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. 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.

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.

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. The ControlRad Trace semi-transparent filter should not be used in lieu of the OEC® 9800/OEC® 9800 Plus' collimators, as they block the most radiation, but can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinical applications may include cholangiography, endoscopic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

Device Description

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. It consists of a ControlRad filter mounted onto the Siemens Medical Artis zee (K181407) C-arm. The ControlRad filter is installed semi-permanently to aid in reducing both patient and clinicians' radiation exposure while providing fluoroscopic imaging of the patient during diagnostic, surgical and interventional procedures. 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. 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 are ControlRad Tablet, ControlRad Filter, ControlRad Hardware, ControlRad Software and Firmware Modules, and ControlRad Communication Interface. ControlRad® Select Model Z contains a titanium filter (2.5mm or 3mm nominal thickness). The system 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.

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 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 CR Trace Filter is installed on top of the GE Healthcare Surgery's OEC® 9900 Elite's collimator. The CR Trace Filter is a semi-transparent filter which reduces the X-ray radiation outside the clinician-selected ROI.

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 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 CR Trace Filter is installed on top of the GE Healthcare Surgery's OEC® 9800 Plus's collimator. The CR Trace Filter is a semi-transparent filter which reduces the X-ray radiation outside the clinician-selected ROI.

AI/ML Overview

The provided FDA 510(k) summary (K211782) describes three devices: ControlRad® Select Model Z, ControlRad® Trace Model 9, and ControlRad® Trace Model 8. The summary indicates that these are "Bundled Special 510(K) submissions" or "Catch-Up" 510(k)s, suggesting that for each device, the current submission refers to minor changes to a previously cleared predicate device of the same name. Therefore, the performance data presented is primarily to demonstrate that the minor changes do not raise new questions of safety and effectiveness, and that the device remains at least as safe and effective as its predicate.

Here's a breakdown of the acceptance criteria and study information provided for each device, based on the input text:

ControlRad® Select Model Z

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Indications for Use: Provide fluoroscopic imaging while reducing patient and clinician radiation exposure (Dose Area Product) outside the ROI compared to Artis zee non-collimated image area. Specific Claim: Reduces at least 85% of the Dose Area Product at 65 kVp and ROI with width and length smaller than 1/5 the edge size of the full FOV.	The device's indications for use are the same as the predicate. The device "is able to reduce DAP as noted in the indications for use" (Dose Area Product (DAP) Reduction test).
Impact of Air Kerma: ControlRad® components integrated with Artis zee system do not significantly increase Air Kerma when compared to Artis zee alone.	"Verification that the ControlRad® components on the reference system do not significantly increase Air Kerma... was met." (Impact of Air Kerma test).
Air Kerma and Air Kerma Rate (AK/AKR) Accuracy: AK and AKR of the subject system (ControlRad® + Artis zee) is ±35% of Artis zee alone, per 21 CFR 1020.32.	"Verification that the AK and AKR of the subject system... is ±35%... was met." (Air Kerma and Air Kerma Rate Accuracy test).
Radiation Dose Structure Report (RDSR) AK Accuracy: Cumulative AKR as referenced in the RDSR of the subject system (ControlRad® + Artis zee) is ±35% of Artis zee alone.	"Verification that the cumulative AKR as referenced in the RDSR of the subject system... is ±35%... was met." (Radiation Dose Structure Report (RDSR) AK Accuracy test).
Reference Air Kerma Warning Functionality: Not impacted by ControlRad® components.	"Verification that the Reference Air Kerma Warning Functionality is not impacted... was met." (Reference Air Kerma Warning Functionality test).
Dose Area Product (DAP) Accuracy: DAP measurements of the subject system (ControlRad® + Artis zee) is ±35% of Artis zee system per IEC 60601-2-43.	"Demonstrate the DAP measurements of the subject system... is ±35%... was met." (Dose Area Product (DAP) Accuracy test).
Filter Attenuation: X-ray radiation attenuation by ControlRad® components shows 44% to 98% attenuation outside the ROI.	"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 was met." (Filter Attenuation Testing).
Leakage Radiation Evaluation: No adverse impact of ControlRad® components on reference device leakage radiation.	Evaluation performed; outcome not explicitly stated as a percentage or specific value, but "Results of all conducted testing was found acceptable".
Stray Radiation Evaluation: No adverse impact of ControlRad® components on reference device stray radiation.	Evaluation performed; outcome not explicitly stated as a percentage or specific value, but "Results of all conducted testing was found acceptable".
Recovery Management: As required by IEC 60601-2-43, section 201.4.101.	"Verification that recovery management of ControlRad® Select Model Z as required by IEC 60601-2-43, section 201.4.101 was met." (Recovery Management test).
Mechanical Impact on Filter Cover: Impact to filter/collimator cover does not create unacceptable risk per IEC 60601-1 requirements.	"Verification that impact to the filter / collimator cover does not create unacceptable risk per IEC 60601-1 requirements was met." (Mechanical Impact on Filter Cover test).
Collision Sensor Functionality Evaluation: Maintained when using ControlRad® filter/collimator covers.	"Verification that the collision sensor functionality is maintained when using the ControlRad® filter / collimator covers was met." (Collision Sensor Functionality Evaluation test).
Focal Spot to Patient Distance: Implementation per IEC 60601-2-54, section 203.9 requirements.	"Verification that the focal spot to skin distance implementation per IEC 60601-2-54, section 203.9 requirements was met." (Focal spot to patient distance test).
Tensile Strength Evaluation: Additional mass from Select Model Z filter does not create unacceptable risk from tensile strength per IEC 60601-1 requirements.	"Verification that additional mass from the Select Model Z filter does not create unacceptable risk from tensile strength per IEC 60601-1 requirements was met." (Tensile Strength Evaluation test).
Filter Motion Reliability Testing: Durability of mechanical filter assembly verified within a random motion stress test.	"Verification that the durability of the mechanical filter assembly in frame of a random motion stress test was met." (Filter Motion Reliability Testing).
Comparative image quality inside the ROI: At least the same image quality as the Siemens Artis zee alone.	"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 was met." (Comparative image quality inside the ROI test).
Comparative image quality outside the ROI: Quantify the level of image quality degradation.	"Quantify the level of image quality degradation outside the region of interest as a result of the CR filter blades was met." (Comparative image quality outside the ROI test).
Image quality evaluation via clinical simulations: Image quality outside the ROI is clinically relevant following degradation due to use of ControlRad filters.	"To validate that the image quality outside the ROI in clinically relevant following degradation due to use of the ControlRad filters was met." (Image quality evaluation via clinical simulations test).
DAP Chamber Change Justification: Justify the change in DAP chamber.	Justification performed; outcome not explicitly detailed, but "Results of all conducted testing was found acceptable".
Touch-In-Glove Bench Test: Sensitivity of ControlRad® tablet with sterile radiation reducing gloves.	"To verify the sensitivity of the ControlRad® tablet when using sterile radiation reducing gloves was met." (Touch-In-Glove Bench Test).
Wireless Devices and Cybersecurity Evaluation: Compliance with FDA Guidance documents: "Radio Frequency Wireless Technology in Medical Devices" and "Postmarket Management of Cyber Security in Medical Devices." Process of preventing unauthorized access, modifications, misuse, denial of use, or unauthorized use of information.	Evaluation performed; "ControlRad® conforms to the cybersecurity requirements by implementing a process of preventing unauthorized access, modifications, misuse or denial of use...".

Sample size for test set and data provenance: The document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence rather than providing detailed clinical study reports. The performance data section describes types of tests conducted (e.g., Impact of Air Kerma, DAP Accuracy, Comparative Image Quality) and generic statements about "verification" that criteria were met. It does not provide specific sample sizes (e.g., number of images, patients, or instances) for any of these tests, nor does it specify the country of origin or whether the data was retrospective or prospective. It only states that "Nonclinical tests were conducted on ControlRad® Select Model Z during product development," implying bench testing rather than clinical data.
Number of experts and qualifications: Not specified. The document mentions "clinically relevant" for image quality, but doesn't detail external expert review or qualifications for establishing ground truth on the test set.
Adjudication method for test set: Not specified.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not explicitly mentioned or detailed. The term "Comparative image quality inside/outside the ROI" indicates a comparison to the Artis zee alone, but no details on human readers, effect sizes, or AI assistance are provided. The device described appears to be a hardware/software add-on that reduces radiation while maintaining image quality or providing contextual information, not primarily an AI algorithm for diagnosis.
Standalone (algorithm-only) performance: The device is described as an accessory that works with existing fluoroscopic X-ray systems (Siemens Artis zee, OEC 9900 Elite, OEC 9800 Plus) to reduce radiation dose in specific areas while maintaining or providing contextual image quality. Its performance is always in conjunction with the base imaging system; therefore, a purely "standalone" algorithm-only performance is not applicable in the context of this device. The testing focuses on the integrated system's performance.
Type of ground truth used: Based on the descriptions of "performance tests," "verification," and "evaluation" against specific metrics (e.g., DAP accuracy, AKR accuracy, image quality compared to the base system), the ground truth appears to be based on physical phantom measurements, quantitative dosimetry, and technical performance metrics as opposed to clinical outcomes or expert consensus on disease presence. For "Comparative image quality," the baseline performance of the unmodified Artis zee system served as a reference. Clinical simulations were mentioned for image quality evaluation, but further details about how "ground truth" was established within those simulations are not provided.
Sample size for training set: Not applicable and not mentioned. This device is an accessory that modifies X-ray output and image processing to reduce dose; it is not presented as a machine learning/AI diagnostic system that would typically require a training set of patient data with ground truth labels.
How ground truth for training set was established: Not applicable, as no training set for an AI/ML algorithm is described. The software components relate to controlling the filter and image processing, not to learning from data.

ControlRad® Trace Model 9

The information for ControlRad® Trace Model 9 is very similar in structure and detail to the Select Model Z.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Indications for Use: Reduce patients and clinicians' radiation exposure (DAP) outside the ROI compared to OEC® 9900 Elite non-collimated image area. Specific Claim: Reduces at least 50% of the DAP at 50 kVp and ROI with width and length smaller than 1/3 the diameter of the full FOV.	The device's indications for use are the same as the predicate. The device "reduces at least 50% of the DAP at 50kVp and ROI with width and length are smaller than 1/3 the diameter of the full FOV" (DAP Reduction Accuracy Test).
Impact on Air Kerma: Evaluate impact on Air Kerma Rate (AKR) of GE Healthcare Surgery's OEC 9900 Elite.	"Impact on Air Kerma Test was performed in order to evaluate the impact... In all performance tests... performed and functioned as intended and observations were as expected."
DAP calculation accuracy: DAP calculations within ±35% of measured DAP values.	"Dose-Area-Product (DAP) calculation accuracy test was performed to demonstrate that DAP calculations... are within ±35% of measured DAP values was met."
DAP Reduction Accuracy: DAP Reduction calculations within ±35% of measured DAP Reduction values.	"Dose-Area-Product (DAP) Reduction Accuracy Test was performed to demonstrate that DAP Reduction calculations... are within ±35% of the DAP Reduction values was met."
ControlRad® Trace Filter Attenuation: Evaluate attenuation level of the filters.	"ControlRad® Trace Filter Attenuation Test was performed to evaluate the attenuation level... In all performance tests... performed and functioned as intended and observations were as expected."
Comparative Image Quality inside the ROI: Image quality within ROI is at least the same as OEC 9900 Elite alone.	"Comparative Image Quality inside the ROI Test was performed to demonstrate that the image quality... within the ROI is of at least the same image quality compared to the image quality of the OEC 9900 Elite alone was met."
Comparative Image Quality outside the ROI: Evaluate filtered image quality outside the ROI.	"Comparative Image Quality outside the ROI Test was performed in order to evaluate the filtered image quality outside the ROI... In all performance tests... performed and functioned as intended and observations were as expected."
Image Quality Clinical Simulations: Evaluate image quality inside/outside ROI and ability of filtered image outside ROI to provide image context to the ROI.	"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... was met."
Touch-In-Gloves Bench Test: Tablet touchscreen operates as intended with sterile radiation protective gloves and touchscreen drape.	"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 was met."
Wireless Technology and Cybersecurity Evaluation: Compliance with FDA Guidance documents and process for preventing unauthorized access, modifications, misuse, denial of use, or unauthorized use of information.	"Wireless Technology and Cybersecurity Evaluation was performed in order to evaluate the ControlRad® Trace Model 9's compliance... ControlRad conforms to the cybersecurity requirementing a process of preventing unauthorized access..."

Sample size for test set and data provenance: No specific sample sizes, country of origin, or whether data was retrospective/prospective are mentioned. "Non-clinical tests were conducted... during product development."
Number of experts and qualifications: Not specified.
Adjudication method for test set: Not specified.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not explicitly mentioned or detailed.
Standalone (algorithm-only) performance: Not applicable. Performance is integrated with the OEC 9900 Elite system.
Type of ground truth used: Based on the descriptions, ground truth appears to be based on physical phantom measurements, quantitative dosimetry, and technical performance metrics compared to the unmodified OEC 9900 Elite system. "Image Quality Clinical Simulations" are mentioned, but details on how ground truth was established within are not provided.
Sample size for training set: Not applicable and not mentioned.
How ground truth for training set was established: Not applicable.

ControlRad® Trace Model 8

The information for ControlRad® Trace Model 8 is also very similar in structure and detail to the other models.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Indications for Use: Reduce patients and clinicians' radiation exposure (DAP) outside the ROI compared to OEC® 9800/9800 Plus non-collimated image area. Specific Claim: Reduces at least 50% of the DAP at 50 kVp and ROI with width and length smaller than 1/3 the diameter of the full FOV.	The device's indications for use are the same as the predicate. The device "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 Test).
Impact on Air Kerma: Evaluate impact on Air Kerma Rate (AKR) of GE Healthcare Surgery's OEC 9800 Plus.	"Impact on Air Kerma Test was performed in order to evaluate the impact... In all performance tests... performed and functioned as intended and observations were as expected."
DAP calculation accuracy: DAP calculations within ±35% of measured DAP values.	"DAP calculation accuracy test was performed to demonstrate that DAP calculations... are within ±35% of measured DAP values was met."
DAP Reduction Accuracy: DAP Reduction calculations within ±35% of measured DAP Reduction values.	"DAP Reduction Accuracy Test was performed to demonstrate that DAP Reduction calculations... are within ±35% of measured DAP Reduction values was met."
ControlRad® Trace Filter Attenuation: Evaluate attenuation level of the filters.	"ControlRad® Trace Filter Attenuation Test was performed to evaluate the attenuation level... In all performance tests... performed and functioned as intended and observations were as expected."
Comparative Image Quality Inside the ROI: Image quality within ROI is at least the same as OEC 9800 Plus alone.	"Comparative Image Quality Inside the ROI Test was performed to demonstrate that the image quality... 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 was met."
Comparative Image Quality Outside the ROI: Evaluate filtered image quality outside the ROI.	"Comparative Image Quality Outside the ROI Test was performed in order to evaluate the filtered image quality outside the ROI... In all performance tests... performed and functioned as intended and observations were as expected."
Image Quality Clinical Simulations: Evaluate image quality inside/outside ROI and ability of filtered image outside ROI to provide image context to the ROI.	"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... was met."
Touch-In-Gloves Bench Test: Tablet touchscreen operates as intended with sterile radiation protective gloves and touchscreen drape.	"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 was met."
Wireless Technology and Cybersecurity Evaluation: Compliance with FDA Guidance documents and process for preventing unauthorized access, modifications, misuse, denial of use, or unauthorized use of information.	"Wireless Technology and Cybersecurity Evaluation was performed in order to evaluate the ControlRad® Trace Model 8's compliance... ControlRad® conforms to the cybersecurity requirements by implementing a process of preventing unauthorized access..."

Sample size for test set and data provenance: No specific sample sizes, country of origin, or whether data was retrospective/prospective are mentioned. "Non-clinical tests were conducted... during product development."
Number of experts and qualifications: Not specified.
Adjudication method for test set: Not specified.
Multi-reader multi-case (MRMC) comparative effectiveness study: Not explicitly mentioned or detailed.
Standalone (algorithm-only) performance: Not applicable. Performance is integrated with the OEC 9800 Plus system.
Type of ground truth used: Based on the descriptions, ground truth appears to be based on physical phantom measurements, quantitative dosimetry, and technical performance metrics compared to the unmodified OEC 9800 Plus system. "Image Quality Clinical Simulations" are mentioned, but details on how ground truth was established within are not provided.
Sample size for training set: Not applicable and not mentioned.
How ground truth for training set was established: Not applicable.

In summary, the 510(k) relies on a conformance approach for these "catch-up" submissions, demonstrating that minor changes to previously cleared devices do not negatively impact safety and effectiveness. The studies described are primarily technical and bench-top validations of the components and system performance against pre-defined engineering and regulatory standards and against the baseline performance of the unmodified C-arm systems. They do not involve extensive human-in-the-loop studies or clinical trials with large patient cohorts to establish nuanced clinical effectiveness or comparative diagnostic accuracy.

Summary

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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

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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

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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.

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)

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Indications for Use

510(k) Number (if known) K211782

Device Name ControlRad® Trace Model 9

Indications for Use (Describe)

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.

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."

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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)
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☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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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-IntensifiedFluoroscopic X-ray System	Image-IntensifiedFluoroscopic X-ray System	Image-IntensifiedFluoroscopic X-ray System
Common Name	Interventional FluoroscopicX-ray System	Interventional FluoroscopicX-ray System	Interventional FluoroscopicX-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: OWBSecondary: JAA, IZI	Primary: OWBSecondary: OXO, JAA	Primary: OWBSecondary: OXO, JAA
	The ControlRad® SelectModel Z is installed on thesystem below:	The ControlRad® TraceModel 9 is installed on thesystem below:	The ControlRad® TraceModel 8is installed onthe 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-intensifiedfluoroscopic X-ray System	Image-intensifiedfluoroscopic X-ray System	Image-intensifiedfluoroscopic X-ray System
Common Name	Interventional FluoroscopicX-Ray System	Interventional FluoroscopicX-Ray	Interventional FluoroscopicX-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.

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.

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 Nameand Manufacturer	510(k)Number	ClearanceDate	Comparable Properties
Primary PredicateControlRad® Select Model ZControlRad®	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 Nameand Manufacturer	510(k)Number	ClearanceDate	Comparable Properties
Primary PredicateControlRad® Trace Model 9ControlRad®	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 PredicateControlRad® Trace Model 8ControlRad®	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® SelectModel Z(K211782)	Primary Predicate DeviceControlRad® SelectModel Z(K202431)	ComparisonResults
RegulationNumber	21 CFR §892.1650	21 CFR §892.1650	Same
Indications foruse Statement	The ControlRad® Select Model Z withSiemens Artis zee is indicated toprovide fluoroscopic of the patientduring diagnostic, surgical, andinterventional procedures whilereducing patients and clinicians'radiation exposure (Dose AreaProduct) outside of the ControlRadSelect Model Z's region of interest(ROI) as compared to Artis zee non-collimated image area.1 TheControlRad Select Model Z semi-transparent filter should not be used inlieu of the Artis zee's collimators, asthey block the most radiation, but canhelp physicians balance dosereduction with the need to visualizestructures outside the ROI when it isconsidered clinically advantageous todo so. Clinical applications mayinclude cardiac angiography, neuro-angiography, general angiography,rotational angiography, multipurposeangiography and whole bodyradiographic/fluoroscopic proceduresas well as procedures next to the tablefor i.e., patient extremities.Additional procedures that can beperformed include angiography in theoperating room, image guided surgeryby X-ray, by image fusion, and bynavigation systems. The examinationtable as an integrated part of thesystem 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 withSiemens Artis zee is indicated toprovide fluoroscopic of the patientduring diagnostic, surgical, andinterventional procedures whilereducing patients and clinicians'radiation exposure (Dose AreaProduct) outside of the ControlRadSelect Model Z's region of interest(ROI) as compared to Artis zee non-collimated image area.1 TheControlRad Select Model Z semi-transparent filter should not be used inlieu of the Artis zee's collimators, asthey block the most radiation, but canhelp physicians balance dosereduction with the need to visualizestructures outside the ROI when it isconsidered clinically advantageous todo so. Clinical applications mayinclude cardiac angiography, neuro-angiography, general angiography,rotational angiography, multipurposeangiography and whole bodyradiographic/fluoroscopic proceduresas well as procedures next to the tablefor i.e., patient extremities.Additional procedures that can beperformed include angiography in theoperating room, image guided surgeryby X-ray, by image fusion, and bynavigation systems. The examinationtable as an integrated part of thesystem can be used for X-ray imaging,surgery and interventions.1 Relative to open Field of View (FOV),	Same
	Z reduces at least 85% of the DoseArea Product at 65 kVp and ROI with	the ControlRad Select Model Zreduces at least 85% of the Dose AreaProduct at 65 kVp and ROI with width
	width and length that are smaller than1/5 the edge size of the full FOV.	and length that are smaller than 1/5the edge size of the full FOV.
X-ray RadiationSource	The X-ray Tube of SiemensMedicalSolutions, Inc. Artis zee	The X-ray Tube of SiemensMedicalSolutions, Inc. Artis zee	Same
SystemConfiguration	ControlRad Filter and ImageProcessing SW/HW mountedon Artiszee	ControlRad Filter and ImageProcessing SW/HW mounted on Artiszee	Same
X-rayModulationComponent	CR Filter2.5mm or 3.0mm	CR Filter2.5mm or 3.0mm	Same
X-ray RadiationModulation	Semi-transparent filter; Reducesradiation outside the aperturetypically by 44% to 98%.	Semi-transparent filter; Reducesradiation outside the aperturetypically by 44% to 98%.	Same
Aperture shape	Blades: Rectangular	Blades: Rectangular	Same
ApertureControl	Set by the user using the CRTablet	Set by the user using the CRTablet	Same
Image AreaProcessed	Area outside ROI	Area outside ROI	Same
Processing Bits	16 bits	16 bits	Same
Processing Rate	30 fps	30 fps	Same
ProcessingOccurrence	Area outside ROI: Only when the CRFilter is engaged	Area outside ROI: Only when the CRFilter is engaged	Same
Image LayoutInformation	All image layout informationoriginally available for SiemensArtis zee plus the following:Percentage of Dose AreaProduct (DAP) reductionwhen using ControlRadFilter and/or SiemensArtis zee CollimatorROI frame borderControlRad Logo andBranding	All image layout informationoriginally available for SiemensArtis zee plus the following:Percentage of Dose AreaProduct (DAP) reductionwhen using ControlRadFilter and/or SiemensArtiszee CollimatorROI frame borderControlRad Logo andBranding	Same
Dose AreaProduct (DAP)Accuracy fortotal x-ray fieldof theControlRadFilter & Artiszee systemscombined*	±35%*	±35%*	Same
ElectricalRequirements	Artis zee Components: Powerrequirements GeneratorPOLYDOROS A100Plus:AC 400 V ± 10 %, 50/60Hz ± 1 HzPower requirements Systemcontrol cabinet: AC 400 V ±10 %, 50/60Hz ± 1 HzControlRad Components: SCIPBOX Input: 230 VAC,0.6ATABLET POWER SUPPLYInput: 24 VDC, 0.5A SELECTFILTER Input: 28 VDC, 0.9AROUTER Input: 12DC, 1AROUTER POWER SUPPLY Input :230VAC, 0.5A	Artis zee Components:Powerrequirements GeneratorPOLYDOROS A100Plus:AC 400 V ± 10 %, 50/60Hz ± 1 HzPower requirements Systemcontrol cabinet: AC 400 V ±10 %, 50/60Hz ± 1 HzControlRad Components: SCIPBOX Input: 230 VAC,0.6ATABLET POWER SUPPLYInput: 24 VDC, 0.5A SELECTFILTER Input: 28 VDC, 0.9AROUTER Input : 12DC, 1AROUTER 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 DeviceControlRad® TraceModel(K211782)	Primary Predicate DeviceControlRad® Trace Model 9(K200663)	ComparisonResults
Device Class	Class II	Class II	Same
Product Codes	Primary: OWBSecondary: OXO, JAA	Primary: OWBSecondary: 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 fluoroscopicand spot-film imaging of thepatient during diagnostic, surgical,and interventional procedureswhilereducing patients andclinicians'radiation exposure(Dose Area Product) outside ofthe ControlRad Trace's region ofinterest (ROI) as compared toOEC® 9900 Elite non- collimatedimage area.1 The ControlRadTrace semi- transparent filtershould not be used in lieu of theOEC® 9900 Elite's collimators, asthey block the most radiation, butcan help physicians balance dosereduction with the need tovisualize structures outside theROI when it is consideredclinically advantageous to do so.Clinical applications may includecholangiography, endoscopic,urologic, orthopedic, neurologic,vascular, cardiac, critical care andemergency room procedures.1Relative to open Field of View(FOV), the ControlRad TraceModel 9 reduces at least 50% ofthe Dose Area Product at 50 kVpand ROI with width and lengththat are smaller than 1/3 thediameter of the full FOV.	The ControlRad® Trace Model9,when used with OEC® 9900 Elite, isindicated to provide fluoroscopicand spot-film imaging of the patientduring diagnostic, surgical, andinterventional procedures whilereducing patients and clinicians'radiation exposure (Dose AreaProduct) outside of the ControlRadTrace's region of interest (ROI) ascompared to OEC® 9900 Elite non-collimated image area.1 TheControlRad Trace semi-transparent filter should not beused in lieu of the OEC® 9900Elite's collimators, as they block themost radiation, but can helpphysicians balance dose reductionwith the need to visualize structuresoutside the ROI when it isconsidered clinically advantageousto do so. Clinical applications mayinclude cholangiography,endoscopic, urologic, orthopedic,neurologic, vascular, cardiac,critical care and emergency roomprocedures.1Relative to open Field of View(FOV), the ControlRad TraceModel 9 reduces at least 50% ofthe Dose Area Product at 50 kVpand ROI with width and lengththat are smaller than 1/3 thediameter of the full FOV.	Same
X-ray ModulationComponent	CR Trace Filter	CR Trace Filter	Same
X-Ray RadiationModulation	Reduces X-ray radiation outside theaperture/ROI typically by 61% to97%	Reduces X-ray radiation outside theaperture/ROI typically by 61% to97%	Same
Aperture Shape	Rectangular	Rectangular	Same
Aperture Control	Set by the user using the CR TraceTablet	Set by the user using the CR TraceTablet	Same
Image AreaProcessed	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
ProcessingOccurrence	Only when the CR Trace Filter isengaged	Only when the CR Trace Filter isengaged	Same
Image LayoutInformation	Dose Area Product (DAP) valueand/or percentage of DAPreduction when using ControlRadTrace Filterand/or OECCollimatorsROI frame border	Dose Area Product (DAP) valueand/or percentage of DAPreduction when using ControlRadTrace Filterand/or OEC CollimatorsROI frame border	Same
Dose Area Product(DAP) Accuracy fortotal x-ray field of theControlRad TraceFilter andOEC systemscombined*	*Overall: ±35%For DAP reported byControlRad®Trace Model 9	*Overall: ±35%For DAP reported byControlRad®Trace Model 9	Same
ElectricalRequirements	60 / 50 Hz; 120 VAC(±10%), 15A200/220/230/240VAC(±10%), 10A	60 / 50 Hz; 120 VAC(±10%), 15A200/220/230/240VAC(±10%), 10A	Same

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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 DeviceControlRad® Trace Model 8(K211782)	Primary Predicate DeviceControlRad® Trace Model 8(K183109)	ComparisonResults
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/OEC9800 Plus, is indicated to providefluoroscopic and spot-film imagingof the patient during diagnostic,surgical, and interventionalprocedures while reducing patientsand clinicians' radiation exposure(Dose Area Product) outside of theControlRad Trace's region ofinterest (ROI) as compared to theOEC 9800/OEC 9800 Plus non-collimated image area. 1TheControlRad Trace semi-transparentfilter should not be used in lieu ofthe OEC 9800/OEC 9800 Plus'collimators, as they block the mostradiation, but can help physiciansbalance dose reduction with theneed to visualize structures outsidethe ROI when it is consideredclinically advantageous to do so.Clinical applications may includecholangiography, endoscopic,urologic, orthopedic, neurologic,vascular, cardiac, critical care andemergency room procedures.1Relative to open Field of View(FOV), the ControlRad Trace Model8 reduces at least 50% of the DoseArea Product at 50 kVp and ROIwith width and length that aresmaller than 1/3 the diameter of thefull FOV.	The ControlRad® Trace Model 8,when used with OEC 9800/OEC9800 Plus, is indicated to providefluoroscopic and spot-film imagingof the patient during diagnostic,surgical, and interventionalprocedures while reducing patientsand clinicians' radiation exposure(Dose Area Product) outside of theControlRad Trace's region ofinterest (ROI) as compared to theOEC 9800/OEC 9800 Plus non-collimated image area. 1TheControlRad Trace semi-transparentfilter should not be used in lieu ofthe OEC 9800/OEC 9800 Plus'collimators, as they block the mostradiation, but can help physiciansbalance dose reduction with theneed to visualize structures outsidethe ROI when it is consideredclinically advantageous to do so.Clinical applications may includecholangiography, endoscopic,urologic, orthopedic, neurologic,vascular, cardiac, critical care andemergency room procedures.1Relative to open Field of View(FOV), the ControlRad Trace Model8 reduces at least 50% of the DoseArea Product at 50 kVp and ROIwith width and length that aresmaller than 1/3 the diameter of thefull FOV.	Same
Comparison Table: ControlRad® Trace Model 8
Device Feature	Subject DeviceControlRad® Trace Model 8(K211782)	Primary Predicate DeviceControlRad® Trace Model 8(K183109)	ComparisonResults
X-ray ModulationComponent	CR Trace Filter	CR Trace Filter	Same
X-ray RadiationModulation	Reduces X-ray radiation outside theaperture/ROI typically by 60% to 90%	Reduces X-ray radiation outside theaperture/ROI typically by 60% to 90%	Same
Aperture shape	Rectangular	Rectangular	Same
Aperture Control	Set by the user using the CR TraceTablet	Set by the user using the CR TraceTablet	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
ProcessingOccurrence	Only when the CR Trace Filter isengaged	Only when the CR Trace Filter isengaged	Same
Image LayoutInformation	Estimated DAP,Estimated percentage of DAP reductionwhen using CR Trace Filter,ROI frame border;	Estimated DAP,Estimated percentage of DAP reductionwhen 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
ElectricalRequirements	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.

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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.

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.

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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.

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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: Electromagneticcompatibility - Requirements and tests
4.	IEC 60601-1-3 Medical Electrical Equipment - Part 1-3: General requirements for basic safetyand essential performance - Collateral Standard: Radiation protection in diagnostic X-rayequipment
5.	IEC 60601-1-6 Medical Electrical Equipment - Part 1-6: General Requirements for Basic Safetyand 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 basicsafety 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 safetyand essential performance of X-ray equipment for interventional procedures.
10.	IEC 60601-2-54 Medical electrical equipment – Part 2-54: Particular requirements for the basicsafety 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

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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 andessential 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 andEssential 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 andessential 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 andEssential 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.

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.