e Volve PACS, is a software device used for viewing and manipulating medical images and other healthcare related electronic records. Digital imaging units (including DR, CR, CT, MR, US, RF, and 2D/3D mammography), other computed and direct radiographic devices, secondary capture devices, document and film scanners, imaging gateways, other imaging devices and healthcare related electronic records can be displayed, processed, managed, stored and communicated across computer networks using this software.

e Volve PACS, can be integrated with a facility's existing Electronic Medical Records System (EMR), Hospital Information System (HIS), Practice Management System, Radiology Information System (RIS) and Dictation System. eVolve PACS, may also be integrated with the facility's Teleradiology Provider's systems. These integrations provide seamless operation and access for Providers and other caregivers to the entire spectrum of a patient's radiology records from the Provider's orders, to images of the exam, to completion data all the way to the interpretations (results/reports).

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation on the eVolve PACS. Mammographic images may only be interpreted using an FDA cleared display that offers at least 5 MP resolution and meets other technical specifications reviewed and accepted by the FDA. eVolve PACS is not intended for diagnostic review or other diagnostic uses on mobile devices.

Device Description

eVolve PACS, uses web-based technology and a secure operating system. This means that virtually any computer at any location can use an Internet browser to access eVolve PACS (and RIS) systems. Whether on-site or from another location, physicians can manage, edit, view and move diagnostic exams quickly and efficiently. As part of eVolve PACS support, eVolve PACS Inc., performs virtually all the system maintenance. eVolve PACS, has been designed to be expandable, with storage beginning at 2 TB and growing to 25 TB onboard or 256 TB expansion.

eVolve PACS is an implementation of an IHE (Integrating the Healthcare Enterprise) compliant Image Archive and Report Repository. This includes the capabilities:

To store and retrieve various kinds of DICOM Objects such as:
- Images from multiple modalities,
- Grayscale Presentation States [GSPS], which specifies the presentations of images as gray scaling, zoom, text and graphical annotations,
- Key Objects [KO], which specifies a particular selection of images for a specified reason and with an attached note,
- Structured Reports [SR].
To process HL7 notification messages from the Order Filler, about Procedure Scheduling, Procedure Updates and Patient Information Updates,
To process DICOM Modality Performed Procedure Step [MPPS] messages from modalities and forward them to the Order Filler.

eVolve PACS is a server application. Its Web-based User Interface is intended for system configuration and monitoring by system administrators.

eVolve PACS, was developed with special emphasis on its telerad features for those facilities that use teleradiology either full time or for night reads.

AI/ML Overview

The provided text describes the eVolve PACS system and its comparison to a predicate device for 510(k) clearance. However, it explicitly states that clinical testing was not necessary and that "Successful Bench Testing should be sufficient in demonstrating substantial equivalence." Therefore, there is no information in the document regarding a study involving acceptance criteria as typically understood for clinical performance, human readers, ground truth establishment, or effect sizes for AI assistance.

The document focuses on non-clinical performance data, primarily validation testing to ensure the device functions as intended and meets technical standards.

Here's a breakdown based on the information provided, highlighting what is not available from the text:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (from text)	Reported Device Performance (from text)
Functional Equivalence to Predicate Device:- Medical image management and processing system- Web-based system architecture- Log-on user ID & password security- Remote monitoring functionality- Standard image viewing layouts (up to 4x4)- WW/WL functionality- Zoom in/Zoom out- Hounsfield Measurement- Linear and angle measurements- Series Comparison- Scout line display- MPR/MIP capabilities- Stack mode- Gray scale invert- Filters- Rotate- Key Image selection- DICOM Print- Windows print- Query/Retrieve- Lossless streaming image compression- Thumbnails selection tools- Reporting Interface with template support, digital signature, and MS office formats (PDF, rtf, text, Docx)- Link to Hospital Information System (HIS)- Link to Radiology Information System (RIS)- Electronic patient record (through Broker Software)- HIPAA Compliant- PACS Server- Radiology Workstation- Basic Image Viewer- Mobile app viewer	Demonstrated Through:- Comparison table showing "Yes" for all listed features/functions for both subject and predicate devices.- "Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met."
Compliance with Standards:- DICOM Set (PS 3.1 - 3.20 (2016))- IEC 60812 Edition 3.0 2018-08 (FMEA)- ANSI AAMI IEC 62304:2006/A1:2016 (Medical device software life cycle processes)- FDA Guidance on Cyber Security: Content of Premarket Submissions for Management of Cybersecurity in Medical Devices (Oct 2, 2014)- FDA Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (May 11, 2005)	"eVolve PACS, and the device has met all the requirements listed in the Standards except for inapplicable requirements."
Safety and Effectiveness Profile (Comparable to predicate device)	"Based on the performance as documented in the Validation Testing, eVolve PACS, was found to have a safe and effectiveness profile that is similar to the predicate device."

2. Sample size used for the test set and the data provenance

Not Applicable / Not Provided: The document states "Clinical testing is not necessary to show substantial equivalence for the subject device. Successful Bench Testing should be sufficient in demonstrating substantial equivalence." Therefore, no patient test set was used. The non-clinical testing refers to "Validation Test Plan" results but does not specify a "sample size" in terms of clinical cases or data provenance.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable / Not Provided: No clinical test set requiring expert ground truth was used.

4. Adjudication method for the test set

Not Applicable / Not Provided: No clinical test set requiring adjudication was used.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No, not done: The device is a PACS system, not an AI-assisted diagnostic tool. No MRMC study was performed, and no AI assistance is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

No, not done (and not applicable): The eVolve PACS is a software device for viewing and managing medical images, not an algorithm providing diagnostic outputs. It is explicitly stated that it "does not intend to replace the skills and judgment of a qualified physician/radiologist."

7. The type of ground truth used

Not Applicable / Not Provided: No clinical ground truth (expert consensus, pathology, outcomes data) was used, as no clinical study was deemed necessary. The "ground truth" for the non-clinical validation was likely the expected functional behavior and compliance with technical standards.

8. The sample size for the training set

Not Applicable / Not Provided: No machine learning or AI models are described as being part of this device, therefore, no training set data would be relevant or provided.

9. How the ground truth for the training set was established

Not Applicable / Not Provided: No machine learning or AI models are described.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written out to the right of the square.

eVolve PACS Inc. % Mr. Carl Alletto Consultant OTech Inc. 8317 Belew Drive McKINNEY TX 75071

August 12, 2021

Re: K211863

Trade/Device Name: eVolve PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Medical image management and processing system Regulatory Class: Class II Product Code: LLZ Dated: April 27, 2021 Received: June 16, 2021

Dear Mr. Alletto:

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. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jessica Lamb For

Thalia T. 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

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Indications for Use

510(k) Number (if known) K211863

Device Name eVolve PACS

Indications for Use (Describe)

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)
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This 510(k) Summary of safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

Submission number: K211863

I. SUBMITTER

Mr. David Donahue Chief Financial Officer eVolve PACS Inc. 3924 Bryn Mawr Drive, Dallas, TX 75225 Phone: 972.567.7300 Email ddonahue@xfinitisolutions.com

Date Prepared: June 3, 2021

II. DEVICE

Name of Device: eVolve PACS Common or Usual Name: Regulation Name: Medical Image Management and Processing System Classification Name: system, image processing, radiological (21 CFR 892.2050) Regulatory Class: II Product Code: LLZ

III. PREDICATE DEVICES

The predicate device is: InstaRISPACS / InstaZFP / InstaMobi V5.0 (K182572), Class II, regulation number; 892.2050, product code LLZ.

IV. DEVICE DESCRIPTION

eVolve PACS is an implementation of an IHE (Integrating the Healthcare Enterprise) compliant Image Archive and Report Repository. This includes the capabilities:

. To store and retrieve various kinds of DICOM Objects such as:
- -Images from multiple modalities,
- -Grayscale Presentation States [GSPS], which specifies the presentations of images as gray scaling, zoom, text and graphical annotations,
- -Key Objects [KO], which specifies a particular selection of images for a specified reason and with an attached note,
- -Structured Reports [SR].
To process HL7 notification messages from the Order Filler, about Procedure ● Scheduling, Procedure Updates and Patient Information Updates,
. To process DICOM Modality Performed Procedure Step [MPPS] messages from modalities and forward them to the Order Filler.

eVolve PACS is a server application. Its Web-based User Interface is intended for system configuration and monitoring by system administrators.

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Image /page/4/Picture/0 description: The image shows the logo for "eVolve, PACS". The text is in a sans-serif font and is a gradient of blue, with the top of the letters being a darker blue and the bottom being a lighter blue. The word "eVolve" is in lowercase, and the word "PACS" is in uppercase.

eVolve PACS, was developed with special emphasis on its telerad features for those facilities that use teleradiology either full time or for night reads.

Key Feature List

. Web-based technology for access from anywhere
. Integration with any modality. RIS. HIS or EMR via DICOM. HL7. desktop Integration. and custom integration
Turnkey installations including all PACS professional services
. eVolve PACS, "off-site" disaster recovery service
eVolve PACS, Net managed VPNs ●
Transmission speed monitors and eVolve PACS, Track to monitor exams sent over . the Internet
eVolve PACS, Secure internal firewall and security features help prevent . unauthorized access to the PACS
Automatic management reports ●
Detailed HIPAA log of all PACS transactions ●
. Exam scheduling
DICOM editing ●
DICOM modality worklist
HL7 Interface engine
Automatic radiology report distribution
Diagnostic viewer ●
CD burning with viewer .
Quick viewer with auto Cobb Angle calculation ●
. Accelerated transmissions
eVolve PACS, Scan for document imaging
. eVolve PACS, eDOCS electronic forms to reduce scanning documents
Pre-fetch
. Multiple worklists

The eVolve PACS, device does not intend to replace the skills and judgment of a qualified physician/radiologist and must be used only by people who are properly trained in the system's functions and capabilities.

The User must be aware of the accuracy and precision limitations of the data displayed, printed or exported from eVolve PACS. The quality of these data depends on the information received, user interaction, and the features in the display device and printer, among others.

V. INDICATIONS FOR USE

eVolve PACS, is a software device used for viewing and manipulating medical images and other healthcare related electronic records. Digital imaging units (including DR, CR, CT. MR. US. RF. and 2D/3D mammography), other computed and direct radiographic devices, secondary capture devices, document and film scanners, imaging gateways, other imaging devices and healthcare related electronic records can be displayed, processed, managed, stored and communicated across computer networks using this software.

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Image /page/5/Picture/0 description: The image shows the logo for "eVolve PACS". The text is in a sans-serif font and is a gradient of blue, with the top of the letters being a lighter blue and the bottom being a darker blue. The word "eVolve" is in lowercase, while "PACS" is in uppercase. There is a slight shadow effect on the letters, giving them a 3D appearance.

eVolve PACS, can be integrated with a facility's existing Electronic Medical Records System (EMR), Hospital Information System (HIS), Practice Management System, Radiology Information System (RIS) and Dictation System. eVolve PACS, may also be integrated with the facility's Teleradiology Provider's systems. These integrations provide seamless operation and access for Providers and other careqivers to the entire spectrum of a patient's radiology records from the Provider's orders, to images of the exam, to completion data all the way to the interpretations (results/reports).

eVolve PACS is not intended for diagnostic review or other diagnostic uses on mobile devices.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES

The subject and predicate devices are both medical image management and processing systems, which are indicated for medical image management, review, and data distribution. Both systems have been developed to replace traditional film handling in radiology. The subject device and the predicate device are substantially equivalent in the areas of general function, application, and intended use.

Any differences between the subject and predicate devices have no negative impact on the device safety or efficacy and does not raise any new potential or increased safety risks and is equivalent in performance to existing legally marketed devices.

Feature/Functions	Subject Device - eVolve PACS	Predicate InstaRISPACS/ InstaZFP/ InstaMobi K182572
SystemIndications for Use	Medical image management and processing system	Medical image management and processing system
WorkstationClientHardware(recommended)	ProcessorIntel Core i5	Core i7 / Quad Core Xeon
	Operating SystemWindows 10 (64 bit)	Windows 8.1 (64 bit)
	DisplayMedical Grade Monitor is recommended. Resolution depends on the modality type.	Medical Grade Monitor is recommended. Resolution depends on the modality type.
	RAMMinimum 8GB RAM	Minimum 8GB RAM
	Hard Disk500 GB	750GB minimum
Server features	System ArchitectureWeb based	Web based
	HardwareVendor Agnostic	Vendor Agnostic
	SecurityLog-on user ID & password	Log-on user ID & password
	Remote monitoringYes	Yes
	DatabasePostgresSQL	MySQLv5.7
ViewerFeatures:	Image Viewing LayoutStd. formats (up to 4*4)	Std. formats (up to 4*4)
	WW/WLYes	Yes

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. S D

	510(k) Summary
--	----------------

Feature/Functions	Subject Device - eVolvePACS	Predicate InstaRISPACS/InstaZFP/InstaMobiK182572
Zoom in/Zoomout	yes	yes
HounsfieldMeasurement	Yes	Yes
Linear and anglemeasurements	Yes	Yes
SeriesComparison	Yes	Yes
Scout linedisplay	Yes	Yes
MPR/MIPcapabilities	Yes	Yes
Stack mode	Yes	Yes
Gray scaleinvert	Yes	Yes
Filters	Yes	Yes
Rotate	Yes	Yes
Key Imageselection	Yes	Yes
DICOM Print	Yes	Yes
Windows print	Yes	Yes
Query/Retrieve	Yes	Yes
Imagecompression	Lossless streaming	Lossless streaming
Selection tools	Thumbnails	Thumbnails
Reportingmodule	ReportingInterface	Can be opened from thefrom study list	Can be opened from thefrom study list
	Report TemplateSupport	User Defined templates	User Defined templates
	Digital Signature	Yes	Yes
	Report Formats	MS office formats: PDF, rtf,text, Docx	MS word
Other features	Link to HospitalInformationSystem (HIS)	Yes	Yes
	Link toRadiologyInformationSystem RIIS)	Yes	Yes
	Electronicpatient record	Through Broker Software	Through Broker Software
	HIPAA	Compliant	Compliant
Configurations	PACS Server	Yes	Yes

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Image /page/7/Picture/0 description: The image shows the words "eVolve, PACS" in a stylized font. The words are in a light blue color that fades to white at the bottom. The word "eVolve" is written in lowercase letters, while the word "PACS" is written in uppercase letters. There is a small comma between the two words.

Feature/Functions	Subject Device - eVolvePACS	Predicate InstaRISPACS/InstaZFP/ InstaMobiK182572
RadiologyWorkstation	Yes	Yes
Basic ImageViewer)	Yes	Yes
Mobile appviewer	Yes	Yes

VII. PERFORMANCE DATA

Clinical testing is not necessary to show substantial equivalence for the subject device. Successful Bench Testing should be sufficient in demonstrating substantial equivalence.

Nonclinical Testing:

The eVolve PACS, has been assessed and tested at the factory and has passed all predetermined testing criteria. The Validation Test Plan was designed to evaluate output functions, and actions performed by eVolve PACS Inc. and followed the process documented in the Validation Test Plan.

Nonclinical testing results are provided in the 510(k). Validation testing indicated that as required by the risk analysis, designated individuals performed all verification and validation activities and that the results demonstrated that the predetermined acceptance criteria were met.

Summary:

Based on the performance as documented in the Validation Testing, eVolve PACS, was found to have a safe and effectiveness profile that is similar to the predicate device.

The following Standards were used to develop eVolve PACS, and the device has met all the requirements listed in the Standards except for inapplicable requirements:

Title of Standard	Date OfRecognition	SpecialtyTaskGroup Area	FDARecognitionNumber	StandardDevelopingOrganization	StandardDesignationNumber andDate
Digital ImagingandCommunicationsin Medicine(DICOM) Set	06/27/2016	Radiology	12-300	NEMA	PS 3.1 - 3.20(2016)
Analysistechniques forsystem reliability -Procedure forfailure mode andeffects analysis(FMEA)	01/14/2019	Radiology	5-120	IEC	60812 Edition3.0 2018-08,
Medical devicesoftware -Software life cycleprocesses[IncludingAmendment 1(2016)]	01/14/2019	Software/Informatics	13-79	ANSI AAMIIEC	62304:2006/A1:2016

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Image /page/8/Picture/0 description: The image shows the logo for "eVolve, PACS". The text is in a sans-serif font and is a gradient of blue, with the top of the letters being a darker blue and the bottom being a lighter blue. The word "eVolve" is in lowercase, and the word "PACS" is in uppercase.

FDA Guidance on Cyber Security: Content of Premarket Submissions for . Management of Cybersecurity in Medical Devices Document Issued on: October 2, 2014
FDA Guidance for the Content of Premarket Submissions for Software Contained in . Medical Devices Document issued on: May 11, 2005

VIII. CONCLUSIONS

The 510(k) Pre-Market Notification for eVolve PACS, contains adequate information, data, and nonclinical test results to enable FDA - CDRH to determine substantial equivalence to the predicate device. The subject device and predicate device are substantially equivalent in the areas of technical characteristics, general function, application, and intended use does not raise any new potential safety risks and is equivalent in performance to existing legally marketed devices.

Nonclinical tests demonstrate that the device is as safe, as effective, and performs comparably to the predicate devices.

Regulation Number and Section

N/A