Aquarius 8600

{0}------------------------------------------------ Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 February 22, 2017 Imaging Dynamics Company Ltd. % Ms. Nicole Wherry Chief Quality Officer 130, 3510 29th Street NE Calgary, Alberta T1Y 7E5 CANADA Re: K170202 Trade/Device Name: Aquarius 8600 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: December 14, 2016 Received: January 23, 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 device-related 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/Resourcesfor You/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. 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) K170202 Device Name Aquarius 8600 ### 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, chest, abdomen, extremities, and other and pediatric 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) | | |-------------------------------------------------|---------------------------------------------| | × 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}------------------------------------------------ # Exhibit # 8: 510(K) Summary # 510(K) Summary, Special 510(k) K # Page 1 of 9 # Date Prepared: 21 February, 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 #### Identification of the Device 21 CFR 807.92(a)(2): 2. | Trade Name: | Aquarius 8600 | |----------------------|-------------------------| | Model Names: | 1717TC and 1417TC | | 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: | K070079, X3C Digital Radiographic Detector, IDC | |----------------------|-------------------------------------------------| | Trade Name: | X3C Digital Radiographic Detector | | Model Names: | X3C | | Common Name: | Digital Imaging X-Ray Detector | | Classification Name: | Stationary X-Ray System | | Product Code: | MQB | | Regulation Number: | 21 CFR 892.1680 | | Device Class: | Class II | {4}------------------------------------------------ # Page 2 of 9 # Reference legally marketed devices K111098, InnovaXion FP, IDC (Imaging Dynamics Company) K122173, Digital Flat Panel X-Ray Detector, 1717SCC K122919, Digital Flat Panel X-Ray Detector, 1417PCA The 510(k) for K122173 and K122919 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 1717TC 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 1717TC and 1417TC represents a modification of our own predicate device cleared under K070079, X3C Digital Radiographic Detector. The Aquarius 8600 1717TC and 1417TC integrates the 510(k) cleared flat panel detectors (K122173 and K122919) 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 1717TC and 1417TC medical devices. Note: The integration of the 1717TC and 1417TC flat panel detectors and Magellan software with the workstation is exactly the same integration as the IDC marketed flat panel, InnovaXion FP, with Magellan software and workstation cleared under K111098. # The Aquarius 8600 will be marketed in two possible configurations: Aquarius 8600 1717TC (tethered, 17 x 17 inch flat panel as a retrofit package with Magellan software) referred to as "1717TC" throughout the rest of this document Aquarius 8600 1417TC (tethered. 14 x 17 inch flat panel as a retrofit package with Magellan software) referred to as "1417TC" throughout the rest of this document. {5}------------------------------------------------ # Page 3 of 9 #### 5. Indications for Use (intended use) 21 CFR 807.92(a)(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. #### 6. Technological Characteristics Summary: Predicate and proposed devices comparison 21 CFR 807.92(a)(6): The proposed 1717TC and 1417TC devices described in this 510(k) have similar technological characteristics and the same indications for use as the predicate device, X3C Digital Radiographic Detector. A summary table comparing the technological properties of the proposed devices to the predicate device has been provided in Table 1. | Characteristic | Proposed IDC<br>Aquarius 8600, model 1717TC | Proposed IDC<br>Aquarius 8600, model 1417TC | Predicate IDC<br>X3C | |------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Feature | Image: Proposed IDC Aquarius 8600, model 1717TC | Image: Proposed IDC Aquarius 8600, model 1417TC | Image: Predicate IDC X3C | | IDC<br>510(k) number | K170202 | K170202 | K070079 | | Reference<br>Device 510(k) # | K122173 | K122919 | K070079 | | Intended Use | 1717TC Digital Flat Panel X-Ray<br>Detector is indicated for digital<br>imaging solutions designed for<br>general radiographic systems for<br>human anatomy. It is intended to<br>replace film or screen based<br>radiographic systems in<br>all<br>general<br>purpose<br>diagnostic<br>procedures. Not to be used for<br>mammography. | 1417TC Digital Flat Panel X-Ray<br>Detector is indicated for digital<br>imaging solutions designed for<br>general radiographic systems for<br>human anatomy. It is intended to<br>replace film or screen based<br>radiographic<br>systems in all<br>general<br>purpose<br>diagnostic<br>procedures. Not to be used for<br>mammography. | X3C<br>X-Ray<br>Detector<br>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>diagnostic<br>general purpose<br>procedures. Not to be used for<br>mammography. | | Detector Type | Amorphous Silicon, TFT | Amorphous Silicon, TFT | D50 Dalsa /K70 Kodak Camera | | Scintillator | CsI:Tl | CsI:Tl | CsI:Tl | | Imaging Area | 17x17 inches | 14x17 inches | 17x17 inches | | Pixel Matrix | 3328 x 3328 | 2816 x 3328 | 3000 x 3000 | | Pixel Pitch | 127 um | 127 um | 144 um | | Resolution | 3.9 lp/mm | 3.9 lp/mm | 3.4 lp/mm | | A/D Conversion | 14/16 bit | 14/16 bit | 14 bit | | Preview Time | < 2 seconds | < 2 seconds | < 6 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. | | Firmware | The Firmware provided with the<br>flat panel will be utilized in this<br>medical device without<br>modification and has the same<br>functionality as the IDC X3C<br>Firmware. | The Firmware provided with the<br>flat panel will be utilized in this<br>medical device without<br>modification and has the same<br>functionality as the IDC X3C<br>Firmware. | IDC Firmware. Has the same<br>functionality as the 1717TC and<br>1417TC flat panel Firmware. | | Software | IDC Magellan 3 is a software<br>program that uses the latest digital<br>imaging and processing<br>techniques to acquire, store,<br>retrieve, transmit, and print<br>medical images for immediate<br>review and disposition.<br>DICOM 3.0 compliant. | IDC Magellan 3 is a software<br>program that uses the latest digital<br>imaging and processing<br>techniques to acquire, store,<br>retrieve, transmit, and print<br>medical images for immediate<br>review and disposition.<br>DICOM 3.0 compliant. | IDC Magellan 3 is a software<br>program that uses the latest<br>digital imaging and processing<br>techniques to acquire, store,<br>retrieve, transmit, and print<br>medical images for immediate<br>review and disposition.<br>DICOM 3.0 compliant. | | Dimensions | 460 x 460 x 15.5 mm | 384 x 460 x 15 mm | 943 x 540 x 388 mm | Table 1: Comparison of the Aquarius 8600. models 1717TC with the X3C Predicate {6}------------------------------------------------ # Page 4 of 9 {7}------------------------------------------------ ### Page 5 of 9 | Weight | 4 kg | 3.1 kg | 75 kg | |-------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------| | Application | General Radiology system<br>Use with upright stand, table,<br>universal stand. | General Radiology system<br>Use with upright stand, table,<br>universal stand. | General Radiology system<br>Use with upright stand, table,<br>universal stand | | Storage and<br>Transportation | Storage and transportation<br>Conditions:<br>Temperature -10 to +50°C<br>Humidity 10 to 80% | Storage and transportation<br>Conditions:<br>Temperature -10 to +50°C<br>Humidity 10 to 80% | Storage and transportation<br>Conditions:<br>Temperature -40 to +40°C<br>Humidity 0 to 70% | * Compliance to NEMA PS 3.1-3.20 "Digital Imaging and Communications in Medicine (DICOM) Set # Key Technology Differences: - A. Dimensions & weight: the predicate IDC X3C is a larger and heavier imaging detector than the proposed 1717TC and 1417TC flat panels. 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, the decrease in size and weight of the proposed 1717TC and 1417TC has led to decreased safety risks when compared to the predicate IDC X3C device. The Risk Assessment identified the predicate IDC X3C to hold a higher risk for injury during potential safety incidents than those of the proposed 1717TC and 1417TC flat panels based on the size and weight of each medical device. The size and weight differences between the predicate device and the proposed 1717TC and 1417TC devices does not affect device performance. - Software: IDC Magellan 3 software was integrated for use on the proposed 1717TC and B. 1417TC flat panel medical devices. The operating systems for the proposed 1717TC and 14147TC flat panels are identical to the predicate X3C detector. 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 1717SCC and 1417PCA detectors and associated firmware for the proposed 1717TC and 1417TC medical devices. No changes were made to the IDC Magellan 3 software for integration with the previously cleared 1717SCC and 1417PCA flat panels for the proposed 1717TC and 1417TC 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. {8}------------------------------------------------ # Page 6 of 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 | | 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 | {9}------------------------------------------------ ## Page 7 of 9 #### 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 1717TC and 1417TC are substantially equivalent to the predicate device, X3C Digital Radiographic Detector. The tests and corresponding results are summarized below: - A. Comparison of the Detective Quantum Efficiency (DQE), Modulation Transfer Function (MTF) and Noise Power Spectrum (NPS). ## Detective Quantum Efficiency Comparison: A comparison of measured DQE curves show that the proposed 1717TC and 1417TC flat panels has similar DQE performance at all spatial frequencies to the predicate IDC X3C detector. The 1717TC and 1417TC flat panels have a reduced pixel pitch and greater pixel count. | | 1717TC and 1417TC | X3C Detector | |---------|-------------------|--------------| | DQE (0) | 0.684 | 0.641 | ## Modulation Transfer Function: A comparison of measured MTF curves show that the 1717TC and 1417TC flat panels have the same or better resolution performance than the predicate IDC X3C detector at all spatial frequencies. | Spatial Frequency | MTF Value | | |-------------------|-------------------|--------------| | | 1717TC and 1417TC | X3C Detector | | 1 lp/mm | 0.517 | 0.385 | | 2 lp/mm | 0.230 | 0.134 | | 3 lp/mm | 0.123 | 0.075 | | 3.5 lp/mm | 0.063 | 0.063 | {10}------------------------------------------------ # Page 8 of 9 ## Noise Power Spectrum: A comparison of measured NPS curves show that the 1717TC and 1417TC flat panels have a similar noise performance profile at spatial frequencies as the predicate IDC X3C detector. | Spatial Frequency | NPS Value | | |-------------------|-------------------|--------------| | | 1717TC and 1417TC | X3C Detector | | 0 lp/mm | 8.01 | 2.21 | | 1 lp/mm | 3.30 | 0.98 | | 2 lp/mm | 1.27 | 0.82 | | 3 lp/mm | 0.64 | 0.82 | | 3.5 lp/mm | 0.58 | 0.81 | - B. Environmental, electrical, mechanical safety, and performance testing was completed for the 1717TC and 1417TC, and all testing passed, based on IEC 60601-1 Medical Electrical Equipment - Part I General Requirements for Basic Safety and Essential Performance, 300 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 1717TC and 1417TC are substantially equivalent to the IDC X3C predicate device. - IDC software has a documented lifecycle based on IEC 62304 Edition1.1:2015 "Medical D. 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 1717TC and 1417TC flat panels and compared to images acquired with the IDC X3C 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 proposed 1717TC and 1417TC devices produce images that are diagnostically similar, and slightly superior, to the predicate device. A copy of the images was submitted as part of this special 510(k) submission. # Clinical Test Summary: No clinical testing was performed for this special 510(k) submission. {11}------------------------------------------------ # Page 9 of 9 "Clinical images were provided; these images were not necessary to establish substantial equivalence based on the modifications to the device (note x-ray system that uses previously cleared detectors) but they provide further evidence in addition to bench testing data to show that the complete system works as intended." #### 8. Conclusion: The Aquarius 8600 1717TC and Aquarius 8600 1417TC medical devices have identical indications for use, and similar technological characteristics as the IDC X3C predicate device. The flat panel components for the Aquarius 8600 1717TC and Aquarius 8600 1417TC are identical to the flat panels listed as reference devices (cleared separately in K102123 and K122919), and employs the same software as the IDC X3C predicate device. The Aquarius 8600 1717TC and Aquarius 8600 1417TC devices are dimensionally smaller and lighter in weight than the predicate IDC X3C detector, which results in a safer medical device. The proposed Aquarius 8600 1717TC and Aquarius 8600 1417TC 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 1717TC and Aquarius 8600 1417TC are substantially equivalent in comparison with the IDC X3C predicate device as described herein.