Ray
Anatomical Site
limbs/extremities and shoulders
Indicated Patient Age Range
all ages
Intended User / Care Setting
Physicians and surgeons during diagnostic or therapeutic treatment/surgical 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 Testing:
The modified OEC Elite™ MiniView™ system with the wireless footswitch was developed under the GE Healthcare's design controls processes and overall quality management system. The system has been tested by an NRTL and certified compliant with the IEC 60601-1 Ed. 3 series, including IEC60601-2-54 and IEC 60601-2-43. All applicable 21CFR Subchapter J performance standards are met. Risk management activities including using risk analysis to identify any potential issues incorporating the wireless footswitch were performed. These issues were reviewed and mitigated with inherent safe designs and labeling. The mitigations were verified and validated as a part of the design verification and validation testing that has been executed with acceptable results. This testing also includes the EMC and coexistence testing per the "Radio Frequency Wireless Technology in Medical Devices" Guidance for Industry and Food and Drug Administration Staff issued on August 14, 2013 (Wireless Guidance).
Clinical Testing:
The subject of this premarket submission, OEC Elite MiniView with the addition of the wireless footswitch, did not require clinical studies to support substantial equivalence.
Design verification and validation testing was performed to confirm that the safety and effectiveness of the devices has not been affected. The test plans and results have been executed with acceptable results.
Key Results: The modified subject device has the same technological characteristics and perform as well as the unmodified predicate device and other similar devices that incorporate a wireless footswitch currently on the market. Based on the successful verification and validation testing, additional engineering bench testing per the FDA Wireless guidance, conformance to standards, and development under GE's Quality Management System, it is believed that the modified OEC MiniView is of comparable type and substantially equivalent to the predicate device OEC Elite MiniView (K160131), and therefore is safe and effective for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, creating a sense of depth and unity. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 12, 2017
GE HUALUN MEDICAL SYSTEMS CO. LTD. % Ms. Lifeng Wang Regulatory Affairs Leader No1 Yong Chang North Road Beijing Economic Technological Development Zone Beijing 100176 Beijing CHINA
Re: K171800
Trade/Device Name: OEC Elite™ MiniView™ Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OXO, JAA Dated: June 15, 2017 Received: June 16, 2017
Dear Ms. Wang:
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 either 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.
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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Michael D. O'Hara For
Robert Ochs. Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K171800
Device Name OEC Elite™ MiniView™
Indications for Use (Describe)
The OEC Elite MiniView (mobile mini C-Arm) is designed to provide physicians with real time general fluoroscopic visualization of patients of all ages. It is intended to aid physicians and surgeons during diagnostic or therapeutic treatment/surgical procedures of the limbs/extremities and shoulders including, but not limited to, orthopedics and emergency medicine.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/7 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a circle. The circle has small, wave-like embellishments around its perimeter, giving it a slightly decorative appearance. The logo is presented in a blue color.
GE Healthcare
510(k) Premarket Notification Submission- OEC Elite™ MiniView™
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
In accordance with the requirements of 21 CFR 807.92 the following summary of information is provided:
| Date:
Submitter: | June 16, 2017
GE HUALUN MEDICAL SYSTEMS CO. Ltd.
No.1 Yong Chang North Road, Beijing Economic
Technological Development Zone
Beijing 100176,China |
|----------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer/
Manufacturing Location | GE HUALUN MEDICAL SYSTEMS CO. Ltd.
No.1 Yong Chang North Road, Beijing Economic
Technological Development Zone
Beijing 100176,China |
| Primary Contact Person: | Lifeng Wang
Regulatory Affairs Manager
GE Healthcare
+86 10 57083145
Lifeng.Wang@ge.com |
| Secondary Contact Person: | Helen Peng
Regulatory Affairs Director
GE Healthcare
+1 262 424-8222
Hong.Peng@ge.com |
| Device Trade Name: | OEC Elite™ MiniView™ |
| Common/Usual Name: | Fluoroscopic X-Ray System, Mobile
Mini Mobile C-Arm, Mini C-Arm |
| Classification Names: | Image-intensified fluoroscopic x-ray system |
| Device Class | Class II |
| Classification regulation: | 21CFR 892.1650 |
| Primary Product Code: | OXO |
| Secondary Product Code: | JAA |
| Predicate Device(s): | K160131, OEC Elite MiniView |
| Device Description: | The OEC Elite™ MiniView™ is a mobile fluoroscopic mini C-
arm system that provides fluoroscopic images of patients of all
ages during diagnostic, treatment, and surgical procedures of the
shoulders, limbs, and extremities. The system consists of a C-arm
attached to an image processing workstation. A CsI(TI) -CMOS
flat panel detector and the identical X-ray source monoblock are
used for image acquisition. |
| | The C-arm supports the high-voltage generator, X-ray tube, X-ray
controls, collimator, and the FPD. The C-arm is capable of
performing linear (vertical, horizontal, orbital) and rotational
motions that allow the user to position the X-Ray imaging
components at various angles and distances with respect to the
patient extremity anatomy to be imaged. The C and support arm
are mechanically balanced allowing for ease of movement and
capable of being "locked" in place using an electronically
controlled braking system. The workstation is a stable mobile
platform that supports the C-arm, image display monitor(s),
image processing equipment/software, recording devices, data
input/output devices and power control systems. |
| | The primary technology change for the subject device compared
to the unmodified predicate OEC Elite MiniView, was to add an
optional wireless footswitch which provides identical
functionalities as the wired footswitch to control X-ray on and
off. |
| Intended Use: | The OEC Elite™ MiniView™ (mobile mini C-arm) is intended to
provide fluoroscopic images of the patient during diagnostic or
therapeutic treatment/surgical procedures of the limbs/extremities
and shoulders. |
| Indications for Use | The OEC Elite™ MiniView™ (mobile mini C-Arm) is designed
to provide physicians with real time general fluoroscopic
visualization of patients of all ages. It is intended to aid
physicians and surgeons during diagnostic or therapeutic
treatment/surgical procedures of the limbs/extremities and
shoulders including, but not limited to, orthopedics and
emergency medicine. |
| Technology: | The modified OEC Elite™ MiniView™ employs the same
fundamental scientific technology as the unmodified predicate
device. The proposed device will provide an optional off-the-shelf
wireless foot switch uses 2.4GHz radio frequency technology
with proprietary private protocols. The introduction of this
wireless footswitch does not change any existing hardware or
software of the predicated device. The new option is equivalent to
the wired footswitch on the predicate in that the functionalities
are identical. The wireless option provides placement flexibility
and reduces cable clutter. |
| Determination of
Substantial Equivalence: | Summary of Non-Clinical Testing: |
| | The modified OEC Elite™ MiniView™ system with the wireless
footswitch was developed under the GE Healthcare's design
controls processes and overall quality management system. |
| | The system has been tested by an NRTL and certified compliant
with the IEC 60601-1 Ed. 3 series, including IEC60601-2-54 and
IEC 60601-2-43. All applicable 21CFR Subchapter J
performance standards are met. |
| | Risk management activities including using risk analysis to
identify any potential issues incorporating the wireless footswitch
were performed. These issues were reviewed and mitigated with
inherent safe designs and labeling. The mitigations were verified
and validated as a part of the design verification and validation
testing that has been executed with acceptable results. This
testing also includes the EMC and coexistence testing per the
"Radio Frequency Wireless Technology in Medical Devices"
Guidance for Industry and Food and Drug Administration Staff
issued on August 14, 2013 (Wireless Guidance). |
| | Clinical Testing:
The subject of this premarket submission, OEC Elite MiniView
with the addition of the wireless footswitch, did not require
clinical studies to support substantial equivalence. |
| | Design verification and validation testing was performed to
confirm that the safety and effectiveness of the devices has not
been affected. The test plans and results have been executed with
acceptable results. |
| Conclusion: | The OEC Elite MiniView incorporates a wireless footswitch for
the user to initiate and terminate x-ray exposures as an option.
The addition of the optional wireless footswitch to the system
does not raise new questions on safety and effectiveness. The
modified subject device has the same technological characteristics
and perform as well as the unmodified predicate device and other
similar devices that incorporate a wireless footswitch currently on
the market. |
| | Based on the successful verification and validation testing,
additional engineering bench testing per the FDA Wireless
guidance, conformance to standards, and development under GE's
Quality Management System, we believe that the modified OEC
MiniView is of comparable type and substantially equivalent to
the predicate device OEC Elite MiniView (K160131), and
therefore is safe and effective for its intended use. |
4
Image /page/4/Picture/0 description: The image shows the logo for General Electric (GE). The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. The circle is surrounded by swirling, water-like shapes, also in blue, which add a dynamic and fluid element to the design. The overall design is simple, clean, and recognizable, reflecting GE's long-standing presence and reputation.
GE Healthcare
510(k) Premarket Notification Submission- OEC Elite™ MiniView™
5
GE Healthcare
Image /page/5/Picture/1 description: The image shows the logo for General Electric (GE). The logo consists of the letters "GE" in a stylized script, enclosed within a blue circle. There are decorative flourishes around the letters, giving the logo a classic and recognizable appearance.