(153 days)
No
The document describes standard image processing and does not mention AI, ML, or related terms.
No.
The device is designed to provide imaging for diagnostic and therapeutic procedures, but it does not directly provide therapeutic treatment itself.
Yes
The device's intended use explicitly states it is "intended to aid physicians and surgeons during diagnostic or therapeutic treatment/surgical procedures." Furthermore, the device description mentions it provides fluoroscopic images "during diagnostic, treatment, and surgical procedures."
No
The device description clearly outlines a physical C-arm system with hardware components like an X-ray source, detector, and workstation, in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Device Function: The OEC Elite MiniView is a mobile C-arm system that uses fluoroscopic X-rays to provide real-time visualization of the patient's body during surgical and diagnostic procedures. It does not analyze samples taken from the body.
- Intended Use: The intended use clearly states it's for "real time fluoroscopic visualization of patients" and to "aid physicians and surgeons during diagnostic or therapeutic treatment/surgical procedures." This involves imaging the patient directly, not analyzing in vitro samples.
Therefore, the OEC Elite MiniView falls under the category of medical imaging devices, not In Vitro Diagnostic devices.
N/A
Intended Use / Indications for 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.
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. 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 (comma separated list FDA assigned to the subject device)
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.
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)
Engineering Bench Testing: Verification and validation including hazard mitigation has been executed with results demonstrating the OEC Elite™ MiniView™ system met design input and user needs. The system has been NRTL tested 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. The OEC Elite™ MiniView™ system was developed under the GE Healthcare's design controls processes, software development life cycle, and overall quality management system. Additional engineering bench testing was performed including: the non-clinical testing identified in the guidance for submission of 510(k)s for Solid State X-Ray Imaging Devices (SSXI); demonstration of system performance; and an imaging performance evaluation using anthropomorphic phantoms (including a pediatric anthropomorphic phantom). All of the image quality/performance testing identified for fluoroscopy found in FDA's “Information for Industry: X-ray Imaging Devices - Laboratory Image Quality and Dose Assessment, Tests and Standards" was performed.
Cadaver Study: A comparison of the subject device to the predicate was also performed by two independent physicians. A total of nineteen orthopedic procedures across a variety of extremity anatomies were performed using two cadavers. Given that the subject device is indicated for extremity-only use, which is characterized by orthopedic / musculoskeletal-related diagnostic and therapeutic/surgical procedures, it was determined that a human cadaver study was appropriate. For all procedures, the study confirmed the clinical capability and overall quality of the images produced by the OEC Elite™ MiniView™ was at least equivalent to that of the Mini 6800 Digital Mobile C-Arm.
Clinical Testing: Cadaver images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device and the bench data provided (bench data was used to compare the modified detector to the reference detector) but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended. The OEC Elite™ MiniView™ mobile fluoroscopic mini C-arm system did not require live human clinical studies 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.
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.
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
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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 (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" (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 (800) 638-2041 or (301) 796-7100 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)
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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
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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/ | |
| Manufacturing | |
| Location | GE Hangwei Medical Systems, Co. Ltd |
| No. 1 Yongchang North Road | |
| Beijing Economic & Technological Development, | |
| Beijing P.R. 100176 China | |
| Primary | |
| Contact | |
| Person: | Lifeng Wang |
| Regulatory Affairs Leader | |
| GE Hangwei Medical Systems, Co. Ltd | |
| +86 10 58068888-70252 | |
| Lifeng.Wang@ge.com | |
| Secondary | |
| Contact | |
| Person: | John Jaeckle |
| Chief Regulatory Affairs Strategist | |
| GE Healthcare | |
| +1 262 424 9547 | |
| John.jaeckle@ge.com | |
| Holly Stark | |
| Director Regulatory Affairs | |
| GE OEC Medical Systems, Inc. | |
| +1 801 536 4553 | |
| holly.stark@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 |
| Marketed Device | OEC Elite™ MiniView™ is a mobile fluoroscopic mini C-Arm system built |
| upon the existing technologies of the predicate device OEC Mini 6800 (K992506 | |
| and reference devices. It is of comparable type and substantially equivalent to its | |
| predicate device OEC Mini 6800 and the identified reference devices Hologic | |
| Insight- FD Mini C-arm and OEC Brivo Series. The intended use has not | |
| changed. The proposed device's indications for use have been revised to better | |
| align with actual patient populations and the system capabilities as substantiated | |
| in the testing and evaluations provided. | |
| 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 |
| K123603 GE's OEC Brivo Series | |
| 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. |
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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] 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.
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510(k) Premarket Notification Submission- OEC Elite™ MiniView™
| Predicate Device | Proposed Device | Discussion of Differences | |
|---|---|---|---|
| OEC Mini 6800 | |||
| Digital Mobile C-arm K992506 | OEC Elite™ | ||
| MiniView™ | |||
| Monitor | > Dual 16" CRT | ||
| Monitors with | |||
| 1000 line | |||
| resolution | > Dual 19" | ||
| Monochrome | |||
| LCD | |||
| Monitors | |||
| with 1280 x | |||
| 1024 | |||
| resolution | Substantially Equivalent | ||
| The monitor displays on the | |||
| proposed device has been | |||
| updated to a LCD monitors. | |||
| This change was driven by | |||
| IT technology advancement | |||
| by using a more state of the | |||
| art display technology which | |||
| is considered adequate for | |||
| viewing extremities and | |||
| represents an improvement | |||
| over the CRT monitors of | |||
| the predicate device and this | |||
| change did not raise any new | |||
| safety and effectiveness | |||
| concerns. | |||
| Display | |||
| articulation | > Fixed | > Small | |
| extension | |||
| with 450° | |||
| swivel | Substantially Equivalent | ||
| The proposed device has | |||
| added display articulation, to | |||
| improve workflow for the | |||
| end user allowing the | |||
| monitor to be extended and | |||
| rotated +180/-270 degrees. | |||
| This change did not raise | |||
| any new safety and | |||
| effectiveness concerns. | |||
| Power | |||
| Failure | |||
| Protection | > N/A | > Backup | |
| Battery | Substantially Equivalent | ||
| The proposed device has | |||
| added a backup battery to | |||
| protect the data integrity in | |||
| hard disk drive when the | |||
| device receives a sudden loss | |||
| of power. It also allows for | |||
| limited additional exposure | |||
| 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
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| | | | | | controllably exit or finish an
in-progress procedure.
This change did not raise
any new safety and
effectiveness concerns. |
|-------------------------------|---|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Physical
Dimensions | > | Depth: 17.7"
(45 cm)
Free Space:
13.8" (35 cm)
Orbital
Rotation: 115°
Lateral
Rotation: +/- 220°
Vertical
Travel: 27" (70
cm)
Panning
Motion: 365° | > | Depth: 18"
(46 cm)
Free Space:
13.4" (34 cm)
Pivoting
Orbital
Rotation:
120°
Lateral
Rotation:
380°
Horizontal
Travel: 77.2"
(196 cm)
Vertical
Travel: 33.4"
(85cm)
Panning
Motion: 366° | Substantially Equivalent
The proposed device
improved the physical
dimensions for workflow
purposes by incorporating a
pivoting orbital rotation
motion. All design changes
meet IEC safety criteria.
This change did not raise
any new safety and
effectiveness concerns. |
| Image
Storage | > | 800 Images | > | 100,000
Images | Substantially Equivalent
The proposed device has
enhanced the system's
storage ability to store more
images. This change did not
raise any new safety and
effectiveness concerns. |
| Removable
Data
Storage | > | Floppy disk | > | USB port | Substantially Equivalent
The proposed device has
updated the technology to
incorporate a USB port to
accommodate standard data
retrieval storage and export
needs. This change was
driven by IT technology
advancement by using a
more state of the art media
which is the USB instead of
the out of date floppy disk
which is not used by the
industry any more. |
| | | | | | This change did not raise
any new safety and
effectiveness concerns. |
| Dose Area
Product
(DAP) | > | N/A | > | Dose Area
Product
(DAP) | Substantially Equivalent
The proposed device has
added the ability for the
physician to see the DAP
displayed for each exam. |
| | | | | | This change did not raise
any new safety and
effectiveness concerns. |
| Imaging
Features | > | Auto X-Ray
technique
control | > | Auto X-Ray
technique
control | Substantially Equivalent
The proposed device
provides AutoTrak feature to
automatically seek anatomy
in the imaging field and
select optimal technique to
reduce the need for taking
additional X-ray images. |
| | > | Noise and
motion
reduction | > | Noise and
motion
reduction | |
| | > | Auto/Manual
Brightness and
Contrast
Control | > | Auto/Manual
Brightness
and Contrast
Control | |
| | > | Negate | > | Negate | This is a workflow
improvement and did not
raise new safety and
effectiveness concerns. |
| | > | Swap and
auto-swap | > | Swap and
auto-swap | |
| | > | Save and auto-
save | > | Save and
auto-save | |
| | > | Last image
hold | > | Last image
hold | |
| | > | Edge
enhancement | > | Edge
enhancement | |
| | > | Zoom & Roam | > | Zoom &
Roam | |
| | > | Image rotation | > | Image
rotation | |
| | > | Image flip/
invert
Smart Metal | > | Image flip/
invert
Smart Metal
AutoTrak | |
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510(k) Premarket Notification Submission- OEC Elite™ MiniView™
| | Reference Device | Proposed Device | Discussion of
Differences |
|--------------|----------------------------------------------------------|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | OEC Brivo Mobile
C-arm - K123603 | OEC Elite™
MiniView™ | |
| Software | 64-bit Linux, with
a Windows-like
operating system | 64-bit Linux, with a
Windows-like
operating system | Substantially
Equivalent |
| | Arbitrated Internal
Communication | Arbitrated Internal
Communication | The operating system is
a contemporary
software OS common
in current medical
devices. The proposed
device's software
platform is based on the
reference device OEC
Brivo (K123603)
software platform with
modifications
specifically made to
support the proposed
device's COMS
detector and associated
changes. Leveraging
the OEC Brivo software
platform and making
necessary modifications
did not raise any new
safety or efficacy
concern and is
determined to be
substantially
equivalent. |
| | Windows like user
interface | Windows like user
interface | |
| Connectivity | Ethernet Wired
Wireless (Optional) | Ethernet Wired
Wireless (Optional) | Substantially
Equivalent
Both devices offer a
wireless adaptor meant
for DICOM
communication with
the archiving systems
such as PACS and RIS,
and DICOM printers on
the hospital's private |
Table 2 Significant Differences between OEC Elite™ MiniView™ and OEC Brivo Mobile C-arm (K123603) device
Page 8 of 12
10
510(k) Premarket Notification Submission- OEC Elite™ MiniView™
| to be an alternate means | |
|---|---|
| to the wired | |
| communication | |
| configuration installed | |
| on all systems by | |
| default. The change in | |
| the proposed device as | |
| compared to the | |
| reference device OEC | |
| Brivo system is that it | |
| used a more up to date | |
| wireless technology, | |
| both of which confirm | |
| to the FCC standards | |
| and same wireless | |
| protocols | |
| EMC testing per IEC | |
| with the WiFi adaptor | |
| integrated in the system | |
| as well as additional | |
| coexistence testing | |
| conducted per the FDA | |
| guidance titled "Radio | |
| Frequency Wireless | |
| Technology in Medical | |
| Devices" issued August | |
| 14th, 2013 | |
| demonstrated that | |
| having the WiFi option | |
| in the proposed device | |
| does not affect the | |
| safety or efficacy of the |
Table 3 Significant Differences between OEC Elite™ MiniView™ and Hologic® Insight-FD Mini C-Arm Fluoroscopic Imaging System (K120388) devices
| devices | |||
|---|---|---|---|
| Reference | |||
| Device | Proposed | ||
| Device | Discussion of Differences | ||
| Hologic® | OEC Elite™ | ||
| Insight-FD Mini | |||
| C-Arm | |||
| Fluoroscopic | |||
| Imaging System | |||
| K120388 | MiniView™ | ||
| Image | |||
| Receptor | CMOS Flat | ||
| Panel Detector | CMOS Flat | ||
| Panel Detector | Substantially Equivalent | ||
| The proposed device uses |
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510(k) Premarket Notification Submission- OEC Elite™ MiniView™
| | | same CMOS flat panel
technology. The change to a
flat panel detector does not
affect the safety or efficacy of
the device. |
|-----------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Pixel Size: 75
Microns | Pixel Size:100
Microns | Substantially Equivalent:
The proposed device's pixel
size is larger for reducing
image noise. The resolution is
higher than the Image
Intensifier on the predicate.
The difference does not affect
the safety or efficacy of the
device. |
| Array Size: 2k x
1.5k | Array Size:
1.3k x 1.3k | Substantially Equivalent
The array size gives a 5 inch
square detector which is
adequate for viewing
extremities. The difference
does not affect the safety or
efficacy of the device. |
| Full Field: 14.5
cm x 11.5 cm
(5.7" x 4.5")
Limited Field:
11 cm (4.3")
square | Full Field: 13
cm (5.1")
circle
Limited Field:
10 cm (4")
circle | Substantially Equivalent
Full field and limited field
sizes in proposed device are
slightly smaller than the
reference device Hologic®
Insight-FD K120388. These
sizes are appropriate for
viewing extremities. |
The changes and differences described above do not change the control mechanism, operating principle, energy type, and intended use found on predicate and reference devices.
Potential electrical, mechanical, and radiation hazards are identified in risk Adverse Effects on Health management including hazard analysis and controlled by:
- · System verification and validation to ensure performance to specifications, Federal Regulations, and user requirements.
- · Adherence and certification to industry and international standards. AAMI/ES and IEC60601-1 Ed.3 and associated collateral and particular standards including IEC 60601-2-54 and IEC 60601-2-43.
- · Meeting the applicable CDRH 21CFR subchapter J performance requirements.
The device is designed and manufactured under the Quality System Regulations
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Image /page/12/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a blue circle. The circle has decorative, droplet-like shapes around its perimeter, giving it a distinctive and recognizable appearance.
510(k) Premarket Notification Submission- OEC Elite™ MiniView™
of 21CFR 820.
| Determination | Summary of Engineering Bench Testing: |
|---|---|
| of Substantial | |
| Equivalence: | Verification and validation including hazard mitigation has been executed with |
| results demonstrating the OEC Elite™ MiniView™ system met design input and | |
| user needs. | |
| The system has been NRTL tested 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. The OEC Elite™ | |
| MiniView™ system was developed under the GE Healthcare's design controls | |
| processes, software development life cycle, and overall quality management | |
| system. The following quality assurance measures were applied to the | |
| development of the system: | |
| • Risk Analysis | |
| • Required Reviews | |
| • Design Reviews | |
| • Testing on unit level (Module verification) | |
| • Integration testing (System verification) | |
| • Performance testing (Verification) | |
| • Safety testing (Verification) | |
| • Simulated use testing (Validation) | |
| Additional engineering bench testing was performed including: the non-clinical | |
| testing identified in the guidance for submission of 510(k)s for Solid State X-Ray | |
| Imaging Devices (SSXI); demonstration of system performance; and an imaging | |
| performance evaluation using anthropomorphic phantoms (including a pediatric | |
| anthropomorphic phantom). All of the image quality/performance testing | |
| identified for fluoroscopy found in FDA's “Information for Industry: X-ray | |
| Imaging Devices - Laboratory Image Quality and Dose Assessment, Tests and | |
| Standards" was performed. |
subject device to the predicate was also performed by two independent physicians. A total of nineteen orthopedic procedures across a variety of extremity anatomies were performed using two cadavers. Given that the subject device is indicated for extremity-only use, which is characterized by orthopedic / musculoskeletal-related diagnostic and therapeutic/surgical procedures, it was determined that a human cadaver study was appropriate. For all procedures, the study confirmed the clinical capability and overall quality of the images produced by the OEC Elite™ MiniView™ was at least equivalent to that of the Mini 6800 Digital Mobile C-Arm.
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Image /page/13/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined in a stylized script, enclosed within a circle. There are decorative flourishes resembling water droplets or stylized leaves around the outer edge of the circle. The logo is presented in a blue color.
510(k) Premarket Notification Submission- OEC Elite™ MiniView™
The substantial equivalence was also based on software documentation for a "Moderate" level of concern device.
Clinical Testing:
Cadaver images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device and the bench data provided (bench data was used to compare the modified detector to the reference detector) but they provide further evidence in addition to the laboratory performance data to show that the complete system works as intended. The OEC Elite™ MiniView™ mobile fluoroscopic mini C-arm system did not require live human clinical studies to support substantial equivalence.