The ControlRad® Select Model Z with the 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, general 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 guided surgery by X-ray, bv image fusion, and by navigation systems. The examination table as an integrated part of the system can be used for Xray imaging, surgery and interventions.

1 Relative to open Field of View (FOV), the ControlRad Select Model Z reduces at least 85% of the Dose Area Product at 65 kVp and ROI with width and length that are smaller than 1/5 the edge size of the full FOV.

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.

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 30 x 40 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 region of interest (ROI) as compared to the Artis zee non-collimated image area. The ControlRad® Select Model Z can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so.

ControlRad® Select Model Z contains a titanium filter. Two filter sizes are available with nominal thicknesses of 2.5mm or 3.0 mm, both of which are partially transparent to X-ray radiation.

AI/ML Overview

1. Table of Acceptance Criteria and Reported Device Performance:

Feature	Acceptance Criteria	Reported Device Performance
Indications for Use	Same as predicate device: Provide fluoroscopic imaging while reducing radiation exposure (Dose Area Product) outside of the Region of Interest (ROI).	Same as predicate device, including the specific quantitative claim: "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."
X-ray Radiation Source	Siemens Medical Solutions, Inc. Artis zee	Same as predicate.
System Configuration	ControlRad Filter and Image Processing SW/HW mounted on Artis zee	Comparable to predicate, with the exception of the size of the ControlRad hardware to attach to the collimator for the Siemens Artis zee 30x40cm detector. Bench Testing and System Validation Testing Summaries provided.
X-ray Modulation Component	CR Filter 2.5mm thru 3.0mm	Same as predicate. Bench Testing and System Validation Summaries provided.
X-ray Radiation Modulation	Semi-transparent filter; Reduces radiation outside the aperture typically by 44% to 98%.	Same as predicate. Bench Testing and System Validation Summaries provided, demonstrating safety and effectiveness comparable to the predicate.
Aperture shape	Blades: Rectangular	Same as predicate. Bench Testing and System Validation Testing Summaries provided.
Aperture Control	Set by the user using the CR Tablet	Same as predicate. Bench Testing and System Validation Testing Summaries provided.
Image Area Processed	Area outside ROI	Same as predicate. Bench Testing and System Validation Testing Summaries provided.
Processing Bits	16 bits	Same as predicate. Bench Testing and System Validation Summaries provided.
Processing Rate	30 fps	Same as predicate. Bench Testing and System Validation Testing Summaries provided.
Processing Occurrence	Area outside ROI: Only when the CR Filter is engaged.	Same as predicate. Bench Testing and System Validation Testing Summaries provided.
Image Layout Information	All image layout information originally available for Siemens Artis zee plus: Percentage of Dose Area Product (DAP) reduction, ROI frame border.	Same as predicate. Bench Testing and System Validation Testing Summaries provided.
Dose Area Product (DAP) Accuracy for total x-ray field	±35%*	Same as predicate. Bench Testing and System Validation Testing Summaries provided.
Electrical Requirements	Artis zee Components: 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.	Same as predicate. Bench Testing and System Validation Testing Summaries provided.
Software Verification	Verification of v3.0.5 software.	Completed.
Impact of Air Kerma (ControlRad components)	Not significantly increase Air Kerma when compared to Artis zee alone.	Verified.
Impact of Cover on Air Kerma	Not affected by the ControlRad® cover (with/without Aluminum) vs. Siemens cover (with/without Aluminum).	Verified.
Air Kerma and Air Kerma Rate Accuracy	±35% of the Artis zee system alone per 21 CFR 1020.32.	Verified.
Radiation Dose Structure Report (RDSR) AK Accuracy	±35% of the Artis zee system alone.	Verified.
Reference Air Kerma Warning Functionality	Not impacted when compared to the Artis zee system alone.	Verified.
CT Dose Area Product (DAP) Accuracy	±35% of the Artis zee system per IEC 60601-2-43.	Demonstrated.
CT 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 size of the full FOV.	Verified.
Accuracy of Procedure Dose Indicators	Not exceed ±35% for any of the dose indicators.	Verified.
ControlRad® Filter Attenuation	Contributes to reduction of Dose Area Product (DAP).	Verified.
Leakage Radiation Evaluation	No unacceptable impact on reference device leakage radiation measurements.	Evaluated.
Stray Radiation Evaluation	No unacceptable impact on reference device stray radiation measurements.	Evaluated.
Recovery Management	Compliant with IEC 60601-2-43, section 201.4.101.	Verified.
Mechanical Impact on Filter Cover	Does not create unacceptable risk per IEC 60601-1 requirements.	Verified.
Anti-Collision Detection	Function in accordance with Siemens Artis zee with ControlRad® Select Model Z filter / collimator cover installed.	Verified.
Focal Spot to Patient Distance	Compliant with IEC 60601-2-54, section 203.9 requirements.	Verified.
Tensile Strength Evaluation	Does not create unacceptable risk from tensile strength per IEC 60601-1 requirements.	Verified.
Filter Motion Assembly Reliability	Reliable over the expected service life of the filter assembly.	Verified.
Comparative image quality inside the ROI	At least the same quality as the image gathered with the Artis zee alone.	Verified.
Comparative image quality outside the ROI	Clinically relevant following degradation due to use of the ControlRad filters.	Characterization testing to quantify degradation and image quality evaluation via clinical simulations for validation.
DAP Chamber Change	Justification of the change from the original chamber used in the Artis zee system.	Justified.
Wireless Devices and Cybersecurity Evaluation	Compliance with FDA Guidance documents.	Evaluated.
Cybersecurity Controls & Justification for Control of Risk	Verified.	Verified.

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

The document does not explicitly state the specific sample sizes used for each individual performance test (e.g., number of images, number of patients). However, it lists various tests conducted, including:

Software Verification: v3.0.5 software.
Impact, Accuracy, and Reduction tests related to Air Kerma and Dose Area Product (DAP): These are quantitative measurements performed on the device.
Image quality evaluation via clinical simulations: This suggests a test set related to clinical scenarios.

The data provenance is implied to be prospective testing conducted by ControlRad, Inc. during product development. The tests are focused on the device's functional performance and adherence to standards rather than analysis of patient data from a specific origin. There is no mention of country of origin for the data or whether it was retrospective.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:

The document does not mention the use of experts to establish a "ground truth" for a specific test set, as this is not a diagnostic AI device requiring expert interpretation for label generation. The tests performed are primarily engineering and performance verification tests against established technical specifications and regulatory standards.

For "Image quality evaluation via clinical simulations," while the document indicates that the image quality outside the ROI was validated as "clinically relevant," it does not specify the number or qualifications of experts involved in this validation.

4. Adjudication Method for the Test Set:

Not applicable. As described above, the studies are largely technical performance verifications against predefined criteria and standards, not studies requiring adjudication of diagnostic interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

No. An MRMC comparative effectiveness study involving human readers and AI assistance was not done. The ControlRad® Select Model Z is a system that modifies the fluoroscopic image acquisition to reduce radiation, not a diagnostic AI that assists human readers in interpreting images. Its primary benefit is radiation dose reduction while maintaining image quality within the ROI and providing contextual information outside it.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done:

Yes, in essence, the majority of the performance verification tests listed were effectively "standalone" tests of the device's technical and physical performance metrics without human interpretation in the loop. These include:

Air Kerma and DAP accuracy and reduction tests.
Software verification.
Mechanical and electrical requirement verifications.
Filter attenuation, leakage radiation, and stray radiation evaluations.

The "Comparative image quality inside the ROI" and "Comparative image quality outside the ROI" also evaluate the output of the system (images) directly against defined quality criteria.

7. The Type of Ground Truth Used:

The "ground truth" for the various performance tests is based on established technical specifications, regulatory standards, and physical measurements. For example:

Dose Area Product (DAP) Accuracy: Based on standards like IEC 60601-2-43 and 21 CFR 1020.32, with an acceptance criterion of ±35%.
Radiation Modulation/Reduction: Based on the device's design specification (e.g., reduces at least 85% of DAP at 65 kVp under certain ROI conditions; typically reduces radiation outside the aperture by 44% to 98%).
Image Quality: Verified against the image quality of the Artis zee system alone within the ROI, and characterized for clinical relevance outside the ROI. These would involve objective image quality metrics.
Safety Standards: Adherence to standards like ISO 14971, IEC 60601 series, and FDA 21 CFR 1020.30-32.

8. The Sample Size for the Training Set:

This information is not provided in the document. The ControlRad® Select Model Z is a hardware and software system for X-ray modulation, not a machine learning model developed with a distinct "training set" in the context of diagnostic AI. While it uses software and firmware, the document describes performance testing rather than machine learning model validation based on a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable as a distinct training set (in the context of machine learning for diagnostic inference) and its ground truth establishment are not described for this device. The software and firmware within the device control the physical mechanisms (filters, etc.) and process images based on pre-defined algorithms and physical principles, rather than learning from a labeled training set in the typical AI sense.

Summary

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November 24, 2021

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

ControlRad, Inc. % Ms. Patricia Jones VP Regulatory Affairs Secure BioMed Evaluations 7828 Hickory Flat Highwav. Suite 120 WOODSTOCK GA 30188

Re: K213455

Trade/Device Name: ControlRad® Select Model Z Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, JAA, IZI Dated: October 25, 2021 Received: October 26, 2021

Dear Ms. Jones:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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

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

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

Sincerely,

, for

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K213455

Device Name ControlRad® Select Model Z

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

Prescription Use (Part 21 CFR 801 Subpart D)	×
Over-The-Counter Use (21 CFR 801 Subpart C)	□

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Image /page/3/Picture/0 description: The image shows the logo for ControlRad. The logo consists of the word "CONTROL" in a dark teal color, followed by "RAD" in a lighter green color. The "RAD" portion of the logo is encircled by a green ring that is thicker on the top and bottom and thinner on the sides.

510(k) SUMMARY: ControlRad® Select Model Z - K213455

Company Name:

ControlRad, Inc. 275 Scientific Dr NW Suite 1100 Norcross, Georgia 30092, USA P: 1-800-522-5148

Date Prepared: October 25, 2021

This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR § 807.92.

1. General Information:

Applicant Name:

ControlRad, Inc. Chris Fair 275 Scientific Dr NW Suite 1100 Norcross, Georgia 30092, USA P: 1-800-522-5148 Establishment Registration Number: 3015709927

2. Contact Person:

Patricia D. Jones, VP of Regulatory Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 Woodstock, GA 30188 770-837-2681 (direct) Regulatory@SecureBME.com (email)

Secondary Contact:

Linda Braddon, Ph.D. Secure BioMed Evaluations 7828 Hickory Flat Hwy Suite 120 Woodstock, GA 30188 770-837-2681 Regulatory@SecureBME.com

1. Device Name and Classification: Trade Name: Classification Name: Common Name: Classification Panel: Requlation Number:
  ControlRad® Select Model Z lmage-intensified fluoroscopic X-ray System Interventional Fluoroscopic X-ray System Radiology 21 CFR §892.1650

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Image /page/4/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in a dark teal sans-serif font, followed by "RAD" in a lighter green sans-serif font. The "RAD" portion of the logo is partially enclosed by a green circle that is darker on the left and lighter on the right, creating a gradient effect.

Device Class:	II
Product Codes:
Primary:	OWB
Secondary:	JAA, IZI

Primary Predicate Device:

Trade Name:	ControlRad® Select Model Z
510(k) Clearance:	K202431
Clearance Date:	December 23, 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:	JAA, IZI

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, 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 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.

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Image /page/5/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in a dark teal sans-serif font, followed by "RAD" in a lighter teal color. To the right of "RAD" is a circular graphic with two teal arcs, one dark and one light, that form a broken circle around the letters.

Device Description: 6.

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.

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 3.0 mm, both of which are partially transparent to X-ray radiation.

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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 sans-serif font on the left side of the logo. To the right of the word "CONTROL" is the word "RAD" in a smaller, lighter green sans-serif font. The word "RAD" is inside of a circle that is made up of two different shades of green.

Based on the user selection of the Artis zee collimator the ControlRad® Filter region of interest (ROI), 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 the semi-transparent titanium filters to deliver a 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.

Reason for Submission:

This Special 510(K) submission is requesting clearance for the ControlRad® Select Model Z to be installed on the Artis zee large collimator.

Technoloqical 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.

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Image /page/7/Picture/0 description: The image shows the logo for ControlRad. The logo consists of the word "CONTROL" in a dark teal color, followed by the word "RAD" in a lighter green color. The "RAD" is partially enclosed in a green circle, with the top and bottom of the circle open.

. 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 whose boundaries are defined by the Siemens' collimator, i.e., the image FOV is defined by the Siemens non-collimated region. The image FOV size is not affected or modified by the ControlRad® Select Model Z.

Within the Siemens Artis zee non-collimated image region, when using a clinician selected Region of Interest ("ROI") on the ControlRad® Tablet, the ControlRad® Filters reduce radiation exposure outside the ROI. The resulting image has two parts:

The image inside the clinician-selected ROI (unfiltered radiation area in the FOV), . which has at least the same image quality in the ROI as the Siemens Artis zee (K181407).
The image outside the clinician-selected ROI (filtered radiation area in the FOV), . a lower-dose processed image which provides peripheral image context to the ROI.

The Siemens Artis zee's collimator, when used, also reduces radiation emission. However, that collimator reduces radiation emission by blocking the delivery of 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 ControlRad® Select Model Z is a product that can be mounted only on the following confiqurations of the Artis zee: floor, ceiling, bi-plane, and zeego systems.

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.

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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 green sans-serif font, followed by the word "RAD" in a lighter green sans-serif font. To the right of the word "RAD" is a circular graphic made up of two curved green shapes, one slightly darker than the other, that partially overlap to form a stylized "C" shape.

Substantial Equivalence:

The ControlRad® Select Model Z is a substantial equivalent to the legally marketed predicate listed below:

Predicate Device Nameand Manufacturer	510(k) Number	Clearance Date	Comparable Properties
Primary PredicateControlRad® SelectModel ZControlRad®	K202431	12/23/2020	• Indications for use• CR Trace Tablet• ControlRad® Trace Filter• ControlRad® Hardware• ControlRad® Software and Firmware Modules• ControlRad® Communication Interface• Dose Reduction Claim

7. Comparison of Technological Characteristics with the Predicate device:

The ControlRad® Select Model Z for use with Siemens Artis zee has the same Indications for Use Statement as the cleared predicate ControlRad® Select Model Z (K202431). The ControlRad® Select Model Z is identical in construction to the predicate with exception to the size of the ControlRad hardware to attach to the collimator that partners with Siemens Artis zee 30x40cm detector. The performance data demonstrates that the ControlRad® Select Model Z is at least as safe and effective as the predicate device and is substantially equivalent to the predicate device. A comparison table of technological characteristics of the ControlRad® Select Model Z device for use with Siemens Artis zee compared to those of the predicate is provided below:

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Image /page/9/Picture/1 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. To the right of the word "RAD" is a circular design with two different shades of green.

Device	Subject DeviceControlRad, Inc'sControlRad® SelectModel Z (Large)	Primary Predicate DeviceControlRad, Inc'sControlRad® SelectModel Z (Small)(K202431)	Comparison Results
Feature
Indications for UseStatement	The ControlRad® Select Model Zwith Siemens Artis zee isindicated to provide fluoroscopicimaging of the patient duringdiagnostic, surgical, andinterventional procedures whilereducing patients and clinicians'radiation exposure (Dose AreaProduct) outside of theControlRad Select Model Z'sregion of interest (ROI) ascompared to Artis zee non-collimated image area.1 TheControlRad Select Model Zsemi-transparent filter should notbe used in lieu of the Artis zee'scollimators, as they block themost radiation, but can helpphysicians balance dosereduction with the need tovisualize structures outside theROI when it is consideredclinically advantageous to do so.Clinical applications may includecardiac angiography, neuro-angiography, generalangiography, rotationalangiography, multipurposeangiography and whole bodyradiographic/fluoroscopicprocedures as well asprocedures next to the table fori.e., patient extremities.Additional procedures that canbe performed includeangiography in the operatingroom, image guided surgery byX-ray, by image fusion, and bynavigation systems. Theexamination table as anintegrated part of the system canbe used for X-ray imaging,surgery and interventions.1 Relative to open Field of View(FOV), the ControlRad SelectModel Z reduces at least 85% ofthe Dose Area Product at 65 kVpand ROI with width and lengththat are smaller than 1/5 theedge size of the full FOV.	The ControlRad® Select Model Zwith Siemens Artis zee isindicated to provide fluoroscopicimaging of the patient duringdiagnostic, surgical, andinterventional procedures whilereducing patients and clinicians'radiation exposure (Dose AreaProduct) outside of theControlRad Select Model Z'sregion of interest (ROI) ascompared to Artis zee non-collimated image area.1 TheControlRad Select Model Zsemi-transparent filter shouldnot be used in lieu of the Artiszee's collimators, as they blockthe most radiation, but can helpphysicians balance dosereduction with the need tovisualize structures outside theROI when it is consideredclinically advantageous to do so.Clinical applications may includecardiac angiography, neuro-angiography, generalangiography, rotationalangiography, multipurposeangiography and whole bodyradiographic/fluoroscopicprocedures as well asprocedures next to the table fori.e., patient extremities.Additional procedures that canbe performed includeangiography in the operatingroom, image guided surgery byX-ray, by image fusion, and bynavigation systems. Theexamination table as anintegrated part of the system canbe used for X-ray imaging,surgery and interventions.1 Relative to open Field of View(FOV), the ControlRad SelectModel Z reduces at least 85% ofthe Dose Area Product at 65 kVpand ROI with width and lengththat are smaller than 1/5 theedge size of the full FOV.	Same:
Technical Specification
X-ray Radiation Source	The X-ray Tube of SiemensMedical Solutions, Inc. Artiszee	The X-ray Tube of SiemensMedical Solutions, Inc. Artiszee	Same: This is the exact samecomponent cleared in theReferenced Device: Siemens'Artis zee (K181407). Providedin this Submission is SystemValidation testing Summaries.
DeviceFeature	Subject DeviceControlRad, Inc'sControlRad® SelectModel Z (Large)	Primary Predicate DeviceControlRad, Inc'sControlRad® SelectModel Z (Small)(K202431)	Comparison Results
System Configuration	ControlRad Filter and ImageProcessing SW/HW mountedon Artis zee	ControlRad Filter and ImageProcessing SW/HW mountedon Artis zee	Comparable: This is theexact same componentscleared in the PrimaryPredicate Device withexception to the size of theControlRad hardware to attachto the collimator that partnerswith Siemens Artis zee30x40cm detector. Provided inthis submission is BenchTesting and System ValidationTesting Summaries.
X-ray ModulationComponent	CR Filter2.5mm thru 3.0mm	CR Filter2.5mm thru 3.0mm	Same: This is the exact samecomponents cleared in thePrimary Predicate Device.Provided in this submission isBench Testing and SystemValidation Summaries.
X-ray RadiationModulation	Semi-transparent filter;Reduces radiation outside theaperture typically by 44% to98%.	Semi-transparent filter;Reduces radiation outside theaperture typically by 44% to98%.	Same: This is the exact samecomponents cleared in thePrimary Predicate Device.Provided in this submission isBench Testing and SystemValidation Summaries 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 Summaries.
Aperture Control	Set by the user using the CRTablet	Set by the user using the CRTablet	Same: This is the exact samefunctionality cleared in thePrimary Predicate Device.Provided in this submission isBench Testing and SystemValidation Testing Summaries.
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 Summaries
DeviceFeature	Subject DeviceControlRad, Inc'sControlRad® SelectModel Z (Large)	Primary Predicate DeviceControlRad, Inc'sControlRad® SelectModel Z (Small)(K202431)	Comparison Results
Processing Bits	16 bits	16 bits	Same: This is the exact samefeature cleared in the PrimaryPredicate Device. Provided inthis submission is BenchTesting and System ValidationSummaries.
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. Summaries.
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 Summaries.
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	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	Same: This is the exact samefeature cleared in the PrimaryPredicate Device. Provided inthis submission is BenchTesting and System ValidationTesting Summaries.
Parameters Accuracy Specifications
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 Summaries.
DeviceFeature	Subject DeviceControlRad, Inc'sControlRad® SelectModel Z (Large)	Primary Predicate DeviceControlRad, Inc'sControlRad® SelectModel Z (Small)(K202431)	Comparison Results
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	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	Same: This is the exact samefeature cleared in the PrimaryPredicate Device. Provided inthis submission is BenchTesting and System ValidationTesting Summaries.

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Image /page/10/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in a dark teal color, and the word "RAD" is in a lighter green color. The word "RAD" is surrounded by a green circle that is broken at the top and bottom.

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Image /page/11/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in a dark teal sans-serif font, followed by "RAD" in the same font, but with a green and teal circular design around it. The logo is simple and modern, with a focus on the company name.

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8. 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 Primary Predicate Device:

V3.0.5 Software Verification: Verification of the v3.0.5 software.
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) when compared to the Artis zee system alone.
Impact of Cover on Air Kerma: Verification that the X-ray radiation for a Siemens Artis zee system with 30cm x 40cm detector and associated collimator (Artis zee Large) with installed CRS Z LD is not affected by the ControlRad® cover with and without addition of the Aluminum versus Siemens cover with and without the Aluminum added to the cover.
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

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Image /page/13/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in a dark teal sans-serif font, and the word "RAD" is in a lighter green sans-serif font. The word "RAD" is surrounded by a green circle that is broken at the top and bottom.

SPECIAL 510(k): ControlRad, Inc ControlRad® Select Model Z 275 Scientific Drive NW #1100 Norcross, GA 30092

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).

Accuracy of Procedure Dose Indicators: Verification that the accuracy of procedure dose indicators reported at the end of a procedure by the ControlRad® Select Model Z Large Detector (CRS Z LD) when installed on a Siemens Artis zee system with 30cm x 40cm detector and associated collimator do not exceed ±35% for any of the dose indicators.
ControlRad® Filter Attenuation: Verification of the claim that ControlRad® Select Model Z when installed in Artis zee C-arm contributes to reduction of Dose Area Product (DAP).
Leakage Radiation 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.
Anti-Collision Detection: Verification of the collision detection function of the Siemens Artis zee with ControlRad® Select Model Z filter / collimator cover installed.
Focal Spot to Patient Distance: Verification that the focal spot to skin distance implementation per IEC 60601-2-54, section 203.9 requirements.
Tensile Strength Evaluation: Verification that additional mass from the Select Model Z filter does not create unacceptable risk from tensile strength per IEC 60601-1 requirements.
Filter Motion Assembly Reliability: Verification of filer motion reliability over the expected service life of the filter assembly.
Comparative image quality inside the ROI: Verification 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: Characterization testing to quantify the level of image quality degradation outside the region of interest as a result of the CR filter blades
lmage quality evaluation via clinical simulations: Validation that the image quality outside the ROI is clinically relevant following degradation due to use of the ControlRad filters.
DAP Chamber Change Justification of 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.
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".
Cybersecurity Controls & Justification for Control of Risk. Verification of cybersecurity risk controls.

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.

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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 sans-serif font, followed by "RAD" in a lighter green sans-serif font. To the right of the word "RAD" is a circular graphic made of two curved green lines, one dark teal and one light green, that form a stylized "C" shape.

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 for the prevention of unauthorized access, modifications, misuse or denial of use, or the unauthorized use of information that is stored, accessed or transferred from a medical device to an external recipient. Provided in the Software Section is the required cybersecurity information.

Summary:

Performance tests were conducted to test the functionality of ControlRad® 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 does not raise any new issues of safety or effectiveness.

9. 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
IEC 60601-1-6 Medical Electrical Equipment - Part 1-6: General Requirementsfor 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 diaqnosis
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.

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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 "RAD" in a lighter green color. The "RAD" is partially enclosed within a green circle, with the top and bottom of the circle cut off by horizontal white lines. The green circle transitions from a darker teal at the top to a lighter green at the bottom.

IEC 60601-2-54 Medical electrical equipment Part 2-54: Particular requirements . for the basic safety and essential performance of X-ray equipmentfor radiography and radioscopy
FDA 21 CFR 1020.30-32 Federal Performance Standard for Diagnostic X-ray . Systems

10. Conclusion as to Substantial Equivalence:

The ControlRad® Select Model Z is installed on the Siemens Artis zee (K181407). The ControlRad® Select Model Z is technologically identical to ControlRad® Select Model Z, cleared in K202431. The comparison of technological characteristics, non-clinical performance data and software validation data demonstrates that the Subject Device does not raise any new questions regarding safety or effectiveness when compared to the Predicate Device that is currently marketed for the same intended use.

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.