The ControlRad™ Trace Model 9, when used with OEC® 9900 Elite, 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 OEC® 9900 Elite non-collimated image area. 1 The ControlRad Trace semi-transparent filter should not be used in lieu of the OEC® 9900 Elite's collimators, as they block the most radiation, but can help physicians balance dose visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

1 Relative to open Field of View (FOV), the ControlRad Trace Model 9 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.

Device Description

The ControlRad™ Trace Model 9 consists of the following main components: ControlRad Trace Tablet, ControlRad Trace Filter, ControlRad Hardware, ControlRad Software and Firmware Modules and ControlRad Communication Interface all installed on the OEC 9900 Elite. The ControlRad™ Trace Model 9 is a system used to assist trained clinicians which 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 9900 Elite non-collimated image area. The ControlRad™ Trace Model 9 can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the ControlRad™ Trace Model 9, based on the provided text:

Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance	Study Proving Performance (from text)
Reduces at least 50% 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 Field of View (FOV).	The ControlRad™ Trace Model 9, when installed on the OEC 9900 Elite, reduces at least 50% of the DAP at 50kVp and ROI with width and length are smaller than 1/3 the diameter of the full FOV.	DAP Reduction Accuracy Test: "DAP Reduction Accuracy Test was performed to demonstrate that DAP Reduction calculations of the ControlRad™ Trace Model 9 when installed in GE Healthcare Surgery's OEC 9900 Elite system are within ±35% of the DAP Reduction values."
DAP calculations are within ±35% of measured DAP values.	DAP calculations of the ControlRad™ Trace Model 9 when installed in GE Healthcare Surgery's OEC 9900 Elite system are within ±35% of measured DAP values.	Dose-Area-Product (DAP) calculation accuracy test: "Dose-Area-Product (DAP) calculation accuracy test was performed to demonstrate that DAP calculations of the ControlRad™ Trace Model 9 when installed in GE Healthcare Surgery's OEC 9900 Elite system are within ±35% of measured DAP values."
Image quality inside the Region of Interest (ROI) is at least the same as the OEC 9900 Elite alone.	The image inside the clinician-selected ROI has at least the same image quality in the ROI as the GE Healthcare Surgery's OEC® 9900 Elite (K122234).	Comparative Image Quality inside the ROI Test: "Comparative Image Quality inside the ROI Test was performed to demonstrate that the image quality of the OEC 9900 Elite with installed ControlRad Trace Model 8 within the ROI is of at least the same image quality compared to the image quality of the OEC 9900 Elite alone."
The filtered image quality outside the ROI provides peripheral image context to the ROI.	The image outside the clinician-selected ROI is a lower-dose processed image which provides peripheral image context to the ROI.	Comparative Image Quality outside the ROI Test: "Comparative Image Quality outside the ROI Test was performed in order to evaluate the filtered image quality outside the ROI of the OEC 9900 Elite with installed ControlRad Trace Model 9 in the periphery image outside the ROI compared to the image quality of the OEC 9900 Elite alone."Image Quality Clinical Simulations: "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 GE Healthcare Surgery's OEC® 9900 Elite with installed ControlRad™ Trace Model 9."
The CR Trace Tablet's touchscreen operates as intended when using sterile radiation protective gloves and touchscreen drape.	The CR Trace Tablet's touchscreen operates as intended when using sterile radiation protective gloves and touchscreen drape.	Touch-In-Gloves Bench Test: "Touch-In-Gloves Bench Test was performed in order to demonstrate that the CR Trace Tablet's touchscreen operates as intended when using sterile radiation protective gloves and touchscreen drape."
Filter motion reliability	Filter motion reliability was tested due to changes in assembly.	Filter motion reliability testing: "Filter motion reliability testing was performed due to changes in assembly of the Trace 9 filter."
Compliance with wireless technology and cybersecurity requirements.	The ControlRad™ Trace Model 9's compliance was evaluated.	Wireless Technology and Cybersecurity Evaluation: "Wireless Technology and Cybersecurity Evaluation was performed in order to evaluate the ControlRad™ Trace Model 9'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'."
Compliance with IEC 60601-1 for instability in transport position and from horizontal/vertical forces.	The device was tested to ensure compliance with IEC 60601-1 around instability.	Instability test: "Due to weight changes with the workstation, an instability test was performed to ensure compliance with IEC 60601-1 Instability in transport position and Instability from horizontal and vertical forces clauses."

Study Details

The provided document describes various performance tests conducted by ControlRad to demonstrate the safety and effectiveness of the ControlRad™ Trace Model 9. However, it does not detail specific study methodologies with the level of granularity requested for some fields (e.g., exact sample sizes for test sets, data provenance, ground truth establishment for training data, MRMC studies). The tests described are primarily bench tests and clinical simulations rather than large-scale clinical trials with human readers.

Here's what can be extracted:

Sample size used for the test set and the data provenance: Not explicitly stated for each test. The studies appear to be retrospective in the sense that they are engineering performance tests and simulations rather than prospective patient studies. The data provenance is implied to be from testing conducted by ControlRad, Inc.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not explicitly stated. For image quality evaluations, the text mentions "clinically simulated image" and "ability of the filtered image outside the ROI to provide image context to the ROI", implying expert review, but the number and qualifications are not specified.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not explicitly stated.
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: No MRMC comparative effectiveness study involving human readers and AI assistance is described. The image quality tests are comparative to the OEC 9900 Elite alone, not comparing human performance with and without the device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The described tests are largely standalone performance evaluations of the device's capabilities (e.g., DAP reduction accuracy, attenuation, filter motion). The "Image Quality Clinical Simulations" also assessed algorithm performance in generating the filtered image and its ability to provide context.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For DAP measurements: Measured DAP values (using a dosimeter or similar equipment)
- For image quality: Likely expert visual assessment against the baseline OEC 9900 Elite images. The term "clinically simulated image" suggests a controlled environment for evaluation.
- For touchscreen and filter motion: Functional verification against expected operational behavior.
The sample size for the training set: Not applicable and not mentioned. This device is an X-ray system enhancement with a filter and image processing, not a machine learning model that requires a "training set" in the conventional sense for image interpretation. The device's software is based on algorithms that modify X-ray output and image display.
How the ground truth for the training set was established: Not applicable, as there's no mention of a traditional machine learning training set.

Summary

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June 24, 2020

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.

ControlRad, Inc. % Linda Braddon, Ph.D. Regulatory Consultant Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 WOODSTOCK GA 30188

Re: K200663

Trade/Device Name: ControlRad™ Trace Model 9 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, OXO, JAA Dated: April 9, 2020 Received: April 10, 2020

Dear Dr. Braddon:

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. 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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

For

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K200663

Device Name

ControlRad™ Trace Model 9

Indications for Use (Describe)

Type of Use (Select one or bothas applicable)

図 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. *

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

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

"An aqency 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."

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-6740

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Image /page/3/Picture/0 description: The image shows the logo for ControlRad. The logo is in green and white. The word "CONTROL" is in dark green, and the word "RAD" is in light green. There is a green circle around the "RAD" part of the logo.

510(k) SUMMARY

ControlRad, Inc's ControlRadTM Trace Model 9

K200663

Applicant's name:	ControlRad, Inc.275 Scientific Dr NWSuite 1100Norcross, Georgia 30092, USAP: 1-800-522-5148
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Contact Person: Linda Braddon, Ph.D. Secure BioMed Evaluations 7828 Hickory Flat Hwy Suite 120 Woodstock, GA 30188 770-837-2681 Regulatory@SecureBME.com
Date Prepared: June 15, 2020

Subject Device:

Device Name	ControlRad™ Trace Model 9
Common Name	Interventional Fluoroscopic X-ray System
Regulation	21 CFR §892.1650
Classification Name	Image-intensified fluoroscopic x-ray system
Class	II
Panel	Radiology
Product Code(s)	Primary: OWBSecondary: OXO, JAA

Predicate Device:

Device Name	ControlRad™ Trace Model 8 (K183109)
Common Name	Interventional Fluoroscopic X-ray System
Regulation	21 CFR §892.1650
Classification Name	Image-intensified fluoroscopic x-ray system
Class	II
Panel	Radiology
Product Code(s)	Primary: OWBSecondary: OXO, JAA

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Image /page/4/Picture/0 description: The image shows the logo for ControlRad. The logo consists of the word "CONTROL" in dark teal, followed by "RAD" in a lighter green. To the right of "RAD" is a circular design with a dark teal lower half and a light green upper half. The letters "RAD" are integrated into the circular design, and there is a trademark symbol to the upper right of the logo.

Reference Device:

GE Healthcare Surgery, OEC® 9900 Elite (K122234) Device Name Common Name Interventional Fluoroscopic X-ray System Regulation 21 CFR §892.1650 Classification Name Image-intensified fluoroscopic x-ray system Class II Radiology Panel Product Code(s) Primary: OWB Secondary: OXO, JAA

Indications for Use

The ControlRad™ Trace Model 9, when used with OEC® 9900 Elite, 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 OEC® 9900 Elite noncollimated image area.1 The ControlRad Trace semi-transparent filter should not be used in lieu of the OEC® 9900 Elite's 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, neurologic, vascular, cardiac, critical care and emergency room procedures.

Device Description

Technological Characteristics

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Image /page/5/Picture/0 description: The image shows the logo for ControlRad. The logo consists of the word "CONTROL" in a bold, sans-serif font, followed by the word "RAD" in a similar font but with a green color. To the right of "RAD" is a stylized green circle, partially enclosing the letters "RAD", with a darker green section at the bottom. There is a trademark symbol to the right of the word "RAD".

The ControlRad" Trace Model 9 components are installed semi-permanently in the cleared GE Healthcare Surgery's OEC® 9900 Elite (K122234) and operate in parallel to the GE Healthcare Surgery's OEC® 9900 Elite. The removal of the ControlRad™ components will restore the device to OEM specifications.

The ControlRad™ Trace Model 9 components provide the following functionalities:

The CR Trace Tablet provides the user operational control of the ControlRad™ Trace . Model 9 device via a Graphical User Interface ("GUI"). The CR Trace Tablet enables the clinician to select a Region of Interest ("ROI") on the image displayed on the CR Trace Tablet, which is the same image that is displayed on the GE Healthcare Surgery's OEC® 9900 Elite's live monitor.
. The CR Trace Filter is installed on top of the GE Healthcare Surgery's OEC® 9900 Elite's collimator. The CR Trace Filter does not affect or modify the functionality of the collimator. The CR 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 9 and between the ControlRad™ Trace Model 9 and the GE Healthcare Surgery's OEC® 9900 Elite.

Principles of Operation

The GE Healthcare Surgery's OEC® 9900 Elite provides an image that its boundaries are defined by the OEC® 9900 Elite'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 9.

Within the OEC® 9900 Elite 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 GE Healthcare Surgery's OEC® 9900 Elite (K122234); and

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Image /page/6/Picture/0 description: The image shows the logo for ControlRad. The logo consists of the word "CONTROL" in a dark teal sans-serif font, followed by "RAD" in a lighter green color. To the right of "RAD" is a circular design with two shades of green, creating a stylized "C" shape. The letters and the circular design are aligned horizontally.

. The image outside the clinician-selected ROI (filtered radiation area in the FOV), a lowerdose processed image which provides peripheral image context to the ROI.
The GE Healthcare Surgery's OEC® 9900 Elite'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 GE Healthcare Surgery's OEC® 9900 Elite's image FOV is limited to the non-collimated region. The ControlRad Trace Filter can be used along with the GE Healthcare Surgery's OEC® 9900 Elite'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.

The clinician has the option not to use the CR Trace Filter. In this case, the GE Healthcare Surgery's OEC® 9900 Elite operates as if the CR Trace Filter was not present.

Comparison of Technological Characteristics with the Predicate devices

The ControlRad™ Trace Model 9 for use with GE Healthcare Surgery's OEC® 9900 Elite has the same intended use and the same indications for use as the cleared predicate. The ControlRad™ Trace Model 9 is identical in construction to the predicate with the only modifications being the design differences to work with OEC® 9900 Elite. The performance data demonstrates that the ControlRad™ Trace Model 9 is at least as safe and effective as the predicate and reference devices and is substantially equivalent to the predicate and reference devices. A comparison table of technological characteristics of the ControlRad™ Trace Model 9 device for use with OEC® 9900 Elite compared to those of the predicates is provided below:

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Image /page/7/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in a bold, sans-serif font in a dark teal color. To the right of the word "CONTROL" is the word "RAD" in a lighter green color, with a circle around it that is also green. The letters "RAD" are also in a bold, sans-serif font.

DeviceFeature510(k) Number	ControlRad, Inc'sControlRad™ TraceModel 9(Subject Device)K200663	ControlRad, Inc'sControlRad™ TraceModel 8(K183109)(Predicate Device)K183109	GE HealthcareSurgery'sOEC 9900 Elite(K122234)(Reference)K122234
Device Class	Class II	Class II	Class II
Product Codes	Primary: OWBSecondary: OXO, JAA	Primary: OWBSecondary: OXO, JAA	Primary: OWBSecondary: OXO, JAA
Regulation Number	21 CFR §892.1650	21 CFR §892.1650	21 CFR §892.1650
Indications for use	The ControlRad™ Trace Model9, when used with OEC® 9900Elite, is indicated to providefluoroscopic and spot-filmimaging of the patient duringdiagnostic, surgical, andinterventional procedures whilereducing patients and clinicians'radiation exposure (Dose AreaProduct) outside of theControlRad Trace's region ofinterest (ROI) as compared toOEC® 9900 Elite non-collimated image area.1 TheControlRad Trace semi-transparent filter should not beused in lieu of the OEC® 9900Elite's collimators, as theyblock the most radiation, butcan help physicians balancedose reduction with the need tovisualize structures outside theROI when it is consideredclinically advantageous to doso. Clinical applications mayinclude cholangiography.endoscopic, urologic,orthopedic, neurologic,vascular, cardiac, critical careand emergency roomprocedures.1Relative to open Field of View(FOV), the ControlRad TraceModel 9 reduces at least 50% ofthe Dose Area Product at 50kVp and ROI with width andlength that are smaller than 1/3the diameter of the full FOV.	The ControlRad™ Trace Model8, when used with OEC®9800/OEC® 9800 Plus, isindicated to providefluoroscopic and spot-filmimaging of the patient duringdiagnostic, surgical, andinterventional procedures whilereducing patients and clinicians'radiation exposure (Dose AreaProduct) outside of theControlRad Trace's region ofinterest (ROI) as compared tothe OEC® 9800/OEC® 9800Plus non-collimated imagearea.1 The ControlRad Tracesemi-transparent filter shouldnot be used in lieu of theOEC® 9800/OEC® 9800 Plus'collimators, as they block themost radiation, but can helpphysicians balance dosereduction with the need tovisualize structures outside theROI when it is consideredclinically advantageous to doso. Clinical applications mayinclude cholangiography,endoscopic, urologic,orthopedic, neurologic,vascular, cardiac, critical careand emergency roomprocedures.1Relative to open Field of View(FOV), the ControlRad TraceModel 8 reduces at least 50%of the Dose Area Product at 50kVp and ROI with width andlength that are smaller than 1/3the diameter of the full FOV.	The OEC® 9900 Elite isdesigned to providefluoroscopic and spot-filmimages of the patient duringdiagnostic, surgical andinterventional procedures.Examples of clinicalapplication may includecholangiography, endoscopy,urologic, orthopedic,neurologic, vascular, cardiac,critical care and emergencyroom procedures.
X-ray Modulation
X-ray ModulationComponent	CR Trace Filter	CR Trace Filter	Iris Collimator andSemitransparentLeaf/Leaves Collimator
Device	ControlRad, Inc'sControlRad™ TraceModel 9(Subject Device)	ControlRad, Inc'sControlRad™ TraceModel 8(K183109)(Predicate Device)	GE HealthcareSurgery'sOEC 9900 Elite(K122234)(Reference)
Feature
X-ray RadiationModulation	Reduces X-ray radiationoutside the aperture/ROItypically by 61% to 97%	Reduces X-ray radiationoutside the aperture/ROItypically by 61% to97%	Completely blocks X-ray radiation outside theaperture
Aperture shape	Rectangular	Rectangular	Leaf/Leaves:Rectangular-Like(2 straight edges and 2round edges)Iris: Octagonal.
Aperture Control	Set by the user using theCR Trace Tablet	Set by the user using theCR Trace Tablet	Set by the user using theCollimator Controlbuttons on GEHealthcare Surgery'sOEC® 9900 Elite's c-arm unit control panel
Image Processing
Image AreaProcessed	Image area outside theROI	Image area outside theROI	Entire Image
Processing Bits	12 bits	12 bits	12 bits
Processing Rate	30 fps	30 fps	30 fps
ProcessingOccurrence	Only when the CRTrace Filter is engaged	Only when the CRTrace Filter is engaged	At all times
Image LayoutInformation	Dose Area Product(DAP) value and/orpercentage of DAPreduction when usingControlRad Trace Filterand/or OEC CollimatorsROI frame border	Dose Area Product(DAP) value and/orpercentage of DAPreduction when usingControlRad Trace Filterand/or OEC CollimatorsROI frame border	Hospital, Physician andPatient's name, date andtime, X-ray Generator'svoltage and currentsettings, Brightness andContrast settings,Magnification level,Accumulated ExposureTime per Examination,Accumulated Air Kerma
Parameters Accuracy Specifications	Dose Area Product(DAP) Accuracy fortotal x-ray field ofthe ControlRadTrace Filter andOEC systemscombined*	*Overall: ±35%For DAP reported byControlRad™ TraceModel 9	*Overall: ±35%For DAP reported byControlRad™ TraceModel 8	Overall accuracy: ±40%(with Iris Field andSutter Field > 5cm).
Electrical Requirements	ElectricalRequirements	60 / 50 Hz; 120 VAC(±10%), 15A	60 / 50 Hz; 120 VAC(±10%), 15A	60 / 50 Hz; 120 VAC(±10%), 15A
DeviceFeature	ControlRad, Inc'sControlRad™ TraceModel 9(Subject Device)	ControlRad, Inc'sControlRad™ TraceModel 8(K183109)(Predicate Device)	GE HealthcareSurgery'sOEC 9900 Elite(K122234)(Reference)
	200/220/230/240VAC(±10%), 10A.	200/220/230/240VAC(±10%), 10A.	200/220/230/240VAC(±10%), 10A.

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Image /page/8/Picture/0 description: The image shows the logo for ControlRad. The logo consists of the word "CONTROL" in a dark green sans-serif font, followed by "RAD" in a lighter green font. To the right of the word "RAD" is a green circle that is broken into two parts, with the top part being a lighter green and the bottom part being a darker green. The letters "RAD" are partially inside the circle.

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Image /page/9/Picture/0 description: The image shows the logo for ControlRad. The logo consists of the word "CONTROL" in a dark green sans-serif font, followed by the word "RAD" in a lighter green sans-serif font. To the right of the word "RAD" is a green circle with a break in the upper right quadrant. The circle is made up of two shades of green, with the darker shade on the bottom and the lighter shade on the top.

Performance Data

ControlRad conducted the following performance tests to demonstrate that the ControlRad"" Trace Model 9 for use with GE Healthcare Surgery's OEC® 9900 Elite complies with performance standards, functions as intended and is at least as safe and effective as the predicate GE Healthcare Surgery's OEC® 9900 Elite:

. Impact on Air Kerma Test was performed in order to evaluate the impact of the ControlRad™ Trace Model 9 on Air Kerma (AKR) measurements of GE Healthcare Surgery's OEC 9900 Elite.
Dose-Area-Product (DAP) calculation accuracy test was performed to demonstrate that . DAP calculations of the ControlRad™ Trace Model 9 when installed in GE Healthcare Surgery's OEC 9900 Elite system are within ±35% of measured DAP values.
. DAP Reduction Accuracy Test was performed to demonstrate the ControlRad™ Trace Model 9 when installed on the OEC 9900 Elite reduces at least 50% of the DAP at 50kVp and ROI with width and length are smaller than 1/3 the diameter of the full FOV.
Dose-Area-Product (DAP) Reduction Accuracy Test was performed to demonstrate that . DAP Reduction calculations of the ControlRad™ Trace Model 9 when installed in GE Healthcare Surgery's OEC 9900 Elite system are within ±35% of the DAP Reduction values.
ControlRad Trace Filter Attenuation Test was performed to evaluate the attenuation level . of the filters of the ControlRad™ Trace Model 9.
. Comparative Image Quality inside the ROI Test was performed to demonstrate that the image quality of the OEC 9900 Elite with installed ControlRad Trace Model 8 within the ROI is of at least the same image quality compared to the image quality of the OEC 9900 Elite alone.
Comparative Image Quality outside the ROI Test was performed in order to evaluate the . filtered image quality outside the ROI of the OEC 9900 Elite with installed ControlRad Trace Model 9 in the periphery image outside the ROI compared to the image quality of the OEC 9900 Elite 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

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Image /page/10/Picture/0 description: The image shows the logo for ControlRad. The logo consists of the word "CONTROL" in a teal sans-serif font, followed by the word "RAD" in the same font but with a green gradient. To the right of the word "RAD" is a circular graphic with a green gradient, and the letters "TM" in a small font.

context to the ROI, of a clinically simulated image obtained by the GE Healthcare Surgery's OEC® 9900 Elite with installed ControlRad™ Trace Model 9.

Touch-In-Gloves Bench Test was performed in order to demonstrate that the CR Trace . Tablet's touchscreen operates as intended when using sterile radiation protective gloves and touchscreen drape.
. Filter motion reliability testing was performed due to changes in assembly of the Trace 9 filter.
. Wireless Technology and Cybersecurity Evaluation was performed in order to evaluate the ControlRad™ Trace Model 9'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".
. Due to weight changes with the workstation, an instability test was performed to ensure compliance with IEC 60601-1 Instability in transport position and Instability from horizontal and vertical forces clauses.

In all performance tests the ControlRad™ Trace Model 9 system when installed in GE Healthcare Surgery's OEC® 9900 Elite system performed and functioned as intended and observations were as expected.

Performance Standards

The ControlRad™ Trace Model 9 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 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 .

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Substantial Equivalence

The ControlRad™ Trace Model 9 is a line extension of the Trace Model family of products (K183109) and is installed on the GE Healthcare Surgery's OEC® 9900 Elite (K122234). The ControlRad™ Trace Model 9 is technological identical to Trace Model 8 with the exception of software modifications necessary for Trace Model 9 to be compatible with the GE Healthcare Surgery's OEC® 9900 Elite (K122234); however, those technological differences do not raise different questions of safety and effectiveness. Performance data demonstrate including filter reliability testing and instability testing confirmed that the ControlRad™ Trace Model 9 is at least as safe and effective as the GE Healthcare Surgery's OEC® 9900 Elite (K122234). In conclusion, the ControlRad™ Trace Model 9 when used with GE Healthcare Surgery's OEC® 9900 Elite is substantially equivalent to that predicate devices.

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.