CuattroDR

{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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of interconnected human profiles. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 October 6, 2016 Cuattro, LLC % Mr. Matthew Taylor Director, Quality Assurance/Regulatory 3760 Rocky Mountain Avenue LOVELAND CO 80538 Re: K161937 Trade/Device Name: CuattroDR Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, LLZ Dated: September 14, 2016 Received: September 15, 2016 Dear Mr. Taylor: 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. Robert Ochs 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}------------------------------------------------ ## 4. Indications for Use (Form 3881) DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use 510(k) Number (if known) K161937 Device Name CuattroDR Indications for Use (Describe) The CuattroDR, when used with a cleared digital image capture device, provides for the capture of digital images in place of conventional film radiographic examinations. The device is intended to be available for retrofit on existing or planned x-ray machines with a cleared digital image capture device. The device is intended for use by trained and qualified personnel in the acquisition and review of radiographic images. The product is not intended for mammography or fluoroscopy applications. 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." FORM FDA 3881 (8/14) Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the word "cuattro" in a lowercase sans-serif font, with a green four-leaf clover above it. The clover is stylized, with rounded leaves and a single stem extending downwards. The word "cuattro" is in a muted blue-green color, contrasting with the brighter green of the clover. The overall design is simple and clean, suggesting a modern and possibly eco-friendly brand. # 510(k) summary ## 510(k) Owner | Cuattro, LLC | | |----------------------------|-----------------| | 3760 Rocky Mountain Avenue | | | Loveland, CO 80538 | | | Phone: | 970-775-2247 | | Facsimile: | 970-775-2247 | | Registration Number: | 3008364043 | | Date Prepared: | August 30, 2016 | ## 510(k) Submitter | Cuattro, LLC | | |----------------------------|----------------| | 3760 Rocky Mountain Avenue | | | Loveland, CO 80538 | | | Phone: | 970-775-2247 | | Facsimile: | 970-775-2247 | | Contact: | Matthew Taylor | | Device Trade Name: | CuattroDR | |----------------------|-------------------------| | Common Name: | Stationary X-Ray System | | Classification Name: | Stationary X-Ray system | | Regulation Number: | 21 CFR 892.1680 | | Product Code: | KPR. LLZ | Substantial equivalence is claimed to the following Legally Marketed Devices: Primary predicate K150725: | Manufacturer: | VISARIS | |----------------------|-------------------------| | Device | Visaris Avanse | | 510(k) Number: | K150725 | | Classification Name: | Stationary X-Ray system | | Regulation Number: | 21 CFR 892.1680 | | Product Code: | KPR, LLZ | {4}------------------------------------------------ Secondary predicate K093480: | Manufacturer: | Cuattro | |----------------------|---------------------------------------------| | Device | UnoMD (CloudDR) | | 510(k) Number: | K093480 | | Classification Name: | Picture Archiving and Communications System | | Regulation Number: | 21 CFR 892.2050 | | Product Code: | LLZ | #### Device Description The CuattroDR device is a software application capable of acquiring x-ray images from commonly commercialized digital flat panels on a Windows based computer workstation. The software can use traditional mouse and keyboard inputs as well as touch screen monitors as an alternative. The use of the CuattroDR software enables the user to use a traditional x-ray generator and capture x-rav images without film. The images are processed and then presented to the user on a touch screen computer monitor, within 12 seconds after the x-ray exposure. The software also has capabilities to send images to hospital medical PACS systems and digital media for archival. In addition to this functionality, the CuattroDR software provides a user interface for generator control in the process of acquiring digital images. ### Indications for Use The CuattroDR, when used with a cleared digital image capture device, provides for the capture of digital images in place of conventional film radiographic examinations. The device is intended to be available for retrofit on existing or planned x-rav machines with a cleared digital image capture device. The device is intended for use by trained and qualified personnel in the acquisition and review of radiographic images. The product is not intended for mammography or fluoroscopy applications. ### Technological Characteristics The technological characteristics are essentially the same as the legally marketed predicate devices: - All three of the devices (the subject device as well as the predicate devices) provide for features used by personnel in the acquisition and review of radiographic images. - . All three of the devices (the subject device as well as the predicate devices) utilize software on a workstation computer with Ethernet capability, and provide DICOM 3.0 compliant connectivity. - All three of the devices (the subject device as well as the predicate devices) are a ● software solution intended for use with already cleared digital image capture devices, utilizing fixed or portable digital image capture devices and wired or wireless digital image capture devices - All three of the devices (the subject device as well as the predicate devices) provide for ● image processing of acquired images to enhance images to help clinicians see more detail in the digital X-Ray image {5}------------------------------------------------ - All three of the devices (the subject device as well as the predicate devices) are stand-. alone software products. - All three of the devices (the subject device as well as the predicate devices) have . essentially the same workstation requirements. - The new CuattroDR device as well as the Visaris Avance® device, in addition to the . image acquisition, processing and viewing, provides a user interface for generator control in the acquisition of images. The Cuattro UnoMD (CloudDR) device does not provide an interface for generator control | Technical<br>Characteristic | CuattroDR<br>(this submission) | Cuattro UnoMD - (Name was<br>changed to CloudDR on FDA<br>registration page 6/30/11) | Visaris<br>Visaris Avanse® | Equivalence /<br>Rationale | |--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | FDA 510(k) # | K161937 | K093480 | K150725 | | | Indications for<br>Use | The CuattroDR, when used with a<br>cleared digital image capture device,<br>provides for the capture of digital<br>images in place of conventional film<br>radiographic examinations.<br>The device is intended to be available<br>for retrofit on existing or planned x-ray<br>machines with a cleared digital image<br>capture device.<br>The device is intended for use by<br>trained and qualified personnel in the<br>acquisition and review of radiographic<br>images. The product is not intended<br>for mammography or fluoroscopy<br>applications. | The Cuattro UnoMD, when used with<br>a cleared digital image capture<br>device, provides for the capture of<br>digital images in place of conventional<br>film radiographic examinations.<br>The device is intended to be available<br>for retrofit on existing or planned x-ray<br>machines with a cleared digital image<br>capture device.<br>The device is intended for use by<br>trained and qualified personnel in the<br>acquisition and review of radiographic<br>images. The product is not intended<br>for mammography or fluoroscopy<br>applications. | The purpose of Visaris Avanse® is to<br>acquire, store, communicate, display<br>and process medical X-ray images. It<br>offers features (e.g. window leveling,<br>zoom, measurements, annotations<br>etc.) routinely used by medical<br>professionals, such as radiologists and<br>radiographers. Visaris Avanse<br>supports printing to DICOM compatible<br>printers. Within a network environment<br>Visaris Avanse may provide other<br>modalities with a DICOM worklist and<br>a DICOM worklist service. Images and<br>worklists can be sent and received<br>using the DICOM protocol. Visaris<br>Avanse has a modular system<br>architecture. It consists of the basic<br>application for image acquisition,<br>processing and viewing as well as a<br>number of other modules for image<br>and worklist management, archiving,<br>search and display. Beside the basic<br>functionality Visaris Avanse also<br>provides a user interface for generator<br>control and image acquisition of<br>medical images DR detectors. | Equivalent -<br>Both devices<br>are intended to<br>be used to<br>provide for the<br>acquisition of<br>digital X-ray<br>images in<br>place of<br>conventional<br>film for<br>radiographic<br>examinations. | | Image<br>acquisition | Cleared digital image capture device<br>(DR), utilizing fixed or portable digital<br>image capture devices and wired or<br>wireless digital image capture devices. | Cleared digital image capture device<br>(DR), utilizing fixed or portable digital<br>image capture devices and wired or<br>wireless digital image capture<br>devices. | Cleared digital image capture device<br>(DR), utilizing fixed or portable digital<br>image capture devices and wired or<br>wireless digital image capture devices. | Equivalent | | Features for<br>use by<br>personnel in<br>the acquisition<br>and review of<br>images | Window leveling<br>Zoom<br>Measurements<br>Annotations / Markers<br>Image Stitching<br>Image flip<br>Image rotate<br>Image crop<br>Image shutter<br>Receptor selection<br>Invert (reverses gray scale)<br>Image reject, with reason selection<br>Add/Delete procedure to study<br>Radiology report<br>Patient search and entry | Window leveling<br>Zoom<br>Measurements<br>Annotations / Markers<br>Image Stitching<br>Image flip<br>Image rotate<br>Image crop<br>Image shutter<br>Receptor selection<br>Invert (reverses gray scale)<br>Image reject, with reason selection<br>Add/Delete procedure to study<br>Radiology report<br>Patient search and entry | Window leveling<br>Zoom<br>Measurements<br>Annotations<br>Image Stitching<br>Patient search and entry<br>Etc. | Equivalent | | Technical<br>Characteristic | CuattroDR<br>(this submission) | Cuattro UnoMD - (Name was<br>changed to CloudDR on FDA<br>registration page 6/30/11) | Visaris<br>Visaris Avanse® | Equivalence /<br>Rationale | | Image<br>Processing | Incorporates Sharp View Image<br>Enhancement System manufactured<br>by Context Vision, AB (K024028)<br>Context Vision is used to enhance<br>images after X-Ray acquisition to help<br>clinicians see more detail in the digital<br>X-Ray image. | Incorporates Sharp View Image<br>Enhancement System manufactured<br>by Context Vision, AB (K024028)<br>Context Vision is used to enhance<br>images after X-Ray acquisition to help<br>clinicians see more detail in the digital<br>X-Ray image. | Advanced anatomy driven image<br>processing (From marketing literature) | Equivalent -<br>Both devices<br>use proprietary<br>image<br>processing | | Generator<br>Control | The CuattroDR device does provide,<br>through an RS-232 interface, the ability<br>to provide control for select X-Ray<br>generators, including AEC - Validated<br>with Sedecal Generators | NONE | Control compatibility with select X-Ray<br>generators - Validated with Sedecal<br>and other generators | Equivalent | | CPU<br>Workstation<br>Requirements | Microsoft Windows Embedded 8.1<br>Industry Pro Operating system that<br>meets minimum system requirements. | Microsoft Windows XP/7/8.1/8<br>Embedded Operating system that<br>meets minimum system<br>requirements. | MS Windows XP/7/8 operating system<br>on any hardware platform meeting the<br>minimum system requirements | Equivalent - All<br>devices run on<br>a Windows<br>platform | | Integration | HIS/RIS - import of Modality Worklist<br>information from the institution HIS/RIS | HIS/RIS - import of Modality Worklist<br>information from the institution<br>HIS/RIS | Images and worklists can be sent and<br>received using the DICOM protocol. | Equivalent | | External<br>Connectivity | DICOM 3.0 Compatible - Export to<br>external PACS, View Stations, CD,<br>DICOM Print | DICOM 3.0 Compatible - Export to<br>external PACS, View Stations, CD,<br>DICOM Print | Images and worklists can be sent and<br>received using the DICOM protocol. | Equivalent | {6}------------------------------------------------ ### Determination of Substantial Equivalence The determination of substantial equivalence is based upon non-clinical performance data. Bench testing has been performed on the device following Cuattro's design control processes, as well as the applicable FDA guidance documents, in particular the guidance on Content of Premarket Submissions for Software Contained in Medical Devices. Bench testing has been performed by a member of the team not directly responsible for software development undertook verification testing of the device. The verification test was in accordance with the following documents: Cuattro Design Output Document, "Design_Output_SWR_00069_MD" Cuattro Design Verification Document, "Design_Verification_SWR_00069_MD" Cuattro Design Validation Document, "Design Validation SWR 00069 MD" Validation testing for the new device included a focus on the difference between the Cuattro UnoMD (CloudDR) device and the new CuattroDR device. This testing, utilizing a Sedecal SHFR generator, five different cleared wired digital image detectors from two manufacturers, and appropriate anatomical phantoms, included: ### Basic Functionality, Establishing/Maintaining Communications, Exposure Feedback kVp Control mAs Control Focal Spot Control mA and Time Controls Unintentional Exposure Prevention Generator Technique Validation Feature {7}------------------------------------------------ Advanced Functionality, AEC Control Workstation Assignment Patient Size Adjustment The results of this bench testing have demonstrated that the device is substantially equivalent to the referenced predicate device. The details of this testing and test results are in this submission in section 18, Performance Testing – Bench #### Conclusion Based upon the analysis of the Indications for Use, Technological Characteristics, and the results of the Bench Testing performed on the device, we have determined that the CuattroDR is safe and effective, and substantially equivalent to the Predicate Device.