The Presidio PACS software is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using DICOM or similar standards. Typical users of this system are trained medical professionals, including physician, nurses, technicians and computer system professionals.

To support the diagnostic interpretation of mammography studies, Presidio PACS will display the full fidelity DICOM image in a non-compressed format. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5Mpixel resolution and meets other technical specifications reviewed and accepted by FDA. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary diagnosis or image interpretation.

It is the user's responsibility to ensure quality, ambient light conditions and image compression ratios are consistent with the clinical application.

Device Description

The Presidio PACS include the following major components: Workstation, Enterprise and RIS.

The Presidio PACS workstation is used to view, edit, manipulate, annotate, analyze, store and distribute images and data that are stored and managed in the Presidio PACS Enterprise for diagnosis. This software-based product provides capabilities for the acceptance, transmission, printing, display, storage, editing and digital processing of medical images and associated data.

All acquired image data is preserved in the format in which it is received. Changes may be made to the presentation of the images. These changes are saved as display definitions only and do not alter the acquired image pixel data. Any and all display definitions applied to an image can always be reversed to the acquired state.

The Presidio PACS workstation may also be used in a remote location, away from the healthcare facility, as long as the workstation has the ability to connect, via network, to the primary healthcare facility where the Presidio PACS Enterprise is located.

The Presidio PACS Workstation extends its diagnostic and productivity capabilities into the mammography reading environment and may also be used for the primary interpretation of digital mammography images with a FDA approve 5MP monitor.

The Presidio PACS Workstation has a modular software architecture which allows adding addition feature or enhancements in the form of plug-ins without any modification to the existing software code base.

Presidio PACS Enterprise software delivers a complete, scalable storage solution for diagnostic images. Images can be stored in uncompressed, lossless or lossy. The system also has the ability to send data to DICOM ready devices via the DICOM standard protocol. It is a DICOM compliant solution for image storage, retrieval and transmission. The Enterprise Archive provides redundancy in long-term storage in several ways, including Redundant Archives, Media Copy, and Application Service Provider (ASP) Archive.

Presidio RIS provides a hospital or clinic with automated tools to electronically schedule and manages patient exam information. The Presidio RIS utilizes a Workstation client that provides referring physicians the added flexibility to instantly view and schedule their own patients' radiographic services.

The Presidio PACS software application is a software only solution and will use 'off the shelf' PC and server hardware technology that meets defined minimum specifications.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Presidio PACS device:

1. Table of Acceptance Criteria and Reported Device Performance:

The provided document does not explicitly state specific numerical acceptance criteria for performance metrics like sensitivity, specificity, or accuracy. It focuses on functional equivalence to predicate devices and software validation. The "reported device performance" is primarily articulated through the comparison table against predicate devices and the general statement about software validation.

Acceptance Criterion (Inferred from comparison to predicates and general descriptions)	Reported Device Performance (as stated in the document)
Functional Equivalence:
Communications (TCP/IP)	YES (vs. YES for predicates)
Image Archive capabilities	YES (vs. YES for predicates)
Image Processing capabilities	YES (vs. YES for predicates)
Image Edit capabilities	YES (vs. YES for predicates)
Edit Patient Demographics	YES (vs. YES for predicates)
Add and remove images	YES (vs. YES for predicates)
Combine studies	YES (vs. YES for predicates)
Edit Patient Orientation Information	YES (vs. YES for predicates)
Set and Edit Routing Information	YES (vs. YES for predicates)
JPEG Lossy/Lossless Compression	YES (vs. YES for predicates)
JPEG 2000 Lossy/Lossless Compression	YES (vs. YES for ImageSVR, NO for DATACOM DC-PACS)
Image Segmentation	YES (vs. YES for predicates)
Image Smoothing	YES (vs. YES for predicates)
Window Level, Pan, Zoom, Variable Smooth Filter, Cine Display	YES (vs. YES for predicates)
DICOM Print	YES (vs. YES for predicates)
Safety:
No patient contact	Meets (stated that device has no patient contact)
Utilized by trained professionals	Meets (stated that device is utilized only by trained professionals)
"Off-the-shelf" hardware	Meets (stated that device uses "off-the-shelf" PC and server hardware)
Compliance with electrical safety standards	Meets (stated that device complies with applicable electrical safety standards)
Software Validation:
Ability to meet intended use and specifications	Confirmed (stated "Software validation has established the device's ability to meet its intended use and established specifications.")
Risk analysis and potential hazards classification	Minor (stated that risks analysis and potential hazards have been classified Minor)
Mammography Interpretation:
Display full fidelity DICOM image	Meets (stated that device displays full fidelity DICOM image in non-compressed format)
Requires FDA approved 5MP monitor	Meets (stated that mammographic images interpreted using FDA approved 5MP monitor)
Lossy compressed/digitized film screen images NOT for primary diagnosis	Policy adhered to (stated these images must not be reviewed for primary diagnosis)

2. Sample Size Used for the Test Set and Data Provenance:

The document does not specify a sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). The evaluation is primarily based on functional equivalence to predicate devices and general software validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not mention the use of experts to establish ground truth for a test set. The evaluation relies on direct comparison of features and capabilities with predicate devices and internal software validation processes.

4. Adjudication Method for the Test Set:

Since no expert review or specific test set with ground truth is described, there is no adjudication method mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A MRMC comparative effectiveness study was NOT done according to this document. The submission focuses on substantial equivalence based on technological characteristics and functional comparison to predicate devices, not on the impact of AI assistance on human readers.

6. Standalone (Algorithm Only) Performance Study:

The document does not describe a standalone (algorithm only) performance study. The device, Presidio PACS, is a Picture Archiving and Communication System, which is a software platform for image management and display, not an AI algorithm designed to make diagnostic predictions independently. The document explicitly states: "The software does not provide any diagnostic assistance to the physician. Any diagnostic determination or treatment is solely determined by a physician and not the software."

7. Type of Ground Truth Used:

No specific "ground truth" (e.g., pathology, outcomes data, expert consensus) is mentioned as being used for performance evaluation in the context of this 510(k) submission. The evaluation centers on functional compliance and equivalence, not diagnostic accuracy of an AI component.

8. Sample Size for the Training Set:

The document does not mention a training set or its sample size. As a PACS system, it handles various medical images but does not involve training an AI model on a dataset in the way a diagnostic AI algorithm would.

9. How the Ground Truth for the Training Set Was Established:

Since there is no mention of a training set, the method for establishing its ground truth is not applicable/described.

Summary of the Study:

The study proving the Presidio PACS meets acceptance criteria is primarily a software validation and substantial equivalence comparison against two predicate devices (ImageSVR PACS and DATACOM DC-PACS).

The key elements of the study are:

Functional Comparison: Demonstrated that Presidio PACS possesses the same core functionalities (image archiving, processing, editing, communication, compression, DICOM capabilities) as its predicates.
Safety Assessment: Declared that the device has no patient contact, is used by trained professionals, utilizes "off-the-shelf" hardware, and complies with electrical safety standards.
Risk Analysis: Concluded that the risks and potential hazards were classified as "Minor."
Software Validation: Stated that software validation confirmed the device's ability to meet its intended use and established specifications.

This submission focuses on the system's capabilities and safety as an image management and display platform rather than the diagnostic performance of an AI component. Therefore, many of the typical performance metrics and study designs associated with AI devices (like specific sample sizes, ground truth establishment, or MRMC studies) are not present in this 510(k).

Summary

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K092125

5. 510(k) Summary of Safety and Effectiveness

Reaonix Security, LLC 2434 Malden Park Dr. Buford, GA 30519

DEC 1 0 2009

Date Summary Prepared: June 5, 2009

Contact Person: Gerald Jackson Reaonix Security, LLC Telephone: 678-985-3434 Fax: 678-985-3434

Device Name: Presidio PACS Trade Name(s): Presidio PACS Classification Name: Picture Archiving and Communications System Classification Regulation: Class II - 892.2050 Panel Code Device: Radiology Product Code: LLZ

Predicate Device Information: Device Name: IMAGESVR PACS Manufacturer: JAGUAR TECHNOLOGY LIMITED Reference: K082808

Device Name: DATACOM DC PACS Manufacturer: DATACOM TECHNOLOGY CORP. Reference: K083182

Device Description:

The Presidio PACS include the following major components: Workstation, Enterprise and RIS.

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The Presidio PACS software application is a software only solution and will use 'off the shelf' PC and server hardware technology that meets defined minimum specifications.

Intended Use:

The Presidio PACS software is intended for the manipulation, management, and display of medical images. It can manage and display images from different modalities and interfaces and can distribute those images to various workstation, image storage and printing devices using DICOM or similar standards. Typical users of this system are trained medical professionals, including physicians, nurses, technicians and computer system professionals.

It is the user's responsibility to ensure quality, ambient light conditions and image compression ratios are consistent with the clinical application.

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Comparison to Predicate Device(s):

Product Name	Presidio PACS	ImageSVR PACS	DATACOM DC-PACS
510(k) Number		K082808	K083182
Communications	TCP/IP	TCP/IP	TCP/IP
Image Archive	YES	YES	YES
Image Processing	Yes	YES	YES
Image Edit	Yes	YES	YES
Edit Patient Demographics	YES	YES	YES
Add and remove images	YES	YES	YES
Combine studies	YES	YES	YES
Edit Patient Orientation Information	YES	YES	YES
Set and Edit Routing Informatiion	YES	YES	YES
JPEG Lossy/Lossless Compression	YES	YES	YES
JPEG 2000 Lossy/Lossless Compression	YES	YES	NO
Image Processing (Image segmentation, image smoothing)	YES	YES	YES
Image Processing (Window Level, Pan, Zoom,Variable Smooth Filter, Cine Display)	YES	YES	YES
DICOM Print	YES	YES	YES

SUBSTANTIAL EQUIVALENCE CONCLUSIONS:

A claim of substantial equivalence is made to ImageSVR (K082808) and DATACOM DC-PACS (K083182). All of them have the same working principle and technologies. The differences are due to the feature design aspects, not relating to the safety or effectiveness aspects. Besides, the submission contains the results of software validation that the risks analysis and the potential hazards have been classified Minor.

Thus they are substantially equivalent.

Technological Characteristics:

The device does not contact the patient, nor does it control any life sustaining devices. The software does not provide any diagnostic assistance to the physician. Any diagnostic determination or treatment is solely determined by a physician and not the software. A physician, providing ample opportunity for competent human intervention, interprets images and information being displayed and printed.

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SAFETY INFORMATION:

The Presidio PACS has no patient contact and is utilized only by trained professionals. Trained professionals allow sufficient review to give identification and intervention in the event of a malfunction. Patient data is limited to authorized individuals. The Presidio PACS utilize "off-the-shelf" servers and Personal computers. It complies with applicable electrical safety standards for standard hardware and peripherals.

TESTING AND CONCLUSIONS:

ﻨ

Software validation has established the device's ability to meet its intended use and established specifications. The information provided in this traditional premarket notification submission has shown that the Presidio PACS is substantially equivalent to the predicate device(s).

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Image /page/4/Picture/0 description: The image shows a logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three heads facing left. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle. The logo is black and white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002.

DEC 1 0 2009

Mr. Gerald Jackson CEO Reaonix Security, LLC 2434 Malden Park Dr. BUFORD GA 30519

Re: K092125

Trade/Device Name: Presidio PACS Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 20, 2009 Received: November 23, 2009

Dear Mr. Jackson:

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.

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

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Enclosure

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

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4. Indication for Use Statement

Indications for Use 510(k) Number (if known): _780 12125 Device Name: _____________ Presidio PACS

Indications for Use:

It is the user's responsibility to ensure quality, ambient light conditions and image compression ratios are consistent with the clinical application.

Prescription Use _ XXX Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

H.R. Lewis

(Division Sign-Off) Division of Reproductive, Abdomina and Radiological Devic 510(k) Number

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).