(120 days)
No
The summary describes a hardware filter and associated software for controlling its position and selecting an ROI to reduce radiation dose. There is no mention of AI or ML algorithms for image analysis, decision making, or automated adjustments beyond user-selected ROI.
No
This device is for fluoroscopic imaging and radiation dose reduction, not for treating a disease or condition.
No.
The device is an accessory that modifies an existing fluoroscopic imaging system (Artis zee) to reduce radiation exposure during imaging, which is used in diagnostic, surgical, and interventional procedures. However, the device itself is not described as performing diagnostic functions such as detection, diagnosis, or assessment of a disease or condition. Its primary function is dose reduction during imaging.
No
The device description explicitly states that the ControlRad® Select Model Z consists of a set of components mounted on the Artis zee system, including a physical ControlRad filter, ControlRad Hardware, and a ControlRad Communication Interface, in addition to software and a tablet. This indicates it is a system with both hardware and software components, not a software-only device.
Based on the provided information, the ControlRad® Select Model Z is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- ControlRad® Select Model Z Function: The ControlRad® Select Model Z is an accessory for a fluoroscopic X-ray system (Siemens Artis zee). Its primary function is to reduce radiation exposure during imaging procedures performed on the patient's body. It does not analyze samples taken from the patient.
- Intended Use: The intended use clearly states it's for providing fluoroscopic imaging of the patient during diagnostic, surgical, and interventional procedures.
Therefore, the ControlRad® Select Model Z falls under the category of medical imaging devices, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
The ControlRad® Select Model Z with Siemens Artis zee is indicated to provide fluoroscopic imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients' and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Select Model Z's region of interest (ROI) as compared to Artis zee non-collimated image area.1 The ControlRad Select Model Z semi-transparent filter should not be used in lieu of the Artis zee's collimators, as they block the most radiation, but can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinical applications may include cardiac angiography, neuro-angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.
Additional procedures that can be performed include angiography in the operating room, image quided surgery by Xray, 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.
Product codes
OWB, JAA, IZI
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 semipermanently (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, surgical and interventional procedures. ControlRad® hereby submits this Traditional 510(k) to request clearance to market the ControlRad® Select Model Z with SW version V1.0.0.7.1 and a dose reduction claim: 85% of the Dose Area Product (DAP) at 65 kVp with width and length that are smaller than 1/5 the edge size of the full Field Of View (FOV).
The ControlRad Filter is an optional component installed on the Siemens Artis zee's collimator to further reduce radiation emissions. The ControlRad Select Model Z is only compatible with the 20x20 detector and associated collimator. Use of this system on other sizes is prohibited.
The additional radiation reduction provided by the ControlRad Filter will be outside the clinician-selected ROI and within the un-collimated region/image FOV.
The main components of the ControlRad® Select Model Z which are used with the Artis zee are:
- ControlRad Tablet
- ControlRad Filter
- ControlRad Hardware
- ControlRad Software and Firmware Modules
- ControlRad Communication Interface
The ControlRad® Select Model Z is a system used to assist trained clinicians which is used to provide 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® Select Model Z's reqion 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 ROI 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-transparent titanium 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 patient and 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 FOV in 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.
Mentions image processing
Yes, "perform image processing.", "lower-dose processed image".
Mentions AI, DNN, or ML
Not Found.
Input Imaging Modality
Fluoroscopic X-ray
Anatomical Site
Not Found. Clinical applications may include cardiac angiography, neuro-angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.
Indicated Patient Age Range
Not Found.
Intended User / Care Setting
Trained clinicians. Diagnostic, surgical, and interventional procedures. Operating room.
Description of the training set, sample size, data source, and annotation protocol
Not Found.
Description of the test set, sample size, data source, and annotation protocol
Not Found.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
ControlRad 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:
- Impact of Air Kerma: Verification that the ControlRad components on the reference system do not significantly increase Air Kerma (ControlRad components integrated with the Artis zee system) is when compared to the Artis zee system alone.
- Air Kerma and Air Kerma Rate Accuracy: Verification that the AK and AKR of the subject system (ControlRad components integrated with the Artis zee system) is ± 35% of the Artis zee system alone per 21 CFR 1020.32.
- Radiation Dose Structure Report (RDSR) AK Accuracy: Verification that the cumulative AKR as referenced in the RDSR of the subject system (ControlRad components integrated with the Artis zee system) is ± 35% of the Artis zee system alone.
- Reference Air Kerma Warning Functionality: Verification that the Reference Air Kerma Warning Functionality is not impacted on the subject system (ControlRad components integrated with the Artis zee system) when compared to the Artis zee system alone.
- Dose Area Product (DAP) Accuracy: Demonstrate the DAP measurements of the subject system (ControlRad components integrated with the Artis zee system) is ± 35% of the Artis zee system per IEC 60601-2-43.
- Dose Area Product (DAP) Reduction: To verify the subject system (ControlRad components integrated with the Artis zee system) is able to reduce DAP as noted in the indications for use (Relative to open Field of View (FOV), the ControlRad Select Model Z reduces at least 85% of the Dose Area Product at 65 kVp and ROI with width and length that are smaller than 1/5 the size of the full FOV).
- Filter Attenuation Testing: Demonstrate the x-ray radiation attenuation by the addition of the ControlRad components on the reference system show a 44 to 98% attenuation outside the ROI.
- Leakage Radiation Evaluation: To evaluate the impact of the ControlRad components on the reference device leakage radiation measurements
- Stray Radiation Evaluation: To evaluate the impact of the ControlRad components on the reference device stray radiation measurements.
- Recovery Management: To verify recovery management of ControlRad Select Model Z as required by IEC 60601-2-43, section 201.4.101
- Mechanical Impact on Filter Cover: To verify that impact to the filter / collimator cover does not create unacceptable risk per IEC 60601-1 requirements.
- Collision Sensor Functionality Evaluation: To verify that the collision sensor functionality is maintained when using the ControlRad filter / collimator covers
- Focal spot to patient distance: To verify the focal spot to skin distance implementation per IEC 60601-2-54, section 203.9 requirements.
- Tensile Strength Evaluation: To verify that additional mass from the Select Model Z filter does not create unacceptable risk from tensile strength per IEC 60601-1 requirements.
- Filter Motion Reliability Testing: To verify the durability of the mechanical filter assembly in frame of a random motion stress test.
- Comparative image quality inside the ROI: Verifies that image quality inside the ROI is at least the same quality as the image that would be gathered with the Artis zee alone.
- Comparative image quality outside the ROI: Quantify the level of image quality degradation outside the region of interest as a result of the CR filter blades.
- Image quality evaluation via clinical simulations: To validate that the image quality outside the ROI in clinically relevant following degradation due to use of the ControlRad filters.
- DAP Chamber Change Justification: To justify the change in DAP chamber from the original chamber used in the Artis zee system as a result of the addition of the CR filter
- Touch-In-Glove Bench Test: To verify the sensitivity of the ControlRad tablet when using sterile radiation reducing gloves
- Wireless Devices and Cybersecurity Evaluation: To evaluate the ControlRad™ Select Model Z's compliance with the requirements of FDA Guidance documents: "Radio Frequency Wireless Technology in Medical Devices" and "Postmarket Management of Cyber Security in Medical Devices".
Results of all conducted testing was found acceptable and do not raise any new issues of safety or effectiveness.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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.
Radiation reduction for the semi-transparent filter will be outside the clinician-selected ROI, typically by 44% to 98%.
Air Kerma and Air Kerma Rate Accuracy of the subject system is ± 35% of the Artis zee system alone.
Radiation Dose Structure Report (RDSR) AK Accuracy: cumulative AKR as referenced in the RDSR of the subject system is ± 35% of the Artis zee system alone.
Dose Area Product (DAP) Accuracy: measurements of the subject system is ± 35% of the Artis zee system.
Filter Attenuation Testing: 44 to 98% attenuation outside the ROI.
Dose Area Product (DAP) Accuracy for total x-ray field of the ControlRad Filter and Artis zee systems combined*: +35%*.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found.
§ 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.
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December 23, 2020
ControlRad, Inc % Linda Braddon, Ph.D. CEO Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 WOODSTOCK GA 30188
Re: K202431
Trade/Device Name: ControlRad® Select Model Z Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA, IZI Dated: December 1, 2020 Received: December 4, 2020
Dear Dr. Braddon:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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,
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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Image /page/2/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in a dark green sans-serif font, and the word "RAD" is in a lighter green sans-serif font. To the right of the word "RAD" is a green circle with a white gap in the middle.
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K202431
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' and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Select Model Z's region of interest (ROI) as compared to Artis zee non-collimated image area.1 The ControlRad Select Model Z semi-transparent filter should not be used in lieu of the Artis zee's collimators, as they block the most radiation, but can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinical applications may include cardiac angiography, neuro-angiography, rotational angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.
Additional procedures that can be performed include angiography in the operating room, image quided surgery by Xray, 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.
1Relative 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)
図 Prescription Use (Part 21 CFR 801 Subpart D)
□ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement on last page.
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TRADITIONAL 510(k): ControlRad, Inc ControlRad Select Model Z 275 Scientific Drive NW #1100 Norcross, GA 30092
510(k) SUMMARY: ControlRad® Select Model Z
Company Name:
ControlRad. Inc. 275 Scientific Dr NW Suite 1100 Norcross, Georgia 30092, USA P: 1-800-522-5148
Date Prepared: December 21, 2020
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.
General Information: 1.
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:
Linda Braddon, Ph.D. Secure BioMed Evaluations 7828 Hickory Flat Hwy Suite 120 Woodstock, GA 30188 770-837-2681 Regulatory@SecureBME.com
Secondary Contact:
Patricia D. Jones,Sr. Directory of Regulatory Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, GA 30188 770-837-2681 (direct) Regulatory@SecureBME.com (email)
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Image /page/4/Picture/1 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 in dark teal and light green, forming a stylized "C" shape.
| 3. Device Name and Classification: | |
|---|---|
| Trade Name: | ControlRad® Select Model Z |
| Classification Name: | Image-intensified fluoroscopic x-ray System |
| Common Name: | Interventional Fluoroscopic X-ray System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR §892.1650 |
| Device Class: | II |
| Product Codes: Primary: | OWB |
| Secondary: | JAA, IZI |
| 4. Primary Predicate Device: | |
| Trade Name: | ControlRad® Trace Model 9 |
| 510(k) Clearance: | K200663 |
| Clearance Date: | June 24, 2020 |
| Classification Name: | Image-intensified fluoroscopic x-ray System |
| Common Name: | Interventional Fluoroscopic X-ray System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR §892.1650 |
| Device Class: | II |
| Product Codes: Primary: | OWB |
| Secondary: | OXO, JAA |
| Reference Device: | |
| Trade Name: | Artis zee |
| 510(k) Clearance: | K181407 |
| Clearance Date: | August 15, 2018 |
| Classification Name: | Image-intensified fluoroscopic x-ray System |
| Common Name: | Interventional Fluoroscopic X-ray System |
| Classification Panel: | Radiology |
| Regulation Number: | 21 CFR §892.1650 |
| Device Class: | II |
| Product Codes: Primary: | OWB |
| Secondary: | IZI, JAA, JAK |
5. Indications for Use:
The ControlRad® Select Model Z with Siemens Artis zee is indicated to provide fluoroscopic imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients' 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. 1The ControlRad Select Model Z semi-transparent filter should not be used in lieu of the Artis zee's collimators, as they block the most radiation, but can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinical applications may include cardiac angiography, neuro-angiography, general angiography, angiography, rotational body radiographic/fluoroscopic procedures as well as procedures next to the table for i.e. patient extremities.
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Image /page/5/Picture/0 description: The image shows the logo for ControlRad. The logo consists of the word "CONTROL" in a dark teal 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 green lines, one dark teal and one light green, that form a broken circle.
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.
6. Substantial Equivalence:
The ControlRad® Select Model Z is substantial equivalent to the legally marketed predicate listed below:
| Predicate Device Name | 510(k) | Clearance | Comparable Properties |
|---|---|---|---|
| and Manufacturer | Number | Date | |
| Primary Predicate | |||
| ControlRad® Trace Model 9 | K200663 | 06/24/2020 | Indications for use CR Trace Table ControlRad Trace Filter ControlRad Hardware ControlRad Software and |
| Firmware Modules ControlRad Communication | |||
| Interface Dose Reduction Claim |
7. 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 semipermanently (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, surgical and interventional procedures. ControlRad® hereby submits this Traditional 510(k) to request clearance to market the ControlRad® Select Model Z with SW version V1.0.0.7.1 and a dose reduction claim: 85% of the Dose Area Product (DAP) at 65 kVp with width and length that are smaller than 1/5 the edge size of the full Field Of View (FOV).
The ControlRad Filter is an optional component installed on the Siemens Artis zee's collimator to further reduce radiation emissions. The ControlRad Select Model Z is only compatible with the 20x20 detector and associated collimator. Use of this system on other sizes is prohibited.
The additional radiation reduction provided by the ControlRad Filter will be outside the clinician-selected ROI and within the un-collimated region/image FOV.
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Image /page/6/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in a dark teal color, and the word "RAD" is in a lighter green color. The word "RAD" is surrounded by a circle that is also in the same green colors.
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 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® Select Model Z's reqion 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 ROI 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-transparent titanium 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 patient and 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 FOV in 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.
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Technological Characteristics:
The ControlRad® Select Model Z consists of the following main components: ControlRad Tablet, ControlRad Filter, ControlRad Hardware, ControlRad Software and Firmware Modules and ControlRad Communication 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.
- . 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 semitransparent filter which reduces the X-ray 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 clinicianselected 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 that its 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); 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.
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Image /page/8/Picture/0 description: The image shows the logo for ControlRad. The logo consists of the word "CONTROL" in a dark teal sans-serif font, followed by "RAD" in a lighter green sans-serif font. To the right of "RAD" is a circular graphic made up of two curved green shapes, one dark teal and one light green, that partially overlap to form a circle.
The Siemens Artis zee's collimator, when used, also reduces radiation emission. However, that collimator reduces radiation emission the delivery of radiation to 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 ROI 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.
8. Comparison of Technological Characteristics with the Predicate devices:
The ControlRad® Select Model Z for use with Siemens Artis zee has similar indications for use as the cleared predicate ControlRad® Trace Model 9 (K200663). The ControlRad® Select Model Z is identical in construction to the predicate with the only modifications being the design differences to integrate with Siemens Artis zee (K181407). 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 predicates is provided below:
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Image /page/9/Picture/1 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.
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Image /page/10/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in a bold, teal font. To the right of the word "CONTROL" is the word "RAD" in a lighter green font, and the word is surrounded by a green circle.
| Device
Feature | Subject Device
ControlRad, Inc's
ControlRad® Select
Model Z | Primary Predicate Device
ControlRad, Inc's
ControlRad® Trace
Model 9
(K200663) | Comparison Results |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| X-ray Radiation Source | The X-ray Tube of Siemens
Medical Solutions, Inc. Artis
zee | The X-ray Tube of GE
Healthcare Surgery's OEC®
9900 Elite | Same: This is the exact same
component cleared in the
Referenced Device: Siemens'
Artis zee (K181407). Provided
in this Submission is System
Validation testing. |
| System Configuration | ControlRad Filter and Image
Processing SW/HW mounted
on Artis zee | ControlRad Filter and Image
Processing SW/HW mounted
on GE Healthcare Surgery's
OEC® 9900 Elite | Same: This is the exact same
components cleared in the
Primary Predicate Device.
Provided in this submission is
Bench Testing and System
Validation Testing. |
| X-ray Modulation
X-ray Modulation
Component | CR Filter
2.5mm or 3.0mm | CR Trace Filter
2.0mm | Comparable: This feature is
not the same as the Primary
Device. This slight change
does not impact the
functionality nor the intended
use of the Subject Device.
Provided in this submission is
Bench Testing and System
Validation testing that
demonstrates that the device
is as safe and effective as the
Primary Predicate Device and
does not raise different
questions of safety and
effectiveness than the
Predicate Device.. |
| X-ray Radiation
Modulation | Semi-transparent filter;
Reduces radiation outside the
aperture typically by 44% to
98%. | Semi-transparent filter;
Reduces radiation outside the
aperture typically by 61% to
97%. | Comparable: System
Validation testing that
demonstrates that the device
is as safe and effective as the
Primary Predicate Device and
does not raise different
questions of safety and
effectiveness than the
Predicate Device. |
| Aperture shape | Blades: Rectangular | Blades: Rectangular | Same: This is the exact same
component cleared in the
Primary Predicate Device.
Provided in this submission is
Bench Testing and System
Validation Testing. |
| Aperture Control | Set by the user using the CR
Tablet | Set by the user using the CR
Trace Tablet | Same: This is the exact same
functionality cleared in the
Primary Predicate Device.
Provided in this submission is
Bench Testing and System
Validation Testing. |
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Image /page/11/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in a bold, teal-colored font. To the right of the word "CONTROL" is the word "RAD" in a smaller, green font, and the word is surrounded by a green circle.
| Device
Feature | Subject Device
ControlRad, Inc's
ControlRad® Select
Model Z | Primary Predicate Device
ControlRad, Inc's
ControlRad® Trace
Model 9
(K200663) | Comparison Results |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Image Area
Processed | Area outside ROI | Area outside ROI | Same: This is the exact same
feature cleared in the Primary
Predicate Device. Provided in
this submission is Bench
Testing and System Validation
Testing. |
| Processing Bits | 16 bits | 12 bits | Comparable: This feature is
not the same as the Primary
Device. This slight change
does not impact the
functionality nor the intended
use of the Subject Device.
Provided in this submission is
Bench Testing and System
Validation testing that
demonstrates that the device
is as safe and effective as the
Primary Predicate Device and
does not raise different
questions of safety and
effectiveness than the
Predicate Device. |
| Processing Rate | 30 fps | 30 fps | Same: This is the exact same
feature cleared in the Primary
Predicate Device. Provided in
this submission is Bench
Testing and System Validation
Testing. |
| Processing
Occurrence | Area outside ROI: Only when
the CR Filter is engaged | Area outside ROI: Only when
the CR Filter is engaged | Same: This is the exact same
feature cleared in the Primary
Predicate Device. Provided in
this submission is Bench
Testing and System Validation
Testing. |
| Image Layout
Information | All image layout
information originally
available for Siemens Artis
zee plus the following:
• Percentage of Dose
Area Product (DAP)
reduction when using
ControlRad Filter
and/or Siemens Arits
zee Collimator
• ROI frame border
• ControlRad Logo and
Branding | All image layout
information originally
available for GE OEC 9900
Elite plus the following:
• Dose Area Product
(DAP) value
• Percentage of DAP
reduction when using
ControlRad Filter
and/or Siemens Arits
zee Collimator
• ROI frame border
• ControlRad Logo and
Branding | Comparable: This feature is
not the same as the Primary
Predicate Device as the Artis
zee already includes the
option to display DAP
infromation, a feature not
present of the OEC 9900 Elite.
This change does not impact
the functionality nor the
intended use of the Subject
Device. Provided in this
submission is Bench Testing
and System Validation testing
that demonstrates that the
device is as safe and effective
as the Primary Predicate
Device and does not raise any
new issues of safety and
effectiveness than the
Predicate Device. |
| Parameters Accuracy Specifications | | | |
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Image /page/12/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in a dark green sans-serif font. To the right of that word is "RAD" in a lighter green font, and the letters are inside of a green circle. The circle is made up of two different shades of green.
| Device
Feature | Subject Device
ControlRad, Inc's
ControlRad® Select
Model Z | Primary Predicate Device
ControlRad, Inc's
ControlRad® Trace
Model 9
(K200663) | Comparison Results |
|--------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Dose Area Product
(DAP) Accuracy for
total x-ray field of the
ControlRad Filter and
Artis zee systems
combined* | +35%* | +35%* | Same: This is the exact same
feature cleared in the Primary
Predicate Device. Provided in
this submission is Bench
Testing and System Validation
Testing. |
| Electrical Requirements | | | |
| Electrical
Requirements | Artis zee Components:
Power requirements
Generator
POLYDOROS A100
Plus:
AC 400 V ± 10 %, 50/60
Hz ± 1 Hz
Power requirements
System control cabinet:
AC 400 V ± 10 %, 50/60
Hz ± 1 Hz
ControlRad Components:
SCIP BOX Input: 230 VAC,
0.6A
TABLET POWER SUPPLY
Input: 24 VDC, 0.5A
SELECT FILTER Input: 28
VDC, 0.9A
ROUTER Input : 12DC, 1A
ROUTER POWER SUPPLY
Input : 230VAC, 0.5A | ControlRad Trace Model 9:
60 / 50 Hz; 120 / 220 VAC,
0.7 / 0.3 A.
GE Healthcare Surgery's
OEC® 9900 Elite with
installed ControlRad Trace
Model 9:
60 / 50 Hz; 120 VAC (±10%),
15A; 200 / 220 / 230 / 240
VAC (±10%), 10A | Same: Same as the reference
device when installed. |
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:
- Impact of Air Kerma: Verification that the ControlRad components on the reference ● system do not significantly increase Air Kerma (ControlRad components integrated with the Artis zee system) is when compared to the Artis zee system alone.
- Air Kerma and Air Kerma Rate Accuracy: Verification that the AK and AKR of the . subject system (ControlRad components integrated with the Artis zee system) is ± 35% of the Artis zee system alone per 21 CFR 1020.32.
- . Radiation Dose Structure Report (RDSR) AK Accuracy: Verification that the cumulative AKR as referenced in the RDSR of the subject system (ControlRad components integrated with the Artis zee system) is ± 35% of the Artis zee system alone.
- Reference Air Kerma Warning Functionality: Verification that the Reference Air ● Kerma Warning Functionality is not impacted on the subject system (ControlRad
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Image /page/13/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in bold, dark green letters. To the right of the word "CONTROL" is the word "RAD" in white letters inside of a green circle.
components integrated with the Artis zee system) when compared to the Artis zee system alone.
- Dose Area Product (DAP) Accuracy: Demonstrate the DAP measurements of the . subject system (ControlRad components integrated with the Artis zee system) is ± 35% of the Artis zee system per IEC 60601-2-43.
- Dose Area Product (DAP) Reduction: To verify the subject system (ControlRad . components integrated with the Artis zee system) is able to reduce DAP as noted in the indications for use (Relative to open Field of View (FOV), the ControlRad Select Model Z reduces at least 85% of the Dose Area Product at 65 kVp and ROI with width and length that are smaller than 1/5 the size of the full FOV).
- . Filter Attenuation Testing: Demonstrate the x-ray radiation attenuation by the addition of the ControlRad components on the reference system show a 44 to 98% attenuation outside the ROI.
- . Leakage Radiation Evaluation: To evaluate the impact of the ControlRad components on the reference device leakage radiation measurements
- . Stray Radiation Evaluation: To evaluate the impact of the ControlRad components on the reference device stray radiation measurements.
- Recovery Management: To verify recovery management of ControlRad Select Model Z as required by IEC 60601-2-43, section 201.4.101
- Mechanical Impact on Filter Cover: To verify that impact to the filter / collimator . cover does not create unacceptable risk per IEC 60601-1 requirements.
- . Collision Sensor Functionality Evaluation: To verify that the collision sensor functionality is maintained when using the ControlRad filter / collimator covers
- Focal spot to patient distance: To verify the focal spot to skin distance . implementation per IEC 60601-2-54, section 203.9 requirements.
- Tensile Strength Evaluation: To verify that additional mass from the Select Model ● Z filter does not create unacceptable risk from tensile strength per IEC 60601-1 requirements.
- Filter Motion Reliability Testing: To verify the durability of the mechanical filter . assembly in frame of a random motion stress test.
- Comparative image quality inside the ROI: Verifies that image quality inside the . ROI is at least the same quality as the image that would be gathered with the Artis zee alone.
- . Comparative image quality outside the ROI: Quantify the level of image quality degradation outside the region of interest as a result of the CR filter blades.
- Image quality evaluation via clinical simulations: To validate that the image quality . outside the ROI in clinically relevant following degradation due to use of the ControlRad filters.
- DAP Chamber Change Justification: To justify the change in DAP chamber from the original chamber used in the Artis zee system as a result of the addition of the CR filter
- Touch-In-Glove Bench Test: To verify the sensitivity of the ControlRad tablet when ● using sterile radiation reducing gloves
- Wireless Devices and Cybersecurity Evaluation: To evaluate the ControlRad™ Select Model Z's compliance with the requirements of FDA Guidance documents:
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Image /page/14/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in a dark teal color, and the word "RAD" is in a lighter green color. The word "RAD" is partially surrounded by a green circle that is darker at the bottom and lighter at the top.
"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. Non-clinical 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.
Summary:
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.
10. Performance Standards:
The ControlRad® Select Model Z complies with the following performance standards:
- ISO 14971 Medical devices Application of risk management to medical devices ●
- IEC 60601-1 Medical Electrical Equipment Part 1: General requirements for ● safety
- . IEC 60601-1-2 Medical Electrical Equipment - Part 2. Collateral standard: Electromagnetic compatibility - Requirements and tests
- IEC 60601-1-3 Medical Electrical Equipment Part 1-3: General requirements ● for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
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Image /page/15/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 the word "RAD" in white letters inside of a green circle. The circle is made up of two different shades of green, with the darker shade on the bottom and the lighter shade on the top.
- IEC 60601-1-6 Medical Electrical Equipment Part 1-6: General Requirements ● for Basic Safety and Essential Performance - Collateral Standard: Usability
- IEC 62304 Medical device software - Software life cycle processes
- 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)]
- . IEC 60601-2-28 Medical electrical equipment - Part 2-28: Particular requirements for the basic safety and essential performance of X-ray tube assemblies for medical diagnosis
- IEC 60601-2-43 Medical electrical equipment - Part 2-43: Particular requirements for the safety and essential performance of X-ray equipment for interventional procedures.
- IEC 60601-2-54 Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy
- FDA 21 CFR 1020.30-32 Federal Performance Standard for Diagnostic X-ray ● Systems
11.Conclusion as to Substantial Equivalence:
The ControlRad® Select Model Z is installed on the Siemens Artis zee (K181407). The ControlRad® Select Model Z is technological identical to Trace Model 9 with the exception of software modifications necessary for ControlRad® Select Model Z to be compatible with the Siemens Artis zee (K181407); however, those technological differences do not raise different questions of safety and effectiveness. Performance data demonstrate including filter reliability testing that the ControlRad® Select Model Z is at least as safe and effective as the Siemens Artis zee (K181407). In conclusion, the ControlRad® Select Model Z when used with Siemens Artis zee is substantially equivalent to that predicate device.