(29 days)
No
The summary describes a hardware filter and associated software/hardware components designed to reduce radiation exposure by attenuating X-rays outside a selected region of interest. There is no mention of AI or ML algorithms being used for image processing, decision-making, or any other function. The focus is on physical attenuation and control of the filter.
No.
The device is indicated for providing fluoroscopic imaging and reducing radiation exposure, which are diagnostic and safety functions, not therapeutic ones.
Yes
The device is described as providing "fluoroscopic imaging of the patient during diagnostic, surgical, and interventional procedures," and its "Intended Use / Indications for Use" section explicitly mentions "diagnostic" procedures.
No
The device description explicitly lists "ControlRad® Filter" and "ControlRad® Hardware" as main components, indicating it includes physical hardware in addition to software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The ControlRad® Select Model Z is an accessory for an X-ray system (Artis zee). Its primary function is to reduce radiation exposure during fluoroscopic imaging procedures performed on the patient. It does not analyze biological specimens.
- Intended Use: The intended use clearly states it's for providing fluoroscopic imaging of the patient during diagnostic, surgical, and interventional procedures.
Therefore, the ControlRad® Select Model Z is a medical device used for imaging and radiation management during in-vivo procedures, not an in-vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes
OWB, JAA, IZI
Device Description
The ControlRad® Select Model Z is a set of components mounted on the Artis zee system and cannot be used independent of the Artis zee system.
The ControlRad® Select Model Z consists of a ControlRad® filter mounted onto the Siemens Medical Artis zee (K181407) C-arm. The ControlRad® filter is installed semipermanently (i.e., the filter may be removed to return the C-arm to its original condition) to aid in reducing both patient and clinicians' radiation exposure while providing fluoroscopic imaging of the patient during diagnostic, surgical and interventional procedures.
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.
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Trained clinicians / diagnostic, surgical, and interventional procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Relative to open Field of View (FOV), the ControlRad Select Model Z reduces at least 85% of the Dose Area Product at 65 kVp and ROI with width and length that are smaller than 1/5 the edge size of the full FOV.
Dose Area Product (DAP) Accuracy for total x-ray field of the ControlRad Filter and Artis zee systems combined*: ±35%*
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
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
1
801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
, for
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) 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) | × |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) | □ |
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3
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
-
- 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
- Device Name and Classification: Trade Name: Classification Name: Common Name: Classification Panel: Requlation Number:
4
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.
5
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.
6
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.
7
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.
8
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
| and Manufacturer | 510(k) Number | Clearance Date | Comparable Properties |
|---|---|---|---|
| Primary Predicate | |||
| ControlRad® Select | |||
| Model Z | |||
| ControlRad® | K202431 | 12/23/2020 | • Indications for use |
| • CR Trace Tablet | |||
| • ControlRad® Trace Filter | |||
| • ControlRad® Hardware | |||
| • ControlRad® Software and Firmware Modules | |||
| • ControlRad® Communication Interface | |||
| • Dose Reduction Claim |
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
ControlRad, Inc's
ControlRad® Select
Model Z (Large) | Primary Predicate Device
ControlRad, Inc's
ControlRad® Select
Model Z (Small)
(K202431) | Comparison Results |
|--------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Feature | | | |
| Indications for Use
Statement | 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, 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.
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. | 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, 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.
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. | Same: |
| Technical Specification | | | |
| X-ray Radiation Source | The X-ray Tube of Siemens
Medical Solutions, Inc. Artis
zee | The X-ray Tube of Siemens
Medical Solutions, Inc. Artis
zee | Same: This is the exact same
component cleared in the
Referenced Device: Siemens'
Artis zee (K181407). Provided
in this Submission is System
Validation testing Summaries. |
| Device
Feature | Subject Device
ControlRad, Inc's
ControlRad® Select
Model Z (Large) | Primary Predicate Device
ControlRad, Inc's
ControlRad® Select
Model Z (Small)
(K202431) | Comparison Results |
| System Configuration | ControlRad Filter and Image
Processing SW/HW mounted
on Artis zee | ControlRad Filter and Image
Processing SW/HW mounted
on Artis zee | Comparable: This is the
exact same components
cleared in the Primary
Predicate Device with
exception to the size of the
ControlRad hardware to attach
to the collimator that partners
with Siemens Artis zee
30x40cm detector. Provided in
this submission is Bench
Testing and System Validation
Testing Summaries. |
| X-ray Modulation
Component | CR Filter
2.5mm thru 3.0mm | CR Filter
2.5mm thru 3.0mm | Same: This is the exact same
components cleared in the
Primary Predicate Device.
Provided in this submission is
Bench Testing and System
Validation Summaries. |
| X-ray Radiation
Modulation | Semi-transparent filter;
Reduces radiation outside the
aperture typically by 44% to
98%. | Semi-transparent filter;
Reduces radiation outside the
aperture typically by 44% to
98%. | Same: This is the exact same
components cleared in the
Primary Predicate Device.
Provided in this submission is
Bench Testing and System
Validation Summaries that
demonstrates that the device
is as safe and effective as the
Primary Predicate Device and
does not raise different
questions of safety and
effectiveness than the
Predicate Device. |
| Aperture shape | Blades: Rectangular | Blades: Rectangular | Same: This is the exact same
component cleared in the
Primary Predicate Device.
Provided in this submission is
Bench Testing and System
Validation Testing Summaries. |
| Aperture Control | Set by the user using the CR
Tablet | Set by the user using the CR
Tablet | Same: This is the exact same
functionality cleared in the
Primary Predicate Device.
Provided in this submission is
Bench Testing and System
Validation Testing Summaries. |
| Image Area
Processed | Area outside ROI | Area outside ROI | Same: This is the exact same
feature cleared in the Primary
Predicate Device. Provided in
this submission is Bench
Testing and System Validation
Testing Summaries |
| Device
Feature | Subject Device
ControlRad, Inc's
ControlRad® Select
Model Z (Large) | Primary Predicate Device
ControlRad, Inc's
ControlRad® Select
Model Z (Small)
(K202431) | Comparison Results |
| Processing Bits | 16 bits | 16 bits | Same: This is the exact same
feature cleared in the Primary
Predicate Device. Provided in
this submission is Bench
Testing and System Validation
Summaries. |
| Processing Rate | 30 fps | 30 fps | Same: This is the exact same
feature cleared in the Primary
Predicate Device. Provided in
this submission is Bench
Testing and System Validation
Testing. Summaries. |
| Processing
Occurrence | Area outside ROI: Only when
the CR Filter is engaged | Area outside ROI: Only when
the CR Filter is engaged | Same: This is the exact same
feature cleared in the Primary
Predicate Device. Provided in
this submission is Bench
Testing and System Validation
Testing Summaries. |
| Image Layout
Information | All image layout
information originally
available for Siemens Artis
zee plus the following:
• Percentage of Dose
Area Product (DAP)
reduction when using
ControlRad Filter
and/or Siemens Arits
zee Collimator
• ROI frame border | All image layout
information originally
available for Siemens Artis
zee plus the following:
• Percentage of Dose
Area Product (DAP)
reduction when using
ControlRad Filter
and/or Siemens Arits
zee Collimator
• ROI frame border | Same: This is the exact same
feature cleared in the Primary
Predicate Device. Provided in
this submission is Bench
Testing and System Validation
Testing Summaries. |
| Parameters Accuracy Specifications | | | |
| Dose Area Product
(DAP) Accuracy for
total x-ray field of the
ControlRad Filter and
Artis zee systems
combined* | ±35%* | ±35%* | Same: This is the exact same
feature cleared in the Primary
Predicate Device. Provided in
this submission is Bench
Testing and System Validation
Testing Summaries. |
| Device
Feature | Subject Device
ControlRad, Inc's
ControlRad® Select
Model Z (Large) | Primary Predicate Device
ControlRad, Inc's
ControlRad® Select
Model Z (Small)
(K202431) | Comparison Results |
| Electrical
Requirements | Artis zee Components:
Power requirements
Generator
POLYDOROS A100
Plus:
AC 400 V ± 10 %, 50/60
Hz ± 1 Hz
Power requirements
System control cabinet:
AC 400 V ± 10 %, 50/60
Hz ± 1 Hz
ControlRad Components:
SCIP BOX Input: 230 VAC,
0.6A
TABLET POWER SUPPLY
Input: 24 VDC, 0.5A
SELECT FILTER Input: 28
VDC, 0.9A
ROUTER Input : 12DC, 1A
ROUTER POWER SUPPLY
Input : 230VAC, 0.5A | Artis zee Components:
Power requirements
Generator
POLYDOROS A100
Plus:
AC 400 V ± 10 %, 50/60
Hz ± 1 Hz
Power requirements
System control cabinet:
AC 400 V ± 10 %, 50/60
Hz ± 1 Hz
ControlRad Components:
SCIP BOX Input: 230 VAC,
0.6A
TABLET POWER SUPPLY
Input: 24 VDC, 0.5A
SELECT FILTER Input: 28
VDC, 0.9A
ROUTER Input : 12DC, 1A
ROUTER POWER SUPPLY
Input : 230VAC, 0.5A | Same: This is the exact same
feature cleared in the Primary
Predicate Device. Provided in
this submission is Bench
Testing and System Validation
Testing Summaries. |
10
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.
11
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.
12
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
13
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.
14
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.
15
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.