ControlRad Select Model Z, ControlRad Trace Model 8, ControlRad Trace Model 9

{0}------------------------------------------------ July 1, 2021 Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo in a blue box. Next to that is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. ControlRad, Inc. % Linda Braddon, Ph.D. CEO Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 WOODSTOCK GA 30188 Re: K211782 Trade/Device Name: ControlRad® Select Model Z, ControlRad® Trace Model 9, ControlRad® Trace Model 8 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA, IZI Dated: June 7, 2021 Received: June 9, 2021 Dear Dr. Braddon: We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part {1}------------------------------------------------ 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, For Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K211782 Device Name ControlRad® Select Model Z #### Indications for Use (Describe) The ControlRad® Select Model Z with Siemens Artis zee is indicated to provide fluoroscopic imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients' radiation exposure (Dose Area Product) outside of the ControlRad Select Model Z's region of interest (ROI) as compared to Artis zee noncollimated image area. 1 The ControlRad Select Model Z semi-transparent filter should not be used in lieu of the Artis zee's collimators, as they block the most radiation, but can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinical applications may include cardiac angiography, neuro-angiography, rotational angiography, multipurpose angography and whole body radiographic/fluoroscopic procedures as well as procedures next to the for i.e. patient extremities. Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for Xray imaging, surgery and interventions. 1 Relative to open Field of View (FOV), the ControlRad® Select Model Z reduces at least 85% of the Dose Area Product at 65 kVp and ROI with width and length that are smaller than 1/5 the edge size of the full FOV. | Type of Use ( <i>Select one or both, as applicable</i> ) | | |--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------| | <div> <span> <span style="font-size: 20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. ***DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*** The burden time for this collection of information is estimated to average 79 hours per response, including the The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K211782 Device Name ControlRad® Trace Model 9 #### Indications for Use (Describe) The ControlRad® Trace Model 9, when used with OEC® 9900 Elite, is indicated to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad® Trace's region of interest (ROI) as compared to OEC® 9900 Elite non-collimated image area. The ControlRad® Trace semi-transparent filter should not be used in lieu of the OEC® 9900 Elite's collimators, as they block the most radiation, but can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinical applications may include cholangiography, endoscopic, urthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. 1 Relative to open Field of View (FOV), the ControlRad® Trace Model 9 reduces at least 50% of the Dose Area Product at 50 kVp and ROI with width and length that are smaller than 1/3 the diameter of the full FOV. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) | <div> <span> <svg class="bi bi-check-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> <path d="M10.97 4.97a.75.75 0 0 1 1.071 1.05l-3.992 4.99a.75.75 0 0 1-1.08.02L4.324 8.384a.75.75 0 1 1 1.06-1.06l2.094 2.093 3.473-4.425a.236.236 0 0 1 .02-.022z" fill-rule="evenodd"></path> </svg> </span> </div> | |----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Over-The-Counter Use (21 CFR 801 Subpart C) | <div> <span> <svg class="bi bi-square" fill="currentColor" height="1em" viewbox="0 0 16 16" width="1em" xmlns="http://www.w3.org/2000/svg"> <path d="M14 1H2a1 1 0 0 0-1 1v12a1 1 0 0 0 1 1h12a1 1 0 0 0 1-1V2a1 1 0 0 0-1-1zM2 0a2 2 0 0 0-2 2v12a2 2 0 0 0 2 2h12a2 2 0 0 0 2-2V2a2 2 0 0 0-2-2H2z" fill-rule="evenodd"></path> </svg> </span> </div> | CONTINUE ON A SEPARATE PAGE IF NEEDEDThis section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ ## Indications for Use 510(k) Number (if known) K211782 Device Name ControlRad® Trace Model 8 #### Indications for Use (Describe) The ControlRad® Trace Model 8, when used with OEC® 9800 Plus, is indicated to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace's region of interest (ROI) as compared to the OEC® 9800/OEC® 9800 Plus non-collimated image area. 1 The ControlRad Trace semi-transparent filter should not be used in lieu of the OEC® 9800/OEC® 9800 Plus' collimators, as they block the most radiation, but can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinical applications may include cholangiography, endoscopic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures. 1 Relative to open Field of View (FOV), the ControlRad® Trace Model 8 reduces at least 50% of the Dose Area Product at50 kVp and ROI with width and length that are smaller than 1/3 the diameter of the full FOV. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| | <div style="display:flex; align-items:center;"><span style="font-size:20px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | |-----------------------------------------------------------------------------------------------------------------------------------------| | <div style="display:flex; align-items:center;"><span style="font-size:20px">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> | CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in dark green, and the word "RAD" is in light green. The word "RAD" is surrounded by a green circle that is darker on the left and lighter on the right. #### ControlRad® Select Model Z 510(k) SUMMARY: ControlRad® Trace Model 9 ControlRad® Trace Model 8 Company Name: ControlRad, Inc. 275 Scientific Dr NW Suite 1100 Norcross, Georgia 30092, USA 1-800-522-5148 June 29, 2021 Date Prepared: This 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92. #### 1. General Information: - Applicant Name: ControlRad, Inc. Chris Fair 275 Scientific Dr NW Suite 1100 Norcross, Georgia 30092, USA P: 1-800-522-5148 Establishment Registration Number: 3015709927 #### 2. Contact Person: Patricia D. Jones, VP of Regulatory Affairs Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, GA 30188 770-837-2681 (direct) Regulatory@SecureBME.com ## Secondary Contact: Linda Braddon, Ph.D. Secure BioMed Evaluations 7828 Hickory Flat Hwy Suite 120 Woodstock, GA 30188 770-837-2681 Regulatory@SecureBME.com - 3. 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: {6}------------------------------------------------ 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 - 4. Primary Predicate Devices for ControlRad® Select Model Z; ControlRad® Trace Model 9 and ControlRad® Trace Model 8: | Information | Primary Predicate | Primary Predicate | Primary Predicate | |----------------------|------------------------------------------------------------------------|-----------------------------------------------------------------------|----------------------------------------------------------------------| | Trade Name | ControlRad® Select Model Z | ControlRad® Trace Model 9 | ControlRad® Trace Model 8 | | 510(k) Clearance | K202431 | K200663 | K183109 | | Clearance Date | December 23, 2020 | June 24, 2020 | May 13, 2019 | | Classification Name | Image-Intensified<br>Fluoroscopic X-ray System | Image-Intensified<br>Fluoroscopic X-ray System | Image-Intensified<br>Fluoroscopic X-ray System | | Common Name | Interventional Fluoroscopic<br>X-ray System | Interventional Fluoroscopic<br>X-ray System | Interventional Fluoroscopic<br>X-ray System | | Classification Panel | Radiology | Radiology | Radiology | | Regulation Number | 21 CFR §892.1650 | 21 CFR §892.1650 | 21 CFR §892.1650 | | Device Class | II | II | II | | Product Codes | Primary: OWB<br>Secondary: JAA, IZI | Primary: OWB<br>Secondary: OXO, JAA | Primary: OWB<br>Secondary: OXO, JAA | | | The ControlRad® Select<br>Model Z is installed on the<br>system below: | The ControlRad® Trace<br>Model 9 is installed on the<br>system below: | The ControlRad® Trace<br>Model 8is installed on<br>the system below: | | Trade Name | Artis zee | GE Healthcare Surgery,<br>OEC® 9900 Elite | GE Healthcare Surgery,<br>OEC® 9800 Plus | | 510(k) Clearance | K181407 | K122234 | K132027 | | Clearance Date | August 15, 2018 | August 16, 2012 | December 5, 2012 | | Classification Name | Image-intensified<br>fluoroscopic X-ray System | Image-intensified<br>fluoroscopic X-ray System | Image-intensified<br>fluoroscopic X-ray System | | Common Name | Interventional Fluoroscopic<br>X-Ray System | Interventional Fluoroscopic<br>X-Ray | Interventional Fluoroscopic<br>X-Ray System | | Classification Panel | Radiology | Radiology | Radiology | | Regulation Number | 892.1650 | 892.1650 | 892.1650 | | Device Class | II | II | II | | Product Codes | Primary: OWB | Primary: OWB | Primary: OWB | #### 5. Indications for Use Statements #### Indications for Use Statement for ControlRad® Select Model Z The ControlRad® Select Model Z with Siemens Artis zee is indicated to provide fluoroscopic imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients' and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Select Model Z's region of interest (ROI) as compared to Artis zee non-collimated image area. ↑ The ControlRad Select Model Z semi-transparent filter should not be used in lieu of the Artis zee's collimators, as they block the most radiation, but can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinical applications may include cardiac angiography, neuro-angiography, angiography, multipurpose angiography general angiography, rotational and whole body radiographic/fluoroscopic procedures as well as procedures next to the for i.e., patient extremities. {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in dark green, and the word "RAD" is in light green. To the right of the word "RAD" is a green circle that is broken into two shades of green. Additional procedures that can be performed include angiography in the operating room, image guided surgery by X-ray, by image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for X-ray imaging, surgery and interventions. 1 Relative to open Field of View (FOV), the ControlRad Select Model Z reduces at least 85% of the Dose Area Product at 65 kVp and ROI with width and length that are smaller than 1/5 the edge size of the full FOV. #### Indications for Use Statement for ControlRad® Trace Model 9 The ControlRad® Trace Model 9, when used with OEC® 9900 Elite, is indicated to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad® Trace's region of interest (ROI) as compared to OEC® 9900 Elite non-collimated image area. 1 The ControlRad® Trace semitransparent filter should not be used in lieu of the OEC® 9900 Elite's collimators, as they block the most radiation, but can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinical applications may include cholanqiography, endoscopic, urologic, orthopedic, neurologic, vascular, critical care and emergency room procedures. 1 Relative to open Field of View (FOV), the ControlRad® Trace Model 9 reduces at least 50% of the Dose Area Product at 50 kVp and ROI with width and length that are smaller than 1/3 the diameter of the full FOV. #### Indications for Use Statement for ControlRad® Trace Model 8 The ControlRad® Trace Model 8, when used with OEC® 9800 Plus, is indicated to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients andclinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace's region of interest (ROI) as comparedto the OEC® 9800/OEC® 9800 Plus non-collimated image area. 1 The ControlRad Trace semi-transparent filter should notbe used in lieu of the OEC® 9800 Plus' collimators, as they block the most radiation, but can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinical applications may include cholangiography, endoscopic, urologic, neurologic, vascular, cardiac, critical care and emergency room procedures. 1 Relative to open Field of View (FOV), the ControlRad Trace Model 8 reduces at least 50% of the Dose Area Product at50 kVp and ROI with width and length that are smaller than 1/3 the diameter of the full FOV. #### Device Descriptions for ControlRad® Select Model Z; ControlRad® Trace Model 9, and 6. ControlRad® Trace Model 8 are provided below: ### ControlRad® Select Model Z Device Description The ControlRad® Select Model Z is a set of components mounted on the Artis zee system and cannot be used independent of the Artis zee system. The ControlRad® Select Model Z consists of a ControlRad filter mounted onto the Siemens Medical Artis zee (K181407) C-arm. The ControlRad filter is installed semi- permanently (i.e., the filter may be removed to return the C-arm to its original condition) to aid in reducing both patient and clinicians' radiation exposure while providing fluoroscopic imaging of the patient during diagnostic, surqical and interventional procedures. ControlRad® hereby submits this Bundled Special 510(k) "Catch-Up" to request clearance to market the ControlRad® Select Model Z with SW version v3.0.1 and a dose reduction claim: 85% of the Dose Area Product (DAP) at 65 kVp with width and length that are smaller than 1/5 the edge size of the full Field Of View (FOV). The ControlRad Filter is an optional component installed on the Siemens Artis zee's collimator to further reduce radiation emissions. The ControlRad Select Model Z is only compatible with the 20x20 detector and associated collimator. Use of this system on other sizes is prohibited. {8}------------------------------------------------ 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. {9}------------------------------------------------ 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. {10}------------------------------------------------ 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 {11}------------------------------------------------ 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. {12}------------------------------------------------ Image /page/12/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in dark green, and the word "RAD" is in light green and is surrounded by a green circle. The circle is darker green on the bottom and lighter green on the top. #### ControlRad® Trace Model 8 Device Description #### Principles of Operation: The GE Healthcare Surgery's OEC® 9800 Plus (K132027) provides an image that its boundaries are defined by the GE Healthcare Surgery's OEC® 9800 Plus's collimator, i.e., the image FOV is defined by the uncollimated region of the GE Healthcare Surgery's OEC® 9800 Plus (K132027). The image FOV size is not affected or modified by the ControlRad® Trace Model 8. Within the image field/un-collimated region of the GE Healthcare Surgery's OEC® 9800 Plus (K132027), the ControlRad® Trace Model 8 allows the clinician to select a Region of Interest ("RO!") and it reduces radiation exposure outside the clinician-selected ROI using the CR Trace Filter, resulting with an image that consists of the following two parts: - · The image inside the clinician-selected ROI (unfiltered radiation area in the FOV), which has at least the same image quality in the ROI as the GE Healthcare Surqery's OEC® 9800 Plus (K132027); and - · The image outside the clinician-selected ROI (filtered radiation area in the FOV), a low-dose processed image which provides peripheral image context to the ROI. The GE Healthcare Surgery's OEC® 9800 Plus's collimator, when used, also reduces radiation emission. However, that collimator reduces radiation emission by blocking the delivery of radiation to the area covered by the collimator. As a result, the GE Healthcare Surgery's OEC® 9800 Plus's image FOV is limited to the un-collimated region. The CR Trace Filter can be used along with the GE Healthcare Surgery's OEC® 9800 Plus's collimator to further reduce radiation emissions, and the additional radiation provided by the CR Trace Filter will be outside the clinician-selected ROI and within the un-collimated region/image FOV. The clinician has the option not to use the CR Trace Filter. In this case, the GE Healthcare Surgery's OEC® 9800 Plus operates as if the CR Trace Filter was not present. #### Reason for Submission: This Bundled Special 510(K) submission provides FDA with "Catch Up" 510(K) information for minor changes made and implemented on the following cleared 510(k) product: ControlRad® Trace Model 8 (K183109). These changes were evaluated and documented via the process identified in FDA's guidance document "Deciding When to Submit a 510(k) for a Change to an Existing Device", October 25, 2017. #### 7. Substantial Equivalence: The ControlRad® Select Model Z is a substantial equivalent to the legally marketed predicate listed below: | Predicate Device Name<br>and Manufacturer | 510(k)<br>Number | Clearance<br>Date | Comparable Properties | |----------------------------------------------------------------|------------------|-------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Primary Predicate<br>ControlRad® Select Model Z<br>ControlRad® | K202431 | 12/23/2020 | Indications for use CR Trace Tablet ControlRad Trace Filter ControlRad Hardware ControlRad Software and Firmware Modules ControlRad Communication Interface Dose Reduction Claim Installed on Siemens Artis zee (K181407) | {13}------------------------------------------------ Image /page/13/Picture/0 description: The image shows the logo for ControlRad. The logo consists of the word "CONTROL" in a bold, sans-serif font, followed by "RAD" in a smaller font size. To the right of the text is a circular graphic with two shades of green, creating a sense of depth and movement. The overall design is clean and modern, conveying a sense of control and innovation. ## The ControlRad® Trace Model 9 is substantial equivalent to the legally marketed predicate listed below: | Predicate Device Name<br>and Manufacturer | 510(k)<br>Number | Clearance<br>Date | Comparable Properties | |---------------------------------------------------------------|------------------|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Primary Predicate<br>ControlRad® Trace Model 9<br>ControlRad® | K200663 | 06/24/2020 | Indications for use CR Trace Tablet ControlRad Trace Filter ControlRad Hardware ControlRad Software and Firmware Modules ControlRad Communication Interface Dose Reduction Claim Installed on GE Healthcare Surgery, OEC ® 9900 Elite (K122234) | The ControlRad® Trace Model 8 is substantial equivalent to the legally marketed predicate listed below: | Predicate Device Name | 510(k) | Clearance | Comparable Properties | |---------------------------------------------------------------|---------|------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | and Manufacturer | Number | Date | | | Primary Predicate<br>ControlRad® Trace Model 8<br>ControlRad® | K183109 | 05/13/2019 | Indications for use CR Trace Tablet ControlRad Trace Filter ControlRad Hardware ControlRad Software and Firmware Modules ControlRad Communication Interface Dose Reduction Claim Installed on GE Healthcare Surgery, OEC® 9800 Plus (K133027) | {14}------------------------------------------------ Image /page/14/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in dark green, and the word "RAD" is in light green. The word "RAD" is inside of a green circle that is darker at the bottom and lighter at the top. ## 8. Comparison of Technological Characteristics with the Predicate Device: The ControlRad® Select Model Z for use with Siemens Artis zee has the same indications for use as the cleared predicate ControlRad® Select Model Z (K202431). The ControlRad® Select Model Z is identical in construction to the predicate. The performance data demonstrates that the ControlRad® Select Model Z is at least as safe and effective as the predicate device and is substantially equivalent to the predicate device. A comparison table of technological characteristics of the ControlRad® Select Model Z device for use with Siemens Artis zee compared to those of the predicate is provided below: | Comparison Table: ControlRad® SelectModel Z | | | | |---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------| | Device Feature | Subject Device ControlRad® Select<br>Model Z<br>(K211782) | Primary Predicate Device<br>ControlRad® SelectModel Z<br>(K202431) | Comparison<br>Results | | Regulation<br>Number | 21 CFR §892.1650 | 21 CFR §892.1650 | Same | | Indications for<br>use Statement | The ControlRad® Select Model Z with<br>Siemens Artis zee is indicated to<br>provide fluoroscopic of the patient<br>during diagnostic, surgical, and<br>interventional procedures while<br>reducing patients and clinicians'<br>radiation exposure (Dose Area<br>Product) outside of the ControlRad<br>Select Model Z's region of interest<br>(ROI) as compared to Artis zee non-<br>collimated image area.1 The<br>ControlRad Select Model Z semi-<br>transparent filter should not be used in<br>lieu of the Artis zee's collimators, as<br>they block the most radiation, but can<br>help physicians balance dose<br>reduction with the need to visualize<br>structures outside the ROI when it is<br>considered clinically advantageous to<br>do so. Clinical applications may<br>include cardiac angiography, neuro-<br>angiography, general angiography,<br>rotational angiography, multipurpose<br>angiography and whole body<br>radiographic/fluoroscopic procedures<br>as well as procedures next to the table<br>for i.e., patient extremities.<br><br>Additional procedures that can be<br>performed include angiography in the<br>operating room, image guided surgery<br>by X-ray, by image fusion, and by<br>navigation systems. The examination<br>table as an integrated part of the<br>system can be used for X-ray imaging,<br>surgery and interventions.<br><br>1 Relative to open Field of View<br>(FOV), the ControlRad Select Model | The ControlRad® Select Model Z with<br>Siemens Artis zee is indicated to<br>provide fluoroscopic of the patient<br>during diagnostic, surgical, and<br>interventional procedures while<br>reducing patients and clinicians'<br>radiation exposure (Dose Area<br>Product) outside of the ControlRad<br>Select Model Z's region of interest<br>(ROI) as compared to Artis zee non-<br>collimated image area.1 The<br>ControlRad Select Model Z semi-<br>transparent filter should not be used in<br>lieu of the Artis zee's collimators, as<br>they block the most radiation, but can<br>help physicians balance dose<br>reduction with the need to visualize<br>structures outside the ROI when it is<br>considered clinically advantageous to<br>do so. Clinical applications may<br>include cardiac angiography, neuro-<br>angiography, general angiography,<br>rotational angiography, multipurpose<br>angiography and whole body<br>radiographic/fluoroscopic procedures<br>as well as procedures next to the table<br>for i.e., patient extremities.<br><br>Additional procedures that can be<br>performed include angiography in the<br>operating room, image guided surgery<br>by X-ray, by image fusion, and by<br>navigation systems. The examination<br>table as an integrated part of the<br>system can be used for X-ray imaging,<br>surgery and interventions.<br><br>1 Relative to open Field of View (FOV), | Same | | | Z reduces at least 85% of the Dose<br>Area Product at 65 kVp and ROI with | the ControlRad Select Model Z<br>reduces at least 85% of the Dose Area<br>Product at 65 kVp and ROI with width | | | | width and length that are smaller than<br>1/5 the edge size of the full FOV. | and length that are smaller than 1/5<br>the edge size of the full FOV. | | | X-ray Radiation<br>Source | The X-ray Tube of SiemensMedical<br>Solutions, Inc. Artis zee | The X-ray Tube of SiemensMedical<br>Solutions, Inc. Artis zee | Same | | System<br>Configuration | ControlRad Filter and Image<br>Processing SW/HW mountedon Artis<br>zee | ControlRad Filter and Image<br>Processing SW/HW mounted on Artis<br>zee | Same | | X-ray<br>Modulation<br>Component | CR Filter<br>2.5mm or 3.0mm | CR Filter<br>2.5mm or 3.0mm…