The AquariusNET Server acquires, stores, transmits, and enables compatible computers on a network to display medical images from medical scanning devices and patient reports of various types. Teleradiology, such as MRI, CT or NM and archiving, image manipulation, 3D and 4D visualization are supported. Calcium scoring from whole body computed tomography derived measurements, for non-invasive detection and quantification of atherosclerotic plaque. Tools for histogram analysis of the density distribution of certain regions of interest are provided. A database management and report generation tool is included.

Device Description

AquariusNET is a device consisting of a DICOM server that receives and stores images from a PACS or other image giving modalities. It archives images in a scalable storage medium and delivers them in response to DICOM Query/Retrieve requests from other DICOM devices on the network (not part of AquariusNET). It also serves image requests to its remote "thin clients", which act as the graphical user interface to the AquariusNET server. The server can host multiple concurrent sessions from remote "thin clients". AquariusNET features an integrated 2D/3D streaming engine which allows regular PCs or notebooks to control the server, and to review 2D images and 3D reconstructions interactively over a network. AquariusNET is capable of image review, communications, archiving, database maintenance, reporting and basic 3D capabilities described elsewhere in this document. It is also capable of full-color Volume Rendering and Calcium Scoring.

AI/ML Overview

The provided text is a 510(k) Premarket Notification Summary for the AquariusNET Server. It describes the device, its features, and its intended use, focusing on its substantial equivalence to predicate devices. However, the document does not contain the following information typically found in a study proving a device meets acceptance criteria:

A table of acceptance criteria and the reported device performance: The document includes a "Feature Comparison Table" that lists features present in the AquariusNET Server and its predicate devices. This table serves to demonstrate functional equivalence, not performance against specific, quantitative acceptance criteria.
Sample size used for the test set and the data provenance: No information about a test set, its size, or data origin is provided.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: No mention of experts or ground truth establishment for a test set.
Adjudication method for the test set: Not applicable as no test set evaluation is described.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No MRMC study is mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: The device is an image communication and storage system with advanced visualization; its performance is described in terms of features rather than an algorithmic standalone performance study.
The type of ground truth used: Not applicable as no ground truth is mentioned for performance evaluation.
The sample size for the training set: No training set is mentioned as this is not a machine learning algorithm claim in the modern sense.
How the ground truth for the training set was established: Not applicable.

Summary of the document's content relevant to acceptance criteria and study:

The document demonstrates substantial equivalence to predicate devices (Imatron Ultra Access Workstation with Cardiac Software Extensions (K972903) and TeraRecon IiVS™ Integrated Image Viewing Station (K994329)) by comparing features.

Acceptance Criteria (Implied by Substantial Equivalence):

The implied acceptance criteria are that the AquariusNET Server possesses equivalent features and performance to the predicate devices for its intended use. The "Feature Comparison Table" acts as the primary evidence for meeting these implied criteria.

Feature	AquariusNET Server Performance (Reported as Present)	Predicate Device 1 (Imatron K972903)	Predicate Device 2 (IiVS K994339)
2D Image Review	Yes	Yes	Yes
Multiplanar reformatting	Yes	Yes	Yes
3D Volume Rendering	Yes	Yes	Yes
Maximum Intensity Projection	Yes	Yes	Yes
Image Archiving	Yes	Yes	Yes
Image Filming	Yes	Yes	Yes
Image Transfer or Network Connectivity	Yes	Yes	Yes
Examination of 2D image data from a calcium scan	Yes	Yes	Yes
Examination of calcium scan as a 3D volume	Yes	Yes	Yes
Semi-automated identification of regions considered calcium	Yes	Yes	No
User override of automatically identified regions	Yes	Yes	No
Automatic calculation of calcium score	Yes	Yes	No
Ability to measure CT numbers on a 2D image	Yes	Yes	Yes
Saving of calcium data with patient exam data	Yes	Yes	No
Creation of a paper calcium report	Yes	Yes	No
Comparison of multiple scans	Yes	Yes	Yes
Indications for use - general medical imaging workstations	Yes	Yes	Yes

Study Proving Acceptance Criteria (as presented in the 510(k) Summary):

The "study" is a feature comparison study against two predicate devices. The document implies that by demonstrating the presence of these features, the device is "substantially equivalent" to legally marketed devices, thereby meeting the regulatory requirements for market clearance.

Sample Size for Test Set & Data Provenance: Not applicable. The submission relies on a feature-by-feature comparison rather than performance testing on a specific dataset.
Number of Experts & Qualifications for Ground Truth: Not applicable. No ground truth for a test set is established.
Adjudication Method: Not applicable.
MRMC Comparative Effectiveness Study: Not performed or reported.
Standalone Performance Study: The document focuses on the functional capabilities of the system rather than an isolated algorithmic performance evaluation.
Type of Ground Truth: Not applicable.
Sample Size for Training Set: Not applicable, as this is not an AI/ML model in the modern sense.
Ground Truth for Training Set: Not applicable.

In essence, the "study" demonstrating acceptance is the comparison table itself, showing that the AquariusNET Server either matches or exceeds the features of its predicate devices, especially regarding calcium scoring functionalities compared to the IiVS, and matches the Imatron Ultra Access Workstation. The FDA's issuance of the 510(k) clearance acts as the formal acceptance that the device is substantially equivalent based on this comparison.

Summary

{0}------------------------------------------------

SEP 1 3 2001

510(k) Premarket Notification Summary of Safety and Effectiveness Information

AquariusNET Server Trade Name:

Image communication and storage system Common Name:

Classification

System, Digital Image Communication, Teleradiology System Name:

Establishment Name & Registration Number: TeraRecon, Inc. Name: Number: Pending

Classification:

$ 892.2020, System, Image Processing. Class I, proposed exempt, final rule pending.

8 892.2050, Picture Archiving and Communication System. Class I, proposed exempt, final rule pending.

90-LLZ & 90-LMD ProCode(s):

Equivalent Device(s):

Imatron Ultra Access Workstation with Cardiac Software Extensions (K972903). 1.
IiVS™ Integrated image Viewing Station (K994329). 2.

These devices are substantially equivalent in terms of basic design, features and intended use.

Description of the Device:

Applicant/Sponsor Name / Address:

TeraRecon, Inc. 2955 Campus Drive, Suite 325, San Mateo, CA 94403 650.372.2668

Contact Person:

Mr. Robert Taylor Executive Vice President TeraRecon Inc., 2955 Campus Drive, Suite 325, San Mateo, CA 94403 650.372.2668

{1}------------------------------------------------

Submission Correspondent:

Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 Pleasant Hill, CA 94523-3389 925.356.2640 / 925.356.2854 FAX

Hardware & Software Information:

The AquariusNET Server utilizes standard "off the shelf" personal computer systems and s The AquariasNET Server utinzes standard "On the Sheat" portuges and windows 2000 operating system, and a Pentium III - class processor or equivalent.

The software designed to control and manipulate the diagnostic images follows the international standard ISO/TEC 12207: 1995 Information Technology - Software Life Cycle Processes Incoment wind standard "ISO/ILC" 12207. 1775 "mormation" Toothers relative to this software has been determined using the decision tree provided in Version 1 of the FDA Software Guidance.

Feature Comparison Table:
---------------------------	--	--	--	--

Feature	AquariusNET Server	Imatron UltraAccess 972903	TeraRecon IiVSK994329
2D Image Review	Yes	Yes	Yes
Multiplanar reformatting	Yes	Yes	Yes
3D Volume Rendering	Yes	Yes	Yes
Maximum IntensityProjection	Yes	Yes	Yes
Image Archiving	Yes	Yes	Yes
Image Filming	Yes	Yes	Yes
Image Transfer orNetwork Connectivity	Yes	Yes	Yes
Examination of 2D imagedata from a calcium scan	Yes	Yes	Yes
Examination of calcium scanas a 3D volume	Yes	Yes	Yes
Semi-automated identificationof regions that are consideredcalcium	Yes	Yes	No
User override ofautomatically identifiedregions	Yes	Yes	No
Automatic calculation ofcalcium score	Yes	Yes	No
Ability to measure CTnumbers on a 2D image	Yes	Yes	Yes
Saving of calcium data withpatient exam data	Yes	Yes	No
Creation of a paper calciumreport	Yes	Yes	No
Comparison of multiple scans	Yes	Yes	Yes
Indications for use - generalmedical imaging workstations	Yes	Yes	Yes

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it, representing medicine and healing. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

TeraRecon, Inc. % Mr. David W. Schlerf Buckman Company, Inc. 200 Gregory Lane, Suite C-100 PLEASANT HILL CA 94523-3389 Re: K012086

Trade/Device Name: AguariusNET Server Regulation Number: 21 CFR 892.2050 Regulation Name: Picture Archiving and Communications System

Regulatory Class: II Product Code: 90 LLZ Dated: June 26, 2001 Received: July 3, 2001

Dear Mr. Schlerf:

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); 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.

SEP 1 3 2001

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your 510(k) premarket

notification. The FDA finding of 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:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brogdon

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

Enclosure

{4}------------------------------------------------

Page 1 of 1

510(k) NUMBER: _______________________________________________________________________________________________________________________________________________________________

DEVICE NAME : AquariusNET Server

INDICATIONS FOR USE:

The AquariusNET Server acquires, stores, transmits, and enables compatible The AquariasNET - Bervor "acquires, dical images from medical scanning devices computers on a fictwork to display tient reports of various types. Teleradiology, such as EDT, CT of NIN and parchiving, image manipulation, 3D and 4D Calcium scoring from whole body computed visualization are supported. visualization are Supported.
tomography derived measurements, for non-invasive detection and quantification of atherosclerotic plaque. Tools for histogram analysis of the density distribution of certain regions of interest are provided. A database management and report generation tool is included.

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

Nancy C. Snowdon

(Division Sign-Off)/
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K012086

Prescription Use
(Per 21 CFR 801.109) √

Over-The-Counter Use (Optional format 1-2-96)

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).