Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary focuses on hardware and software components for radiation dose reduction through filtering and ROI definition, with no mention of AI/ML terms, training data, or performance metrics typically associated with AI/ML algorithms.

Therapeutic

No.
The device is indicated for providing imaging and reducing radiation exposure during procedures, not for treating a disease or condition.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" section states that the device is "indicated to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures." This explicitly mentions diagnostic procedures.

SaMD (Software as a Medical Device)

No

The device description explicitly lists hardware components such as a "ControlRad Trace Tablet," "ControlRad Trace Filter," and "ControlRad Hardware," in addition to software and firmware.

IVD (In Vitro Diagnostic)

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 taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
Device Function: The ControlRad™ Trace Model 9 is an accessory for an X-ray system (OEC® 9900 Elite). Its primary function is to reduce radiation exposure during imaging procedures by modulating the X-ray beam.
Intended Use: The intended use clearly states it's for "fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures." This involves imaging the patient directly, not analyzing samples taken from the patient.

The device is a medical device used in conjunction with an imaging system, but it does not fit the definition of an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ControlRad™ Trace Model 9, when used with OEC® 9900 Elite, is indicated to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace's region of interest (ROI) as compared to OEC® 9900 Elite non-collimated image area. 1 The ControlRad Trace semi-transparent filter should not be used in lieu of the OEC® 9900 Elite's collimators, as they block the most radiation, but can help physicians balance dose visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
1 Relative to open Field of View (FOV), the ControlRad Trace Model 9 reduces at least 50% of the Dose Area Product at 50 kVp and ROI with width and length that are smaller than 1/3 the diameter of the full FOV.

Product codes

OWB, OXO, JAA

Device Description

The ControlRad™ Trace Model 9 consists of the following main components: ControlRad Trace Tablet, ControlRad Trace Filter, ControlRad Hardware, ControlRad Software and Firmware Modules and ControlRad Communication Interface all installed on the OEC 9900 Elite. The ControlRad™ Trace Model 9 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 Trace's region of interest (ROI) as compared to the OEC 9900 Elite non-collimated image area. The ControlRad™ Trace Model 9 can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Fluoroscopic X-ray

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Trained clinicians / Not Found

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

Impact on Air Kerma Test: Performed to evaluate the impact of the ControlRad™ Trace Model 9 on Air Kerma (AKR) measurements of GE Healthcare Surgery's OEC 9900 Elite.
Dose-Area-Product (DAP) calculation accuracy test: Performed to demonstrate that DAP calculations of the ControlRad™ Trace Model 9 when installed in GE Healthcare Surgery's OEC 9900 Elite system are within ±35% of measured DAP values.
DAP Reduction Accuracy Test: Performed to demonstrate that the ControlRad™ Trace Model 9 when installed on the OEC 9900 Elite reduces at least 50% of the DAP at 50kVp and ROI with width and length are smaller than 1/3 the diameter of the full FOV.
Dose-Area-Product (DAP) Reduction Accuracy Test: Performed to demonstrate that DAP Reduction calculations of the ControlRad™ Trace Model 9 when installed in GE Healthcare Surgery's OEC 9900 Elite system are within ±35% of the DAP Reduction values.
ControlRad Trace Filter Attenuation Test: Performed to evaluate the attenuation level of the filters of the ControlRad™ Trace Model 9.
Comparative Image Quality inside the ROI Test: Performed to demonstrate that the image quality of the OEC 9900 Elite with installed ControlRad Trace Model 8 within the ROI is of at least the same image quality compared to the image quality of the OEC 9900 Elite alone.
Comparative Image Quality outside the ROI Test: Performed to evaluate the filtered image quality outside the ROI of the OEC 9900 Elite with installed ControlRad Trace Model 9 in the periphery image outside the ROI compared to the image quality of the OEC 9900 Elite alone.
Image Quality Clinical Simulations: Performed to evaluate the image quality inside and outside the ROI and the ability of the filtered image outside the ROI to provide image context to the ROI, of a clinically simulated image obtained by the GE Healthcare Surgery's OEC® 9900 Elite with installed ControlRad™ Trace Model 9.
Touch-In-Gloves Bench Test: Performed to demonstrate that the CR Trace Tablet's touchscreen operates as intended when using sterile radiation protective gloves and touchscreen drape.
Filter motion reliability testing: Performed due to changes in assembly of the Trace 9 filter.
Wireless Technology and Cybersecurity Evaluation: Performed to evaluate the ControlRad™ Trace Model 9's compliance with the requirements set forth in FDA Guidance documents titled "Radio Frequency Wireless Technology in Medical Devices" and "Postmarket Management of Cyber Security in Medical Devices".
Instability test: Performed to ensure compliance with IEC 60601-1 Instability in transport position and Instability from horizontal and vertical forces clauses, due to weight changes with the workstation.

Key results: In all performance tests the ControlRad™ Trace Model 9 system when installed in GE Healthcare Surgery's OEC® 9900 Elite system performed and functioned as intended and observations were as expected.

Key Metrics

DAP Accuracy for total x-ray field of the ControlRad Trace Filter and OEC systems combined: *Overall: ±35% For DAP reported by ControlRad™ Trace Model 9

Predicate Device(s)

K183109

Reference Device(s)

K122234

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

June 24, 2020

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a sans-serif font.

ControlRad, Inc. % Linda Braddon, Ph.D. Regulatory Consultant Secure BioMed Evaluations 7828 Hickory Flat Highway, Suite 120 WOODSTOCK GA 30188

Re: K200663

Trade/Device Name: ControlRad™ Trace Model 9 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB, OXO, JAA Dated: April 9, 2020 Received: April 10, 2020

Dear Dr. Braddon:

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

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

1

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K200663

Device Name

ControlRad™ Trace Model 9

Indications for Use (Describe)

The ControlRad™ Trace Model 9, when used with OEC® 9900 Elite, is indicated to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace's region of interest (ROI) as compared to OEC® 9900 Elite non-collimated image area. 1 The ControlRad Trace semi-transparent filter should not be used in lieu of the OEC® 9900 Elite's collimators, as they block the most radiation, but can help physicians balance dose visualize structures outside the ROI when it is considered clinically advantageous to do so. Clinications may include cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

1 Relative to open Field of View (FOV), the ControlRad Trace Model 9 reduces at least 50% of the Dose Area Product at 50 kVp and ROI with width and length that are smaller than 1/3 the diameter of the full FOV.

Type of Use (Select one or bothas applicable)

図 Prescription Use (Part 21 CFR 801 Subpart D)

□ Over-The-Counter Use (21 CFR 801 Subpart C

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW. *

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An aqency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (7/17)

Page 1 of 1

PSC Publishing Services (301) 443-6740

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Image /page/3/Picture/0 description: The image shows the logo for ControlRad. The logo is in green and white. The word "CONTROL" is in dark green, and the word "RAD" is in light green. There is a green circle around the "RAD" part of the logo.

510(k) SUMMARY

ControlRad, Inc's ControlRadTM Trace Model 9

K200663

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

-------------------	-------------------------------------------------------------------------------------------------------------

Contact Person: Linda Braddon, Ph.D. Secure BioMed Evaluations 7828 Hickory Flat Hwy Suite 120 Woodstock, GA 30188 770-837-2681 Regulatory@SecureBME.com
Date Prepared: June 15, 2020

Subject Device:

Device Name	ControlRad™ Trace Model 9
Common Name	Interventional Fluoroscopic X-ray System
Regulation	21 CFR §892.1650
Classification Name	Image-intensified fluoroscopic x-ray system
Class	II
Panel	Radiology
Product Code(s)	Primary: OWB
Secondary: OXO, JAA

Predicate Device:

Device Name	ControlRad™ Trace Model 8 (K183109)
Common Name	Interventional Fluoroscopic X-ray System
Regulation	21 CFR §892.1650
Classification Name	Image-intensified fluoroscopic x-ray system
Class	II
Panel	Radiology
Product Code(s)	Primary: OWB
Secondary: OXO, JAA

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Image /page/4/Picture/0 description: The image shows the logo for ControlRad. The logo consists of the word "CONTROL" in dark teal, followed by "RAD" in a lighter green. To the right of "RAD" is a circular design with a dark teal lower half and a light green upper half. The letters "RAD" are integrated into the circular design, and there is a trademark symbol to the upper right of the logo.

Reference Device:

GE Healthcare Surgery, OEC® 9900 Elite (K122234) Device Name Common Name Interventional Fluoroscopic X-ray System Regulation 21 CFR §892.1650 Classification Name Image-intensified fluoroscopic x-ray system Class II Radiology Panel Product Code(s) Primary: OWB Secondary: OXO, JAA

Indications for Use

The ControlRad™ Trace Model 9, when used with OEC® 9900 Elite, is indicated to provide fluoroscopic and spot-film imaging of the patient during diagnostic, surgical, and interventional procedures while reducing patients and clinicians' radiation exposure (Dose Area Product) outside of the ControlRad Trace's region of interest (ROI) as compared to OEC® 9900 Elite noncollimated image area.1 The ControlRad Trace semi-transparent filter should not be used in lieu of the OEC® 9900 Elite'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 cholangiography, endoscopic, urologic, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.

1 Relative to open Field of View (FOV), the ControlRad Trace Model 9 reduces at least 50% of the Dose Area Product at 50 kVp and ROI with width and length that are smaller than 1/3 the diameter of the full FOV.

Device Description

The ControlRad™ Trace Model 9 consists of the following main components: ControlRad Trace Tablet, ControlRad Trace Filter, ControlRad Hardware, ControlRad Software and Firmware Modules and ControlRad Communication Interface all installed on the OEC 9900 Elite. The ControlRad™ Trace Model 9 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 Trace's region of interest (ROI) as compared to the OEC 9900 Elite non-collimated image area. The ControlRad™ Trace Model 9 can help physicians balance dose reduction with the need to visualize structures outside the ROI when it is considered clinically advantageous to do so.

Technological Characteristics

The ControlRad™ Trace Model 9 consists of the following main components: ControlRad Trace Tablet, ControlRad Trace Filter, ControlRad Hardware, ControlRad Software and Firmware Modules and ControlRad Communication Interface all installed on the OEC 9900 Elite.

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Image /page/5/Picture/0 description: The image shows the logo for ControlRad. The logo consists of the word "CONTROL" in a bold, sans-serif font, followed by the word "RAD" in a similar font but with a green color. To the right of "RAD" is a stylized green circle, partially enclosing the letters "RAD", with a darker green section at the bottom. There is a trademark symbol to the right of the word "RAD".

The ControlRad" Trace Model 9 components are installed semi-permanently in the cleared GE Healthcare Surgery's OEC® 9900 Elite (K122234) and operate in parallel to the GE Healthcare Surgery's OEC® 9900 Elite. The removal of the ControlRad™ components will restore the device to OEM specifications.

The ControlRad™ Trace Model 9 components provide the following functionalities:

The CR Trace Tablet provides the user operational control of the ControlRad™ Trace . Model 9 device via a Graphical User Interface ("GUI"). The CR Trace Tablet enables the clinician to select a Region of Interest ("ROI") on the image displayed on the CR Trace Tablet, which is the same image that is displayed on the GE Healthcare Surgery's OEC® 9900 Elite's live monitor.
. The CR Trace Filter is installed on top of the GE Healthcare Surgery's OEC® 9900 Elite's collimator. The CR Trace Filter does not affect or modify the functionality of the collimator. The CR Trace Filter is a semi-transparent filter which reduces the X-ray radiation outside the clinician-selected ROI, typically by 61% to 97%. The actual dose reduction achieved will depend upon specific imaging parameters such as OEC collimator settings, the kVp and the percentage of the OEC non-collimated image covered by the ControlRad Trace Filter.
The ControlRad Hardware, Software and Firmware Modules control the ControlRad Trace . Filter's positioning, which is determined by the location of the clinician-selected ROI and perform image processing.
The ControlRad Communication Interface provides communication between the various . components of the ControlRad™ Trace Model 9 and between the ControlRad™ Trace Model 9 and the GE Healthcare Surgery's OEC® 9900 Elite.

Principles of Operation

The GE Healthcare Surgery's OEC® 9900 Elite provides an image that its boundaries are defined by the OEC® 9900 Elite's collimator, i.e. the image FOV is defined by the OEC non-collimated region. The image FOV size is not affected or modified by the ControlRad™ Trace Model 9.

Within the OEC® 9900 Elite non-collimated image region, when using a clinician selected Region of Interest ("ROI") on the ControlRad Trace Tablet, the ControlRad Trace 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 GE Healthcare Surgery's OEC® 9900 Elite (K122234); and

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Image /page/6/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. To the right of "RAD" is a circular design with two shades of green, creating a stylized "C" shape. The letters and the circular design are aligned horizontally.

. The image outside the clinician-selected ROI (filtered radiation area in the FOV), a lowerdose processed image which provides peripheral image context to the ROI.
The GE Healthcare Surgery's OEC® 9900 Elite'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 GE Healthcare Surgery's OEC® 9900 Elite's image FOV is limited to the non-collimated region. The ControlRad Trace Filter can be used along with the GE Healthcare Surgery's OEC® 9900 Elite's collimator to further reduce radiation emissions, and the additional radiation reduction provided by the ControlRad Trace Filter will be outside the clinician-selected ROI and within the un-collimated region/image FOV.

The clinician has the option not to use the CR Trace Filter. In this case, the GE Healthcare Surgery's OEC® 9900 Elite operates as if the CR Trace Filter was not present.

Comparison of Technological Characteristics with the Predicate devices

The ControlRad™ Trace Model 9 for use with GE Healthcare Surgery's OEC® 9900 Elite has the same intended use and the same indications for use as the cleared predicate. The ControlRad™ Trace Model 9 is identical in construction to the predicate with the only modifications being the design differences to work with OEC® 9900 Elite. The performance data demonstrates that the ControlRad™ Trace Model 9 is at least as safe and effective as the predicate and reference devices and is substantially equivalent to the predicate and reference devices. A comparison table of technological characteristics of the ControlRad™ Trace Model 9 device for use with OEC® 9900 Elite compared to those of the predicates is provided below:

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Image /page/7/Picture/0 description: The image shows the logo for ControlRad. The word "CONTROL" is in a bold, sans-serif font in a dark teal color. To the right of the word "CONTROL" is the word "RAD" in a lighter green color, with a circle around it that is also green. The letters "RAD" are also in a bold, sans-serif font.

| Device
Feature
510(k) Number | ControlRad, Inc's
ControlRad™ Trace
Model 9
(Subject Device)
K200663 | ControlRad, Inc's
ControlRad™ Trace
Model 8
(K183109)
(Predicate Device)
K183109 | GE Healthcare
Surgery's
OEC 9900 Elite
(K122234)
(Reference)
K122234 | |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|
| Device Class | Class II | Class II | Class II | |
| Product Codes | Primary: OWB
Secondary: OXO, JAA | Primary: OWB
Secondary: OXO, JAA | Primary: OWB
Secondary: OXO, JAA | |
| Regulation Number | 21 CFR §892.1650 | 21 CFR §892.1650 | 21 CFR §892.1650 | |
| Indications for use | The ControlRad™ Trace Model
9, when used with OEC® 9900
Elite, is indicated to provide
fluoroscopic and spot-film
imaging of the patient during
diagnostic, surgical, and
interventional procedures while
reducing patients and clinicians'
radiation exposure (Dose Area
Product) outside of the
ControlRad Trace's region of
interest (ROI) as compared to
OEC® 9900 Elite non-
collimated image area.1 The
ControlRad Trace semi-
transparent filter should not be
used in lieu of the OEC® 9900
Elite'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 cholangiography.
endoscopic, urologic,
orthopedic, neurologic,
vascular, cardiac, critical care
and emergency room
procedures.
1Relative to open Field of View
(FOV), the ControlRad Trace
Model 9 reduces at least 50% of
the Dose Area Product at 50
kVp and ROI with width and
length that are smaller than 1/3
the diameter of the full FOV. | The ControlRad™ Trace Model
8, when used with OEC®
9800/OEC® 9800 Plus, is
indicated to provide
fluoroscopic and spot-film
imaging of the patient during
diagnostic, surgical, and
interventional procedures while
reducing patients and clinicians'
radiation exposure (Dose Area
Product) outside of the
ControlRad Trace's region of
interest (ROI) as compared to
the OEC® 9800/OEC® 9800
Plus non-collimated image
area.1 The ControlRad Trace
semi-transparent filter should
not be used in lieu of the
OEC® 9800/OEC® 9800 Plus'
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 cholangiography,
endoscopic, urologic,
orthopedic, neurologic,
vascular, cardiac, critical care
and emergency room
procedures.
1Relative to open Field of View
(FOV), the ControlRad Trace
Model 8 reduces at least 50%
of the Dose Area Product at 50
kVp and ROI with width and
length that are smaller than 1/3
the diameter of the full FOV. | The OEC® 9900 Elite is
designed to provide
fluoroscopic and spot-film
images of the patient during
diagnostic, surgical and
interventional procedures.
Examples of clinical
application may include
cholangiography, endoscopy,
urologic, orthopedic,
neurologic, vascular, cardiac,
critical care and emergency
room procedures. | |
| X-ray Modulation | | | | |
| X-ray Modulation
Component | CR Trace Filter | CR Trace Filter | Iris Collimator and
Semitransparent
Leaf/Leaves Collimator | |
| Device | ControlRad, Inc's
ControlRad™ Trace
Model 9
(Subject Device) | ControlRad, Inc's
ControlRad™ Trace
Model 8
(K183109)
(Predicate Device) | GE Healthcare
Surgery's
OEC 9900 Elite
(K122234)
(Reference) | |
| Feature | | | | |
| X-ray Radiation
Modulation | Reduces X-ray radiation
outside the aperture/ROI
typically by 61% to 97% | Reduces X-ray radiation
outside the aperture/ROI
typically by 61% to
97% | Completely blocks X-
ray radiation outside the
aperture | |
| Aperture shape | Rectangular | Rectangular | Leaf/Leaves:
Rectangular-Like
(2 straight edges and 2
round edges)
Iris: Octagonal. | |
| Aperture Control | Set by the user using the
CR Trace Tablet | Set by the user using the
CR Trace Tablet | Set by the user using the
Collimator Control
buttons on GE
Healthcare Surgery's
OEC® 9900 Elite's c-
arm unit control panel | |
| Image Processing | | | | |
| Image Area
Processed | Image area outside the
ROI | Image area outside the
ROI | Entire Image | |
| Processing Bits | 12 bits | 12 bits | 12 bits | |
| Processing Rate | 30 fps | 30 fps | 30 fps | |
| Processing
Occurrence | Only when the CR
Trace Filter is engaged | Only when the CR
Trace Filter is engaged | At all times | |
| Image Layout
Information | Dose Area Product
(DAP) value and/or
percentage of DAP
reduction when using
ControlRad Trace Filter
and/or OEC Collimators
ROI frame border | Dose Area Product
(DAP) value and/or
percentage of DAP
reduction when using
ControlRad Trace Filter
and/or OEC Collimators
ROI frame border | Hospital, Physician and
Patient's name, date and
time, X-ray Generator's
voltage and current
settings, Brightness and
Contrast settings,
Magnification level,
Accumulated Exposure
Time per Examination,
Accumulated Air Kerma | |
| Parameters Accuracy Specifications | Dose Area Product
(DAP) Accuracy for
total x-ray field of
the ControlRad
Trace Filter and
OEC systems
combined* | *Overall: ±35%
For DAP reported by
ControlRad™ Trace
Model 9 | *Overall: ±35%
For DAP reported by
ControlRad™ Trace
Model 8 | Overall accuracy: ±40%
(with Iris Field and
Sutter Field > 5cm). |
| Electrical Requirements | Electrical
Requirements | 60 / 50 Hz; 120 VAC
(±10%), 15A | 60 / 50 Hz; 120 VAC
(±10%), 15A | 60 / 50 Hz; 120 VAC
(±10%), 15A |
| Device
Feature | ControlRad, Inc's
ControlRad™ Trace
Model 9
(Subject Device) | ControlRad, Inc's
ControlRad™ Trace
Model 8
(K183109)
(Predicate Device) | GE Healthcare
Surgery's
OEC 9900 Elite
(K122234)
(Reference) | |
| | 200/220/230/240VAC
(±10%), 10A. | 200/220/230/240VAC
(±10%), 10A. | 200/220/230/240VAC
(±10%), 10A. | |

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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 "RAD" in a lighter green font. To the right of the word "RAD" is a green circle that is broken into two parts, with the top part being a lighter green and the bottom part being a darker green. The letters "RAD" are partially inside the circle.

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Image /page/9/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 green circle with a break in the upper right quadrant. The circle is made up of two shades of green, with the darker shade on the bottom and the lighter shade on the top.

Performance Data

ControlRad conducted the following performance tests to demonstrate that the ControlRad"" Trace Model 9 for use with GE Healthcare Surgery's OEC® 9900 Elite complies with performance standards, functions as intended and is at least as safe and effective as the predicate GE Healthcare Surgery's OEC® 9900 Elite:

. Impact on Air Kerma Test was performed in order to evaluate the impact of the ControlRad™ Trace Model 9 on Air Kerma (AKR) measurements of GE Healthcare Surgery's OEC 9900 Elite.
Dose-Area-Product (DAP) calculation accuracy test was performed to demonstrate that . DAP calculations of the ControlRad™ Trace Model 9 when installed in GE Healthcare Surgery's OEC 9900 Elite system are within ±35% of measured DAP values.
. DAP Reduction Accuracy Test was performed to demonstrate the ControlRad™ Trace Model 9 when installed on the OEC 9900 Elite reduces at least 50% of the DAP at 50kVp and ROI with width and length are smaller than 1/3 the diameter of the full FOV.
Dose-Area-Product (DAP) Reduction Accuracy Test was performed to demonstrate that . DAP Reduction calculations of the ControlRad™ Trace Model 9 when installed in GE Healthcare Surgery's OEC 9900 Elite system are within ±35% of the DAP Reduction values.
ControlRad Trace Filter Attenuation Test was performed to evaluate the attenuation level . of the filters of the ControlRad™ Trace Model 9.
. Comparative Image Quality inside the ROI Test was performed to demonstrate that the image quality of the OEC 9900 Elite with installed ControlRad Trace Model 8 within the ROI is of at least the same image quality compared to the image quality of the OEC 9900 Elite alone.
Comparative Image Quality outside the ROI Test was performed in order to evaluate the . filtered image quality outside the ROI of the OEC 9900 Elite with installed ControlRad Trace Model 9 in the periphery image outside the ROI compared to the image quality of the OEC 9900 Elite alone.
. Image Quality Clinical Simulations was preformed to evaluate the image quality inside and outside the ROI and the ability of the filtered image outside the ROI to provide image

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Image /page/10/Picture/0 description: The image shows the logo for ControlRad. The logo consists of the word "CONTROL" in a teal sans-serif font, followed by the word "RAD" in the same font but with a green gradient. To the right of the word "RAD" is a circular graphic with a green gradient, and the letters "TM" in a small font.

context to the ROI, of a clinically simulated image obtained by the GE Healthcare Surgery's OEC® 9900 Elite with installed ControlRad™ Trace Model 9.

Touch-In-Gloves Bench Test was performed in order to demonstrate that the CR Trace . Tablet's touchscreen operates as intended when using sterile radiation protective gloves and touchscreen drape.
. Filter motion reliability testing was performed due to changes in assembly of the Trace 9 filter.
. Wireless Technology and Cybersecurity Evaluation was performed in order to evaluate the ControlRad™ Trace Model 9's compliance with the requirements set forth in FDA Guidance documents titled "Radio Frequency Wireless Technology in Medical Devices" and "Postmarket Management of Cyber Security in Medical Devices".
. Due to weight changes with the workstation, an instability test was performed to ensure compliance with IEC 60601-1 Instability in transport position and Instability from horizontal and vertical forces clauses.

In all performance tests the ControlRad™ Trace Model 9 system when installed in GE Healthcare Surgery's OEC® 9900 Elite system performed and functioned as intended and observations were as expected.

Performance Standards

The ControlRad™ Trace Model 9 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 Requirements for Basic . Safety and Essential Performance - Collateral Standard: Usability
IEC 62304 Medical device software Software life cycle processes .
FDA 21 CFR 1020.30-32 Federal Performance Standard for Diagnostic X-ray Systems .

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Image /page/11/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. To the right of the word "RAD" is a circular design with two shades of green, creating a visual element that complements the text. The letters are in a sans-serif font, giving the logo a modern and clean appearance.

Substantial Equivalence

The ControlRad™ Trace Model 9 is a line extension of the Trace Model family of products (K183109) and is installed on the GE Healthcare Surgery's OEC® 9900 Elite (K122234). The ControlRad™ Trace Model 9 is technological identical to Trace Model 8 with the exception of software modifications necessary for Trace Model 9 to be compatible with the GE Healthcare Surgery's OEC® 9900 Elite (K122234); however, those technological differences do not raise different questions of safety and effectiveness. Performance data demonstrate including filter reliability testing and instability testing confirmed that the ControlRad™ Trace Model 9 is at least as safe and effective as the GE Healthcare Surgery's OEC® 9900 Elite (K122234). In conclusion, the ControlRad™ Trace Model 9 when used with GE Healthcare Surgery's OEC® 9900 Elite is substantially equivalent to that predicate devices.