(161 days)
No
The document describes modifications to a digital imaging system, focusing on software for communication, generator control (including Automatic Brightness Stabilization), and integration of different flat-panel detectors. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies. The image processing mentioned is standard for digital imaging systems and does not imply AI/ML.
No.
The device provides fluoroscopic imaging for guidance and visualization, not for direct therapeutic intervention.
No
The device is described as providing fluoroscopic imaging for guidance and visualization during procedures, not for making a diagnosis.
No
The device description explicitly states it is a "Digital Imaging System" and includes integration with flat-panel digital detectors and an x-ray generator, which are hardware components. While it includes software modifications and additions, it is not solely software.
Based on the provided text, the Insight Agile DRF is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device provides "fluoroscopic imaging" for "guidance and visualization during routine fluoroscopic and image-guided procedures." This involves imaging the inside of the body using X-rays, which is an in vivo (within the living body) procedure.
- Device Description: The description details a "fluoroscopic imaging chain" that "acquire, process, and display fluoroscopic images." This aligns with in vivo imaging, not testing samples outside the body.
- Input Imaging Modality: The input modality is "Fluoroscopic x-ray," which is used for imaging within the body.
- Anatomical Site: While not specified, the procedures mentioned (feeding tube and catheter insertion) are performed on the patient's body.
- Performance Studies: The performance studies involve "phantom images" and "fluoroscopic patient exam images," further indicating in vivo imaging.
In vitro diagnostics (IVDs) are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening. The Insight Agile DRF does not perform this type of testing.
N/A
Intended Use / Indications for Use
The Insight Agile DRF is intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device provides fluoroscopic imaging and is used for guidance and visualization during routine fluoroscopic and image-guided procedures. The device is to be used in professional healthcare facilities, in a variety of image-guided procedures such as feeding tube and catheter insertion on pediatric and neonates (birth to one month). This device is not indicated for large/obese patients or interventional use. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications. (Rx Only)
Product codes
JAA, OXO, RCC, QHY
Device Description
The Insight Agile DRF Digital Imaging System is a modification of Insight Enhanced DRF, a previously cleared (K200396) fluoroscopic imaging chain employing a flatpanel digital detector (Vieworks 1212G) to replace the image intensifier and video camera on GE R&F systems (P500, Legacy and Advantx). This system has now been modified in the following manner: 1) the digital interface board (DIB) that provides communications with the GE systems has been replaced with a software program that utilizes virtual serial ports. 2) Another software program has been added to allow the system to communicate with and control a Source-Ray x-ray generator. The generator interface provides for Automatic Brightness Stabilization (ABS) control and optional manual control through a graphical user interface on the Insight Aqile image acquisition screen. 3) A second dynamic flat-panel detector (Rayence 1212FCA, K202722) has been integrated to provide an alternate digital detector. 4) the software risk assessment has been changed from minor to moderate. 5) the Indications for Use has been changed to that of the predicate device.
With these modifications, Insight Agile DRF is a fluoroscopic imaging chain that can acquire, process, and display fluoroscopic images when installed on any suitable positioning system in a fixed room, on a mobile or portable stand. Another purpose of this application is to expand the indications for use.
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
Pediatric and neonates (birth to one month)
Intended User / Care Setting
Qualified/trained medical professionals in professional healthcare facilities
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
Bench testing was performed on the subject device with the Rayence 1212FCA on the system to assess substantial equivalence of the device and with the Vieworks detector in terms of image quality. Both detectors were integrated with the Source-Ray generator. Phantom images were acquired with the subject device and compared to the predicate device. These images and the doses used to acquire them were analyzed and compared.
A radiologist was provided a series of fluoroscopic patient exam images to evaluate the image quality produced by the subject device compared to 2 OEC (9800 and 9900) mobile c arms.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Study Type: Bench testing, Radiologist evaluation.
Sample Size: Not explicitly stated for bench testing, series of images for radiologist evaluation.
Key Results:
- Bench testing demonstrated substantial equivalence to the predicate device in terms of imaging performance regarding phantom images and doses.
- The system passed all electrical, mechanical and radiation safety testing against IEC 60601-1-3, IEC60601-2-54 and 21 CFR 1020.32.
- A radiologist found the Imaging Engineering images to be of high quality, high resolution, and clinically acceptable for the intended use and fully comparable to the OEC images.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1650 Image-intensified fluoroscopic x-ray system.
(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
July 27, 2021
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Imaging Engineering, LLC % Mr. George Jachode President 1318 NW 7th Ave CAPE CORAL FL 33993
Re: K210469
Trade/Device Name: Insight Agile DRF Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: JAA, OXO, RCC, QHY Dated: July 12, 2021 Received: July 19, 2021
Dear Mr. Jachode:
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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see
1
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 medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
, for
Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210469
Device Name
Insight Agile DRF
Indications for Use (Describe)
The Insight Agile DRF is intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device provides fluoroscopic imaging and is used for guidance and visualization during routine fluoroscopic and image-guided procedures. The device is to be used in professional healthcare facilities, in a variety of image-guided procedures such as feeding tube and catheter insertion on pediatric and neonates (birth to one month). This device is not indicated for large/obese patients or interventional use. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intendedfor mammography applications. (Rx Only)
| 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 three overlapping squares of different colors. The top square is orange, the bottom left square is dark blue, and the center square where the other two overlap is light blue. The squares are made up of smaller squares arranged in a grid pattern.
Exhibit 5: 510(k) Summary
1. Trade/proprietary name: Insight Agile DRF
| 510(k) Clearance #: | K210469 |
|---|---|
| Regulation Name: | Image-Intensified Fluoroscopic X-ray System |
| Regulation Number: | 21 CFR 892.1650 |
| Regulatory Class: | Class II |
| Product Code: | JAA, OXO, RCC and QHY |
| Common/Usual Name: | Mobile Fluoroscopic System |
2. Predicate Device: K191503
| Trade Name: | MobileRay Pulse SE Digital Imaging System |
|---|---|
| Manufacturer: | PortaVision Medical, LLC |
| Regulation Number: | 21 CFR 892.1650 |
| Regulatory Class: | Class II |
| Product Code: | OWB, JAA, QHY, OXO and RCC |
| Common/Usual Name: | Mobile Fluoroscopic System |
3. Reference Devices: (Used with this device)
| Trade Name: | Insight Enhanced DRF Digital Imaging System |
|---|---|
| 510(k) Clearance #: | K200396 |
| Clearance date: | 03/06/2020 |
| Classification Name: | Image Intensified Fluoroscopic X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21CFR 892.1650 (Produce Code: JAA) |
| Device Class: | Class II |
| Trade Name: | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
| 510(k) Clearance #: | K202722 |
| Clearance date: | 10/26/2020 |
| Classification Name: | Image Intensified Fluoroscopic X-ray System |
| Classification Panel: | Radiology |
| CFR Section: | 21CFR 892.1680 (Produce Code: MQB) |
| Device Class: | Class II |
4. Device Description
The Insight Agile DRF Digital Imaging System is a modification of Insight Enhanced DRF, a previously cleared (K200396) fluoroscopic imaging chain employing a flatpanel digital detector (Vieworks 1212G) to replace the image intensifier and video camera on GE R&F systems (P500, Legacy and Advantx). This system has now been modified in the following manner: 1) the digital interface board (DIB) that provides communications with the GE systems has been replaced with a software program that utilizes virtual serial ports.
4
Image /page/4/Picture/0 description: The image shows three overlapping squares of different colors. The square on the left is dark blue, the square on the top is orange, and the square in the middle where the other two overlap is light blue. Each square is made up of smaller squares arranged in a grid pattern.
- Another software program has been added to allow the system to communicate with and control a Source-Ray x-ray generator. The generator interface provides for Automatic Brightness Stabilization (ABS) control and optional manual control through a graphical user interface on the Insight Aqile image acquisition screen. 3) A second dynamic flat-panel detector (Rayence 1212FCA, K202722) has been integrated to provide an alternate digital detector. 4) the software risk assessment has been changed from minor to moderate. 5) the Indications for Use has been changed to that of the predicate device.
With these modifications, Insight Agile DRF is a fluoroscopic imaging chain that can acquire, process, and display fluoroscopic images when installed on any suitable positioning system in a fixed room, on a mobile or portable stand. Another purpose of this application is to expand the indications for use.
5. Indications for Use
The Insight Agile DRF is intended for use by a qualified/trained medical professionals, who have full understanding of the safety information and emergency procedures as well as the capabilities and functions of the device. The device provides fluoroscopic imaging and is used for quidance and visualization during routine fluoroscopic and image-guided procedures. The device is to be used in professional healthcare facilities, in a variety of image-guided procedures such as feeding tube and catheter insertion on pediatric patients and neonates (birth to one month). This device is not indicated for large/obese patients or interventional use. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. The system is not intended for mammography applications. (Rx Only)
6. Summary of Design Control Risk Management
The Insight Agile DRF fluoroscopic imaging chain has been developed to provide OEMs and System Integrators a fluoroscopic imaging chain system that can be integrated with a suitable positioning system. It provides optimized workflow when imaging patients while meeting critical functional requirements and international safety standards. The risks and the hazardous impact of the device design were analyzed with FMEA method. The specific risk control and protective measures to mitigate the risks from the device design and production phase were reviewed and implemented in the new product design phase. The overall assessment concluded that all risks and hazardous conditions identified arising from the design and production were successfully mitigated and accepted.
5
Image /page/5/Figure/0 description: The image shows a grid of squares with three different colors. The bottom left section of the grid is dark blue, the top right section is orange, and the overlapping section is light blue. The squares are arranged in a rectangular pattern.
7. Substantial Equivalence
The Insight Agile™ DRF fluoroscopic imaging chain conforms to the FDA recognized standards as like the predicate device. Based on the recognized standard conformity evidence related to the electro-, mechanical, software-, clinical-and risk management, it is the sponsor's opinion that the subject device is a safe and effective device.
| Characteristic | MobileRay Pulse SE Digital
Imaging System
(K191503) | Insight Agile DRF
Digital Imaging
System |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Power source | 120 VAC 50/60 HZ
2.5 amps | 120 VAC 50/60 HZ
3.5 amps |
| Generator Type | High frequency inverter type | SAME |
| Output Power | 4 kW | 80 W |
| Fluoroscopy | 0.5 - 10 mA (pulsed)
40 - 25kV | 0.1 - 5 mA (Cont.)
35 - 80 kV |
| Image acquisition | Up to up to 7.5 fps (fluoro) | Up to 30 fps (fluoro) |
| X-ray Tube | Stationary Anode | SAME |
| Indicators | Display on workstation monitor | SAME |
| Collimator | Multi-leaf adjustable motorized,
Collimare Touch LED | Fixed Aperture with 0.1 mm
Cu fixed filter |
| Digital Panel Specification | PerkinElmer XRpad2 3025 4346 | Vieworks 1212G
Rayence 1212FCA |
| Pixel Pitch | 100 μm | Vw 1212G 145 μm
Ray.1212FCA 194 μm |
| Matrix | 2508 x 3004 | Vx 2000 x 2000
Ray 1536 x 1536 |
| A/D conversion | 16 bits | SAME |
| Image Acquisition | Amorphous Si direct deposition
Csl:TI | Vw 1212G SAME
Ray IZGO CsI:TI |
| Performance Standard | 21 CFR 1202.30 | SAME |
| Electrical Safety | IEC60601-1:2005 + A1 (2012)
IEC60601-1-2:2007
IEC60601-1-3:2008
IEC60601-2-28:2010
IEC60601-2-43:2010
IEC60601-2-54:2009 | IEC60601-1-
2:2014+ANSI+AAMI
IEC60601-1-
3:2008+A1:2013
IEC60601-2-54:2009
+AMD1:2015+AMD2:2018 |
6
Image /page/6/Picture/0 description: The image shows two overlapping squares, each made up of smaller squares. The square on the left is primarily blue, while the square on the right is orange. Where the squares overlap, the smaller squares are light blue, indicating a combination of the two original colors. The arrangement suggests a concept of intersection or overlap between two distinct entities.
The following table compares The MobileRay Pulse SE software (predicate device) to the subject device software.
| Feature | Predicate Device
MobileRay Pulse SE
K191503 | Subject Device |
|----------------------------------|---------------------------------------------------|----------------|
| Acquiring image from
detector | Yes | Yes |
| Viewing image | Yes | Yes |
| Change window/level | Yes | Yes |
| Invert | Yes | Yes |
| Lookup Table | Yes | Yes |
| Zoom | Yes | Yes |
| Pan | Yes | Yes |
| Noise Reduction | Yes | Yes |
| Patient Information | Yes | Yes |
| Annotation | Yes | Yes |
| Image rotation | Yes | Yes |
| X-Ray generator control | Yes | Yes |
| DICOM worklist and Send | Yes | Yes |
8. Difference Discussion
The predicate device is a portable system that employs a more powerful generator than the subject device. The predicate device has an indication for use statement that includes radiography and interventional use. The subject device has a lower power generator but does have similar technological characteristics as it relates to fluoroscopic imaging as the predicate device. The indication for use statement of the subject device therefore does not include either radiography or interventional use and further restricts the patient population it is indicated for. Accordingly, the subject device is only substantially equivalent to the fluoroscopic imaging characteristics of the predicate device.
7
Image /page/7/Picture/0 description: The image shows a square grid of small squares. The grid is composed of three different colors: orange, blue, and light blue. The orange squares are located in the upper right corner, the blue squares are located in the lower left corner, and the light blue squares are located in the center where the orange and blue squares overlap.
Insight Agile™ DRF
Digital Imaging System
The predicate device is a portable fluoroscopic and radiographic system. Insight Agile DRF is a fluoroscopic imaging chain that can be installed on any suitable positioning system including the predicate device. Insight Enhanced DRF and the Vieworks flat panel detector have already been cleared as a fluoroscopic imaging chain component (K200396) to upgrade the image intensifier and video camera on GE R&F systems. The Rayence 1212FCA detector has been previously cleared for MQB (K202722).
9. Summary of the technological characteristics of the device compared to the predicate device.
The predicate device employs a different fluoroscopic imaging chain consisting of a Sedecal x-rav generator. Collimator. Perkin Elmer digital x-ray detector and console software provided by RADinfo Systems, Inc. Insight Agile DRF employs a Source-Ray x-ray generator, a manual collimator, a Vieworks or Rayence digital x-ray detector and the Insight Agile DRF console software.
Two dFPD detectors are being applied for clearance in this application. One of the dFPDs is manufactured by Vieworks and was cleared previously with Insight Enhanced (K200396). The second dFPD is manufactured by Rayence (1212FCA), this detector is based on 3rd generation flat panel television technology (Indium Zinc Gallium Oxide or IZGO). This technology provides a lower noise floor and much longer detector lifetime compared with a-Si based dFPDs due to its ten-fold increase in radiation damage resistance.
The Rayence 1212FCA was recently cleared for MQB (K202722). A complete SSXI data report for the Rayence 1212FCA detector is provided along with bench test data to establish substantial equivalency.
10. Description of non-clinical tests.
Bench testing was performed on the subject device with the Rayence 1212FCA on the system to assess substantial equivalence of the device and with the Vieworks detector in terms of image quality. Both detectors were integrated with the Source-Ray generator. Phantom images were acquired with the subject device and compared to the predicate device. These images and the doses used to acquire them were analyzed and compared. In conclusion, the tests obtained demonstrated substantial equivalence to the predicate device in terms of imaging performance.
Additional bench testing was performed by Imaging Engineering on the Insight Agile DRF system to determine if the system complies with IEC 60601-1-3, IEC60601-2-54 and 21 CFR 1020.32. The test results are provided in Exhibit 18. The system passed all electrical, mechanical and radiation safety testing. EMC and Electrical Safety performance for the Rayence digital receptor panel had previously been submitted to FDA in K202722.
8
Image /page/8/Figure/0 description: The image shows a square grid of smaller squares, with three distinct colors. The bottom left portion of the grid is dark blue, the top right portion is orange, and the overlapping center portion is light blue. The arrangement of colors creates a visually interesting pattern.
Insight Agile™ DRF
Digital Imaging System
A radiologist was provided a series of fluoroscopic patient exam images to evaluate the image quality produced by the subject device compared to 2 OEC (9800 and 9900) mobile c arms. A report of their findings is included in Exhibit 16. This report includes the following statement "I found the Imaging Engineering images to be of high quality, high resolution, and clinically acceptable for the intended use and fully comparable to the OEC images."
Software has been written and validated according to the FDA Software Guidance: Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document issued on: May 11, 2005. Cybersecurity concerns have been addressed in accordance with: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices Guidance for Industry and Food and Drug Administration Staff (October 2, 2014).
11. Description of clinical tests.
No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed modification. Bench testing was performed to assess the device safety and effectiveness.
12. Conclusion as to Substantial Equivalence.
The Insight Agile DRF Digital Imaging System, the subject device is substantially equivalent to the fluoroscopic imaging properties of the predicate (K191503). The design principle and the applicable standards for the subject device are similar to those of the predicate device. The statement for use of the predicate device has been modified to remove radiographic and interventional use and to restrict the population demographics to reflect the limitations of the subject device. The performance test and non-clinical consideration result demonstrate that these differences do not raise any new questions of safety and effectiveness. Therefore, it is the sponsor's opinion that the subject device appears to be as safe and effective as the predicate device for fluoroscopic use.