OEC Elite MiniView

K160131 · Ge Hangwei Medical Systems Co., Ltd. · OXO · Jun 21, 2016 · Radiology

Device Facts

• Record ID: K160131
• Device Name: OEC Elite MiniView
• Applicant: Ge Hangwei Medical Systems Co., Ltd.
• Product Code: OXO · Radiology
• Decision Date: Jun 21, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1650
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The OEC Elite MiniView (mobile mini C-Arm) is designed to provide physicians with real time goopic 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.

Device Story

Mobile mini C-arm fluoroscopic imaging system; provides real-time visualization for orthopedic/emergency procedures on limbs, extremities, and shoulders. Inputs: X-ray radiation transmitted through patient anatomy. Transformation: X-ray source monoblock generates radiation; CsI(Tl)-CMOS flat panel detector captures images; workstation processes, displays, and stores images. Output: Real-time fluoroscopic images on LCD monitors. Used in clinical/surgical settings by physicians/surgeons. Features: powered braking system, motorized C-arm positioning, AutoTrak technique control, noise/motion reduction, edge enhancement, zoom/roam, and image storage. Benefits: improved image quality, workflow efficiency, and dose management compared to conventional image intensifiers; supports diagnostic/therapeutic decision-making during surgery.

Clinical Evidence

No live human clinical studies performed. Evidence includes extensive bench testing (verification/validation), system performance testing per FDA guidance for Solid State X-Ray Imaging Devices (SSXI), and imaging performance evaluation using anthropomorphic phantoms. A cadaver study involving 19 orthopedic procedures across various extremity anatomies was conducted, comparing the subject device to the predicate. Results confirmed clinical capability and image quality were at least equivalent to the predicate.

Technological Characteristics

Mobile mini C-arm; X-ray source monoblock; CsI(Tl)-CMOS flat panel detector; workstation with LCD monitors. Connectivity: Ethernet/Wireless (DICOM). Standards: IEC 60601-1 Ed.3, IEC 60601-2-54, IEC 60601-2-43, 21 CFR Subchapter J. Software: 64-bit Linux-based OS. Mechanical: electronically controlled braking system, pivoting orbital rotation.

Indications for Use

Indicated for real-time fluoroscopic visualization of patients of all ages during diagnostic or therapeutic surgical procedures of limbs, extremities, and shoulders, including orthopedics and emergency medicine.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Mini 6800 Digital Mobile C-arm (K992506)

Reference Devices

• Hologic Insight- FD Mini C-arm Fluoroscopic Imaging System (K120388)
• GE's OEC Brivo Series (K123603)

Submission Summary (Full Text)

{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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other to create a sense of depth and connection.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 21, 2016

GE Hangwei Medical Systems Co., Ltd Lifeng Wang Regulatory Affairs Leader No. 1 Yongchang North Road Beijing Economic & Technological Development Beijing P.R. 100176 CHINA

Re: K160131

Trade/Device Name: OEC Elite MiniView Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OXO, JAA Dated: 5/05/2016 Received: 5/09/2016

Dear Lifeng 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

{1}------------------------------------------------

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.

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 [phone] or [phone] 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" (21CFR 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Robert Oaks

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)

K160131

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 goopic 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) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### 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 [e-mail]

"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/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. The letters are also blue. There is a white border around the circle, and there are three white teardrop shapes around the outside of the circle.

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: | January 18, 2016 |
|--------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | GE Hangwei Medical Systems, Co. Ltd |
| | No. 1 Yongchang North Road |
| | Beijing Economic & Technological Development, |
| | Beijing P.R. 100176 China |
| Manufacturer/<br>Manufacturing<br>Location | GE Hangwei Medical Systems, Co. Ltd |
| | No. 1 Yongchang North Road |
| | Beijing Economic & Technological Development, |
| | Beijing P.R. 100176 China |
| Primary<br>Contact<br>Person: | Lifeng Wang |
| | Regulatory Affairs Leader |
| | GE Hangwei Medical Systems, Co. Ltd |
| | [phone]-70252 |
| | [e-mail] |
| Secondary<br>Contact<br>Person: | John Jaeckle |
| | Chief Regulatory Affairs Strategist |
| | GE Healthcare |
| | [phone] |
| | [e-mail] |
| | Holly Stark |
| | Director Regulatory Affairs |
| | GE OEC Medical Systems, Inc. |
| | [phone] |
| | [e-mail] |
| Device Trade<br>Name: | OEC Elite™ MiniView™ |
| Common/Usual<br>Name: | Fluoroscopic X-Ray System, Mobile<br>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 |
| Marketed Device | OEC Elite™ MiniView™ is a mobile fluoroscopic mini C-Arm system built<br>upon the existing technologies of the predicate device OEC Mini 6800 (K992506<br>and reference devices. It is of comparable type and substantially equivalent to its<br>predicate device OEC Mini 6800 and the identified reference devices Hologic<br>Insight- FD Mini C-arm and OEC Brivo Series. The intended use has not<br>changed. The proposed device's indications for use have been revised to better<br>align with actual patient populations and the system capabilities as substantiated<br>in the testing and evaluations provided.<br>The system is labeled as the OEC Elite™ MiniView™ |
| Predicate Device(s): | K992506, Mini 6800 Digital Mobile C-arm |
| Reference Device(s) | K120388, Hologic Insight- FD mini C-arm Fluoroscopic Imaging System<br>K123603 GE's OEC Brivo Series |
| Device Description: | The OEC Elite™ MiniView™ is a mobile fluoroscopic mini C-arm system that<br>provides fluoroscopic images of patients of all ages during diagnostic, treatment,<br>and surgical procedures of the shoulders, limbs, and extremities. The system<br>consists of a C-arm attached to an image processing workstation. A CsI(TI) -<br>CMOS flat panel detector and the identical X-ray source monoblock are used for<br>image acquisition.<br><br>The C-arm supports the high-voltage generator, X-ray tube, X-ray controls,<br>collimator, and the FPD. The C-arm is capable of performing linear (vertical,<br>horizontal, orbital) and rotational motions that allow the user to position the X-<br>Ray imaging components at various angles and distances with respect to the<br>patient extremity anatomy to be imaged. The C and support arm are<br>mechanically balanced allowing for ease of movement and capable of being<br>"locked" in place using an electronically controlled braking system. The<br>workstation is a stable mobile platform that supports the C-arm, image display<br>monitor(s), image processing equipment/software, recording devices, data<br>input/output devices and power control systems. |

{4}------------------------------------------------

Image /page/4/Picture/5 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized script, enclosed within a circular frame. The frame has decorative swirls or flourishes around the letters, giving it a classic and recognizable appearance. The logo is presented in a light blue color.

{5}------------------------------------------------

- The OEC Elite™ MiniView™ (mobile mini C-arm) is intended to provide Intended Use: fluoroscopic images of the patient during diagnostic or therapeutic treatment/surgical procedures of the limbs/extremities and shoulders. The OEC Elite™ MiniView™ (mobile mini C-Arm) is designed to provide Indications for physicians with real time general fluoroscopic visualization of patients of all Use 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. The OEC Elite™ MiniView™ employs the same fundamental scientific Technology: technology as that of the predicate device OEC Mini 6800(K992506) and the reference device Hologic Insight FD Mini C-arm (K120388). Its software uses virtually the same architectural design of the reference device OEC Brivo Series (K123603) with modifications being made to support the flat panel detector, the necessary imaging and post processing applications related to the FPD, and device specific features/functionality. The primary change on the C-arm is the replacement of the predicate's conventional image intensifier with Thallium-doped Cesium Iodide [Cs](Tl)] solid state flat panel X-ray detector with Complementary Metal Oxide Semiconductor (CMOS) photodiodes. The X-Ray source monoblock remains unchanged from that of the OEC Mini 6800. On the workstation, the main hardware changes include using an up to date computer that offers more image storage, processing power and speed, and LCD monitors. The mechanical design is improved for usability, maneuverability, and positioning. The weight of the C-arm is reduced and it is better balanced. The system is equipped with and one-button activated powered braking system that secures key joints to eliminate drift. The tables below compare the main performance data of the proposed device with the predicate device and the referenced devices.
Image /page/5/Picture/3 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circular border. The color of the logo is a light blue.

{6}------------------------------------------------

Image /page/6/Picture/0 description: The image shows the logo for General Electric (GE). The logo is a blue circle with the letters "GE" in a stylized font in the center. There are three white teardrop shapes around the outside of the circle. The logo is simple and recognizable.

510(k) Premarket Notification Submission- OEC Elite™ MiniView™

| | Predicate Device | Proposed Device | Discussion of Differences |
|--------------------------------|------------------------------------------------------------|----------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | OEC Mini 6800<br>Digital Mobile C-arm K992506 | OEC Elite™<br>MiniView™ | |
| Monitor | > Dual 16" CRT<br>Monitors with<br>1000 line<br>resolution | > Dual 19"<br>Monochrome<br>LCD<br>Monitors<br>with 1280 x<br>1024<br>resolution | Substantially Equivalent<br>The monitor displays on the<br>proposed device has been<br>updated to a LCD monitors.<br>This change was driven by<br>IT technology advancement<br>by using a more state of the<br>art display technology which<br>is considered adequate for<br>viewing extremities and<br>represents an improvement<br>over the CRT monitors of<br>the predicate device and this<br>change did not raise any new<br>safety and effectiveness<br>concerns. |
| Display<br>articulation | > Fixed | > Small<br>extension<br>with 450°<br>swivel | Substantially Equivalent<br>The proposed device has<br>added display articulation, to<br>improve workflow for the<br>end user allowing the<br>monitor to be extended and<br>rotated +180/-270 degrees.<br>This change did not raise<br>any new safety and<br>effectiveness concerns. |
| Power<br>Failure<br>Protection | > N/A | > Backup<br>Battery | Substantially Equivalent<br>The proposed device has<br>added a backup battery to<br>protect the data integrity in<br>hard disk drive when the<br>device receives a sudden loss<br>of power. It also allows for<br>limited additional exposure<br>time for the ability to |

## Table 1 Significant Differences between OEC Elite™ MiniView™ and OEC Mini 6800 Digital Mobile C-arm(K992506)

Page 5 of 12

{7}------------------------------------------------

Image /page/7/Picture/0 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. There are three droplet-shaped elements surrounding the circle, positioned at the top, left, and right. The logo is rendered in a light blue color.

| | | | | | controllably exit or finish an<br>in-progress procedure.<br>This change did not raise<br>any new safety and<br>effectiveness concerns. |
|-------------------------------|---|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Physical<br>Dimensions | > | Depth: 17.7"<br>(45 cm)<br>Free Space:<br>13.8" (35 cm)<br>Orbital<br>Rotation: 115°<br>Lateral<br>Rotation: +/- 220°<br>Vertical<br>Travel: 27" (70<br>cm)<br>Panning<br>Motion: 365° | > | Depth: 18"<br>(46 cm)<br>Free Space:<br>13.4" (34 cm)<br>Pivoting<br>Orbital<br>Rotation:<br>120°<br>Lateral<br>Rotation:<br>380°<br>Horizontal<br>Travel: 77.2"<br>(196 cm)<br>Vertical<br>Travel: 33.4"<br>(85cm)<br>Panning<br>Motion: 366° | Substantially Equivalent<br>The proposed device<br>improved the physical<br>dimensions for workflow<br>purposes by incorporating a<br>pivoting orbital rotation<br>motion. All design changes<br>meet IEC safety criteria.<br>This change did not raise<br>any new safety and<br>effectiveness concerns. |
| Image<br>Storage | > | 800 Images | > | 100,000<br>Images | Substantially Equivalent<br>The proposed device has<br>enhanced the system's<br>storage ability to store more<br>images. This change did not<br>raise any new safety and<br>effectiveness concerns. |
| Removable<br>Data<br>Storage | > | Floppy disk | > | USB port | Substantially Equivalent<br>The proposed device has<br>updated the technology to<br>incorporate a USB port to<br>accommodate standard data<br>retrieval storage and export<br>needs. This change was<br>driven by IT technology<br>advancement by using a<br>more state of the art media<br>which is the USB instead of<br>the out of date floppy disk<br>which is not used by the<br>industry any more. |
| | | | | | This change did not raise<br>any new safety and<br>effectiveness concerns. |
| Dose Area<br>Product<br>(DAP) | > | N/A | > | Dose Area<br>Product<br>(DAP) | Substantially Equivalent<br><br>The proposed device has<br>added the ability for the<br>physician to see the DAP<br>displayed for each exam. |
| | | | | | This change did not raise<br>any new safety and<br>effectiveness concerns. |
| Imaging<br>Features | > | Auto X-Ray<br>technique<br>control | > | Auto X-Ray<br>technique<br>control | Substantially Equivalent<br><br>The proposed device<br>provides AutoTrak feature to<br>automatically seek anatomy<br>in the imaging field and<br>select optimal technique to<br>reduce the need for taking<br>additional X-ray images. |
| | > | Noise and<br>motion<br>reduction | > | Noise and<br>motion<br>reduction | |
| | > | Auto/Manual<br>Brightness and<br>Contrast<br>Control | > | Auto/Manual<br>Brightness<br>and Contrast<br>Control | |
| | > | Negate | > | Negate | This is a workflow<br>improvement and did not<br>raise new safety and<br>effectiveness concerns. |
| | > | Swap and<br>auto-swap | > | Swap and<br>auto-swap | |
| | > | Save and auto-<br>save | > | Save and<br>auto-save | |
| | > | Last image<br>hold | > | Last image<br>hold | |
| | > | Edge<br>enhancement | > | Edge<br>enhancement | |
| | > | Zoom & Roam | > | Zoom &<br>Roam | |
| | > | Image rotation | > | Image<br>rotation | |
| | > | Image flip/<br>invert<br>Smart Metal | > | Image flip/<br>invert<br>Smart Metal<br>AutoTrak | |

{8}------------------------------------------------

Image /page/8/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a blue circle. There are three stylized water droplets or swirls surrounding the circle, positioned at the top, left, and right. The logo is simple and recognizable, representing the brand identity of General Electric.

{9}------------------------------------------------

Image /page/9/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' in a stylized, cursive font, enclosed within a blue circle. There are also some white, teardrop-shaped elements surrounding the circle, giving the impression of motion or energy. The logo is simple, yet recognizable, and represents the brand identity of General Electric.

510(k) Premarket Notification Submission- OEC Elite™ MiniView™

| | Reference Device | Proposed Device | Discussion of<br>Differences |
|--------------|----------------------------------------------------------|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | OEC Brivo Mobile<br>C-arm - K123603 | OEC Elite™<br>MiniView™ | |
| Software | 64-bit Linux, with<br>a Windows-like<br>operating system | 64-bit Linux, with a<br>Windows-like<br>operating system | Substantially<br>Equivalent |
| | Arbitrated Internal<br>Communication | Arbitrated Internal<br>Communication | The operating system is<br>a contemporary<br>software OS common<br>in current medical<br>devices. The proposed<br>device's software<br>platform is based on the<br>reference device OEC<br>Brivo (K123603)<br>software platform with<br>modifications<br>specifically made to<br>support the proposed<br>device's COMS<br>detector and associated<br>changes. Leveraging<br>the OEC Brivo software<br>platform and making<br>necessary modifications<br>did not raise any new<br>safety or efficacy<br>concern and is<br>determined to be<br>substantially<br>equivalent. |
| | Windows like user<br>interface | Windows like user<br>interface |…