(171 days)
No
The description mentions "Auto-ROI Processor" and "auto collimation" which suggests automated image processing, but there is no mention of AI, ML, or related terms like neural networks or deep learning. The performance testing described focuses on phantom studies and comparison to a predicate device, not on training or validation of an AI/ML model.
No
The device is described as an accessory to an x-ray imaging system, designed to manage exposure and enhance imaging quality during diagnostic and interventional procedures, not to treat a disease or condition.
No
The device is an optional accessory to a radiographic/fluoroscopic imaging system. Its stated purpose is to provide an automated Region of Interest for managing exposure and to improve image quality for interventional procedures, but it does not directly diagnose conditions. The original system it attaches to (Omega's CS-series-FP) is described as being for "diagnostic" applications, but the CA-100S itself is a modification device to that system.
No
The device description explicitly lists hardware components such as a Shutter, ROI Electronics Unit, Auto-ROI Processor, two ROI Control Panels, and a Monitor. It is described as a "secondary fast collimator system" which is a physical component.
Based on the provided text, 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 about a person's health.
- Device Function: The description clearly states that this device is an optional secondary fast collimator system used with a radiographic/fluoroscopic x-ray system. Its purpose is to manage exposure to the patient and operator by defining a Region of Interest (ROI) during imaging procedures.
- Intended Use: The intended use is for radiographic applications including cardiac, vascular, general radiographic/fluoroscopic diagnostic, and interventional x-ray imaging. These are all imaging procedures performed directly on the patient, not on specimens taken from the patient.
The device is an accessory to an imaging system used for diagnostic and interventional procedures performed in vivo (within the living body), not in vitro (in glass, referring to laboratory testing of specimens).
N/A
Intended Use / Indications for Use
The Omega Medical Imaging, LLC CS-series-FP (SSXI) systems with optional accessory device CA-100S as a modification device to provide an automated Region of interest that manages exposure to the patient and operator. The system is intended for use in Radiographic applications including cardiac, vascular, general radiographic/ fluoroscopic diagnostic, and interventional x-ray imaging for General Populations.
At no time will the CA-100S be considered as a replacement for the primary collimator shall always be used, in accordance with good medical practice, to define a Region of Interest
Product codes (comma separated list FDA assigned to the subject device)
JAA, OWB
Device Description
This 510(k) submission is for the addition of an optional secondary fast collimator system (Model: CA-100S). The CA-100S will only be used with the following FDA cleared device: Omega's CSseries-FP ( K121293). The-CA-100S system is composed of a Shutter, a ROI Electronics Unit, an Auto-ROI Processor, two ROI Control Panels and a Monitor (See Figure 1).
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
Not Found
Indicated Patient Age Range
General Populations
Intended User / Care Setting
The system is intended to be installed by trained technicians and operated by professionals trained in its use and the associated medical 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)
SE was determined on Bench performance testing. Included in this report is detailed data comparing performance with the existing Omega Medical Imaging CS-series-FP system utilizing the CA-100S integrated into an existing system. The tests that were performed utilized commercially available Phantoms such as the Phillips Phantom, and including a fabricated Moving Catheter to exercise the auto ROI functionality.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
March 29, 2019
Image /page/0/Picture/1 description: The image contains the logos of the Department of Health and Human Services (HHS) and the Food and Drug Administration (FDA). The HHS logo is on the left, featuring an abstract symbol. To the right is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" and "ADMINISTRATION" in blue text.
Omega Medical Imaging, LLC % Mr. John Newman Manager of Quality and Regulatory Affairs 675 Hickman Circle SANFORD FL 32771
Re: K182834
Trade/Device Name: CS-Series-FP Radiographic Fluroscopy System with Optional Accessory Device CA-100S (ROI Assembly) Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: JAA, OWB Dated: February 18, 2019 Received: February 21, 2019
Dear Mr. Newman:
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/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 medical devices and radiation-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,
Michael D. O'Hara For
Thalia Mills, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K182834
Device Name
CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA-100S (ROI Assembly)
Indications for Use (Describe)
The Omega Medical Imaging, LLC CS-series-FP (SSXI) systems with optional accessory device CA-100S as a modification device to provide an automated Region of interest that manages exposure to the patient and operator. The system is intended for use in Radiographic applications including cardiac, vascular, general radiographic/ fluoroscopic diagnostic, and interventional x-ray imaging for General Populations.
At no time will the CA-100S be considered as a replacement for the primary collimator shall always be used, in accordance with good medical practice, to define a Region of Interest
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) |
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 agency 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."
3
Image /page/3/Picture/0 description: The image shows the logo for Omega Medical Imaging. The logo consists of a blue stylized "O" on the left, followed by the text "OMEGA MEDICAL" in a sans-serif font. Below "OMEGA MEDICAL" is the word "IMAGING" in a smaller font, with a line on either side.
Traditional 510(k) SUMMARY for K182834
| Company Name: | Omega Medical Imaging, LLC | |||
|---|---|---|---|---|
| Address: | 675 Hickman Cir, Sanford, FI 32771 | |||
| Telephone No: | 407-323-9400 | |||
| Registration No: | 1052701 | |||
| Contact person: | John Newman (Manager of Regulatory Affairs) | |||
| Date Prepared: | 02/13/2019 | |||
| Device (trade) name: | CS-series-FP Radiographic / Fluoroscopic Systems with Optional CA- | |||
| 100S (ROI Assembly) | ||||
| Common/usual name: | Fluoroscopic/Radiographic X-ray system | |||
| Classification Name: | Image-intensified Fluoroscopic x-ray system | |||
| Classification Panel: | Radiology | |||
| CFR section: | 892.1650 | |||
| Device Class: | Class II | |||
| Primary Product code: | JAA | |||
| Secondary product code: | OWB | |||
| Predicate Device K121293 | ||||
| Company Name: | Omega Medical Imaging, LLC | |||
| Address: | 675 Hickman Circle, Sanford, Florida 32771 | |||
| Telephone No: | 407-323-9400 | |||
| Registration No: | 1052701 | |||
| Contact person: | Brian J. Fleming | |||
| Date Prepared: | 04/20/2012 | |||
| Device (trade) name: | CS-series-FP with 3030+ Option radiographic/fluoroscopy system | |||
| Common/usual name: | Image Intensified Fluoroscopic/Radiographic X-ray system | |||
| Classification Name: | Image-intensified fluoroscopic x-ray system | |||
| Classification Panel: | Radiology | |||
| CFR section: | 892.1650 |
4
| Device Class: | Class II |
|---|---|
| Product code: | JAA and OWB |
Predicate Device(s):
- Omega Medical Imaging CS-series-FP (K121293)
Reference Device:
Toshiba Infinix Spot Fluoroscopy (K113052)
| Trade Name: | INFX-8000C [Infinix-CCi] |
|---|---|
| Common Name: | Solid State X-ray System, Interventional |
| Device Classification: | Class II (per 21 CFR 892.1650) |
| Product Code / Description: | MQB |
Device description:
This 510(k) submission is for the addition of an optional secondary fast collimator system (Model: CA-100S). The CA-100S will only be used with the following FDA cleared device: Omega's CSseries-FP ( K121293). The-CA-100S system is composed of a Shutter, a ROI Electronics Unit, an Auto-ROI Processor, two ROI Control Panels and a Monitor (See Figure 1) .
Conventional Collimation
Image /page/4/Picture/9 description: The image is a black and white X-ray. The X-ray shows a medical device that appears to be a catheter or lead wire inserted into a body cavity, possibly the heart or a major blood vessel. The device has several dark, radiopaque markers along its length, which are used to visualize its position under X-ray. The surrounding tissue and bone structure are visible in varying shades of gray, providing context for the device's placement within the body.
CA-100S Auto ROI
Image /page/4/Picture/11 description: The image is a black and white x-ray. The x-ray shows a medical device that is implanted in a person's chest. The device has wires that are connected to the heart. A white box is drawn around the lower right portion of the image to highlight the device.
Optimized Dose Reduction: Advanced Auto Collimation
Omega's (CA-100S) allows for auto collimation while maintaining a perspective of surrounding anatomy. The blended image incorporates a lower frequency refresh of the peripheral image area. This combined image (live fluoroscopy of ROI + background refreshed at a rate of once or twice per second) increases the quality of information presented during interventional procedures.
- Image quality is improved via auto-collimation resulting in a reduced FOV and subsequently less X-ray scatter.
- Anatomical landmarks and devices visible outside the Region of Interest (ROI) provide important clinical . information which are viewed at a reduced exposure level.
- . The CA-100S can be sized and positioned in manual mode, as opposed to conventional collimation, which is generally limited to positioning about the center of the image.
- Auto ROI automatically follows the movement of devices i.e. endoscopes, catheters, etc., minimizing distraction and input requirements for the operator.
5
Image /page/5/Picture/0 description: This image shows a diagram of an X-ray machine and its components. The diagram includes labels for the secondary collimator CA-100S, X-ray tube, primary collimator, ROI control panels, ROI electronics unit (1), auto ROI processor (2), monitor (5), and network connections (3, 4, A, B). The diagram is labeled as "Figure 1".
During a fluoroscopy procedure, the physician's attention is focused on a narrow region of interest (ROI) or a small reqion within the full field of view after collimating down to an area that will best suit the procedure with the primary collimator. (Figure 2)
Image /page/5/Picture/2 description: This image shows a medical x-ray. There are two visible wires or tubes that are inserted into the body. The wires are thin and dark, and they appear to be connected to some sort of device. The image is grayscale, and the background is blurry.
Image /page/5/Picture/3 description: The image shows a black and white x-ray of a medical device implanted in a patient. The device appears to be a pacemaker or similar cardiac implantable electronic device (CIED). The device is connected to a lead that is inserted into the heart. The image is likely used for medical purposes, such as monitoring the device's function or diagnosing a problem.
Image /page/5/Picture/4 description: This is a grayscale image of a medical procedure, likely an X-ray or fluoroscopy, showing internal structures of the chest. A thin, flexible wire or catheter is visible, snaking through the chest cavity and into the heart. The white square highlights a region of interest, possibly indicating the location of a medical device or area of focus during the procedure. The image suggests a cardiology-related intervention, such as pacemaker placement or electrophysiology study.
Figure 2, Primary / Conventional Collimator Figure 3, Secondary Collimator, CA-100S, Shutter
Figure 4, Blended image from both collimators.
This smaller region of interest (ROI) captured by the secondary collimator (CA-100S) is a small area within the area defined by the pre-existing primary collimator. (See Figure 3) The area outside the ROI receives much less attention by the physician but is exposed. The CA-100S secondary collimator may be used to additionally shield anatomy that is not the primary focus of the physician but is required to maintain peripheral imaging. The CA-100S ROI image processing combines the live ROI with the legacy image of the full field of view (defined by the primary collimator). This allows for the collimation of the ROI without impacting the doctors normal work flow, visualisation, orientation and navigation. (See Figure 4)
The ROI always contains the central beam for accurate calculations of Air Kerma values.
The CA-100S offers additional collimation by shielding parts of the FOV without loss of visual information available to the physician or operator. The host image processing required a minimal software update and the mounting hardware was revised to attach the shutter below the primary collimator as detailed in the Substantial Equivalence section, the X-Ray Generator and Generator Interface are not changed. The system is configured with Omega's permanently floor mounted C-Arm that provides motorized positioning of the x-ray source and image receptor, along with a patient table with options for elevating and tilting.
6
- System components integrated for this option are: ●
- CA-100S secondary collimator Components detailed in Yellow. a.
- Image Processor / Workstation b.
- Associated electrical / electronic / hardware components (See illustration below) C.
Typical system configuration consisting of integrated components such as the X-Ray generator, Image Processor, collimator, X-ray Tube, Positioner and patient table.
Image /page/6/Figure/5 description: The image is a diagram of a CA-100S system, with the CA-100S components highlighted in yellow and the FDA-approved system components in gray. The diagram shows the different components of the system, including the detector, ion chamber, primary collimator, secondary collimator, X-ray tube, ROI controls, ROI electronics unit, auto ROI processor, ROI monitor, live monitor, ref monitor, image processor, primary collimator control, and generator interface/X-ray generator. The diagram also shows the flow of image data and status information between the different components.
7
OPERATION
The CA-100S collimator is installed between the X-ray source and the primary collimator (See Figure 5). The opening of the secondary collimator shutters is adjustable in position. When the secondary collimator shutter function is enabled, only the ROI is continuously exposed and always includes the central beam from the X-ray tube this does not affect Air Kerma rate, Accumulated Air Kerma or Accumulated Fluoro Time as calculations are derived from kV, mA, exposure time and SOD. The secondary collimator shutter periodically opens fully to allow the acquisition of
a FOV frame (defined by the primary collimator) that provides the background peripheral area. The image processing software then provides a combined, or "blended" image comprising the ROI frame and the most recently acquired FOV frame.
The Product is permanently incorporated in the host fluoroscopy system (Omega's CS-series-FP) and its clinical environment. The system is intended to be installed by trained technicians and operated by professionals trained in its use and the associated medical interventional procedures. The CA-100S Product functions in ON Mode, OFF Mode or Bypass Mode. In ON Mode, the secondary collimator shutter is activated, and the images are blended. In OFF Mode, the secondary collimator shutter is not driven, and the shutter blades are retracted fully while the images pass through both collimators without blending images (i.e. all image frames are FQV image frames defined by the primary collimator). In BYPASS Mode, the secondary collimator shutter driver is powered down (all shutter blades are retracted) and all received images bypass the CA 100-S image processing path.
The Product consists of a Shutter, a ROI Electronics Unit, an Auto-ROI Processor with Status / Reduction Monitor and two ROI Control Panels. Their operations are described below.
Image /page/7/Picture/5 description: The image shows a close-up of a robotic arm with a circular platform attached to it. The platform has a square opening in the center, revealing a small object inside. The robotic arm is gray and has a smooth, rounded design, while the platform is silver and has a more angular shape. The image is well-lit and has a shallow depth of field, which helps to focus attention on the robotic arm and platform.
Shutter
The shutter consists of four lead blades that are moved into positions defined by the operator or automatically by the ROI Processor to determine and select the Region of Interest. Each shutter blade is moved by the application of a current which drives its magnetic coil. The electromotive force is counterbalanced by the retracting force of the spring. This current is limited to 1 Amp. The driving voltage is limited to ±30V peak.
The Shutter provides position feedback via low voltage (10V peak) signaling. Power for the feedback circuit is provided externally as 12V, limited to approximately 200mA. When not driven, the shutter is mechanically retracted by strong springs. In this state, it is essentially transparent to the optical path of the Host System.
Neither operators nor patients will come into contact with the shutter.
The enclosure is made of plated steel and aluminum. All moving parts and electrical components are completely enclosed. External electrical connections are made with shielded cables. Electrical components are galvanically isolated from the housing. The shutter and associated cables are enclosed by the housing of the Host System.
8
Image /page/8/Picture/0 description: The image shows a gray electronic device. The device has a rectangular shape with a flat top and a front panel. The front panel has several buttons, switches, and ports. There are also some ventilation holes on the front panel. The device has two metal brackets on either side, each with two holes.
ROI Electronics Unit ("REU")
The REU controls the overall operations of the Product. It receives images from the receptor panel and transmits images to the Host System's image processor. If the received image is an ROI frame, it combines the frame with the background from the most recent FOV frame.
The REU drives the four shutter blades through independent channels and receives position feedback through independent channels. The REU holds the blade positions constant while X-ray emission is in progress. The shutter blades are only moved when there is no X-rav emission.
The REU receives and responds to user inputs via the ROI Control Panels. (See section below for details.)
The REU receives and responds to signals representing the state of a fluoro sequence, the state of X-ray emission, the source-to-image distance, pending or in-progress table movement, flip and rotation offset, and magnification mode.
The REU sends positions of the boundaries of the ROI and the overall operating status to the Host System for display on its main screen.
The REU sends blended images to the Auto-ROI Processor and receives the calculated (recommended) locations for the shutter blades. In auto-ROI mode the REU drives the blades to these locations.
*On detecting conditions that may compromise operations or longevity of the Product, the REU puts the Product in OFF Mode. On detecting conditions that may compromise the image, a loss of communication with, or control over, other modules, the REU puts the Product in Bypass Mode.
The REU is installed in an electronics cabinet. Neither operators nor patients will come into contact with the REU.
The REU's electrical and electronic components are housed in a metallic enclosure. All panels of the enclosure are bonded to each other. A protective earth terminal is provided.
The REU is intended to operate on a 120/240 Vac, 50/60Hz, single-phase output from an uninterruptible power supply. The component power supply unit ("PSU") is
recognized to UL60950-1 and ES60601-1. The Earth terminal of the PSU is bonded to the enclosure.
9
Image /page/9/Picture/0 description: The image contains two identical panels with a screen and several buttons. The buttons are labeled "Video Bypass", "ROI ON/OFF", "Auto/Manual ROI", and "High/Low Reduction". The screen is black and rectangular. The panels are gray and have rounded corners.
ROI Control Panels ("RCP")
A bedside RCP and a control room/booth RCP provide facilities for the user to control the operation of the Product. Four buttons and a trackpad are provided on each RCP to control ROI functionality.
The RCP communicates with the REU over a shielded cable which also carries 12V to power the RCP. The 12V power source provides 2A of current to both RCPs and other circuits drawing on this rail. Each RCP consumes about 100mA.
The RCP's electrical and electronics components are fully enclosed in a metallic enclosure that provides ingress protection aqainst fluids (jets or strong sprays). The trackpad is exposed to touch. The touch surface is tied to the enclosure and isolated from the rest of the circuits. A shielded cable connects the RCP to the REU. The shield of the cable is tied to the enclosure.
Image /page/9/Picture/5 description: The image shows a computer setup with a desktop tower, a monitor, and a network adapter. The desktop tower is labeled with the number 2, and it has a sleek design with red accents. The monitor is labeled with the number 5, and it is connected to the network adapter, which is labeled with the number 4.
Auto-ROI Processor ("ARP")
A dedicated computing device receives and analyzes the processed images from the REU. From these images, the ARP calculates the ROI settings that provide the most useful image to the physician or operator. The ARP also generates display data that indicates the operating status and/or status messages. The ARP communicates with the REU via a single Gigabit Ethernet ("GigE") connection over CAT5E or CAT6 copper cables with magnetic isolation at the connectors.
The ARP is enclosed in a metallic housing and is intended to be installed in a control room or electronics room. It is intended to operate on a 120Vac, 60Hz, single-phase output from an uninterruptible power supply.
10
Mechanical Differences between Predicate devices and System with CA-100S installed:
- Minor mechanical changes to mount the CA-100S Sutter under the Primary Collimator as illustrated in Figure 7.
Image /page/10/Figure/2 description: The image contains two figures, labeled Figure 6 and Figure 7, which show a predicate device and a predicate device with CA-100S installed, respectively. Both figures show the primary collimator and X-Ray tube. Figure 7 also shows the CA-100S shutter, which is labeled as the secondary collimator. The figures appear to be diagrams or schematics of the devices.
11
Software Changes to MX-200 Image Processor for implementation of CA-100S into the predicate devices:
Omega – CA-100S Update
-
- PC Hardware
- a. Add RS232 Port To PC (USB to RS232).
-
- PC Application
- a. Add Setup to select COM Port for RS232.
- b. Set up Serial Port (57600, 8, 1, N) in software.
- c. Add software to send and receive Serial messages.
- i. CRC Message Calculation.
- ii. Decode Received Message.
- iii. Encode Transmit Message.
- d. Add function to receive box coordinates and status from serial port connected to IKOMed system.
- e. Add Function for sending Frame Rate, Rotation, Flip and Mirror Serial Message to IKOMed system.
- Add call to send Frame Rate to IKOMed serial port when frame rate is changed. f.
- g. Add call to send rotation to IKOMed serial port when rotation is changed.
- Add call to send mirror and flip to IKOMed serial port when mirror or flip is changed. h.
- Add call to send frame rate, rotation, mirror and flip to IKOMed serial port when acquisition i. starts.
- Add message to send box coordinates and Status to Embedded. j.
- k. Add message to get box coordinates and Status from Embedded.
- Close IKOMed serial port when application ends. -
3) Embedded
- a. Database Modifications
- i. Modify RECORD to add
-
- Add Left(11(16) bits), Top(11(16) bits), Right(11(16) bits), Bottom(11(16) bits) Positions and Status (4 bits, store in 4 bits from Reserved), Total = 48 bits(6 Bytes).
-
- Why is STUDY LIST, SERIES LIST, AND IMAGE LIST padded by SECTORSIZE-12 ?
-
- Calculate STUDY LIST, SERIES LIST, AND IMAGE LIST to verify they still fit in memory, else reduce MAXIMAGES value.
-
- i. Modify RECORD to add
- b. Software Modifications
- i. Add message to Receive box coordinates and Status from PC.
- ii. Add message to send box coordinates to PC App.
- iii. Add Box Coordinates and status to image database records.
- iv. Add function to display and draw box.
- v. Add function to display status.
12
Reason for Submission:
- Modification of a cleared device.
Comparison with Predicate Devices:
| Indications for use comparison: | ||
|---|---|---|
| 510(k) | ||
| Number and | ||
| Device | ||
| Name | K121293 | |
| CS-series-FP with 3030+ Option | ||
| Radiographic/fluoroscopy system | K182834 (This Submission) | |
| CS-series-FP with optional CA-100S | ||
| Intended | ||
| Use | The Omega Medical Imaging, LLC. CS-series-FP | |
| with 3030+ Option systems are intended for use in | ||
| radiographic/fluoroscopic applications including | ||
| cardiac, vascular, general radiographic/fluoroscopic | ||
| diagnostic, and interventional x-ray imaging. | The Omega Medical Imaging, LLC CS-series-FP | |
| (SSXI) systems with optional accessory device CA- | ||
| 100S as a modification device to provide an | ||
| automated Region of interest that manages exposure | ||
| to the patient and operator. The System is intended | ||
| for use in Radiographic/fluoroscopic applications | ||
| including cardiac, vascular, general | ||
| radiographic/fluoroscopic diagnostic, and | ||
| interventional x-ray imaging for General Populations. | ||
| At no time will the CA-100S be considered as a | ||
| replacement for the primary collimator. The primary | ||
| collimator shall always be used, in accordance with | ||
| good medical practice, to define a Region of Interest | ||
| Classification | ||
| Name: | Image-intensified Fluoroscopic X-ray system | Image-intensified Fluoroscopic X-ray system |
| CFR | ||
| Regulation #: | 892.1650, 892.1600 | 892.1650 |
| Device Class | Class II | Class II |
| Classification | ||
| Product | ||
| Code: | JAA, OWB | JAA, OWB |
PRODUCT OVERVIEW
The CA-100S is a secondary collimator that can only be used in conjunction with the primary collimator. When using the CA-100S, the primary collimator shall be used to manually define a region of interest. Once this ROI has been established by the primary collimator, the CA-100S can be used to further reduce the size of the ROI beyond the ROI initially established with the primary collimator. Due to the reduction in size of the ROI, the CA-100S can offer a reduction in Dose Area Product to patients and medical staff by reducing the area of exposure. At no time will the CA-100S be considered as a replacement for the primary collimator. The primary collimator shall always be used, in accordance with good medical practice, to define a ROI.
13
- · Predicate devices Omega CS-series-FP utilizes only a primary collimator. The collimator can be manually focused on the region of interest and the surrounding FOV (Full field of view) will not exist.
- · The intended use of the modified device (with addition of CA-100S), as described in the labeling, has not changed as a result of the modification for this filling.
Substantial Equivalence:
- SE was determined on Bench performance testing. Included in this report is detailed data comparing performance with the existing Omega Medical Imaging CS-series-FP system utilizing the CA-100S integrated into an existing system. The tests that were performed utilized commercially available Phantoms such as the Phillips Phantom, and including a fabricated Moving Catheter to exercise the auto ROI functionality.
This device is substantially equivalent to Omega Medical Imaging CS-series-FP K121293 marketed by Omega Medical Imaging LLC. The Omega CS-series-FP with Optional accessory device Model CA-100S. The basic system configuration, method of operation, base software and manufacturing process remain unchanged from the cleared device. There are no new indications for use or intended use of the device
Safety information:
- · The Omega CS-series-FP with the CA-100S option systems comply with the applicable requirements of 21 CFR 1020.30, 21 CFR 1020.31, and 21 CFR 1020.32.
- · The Omega CS-series-FP with the CA-100S option systems comply with the international safety standards EN 60601-1, IEC 60601-1-2, IEC 60601-1-4, IEC 60601-1-4, IEC 60601-1-6, IEC 60601-2-54, EN ISO 15223-1 and EN ISO 14971.
- · The Omega CS-series-FP with the CA-100S option systems comply with UL 60601-1 and CAN/USA C22.2 No.601.1-M90
- The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with applicable parts of the IEC60601-1 standards and its collateral standards. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR § 1020, that apply to this device will be met and reported in this initial report.
- . This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR Subchapter J, Federal Diagnostic X-ray Equipment Standard].
Safety is assured through a risk management process and manufacturing is in compliance with the Quality System Requlations
Conclusion:
- The technological characteristics of Omega CS-series-FP with Optional accessory device . Model CA-100S is substantially equivalent to the Omega Medical Imaging CS-series-FP K121293. This determination was made by comparing intended uses, designs, materials and performance. Any differences between the devices do not raise any issues of safety and
14
effectiveness. The Omega CS-series-FP with Optional accessory device Model CA-100S, incorporates modifications to the cleared device which include an additional of a secondary collimator that further protects non-essential anatomy from ionizing radiation. While these modifications do introduce new technological characteristics, they did not raise different questions of Substantial Equivalence compared to the predicate device. The modifications incorporated into the Omega CS-series-FP, do not alter the indications for use or the intended uses associated with the previously cleared device, as described in the labeling. It is the contention of Omega Medical Imaging that all new safety issues have been addressed in the design of this change and that adequate evidence of this is presented with this submission.
Referenced Guidance Documents:
- · Guidance for this submission of 510(k) for Indications of use as provided in: Pediatric Information for X-ray Imaging Device Premarket Notifications (Document issued on November 28th, 2017) Guidance for Industry and Food and Druq Administration Staff.
- Guidance for the Content of Premarket Submissions for Management of Cybersecurity in Medical Devices. (Document issued on October 2, 2014)
- · Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (Document issued on May 11, 2005)
- · Guidance for Industry and FDA Staff: Information to Support a Claim of Electromagnetic Compatibility (EMC) of Electrically-powered Medical Devices. (Document issued on July11, 2016)
- · Guidance for this submission of 510(k) for (SSXID) Solid State X-ray Imaging Devices issued on: September 1, 2016 was used to establish substantial equivalence
- Guidance for industry and FDA Staff User Fees and Refunds for Premarket Notification Submissions 510(k)s, (Document issued on October 2, 2017)
- Guidance for industry and FDA Staff Refuse to Accept Policy for 510(k) (Document issued on January 30, 2018)
- · Guidance for industry and FDA Staff -Format for Traditional and Abbreviated 510(k)s (Document issued on Auqust 12, 2005)
- Guidance for industry and FDA Staff Deciding when to submit a 510(k) for a change to an existing device. (Document issued on October 25, 2017)
- · Guidance for industry and FDA Staff The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] (Document Issued on July 28, 2014)
- Guidance for industry and FDA Staff Guidance for Off-The-Shelf Software Use in Medical Devices (Document issued on September 9, 1999)
- · Guidance for industry and FDA Staff Guidance for the Content of Premarket Submission for Software in Medical Devices. (Document issued February 3, 2016)
15
- Pulsation and Collimation During Fluoroscopy to Decrease Radiation: A Cadaver Study . Yamashita, Kazuta, MD1; Higashino, Kosaku, MD, PhD1,a; Hayashi, Hiroaki, PhD1; Hayashi, Fumio, MD1; Fukui, Yoshihiro, MD, PhD1; Sairyo, Koichi, MD, PhD1
- JBJS Open Access: December 28, 2017 Volume 2 Issue 4 p e0039 ● doi: 10.2106/JBJS.OA.17.00039 Scientific Articles
- . Med Phys. 2016 Mar:43(3):1531-8. doi: 10.1118/1.4941955.
Significant radiation reduction in interventional fluoroscopy using a novel eye controlled movable region of interest.
Balter S1, Simon D2, Itkin M3, Granada JF4, Melman H5, Dangas G6.
- . Lindsay Machan from the Department of Radiology, University of British Columbia, Vancouver, Canada discussing Ikomed solution 5 years ago .....
https://interventionalnews.com/dynamic-collimation-reduces-radiation-exposure-in-the-interventionalsuite/