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.

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.

AI/ML Overview

The provided text describes the CuattroDR device, a software application for acquiring and processing digital X-ray images. The submission aims to demonstrate substantial equivalence to predicate devices, but does not contain the information requested in the prompt regarding acceptance criteria and a study proving the device meets them.

The document discusses:

Indications for Use: The CuattroDR is for capturing digital images in place of conventional film radiographic examinations, intended for retrofit on existing X-ray machines with cleared digital image capture devices. It's for use by trained personnel and not for mammography or fluoroscopy.
Technological Characteristics: It outlines features like image acquisition, processing, viewing, DICOM 3.0 compliance, and generator control. It compares these features to two predicate devices (Visaris Avanse and Cuattro UnoMD/CloudDR).
Determination of Substantial Equivalence: This is based on non-clinical performance data (bench testing).
Bench Testing: This involved verification and validation testing, focusing on differences between the CuattroDR and Cuattro UnoMD (CloudDR). The testing utilized a Sedecal SHFR generator, five different cleared wired digital image detectors from two manufacturers, and appropriate anatomical phantoms.
- Basic Functionality Tested: Establishing/Maintaining Communications, Exposure Feedback, kVp Control, mAs Control, Focal Spot Control, mA and Time Controls, Unintentional Exposure Prevention, Generator Technique Validation Feature.
- Advanced Functionality Tested: AEC Control, Workstation Assignment, Patient Size Adjustment.

The document explicitly states that the determination of substantial equivalence is based on non-clinical performance data (bench testing) and does not refer to clinical studies or patient data.

Therefore, I cannot provide answers to the following questions from the input because the information is not present in the provided text:

A table of acceptance criteria and the reported device performance
Sample size used for the test set and the data provenance
Number of experts used to establish the ground truth for the test set and their qualifications
Adjudication method for the test set
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, the effect size of how much human readers improve with AI vs without AI assistance
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The type of ground truth used
The sample size for the training set
How the ground truth for the training set was established

The document focuses on demonstrating substantial equivalence through non-clinical bench testing of its technical and functional characteristics against predicate devices, rather than presenting a clinical study with detailed performance metrics and ground truth establishment.

Summary

{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

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

TechnicalCharacteristic	CuattroDR(this submission)	Cuattro UnoMD - (Name waschanged to CloudDR on FDAregistration page 6/30/11)	VisarisVisaris Avanse®	Equivalence /Rationale
FDA 510(k) #	K161937	K093480	K150725
Indications forUse	The CuattroDR, when used with acleared digital image capture device,provides for the capture of digitalimages in place of conventional filmradiographic examinations.The device is intended to be availablefor retrofit on existing or planned x-raymachines with a cleared digital imagecapture device.The device is intended for use bytrained and qualified personnel in theacquisition and review of radiographicimages. The product is not intendedfor mammography or fluoroscopyapplications.	The Cuattro UnoMD, when used witha cleared digital image capturedevice, provides for the capture ofdigital images in place of conventionalfilm radiographic examinations.The device is intended to be availablefor retrofit on existing or planned x-raymachines with a cleared digital imagecapture device.The device is intended for use bytrained and qualified personnel in theacquisition and review of radiographicimages. The product is not intendedfor mammography or fluoroscopyapplications.	The purpose of Visaris Avanse® is toacquire, store, communicate, displayand process medical X-ray images. Itoffers features (e.g. window leveling,zoom, measurements, annotationsetc.) routinely used by medicalprofessionals, such as radiologists andradiographers. Visaris Avansesupports printing to DICOM compatibleprinters. Within a network environmentVisaris Avanse may provide othermodalities with a DICOM worklist anda DICOM worklist service. Images andworklists can be sent and receivedusing the DICOM protocol. VisarisAvanse has a modular systemarchitecture. It consists of the basicapplication for image acquisition,processing and viewing as well as anumber of other modules for imageand worklist management, archiving,search and display. Beside the basicfunctionality Visaris Avanse alsoprovides a user interface for generatorcontrol and image acquisition ofmedical images DR detectors.	Equivalent -Both devicesare intended tobe used toprovide for theacquisition ofdigital X-rayimages inplace ofconventionalfilm forradiographicexaminations.
Imageacquisition	Cleared digital image capture device(DR), utilizing fixed or portable digitalimage capture devices and wired orwireless digital image capture devices.	Cleared digital image capture device(DR), utilizing fixed or portable digitalimage capture devices and wired orwireless digital image capturedevices.	Cleared digital image capture device(DR), utilizing fixed or portable digitalimage capture devices and wired orwireless digital image capture devices.	Equivalent
Features foruse bypersonnel inthe acquisitionand review ofimages	Window levelingZoomMeasurementsAnnotations / MarkersImage StitchingImage flipImage rotateImage cropImage shutterReceptor selectionInvert (reverses gray scale)Image reject, with reason selectionAdd/Delete procedure to studyRadiology reportPatient search and entry	Window levelingZoomMeasurementsAnnotations / MarkersImage StitchingImage flipImage rotateImage cropImage shutterReceptor selectionInvert (reverses gray scale)Image reject, with reason selectionAdd/Delete procedure to studyRadiology reportPatient search and entry	Window levelingZoomMeasurementsAnnotationsImage StitchingPatient search and entryEtc.	Equivalent
TechnicalCharacteristic	CuattroDR(this submission)	Cuattro UnoMD - (Name waschanged to CloudDR on FDAregistration page 6/30/11)	VisarisVisaris Avanse®	Equivalence /Rationale
ImageProcessing	Incorporates Sharp View ImageEnhancement System manufacturedby Context Vision, AB (K024028)Context Vision is used to enhanceimages after X-Ray acquisition to helpclinicians see more detail in the digitalX-Ray image.	Incorporates Sharp View ImageEnhancement System manufacturedby Context Vision, AB (K024028)Context Vision is used to enhanceimages after X-Ray acquisition to helpclinicians see more detail in the digitalX-Ray image.	Advanced anatomy driven imageprocessing (From marketing literature)	Equivalent -Both devicesuse proprietaryimageprocessing
GeneratorControl	The CuattroDR device does provide,through an RS-232 interface, the abilityto provide control for select X-Raygenerators, including AEC - Validatedwith Sedecal Generators	NONE	Control compatibility with select X-Raygenerators - Validated with Sedecaland other generators	Equivalent
CPUWorkstationRequirements	Microsoft Windows Embedded 8.1Industry Pro Operating system thatmeets minimum system requirements.	Microsoft Windows XP/7/8.1/8Embedded Operating system thatmeets minimum systemrequirements.	MS Windows XP/7/8 operating systemon any hardware platform meeting theminimum system requirements	Equivalent - Alldevices run ona Windowsplatform
Integration	HIS/RIS - import of Modality Worklistinformation from the institution HIS/RIS	HIS/RIS - import of Modality Worklistinformation from the institutionHIS/RIS	Images and worklists can be sent andreceived using the DICOM protocol.	Equivalent
ExternalConnectivity	DICOM 3.0 Compatible - Export toexternal PACS, View Stations, CD,DICOM Print	DICOM 3.0 Compatible - Export toexternal PACS, View Stations, CD,DICOM Print	Images and worklists can be sent andreceived 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.

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.