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.

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.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided FDA 510(k) summary for the ControlRad® Select Model Z:

Acceptance Criteria and Device Performance

The provided document details various performance tests conducted to demonstrate the device's safety and effectiveness. The acceptance criteria are implicit in the "Verification" or "Accuracy" statements, and the "Reported Device Performance" is the stated outcome of these tests.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify exact sample sizes (e.g., number of images, patients, or test runs) for each specific test mentioned in the "Performance Data" section. It primarily relies on bench testing, system validation testing, and simulated clinical use tests.

Data Provenance: The studies appear to be non-clinical bench and system validation tests conducted by the manufacturer, rather than studies involving human subjects in a real-world clinical setting. The "clinical simulations" suggest a controlled environment. There is no information regarding the country of origin of data in terms of patient data, as no patient data appears to have been formally collected for this 510(k) submission. These are engineering and performance validation tests.

3. Number of Experts and Qualifications for Ground Truth

The document does not specify the number of experts or their qualifications used to establish ground truth for the test set.

For "Comparative image quality inside the ROI" and "Image quality evaluation via clinical simulations," it states that these validate the image quality, implying expert assessment. However, the specific number and qualifications of these "experts" (e.g., radiologists) are not provided.
The overall evaluation is based on meeting technical performance standards and demonstrating substantial equivalence to a predicate device, which primarily involves engineering validation rather than human interpretation assessment of image quality.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (e.g., 2+1, 3+1) for the test set. Given that the studies are primarily technical performance validations (bench and system tests, not reader studies), such adjudication methods would typically not be applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The submission focuses on demonstrating substantial equivalence through technical performance tests and comparing the device's technical specifications to a predicate device. The goal is to show the device functions as intended and safely, not to quantify improvement in human reader performance with AI assistance.

6. Standalone (Algorithm Only) Performance

The device is an add-on component to an existing fluoroscopic x-ray system (Siemens Artis zee). It is described as a "set of components mounted on the Artis zee system and cannot be used independent of the Artis zee system." Therefore, a standalone performance study in the sense of an "algorithm only without human-in-the-loop" would not be applicable as the device itself is a physical and integrated system component, not just a software algorithm for interpretation. Its function is to modify the X-ray field and subsequent image processing, which inherently involves human operation and interaction with the Artis zee system.

7. Type of Ground Truth Used

The ground truth used for these tests is primarily engineering specifications and established performance standards (e.g., 21 CFR 1020.32, IEC 60601 series).

For radiation dose metrics, the ground truth is derived from quantitative measurements verifying compliance with specified tolerances (e.g., ±35% accuracy for AK, AKR, DAP).
For image quality, the ground truth for "inside the ROI" is the image quality of the predicate Artis zee system alone. For "outside the ROI," it's about validating that the degraded image quality remains "clinically relevant" through "clinical simulations," suggesting a qualitative assessment against a clinical utility standard.
For mechanical, electrical, and software aspects, the ground truth is conformance to relevant international standards (ISO, IEC) and FDA guidance documents.

8. Sample Size for the Training Set

The document does not mention a "training set" or "training data" in the conventional sense associated with machine learning or AI models. This device primarily involves hardware modifications and associated software that controls the physical filter and image processing. It is not an AI algorithm that learns from a dataset like an image classification model.

9. How the Ground Truth for the Training Set was Established

As no training set is discussed or implied to be part of the device's development or validation process (as it's not a machine learning model), this question is not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the agency's name on the right. The symbol on the left is a stylized depiction of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters. The words "FOOD & DRUG" are larger than the other words.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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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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)

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 PredicateControlRad® Trace Model 9	K200663	06/24/2020	Indications for use CR Trace Table ControlRad Trace Filter ControlRad Hardware ControlRad Software andFirmware Modules ControlRad CommunicationInterface 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 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 ●

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.

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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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. The word "RAD" is inside of a green circle that is broken at the top and bottom.

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/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.

DeviceFeature	Subject DeviceControlRad, Inc'sControlRad® SelectModel Z	Primary Predicate DeviceControlRad, Inc'sControlRad® TraceModel 9(K200663)	Comparison Results
X-ray Radiation Source	The X-ray Tube of SiemensMedical Solutions, Inc. Artiszee	The X-ray Tube of GEHealthcare Surgery's OEC®9900 Elite	Same: This is the exact samecomponent cleared in theReferenced Device: Siemens'Artis zee (K181407). Providedin this Submission is SystemValidation testing.
System Configuration	ControlRad Filter and ImageProcessing SW/HW mountedon Artis zee	ControlRad Filter and ImageProcessing SW/HW mountedon GE Healthcare Surgery'sOEC® 9900 Elite	Same: This is the exact samecomponents cleared in thePrimary Predicate Device.Provided in this submission isBench Testing and SystemValidation Testing.
X-ray ModulationX-ray ModulationComponent	CR Filter2.5mm or 3.0mm	CR Trace Filter2.0mm	Comparable: This feature isnot the same as the PrimaryDevice. This slight changedoes not impact thefunctionality nor the intendeduse of the Subject Device.Provided in this submission isBench Testing and SystemValidation testing thatdemonstrates that the deviceis as safe and effective as thePrimary Predicate Device anddoes not raise differentquestions of safety andeffectiveness than thePredicate Device..
X-ray RadiationModulation	Semi-transparent filter;Reduces radiation outside theaperture typically by 44% to98%.	Semi-transparent filter;Reduces radiation outside theaperture typically by 61% to97%.	Comparable: SystemValidation testing thatdemonstrates that the deviceis as safe and effective as thePrimary Predicate Device anddoes not raise differentquestions of safety andeffectiveness than thePredicate Device.
Aperture shape	Blades: Rectangular	Blades: Rectangular	Same: This is the exact samecomponent cleared in thePrimary Predicate Device.Provided in this submission isBench Testing and SystemValidation Testing.
Aperture Control	Set by the user using the CRTablet	Set by the user using the CRTrace Tablet	Same: This is the exact samefunctionality cleared in thePrimary Predicate Device.Provided in this submission isBench Testing and SystemValidation 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.

DeviceFeature	Subject DeviceControlRad, Inc'sControlRad® SelectModel Z	Primary Predicate DeviceControlRad, Inc'sControlRad® TraceModel 9(K200663)	Comparison Results
Image AreaProcessed	Area outside ROI	Area outside ROI	Same: This is the exact samefeature cleared in the PrimaryPredicate Device. Provided inthis submission is BenchTesting and System ValidationTesting.
Processing Bits	16 bits	12 bits	Comparable: This feature isnot the same as the PrimaryDevice. This slight changedoes not impact thefunctionality nor the intendeduse of the Subject Device.Provided in this submission isBench Testing and SystemValidation testing thatdemonstrates that the deviceis as safe and effective as thePrimary Predicate Device anddoes not raise differentquestions of safety andeffectiveness than thePredicate Device.
Processing Rate	30 fps	30 fps	Same: This is the exact samefeature cleared in the PrimaryPredicate Device. Provided inthis submission is BenchTesting and System ValidationTesting.
ProcessingOccurrence	Area outside ROI: Only whenthe CR Filter is engaged	Area outside ROI: Only whenthe CR Filter is engaged	Same: This is the exact samefeature cleared in the PrimaryPredicate Device. Provided inthis submission is BenchTesting and System ValidationTesting.
Image LayoutInformation	All image layoutinformation originallyavailable for Siemens Artiszee plus the following:• Percentage of DoseArea Product (DAP)reduction when usingControlRad Filterand/or Siemens Aritszee Collimator• ROI frame border• ControlRad Logo andBranding	All image layoutinformation originallyavailable for GE OEC 9900Elite plus the following:• Dose Area Product(DAP) value• Percentage of DAPreduction when usingControlRad Filterand/or Siemens Aritszee Collimator• ROI frame border• ControlRad Logo andBranding	Comparable: This feature isnot the same as the PrimaryPredicate Device as the Artiszee already includes theoption to display DAPinfromation, a feature notpresent of the OEC 9900 Elite.This change does not impactthe functionality nor theintended use of the SubjectDevice. Provided in thissubmission is Bench Testingand System Validation testingthat demonstrates that thedevice is as safe and effectiveas the Primary PredicateDevice and does not raise anynew issues of safety andeffectiveness than thePredicate 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.

DeviceFeature	Subject DeviceControlRad, Inc'sControlRad® SelectModel Z	Primary Predicate DeviceControlRad, Inc'sControlRad® TraceModel 9(K200663)	Comparison Results
Dose Area Product(DAP) Accuracy fortotal x-ray field of theControlRad Filter andArtis zee systemscombined*	+35%*	+35%*	Same: This is the exact samefeature cleared in the PrimaryPredicate Device. Provided inthis submission is BenchTesting and System ValidationTesting.
Electrical Requirements
ElectricalRequirements	Artis zee Components:Power requirementsGeneratorPOLYDOROS A100Plus:AC 400 V ± 10 %, 50/60Hz ± 1 HzPower requirementsSystem control cabinet:AC 400 V ± 10 %, 50/60Hz ± 1 HzControlRad Components:SCIP BOX Input: 230 VAC,0.6ATABLET POWER SUPPLYInput: 24 VDC, 0.5ASELECT FILTER Input: 28VDC, 0.9AROUTER Input : 12DC, 1AROUTER POWER SUPPLYInput : 230VAC, 0.5A	ControlRad Trace Model 9:60 / 50 Hz; 120 / 220 VAC,0.7 / 0.3 A.GE Healthcare Surgery'sOEC® 9900 Elite withinstalled ControlRad TraceModel 9:60 / 50 Hz; 120 VAC (±10%),15A; 200 / 220 / 230 / 240VAC (±10%), 10A	Same: Same as the referencedevice 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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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.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.

Acceptance Criteria Category	Specific Acceptance Criteria	Reported Device Performance
Radiation Dose	Dose Area Product (DAP) Reduction: 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, relative to open Field of View (FOV).	The device is able to reduce DAP as noted in the indications for use, meeting the "at least 85% reduction" criteria.
	Filter Attenuation: Shows a 44% to 98% attenuation outside the ROI.	The device demonstrated a 44% to 98% attenuation outside the ROI. (Note: The "Comparison of Technological Characteristics" table also states "Reduces radiation outside the aperture typically by 44% to 98%").
	Impact of Air Kerma: Does not significantly increase Air Kerma when compared to the Artis zee system alone.	Verified that the ControlRad components on the reference system do not significantly increase Air Kerma when compared to the Artis zee system alone.
	Air Kerma and Air Kerma Rate Accuracy (per 21 CFR 1020.32): AK and AKR of the subject system (ControlRad components integrated with the Artis zee system) is ± 35% of the Artis zee system alone.	Verified that the AK and AKR 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 (ControlRad components integrated with the Artis zee system) is ± 35% of the Artis zee system alone.	Verified that the cumulative AKR as referenced in the RDSR of the subject system is ± 35% of the Artis zee system alone.
	Reference Air Kerma Warning Functionality: Reference Air Kerma Warning Functionality is not impacted on the subject system when compared to the Artis zee system alone.	Verified that the Reference Air Kerma Warning Functionality is not impacted.
	Dose Area Product (DAP) Accuracy (per IEC 60601-2-43): DAP measurements of the subject system (ControlRad components integrated with the Artis zee system) is ± 35% of the Artis zee system.	Demonstrated the DAP measurements of the subject system is ± 35% of the Artis zee system. (Note: The "Comparison of Technological Characteristics" table specifies "+35%*" for DAP Accuracy, likely referring to the upper limit of the acceptable deviation).
Image Quality	Comparative Image Quality Inside the ROI: Image quality inside the ROI is at least the same quality as the image that would be gathered with the Artis zee alone.	Verified 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. (Implied acceptance is that degradation is acceptable for clinical context).	Quantified 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: Validate that the image quality outside the ROI is clinically relevant following degradation due to use of the ControlRad filters.	Validated that the image quality outside the ROI is clinically relevant following degradation due to use of the ControlRad filters.
Safety & Mechanical	Leakage Radiation Evaluation: Evaluate the impact of the ControlRad components on the reference device leakage radiation measurements (Implied acceptance is no unacceptable increase).	Evaluated the impact of the ControlRad components on the reference device leakage radiation measurements.
	Stray Radiation Evaluation: Evaluate the impact of the ControlRad components on the reference device stray radiation measurements (Implied acceptance is no unacceptable increase).	Evaluated the impact of the ControlRad components on the reference device stray radiation measurements.
	Recovery Management (per IEC 60601-2-43, section 201.4.101): Verify recovery management.	Verified recovery management.
	Mechanical Impact on Filter Cover (per IEC 60601-1): Verify that impact to the filter / collimator cover does not create unacceptable risk.	Verified that impact to the filter / collimator cover does not create unacceptable risk.
	Collision Sensor Functionality Evaluation: Verify that the collision sensor functionality is maintained when using the ControlRad filter / collimator covers.	Verified that the collision sensor functionality is maintained.
	Focal spot to patient distance (per IEC 60601-2-54, section 203.9): Verify the focal spot to skin distance implementation.	Verified the focal spot to skin distance implementation.
	Tensile Strength Evaluation (per IEC 60601-1): Verify that additional mass from the Select Model Z filter does not create unacceptable risk from tensile strength.	Verified that additional mass from the Select Model Z filter does not create unacceptable risk from tensile strength.
	Filter Motion Reliability Testing: Verify the durability of the mechanical filter assembly in frame of a random motion stress test.	Verified the durability of the mechanical filter assembly.
Usability & Software	Touch-In-Glove Bench Test: Verify the sensitivity of the ControlRad tablet when using sterile radiation reducing gloves.	Verified the sensitivity of the ControlRad tablet when using sterile radiation reducing gloves.
	Wireless Devices and Cybersecurity Evaluation: Compliance with FDA Guidance documents: "Radio Frequency Wireless Technology in Medical Devices" and "Postmarket Management of Cyber Security in Medical Devices".	Evaluated compliance with wireless and cybersecurity guidance. Implemented 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.
	Software Documentation for Moderate Level of Concern: Conformance with special controls for medical devices containing software (per FDA's Guidance Documents "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "Off-The-Shelf Software Use in Medical Devices").	Documentation included; performance data demonstrates continued conformance; risk analysis completed, and risk control implemented; testing results support all software specifications met acceptance criteria; verification and validation found acceptable.
	Usability Testing (per IEC 60601-1-6): Usability related hazards are addressed in system tests according to the operator's manual and in simulated clinical use tests with customer feedback. Customer employees are adequately trained.	Usability testing showed that usability related hazards are addressed in the system test and in simulated clinical use tests with customer report and feedback form. Customer employees are adequately trained.
DAP Chamber	DAP Chamber Change Justification: 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.	Justified the change in DAP chamber.