(153 days)
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™ 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 OEC Elite™ MiniView™ is a mobile fluoroscopic mini C-arm system. The provided document is a 510(k) Premarket Notification Submission, which focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria in the typical sense of a clinical trial for a novel AI device. However, based on the information provided, we can extract details about the performance evaluation done to demonstrate this equivalence.
Here's an analysis based on the provided text, structured according to your request:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with corresponding performance metrics like sensitivity, specificity, or AUC as one might find for an AI diagnostic algorithm. Instead, the evaluation focuses on demonstrating that the performance of the proposed device (OEC Elite™ MiniView™) is at least equivalent to the predicate device (OEC Mini 6800 Digital Mobile C-arm) and reference devices in terms of image quality and clinical capability.
The "acceptance criteria" here implicitly revolve around ensuring the safety and effectiveness of the updated device, which includes:
- Meeting design input and user needs.
- Compliance with regulatory standards (IEC 60601-1 Ed.3 series, IEC 60601-2-54, IEC 60601-2-43, and 21CFR Subchapter J performance standards).
- Image quality and clinical capability at least equivalent to the predicate device.
| Performance Aspect | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Overall Performance | System meets design input, user needs, and regulatory standards; image quality and clinical capability at least equivalent to predicate. | "The system has been NRTL tested and certified compliant... All applicable 21CFR Subchapter J performance standards are met. The OEC Elite™ MiniView™ system was developed under the GE Healthcare's design controls processes... and additional engineering bench testing was performed... to demonstrate system performance." |
| Image Quality | Image quality metrics (e.g., resolution, noise reduction) are adequate for viewing extremities and are at least equivalent to predicate/reference devices. | Pixel Size: Proposed Device: 100 Microns. (Reference Device: 75 Microns). Reported: "larger for reducing image noise. The resolution is higher than the Image Intensifier on the predicate."Array Size: Proposed Device: 1.3k x 1.3k. Reported: "adequate for viewing extremities."Field Size: Proposed Device: Full Field 13 cm circle, Limited Field 10 cm circle. Reported: "appropriate for viewing extremities." |
| Clinical Capability | Demonstrated ability to provide fluoroscopic visualization in diagnostic/therapeutic/surgical procedures of limbs/extremities/shoulders equivalently to the predicate. | Cadaver study results: "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." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document mentions a cadaver study involving two cadavers on which nineteen orthopedic procedures were performed across a variety of extremity anatomies.
- Data Provenance: The cadaver study was performed as part of the submission process, implying it was a prospective evaluation specifically for this device. The country of origin of the cadavers is not specified in the provided text.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: Two independent physicians were used to evaluate the images.
- Qualifications of Experts: The document states they were "two independent physicians", and given the nature of the device (fluoroscopic imaging for orthopedic procedures), it's highly probable these were orthopedic surgeons or radiologists with expertise in musculoskeletal imaging and procedures. However, their specific specializations or years of experience are not explicitly stated in the provided text.
4. Adjudication Method for the Test Set
The document states: "The performance of the subject device to the predicate was also performed by two independent physicians." It further states that 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." This implies a consensus or comparative evaluation by the two physicians. However, a specific adjudication method (e.g., 2+1, 3+1, etc.) is not explicitly detailed. It's presented as a direct comparison where both physicians apparently agreed on the equivalence.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- Not a typical MRMC study: The evaluation described is not a traditional MRMC comparative effectiveness study focused on quantifying human reader improvement with AI assistance. This device is an imaging system (hardware and software for image acquisition and processing), not an AI-powered diagnostic aide designed to improve human reader performance for a specific task.
- Focus on System Equivalence: The study aimed to demonstrate the system's overall clinical capability and image quality equivalence to a predicate device, as evaluated by human readers (the two physicians), rather than measuring the effect size of AI assistance on human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Standalone "Algorithm" Performance: The device itself is an imaging system, not purely an algorithm. Its performance is inherent in the images it produces. Therefore, "standalone" in this context refers to the system's ability to produce diagnostically acceptable images.
- Bench Testing and Image Quality Tests: The document details extensive "engineering bench testing" and "image quality/performance testing" identified for fluoroscopy. These tests evaluate the system's technical image output without human interpretation as the primary endpoint. This can be considered the equivalent of "standalone" performance for an imaging device. Specifically mentioned are:
- Demonstration of system performance.
- Imaging performance evaluation using anthropomorphic phantoms (including a pediatric anthropomorphic phantom).
- All image quality/performance testing identified for fluoroscopy in FDA's "Information for Industry: X-ray Imaging Devices - Laboratory Image Quality and Dose Assessment, Tests and Standards" was performed.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
- For the Cadaver Study (Test Set): The ground truth for evaluating clinical capability and image quality seems to be based on expert consensus (or agreement) between the two independent physicians regarding the equivalence of the images produced by the OEC Elite™ MiniView™ compared to the predicate device for diagnostic and procedural guidance in the cadaveric setting. There is no mention of pathology or outcomes data for this specific evaluation, as it's a technical performance and clinical utility assessment on cadavers.
- For Bench Testing: The ground truth for bench testing and phantom studies would be defined by known physical properties of the phantoms and established engineering specifications and standards for image quality metrics.
8. The Sample Size for the Training Set
The document describes a medical imaging device (C-arm), not an AI algorithm that requires a separate training set. Therefore, the concept of a "training set sample size" as typically applied to machine learning models is not applicable here. The device's underlying technology and software architecture are based on existing, proven designs (predicate and reference devices), with modifications validated through engineering bench tests and the cadaver study.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, there is no explicit "training set" in the context of an AI algorithm described in this document. The device's development involved standard engineering practices, which could be considered an iterative design and testing process that refines the system's performance. The "ground truth" during this development would be based on engineering specifications, performance targets, and established imaging principles, rather than a labeled dataset for training an AI model.
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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
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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
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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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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/ManufacturingLocation | GE Hangwei Medical Systems, Co. Ltd |
| No. 1 Yongchang North Road | |
| Beijing Economic & Technological Development, | |
| Beijing P.R. 100176 China | |
| PrimaryContactPerson: | Lifeng Wang |
| Regulatory Affairs Leader | |
| GE Hangwei Medical Systems, Co. Ltd | |
| +86 10 58068888-70252 | |
| Lifeng.Wang@ge.com | |
| SecondaryContactPerson: | 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 TradeName: | OEC Elite™ MiniView™ |
| Common/UsualName: | Fluoroscopic X-Ray System, MobileMini 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 builtupon the existing technologies of the predicate device OEC Mini 6800 (K992506and reference devices. It is of comparable type and substantially equivalent to itspredicate device OEC Mini 6800 and the identified reference devices HologicInsight- FD Mini C-arm and OEC Brivo Series. The intended use has notchanged. The proposed device's indications for use have been revised to betteralign with actual patient populations and the system capabilities as substantiatedin 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 SystemK123603 GE's OEC Brivo Series |
| Device Description: | The OEC Elite™ MiniView™ is a mobile fluoroscopic mini C-arm system thatprovides fluoroscopic images of patients of all ages during diagnostic, treatment,and surgical procedures of the shoulders, limbs, and extremities. The systemconsists 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 forimage 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 thepatient extremity anatomy to be imaged. The C and support arm aremechanically balanced allowing for ease of movement and capable of being"locked" in place using an electronically controlled braking system. Theworkstation is a stable mobile platform that supports the C-arm, image displaymonitor(s), image processing equipment/software, recording devices, datainput/output devices and power control systems. |
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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.
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- 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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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 6800Digital Mobile C-arm K992506 | OEC Elite™MiniView™ | ||
| Monitor | > Dual 16" CRTMonitors with1000 lineresolution | > Dual 19"MonochromeLCDMonitorswith 1280 x1024resolution | Substantially EquivalentThe monitor displays on theproposed device has beenupdated to a LCD monitors.This change was driven byIT technology advancementby using a more state of theart display technology whichis considered adequate forviewing extremities andrepresents an improvementover the CRT monitors ofthe predicate device and thischange did not raise any newsafety and effectivenessconcerns. |
| Displayarticulation | > Fixed | > Smallextensionwith 450°swivel | Substantially EquivalentThe proposed device hasadded display articulation, toimprove workflow for theend user allowing themonitor to be extended androtated +180/-270 degrees.This change did not raiseany new safety andeffectiveness concerns. |
| PowerFailureProtection | > N/A | > BackupBattery | Substantially EquivalentThe proposed device hasadded a backup battery toprotect the data integrity inhard disk drive when thedevice receives a sudden lossof power. It also allows forlimited additional exposuretime for the ability to |
Table 1 Significant Differences between OEC Elite™ MiniView™ and OEC Mini 6800 Digital Mobile C-arm(K992506)
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| controllably exit or finish anin-progress procedure.This change did not raiseany new safety andeffectiveness concerns. | |||||
|---|---|---|---|---|---|
| PhysicalDimensions | > | Depth: 17.7"(45 cm)Free Space:13.8" (35 cm)OrbitalRotation: 115°LateralRotation: +/- 220°VerticalTravel: 27" (70cm)PanningMotion: 365° | > | Depth: 18"(46 cm)Free Space:13.4" (34 cm)PivotingOrbitalRotation:120°LateralRotation:380°HorizontalTravel: 77.2"(196 cm)VerticalTravel: 33.4"(85cm)PanningMotion: 366° | Substantially EquivalentThe proposed deviceimproved the physicaldimensions for workflowpurposes by incorporating apivoting orbital rotationmotion. All design changesmeet IEC safety criteria.This change did not raiseany new safety andeffectiveness concerns. |
| ImageStorage | > | 800 Images | > | 100,000Images | Substantially EquivalentThe proposed device hasenhanced the system'sstorage ability to store moreimages. This change did notraise any new safety andeffectiveness concerns. |
| RemovableDataStorage | > | Floppy disk | > | USB port | Substantially EquivalentThe proposed device hasupdated the technology toincorporate a USB port toaccommodate standard dataretrieval storage and exportneeds. This change wasdriven by IT technologyadvancement by using amore state of the art mediawhich is the USB instead ofthe out of date floppy diskwhich is not used by theindustry any more. |
| This change did not raiseany new safety andeffectiveness concerns. | |||||
| Dose AreaProduct(DAP) | > | N/A | > | Dose AreaProduct(DAP) | Substantially EquivalentThe proposed device hasadded the ability for thephysician to see the DAPdisplayed for each exam. |
| This change did not raiseany new safety andeffectiveness concerns. | |||||
| ImagingFeatures | > | Auto X-Raytechniquecontrol | > | Auto X-Raytechniquecontrol | Substantially EquivalentThe proposed deviceprovides AutoTrak feature toautomatically seek anatomyin the imaging field andselect optimal technique toreduce the need for takingadditional X-ray images. |
| > | Noise andmotionreduction | > | Noise andmotionreduction | ||
| > | Auto/ManualBrightness andContrastControl | > | Auto/ManualBrightnessand ContrastControl | ||
| > | Negate | > | Negate | This is a workflowimprovement and did notraise new safety andeffectiveness concerns. | |
| > | Swap andauto-swap | > | Swap andauto-swap | ||
| > | Save and auto-save | > | Save andauto-save | ||
| > | Last imagehold | > | Last imagehold | ||
| > | Edgeenhancement | > | Edgeenhancement | ||
| > | Zoom & Roam | > | Zoom &Roam | ||
| > | Image rotation | > | Imagerotation | ||
| > | Image flip/invertSmart Metal | > | Image flip/invertSmart MetalAutoTrak |
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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.
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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 ofDifferences | |
|---|---|---|---|
| OEC Brivo MobileC-arm - K123603 | OEC Elite™MiniView™ | ||
| Software | 64-bit Linux, witha Windows-likeoperating system | 64-bit Linux, with aWindows-likeoperating system | SubstantiallyEquivalent |
| Arbitrated InternalCommunication | Arbitrated InternalCommunication | The operating system isa contemporarysoftware OS commonin current medicaldevices. The proposeddevice's softwareplatform is based on thereference device OECBrivo (K123603)software platform withmodificationsspecifically made tosupport the proposeddevice's COMSdetector and associatedchanges. Leveragingthe OEC Brivo softwareplatform and makingnecessary modificationsdid not raise any newsafety or efficacyconcern and isdetermined to besubstantiallyequivalent. | |
| Windows like userinterface | Windows like userinterface | ||
| Connectivity | Ethernet WiredWireless (Optional) | Ethernet WiredWireless (Optional) | SubstantiallyEquivalentBoth devices offer awireless adaptor meantfor DICOMcommunication withthe archiving systemssuch as PACS and RIS,and DICOM printers onthe hospital's private |
Table 2 Significant Differences between OEC Elite™ MiniView™ and OEC Brivo Mobile C-arm (K123603) device
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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 | |||
|---|---|---|---|
| ReferenceDevice | ProposedDevice | Discussion of Differences | |
| Hologic® | OEC Elite™ | ||
| Insight-FD MiniC-ArmFluoroscopicImaging SystemK120388 | MiniView™ | ||
| ImageReceptor | CMOS FlatPanel Detector | CMOS FlatPanel Detector | Substantially EquivalentThe proposed device uses |
Image /page/10/Picture/6 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 three white swirls around the outside of the circle. The logo is simple and recognizable, representing the company's brand identity.
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Image /page/11/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters 'GE' intertwined within a circle. There are decorative swirls emanating from the circle at the top, bottom, left, and right. The logo is a light blue color.
510(k) Premarket Notification Submission- OEC Elite™ MiniView™
| same CMOS flat paneltechnology. The change to aflat panel detector does notaffect the safety or efficacy ofthe device. | ||
|---|---|---|
| Pixel Size: 75Microns | Pixel Size:100Microns | Substantially Equivalent:The proposed device's pixelsize is larger for reducingimage noise. The resolution ishigher than the ImageIntensifier on the predicate.The difference does not affectthe safety or efficacy of thedevice. |
| Array Size: 2k x1.5k | Array Size:1.3k x 1.3k | Substantially EquivalentThe array size gives a 5 inchsquare detector which isadequate for viewingextremities. The differencedoes not affect the safety orefficacy of the device. |
| Full Field: 14.5cm x 11.5 cm(5.7" x 4.5")Limited Field:11 cm (4.3")square | Full Field: 13cm (5.1")circleLimited Field:10 cm (4")circle | Substantially EquivalentFull field and limited fieldsizes in proposed device areslightly smaller than thereference device Hologic®Insight-FD K120388. Thesesizes are appropriate forviewing 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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510(k) Premarket Notification Submission- OEC Elite™ MiniView™
of 21CFR 820.
| Determination | Summary of Engineering Bench Testing: |
|---|---|
| of SubstantialEquivalence: | Verification and validation including hazard mitigation has been executed withresults demonstrating the OEC Elite™ MiniView™ system met design input anduser needs. |
| The system has been NRTL tested and certified compliant with the IEC 60601-1Ed. 3 series, including IEC60601-2-54 and IEC 60601-2-43. All applicable21CFR Subchapter J performance standards are met. The OEC Elite™MiniView™ system was developed under the GE Healthcare's design controlsprocesses, 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-clinicaltesting identified in the guidance for submission of 510(k)s for Solid State X-RayImaging Devices (SSXI); demonstration of system performance; and an imagingperformance evaluation using anthropomorphic phantoms (including a pediatricanthropomorphic 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 andStandards" 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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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.
Based on the successful verification and validation testing, additional bench Conclusion: testing, the cadaver study, conformance to standards, and development under GE Healthcare's quality system, GE Healthcare believes that the OEC Elite™ MiniView™ is of comparable type and substantially equivalent to the predicate device OEC Mini 6800(K992506) with support from the reference devices, and therefore is safe and effective for its intended use.
§ 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.