(186 days)
NuVasive, LessRay™ (K123226)
No
The summary does not mention AI, ML, deep learning, or any related terms. The device description focuses on hardware components and software/firmware for controlling radiation output based on a defined region of interest, which is a rule-based or algorithmic approach, not necessarily AI/ML. There is no mention of training or test data sets, which are typical for AI/ML models.
No
The device is indicated to provide fluoroscopic and spot-film imaging for diagnostic, surgical, and interventional procedures, with the primary function of reducing radiation exposure during these imaging processes. It does not actively treat or cure any medical condition.
No
The device is an accessory that helps reduce radiation exposure during fluoroscopic and spot-film imaging. It is an image optimization and dose reduction tool, not a device that directly performs diagnostic functions. The "diagnostic" procedures mentioned in the Intended Use refer to the context in which the imaging (produced by the OEC® 9800/OEC® 9800 Plus system) is used, not the function of the ControlRad™ Trace itself.
No
The device description explicitly lists hardware components such as a "ControlRad Trace Tablet," "ControlRad Trace Filter," and "ControlRad Hardware."
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The ControlRad™ Trace Model 8 is an accessory for an X-ray system (OEC® 9800/OEC® 9800 Plus). Its primary function is to reduce radiation exposure during imaging procedures by adjusting 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.
- Device Description: The description details hardware components related to X-ray filtering and control, not laboratory testing equipment.
- Input Modality: The input modality is "Fluoroscopic x-ray," which is an imaging technique, not a method for analyzing biological samples.
The device is a medical imaging accessory designed to improve the safety of X-ray procedures by managing radiation dose. It does not perform any diagnostic tests on biological samples.
N/A
Intended Use / Indications for Use
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. 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, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
1 Relative 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.
Product codes
OWB. OXO, JAA
Device Description
The ControlRad™ Trace Model 8 is an accessory to the cleared OEC 9800/OEC 9800 Plus system. The ControlRad™ Trace Model 8 accessory installed in the OEC 9800/OEC 9800 Plus is a system used to assist trained clinicians. The system 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 9800/OEC 9800 Plus non-collimated image area. The ControlRad™ Trace Model 8 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™ Trace Model 8 consists of the following main components: ControlRad Trace Tablet, ControlRad Trace Filter, ControlRad Hardware, ControlRad Software and Firmware Modules and ControlRad Communication Interface.
The ControlRad™ Trace Model 8 components are installed semi-permanently in the cleared OEC 9800/OEC 9800 Plus, and operate in parallel to the OEC 9800/OEC 9800 Plus. The ControlRad" Trace Model 8 components provide the following functionalities:
- The ControlRad Trace Tablet provides the user operational control of the ControlRad" ● Trace Model 8 device via a Graphical User Interface ("GUI"). The ControlRad Trace Tablet enables the clinician to select a Region of Interest ("ROI") on the image displayed on the ControlRad Trace Tablet, which is the image that is displayed on the OEC 9800/OEC 9800 Plus's live monitor.
- · The ControlRad Trace Filter is installed on top of the OEC 9800/OEC 9800 Plus's collimator. The ControlRad Trace Filter does not affect or modify the functionality of the OEC collimator. The ControlRad 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 8 and between the ControlRad™ Trace Model 8 and the OEC 9800/OEC 9800 Plus.
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
Clinicians, diagnostic, surgical, and interventional procedures, critical care and emergency room procedures settings.
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)
ControlRad conducted the following performance tests to demonstrate that the ControlRad"" Trace Model 8 for use with OEC 9800/OEC 9800 Plus complies with performance standards, functions as intended and is at least as safe and effective as the predicate GE Healthcare Surgery's OEC 9800 Plus:
- Impact on Air Kerma Test was performed in order to evaluate the impact of the ControlRad™ Trace Model 8 on actual Air Kerma (AKR) of the OEC 9800/OEC 9800 Plus.
- DAP calculation accuracy test was performed to demonstrate that DAP calculations of the . ControlRad™ Trace Model 8 when installed in OEC 9800/OEC 9800 Plus system are within ±35% of measured DAP values.
- . DAP Reduction Test was preformed to demonstrate that the ControlRad™ Trace Model 8 when installed in the OEC 9800/OEC 9800 Plus system reduces at least 50% of the DAP at 50 kVp and ROI with width and length that are smaller than 1/3 the diameter of the full FOV.
- DAP Reduction Accuracy Test was performed to demonstrate that DAP Reduction . calculations of the ControlRad™ Trace Model 8 when installed in OEC 9800/OEC 9800 Plus system are within ±35% of measured DAP Reduction values.
- ControlRad Trace Filter Attenuation Test was performed to evaluate the attenuation level . of the filters of the ControlRad™ Trace Model 8.
- . Comparative Image Quality Inside the ROI Test was performed to demonstrate that the image quality of the OEC 9800/OEC 9800 Plus with installed ControlRad Trace Model 8 within the ROI is of at least with the same image quality compared to the image quality of the OEC 9800/OEC 9800 Plus alone.
- Comparative Image Quality Outside the ROI Test was performed in order to evaluate the . filtered image quality outside the ROI of the OEC 9800/OEC 9800 Plus with installed ControlRad Trace Model 8 in the periphery image outside the ROI compared to the image quality of the OEC 9800/OEC 9800 Plus 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 context to the ROI, of a clinically simulated image obtained by the OEC 9800/OEC 9800 Plus with installed ControlRad™ Trace Model 8.
- . Touch-In-Gloves Bench Test was performed in order to demonstrate that the ControlRad Trace Tablet's touchscreen operates as intended when using sterile radiation protective gloves and touchscreen drape.
- . Wireless Technology and Cybersecurity Evaluation was performed in order to evaluate the ControlRad™ Trace Model 8'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".
In all performance tests the ControlRad™ Trace Model 8 system when installed in OEC 9800/OEC 9800 Plus system performed and functioned as intended and observations were as expected.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Dose Area Product (DAP) accuracy: Overall: ±35% (for DAP reported by ControlRad™ Trace Model 8)
Predicate Device(s)
GE Healthcare Surgery, OEC® 9800 Plus (K132027)
Reference Device(s)
NuVasive, LessRay™ (K123226)
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".
May 13, 2019
ControlRad, Inc. % Sasha Gelfand QA/RA Director ControlRad, Ltd. 20 HaTaas St. Kfar Saba, 4442520 ISRAEL
Re: K183109
Trade/Device Name: ControlRad™ Trace Model 8 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: OWB. OXO, JAA Dated: March 28, 2019 Received: April 1, 2019
Dear Sasha Gelfand:
We have reviewed vour 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
1
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 and Part 809); 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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K183109
Device Name ControlRad™ Trace Model 8
Indications for Use (Describe)
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. 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, orthopedic, neurologic, vascular, cardiac, critical care and emergency room procedures.
1 Relative 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Ise (Part 21 CER 801 Subnart D) | Over_The_Counter I Isa (21 CER 801 Subnart C) |
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3
510(k) SUMMARY
ControlRad, Inc's ControlRad™ Trace Model 8
- Applicant's name: ControlRad, Inc. 150 N. Radnor Chester Road Suite F-200 Radnor, PA 19087, USA P: +1 610 977 2422
- Sasha Gelfand Contact Person: QA&RA Director ControlRad, Ltd. 20, Hataas Street, Kfar Saba, 4442520, Israel P: +972 72 2512469
- Date Prepared: March 21, 2019
- Name of Device: ControlRad™ Trace Model 8
- Common or Usual Name: Accessory to Image-Intensified Fluoroscopic X-ray System
- Classification: Classification Regulation No: 21 CFR §892.1650 Classification Name: Image-intensified fluoroscopic x-ray system Regulation Class: II Classification Panel: Radiology OWB - Interventional fluoroscopic x-ray system Product Code: Primary: Secondary: OXO - Image-Intensified Fluoroscopic X-ray System, Mobile; JAA - System, x-ray, fluoroscopic, image-intensified Predicate Device: GE Healthcare Surgery, OEC® 9800 Plus (K132027)
- Reference Device: NuVasive, LessRay™ (K123226)
4
Indications for Use
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, vascular, cardiac, critical care and emergency room procedures.
1 Relative 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.
Device Description
The ControlRad™ Trace Model 8 is an accessory to the cleared OEC 9800/OEC 9800 Plus system. The ControlRad™ Trace Model 8 accessory installed in the OEC 9800/OEC 9800 Plus is a system used to assist trained clinicians. The system 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 9800/OEC 9800 Plus non-collimated image area. The ControlRad™ Trace Model 8 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 8 consists of the following main components: ControlRad Trace Tablet, ControlRad Trace Filter, ControlRad Hardware, ControlRad Software and Firmware Modules and ControlRad Communication Interface.
The ControlRad™ Trace Model 8 components are installed semi-permanently in the cleared OEC 9800/OEC 9800 Plus, and operate in parallel to the OEC 9800/OEC 9800 Plus. The ControlRad" Trace Model 8 components provide the following functionalities:
- The ControlRad Trace Tablet provides the user operational control of the ControlRad" ● Trace Model 8 device via a Graphical User Interface ("GUI"). The ControlRad Trace Tablet
5
enables the clinician to select a Region of Interest ("ROI") on the image displayed on the ControlRad Trace Tablet, which is the image that is displayed on the OEC 9800/OEC 9800 Plus's live monitor.
- · The ControlRad Trace Filter is installed on top of the OEC 9800/OEC 9800 Plus's collimator. The ControlRad Trace Filter does not affect or modify the functionality of the OEC collimator. The ControlRad 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 8 and between the ControlRad™ Trace Model 8 and the OEC 9800/OEC 9800 Plus.
Principles of Operation
The OEC 9800/OEC 9800 Plus provides an image that its boundaries are defined by the OEC 9800/OEC 9800 Plus'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 8.
Within the OEC 9800/OEC 9800 Plus 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 OEC 9800/OEC 9800 Plus; and
- · The image outside the clinician-selected ROI (filtered radiation area in the FOV), which has a lower-dose processed image, providing peripheral image context to the ROI.
The OEC 9800/OEC 9800 Plus'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 OEC 9800/OEC 9800 Plus's image FOV is limited to the noncollimated region. The ControlRad Trace Filter can be used along with the OEC 9800/OEC 9800 Plus'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.
6
The clinician has the option not to use the ControlRad Trace Filter. In this case, the OEC 9800/OEC 9800 Plus operates as if the ControlRad Trace Filter was not present. Comparison of Technological Characteristics with the Predicate Device
The ControlRad™ Trace Model 8 for use with OEC 9800/OEC 9800 Plus has the same intended use and the same indications for use of the cleared predicate/parent device, except for the inclusion of the subject accessory's specific function of radiation exposure reduction, which does not affect/modify the predicate parent device's cleared indications for use.
The ControlRad™ Trace Model 8 has different components and thus different technological characteristics than the OEC 9800/OEC 9800 Plus. However, those technological differences do not raise different questions of safety and effectiveness as this accessory raises the same questions as the cleared parent device's collimator component with respect to the system's image FOV, image quality, and radiation emissions. FDA's clearance of Nuvasive's 510(k)-cleared Lessray System (K173314) ("Lessray"), which is an accessory to fluoroscopic systems and a reference device, shows that acceptable methods exist for evaluating whether those technological differences impact the safety and/or effectiveness of the parent device. The performance data demonstrates that the ControlRad™ Trace Model 8 for use with OEC 9800/OEC 9800 Plus is at least as safe and effective as the OEC 9800 Plus. Thus, the ControlRad™ Trace Model 8 when used with OEC 9800/OEC 9800 Plus is substantially equivalent to that parent/predicate device.
A comparison table of technological characteristics of the ControlRad™ Trace Model 8 accessory device for use with GE Healthcare Surgery's OEC 9800 Plus (K132027) compared to those of the predicate/parent device is provided below:
7
| Feature | ControlRad, Inc's
ControlRad™ Trace Model 8
(Subject Device) | GE Healthcare Surgery's
OEC 9800 Plus (K132027)
(Predicate Device) |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K183109 | K132027 |
| Device Class | Same | Class II |
| Product Codes | Same | Primary: OWB
Secondary: OXO, JAA |
| Regulation Number | Same | 21 CFR §892.1650 |
| Indications for use | 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.
1 Relative 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 9800 Plus is designed to
provide fluoroscopic and spot-film
imaging of the patient during diagnostic,
surgical and interventional procedures.
Clinical application may include
cholangiography, endoscopy,
urologic, orthopedic, neurologic,
vascular, cardiac, critical care and
emergency room procedures. |
| X-ray Modulation | | |
| X-ray Modulation
Component | ControlRad Trace Filter | Iris Collimator and Leaves Collimator |
| X-ray Radiation
Modulation | Reduces X-ray radiation outside the
aperture/ROI typically by 61% to 97% | Completely blocks X-ray radiation
outside the aperture |
| Aperture shape | Rectangular | Leaf/Leaves: Rectangular-Like
(2 straight edges and 2 round edges)
Iris: Octagonal. |
| Aperture Control | Set by the user using the ControlRad Trace
Tablet | Set by the user using the Collimator
Control buttons on OEC 9800 Plus's C-
arm unit control panel |
| Device
Feature | ControlRad, Inc's
ControlRad™ Trace Model 8
(Subject Device) | GE Healthcare Surgery's
OEC 9800 Plus (K132027)
(Predicate Device) |
| | Image Processing | |
| Image Area Processed | Image area outside the ROI | Entire Image |
| Processing Bits | Same | 12 bits |
| Processing Rate | Same | 30 fps |
| Processing
Occurrence | Only when the ControlRad 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; | 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 | Overall: ±35%
For DAP reported by ControlRad™ Trace
Model 8 | Overall accuracy: ±40%
(with Iris Field and Sutter Field > 5cm). |
| Electrical Requirements | | |
| Electrical
Requirements | Same | 60/50 Hz; 120 VAC (±10%), 15A
200/220/230/240VAC (±10%), 10A. |
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Performance Data
ControlRad conducted the following performance tests to demonstrate that the ControlRad"" Trace Model 8 for use with OEC 9800/OEC 9800 Plus complies with performance standards, functions as intended and is at least as safe and effective as the predicate GE Healthcare Surgery's OEC 9800 Plus:
- Impact on Air Kerma Test was performed in order to evaluate the impact of the ControlRad™ Trace Model 8 on actual Air Kerma (AKR) of the OEC 9800/OEC 9800 Plus.
- DAP calculation accuracy test was performed to demonstrate that DAP calculations of the . ControlRad™ Trace Model 8 when installed in OEC 9800/OEC 9800 Plus system are within ±35% of measured DAP values.
- . DAP Reduction Test was preformed to demonstrate that the ControlRad™ Trace Model 8 when installed in the OEC 9800/OEC 9800 Plus system reduces at least 50% of the DAP at 50 kVp and ROI with width and length that are smaller than 1/3 the diameter of the full FOV.
9
- DAP Reduction Accuracy Test was performed to demonstrate that DAP Reduction . calculations of the ControlRad™ Trace Model 8 when installed in OEC 9800/OEC 9800 Plus system are within ±35% of measured DAP Reduction values.
- ControlRad Trace Filter Attenuation Test was performed to evaluate the attenuation level . of the filters of the ControlRad™ Trace Model 8.
- . Comparative Image Quality Inside the ROI Test was performed to demonstrate that the image quality of the OEC 9800/OEC 9800 Plus with installed ControlRad Trace Model 8 within the ROI is of at least with the same image quality compared to the image quality of the OEC 9800/OEC 9800 Plus alone.
- Comparative Image Quality Outside the ROI Test was performed in order to evaluate the . filtered image quality outside the ROI of the OEC 9800/OEC 9800 Plus with installed ControlRad Trace Model 8 in the periphery image outside the ROI compared to the image quality of the OEC 9800/OEC 9800 Plus 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 context to the ROI, of a clinically simulated image obtained by the OEC 9800/OEC 9800 Plus with installed ControlRad™ Trace Model 8.
- . Touch-In-Gloves Bench Test was performed in order to demonstrate that the ControlRad Trace Tablet's touchscreen operates as intended when using sterile radiation protective gloves and touchscreen drape.
- . Wireless Technology and Cybersecurity Evaluation was performed in order to evaluate the ControlRad™ Trace Model 8'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".
In all performance tests the ControlRad™ Trace Model 8 system when installed in OEC 9800/OEC 9800 Plus system performed and functioned as intended and observations were as expected.
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Performance Standards
The ControlRad™ Trace Model 8 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 1-2. 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 o
Substantial Equivalence
The ControlRad™ Trace Model 8 for use with OEC 9800/OEC 9800 Plus has the same intended use and the same indications for use of the cleared predicate/parent device (K132027), except for the inclusion of the subject accessory's specific function exposure reduction, which does not affect/modify the predicate parent device's cleared indications for use. The ControlRad™ Trace Model 8 has different technological characteristics than the GE Healthcare Surgery's OEC 9800 Plus (K132027), however those technological differences do not raise different questions of safety and effectiveness. Performance data demonstrate that the ControlRad™ Trace Model 8 for use with OEC 9800/OEC 9800 Plus is at least as safe and effective as the OEC 9800 Plus (K132027). Thus, the ControlRad™ Trace Model 8 when used with OEC 9800/OEC 9800 Plus is substantially equivalent to that parent/predicate device.