Insight Enhanced DRF Digital Imaging System

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March 6, 2020 Imaging Engineering, LLC % Mr. George Jachode President 1318 NW 7th Avenue CAPE CORAL FL 33993 Re: K200396 Trade/Device Name: Insight Enhanced™ DRF Digital Imaging System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: Class II Product Code: JAA Dated: February 12, 2020 Received: February 18, 2020 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. 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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) K200396 Device Name Insight Enhanced™ DRF Digital Imaging System Indications for Use (Describe) Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for obtaining fluoroscopic radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Date Special 510K summary prepared: February 10, 2020 | Submitter's Name: | Imaging Engineering, LLC | |------------------------|--------------------------------------------| | Submitter's Address: | 1318 NW 7th Ave, Cape Coral, Florida 33993 | | Submitter's Telephone: | (239) 223-1371 | | Contact person: | George Jachode/President | | Official Correspondent: | George Jachode (g.jachode@imagingengineeringllc.com) | |-------------------------|------------------------------------------------------| | Address: | 1318 NW 7th Ave, Cape Coral, Florida 33993 | | Telephone: | (239) 223-1371 | #### Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known: | 510K Number: | | |-------------------------|------------------------------------------------| | Trade/proprietary name: | Insight Enhanced™ DRF Digital Imaging System | | Model Number: | EN-1000-00 | | Regulation Name: | Image-Intensified Fluoroscopic X-ray System | | Regulation Number: | 21 CFR 892. 1650 | | Regulatory Class: | Class II | | Product Code: | JAA and LLZ | | Predicate Device | | | Trade Name: | Insight Essentials™ DRF Digital Imaging System | | 510(k) Clearance #: | K191310 | | Clearance date: | 06/10/2019 | | Classification Name: | Image Intensified Fluoroscopic X-ray System | | Classification Panel: | Radiology | | CFR Section: | 21CFR 892.1650 (Produce Code; JAA and LLZ) | | Device Class: | Class II | {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows two overlapping squares. The square on the left is blue, and the square on the right is orange. The overlapping area is light blue. Each square is made up of smaller squares. Insight Enhanced™ DRF Digital Imaqing System # 2. Device Description The Insight Enhanced™ DRF Digital Imaging System is designed to provide an additional imaging acquisition device to the existing image intensifier, camera and user interface with a dynamic flat-panel detector (dFPD) on the following FDA approved R&F fluoroscopic imaging systems employing an image intensifier: GE Advantx, GE Legacy, GE P500 and Shimadzu YSF300. The subject fluoro system Insight Enhanced is based on the predicate Insight Essentials. The following dynamic digital detectors are added to the predicate system: Vivix-D 1212G and Vivix-D 1717G. The x-ray generator, beam-limiting device and patient positioner, necessary for a full fluoroscopy system are not part of the subject device software stays unchanged from the predicate Insight Essentials DRF. The Insight Enhanced™ DRF Digital Imaging System allows the operator to view and enhance high-definition fluoroscopy images. High resolution digital spot images may also be acquired at single or rapid acquisition rates, up to 30 fps. Images may be viewed and enhanced enabling the operator to bring out diagnostic details difficult or impossible to see using conventional imaging techniques. Images can be stored locally for short term storage. The Insight Enhanced™ DRF Digital Imaging System enables the operator to produce hardcopy images with a laser printer or send images over a network for longer-term storage. The major system components include: a fluoroscopic video camera, monitors, and an image processor PC. #### 3. Indications for Use Intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for obtaining fluoroscopic radiographic images of the skull, spinal column, chest, abdomen, extremities, and other body parts, # 4. Summary of Design Control Risk Management The Insight Enhanced™ DRF Digital Imaging System has been developed to provide medical professionals 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 three overlapping squares of different colors. The square on the left is dark blue, the square on the top right is orange, and the square in the middle where the other two overlap is light blue. The squares are made up of smaller squares arranged in a grid pattern. # 5. Substantial Equivalence The Insight Enhanced™ DRF Digital Imaging System conforms to the FDA recognized standards as like the predicate device. Based on the recognized standard conformity evidences related to the electro-, mechanical, software-, clinical-and risk management, it's the sponsor's opinion that the subject device is a safe and effective device. | Characteristic | Insight Essentials<br>DRF Digital Imaging<br>System<br>(K191310) | Insight Enhanced<br>DRF Digital<br>Imaging System | |----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------| | Intended Use: | Intended for use by a<br>qualified/trained doctor or<br>technician on both adult<br>and pediatric subjects for<br>obtaining fluoroscopic<br>radiographic images of the<br>skull, spinal column, chest,<br>abdomen, extremities, and<br>other body parts. | SAME | | Power source | 120 VAC 50/60 HZ<br>2.5 amps | 120 VAC 50/60 HZ<br>2.5 amps | | Image acquisition | Up to 15 FPS (spot), up to<br>30 fps (fluoro) | SAME | | File compatibility | DICOM | SAME | | Digital Video Source | Basler ACE1920-40gm<br>CMOS camera | VIVIX-D 1212 and<br>VIVIX-D 1717 dFPD | | Digital Resolution | 1k x 1k 12 bit | SAME | | Electrical safety | IEC 60601-1:<br>IEC 60601-1-2<br>IEC 60601-1-3 | SAME | {6}------------------------------------------------ Image /page/6/Figure/0 description: The image shows a square grid pattern with three different colors. The top right section of the grid is orange, the bottom left section is dark blue, and the overlapping center section is light blue. The grid appears to be a square shape, with each color occupying a distinct area within the square. # 6. Difference Discussion The dynamic flat-panel detectors Vivix-D1212G and Vivix-D 1717G have been added to the predicate system Insight Essentials in order to provide image acquisition support in addition to the existing CMOS camera. # 7. Summary of the technological characteristics of the device compared to the predicate device Both the subject device and the predicate device have the identical software program that provides a Graphical User Interface (GUI), image processing and patient workflow functions. Two dFPD detectors have been added to the existing device Insight Essentials, to acquire fluoroscopic and spot images. The dFPDs are both manufactured by the same company Vieworks, use the same manufacturing technology but are of different sizes (12x12 inch and 17x17 inch). The subject device can now be configured with either a CMOS camera or one of the 2 dFPDs. The VIVIX-D1212 dFPD has already been cleared by the FDA (K180473) for use on a mobile c arm. The Vivix-D 1717 uses the same architecture as the Vivix-D 1212 (K180473) and the only major difference is its larger size. A complete SSXI data report for the VIVIX-D 1717 is provided along with bench test data to establish substantial equivalency. # 8. Description of non-clinical tests. Bench testing was performed on the Vivix digital detectors used with the subject system Insight Enhanced, in order to assess substantial equivalence to the predicate device Insight Essentials. Phantom images were acquired with the subject device and compared to the predicate device, also installed on the same GE Legacy R&F system. 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. #### 9. 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. {7}------------------------------------------------ Image /page/7/Figure/0 description: The image shows three overlapping squares. The square on the left is dark blue, the square on the top right is orange, and the square in the middle where the other two overlap is light blue. The squares are made up of smaller squares arranged in a grid pattern. # 10. Conclusion as to Substantial Equivalence. The Insight Enhanced™ DRF Digital Imaging System, the subject device is substantially equivalent to the predicate (K191310). The intended use, the design principle, and the applicable standards for the subject device are identical to those of the predicate 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.