The BRIT PACS Systems is an image management system whose intended use is to provide (scaleable) DICOM compatible PACS solutions for hospital and related institutions/sites, which will archive/ distribute/ retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR, and other devices) and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentation", and will include standard features and other Mammo tools. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammography images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.

Application areas include imaging centers, radiologist central reading rooms, and any other locations where trained medical professionals would require access or desire patient images, demographic information, or other patient medical information captured in the system.

Device Description

BRIT PACS Systems provides custom, turn-key solutions for PACS and teleradiology based systems on the latest DICOM standards. Using PACS, medical images can be made available at multiple locations - virtually anywhere at any time. Modular components make BRIT's solutions flexible, upgradeable, and scaleable.

BRIT SCAN is a high-quality film digitization system that allows standard radiographs to be converted into electronic images for transmission to PACS and teleradiolgy systems. BRIT Scan allows the users to integrate standard radiographic studies, which are often used for comparison studies, into the PACS strategy.

BRIT Quality Workbench is a DICOM based application that runs on a PC and is used to provide patient demographic and image data quality control functions within the PACS system.

BRIT Roentgen RIS provides a hospital or clinic with automated tools to electronically schedule and manage patient exam information. The Roentgen RIS utilizes a web based client that provides referring physicians the added flexibility to instantly view and schedule their own patients' radiographic services. The Roentgen RIS also accesses the same database as BRIT'S PACS solution.

BRIT Roentgen Files is the main product for exam and report storage in a PACS environment. It runs a DICOM Server and Web Server plus a selection of the following applications, all using the same database.

DICOM Archive
Modality Worklist Server
HL-7 Interface Engine
Order Entry/Scheduling package

BRIT Viewing Workbenches offer different viewing applications to address the differing needs of the users.

BRIT Vision is a diagnostic reading workbench which provides radiologists and high-power users a fully configured 12-bit DICOM image viewing workstation.

BRIT Vision Mammography Module is an optional diagnostic module utilizing 5MP monitors that runs in the BRIT Vision medical image viewing workstation.

BRIT View is a clinical viewing workstation or diagnostic reading workbench which provides high quality image viewing and manipulation capabilities in a fully configured 12-bit DICOM workstation, for use in radiology or non-radiological area of the facility such as ER, Surgery, ICU, and other areas.

BRIT Lite is a viewing application that responds to the needs of healthcare organization that require access to images anywhere, anytime, but without the need for advanced visualization tools or large application on each workstation.

BRIT Roentgen Burner is a DICOM compliant automated solution for producing custom-labeled CD's and or DVD's that contain medical images plus BRIT's image viewing software. Radiological studies are sent to this device from any BRIT DICOM workstation on the network.

BRIT Roentgen Works is a workflow management service for radiologists to provide remote reading services for multiple health care facilities.

AI/ML Overview

This 510(k) submission for the "BRIT PACS Systems" device does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and a definitive study. A 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the same way a PMA (Premarket Approval) might.

Here's what can be extracted and what is explicitly not available in the provided text:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Not provided. This submission focuses on substantial equivalence to predicate devices, not specific performance metrics or acceptance criteria for a novel device.	Not provided. Performance is implied to be equivalent to predicate devices without specific quantitative measures.

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

Sample size for test set: Not provided. The submission does not detail a specific test set or clinical study.
Data provenance: Not applicable, as no specific test data is presented. The submission relies on establishing equivalence to existing FDA-cleared PACS systems.

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

Number of experts: Not applicable, as no specific test set requiring expert ground truth establishment is detailed.
Qualifications of experts: Not applicable.

4. Adjudication method for the test set

Adjudication method: Not applicable, as no test set requiring adjudication is detailed.

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

MRMC study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted or reported in this submission.
Effect size: Not applicable, as no MRMC study was performed and this device is a PACS, not an AI-assisted diagnostic tool.

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

Standalone study: No, a standalone performance study (algorithm only) was not conducted or reported. This device is a PACS, which is inherently a system where humans interact with images and information.

7. The type of ground truth used

Type of ground truth: Not applicable, as no specific test or clinical validation data requiring an independent ground truth is discussed. The submission relies on the established function and safety of predicate PACS devices.

8. The sample size for the training set

Sample size for training set: Not applicable. This device is a Picture Archiving and Communications System (PACS). It is a software system for managing and displaying medical images and information, not an AI/ML algorithm that requires a training set in the typical sense. Its functionality is based on DICOM standards, system integration, and user interface development.

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

Ground truth for training set: Not applicable, as this is not an AI/ML device requiring a training set with established ground truth.

Summary of what is present in the 510(k) document:

Device Name: BRIT PACS Systems
Intended Use: To provide DICOM compatible PACS solutions for archiving, distributing, retrieving, and displaying images (CR, CT, DR, MR, mammography) and data from hospital modalities and information systems. It also includes displaying structured reports.
Predicate Devices: K062477 AMICAS Vision Series PACS and K041935 DR Systems PACS.
Substantial Equivalence Conclusion: The submitter concludes that the intended use and technological characteristics are equivalent to the predicate devices.
Safety Information: The device has no patient contact and is used by trained professionals who can identify and intervene in case of malfunction. Patient data is limited to authorized individuals.
Mammography Specifics: Mentions that lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammography images for interpretation require an FDA approved monitor with at least 5-megapixel resolution.

In essence, this 510(k) submission is a "substantial equivalence" filing for a PACS system, which is a foundational medical IT infrastructure, not a novel diagnostic AI algorithm that would typically require extensive performance studies with acceptance criteria, ground truth, and reader studies.

Summary

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MAR 2 $ 2009

Ka81168
Page 1 of 3

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS (21CFR 807.92)

DATE PREPARED: 4/21/2008 I.

II. SUBMITTER: BRIT Systems, Inc. 1909 Hi-Line Dr.
CONTACT PERSON: III.

Dallas, TX 75207

Robert Murry VP of Engineering bob@brit.com Phone: 214-630-0636 214-630-1638 Fax:

IV. DEVICE NAME:

Classification Name: Trade/Proprietary Name: Picture Archiving and Communications System (PACS) BRIT PACS SYSTEMS

V. DEVICE CLASSIFICATION Class II CFR section: 892.2050 Product code: LLZ Panel: Radiology

VL PREDICATE DEVICES:

K062477 AMICAS Vision Series PACS Class II Decision Date: 10/27/2007

K041935 DR Systems PACS Class II Decision Date: 08/16/2004

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KC81/68
Page 2 of 3

SUBSTANTIAL EQUIVALENCE CONCLUSIONS: VII.

BRIT Systems concludes that the intended use for the BRIT PACS Systems is the same as that of the predicate devices, and that the technological characteristics demonstrate that they are equivalent to the predicate device. A comparison of the technological characteristics of the predicate and legally marketed devices available has been performed.

Thus, this premarket notification has demonstrated substantial equivalence.

VIII. DEVICE DESCRIPTION AND INTENDED USE:

System Description:

BRIT Quality Workbench is a DICOM based application that runs on a PC and is used to provide patient demographic and image data quality control functions within the PACS system.

DICOM Archive �
Modality Worklist Server �
HL-7 Interface Engine �
Order Entry/Scheduling package ◆

BRIT Viewing Workbenches offer different viewing applications to address the differing needs of the users.

BRIT Vision is a diagnostic reading workbench which provides radiologists and high-power users a fully configured 12-bit DICOM image viewing workstation.

BRIT Vision Mammography Module is an optional diagnostic module utilizing 5MP monitors that runs in the BRIT Vision medical image viewing workstation.

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BRIT Roentgen Works is a workflow management service for radiologists to provide remote reading services for multiple health care facilities.

Indications for Use:

IX. SAFETY INFORMATION:

The BRIT PACS Systems has no patient contact and is utilized only by trained professionals. Trained professionals allow sufficient review to afford identification and intervention in the event of a malfunction have evaluated the output of the device. Patient data is limited to authorized individuals.

X. CONCLUSION:

BRIT PACS Systems believes sufficient information is included to reach a determination of substantial equivalence. We conclude that the subject device is as safe and effective including the component and accessory devices.

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 3 2009

Mr. Robert Murry VP of QA/Engineering BRIT Systems 1909 Hi Line Drive DALLAS TX 75207

Re: K081168

Trade/Device Name: BRIT PACS Systems Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications systems Regulatory Class: II Product Code: LLZ Dated: February 18, 2009 Received: February 19, 2009

Dear Mr. Murry:

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 such 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.

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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; 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding os substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter.

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	(240) 276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	(240) 276-0115
21 CFR 892.xxx	(Radiology)	(240) 276-0120
Other		(240) 276-0100

Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufactures, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry.suppot/index.html.

Sincerely yours,

Janine M. Morris

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

Enclosure

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K081168

MAR 2 3 2009

510(k) Number (if known): N/A Kosilla

Device Name: BRIT PACS Systems

Indications for Use:

The BRIT PACS Systems is an image management system whose intended use is to provide (scaleable ) DICOM compatible PACS solutions for hospital and related institutions/sites, which will archive/ distribute/ retrieve and display images and data from all hospital modalities (such as CR, CT, DR, MR and other devices) and information systems. This also includes the display of structured reports and mammography images that have been created according to DICOM "For Presentations, and will include standard features and other Mammo tools. Lossy compressed mammography images and digitized film screen images must not be used for primary image interpretations. Mammography images may only be interpreted using an FDA approved monitor that offers at least 5 mega pixel resolution and meets other technical specifications approved by the FDA.

Application areas include imaging centers, radiologist central reading rooms and any other locations where trained medical professionals would require access or desire patient images, demographic information or other patient medical information captured in the system.

(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED.) Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) Over the Counter Use

Tozu In Whan

(Division Sigi Division of Reproductive, Abdominal and Radiological Davices 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).