The StatPacs™ is a software based PACS product intended to be used by radiologists, technologists and clinicians, to operate on specified off the shelf hardware that will provide a teleradiology and PACS solution for hospital and remote site use. The StatPacs™ software will transmit, receive, display, and store 2D/3D images for clinical evaluation and diagnosis by way of industry standard networked gateways including VPNs, and LAN/WAN through DICOM allowing StatPacs™ to interface to all modalities including but not limited to, CT, MRI, Ultrasound (US), CR, DR, Nuclear Medicine (NM), PET, digitized radiographic films and all administration systems. StatView™ with the Exam Manager™ application, is a primary user interface for processing of medical images for primary image diagnosis. Image compression and encryption adhere to standard industry protocol. StatPacs™, is not to be used for mammography imaging.

Device Description

The StatPacs™ is a software based PACS product, intended to be used by radiologists technologists and clinicians, to operate on specified off the shelf hardware (OTS) that will provide teleradiology and PACS solution for hospitals/clinics and remote site use. The StatPacs™ software will transmit, receive, display, and store 2D/3D images for clinical evaluation and diagnosis. Networked gateways, including LAN/WAN through DICOM and other industry standards allow StatPacs™ to interface to all modalities including but not limited to, CT, MRI, Ultrasound (US), CR, DR, Nuclear Medicine (NM), PET, digitized radiographic films and all administration systems. StatRad, LLC provides and installs off the shelf hardware including a hospital and central server, at client hospitals and off site facilities to ensure a safe, secured, private network for image transmission via the internet. No equipment is installed in the patient environment. Additionally, VPN's and other encryption methodology are utilized and allow rapid transmission of image compression and encryption adhere to standard industry protocol. StatView™ with the Exam Manager™ application is a primary user interface for processing of medical images for primary image diagnosis. StatPacs™, is not to be used for mammography imaging.

AI/ML Overview

This submission package for StatPacs™ refers to a Picture Archiving and Communications System (PACS) software. A PACS is a system that allows for the storage, retrieval, distribution, and presentation of medical images. These systems are well-established, and the regulatory filing here is for a new version or offering of such a system. The key to understanding this document is recognizing that the primary claim is for substantial equivalence to existing PACS devices. This means the manufacturer is arguing that their device is so similar to previously cleared devices (predicates) that it doesn't raise new questions of safety or effectiveness.

Therefore, the "acceptance criteria" and "study" information you're asking for in the context of an AI-powered device or a study proving device performance in a clinical diagnostic sense, is not present here. This document primarily focuses on demonstrating that the StatPacs™ system behaves like other PACS systems already on the market. There is no mention of AI, specific diagnostic performance metrics like sensitivity/specificity, or clinical studies designed to show a performance benefit.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance & 6. Standalone Algorithm Performance:

This submission does not contain specific "acceptance criteria" or reported "device performance" in the sense of diagnostic accuracy or clinical utility metrics (e.g., sensitivity, specificity, AUC) for an AI algorithm. The device, StatPacs™, is a PACS software, and its claimed performance is its ability to function as a PACS system, similar to its predicate devices. The acceptance criteria for such a device are typically related to:

Functionality: Transmit, receive, display, and store 2D/3D images.
Connectivity: Interface with various modalities (CT, MRI, US, CR, DR, NM, PET, digitized films) via industry standards (DICOM, LAN/WAN, VPNs).
Image Handling: Image compression and encryption adhering to standard industry protocols.
Safety & Effectiveness: No new issues of safety or effectiveness compared to predicate devices.

The "reported device performance" is essentially that it meets these functional requirements and is substantially equivalent to predicate PACS systems. There is no standalone (algorithm-only) performance study described because it's a PACS system, not a diagnostic AI algorithm.

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

Not applicable. This 510(k) submission does not describe a clinical study with a test set of patient cases to evaluate diagnostic performance. The substantial equivalence argument relies on comparing the technical and functional characteristics of StatPacs™ to predicate PACS devices.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Not applicable. As no clinical diagnostic performance study is described, there's no mention of experts establishing ground truth for a test set.

4. Adjudication Method for the Test Set:

Not applicable. No test set or corresponding adjudication method is described.

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

No MRMC study was done or reported in this document. The submission is for a PACS system, not an AI-assisted diagnostic tool that would typically undergo such a study to assess human reader improvement.

7. Type of Ground Truth Used:

Not applicable. No ground truth is established or used in the context of diagnostic performance for this submission, as it's a PACS system.

8. Sample Size for the Training Set:

Not applicable. As this is not an AI diagnostic algorithm, there is no mention of a training set of data.

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

Not applicable. Since there is no training set mentioned, there is no information on how ground truth for it would be established.

Summary regarding the nature of the submission:

This 510(k) summary is for a Picture Archiving and Communications System (PACS). It emphasizes software-based functionality for image handling (transmit, receive, display, store) and connectivity with various medical imaging modalities. The core of the submission is the claim of substantial equivalence to existing, legally marketed PACS devices (predicates). This means the StatPacs™ system behaves in a functionally similar manner to already approved PACS, rather than introducing new diagnostic capabilities that would require a detailed clinical performance study with acceptance criteria, test sets, ground truth, and AI-specific evaluations. The FDA's letter confirms substantial equivalence based on the provided information, not on a clinical performance study demonstrating unique diagnostic accuracy.

Summary

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SEP 1 5 2009

510k Summary of Safety & Effectiveness

K092134
P. 1 of 2

This summary of 510k Safety and Effectiveness information is being submitted in accordance with the requirements of the SMDA 1990 and 21 CFR 807.92.

Date of Submission:	(updated 8/04/09)
Submitter/Mfg:	StatRad, LLC
Company Contact:	Joe Moock, CEO
Preparer/510k Contact:	Linda J. Moore, Regulatory Consultant, 408-504-0565 lindajm@aol.com
Device NameCommon/usual name:Proprietary Name:	Picture Archiving & Communications System (PACS)Medical Imaging Processing/Teleradiology SystemStatPacs™
Predicate device(s):	Virtual Radiologic Corporation11995 Singletree LaneMinneapolis, MN 55344 vRad PACS K090649
	Mercury Computer Systems Inc.199 Riverneck Rd.Chelmsford, MA 01824-2820 VISAGE PACS/CS K062490
	VISAGE IMAGING, INC1815 ASTON AVENUE, SUITE 107CARLSBAD, CALIFORNIA, 92008 VISAGE PACS/CS K082269

Description/Intended use:

Networked gateways, including LAN/WAN through DICOM and other industry standards allow StatPacs™ to interface to all modalities including but not limited to, CT, MRI, Ultrasound (US), CR, DR, Nuclear Medicine (NM), PET, digitized radiographic films and all administration systems. StatRad, LLC provides and installs off the shelf hardware including a hospital and central server, at client hospitals and off site facilities to ensure a safe, secured, private network for image transmission via the internet. No equipment is installed in the patient environment. Additionally, VPN's and other encryption methodology are utilized and allow rapid transmission of image compression and encryption adhere to standard industry protocol. StatView™ with the Exam Manager™ application is a primary user interface for processing of medical images for primary image diagnosis. StatPacs™, is not to be used for mammography imaging.

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Technical Characteristics:

This is a medical imaging software device that is used with OTS computer hardware in a picture archiving and communications system user environment. The device does not contact the patient, nor does it control any life sustaining devices. The technical characteristics are similar in design, technical requirements and intended use to predicate devices.

Substantial Equivalence Summary

The StatPacs™ is substantially equivalent in design, technical requirements, and intended use to diagnostic radiological workstations, PACS and image management systems as substantiated in the feature comparison. The predicate device comparison clearly demonstrates that StatPacs™ is substantially equivalent in all areas such as functionality, user/software features, OTS hardware components and connectivity.

Conclusions:

Based on the information provided in this premarket notification submission, StatPacs™ is substantially equivalent to predicate devices and raises no new issues of safety or effectiveness from its predicate devices.

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Image /page/2/Picture/0 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three stripes representing the three levels of government: federal, state, and local. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

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

SEP 15 2009

StatRad LLC % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K092134

Trade/Device Name: StatPacs™ Picture Archiving and Communications Systems (PACS) Software Regulation Number: 21 CFR 892.2050

Regulation Name: Picture archiving and communications system

Regulatory Class: II

Product Code: LLZ

Dated: September 1, 2009

Received: September 2, 2009

Dear Mr. Job:

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 mav 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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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.

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.html

Sincerely yours,

Lucia M. Merritt

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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510k # K 09 21 34

Device Name:

StatPacs™ Picture Archiving and Communications Systems (PACS) Software

Indications for Use

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence or CDRH, Office of Device Evaluation (ODE)

lankh

Dimiti Voikore

(Division Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number

P. 1 of 1

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).