The ControlRad™ Trace Model 8, when used with OEC® 9800/OEC® 9800 Plus, is indicated to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace's region of interest (ROI) as compared to the OEC® 9800/OEC® 9800 Plus non-collimated image area. The ControlRad Trace semi-transparent filter should not be used in lieu of the OEC® 9800/OEC® 9800 Plus' collimators, as they block the most radiation, but can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinical applications may include cholangiography, endoscopic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

Device Description

The ControlRad™ Trace Model 8 is an accessory to the cleared OEC 9800/OEC 9800 Plus system. The ControlRad™ Trace Model 8 accessory installed in the OEC 9800/OEC 9800 Plus is a system used to assist trained clinicians. The system is used to provide X-ray images when the clinician performs a medical procedure while reducing the patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace's region of interest (ROI) as compared to the OEC 9800/OEC 9800 Plus non-collimated image area. The ControlRad™ Trace Model 8 can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so.

The ControlRad™ Trace Model 8 consists of the following main components: ControlRad Trace Tablet, ControlRad Trace Filter, ControlRad Hardware, ControlRad Software and Firmware Modules and ControlRad Communication Interface.

AI/ML Overview

The ControlRad™ Trace Model 8 is an accessory to the OEC 9800/OEC 9800 Plus fluoroscopic systems, designed to reduce patient and clinician radiation exposure outside a selected Region of Interest (ROI) while maintaining imaging capability.

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document describes several performance tests. The table below lists the acceptance criteria and the reported performance as described.

Test	Acceptance Criteria	Reported Device Performance
DAP calculation accuracy	Within ±35% of measured DAP values. (For DAP reported by ControlRad™ Trace Model 8)	DAP calculations of the ControlRad™ Trace Model 8 were within ±35% of measured DAP values. (Matches predicate device's overall accuracy of ±40%)
DAP Reduction	At least 50% reduction of the Dose Area Product (DAP) at 50 kVp and ROI with width and length that are smaller than 1/3 the diameter of the full FOV.	The ControlRad™ Trace Model 8 reduces at least 50% of the DAP at 50 kVp and ROI with width and length that are smaller than 1/3 the diameter of the full FOV.
DAP Reduction Accuracy	Within ±35% of measured DAP Reduction values.	DAP Reduction calculations of the ControlRad™ Trace Model 8 were within ±35% of measured DAP Reduction values.
ControlRad Trace Filter Attenuation	To evaluate the attenuation level of the filters. (Specific quantitative criteria not explicitly stated, but the device description mentions typical reduction of 61% to 97%)	Test was performed to evaluate the attenuation level. (Implied to meet expectations based on overall statement: "performed and functioned as intended and observations were as expected.")
Comparative Image Quality Inside the ROI	Image quality within the ROI is at least the same as the OEC 9800/OEC 9800 Plus alone.	Image quality of the OEC 9800/OEC 9800 Plus with installed ControlRad Trace Model 8 within the ROI is of at least with the same image quality compared to the image quality of the OEC 9800/OEC 9800 Plus alone.
Comparative Image Quality Outside the ROI	The filtered image quality outside the ROI provides peripheral image context. (Specific quantitative criteria not explicitly stated regarding perceptual quality, but rather functional context.)	Test was performed to evaluate the filtered image quality outside the ROI and the ability of the filtered image outside the ROI to provide image context. (Implied to meet expectations based on overall statement: "performed and functioned as intended and observations were as expected.")
Image Quality Clinical Simulations	To evaluate image quality inside and outside the ROI and the ability of the filtered image outside the ROI to provide image context. (Reaffirms functional purpose of peripheral image context)	Test was performed to evaluate the image quality inside and outside the ROI and the ability of the filtered image outside the ROI to provide image context. (Implied to meet expectations based on overall statement: "performed and functioned as intended and observations were as expected.")
Touch-In-Gloves Bench Test	Touchscreen operates as intended when using sterile radiation protective gloves and touchscreen drape.	The ControlRad Trace Tablet's touchscreen operates as intended when using sterile radiation protective gloves and touchscreen drape.
Wireless Technology and Cybersecurity	Compliance with FDA Guidance documents titled "Radio Frequency Wireless Technology in Medical Devices" and "Postmarket Management of Cyber Security in Medical Devices".	The evaluation confirmed compliance with the requirements set forth in the specified FDA Guidance documents.
Impact on Air Kerma Test	(Not explicitly stated quantitative acceptance criteria, but generally implied to show the impact is safe and within expected parameters or within acceptable limits).	Test was performed to evaluate the impact on actual Air Kerma (AKR). (Implied to meet expectations based on overall statement: "performed and functioned as intended and observations were as expected.")

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

The provided summary does not specify the sample sizes for any of the performance tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective nature of the data). The tests appear to be conducted as laboratory/bench tests or simulated clinical scenarios rather than involving patient data from a specific geography.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

The document does not provide information on the number of experts used or their qualifications for establishing ground truth, particularly concerning image quality assessments. It mentions "trained clinicians" but does not detail their involvement in ground truth establishment for the performance tests.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

The document does not specify any adjudication method for the test set results, particularly for subjective assessments like image quality.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. The evaluation focused on the device's performance in terms of radiation reduction and image quality, not on human reader improvement with or without AI assistance. The ControlRad Trace Model 8 is not presented as an AI-assisted diagnostic tool but rather a radiation modulation accessory.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device is an accessory to a fluoroscopic system and involves a "clinician-selected ROI." Therefore, its operation inherently involves a "human-in-the-loop." The performance tests evaluate the device's technical capabilities (e.g., DAP reduction, image quality within/outside ROI, calculation accuracy, filter attenuation), which could be considered "standalone" in evaluating the physical and computational aspects of the device itself, but its intended use is always with a human operator. The document does not describe a purely algorithm-only performance evaluation separate from its integration with the OEC system and clinician interaction.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For quantitative measures like DAP and DAP reduction, the "ground truth" was established by measured physical values using appropriate dosimetry equipment. For image quality assessments, it implicitly relies on a comparison to the image quality of the OEC 9800/OEC 9800 Plus alone, suggesting a comparative visual assessment as the basis for "ground truth" for image quality, presumably against a predetermined standard or the predicate device's baseline. There is no mention of expert consensus, pathology, or outcomes data specific to establishing ground truth for these performance tests.

8. The sample size for the training set:

The document does not mention a training set in the context of machine learning or AI models. The ControlRad™ Trace Model 8 is described as an accessory with hardware, software, and firmware modules that control a physical filter and perform image processing based on a user-selected ROI. It does not appear to involve a learning algorithm that would require a distinct training set in the typical AI/ML sense.

9. How the ground truth for the training set was established:

As no training set is described or implied for an AI/ML model, this information is not applicable based on the provided document. The device's operation is based on pre-programmed logic and physical principles rather than learned patterns.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

May 13, 2019

ControlRad, Inc. % Sasha Gelfand QA/RA Director ControlRad, Ltd. 20 HaTaas St. Kfar Saba, 4442520 ISRAEL

Re: K183109

Trade/Device Name: ControlRad™ Trace Model 8 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB. OXO, JAA Dated: March 28, 2019 Received: April 1, 2019

Dear Sasha Gelfand:

We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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

statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K183109

Device Name ControlRad™ Trace Model 8

Indications for Use (Describe)

1 Relative to open Field of View (FOV), the ControlRad Trace Model 8 reduces at least 50% of the Dose Area Product at 50 kVp and ROI with width and length that are smaller than 1/3 the diameter of the full FOV.

Type of Use (Select one or both, as applicable)
Prescription Ise (Part 21 CER 801 Subnart D)	Over_The_Counter I Isa (21 CER 801 Subnart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) SUMMARY

ControlRad, Inc's ControlRad™ Trace Model 8

Applicant's name: ControlRad, Inc. 150 N. Radnor Chester Road Suite F-200 Radnor, PA 19087, USA P: +1 610 977 2422
Sasha Gelfand Contact Person: QA&RA Director ControlRad, Ltd. 20, Hataas Street, Kfar Saba, 4442520, Israel P: +972 72 2512469
Date Prepared: March 21, 2019
Name of Device: ControlRad™ Trace Model 8
Common or Usual Name: Accessory to Image-Intensified Fluoroscopic X-ray System
Classification: Classification Regulation No: 21 CFR §892.1650 Classification Name: Image-intensified fluoroscopic x-ray system Regulation Class: II Classification Panel: Radiology OWB - Interventional fluoroscopic x-ray system Product Code: Primary: Secondary: OXO - Image-Intensified Fluoroscopic X-ray System, Mobile; JAA - System, x-ray, fluoroscopic, image-intensified Predicate Device: GE Healthcare Surgery, OEC® 9800 Plus (K132027)
Reference Device: NuVasive, LessRay™ (K123226)

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

Indications for Use

The ControlRad™ Trace Model 8, when used with OEC 9800/OEC 9800 Plus, is indicated to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace's region of interest (ROI) as compared to the OEC 9800/OEC 9800 Plus non-collimated image area.1 The ControlRad Trace semi-transparent filter should not be used in lieu of the OEC 9800/OEC 9800 Plus' collimators, as they block the most radiation, but can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinical applications may include cholangiography, endoscopic, urologic, orthopedic, vascular, cardiac, critical care and emergency room procedures.

Device Description

Technological Characteristics

The ControlRad™ Trace Model 8 components are installed semi-permanently in the cleared OEC 9800/OEC 9800 Plus, and operate in parallel to the OEC 9800/OEC 9800 Plus. The ControlRad" Trace Model 8 components provide the following functionalities:

The ControlRad Trace Tablet provides the user operational control of the ControlRad" ● Trace Model 8 device via a Graphical User Interface ("GUI"). The ControlRad Trace Tablet

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

enables the clinician to select a Region of Interest ("ROI") on the image displayed on the ControlRad Trace Tablet, which is the image that is displayed on the OEC 9800/OEC 9800 Plus's live monitor.

· The ControlRad Trace Filter is installed on top of the OEC 9800/OEC 9800 Plus's collimator. The ControlRad Trace Filter does not affect or modify the functionality of the OEC collimator. The ControlRad Trace Filter is a semi-transparent filter which reduces the X-ray radiation outside the clinician-selected ROI, typically by 61% to 97%. The actual dose reduction achieved will depend upon specific imaging parameters such as OEC collimator settings, the kVp and the percentage of the OEC non-collimated image covered by the ControlRad Trace Filter.
The ControlRad Hardware, Software and Firmware Modules control the ControlRad Trace . Filter's positioning, which is determined by the location of the clinician-selected ROI, and perform image processing.
. The ControlRad Communication Interface provides communication between the various components of the ControlRad™ Trace Model 8 and between the ControlRad™ Trace Model 8 and the OEC 9800/OEC 9800 Plus.

Principles of Operation

The OEC 9800/OEC 9800 Plus provides an image that its boundaries are defined by the OEC 9800/OEC 9800 Plus's collimator. i.e. the image FOV is defined by the OEC non-collimated region. The image FOV size is not affected or modified by the ControlRad™ Trace Model 8.

Within the OEC 9800/OEC 9800 Plus non-collimated image region, when using a clinician selected Region of Interest ("ROI") on the ControlRad Trace Tablet, the ControlRad Trace Filters reduce radiation exposure outside the ROI. The resulting image has two parts:

The image inside the clinician-selected ROI (unfiltered radiation area in the FOV), which ● has at least the same image quality in the ROI as the OEC 9800/OEC 9800 Plus; and
· The image outside the clinician-selected ROI (filtered radiation area in the FOV), which has a lower-dose processed image, providing peripheral image context to the ROI.

The OEC 9800/OEC 9800 Plus's collimator, when used, also reduces radiation emission. However, that collimator reduces radiation emission by blocking the delivery of radiation to the area covered by the collimator. As a result, the OEC 9800/OEC 9800 Plus's image FOV is limited to the noncollimated region. The ControlRad Trace Filter can be used along with the OEC 9800/OEC 9800 Plus's collimator to further reduce radiation emissions, and the additional radiation reduction provided by the ControlRad Trace Filter will be outside the clinician-selected ROI and within the un-collimated region/image FOV.

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

The clinician has the option not to use the ControlRad Trace Filter. In this case, the OEC 9800/OEC 9800 Plus operates as if the ControlRad Trace Filter was not present. Comparison of Technological Characteristics with the Predicate Device

The ControlRad™ Trace Model 8 for use with OEC 9800/OEC 9800 Plus has the same intended use and the same indications for use of the cleared predicate/parent device, except for the inclusion of the subject accessory's specific function of radiation exposure reduction, which does not affect/modify the predicate parent device's cleared indications for use.

The ControlRad™ Trace Model 8 has different components and thus different technological characteristics than the OEC 9800/OEC 9800 Plus. However, those technological differences do not raise different questions of safety and effectiveness as this accessory raises the same questions as the cleared parent device's collimator component with respect to the system's image FOV, image quality, and radiation emissions. FDA's clearance of Nuvasive's 510(k)-cleared Lessray System (K173314) ("Lessray"), which is an accessory to fluoroscopic systems and a reference device, shows that acceptable methods exist for evaluating whether those technological differences impact the safety and/or effectiveness of the parent device. The performance data demonstrates that the ControlRad™ Trace Model 8 for use with OEC 9800/OEC 9800 Plus is at least as safe and effective as the OEC 9800 Plus. Thus, the ControlRad™ Trace Model 8 when used with OEC 9800/OEC 9800 Plus is substantially equivalent to that parent/predicate device.

A comparison table of technological characteristics of the ControlRad™ Trace Model 8 accessory device for use with GE Healthcare Surgery's OEC 9800 Plus (K132027) compared to those of the predicate/parent device is provided below:

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

Feature	ControlRad, Inc'sControlRad™ Trace Model 8(Subject Device)	GE Healthcare Surgery'sOEC 9800 Plus (K132027)(Predicate Device)
510(k) Number	K183109	K132027
Device Class	Same	Class II
Product Codes	Same	Primary: OWBSecondary: OXO, JAA
Regulation Number	Same	21 CFR §892.1650
Indications for use	The ControlRad™ Trace Model 8, whenused with OEC 9800/OEC 9800 Plus, isindicated to provide fluoroscopic andspot-film imaging of the patient duringdiagnostic, surgical, and interventionalprocedures while reducing patients andclinicians' radiation exposure (Dose AreaProduct) outside of the ControlRadTrace's region of interest (ROI) ascompared to the OEC 9800/OEC 9800Plus non-collimated image area.1 TheControlRad Trace semi-transparent filtershould not be used in lieu of the OEC9800/OEC 9800 Plus' collimators, asthey block the most radiation, but canhelp physicians balance dose reductionwith the need to visualize structuresoutside the ROI when it is consideredclinically advantageous to do so. Clinicalapplications may includecholangiography, endoscopic, urologic,orthopedic, neurologic, vascular, cardiac,critical care and emergency roomprocedures.1 Relative to open Field of View (FOV), theControlRad Trace Model 8 reduces at least50% of the Dose Area Product at 50 kVpand ROI with width and length that aresmaller than 1/3 the diameter of the fullFOV.	The OEC 9800 Plus is designed toprovide fluoroscopic and spot-filmimaging of the patient during diagnostic,surgical and interventional procedures.Clinical application may includecholangiography, endoscopy,urologic, orthopedic, neurologic,vascular, cardiac, critical care andemergency room procedures.
X-ray Modulation
X-ray ModulationComponent	ControlRad Trace Filter	Iris Collimator and Leaves Collimator
X-ray RadiationModulation	Reduces X-ray radiation outside theaperture/ROI typically by 61% to 97%	Completely blocks X-ray radiationoutside the aperture
Aperture shape	Rectangular	Leaf/Leaves: Rectangular-Like(2 straight edges and 2 round edges)Iris: Octagonal.
Aperture Control	Set by the user using the ControlRad TraceTablet	Set by the user using the CollimatorControl buttons on OEC 9800 Plus's C-arm unit control panel
DeviceFeature	ControlRad, Inc'sControlRad™ Trace Model 8(Subject Device)	GE Healthcare Surgery'sOEC 9800 Plus (K132027)(Predicate Device)
	Image Processing
Image Area Processed	Image area outside the ROI	Entire Image
Processing Bits	Same	12 bits
Processing Rate	Same	30 fps
ProcessingOccurrence	Only when the ControlRad Trace Filter isengaged	At all times
Image LayoutInformation	Dose Area Product (DAP) value and /orPercentage of DAP reduction when usingControlRad Trace Filter and/or OECCollimators,ROI frame border;	Hospital, Physician and Patient's name,date and time, X-ray Generator's voltageand current settings, Brightness andContrast settings, Magnification level,Accumulated Exposure Time perExamination, Accumulated Air Kerma;
Parameters Accuracy Specifications
Dose Area Product(DAP) Accuracy	Overall: ±35%For DAP reported by ControlRad™ TraceModel 8	Overall accuracy: ±40%(with Iris Field and Sutter Field > 5cm).
Electrical Requirements
ElectricalRequirements	Same	60/50 Hz; 120 VAC (±10%), 15A200/220/230/240VAC (±10%), 10A.

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

Performance Data

ControlRad conducted the following performance tests to demonstrate that the ControlRad"" Trace Model 8 for use with OEC 9800/OEC 9800 Plus complies with performance standards, functions as intended and is at least as safe and effective as the predicate GE Healthcare Surgery's OEC 9800 Plus:

Impact on Air Kerma Test was performed in order to evaluate the impact of the ControlRad™ Trace Model 8 on actual Air Kerma (AKR) of the OEC 9800/OEC 9800 Plus.
DAP calculation accuracy test was performed to demonstrate that DAP calculations of the . ControlRad™ Trace Model 8 when installed in OEC 9800/OEC 9800 Plus system are within ±35% of measured DAP values.
. DAP Reduction Test was preformed to demonstrate that the ControlRad™ Trace Model 8 when installed in the OEC 9800/OEC 9800 Plus system reduces at least 50% of the DAP at 50 kVp and ROI with width and length that are smaller than 1/3 the diameter of the full FOV.

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

DAP Reduction Accuracy Test was performed to demonstrate that DAP Reduction . calculations of the ControlRad™ Trace Model 8 when installed in OEC 9800/OEC 9800 Plus system are within ±35% of measured DAP Reduction values.
ControlRad Trace Filter Attenuation Test was performed to evaluate the attenuation level . of the filters of the ControlRad™ Trace Model 8.
. Comparative Image Quality Inside the ROI Test was performed to demonstrate that the image quality of the OEC 9800/OEC 9800 Plus with installed ControlRad Trace Model 8 within the ROI is of at least with the same image quality compared to the image quality of the OEC 9800/OEC 9800 Plus alone.
Comparative Image Quality Outside the ROI Test was performed in order to evaluate the . filtered image quality outside the ROI of the OEC 9800/OEC 9800 Plus with installed ControlRad Trace Model 8 in the periphery image outside the ROI compared to the image quality of the OEC 9800/OEC 9800 Plus alone.
. Image Quality Clinical Simulations was preformed to evaluate the image quality inside and outside the ROI and the ability of the filtered image outside the ROI to provide image context to the ROI, of a clinically simulated image obtained by the OEC 9800/OEC 9800 Plus with installed ControlRad™ Trace Model 8.
. Touch-In-Gloves Bench Test was performed in order to demonstrate that the ControlRad Trace Tablet's touchscreen operates as intended when using sterile radiation protective gloves and touchscreen drape.
. Wireless Technology and Cybersecurity Evaluation was performed in order to evaluate the ControlRad™ Trace Model 8's compliance with the requirements set forth in FDA Guidance documents titled "Radio Frequency Wireless Technology in Medical Devices" and "Postmarket Management of Cyber Security in Medical Devices".

In all performance tests the ControlRad™ Trace Model 8 system when installed in OEC 9800/OEC 9800 Plus system performed and functioned as intended and observations were as expected.

{10}------------------------------------------------

Performance Standards

The ControlRad™ Trace Model 8 complies with the following performance standards:

ISO 14971 Medical devices Application of risk management to medical devices ●
IEC 60601-1 Medical Electrical Equipment Part 1: General requirements for safety ●
. IEC 60601-1-2 Medical Electrical Equipment - Part 1-2. Collateral standard: Electromagnetic compatibility - Requirements and tests
. IEC 60601-1-3 Medical Electrical Equipment - Part 1-3: General requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
. IEC 60601-1-6 Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability
IEC 62304 Medical device software – Software life cycle processes
FDA 21 CFR 1020.30-32 Federal Performance Standard for Diagnostic X-ray Systems o

Substantial Equivalence

The ControlRad™ Trace Model 8 for use with OEC 9800/OEC 9800 Plus has the same intended use and the same indications for use of the cleared predicate/parent device (K132027), except for the inclusion of the subject accessory's specific function exposure reduction, which does not affect/modify the predicate parent device's cleared indications for use. The ControlRad™ Trace Model 8 has different technological characteristics than the GE Healthcare Surgery's OEC 9800 Plus (K132027), however those technological differences do not raise different questions of safety and effectiveness. Performance data demonstrate that the ControlRad™ Trace Model 8 for use with OEC 9800/OEC 9800 Plus is at least as safe and effective as the OEC 9800 Plus (K132027). Thus, the ControlRad™ Trace Model 8 when used with OEC 9800/OEC 9800 Plus is substantially equivalent to that parent/predicate device.

Regulation Number and Section

§ 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.