Aquarius 8600 1417TG and Aquarius 8600 1717TG

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol of three human profiles facing to the right, with flowing lines representing hair or clothing. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 12, 2017 Imaging Dynamics Company Ltd. % Ms. Nicole Wherry Chief Quality Officer #130, 5310-29th Street NE Calgary, AB T1Y 7E5 CANADA Re: K171169 Trade/Device Name: Aquarius 8600 1417TG and Aquarius 8600 1717TG Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: September 21, 2017 Received: September 25, 2017 Dear Ms. Wherry: 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. 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. {1}------------------------------------------------ If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance. You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. Michael D.'Hara For Robert Ochs, 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) K171169 Device Name Aquarius 8600 1417TG and Aquarius 8600 1717TG Indications for Use (Describe) Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, extremities, and other body parts on both adult and pediatic patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography. | Type of Use (Select one or both, as applicable) | | |--------------------------------------------------------------------------|-------------------------------------------------------------------------| | <div> <span>☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span>☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | ### 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}------------------------------------------------ # Date Prepared: October 03, 2017 ### 1. Submitter 21 CFR 807.92(a)(1): Imaging Dynamics Company, Ltd. (IDC) #130, 3510-29th Street N.E. Calgary, Alberta, Canada T1Y 7E5 Tel: 403.251.9939 Fax: 403.251.1771 Contact: Nicole Wherry #### 2. Identification of the Device 21 CFR 807.92(a)(2): | Trade Name: | Aquarius 8600 1417TG and Aquarius 8600 1717TG | |----------------------|-----------------------------------------------| | Model Names: | 1417TG and 1717TG | | Common Name: | Flat Panel Detector | | Classification Name: | Stationary X-Ray System | | Product Code: | MQB | | Regulation Number: | 21 CFR 892.1680 | | Device Class: | Class II | ### 3. Equivalent legally marketed devices 21 CFR 807.92(a)(3): | Predicate device: | K170202, Aquarius 8600 1417TC and Aquarius 8600 1717TC, IDC | |----------------------|-------------------------------------------------------------| | Clearance Date: | February 22, 2017 | | Trade Name: | Aquarius 8600 | | Model Names: | 1417TC and 1717TC | | Common Name: | Flat Panel Detector | | Classification Name: | Stationary X-Ray System | | Product Code: | MQB | | Regulation Number: | 21 CFR 892.1680 | | Device Class: | Class II | {4}------------------------------------------------ # Reference legally marketed devices # K122928, DIGITAL FLAT PANEL X-RAY DETECTOR 1417PGA # K122182, DIGITAL FLAT PLANEL X-RAY DETECTOR 1717SGC The 510(k) for K122928 and K122182 was submitted by the original equipment manufacturer. Imaging Dynamics Company Ltd. maintains adequate information demonstrating our legal right to distribute the device. ### 4. Description of the Device 21 CFR 807.92(a)(4): The Aquarius 8600 1717TG and Aquarius 8600 1417TG are digital flat panels, specifically termed solid state digital X-Ray detector. This technology couples a scintillator with an a-Si TFT sensor, and through integration with a radiographic imaging system, x-ray images can be captured and digitalized. The resulting RAW files are DICOM 3.0 compatible allowing image files to be processed by IDC Magellan software. The Aquarius 8600 1717TG and the Aquarius 8600 1417TG represents a modification of our own predicate device cleared under K170202, Aquarius 8600 1717TC. The Aquarius 8600 1717TG and Aquarius 8600 1417TG integrates the 510(k) cleared flat panel detectors (K122928 and K122182) with IDC Magellan software and workstation. There were no changes made to the cleared panels, workstation or software. All components were integrated and tested to make the Aquarius 8600 1717TG and Aquarius 8600 1417TG medical devices. # The Aquarius 8600 will be marketed in two additional possible configurations: Aquarius 8600 1717TG (tethered, 17 x 17 inch flat panel as a retrofit package with Magellan software). Aquarius 8600 1417TG (tethered, 14 x 17 inch flat panel as a retrofit package with Magellan software). {5}------------------------------------------------ ### Indications for Use (intended use) 21 CFR 807.92(a)(5): 5. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric patients. Applications can be performed with patient sitting, standing or lying in the prone or supine positions. Not intended for mammography. The intended use for the Aquarius 8600 1417TG and Aquarius 8600 1717TG (subject devices) has not changed from the intended use of the predicate device, Aquarius 8600 1717TC. ### Technological Characteristics Summary: Predicate and proposed devices comparison 6. 21 CFR 807.92(a)(6): The proposed Aquarius 8600 1417TG and Aquarius 8600 1717TG devices described in this 510(k) have similar technological characteristics and the same indications for use as the predicate device, Aquarius 8600 models 1717TC. A summary table comparing the technological properties of the proposed devices to the predicate device has been provided in Table 1. {6}------------------------------------------------ | Table 1: Comparison of the Aquarius 8600 1717TG and Aquarius 8600 1417TG, with the | | |------------------------------------------------------------------------------------|--| | Aquarius 8600 1717TC Predicate device | | | Characteristic | Proposed<br>Imaging Dynamics Company Ltd.<br>Aquarius 8600 1717TG | Proposed<br>Imaging Dynamics Company Ltd.<br>Aquarius 8600 1417TG | Predicate<br>Imaging Dynamics Company Ltd.<br>Aquarius 8600 1717TC | |---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Image: Aquarius 8600 1717TG | Image: Aquarius 8600 1417TG | Image: Aquarius 8600 1717TC | | 510(k)<br>number | K171169 | K171169 | K170202 | | Intended Use | Aquarius 8600 1717TG Digital<br>Flat Panel X-Ray Detector is<br>indicated for digital imaging<br>solutions designed for general<br>radiographic systems for human<br>anatomy. It is intended to<br>replace film or screen based<br>radiographic systems in all<br>general purpose diagnostic<br>procedures. Not to be used for<br>mammography. | Aquarius 8600 1417TG Digital Flat<br>Panel X-Ray Detector is indicated<br>for digital imaging solutions<br>designed for general radiographic<br>systems for human anatomy. It is<br>intended to replace film or screen<br>based radiographic systems in all<br>general purpose diagnostic<br>procedures. Not to be used for<br>mammography. | Aquarius 8600 1717TC Digital<br>Flat Panel X-Ray Detector is<br>indicated for digital imaging<br>solutions designed for general<br>radiographic systems for human<br>anatomy. It is intended to<br>replace film or screen based<br>radiographic systems in all<br>general purpose diagnostic<br>procedures. Not to be used for<br>mammography | | Detector<br>Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT | Amorphous Silicon, TFT | | Scintillator | Gd2O2S:Tb | Gd2O2S:Tb | Csl:Tl | | Imaging Area | 17x17 inches | 14x17 inches | 17x17 inches | | Pixel Matrix | 3328 x 3328 | 2816 x 3328 | 3328 x 3328 | | Pixel Pitch | 127 μm | 127 μm | 127 μm | | | | | | | Resolution | 3.9 lp/mm | 3.9 lp/mm | 3.9 lp/mm | | A/D Conversion | 14/16 bit | 14/16 bit | 14 bit | | Preview Time | ≤ 2 seconds | ≤ 2 seconds | ≤ 2 seconds | | Data Output | RAW<br>*the RAW files are convertible<br>into DICOM 3.0 by console<br>software. | RAW<br>*the RAW files are convertible<br>into DICOM 3.0 by console<br>software. | RAW<br>*the RAW files are convertible<br>into DICOM 3.0 by console<br>software. | | Dimensions | 460 x 460 x 15.5 mm | 384 x 460 x 15 mm | 460 x 460 x 15.5 mm | | Weight | 4 kg | 3.1 kg | 4 kg | | Application | General Radiology system or<br>Portable system<br>Available with upright stand,<br>table, universal stand. | General Radiology system or<br>Portable system<br>Available with upright stand,<br>table, universal stand. | General Radiology system or<br>Portable system<br>Available with upright stand,<br>table, universal stand. | | Added Optional Components | - | - | - | {7}------------------------------------------------ {8}------------------------------------------------ * Compliance to NEMA PS 3.1-3.20 "Digital Imaging and Communications in Medicine (DICOM) Set ## Key Technology Differences: - A. The only difference between the predicate device and the subject devices is the use of a variant scintillator. The proposed Aquarius 8600 1717TG and Aquarius 8600 1417TG subject device use Gadox scintillators whereas the predicate device uses Cesium Iodide scintillators. Risk management activities are based on ISO 14971:2007 "Medical Devices – Application of Risk Management to Medical Devices". As identified in the IDC FMEA Risk Assessment, there are no differences in risk based on this change. The scintillator differences between the predicate device and the proposed Aquarius 8600 1717TG and Aquarius 8600 1417TG devices does not affect device performance. - B. Software: IDC Magellan 3 software was integrated for use on the proposed Aquarius 8600 1717TG and Aquarius 8600 1417TG flat panel medical devices. The operating systems for the proposed Aquarius 8600 1717TG and Aquarius 8600 14147TG flat panels are identical to the predicate Aquarius 8600 1717TC model. IDC will supply the workstation and software with the medical devices proposed in this 510(k) application. No changes were made to the previously cleared 1717SGC and 1417PGA detectors and associated firmware for the proposed Aquarius 8600 1717TG medical device. No changes were made to the IDC Magellan 3 software for integration with the previously cleared 1717SCC and 1417PCA flat panels for the proposed Aquarius 8600 1717TG and Aquarius 8600 1417TG medical devices. As regular software maintenance was performed, full system level verification, validation and regression testing was performed. No changes have been made to the IDC Magellan 3 software for integration with potential wireless technology. The FDA will be notified if changes will be required for wireless technology, at which time a separate premarket application will be submitted. {9}------------------------------------------------ # IDC Recommended Generator Specifications. Exposure is controlled manually by the user through a hand-held trigger. Recommended generator specifications are provided to the user and identified below. If additional generator compatibility information is required customers will be notified to contact the Imaging Dynamics Help Desk. | Generator | Property | Power Requirement | |-------------------------------------|-----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 40 kW CMP 200 DR<br>X-ray generator | Line Voltage | 208 VAC – 5% to 230 VAC + 10%, 1 phase<br>208 VAC – 5% to 230 VAC + 10%, 3 phase<br>400 VAC ± 10%, 3 phase<br>480 VAC ± 10%, 3 phase | | | Line Frequency | 50/60 Hz | | | Momentary Current | 275 Amps at 208 VAC (1 phase)<br>154 Amps/phase at 208 VAC (3 phase)<br>250 Amps at 230 VAC (1 phase)<br>139 Amps/phase at 230 VAC (3 phase)<br>80 Amps/phase at 400 VAC<br>65 Amps/phase at 480 VAC | | | Nominal Current | ≤ 5 Amps | | | Momentary Power Consumption | 55 kVA | | 50 kW CMP 200 DR<br>X-ray generator | Line Voltage | 208 VAC - 5% to 230 VAC + 10%, 3 phase<br>400 VAC ± 10%, 3 phase<br>480 VAC ± 10%, 3 phase | | | Line Frequency | 50/60 Hz | | | Momentary Current | 192 Amps/phase at 208 VAC<br>174 Amps/phase at 230 VAC<br>100 Amps/phase at 400 VAC<br>80 Amps/phase at 480 VAC | | | Nominal Current | ≤ 5 Amps | | | Momentary Power Consumption | 65 kVA | | 65 kW CMP 200 DR<br>X-ray generator | Line Voltage | 400 VAC ± 10%, 3 phase<br>480 VAC ± 10%, 3 phase | | | Line Frequency | 50/60 Hz | | | Momentary Current | 125 Amps/phase at 400 VAC<br>105 Amps/phase at 480 VAC | | | Nominal Current | ≤ 5 Amps | | | Momentary Power Consumption | 85 kVA | {10}------------------------------------------------ #### 7. Summary of Safety and Performance Testing 21 CFR 807.92(b) ### Non-Clinical Test Summary: The results of the non-clinical studies demonstrate the Aquarius 8600 1717TG and Aquarius 8600 1417TG are substantially equivalent to the predicate device. Aquarius 8600 1717TC. The tests and corresponding results are summarized below: - Comparison of the Detective Quantum Efficiency (DQE), Modulation Transfer Function A. (MTF) and Noise Power Spectrum (NPS). ## Detective Quantum Efficiency Comparison: A comparison of measured DQE curves show that the proposed Aquarius 8600 1717TG and Aquarius 8600 1417TG devices have slightly reduced DQE performance at all spatial frequencies than the predicate device, the difference increasing as the spatial frequency increases. | | Aquarius 8600 1417TG<br>Aquarius 8600 1717TG | Aquarius 8600 1717TC | |---------|----------------------------------------------|----------------------| | DQE (0) | 0.446 | 0.684 | ## Modulation Transfer Function: A comparison of measured MTF curves show that the Aquarius 8600 1717TG and Aquarius 8600 1417TG flat panels show similar but slightly improved response to the predicate device. Values tested below 1 lp/mm and above 3.5 lp/mm have been omitted from this summary. Values are an average of 4 measurements taken from 2.7uGy to 26.83uGy for the Aquarius 8600 1417TG panel and 1.7uGy to 10.1uGy for the Aquarius 8600 1717TG panel. The Complete MTF values and linearity graphs can be found in section 3 to 5) of the associate SSXI Non-Clinical Report. | Spatial Frequency | MTF Value | | | |-------------------|-------------------------|-------------------------|----------------------| | | Aquarius 8600<br>1417TG | Aquarius 8600<br>1717TG | Aquarius 8600 1717TC | | 1 lp/mm | 0.596 | 0.585 | 0.502 | | 2 lp/mm | 0.290 | 0.283 | 0.230 | | 3 lp/mm | 0.142 | 0.144 | 0.104 | | 3.5 lp/mm | 0.095 | 0.103 | 0.083 | {11}------------------------------------------------ ## Noise Power Spectrum: A comparison of measured NPS curves show that the Aquarius 8600 1717TG and Aquarius 8600 1417TG flat panels have a similar noise performance profile at spatial frequencies as the predicate device. | Spatial Frequency | NPS Value | | |-------------------|----------------------------------------------|----------------------| | | Aquarius 8600 1417TG<br>Aquarius 8600 1717TG | Aquarius 8600 1717TC | | 0 lp/mm | 8.56 | 8.10 | | 1 lp/mm | 4.21 | 3.20 | | 2 lp/mm | 1.43 | 1.20 | | 3 lp/mm | 0.64 | 0.60 | | 3.5 lp/mm | 0.52 | 0.55 | - B. Environmental, electrical, mechanical safety, and performance testing was completed for the Aquarius 8600 1717TG and Aquarius 8600 1417TG, and all testing passed, based on IEC 60601-1 Medical Electrical Equipment - Part I General Requirements for Basic Safety and Essential Performance, 3rd edition + CORR. 1:2006 + CORR. 2:2007 + A1:2012. EMC testing was completed based on IEC 60601-1-2:2007. - C. "Guidance For The Submission of 510(K)s For Solid State X-Ray Imaging Devices" was utilized for clinical and non-clinical considerations. Results indicate the Aquarius 8600 1717TG and Aquarius 8600 1417TG are substantially equivalent to the IDC Aquarius 8600 1717TC predicate device. - D. IDC software has a documented lifecycle based on IEC 62304 Edition1.1:2015 "Medical Device Software - Software Lifecycle Processes". IDC software design and requirements specifications, classification of hazards, and full verification, validation, and regression testing is based on the FDA documents "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" and "General Principles of Software Validation; Final Guidance for Industry and FDA Staff". - E. Laboratory images using phantoms were acquired with the proposed IDC Aquarius 8600 1717TG subject device and compared to images acquired with the IDC Aquarius 8600 1717TC predicate device. A Radiological Technologist certified in the United States of America and Canada has reviewed the images (included in this submission) and determined the subject device produce images that are diagnostically similar, and slightly superior, to the predicate device. ### F. Clinical Test Summary: No clinical testing was performed for this special 510(k) submission. {12}------------------------------------------------ #### 8. Conclusion: The Aquarius 8600 1717TG and Aquarius 8600 1417TG medical devices have identical indications for use, and similar technological characteristics as the Aquarius 8600 1717TC predicate device. The flat panel components for the Aquarius 8600 1717TG and Aquarius 8600 1417TG are identical to the flat panels listed as reference devices (cleared separately in K122182 and K122928), and employs the same software as the IDC Aquarius 8600 17177C predicate device. The proposed Aquarius 8600 1717TG and Aquarius 8600 1417TG Flat Panels conform to US Performance Standards and are UL listed to US Standards for safety for medical devices. In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification, it is the opinion of IDC that the Aquarius 8600 1717TG and Aquarius 8600 1417TG are substantially equivalent in comparison with the IDC Aquarius 8600 1717TC predicate device as described herein.