FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

The ControlRad® Select Model Z with Siemens Artis zee is indicated to provide fluoroscopic imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients' radiation exposure (Dose Area Product) outside of the ControlRad Select Model Z's region of interest (ROI) as compared to Artis zee noncollimated image area. 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.

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.

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.

§ 892.1650 Image-intensified fluoroscopic x-ray system.