ControlRad Select Model Z

K213455 · Controlrad, Inc. · OWB · Nov 24, 2021 · Radiology

Device Facts

• Record ID: K213455
• Device Name: ControlRad Select Model Z
• Applicant: Controlrad, Inc.
• Product Code: OWB · Radiology
• Decision Date: Nov 24, 2021
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 892.1650
• Device Class: Class 2

Intended Use

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.

Device Story

ControlRad Select Model Z is an add-on system for Siemens Artis zee C-arm fluoroscopy systems. It consists of a semi-transparent titanium filter (2.5mm or 3.0mm thick) mounted on the Artis zee collimator, a dedicated tablet, and control hardware/software. Clinicians use the tablet to define a Region of Interest (ROI) on the live X-ray image. The system automatically positions the filter to attenuate X-rays outside the ROI while leaving the ROI unfiltered. This reduces radiation dose (Dose Area Product) to patients and clinicians in the periphery while maintaining image quality within the ROI. The device is used in clinical settings (OR, interventional suites) by trained clinicians. It provides peripheral context at a lower dose, helping physicians balance radiation reduction with the need for anatomical visualization. It does not replace standard collimators but functions in parallel to them.

Clinical Evidence

Bench testing only. Testing included software verification, Air Kerma and DAP accuracy (±35% of Artis zee alone), radiation dose structure report accuracy, leakage/stray radiation evaluation, mechanical/collision testing, and image quality evaluation via clinical simulations to ensure peripheral context remains relevant after filter attenuation.

Technological Characteristics

Components: Titanium filter (2.5-3.0mm), tablet, control hardware, and communication interface. Mounts semi-permanently on Siemens Artis zee C-arm. Energy source: Integrated with X-ray system. Connectivity: Proprietary communication interface to Artis zee. Software: Moderate level of concern. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 62304, IEC 60601-2-43, IEC 60601-2-54, 21 CFR 1020.30-32.

Indications for Use

Indicated for patients undergoing diagnostic, surgical, and interventional fluoroscopic procedures, including cardiac, neuro, and general angiography, and whole-body radiographic/fluoroscopic procedures. No specific age or gender contraindications stated.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• ControlRad® Select Model Z (K202431)

Reference Devices

• Artis zee (K181407)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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)

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.

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

| Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 2em;"><b>×</b></span> |
|----------------------------------------------|-----------------------------------------------|
| Over-The-Counter Use (21 CFR 801 Subpart C) | <span>□</span> |

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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) [e-mail] (email)

### Secondary Contact:

Linda Braddon, Ph.D. Secure BioMed Evaluations 7828 Hickory Flat Hwy Suite 120 Woodstock, GA 30188 770-837-2681 [e-mail]

- 3. 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 |

4. 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.

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: 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 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.

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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 Name<br>and Manufacturer | 510(k) Number | Clearance Date | Comparable Properties |
|--------------------------------------------------------------------------|---------------|----------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <b>Primary Predicate</b><br>ControlRad® Select<br>Model Z<br>ControlRad® | K202431 | 12/23/2020 | • Indications for use<br>• CR Trace Tablet<br>• ControlRad® Trace Filter<br>• ControlRad® Hardware<br>• ControlRad® Software and Firmware Modules<br>• ControlRad® Communication Interface<br>• 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 Device<br>ControlRad, Inc's<br>ControlRad® Select<br>Model Z (Large) | Primary Predicate Device<br>ControlRad, Inc's<br>ControlRad® Select<br>Model Z (Small)<br>(K202431) | Comparison Results |
|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | | | |
| Indications for Use<br>Statement | The ControlRad® Select Model Z<br>with Siemens Artis zee is<br>indicated to provide fluoroscopic<br>imaging of the patient during<br>diagnostic, surgical, and<br>interventional procedures while<br>reducing patients and clinicians'<br>radiation exposure (Dose Area<br>Product) outside of the<br>ControlRad Select Model Z's<br>region of interest (ROI) as<br>compared to Artis zee non-<br>collimated image area.1 The<br>ControlRad Select Model Z<br>semi-transparent filter should not<br>be used in lieu of the Artis zee's<br>collimators, as they block the<br>most radiation, but can help<br>physicians balance dose<br>reduction with the need to<br>visualize structures outside the<br>ROI when it is considered<br>clinically advantageous to do so.<br>Clinical applications may include<br>cardiac angiography, neuro-<br>angiography, general<br>angiography, rotational<br>angiography, multipurpose<br>angiography and whole body<br>radiographic/fluoroscopic<br>procedures as well as<br>procedures next to the table for<br>i.e., patient extremities.<br><br>Additional procedures that can<br>be performed include<br>angiography in the operating<br>room, image guided surgery by<br>X-ray, by image fusion, and by<br>navigation systems. The<br>examination table as an<br>integrated part of the system can<br>be used for X-ray imaging,<br>surgery and interventions.<br><br>1 Relative to open Field of View<br>(FOV), the ControlRad Select<br>Model Z reduces at least 85% of<br>the Dose Area Product at 65 kVp<br>and ROI with width and length<br>that are smaller than 1/5 the<br>edge size of the full FOV. | The ControlRad® Select Model Z<br>with Siemens Artis zee is<br>indicated to provide fluoroscopic<br>imaging of the patient during<br>diagnostic, surgical, and<br>interventional procedures while<br>reducing patients and clinicians'<br>radiation exposure (Dose Area<br>Product) outside of the<br>ControlRad Select Model Z's<br>region of interest (ROI) as<br>compared to Artis zee non-<br>collimated image area.1 The<br>ControlRad Select Model Z<br>semi-transparent filter should<br>not be used in lieu of the Artis<br>zee's collimators, as they block<br>the most radiation, but can help<br>physicians balance dose<br>reduction with the need to<br>visualize structures outside the<br>ROI when it is considered<br>clinically advantageous to do so.<br>Clinical applications may include<br>cardiac angiography, neuro-<br>angiography, general<br>angiography, rotational<br>angiography, multipurpose<br>angiography and whole body<br>radiographic/fluoroscopic<br>procedures as well as<br>procedures next to the table for<br>i.e., patient extremities.<br><br>Additional procedures that can<br>be performed include<br>angiography in the operating<br>room, image guided surgery by<br>X-ray, by image fusion, and by<br>navigation systems. The<br>examination table as an<br>integrated part of the system can<br>be used for X-ray imaging,<br>surgery and interventions.<br><br>1 Relative to open Field of View<br>(FOV), the ControlRad Select<br>Model Z reduces at least 85% of<br>the Dose Area Product at 65 kVp<br>and ROI with width and length<br>that are smaller than 1/5 the<br>edge size of the full FOV. | Same: |
| Technical Specification | | | |
| X-ray Radiation Source | The X-ray Tube of Siemens<br>Medical Solutions, Inc. Artis<br>zee | The X-ray Tube of Siemens<br>Medical Solutions, Inc. Artis<br>zee | Same: This is the exact same<br>component cleared in the<br>Referenced Device: Siemens'<br>Artis zee (K181407). Provided<br>in this Submission is System<br>Validation testing Summaries. |
| Device<br>Feature | Subject Device<br>ControlRad, Inc's<br>ControlRad® Select<br>Model Z (Large) | Primary Predicate Device<br>ControlRad, Inc's<br>ControlRad® Select<br>Model Z (Small)<br>(K202431) | Comparison Results |
| System Configuration | ControlRad Filter and Image<br>Processing SW/HW mounted<br>on Artis zee | ControlRad Filter and Image<br>Processing SW/HW mounted<br>on Artis zee | Comparable: This is the<br>exact same components<br>cleared in the Primary<br>Predicate Device with<br>exception to the size of the<br>ControlRad hardware to attach<br>to the collimator that partners<br>with Siemens Artis zee<br>30x40cm detector. Provided in<br>this submission is Bench<br>Testing and System Validation<br>Testing Summaries. |
| X-ray Modulation<br>Component | CR Filter<br>2.5mm thru 3.0mm | CR Filter<br>2.5mm thru 3.0mm | Same: This is the exact same<br>components cleared in the<br>Primary Predicate Device.<br>Provided in this submission is<br>Bench Testing and System<br>Validation Summaries. |
| X-ray Radiation<br>Modulation | Semi-transparent filter;<br>Reduces radiation outside the<br>aperture typically by 44% to<br>98%. | Semi-transparent filter;<br>Reduces radiation outside the<br>aperture typically by 44% to<br>98%. | Same: This is the exact same<br>components cleared in the<br>Primary Predicate Device.<br>Provided in this submission is<br>Bench Testing and System<br>Validation Summaries that<br>demonstrates that the device<br>is as safe and effective as the<br>Primary Predicate Device and<br>does not raise different<br>questions of safety and<br>effectiveness than the<br>Predicate Device. |
| Aperture shape | Blades: Rectangular | Blades: Rectangular | Same: This is the exact same<br>component cleared in the<br>Primary Predicate Device.<br>Provided in this submission is<br>Bench Testing and System<br>Validation Testing Summaries. |
| Aperture Control | Set by the user using the CR<br>Tablet | Set by the user using the CR<br>Tablet | Same: This is the exact same<br>functionality cleared in the<br>Primary Predicate Device.<br>Provided in this submission is<br>Bench Testing and System<br>Validation Testing Summaries. |
| Image Area<br>Processed | Area outside ROI | Area outside ROI | Same: This is the exact same<br>feature cleared in the Primary<br>Predicate Device. Provided in<br>this submission is Bench<br>Testing and System Validation<br>Testing Summaries |
| Device<br>Feature | Subject Device<br>ControlRad, Inc's<br>ControlRad® Select<br>Model Z (Large) | Primary Predicate Device<br>ControlRad, Inc's<br>ControlRad® Select<br>Model Z (Small)<br>(K202431) | Comparison Results |
| Processing Bits | 16 bits | 16 bits | Same: This is the exact same<br>feature cleared in the Primary<br>Predicate Device. Provided in<br>this submission is Bench<br>Testing and System Validation<br>Summaries. |
| Processing Rate | 30 fps…