Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a hardware-based radiation filtering system controlled via a tablet, with no mention of AI or ML algorithms for image processing, decision making, or other functions.

Therapeutic

No
The device is described as providing fluoroscopic imaging and reducing radiation exposure during diagnostic, surgical, and interventional procedures. Its primary function is to optimize imaging and radiation dose, not to treat a specific disease or condition.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "indicated to provide fluoroscopic imaging of the patient during diagnostic, surgical, and interventional procedures." Fluoroscopic imaging for diagnostic purposes clearly identifies it as a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly lists "ControlRad Hardware" and "ControlRad Filter" as main components, indicating it includes physical hardware in addition to software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
Device Function: The ControlRad devices described are accessories for fluoroscopic X-ray systems (Siemens Artis zee and OEC systems). Their primary function is to reduce radiation exposure during imaging procedures performed directly on the patient's body. They manipulate the X-ray beam in vivo (within the living body) rather than analyzing samples in vitro (outside the living body).
Intended Use: The intended use clearly states that the devices provide fluoroscopic imaging of the patient during diagnostic, surgical, and interventional procedures. This involves imaging the patient directly, not analyzing samples.

Therefore, the ControlRad devices fall under the category of medical imaging devices, not In Vitro Diagnostic devices.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ControlRad® Select Model Z with Siemens Artis zee is indicated to provide fluoroscopic imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients' radiation exposure (Dose Area Product) outside of the ControlRad Select Model Z's region of interest (ROI) as compared to Artis zee noncollimated image area. 1 The ControlRad Select Model Z semi-transparent filter should not be used in lieu of the Artis zee'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 cardiac angiography, neuro-angiography, rotational angiography, multipurpose angography and whole body radiographic/fluoroscopic procedures as well as procedures next to the for i.e. patient extremities.

Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for Xray imaging, surgery and interventions.

1 Relative to open Field of View (FOV), the ControlRad® Select Model Z reduces at least 85% of the Dose Area Product at 65 kVp and ROI with width and length that are smaller than 1/5 the edge size of the full FOV.

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. 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, urthopedic, 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.

The ControlRad® Trace Model 8, when used with OEC® 9800 Plus, is indicated to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures 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, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

1 Relative to open Field of View (FOV), the ControlRad® Trace Model 8 reduces at least 50% of the Dose Area Product at50 kVp and ROI with width and length that are smaller than 1/3 the diameter of the full FOV.

Product codes (comma separated list FDA assigned to the subject device)

OWB, JAA, IZI

Device Description

ControlRad® Select Model Z Device Description
The ControlRad® Select Model Z is a set of components mounted on the Artis zee system and cannot be used independent of the Artis zee system.

The ControlRad® Select Model Z consists of a ControlRad filter mounted onto the Siemens Medical Artis zee (K181407) C-arm. The ControlRad filter is installed semi- permanently (i.e., the filter may be removed to return the C-arm to its original condition) to aid in reducing both patient and clinicians' radiation exposure while providing fluoroscopic imaging of the patient during diagnostic, surqical and interventional procedures. ControlRad® hereby submits this Bundled Special 510(k) "Catch-Up" to request clearance to market the ControlRad® Select Model Z with SW version v3.0.1 and a dose reduction claim: 85% of the Dose Area Product (DAP) at 65 kVp with width and length that are smaller than 1/5 the edge size of the full Field Of View (FOV).

The ControlRad Filter is an optional component installed on the Siemens Artis zee's collimator to further reduce radiation emissions. The ControlRad Select Model Z is only compatible with the 20x20 detector and associated collimator. Use of this system on other sizes is prohibited.

The additional radiation reduction provided by the ControlRad Filter will be outside the clinician-selected ROI and within the un-collimated region/image FOV.

The main components of the ControlRad® Select Model Z which are used with the Artis zee are:

ControlRad Tablet
ControlRad Filter
ControlRad Hardware
ControlRad Software and Firmware Modules
ControlRad Communication Interface

The ControlRad® Select Model Z is a system used to assist trained clinicians which is used to provide Xrav images when the clinician performs a medical procedure the patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad® Select Model Z's region of interest (ROI) as compared to the Artis zee non-collimated image area. The ControlRad® Select Model Z can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so.

ControlRad® Select Model Z contains a titanium filter. Two filter sizes are available with nominal thicknesses of 2.5mm or 3mm. both of which are partially transparent to X-ray radiation.

Based on the user selection of the Artis zee collimator the ControlRad Filter region of interest (ROI) the radiation will be reduced. The X-ray beam inside the ROL is not impacted by the ControlRad Filters. All radiation outside the ROI and inside the Artis zee collimated area will be filtered. This 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® Select Model Z allows physicians to select a customizable region of interest (ROI) using a ControlRad dedicated screen Tablet. The proprietary technology then adjusts semi-tranium filters to deliver the designed high-quality image. This allows the Artis zee to generate an image in the selected physician's ROI while providing a lower radiation dose to the periphery. The result is a reduction in the overall radiation dose and exposure to the healthcare team while providing the physician the contextual information needed outside the ROI.

The workflow is therefore supported with lower radiation than with conventional imaging settings. The ControlRad Filter is designed to always include the center of the ROI. Therefore, when selecting an ROI by the user, the actual ROI might be expanded to include the center of the FOV.

The ControlRad® Select Model Z is a product that can be mounted only on the following configurations of the Artis zee: floor, ceiling, and bi-plane systems.

ControlRad® Trace Model 9 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.

ControlRad® Trace Model 8 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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Fluoroscopic X-ray, Spot-film imaging

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Trained clinicians; diagnostic, surgical, and interventional procedures in clinical settings.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

ControlRad® Select Model Z Performance Data:

Impact of Air Kerma: Verification that the ControlRad® components on the reference system do not significantly increase Air Kerma (ControlRad® components integrated with the Artis zee system) when compared to the Artis zee system alone.
Air Kerma and Air Kerma Rate Accuracy: Verification that the AK and AKR of the subject system (ControlRad® components integrated with the Artis zee system) is ±35% of the Artis zee system alone per 21 CFR 1020.32.
Radiation Dose Structure Report (RDSR) AK Accuracy: Verification that the cumulative AKR as referenced in the RDSR of the subject system (ControlRad® components integrated with the Artis zee system) is ± 35% of the Artis zee system alone.
Reference Air Kerma Warning Functionality: Verification that the Reference Air Kerma Warning Functionality is not impacted on the subject system (ControlRad® components integrated with the Artis zee system) when compared to the Artis zee system alone.
Dose Area Product (DAP) Accuracy: Demonstrate the DAP measurements of the subject system (ControlRad® components integrated with the Artis zee system) is ±35% of the Artis zee system per IEC 60601-2-43.
Dose Area Product (DAP) Reduction: To verify the subject system (ControlRad® components integrated with the Artis zee system) is able to reduce DAP as noted in the indications for use (Relative to open Field of View (FOV), the ControlRad® Select Model Z reduces at least 85% of the Dose Area Product at 65 kVp and ROI with width and length that are smaller than 1/5 the size of the full FOV).
Filter Attenuation Testing: Demonstrate the x-ray radiation attenuation by the addition of the ControlRad® components on the reference system show a 44 to 98% attenuation outside the ROI.
Leakage Radiation Evaluation: To evaluate the impact of the ControlRad® components on the reference device leakage radiation measurements.
Stray Radiation Evaluation: To evaluate the impact of the ControlRad® components on the reference device stray radiation measurements.
Recovery Management: To verify recovery management of ControlRad® Select Model Z as required by IEC 60601-2-43, section 201.4.101
Mechanical Impact on Filter Cover: To verify that impact to the filter / collimator cover does not create unacceptable risk per IEC 60601-1 requirements.
Collision Sensor Functionality Evaluation: To verify that the collision sensor functionality is maintained when using the ControlRad® filter / collimator covers.
Focal spot to patient distance: To verify the focal spot to skin distance implementation per IEC 60601-2-54, section 203.9 requirements.
Tensile Strength Evaluation: To verify that additional mass from the Select Model Z filter does not create unacceptable risk from tensile strength per IEC 60601-1 requirements.
Filter Motion Reliability Testing: To verify the durability of the mechanical filter assembly in frame of a random motion stress test.
Comparative image quality inside the ROI: Verifies that image quality inside the ROI is at least the same quality as the image that would be gathered with the Artis zee alone.
Comparative image quality outside the ROI: Quantify the level of image quality degradation outside the region of interest as a result of the CR filter blades.
Image quality evaluation via clinical simulations: To validate that the image quality outside the ROI in clinically relevant following degradation due to use of the ControlRad filters.
DAP Chamber Change Justification: To justify the change in DAP chamber from the original chamber used in the Artis zee system as a result of the addition of the CR filter
Touch-In-Glove Bench Test: To verify the sensitivity of the ControlRad® tablet when using sterile radiation reducing gloves.
Wireless Devices and Cybersecurity Evaluation: To evaluate the ControlRad® Select Model Z's compliance with the requirements of FDA Guidance documents: "Radio Frequency Wireless Technology in Medical Devices" and "Postmarket Management of Cyber Security in Medical Devices".

Results of all conducted testing was found acceptable and do not raise any new issues of safety or effectiveness.

ControlRad® Trace Model 9 Performance Data:

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 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.
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".

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.

ControlRad® Trace Model 8 Performance Data:

Impact on Air Kerma Test was performed in order to evaluate the impact of the ControlRad® Trace Model 8 on Air Kerma (AKR) measurements of GE Healthcare Surgery's 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.
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 GE Healthcare Surgery's OEC 9800 with installed ControlRad® Trace Model 8 within the ROI is at least with the same image quality compared to the image quality of the GE Healthcare Surgery's 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 GE Healthcare Surgery's OEC 9800 with installed ControlRad® Trace Model 8 in the periphery image outside the ROI compared to the image quality of the GE Healthcare Surgery's OEC 9800 Plus alone.
Image Quality Clinical Simulations 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 to the ROI, of a clinically simulated image obtained by the GE Healthcare Surgery's OEC® 9800 Plus with installed ControlRad® Trace Model 8.
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.
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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K202431, K200663, K183109

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

0

July 1, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in a blue box. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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

Re: K211782

Trade/Device Name: ControlRad® Select Model Z, ControlRad® Trace Model 9, 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, JAA, IZI Dated: June 7, 2021 Received: June 9, 2021

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

1

801); 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/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

2

Indications for Use

510(k) Number (if known) K211782

Device Name ControlRad® Select Model Z

Indications for Use (Describe)

The ControlRad® Select Model Z with Siemens Artis zee is indicated to provide fluoroscopic imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients' radiation exposure (Dose Area Product) outside of the ControlRad Select Model Z's region of interest (ROI) as compared to Artis zee noncollimated image area. 1 The ControlRad Select Model Z semi-transparent filter should not be used in lieu of the Artis zee'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 cardiac angiography, neuro-angiography, rotational angiography, multipurpose angography and whole body radiographic/fluoroscopic procedures as well as procedures next to the for i.e. patient extremities.

Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for Xray imaging, surgery and interventions.

1 Relative to open Field of View (FOV), the ControlRad® Select Model Z reduces at least 85% of the Dose Area Product at 65 kVp and ROI with width and length that are smaller than 1/5 the edge size of the full FOV.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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

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:

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3

Indications for Use

510(k) Number (if known) K211782

Device Name ControlRad® Trace Model 9

Indications for Use (Describe)

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. 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, urthopedic, 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.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDEDThis 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."

4

Indications for Use

510(k) Number (if known) K211782

Device Name ControlRad® Trace Model 8

Indications for Use (Describe)

The ControlRad® Trace Model 8, when used with OEC® 9800 Plus, is indicated to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures 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, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

1 Relative to open Field of View (FOV), the ControlRad® Trace Model 8 reduces at least 50% of the Dose Area Product at50 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 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 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."

5

Image /page/5/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in dark green, and the word "RAD" is in light green. The word "RAD" is surrounded by a green circle that is darker on the left and lighter on the right.

ControlRad® Select Model Z 510(k) SUMMARY: ControlRad® Trace Model 9 ControlRad® Trace Model 8

Company Name: ControlRad, Inc. 275 Scientific Dr NW Suite 1100 Norcross, Georgia 30092, USA 1-800-522-5148

June 29, 2021 Date Prepared:

This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

1. General Information:

Applicant Name:
ControlRad, Inc. Chris Fair 275 Scientific Dr NW Suite 1100 Norcross, Georgia 30092, USA P: 1-800-522-5148 Establishment Registration Number: 3015709927

2. Contact Person:

Patricia D. Jones, VP of Regulatory Affairs Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, GA 30188 770-837-2681 (direct) Regulatory@SecureBME.com

Secondary Contact:

Linda Braddon, Ph.D. Secure BioMed Evaluations 7828 Hickory Flat Hwy Suite 120 Woodstock, GA 30188 770-837-2681 Regulatory@SecureBME.com

1. Device Name and Classification : Trade Name:
  ControlRad® Select Model Z ControlRad® Trace Model 9 ControlRad® Trace Model 8 Image-Intensified Fluoroscopic X-ray System

Classification Name:

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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 dark green, followed by "RAD" in light green. The "RAD" is partially enclosed in a green circle, with the top half of the circle being a lighter shade of green and the bottom half being a darker shade of green. The logo is simple and modern, with a focus on the company's name.

Common Name: Classification Panel: Regulation Number: Device Class: Product Codes:

Interventional Fluoroscopic X-ray System Radiology 21 CFR §892.1650 . Primary: OWB Secondary: JAA, IZI

1. Primary Predicate Devices for ControlRad® Select Model Z; ControlRad® Trace Model 9 and ControlRad® Trace Model 8:

Information	Primary Predicate	Primary Predicate	Primary Predicate
Trade Name	ControlRad® Select Model Z	ControlRad® Trace Model 9	ControlRad® Trace Model 8
510(k) Clearance	K202431	K200663	K183109
Clearance Date	December 23, 2020	June 24, 2020	May 13, 2019
Classification Name	Image-Intensified
Fluoroscopic X-ray System	Image-Intensified
Fluoroscopic X-ray System	Image-Intensified
Fluoroscopic X-ray System
Common Name	Interventional Fluoroscopic
X-ray System	Interventional Fluoroscopic
X-ray System	Interventional Fluoroscopic
X-ray System
Classification Panel	Radiology	Radiology	Radiology
Regulation Number	21 CFR §892.1650	21 CFR §892.1650	21 CFR §892.1650
Device Class	II	II	II
Product Codes	Primary: OWB
Secondary: JAA, IZI	Primary: OWB
Secondary: OXO, JAA	Primary: OWB
Secondary: OXO, JAA
	The ControlRad® Select
Model Z is installed on the
system below:	The ControlRad® Trace
Model 9 is installed on the
system below:	The ControlRad® Trace
Model 8is installed on
the system below:
Trade Name	Artis zee	GE Healthcare Surgery,
OEC® 9900 Elite	GE Healthcare Surgery,
OEC® 9800 Plus
510(k) Clearance	K181407	K122234	K132027
Clearance Date	August 15, 2018	August 16, 2012	December 5, 2012
Classification Name	Image-intensified
fluoroscopic X-ray System	Image-intensified
fluoroscopic X-ray System	Image-intensified
fluoroscopic X-ray System
Common Name	Interventional Fluoroscopic
X-Ray System	Interventional Fluoroscopic
X-Ray	Interventional Fluoroscopic
X-Ray System
Classification Panel	Radiology	Radiology	Radiology
Regulation Number	892.1650	892.1650	892.1650
Device Class	II	II	II
Product Codes	Primary: OWB	Primary: OWB	Primary: OWB

5. Indications for Use Statements

Indications for Use Statement for ControlRad® Select Model Z

The ControlRad® Select Model Z with Siemens Artis zee is indicated to provide fluoroscopic imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients' and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Select Model Z's region of interest (ROI) as compared to Artis zee non-collimated image area. ↑ The ControlRad Select Model Z semi-transparent filter should not be used in lieu of the Artis zee'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 cardiac angiography, neuro-angiography, angiography, multipurpose angiography general angiography, rotational and whole body radiographic/fluoroscopic procedures as well as procedures next to the for i.e., patient extremities.

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Image /page/7/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in dark green, and the word "RAD" is in light green. To the right of the word "RAD" is a green circle that is broken into two shades of green.

Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions.

1 Relative to open Field of View (FOV), the ControlRad Select Model Z reduces at least 85% of the Dose Area Product at 65 kVp and ROI with width and length that are smaller than 1/5 the edge size of the full FOV.

Indications for Use Statement for ControlRad® Trace Model 9

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 semitransparent 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 cholanqiography, endoscopic, urologic, orthopedic, neurologic, vascular, 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.

Indications for Use Statement for ControlRad® Trace Model 8

The ControlRad® Trace Model 8, when used with OEC® 9800 Plus, is indicated to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients andclinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace's region of interest (ROI) as comparedto the OEC® 9800/OEC® 9800 Plus non-collimated image area. 1 The ControlRad Trace semi-transparent filter should notbe used in lieu of the 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, neurologic, vascular, cardiac, critical care and emergency room procedures.

1 Relative to open Field of View (FOV), the ControlRad Trace Model 8 reduces at least 50% of the Dose Area Product at50 kVp and ROI with width and length that are smaller than 1/3 the diameter of the full FOV.

Device Descriptions for ControlRad® Select Model Z; ControlRad® Trace Model 9, and 6. ControlRad® Trace Model 8 are provided below:

ControlRad® Select Model Z Device Description

The ControlRad® Select Model Z is a set of components mounted on the Artis zee system and cannot be used independent of the Artis zee system.

The ControlRad® Select Model Z consists of a ControlRad filter mounted onto the Siemens Medical Artis zee (K181407) C-arm. The ControlRad filter is installed semi- permanently (i.e., the filter may be removed to return the C-arm to its original condition) to aid in reducing both patient and clinicians' radiation exposure while providing fluoroscopic imaging of the patient during diagnostic, surqical and interventional procedures. ControlRad® hereby submits this Bundled Special 510(k) "Catch-Up" to request clearance to market the ControlRad® Select Model Z with SW version v3.0.1 and a dose reduction claim: 85% of the Dose Area Product (DAP) at 65 kVp with width and length that are smaller than 1/5 the edge size of the full Field Of View (FOV).

The ControlRad Filter is an optional component installed on the Siemens Artis zee's collimator to further reduce radiation emissions. The ControlRad Select Model Z is only compatible with the 20x20 detector and associated collimator. Use of this system on other sizes is prohibited.

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Image /page/8/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in a dark teal sans-serif font, followed by "RAD" in a lighter green color. To the right of the text is a circular graphic with a gradient from dark teal to light green, partially surrounding the "RAD" text.

ControlRad® Select Model Z Device Description

The additional radiation reduction provided by the ControlRad Filter will be outside the clinician-selected ROI and within the un-collimated region/image FOV.

The main components of the ControlRad® Select Model Z which are used with the Artis zee are:

ControlRad Tablet
. ControlRad Filter
. ControlRad Hardware
. ControlRad Software and Firmware Modules
. ControlRad Communication Interface

The ControlRad® Select Model Z is a system used to assist trained clinicians which is used to provide Xrav images when the clinician performs a medical procedure the patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad® Select Model Z's region of interest (ROI) as compared to the Artis zee non-collimated image area. The ControlRad® Select Model Z can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so.

ControlRad® Select Model Z contains a titanium filter. Two filter sizes are available with nominal thicknesses of 2.5mm or 3mm. both of which are partially transparent to X-ray radiation.

Based on the user selection of the Artis zee collimator the ControlRad Filter region of interest (ROI) the radiation will be reduced. The X-ray beam inside the ROL is not impacted by the ControlRad Filters. All radiation outside the ROI and inside the Artis zee collimated area will be filtered. This 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® Select Model Z allows physicians to select a customizable region of interest (ROI) using a ControlRad dedicated screen Tablet. The proprietary technology then adjusts semi-tranium filters to deliver the designed high-quality image. This allows the Artis zee to generate an image in the selected physician's ROI while providing a lower radiation dose to the periphery. The result is a reduction in the overall radiation dose and exposure to the healthcare team while providing the physician the contextual information needed outside the ROI.

The workflow is therefore supported with lower radiation than with conventional imaging settings. The ControlRad Filter is designed to always include the center of the ROI. Therefore, when selecting an ROI by the user, the actual ROI might be expanded to include the center of the FOV.

The ControlRad® Select Model Z is a product that can be mounted only on the following configurations of the Artis zee: floor, ceiling, and bi-plane systems.

Technological Characteristics:

The ControlRad® Select Model Z consists of the following main components: ControlRad Filter, ControlRad Hardware, ControlRad Software and Firmware Modules and ControlRadion Interface all installed on the Siemens Artis zee. The ControlRad® Select Model Z components are installed semi-permanently on the cleared Siemens Artis zee (K181407) and operate in parallel to the Siemens Artis zee. The removal of the ControlRad® components will restore the device to OEM specifications.

The ControlRad® Select Model Z components provide the following functionalities:

The CR Tablet provides the user operational control of the ControlRad Select Model Z device via a Graphical User Interface ("GUI"). The CR Tablet enables the clinician to select a Region of Interest ("ROI") on the image displayed on the CR Tablet, which is the same image that is displayed on the Siemens Artis zee's live monitor.

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Image /page/9/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in a dark teal sans-serif font, followed by "RAD" in a lighter green sans-serif font. To the right of the text is a circular graphic with two curved lines, one dark teal and one light green, that form a circle around the letters "RAD".

ControlRad® Select Model Z Device Description

The CR Filter is installed on top of the Artis zee's collimator. The CR Filter does not affect or modify the functionality of the collimator. The CR Filter is a semi- transparent filter which reduces the Xray radiation outside the clinician-selected ROI typically by 44% to 98%. The actual dose reduction achieved will depend upon specific imaging parameters such as Siemens collimator settings, the kVp and the percentage of the non-collimated image covered by the ControlRad Filter.
· The ControlRad Hardware, Software and Firmware Modules control the ControlRad Filter 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® Select Model Z and the Artis zee.

Principles of Operation:

The Siemens Artis zee provides an image whose boundaries are defined by the Siemens'collimator, i.e., the image FOV is defined by the Siemens non-collimated region. The image FOV size is not affected or modified by the ControlRad® Select Model Z.

Within the Siemens Artis zee non-collimated image region, when using a clinician selected Region of Interest ("ROI") on the ControlRad Tablet, the ControlRad 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 Siemens Artis zee (K181407).
The image outside the clinician-selected ROI (filtered radiation area in the FOV), alower-dose processed image which provides peripheral image context to the ROI.

The Siemens Artis zee's collimator, when used, also reduces radiation emission. However, that collimator reduces radiation emission by blocking the delivery of radiationto the area covered by the collimator. As a result, the Siemens Artis zee's image FOV is limited to the non-collimated region. The ControlRad Filter can be used along with the Siemens Artis zee's collimator to further reduce radiation emissions, and the additional radiation reduction provided by the ControlRad Filter will be outside the clinician-selected RO1 and within the un-collimated region/image FOV. The clinician has the option not to use the CR Filter. In this case, the Siemens Artis zee operates as if the CR Filter was not present.

Reason for Submission:

This Bundled Special 510(K) submission provides FDA with "Catch Up" 510(k) information for minor changes made and implemented on the following cleared 510(k) product: ControlRad® Select Model Z (K202431). These changes were evaluated and documented via the process identified in FDA's quidance document "Deciding When to Submit a 510(k) for a Change to an Existing Device", October 25, 2017.

ControlRad® Trace Model 9 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.

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Image /page/10/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in a dark teal sans-serif font, followed by "RAD" in a lighter green sans-serif font. To the right of "RAD" is a circular graphic with two shades of green, with the darker shade on the top and the lighter shade on the bottom.

ControlRad® Trace Model 9 Device Description

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.

Technological Characteristics:

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 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 whose 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
The image outside the clinician-selected ROI (filtered radiation area in the FOV), a lower-● dose 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

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Image /page/11/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 sans-serif font, enclosed in a circular gradient of green. The gradient transitions from a darker teal at the bottom to a lighter green at the top.

ControlRad® Trace Model 9 Device Description

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 reduction provided by the ControlRad® Trace Filter will be outside the clinician-selected ROI and within the uncollimated 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.

Reason for Submission:

This Bundled Special 510(K) submission provides FDA with "Catch Up" 510(K) information for minor changes made and implemented on the following cleared 510(k) product: ControlRad® Trace Model 9 (K200663). These changes were evaluated and documented via the process identified in FDA's guidance document "Deciding When to Submit a 510(k) for a Change to an Existing Device", October 25, 2017.

ControlRad® Trace Model 8 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.

Technological Characteristics:

The ControlRad® Trace Model 8 consists of the following main components: ControlRad ("CR") Trace Tablet, CR Trace Filter, CR Hardware, CR Software and Firmware Modules and CR Communication Interface.

The ControlRad® Trace Model 8 components are installed semi-permanently on the cleared GE Healthcare Surgery's OEC® 9800 Plus (K132027) and operate in parallel to the GE Healthcare Surgery's OEC® 9800 Plus. The ControlRad® Trace Model 8 components provide the following functionalities:

The CR Trace Tablet provides the user operational control of the ControlRad® Trace Model 8 ● device via a Graphical User Interface ("GUI"). The CR Trace Tablet enables the clinician to select a Reqion 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® 9800 Plus's live monitor.
. The CR Trace Filter is installed on top of the GE Healthcare Surgery's OEC® 9800 Plus'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 60% to 90%.
The CR Hardware, Software and Firmware Modules control the CR Trace Filter's positioning, . which is determined by the location of the clinician-selected ROI and perform image processing.
. The CR Communication Interface provides communication between the various components of the ControlRad® Trace Model 8 and between the ControlRad® Trace Model 8 and the GE Healthcare Surgery's OEC® 9800 Plus.

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Image /page/12/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in dark green, and the word "RAD" is in light green and is surrounded by a green circle. The circle is darker green on the bottom and lighter green on the top.

ControlRad® Trace Model 8 Device Description

Principles of Operation:

The GE Healthcare Surgery's OEC® 9800 Plus (K132027) provides an image that its boundaries are defined by the GE Healthcare Surgery's OEC® 9800 Plus's collimator, i.e., the image FOV is defined by the uncollimated region of the GE Healthcare Surgery's OEC® 9800 Plus (K132027). The image FOV size is not affected or modified by the ControlRad® Trace Model 8.

Within the image field/un-collimated region of the GE Healthcare Surgery's OEC® 9800 Plus (K132027), the ControlRad® Trace Model 8 allows the clinician to select a Region of Interest ("RO!") and it reduces radiation exposure outside the clinician-selected ROI using the CR Trace Filter, resulting with an image that consists of the following 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 Surqery's OEC® 9800 Plus (K132027); and
· The image outside the clinician-selected ROI (filtered radiation area in the FOV), a low-dose processed image which provides peripheral image context to the ROI.

The GE Healthcare Surgery's 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 GE Healthcare Surgery's OEC® 9800 Plus's image FOV is limited to the un-collimated region. The CR Trace Filter can be used along with the GE Healthcare Surgery's OEC® 9800 Plus's collimator to further reduce radiation emissions, and the additional radiation provided by the CR 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® 9800 Plus operates as if the CR Trace Filter was not present.

Reason for Submission:

This Bundled Special 510(K) submission provides FDA with "Catch Up" 510(K) information for minor changes made and implemented on the following cleared 510(k) product: ControlRad® Trace Model 8 (K183109). These changes were evaluated and documented via the process identified in FDA's guidance document "Deciding When to Submit a 510(k) for a Change to an Existing Device", October 25, 2017.

7. Substantial Equivalence:

The ControlRad® Select Model Z is a substantial equivalent to the legally marketed predicate listed below:

| Predicate Device Name
and Manufacturer | 510(k)
Number | Clearance
Date | Comparable Properties |
|----------------------------------------------------------------|------------------|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Predicate
ControlRad® Select Model Z
ControlRad® | K202431 | 12/23/2020 | Indications for use CR Trace Tablet ControlRad Trace Filter ControlRad Hardware ControlRad Software and Firmware Modules ControlRad Communication Interface Dose Reduction Claim Installed on Siemens Artis zee (K181407) |

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Image /page/13/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 "RAD" in a smaller font size. To the right of the text is a circular graphic with two shades of green, creating a sense of depth and movement. The overall design is clean and modern, conveying a sense of control and innovation.

The ControlRad® Trace Model 9 is substantial equivalent to the legally marketed predicate listed below:

| Predicate Device Name
and Manufacturer | 510(k)
Number | Clearance
Date | Comparable Properties |
|---------------------------------------------------------------|------------------|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary Predicate
ControlRad® Trace Model 9
ControlRad® | K200663 | 06/24/2020 | Indications for use CR Trace Tablet ControlRad Trace Filter ControlRad Hardware ControlRad Software and Firmware Modules ControlRad Communication Interface Dose Reduction Claim Installed on GE Healthcare Surgery, OEC ® 9900 Elite (K122234) |

The ControlRad® Trace Model 8 is substantial equivalent to the legally marketed predicate listed below:

Predicate Device Name	510(k)	Clearance	Comparable Properties
and Manufacturer	Number	Date
Primary Predicate
ControlRad® Trace Model 8
ControlRad®	K183109	05/13/2019	Indications for use CR Trace Tablet ControlRad Trace Filter ControlRad Hardware ControlRad Software and Firmware Modules ControlRad Communication Interface Dose Reduction Claim Installed on GE Healthcare Surgery, OEC® 9800 Plus (K133027)

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Image /page/14/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in dark green, and the word "RAD" is in light green. The word "RAD" is inside of a green circle that is darker at the bottom and lighter at the top.

8. Comparison of Technological Characteristics with the Predicate Device:

The ControlRad® Select Model Z for use with Siemens Artis zee has the same indications for use as the cleared predicate ControlRad® Select Model Z (K202431). The ControlRad® Select Model Z is identical in construction to the predicate. The performance data demonstrates that the ControlRad® Select Model Z is at least as safe and effective as the predicate device and is substantially equivalent to the predicate device. A comparison table of technological characteristics of the ControlRad® Select Model Z device for use with Siemens Artis zee compared to those of the predicate is provided below:

Comparison Table: ControlRad® SelectModel Z
Device Feature	Subject Device ControlRad® Select
Model Z
(K211782)	Primary Predicate Device
ControlRad® SelectModel Z
(K202431)	Comparison
Results
Regulation
Number	21 CFR §892.1650	21 CFR §892.1650	Same
Indications for
use Statement	The ControlRad® Select Model Z with
Siemens Artis zee is indicated to
provide fluoroscopic of the patient
during diagnostic, surgical, and
interventional procedures while
reducing patients and clinicians'
radiation exposure (Dose Area
Product) outside of the ControlRad
Select Model Z's region of interest
(ROI) as compared to Artis zee non-
collimated image area.1 The
ControlRad Select Model Z semi-
transparent filter should not be used in
lieu of the Artis zee'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 cardiac angiography, neuro-
angiography, general angiography,
rotational angiography, multipurpose
angiography and whole body
radiographic/fluoroscopic procedures
as well as procedures next to the table
for i.e., patient extremities.

Additional procedures that can be
performed include angiography in the
operating room, image guided surgery
by X-ray, by image fusion, and by
navigation systems. The examination
table as an integrated part of the
system can be used for X-ray imaging,
surgery and interventions.

1 Relative to open Field of View
(FOV), the ControlRad Select Model | The ControlRad® Select Model Z with
Siemens Artis zee is indicated to
provide fluoroscopic of the patient
during diagnostic, surgical, and
interventional procedures while
reducing patients and clinicians'
radiation exposure (Dose Area
Product) outside of the ControlRad
Select Model Z's region of interest
(ROI) as compared to Artis zee non-
collimated image area.1 The
ControlRad Select Model Z semi-
transparent filter should not be used in
lieu of the Artis zee'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 cardiac angiography, neuro-
angiography, general angiography,
rotational angiography, multipurpose
angiography and whole body
radiographic/fluoroscopic procedures
as well as procedures next to the table
for i.e., patient extremities.

Additional procedures that can be
performed include angiography in the
operating room, image guided surgery
by X-ray, by image fusion, and by
navigation systems. The examination
table as an integrated part of the
system can be used for X-ray imaging,
surgery and interventions.

ControlRad Components: SCIP
BOX Input: 230 VAC,0.6A
TABLET POWER SUPPLY
Input: 24 VDC, 0.5A SELECT
FILTER Input: 28 VDC, 0.9A
ROUTER Input: 12DC, 1A
ROUTER POWER SUPPLY Input :
230VAC, 0.5A | Artis zee Components:Power
requirements Generator
POLYDOROS A100
Plus:
AC 400 V ± 10 %, 50/60
Hz ± 1 Hz
Power requirements System
control cabinet: AC 400 V ±
10 %, 50/60
Hz ± 1 Hz

ControlRad Components: SCIP
BOX Input: 230 VAC,0.6A
TABLET POWER SUPPLY
Input: 24 VDC, 0.5A SELECT
FILTER Input: 28 VDC, 0.9A
ROUTER Input : 12DC, 1A
ROUTER POWER SUPPLY Input :
230VAC, 0.5A | Same |

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Image /page/15/Picture/0 description: The image shows the logo for ControlRad. The logo has the word "CONTROL" in dark green, followed by "RAD" in a lighter green color. The "RAD" is surrounded by a green circle that is broken into two different shades of green.

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Image /page/16/Picture/0 description: The image shows the logo for ControlRad. The logo consists of the word "CONTROL" in dark green, followed by the word "RAD" in light green. To the right of the word "RAD" is a green circle with a white line through the middle.

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 primary predicate which works with OEC® 9900 Elite. The performance data demonstrates that the ControlRad® Trace Model 9 is at least as safe and effective as the predicate device and is substantially equivalent to that predicate device. A comparison table of technological characteristics of the ControlRad® Trace Model 9 device for use with OEC® 9900 Elite comparison is provided below:

Comparison Table: ControlRad® Trace Model 9
Device Feature	Subject Device
ControlRad® TraceModel
(K211782)	Primary Predicate Device
ControlRad® Trace Model 9
(K200663)	Comparison
Results
Device Class	Class II	Class II	Same
Product Codes	Primary: OWB
Secondary: OXO, JAA	Primary: OWB
Secondary: OXO, JAA	Same
Regulation Number	21 CFR §892.1650	21 CFR §892.1650	Same
Indications for use	The ControlRad® Trace Model9,
when used with OEC® 9900 Elite,
is indicated to provide fluoroscopic
and spot-film imaging of the
patient during diagnostic, surgical,
and interventional procedures
whilereducing 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
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.
1Relative 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.	The ControlRad® Trace Model9,
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 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.
1Relative 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.	Same
X-ray Modulation
Component	CR Trace Filter	CR Trace Filter	Same
X-Ray Radiation
Modulation	Reduces X-ray radiation outside the
aperture/ROI typically by 61% to
97%	Reduces X-ray radiation outside the
aperture/ROI typically by 61% to
97%	Same
Aperture Shape	Rectangular	Rectangular	Same
Aperture Control	Set by the user using the CR Trace
Tablet	Set by the user using the CR Trace
Tablet	Same
Image Area
Processed	Image area outside the ROI	Image area outside the ROI	Same
Processing Bits	12 bits	12 bits	Same
Processing Rate	30 fps	30 fps	Same
Processing
Occurrence	Only when the CR Trace Filter is
engaged	Only when the CR Trace Filter is
engaged	Same
Image Layout
Information	Dose Area Product (DAP) value
and/or percentage of DAP
reduction when using ControlRad
Trace Filterand/or OEC
Collimators
ROI frame border	Dose Area Product (DAP) value
and/or percentage of DAP
reduction when using ControlRad
Trace Filterand/or OEC Collimators
ROI frame border	Same
Dose Area Product
(DAP) Accuracy for
total x-ray field of the
ControlRad Trace
Filter and
OEC systems
combined*	*Overall: ±35%
For DAP reported byControlRad®
Trace Model 9	*Overall: ±35%
For DAP reported byControlRad®
Trace Model 9	Same
Electrical
Requirements	60 / 50 Hz; 120 VAC
(±10%), 15A
200/220/230/240VAC
(±10%), 10A	60 / 50 Hz; 120 VAC
(±10%), 15A
200/220/230/240VAC
(±10%), 10A	Same

17

Image /page/17/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in a dark teal sans-serif font. To the right of the word "CONTROL" is the word "RAD" in a lighter green color, and the letters are surrounded by a green circle that is broken at the top and bottom.

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Image /page/18/Picture/0 description: The image shows the logo for ControlRad. The logo consists of the word "CONTROL" in dark green, followed by the word "RAD" in light green. To the right of the word "RAD" is a circular graphic with a dark green top and light green bottom, separated by a white line.

The ControlRad® Trace Model 8 for use with GE Healthcare Surgery's OEC® 9800 Plus (K132027) has the same indications for use as the cleared predicate ControlRad® Trace Model 8 (K183109). The ControlRad® Trace Model 8 is identical in construction to the predicate. The performance data demonstrates that the ControlRad® Trace Model 8 is at least as safe and effective as the predicate device and is substantially equivalent to the predicate device. A comparison table of technological characteristics of the ControlRad® Trace Model 8 device for use with GE Healthcare Surgery's OEC® 9800 Plus (K132027) comparison information is provided below:

Comparison Table: ControlRad® Trace Model 8
Device Feature	Subject Device
ControlRad® Trace Model 8
(K211782)	Primary Predicate Device
ControlRad® Trace Model 8
(K183109)	Comparison
Results
Device Class	Class II	Class II	Same
Product Codes	Primary: OWB Secondary: OXO, JAA	Primary: OWB Secondary: OXO, JAA	Same
Regulation Number	21 CFR §892.1650	21 CFR §892.1650	Same
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. 1The
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, neurologic,
vascular, cardiac, critical care and
emergency room procedures.
1Relative 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.	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. 1The
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, neurologic,
vascular, cardiac, critical care and
emergency room procedures.
1Relative 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.	Same
Comparison Table: ControlRad® Trace Model 8
Device Feature	Subject Device
ControlRad® Trace Model 8
(K211782)	Primary Predicate Device
ControlRad® Trace Model 8
(K183109)	Comparison
Results
X-ray Modulation
Component	CR Trace Filter	CR Trace Filter	Same
X-ray Radiation
Modulation	Reduces X-ray radiation outside the
aperture/ROI typically by 60% to 90%	Reduces X-ray radiation outside the
aperture/ROI typically by 60% to 90%	Same
Aperture shape	Rectangular	Rectangular	Same
Aperture Control	Set by the user using the CR Trace
Tablet	Set by the user using the CR Trace
Tablet	Same
Image Area Processed	Image area outside the ROI	Image area outside the ROI	Same
Processing Bits	Same	Same	Same
Processing Rate	Same	Same	Same
Processing
Occurrence	Only when the CR Trace Filter is
engaged	Only when the CR Trace Filter is
engaged	Same
Image Layout
Information	Estimated DAP,
Estimated percentage of DAP reduction
when using CR Trace Filter,
ROI frame border;	Estimated DAP,
Estimated percentage of DAP reduction
when using CR Trace Filter,
ROI frame border;	Same
Dose Area Product
(DAP) Accuracy	Overall: ±35%
For DAP reported by ControlRad®
Trace Model 8	Overall: ±35%
For DAP reported by ControlRad®
Trace Model 8	Same
Electrical
Requirements	Same	Same	Same

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Image /page/19/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 circular graphic made up of two curved lines, one dark green and one light green, that form a circle around the word "RAD".

9. Performance Data:

ControlRad® conducted the following performance tests to demonstrate that the ControlRad Select Model Z for use with Siemens Artis zee complies with performance standards, functions as intended and is at least as safe and effective as the predicate Siemens Artis zee.

ControlRad® Select Model Z Performance Data:

Impact of Air Kerma: Verification that the ControlRad® components on the ● referencesystem do not significantly increase Air Kerma (ControlRad® components integrated with the Artis zee system) when compared to the Artis zee system alone.
Air Kerma and Air Kerma Rate Accuracy: Verification that the AK and . AKR of the subject system (ControlRad® components integrated with the Artis zee system) is ±35% of the Artis zee system alone per 21 CFR 1020.32.
Radiation Dose Structure Report (RDSR) AK Accuracy: Verification that ● the cumulative AKR as referenced in the RDSR of the subject system (ControlRad® components integrated with the Artis zee system) is ± 35% of the Artis zee systemalone.
Reference Air Kerma Warning Functionality: Verification that the ●

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Image /page/20/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 circular design around it. The circular design is split into two shades of green, with the darker shade at the top and the lighter shade at the bottom.

Reference Air Kerma Warning Functionality is not impacted on the subject system (ControlRad® components integrated with the Artis zee system) when compared to the Artis zee system alone.

Dose Area Product (DAP) Accuracy: Demonstrate ● the DAP measurements of the subject system (ControlRad® components integrated with the Artis zee system) is ±35% of the Artis zee system per IEC 60601-2-43.
Dose Area Product (DAP) Reduction: To verify the subject system . (ControlRad® components integrated with the Artis zee system) is able to reduce DAP as noted in the indications for use (Relative to open Field of View (FOV), the ControlRad® Select Model Z reduces at least 85% of the Dose Area Product at 65 kVp and ROI with width and length that are smaller than 1/5 the size of the full FOV).
Filter Attenuation Testing: Demonstrate the x-ray radiation attenuation by ● the addition of the ControlRad® components on the reference system show a 44 to 98%attenuation outside the ROI.
Leakage Radiation Evaluation: To evaluate the impact of the ControlRad® components on the reference device leakage radiation measurements.
. Stray Radiation Evaluation: To evaluate the impact of the ControlRad® components on the reference device stray radiation measurements.
. Recovery Management: To verify recovery management of ControlRad® Select Model Z as required by IEC 60601-2-43, section 201.4.101
Mechanical Impact on Filter Cover: To verify that impact to the filter / ● collimator cover does not create unacceptable risk per IEC 60601-1 requirements.
Collision Sensor Functionality Evaluation: To verify that the collision . sensor functionality is maintained when using the ControlRad® filter / collimator covers.
Focal spot to patient distance: To verify the focal spot to skin distance . implementation per IEC 60601-2-54, section 203.9 requirements.
. Tensile Strength Evaluation: To verify that additional mass from the Select Model Z filter does not create unacceptable risk from tensile strength per IEC 60601-1 requirements.
Filter Motion Reliability Testing: To verify the durability of the mechanical ● filter assembly in frame of a random motion stress test.
Comparative image quality inside the ROI: Verifies that image quality . inside the ROI is at least the same quality as the image that would be gathered with the Artis zee alone.
Comparative image quality outside the ROI: Quantify the level of image . quality degradation outside the region of interest as a result of the CR filter blades.
Image quality evaluation via clinical simulations: To validate that the . image quality outside the ROI in clinically relevant following degradation

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Image /page/21/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 white horizontal line through the middle.

due to use of the ControlRad filters.

. DAP Chamber Change Justification: To justify the change in DAP chamber from the original chamber used in the Artis zee system as a result of the addition of the CR filter
Touch-In-Glove Bench Test: To verify the sensitivity of the ControlRad® tablet when using sterile radiation reducing gloves.
Wireless Devices and Cybersecurity Evaluation: To evaluate the . ControlRad® Select Model Z's compliance with the requirements of FDA Guidance documents: "Radio Frequency Wireless Technology in Medical Devices" and "Postmarket Management of Cyber Security in Medical Devices".

Verification and Validation:

Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 and "Off-The-Shelf Software Use in Medical Devices" is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Nonclinical tests were conducted on ControlRad® Select Model Z during product development.

The Risk analysis was completed, and risk control was implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.

ControlRad® Select Model Z was tested and found to be safe and effective for intended users, uses and use environments through the design control verification and validation process. Usability testing per IEC 60601-1-6 showed that usability related hazards are addressed in the system test according to the operator's manual and in simulated clinical use tests with customer report and feedback form. Customer employees are adequately trained in the use of this equipment.

ControlRad® conforms to the cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed or transferred from a medical device to an external recipient. Provided in the Software Section is the required cybersecurity information.

Summarv:

Performance tests were conducted to test the functionality of ControlRad® Select Model Z System. These tests have been performed to assess the functionality of the Subject Device. Results of all conducted testing was found acceptable and do not raise any new issues of safety or effectiveness.

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Image /page/22/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in a dark teal sans-serif font, followed by "RAD" in a lighter green sans-serif font. The "RAD" is surrounded by a green circle that is darker at the top and lighter at the bottom, giving it a gradient effect.

ControlRad® Trace Model 9 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 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.
. 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".

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.

23

Image /page/23/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in dark green, followed by "RAD" in a lighter green. To the right of the text is a circular design with two shades of green, creating a visual element that complements the text.

Verification and Validation:

Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software in Medical Devices" issued on May 11, 2005 and "Off-The-Shelf Software Use in Medical Devices" is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on ControlRad® Trace Model 9 during product development.

The Risk analysis was completed, and risk control was implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.

ControlRad® Trace Model 9 was tested and found to be safe and effective for intended users, uses and use environments through the design control verification and validation process. Usability testing per IEC 60601-1-6 showed that usability related hazards are addressed in the system test according to the operator's manual and in simulated clinical use tests with customer report and feedback form. Customer employees are adequately trained in the use of this equipment.

ControlRad conforms to the cybersecurity requirementing a process of preventing unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed or transferred from a medical device to an external recipient. Provided in the Software Section is the required cybersecurity information.

Summary:

Performance tests were conducted to test the functionality of ControlRad® Trace Model 9 System. These tests have been performed to assess the functionality of the Subject Device. Results of all conducted testing was found acceptable and do not raise any new issues of safety or effectiveness.

ControlRad Trace Model 8 Performance Data:

ControlRad® conducted the following performance tests to demonstrate that the ControlRad® Trace Model 8 for use with GE Healthcare Surgery's 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 Air Kerma (AKR) measurements of GE Healthcare Surgery's 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.

24

Image /page/24/Picture/0 description: The image shows the logo for ControlRad. The logo consists of the word "CONTROL" in dark green, followed by the word "RAD" in green. The word "RAD" is partially enclosed in a green circle that is darker at the bottom and lighter at the top.

. 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.
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 GE Healthcare Surgery's OEC 9800 with installed ControlRad® Trace Model 8 within the ROI is at least with the same image quality compared to the image quality of the GE Healthcare Surgery's 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 GE Healthcare Surgery's OEC 9800 with installed ControlRad® Trace Model 8 in the periphery image outside the ROI compared to the image quality of the GE Healthcare Surgery's OEC 9800 Plus alone.
Image Quality Clinical Simulations 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 to the ROI, of a clinically simulated image obtained by the GE Healthcare Surgery's OEC® 9800 Plus with installed ControlRad® Trace Model 8.
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 qloves 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.

Verification and Validation:

Software Documentation for a Moderate Level of Concern software per FDA's Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" issued on May 11, 2005 and "Off-The-Shelf Software Use in Medical Devices" is also included as part of this submission. The performance data demonstrates continued conformance with special controls for medical devices containing software. Non-clinical tests were conducted on ControlRad® Select Model 8 during product development.

The Risk analysis was completed, and risk control was implemented to mitigate identified hazards. The testing results support that all the software specifications have met the acceptance criteria. Testing for verification and validation for the device was found acceptable to support the claims of substantial equivalence.

25

Image /page/25/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in dark teal, followed by "RAD" in green. The "RAD" is surrounded by a green circle that is darker at the top and lighter at the bottom. The logo is simple and modern.

ControlRad® Select Model 8 was tested and found to be safe and effective for intended users, uses and use environments through the design control verification and validation process. Usability testing per IEC 60601-1-6 showed that usability related hazards are addressed in the system test according to the operator's manual and in simulated clinical use tests with customer report and feedback form. Customer employees are adequately trained in the use of this equipment.

ControlRad® conforms to the cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or the unauthorized use of information that is stored, accessed or transferred from a medical device to an external recipient. Provided in the Software Section is the required cybersecurity information.

Summary:

Performance tests were conducted to test the functionality of ControlRad® Select Model 8 System. These tests have been performed to assess the functionality of the Subject Device. Results of all conducted testing was found acceptable and do not raise any new issues of safety or effectiveness.

10. Performance Standards for ControlRad® Select Model Z, ControlRad® Trace Model 9, and ControlRad® Trace Model 8

ControlRad® Select Model Z complies with the following performance standards:
1.	ISO 14971 Medical devices – Application of risk management to medical devices
2.	IEC 60601-1 - Medical Electrical Equipment Part 1: General requirements for safety
3.	IEC 60601-1-2 Medical Electrical Equipment – Part 2. Collateral standard: Electromagnetic
compatibility - Requirements and tests
4.	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
5.	IEC 60601-1-6 Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety
and Essential Performance - Collateral Standard: Usability
6.	IEC 62304 Medical device software - Software life cycle processes
7.	IEC 60825-1 Safety of laser products – Part1: Equipment classification and requirements
[Including: Technical Corrigendum 1 (2008), interpretation Sheet 1 (2007), Interpretation Sheet 2
(2007)]
8.	IEC 60601-2-28 Medical electrical equipment – Part 2-28: Particular requirements for the basic
safety and essential performance of X-ray tube assemblies for medical diagnosis
9.	IEC 60601-2-43 Medical electrical equipment – Part 2-43: Particular requirements for the safety
and essential performance of X-ray equipment for interventional procedures.
10.	IEC 60601-2-54 Medical electrical equipment – Part 2-54: Particular requirements for the basic
safety and essential performance of X-ray equipment for radiography and radioscopy
11.	FDA 21 CFR 1020.30-32 Federal Performance Standard for Diagnostic X-ray Systems

26

Image /page/26/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in dark green, and the word "RAD" is in light green and is surrounded by a green circle. The circle is darker green on the bottom and lighter green on the top.

ControlRad® Trace Model 9 complies with the following performance standards:
1.	ISO 14971 Medical devices - Application of risk management to medical devices
2.	IEC 60601-1 - Medical Electrical Equipment Part 1: General requirements for safety
3.	IEC 60601-1-2 Medical Electrical Equipment - Part 2. Collateral standard: Electromagnetic compatibility

Requirements and tests |
| 4. | 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 |
| 5. | IEC 60601-1-6 Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and
Essential Performance - Collateral Standard: Usability |
| 6. | IEC 62304 Medical device software – Software life cycle processes |
| 7. | FDA 21 CFR 1020.30-32 Federal Performance Standard for Diagnostic X-ray Systems |

ControlRad® Trace Model 8 complies with the following performance standards:

1.	ISO 14971 Medical devices - Application of risk management to medical devices
2.	IEC 60601-1 - Medical Electrical Equipment Part 1: General requirements for safety
3.	IEC 60601-1-2 Medical Electrical Equipment - Part 2. Collateral standard: Electromagnetic compatibility

Requirements and tests |
| 4. | 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 |
| 5. | IEC 60601-1-6 Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safety and
Essential Performance - Collateral Standard: Usability |
| 6. | IEC 62304 Medical device software – Software life cycle processes |
| 7. | FDA 21 CFR 1020.30-32 Federal Performance Standard for Diagnostic X-ray Systems |

Conclusion as to Substantial Equivalence: 11.

ControlRad Select Model Z Conclusión Statement:

The ControlRad® Select Model Z is installed on the Siemens Artis zee (K181407). The ControlRad® Select Model Z is technologically identical to ControlRad® Select Model Z, cleared in K202431. Minor changes implemented via the "Letter to File" process do not raise any new questions regarding safety and effectiveness of the device as demonstrated through updated performance testing.

ControlRad Trace Model 9 Conclusión Statement:

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 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 Heathcare Surgery's OEC® 9900 Elite is substantially equivalent to that predicate devices.

ControlRad Trace Model 8 Conclusión Statement:

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 in the primary predicate device (K183109). Minor changes implemented via the "Letter to File" process do not raise any new questions regarding safety and effectiveness of the device as demonstrated through updated applicable bench test summaries of performance testing and the conducted risk analysis. 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 cleared predicate device.