Advanced 3D Web PACS™ is a PACS and teleradiology system used to receive DICOM and other medical images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. Advanced 3D Web PACS™ is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information,

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammodraphic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA

Device Description

Advanced 3D Web PACS™ is a PACS system, comprised of acquisition components (Medweb secure DICOM Proxy Web Server, ), a central system manager component (Medical Transcription Server), a diagnostic workstation component (Radiologist Dashboard©), and an archiving component (DICOM Archive). The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. After receiving the procedure information or after receiving image objects, the central system manager searches for and retrieves relevant prior procedure data from the archive component. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the item from the operator work list. The image data is transmitted to and rendered on the user's workstation using the diagnostic workstation components. After using the workstation to view the images, the user optionally dictates a report into the system, after which, a user can play back the dictation and transcribe it to text. Once Advanced 3D Web PACS™ central system manager registers a report, the report is available for access by the referring physician, or it can be exported into an information system. At some configured point in time, the image data and the report information is delivered to the archiving component for backup and long-term storage.

AI/ML Overview

This 510(k) summary for the Advanced 3D Web PACS™ system does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

Here's why and what information is present:

Missing Information:

Table of Acceptance Criteria and Reported Device Performance: This document does not specify any quantitative or qualitative acceptance criteria for the device's performance, nor does it provide any reported performance metrics against such criteria.
Sample size and data provenance for the test set: No information on a test set, its size, or data provenance is provided.
Number of experts and qualifications for ground truth: No experts or ground truth establishment are mentioned.
Adjudication method: Not applicable as no ground truth establishment is described.
Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No such study is mentioned. The device is a PACS system, not an AI-assisted diagnostic tool in the sense of improving human reader performance.
Standalone (algorithm-only) performance study: Not applicable as the device is a PACS system for image management, not a diagnostic algorithm with standalone performance metrics.
Type of ground truth used: No ground truth is mentioned.
Sample size for the training set: No training set is mentioned.
How ground truth for the training set was established: Not applicable as no training set or ground truth is mentioned.

Information Present in the Document:

This document is a 510(k) summary for a Picture Archiving and Communications System (PACS). Its primary purpose is to demonstrate substantial equivalence to previously cleared predicate devices, not to present a detailed performance study with acceptance criteria.

The key points from the summary are:

Device Name: Advanced 3D Web PACS™ Picture Archiving and Communications System
Applicant: Nexsys, Inc., dba Medweb, LLC
Intended Use: A PACS and teleradiology system used to receive, organize, store, and make medical images, scheduling information, and textual reports available across a network. It is for hospitals, imaging centers, radiologist reading practices, and authorized users.
Software Development: Nexsys certifies that the software is designed, developed, tested, and validated according to written procedures.
Safety and Effectiveness:
- Labeling contains instructions, warnings, and cautions.
- User responsibility to ensure display quality and environmental lighting.
- "Level of concern" is "minor" as the failure or latent design flaw of the software or "off the shelf" hardware components is not expected to result in death or injury.
Substantial Equivalence: The device is deemed substantially equivalent in design and intended use to predicate devices such as AccuImage AccuView (K990241), Neo Imagery Technologies Insight Diagnostic Imaging Workstation (K982535), and Picker Voxel Q™ and Voyager™ (K962010). The document states that "all of the functions that Advanced 3D Web PACS™ performs are available in at least one of the listed substantially equivalent devices."
Limitations: Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA-approved monitor with at least 5 Mpixel resolution and other technical specifications.

In summary, this document is a regulatory submission focused on demonstrating equivalence and safe operation for a PACS system, not a clinical validation study with specific performance metrics and acceptance criteria.

Summary

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322

510(k) SUMMARY

In accordance with the provisions of the Safe Medical Device Act of 1990. Nexsys, Inc., dba Medweb, LLC, is providing a summary of safety and effectiveness information regarding the Advanced 3D Web PACS™ , Picture Archiving and Communications System.

1.1 Company Identification

Establishment Registration: 2953193 Owner Operator Number: 9017001 Nexsys Electronics, Inc. dba Medweb LLC 667 Folsom St. San Francisco CA 94107 Contact: Florent Saint-Elair Tel: (415) 541-9980 Fax: (510) 276-2648

1.2 Official Correspondent

Gary J. Allsebrook, Consultant Requlatory Management Services 16303 Panoramic Wav San Leandro CA USA 94578-1116 Tel/fax: (510) 276-2648 Cell: (510) 388-5001 Email: regman10@comcast.net

1.3 Date of Submission

November 28, 2006

1.4 Device Name

Classification Name: Common/Usual Name: Proprietary Name:

PACS Soft-copy reading and acquisition system Advanced 3D Web PACS TM

1.5 Substantial Equivalence

Advanced 3D Web PACS™ has indications for use and a target population similar to other medical image management devices, including Acculmage, AccuView, (K990241), Neo Imagery Technologies, Insight Diagnostic Imaging Workstation (K982535) and Picker, Voxel Q™ and Voyager™ (K962010). All of

DEC 1 2 2006

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the functions that Advanced 3D Web PACS™ performs are available in at least one of the listed substantially equivalent devices. In most cases, the function is available in all of them. There are no significant differences between Advanced 3D Web PACS™ and the collective functions of all the predicate devices.

1.6 Device Description and Intended Use

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA

Advanced 3D Web PACS™ is a PACS and teleradiology system used to receive DICOM images, scheduling information and textual reports, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. Advanced 3D Web PACS™ is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report information.

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1.7 Software Development

Nexsys Electronics, Inc, dba Medweb LLC certifies that the Advanced 3D Web software is designed, developed, tested and validated according to PACS TM written procedures. These procedures identify individuals within the organization

responsible for developing and approving product specifications, coding and testing, validation testing and field maintenance. The software developed for this product is used to provide diagnostic quality images and associated information for the intended users.

1.8 Safety and Effectiveness

General Safety and Effectiveness Concerns:

The device labeling contains instructions for use and any warnings or cautions to provide for the safe and effective use of the device. It is the user's responsibility to insure that display quality, environmental lighting and other possible distractions are consistent with a clinical environment. . Advanced 3D Web PACS™ is a software application(s) device. The hardware components specified are all "off the shelf" computer components.

It is our conclusion that there is no software (or hardware component in the Advanced 3D Web PACS™ device, which would be used in conjunction with the Advanced 3D Web PACS™ device) that we know of, whose failure or latent design flaw would be expected to result in death or injury to a patient. Thus the "level of concern" on the Advanced 3D Web PACS™ device is "minor".

Substantial Equivalence Summary:

Advanced 3D Web PACS™ is substantially equivalent in design and intended use(s) to diagnostic workstations, PACS and image management systems and substantiated in the substantial equivalence comparison chart in Tab 8. Any differences between the Advanced 3D Web PACS™ and the predicate devices have no significant influence on safety and effectiveness. Advanced 3D Web PACS™ , therefore, raises no new issues of safety or effectiveness from the predicate devices.

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Image /page/3/Picture/0 description: The image shows a circular logo with text around the perimeter and a stylized graphic in the center. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" and is arranged around the top and left side of the circle. The graphic in the center consists of three curved lines that appear to be stylized representations of a human figure.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

Nexsys Electronics, Inc. dba Medweb LLC % Mr. Gary J. Allsebrook Consultant Regulatory Management Services 16303 Panoramic Way SAN LEANDRO CA 94578-1116

DEC 1 2 2006

Re: K063221

Trade/Device Name: Nexsys, dba Medweb, LLC Advanced 3D Web PACS™ Picture Archiving and Communications System

Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 20, 2006 Received: October 24, 2006

Dear Mr. Allsebrook:

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 (Premarket Approval), 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.

Image /page/3/Picture/11 description: The image is a circular logo with the text "1906-2006" at the top and "Centennial" at the bottom. The letters "FDA" are prominently displayed in the center of the logo. There are four stars below the word "Centennial". The logo appears to be a commemorative emblem for the centennial anniversary of the FDA.

Protecting and Promoting Public Health

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Page 2 --

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast of advised that I between that your device complies with other requirements of the Act that I DIT has made a and regulations administered by other Federal agencies. You must or any I cactar surates and regularents, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CI IT at 607), laocing (21 OF X 1 a 1 2 1 2 3 1 2 3 1 2 1 and if applicable, the electronic fordiner and quality byevisions (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) I his icher will and in you w ought in the FDA finding of substantial equivalence of your device to a legally premaired predicated. "The 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 If you desire specific do ne 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 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under (21GF KT art 607.77). "100 may of Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150

on at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known): K063221

Nexsys, dba Medweb, LLC, Advanced 3D Web PACS™ Device Name: Picture Archiving and Communications System

Indications For Use:

(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 901.109)

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Over-the-Counter Use

David R. Ingram

(Optional Format 1-2-96)

(Division Sign-Off) Division of Reproductive, Abdomin and Radiological Devices 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).