UROSTATION - 3D PROSTATE SUITE is a computer-based software application intended to process, visualize and record 3D digital ultrasound images of the prostate.

UROSTATION - 3D PROSTATE SUITE is intended to be used by physicians in the clinic or hospital for 2D and 3D visualization of ultrasound images of the prostate gland. Additional software features include patient data management, multi-planar reconstruction and 3D image registration.

Device Description

UROSTATION - 3D PROSTATE SUITE is a computer-based software application designed to process, visualize and record 3D digital ultrasound images of the prostate, and to manage patient and clinical data in the context of transrectal prostate biopsy.

AI/ML Overview

This 510(k) summary does not contain the acceptance criteria or a study proving that the device meets acceptance criteria in the traditional sense of a clinical performance study with statistical endpoints.

Instead, the submission focuses on demonstrating substantial equivalence to a predicate device (3-D Imaging Workstation, K081093) based on shared intended use, technological characteristics, and functions. The "study" here is a comparison of features and capabilities.

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

1. Table of Acceptance Criteria and Reported Device Performance:

Feature/Characteristic	Acceptance Criteria (Implied by Predicate)	Reported Device Performance (UROSTATION - 3D PROSTATE SUITE)
Intended Use	Process, visualize and record 3D digital ultrasound images of the prostate	Process, visualize and record 3D digital ultrasound images of the prostate
Function - Image Acquisition	2D/3D image acquisition	2D/3D image acquisition
Function - Image Viewing/Reviewing	2D/3D image viewing/reviewing	2D/3D image viewing/reviewing
Function - Image Processing	2D/3D image processing	2D/3D image processing
Function - Image Storage	2D/3D image storage	2D/3D image storage
Function - Multi-Planar Reformatting (MPR)	Multi-Planar Reformatting (MPR) (implied by predicate's "Volume rendering", "Segmentation")	Multi-Planar Reformatting (MPR)
Function - Patient and Clinical Data Management	Patient and clinical data management	Patient and clinical data management
Data Source	3D TRUS scanners	3D TRUS scanners
Physical Characterization	Software package, operates on off-the-shelf hardware, Windows OS	Software package, operates on off-the-shelf hardware, Windows OS
Differences from Predicate	Not applicable; differences are noted as not raising safety/effectiveness concerns.	• Linear workflow adapted to physician's practice. • Dedicated algorithm to visualize biopsies w.r.t. a single reference image. • No measurement features.

Note on Acceptance Criteria: The acceptance criteria are implied by the features of the predicate device. The goal of this 510(k) is to show UROSTATION performs similarly or introduces no new risks despite differences. There are no explicit quantitative performance metrics or thresholds mentioned as "acceptance criteria" for a study to meet.

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

Sample Size: Not applicable. The document describes a comparison to a predicate device's functionalities, not a clinical test set for performance evaluation.
Data Provenance: Not applicable. No specific data or images were used for performance evaluation in a clinical study context.

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. No ground truth was established by experts for a test set in this submission.
Qualifications of Experts: Not applicable.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Adjudication Method: Not applicable. No test set requiring expert adjudication was conducted.

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

MRMC Study: No. This submission does not include an MRMC comparative effectiveness study. The device is image processing software, not an AI diagnostic tool requiring evaluation of human reader performance.
Effect Size: Not applicable.

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

Standalone Study: No. This submission does not describe a standalone performance study. The device's function is to process and visualize images for physician use, not to make independent diagnoses.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Type of Ground Truth: Not applicable. No ground truth data (e.g., pathology, outcomes) was used for performance validation in this context. The "ground truth" for substantial equivalence is the predicate device's established safety and effectiveness.

8. The sample size for the training set:

Sample Size: Not applicable. The document does not mention any machine learning or AI components that would require a "training set" in the context of performance evaluation. It describes software with image processing and display algorithms.

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

How Ground Truth Was Established: Not applicable, as there is no mention of a training set.

Summary

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K100793 - Page 1 of 3

510(k) SUMMARY 5.

SEP 2222010 510(k) Summary for UROSTATION - 3D PROSTATE SUITE

The 510(k) summary is submitted in accordance with the requirements of 21 CFR 807.92.

510(k) Owner:	KOELIS5, avenue du Grand Sablon 38700 La TroncheFRANCEPhone: +33 476 637 588 Fax: +33 476 549.561
Contact Name	Cécile DESMULIEMail: cecile.desmulie@koelis.com
Date Prepared	03/17/2010

Proposed Device:

Trade Name:	UROSTATION - 3D PROSTATE SUITE
Common Name:	Medical Image Processing Software System
Classification Name:	System, Image processing, RadiologicalPicture archiving and communication system,21 CFR PART 892.2050
Device Class	II
Product Code	LLZ

Predicate Device:

The Urostation system is substantially equivalent to:

510(k) Number	K081093
Device Name	3-D Imaging Workstation

Intended Use:

UROSTATION - 3D PROSTATE SUITE is a computer-based software application intended to process, visualize and record 3D digital ultrasound images of the prostate.

Indications for Use:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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K100793 - Page 2 of 3

Device Description:

Hardware Platform and Operating System

The application runs on standard Intel PCs under Microsoft Windows® XP operating system

Peripheral and accessories

The application is controlled by a footswitch and a manual input device. It is designed to work with commercially available 3D ultrasound scanner through Ethernet connection, 3D transrectal ultrasound probe and needle guide.

Software Features

UROSTATION - 3D PROSTATE SUITE implements image fusion and display algorithms to provide 3D representation of prostate biopsies.

A typical workflow enables the physician to intraoperatively visualize the 3D mapping of biopsies with respect to a reference image of the patient's prostate.

For that purpose, 3D digital images may be transferred at any time from the 3D ultrasound scanner to the Urostation for process and display, while the physician keeps track of the organ using the usual 2D live ultrasound mode.

Alternatively, UROSTATION - 3D PROSTATE SUTE also provides a review mode that allows the mapping of histologic results on the said 3D representation of the patient's prostate. Patient information, images and 3D biopsy cartography may be stored or printed for future retrieval and examination.

Technological Characteristics compared with the predicate device:

UROSTATION - 3D PROSTATE SUITE utilizes the same technological characteristics as the predicate device.

Both are PC-based software applications that provide 2D/3D medical image acquisition and visualization for enhanced observation and analysis of the prostate gland.
Both devices provide in addition patient and clinical data management features. -
Both deal with ultrasound images received from commercially available imaging devices.

UROSTATION - 3D PROSTATE SUITE also presents differences with the predicate device. These differences do not raise any safety or effectiveness concern.

The software architecture follows a linear workflow adapted to the physician's . practice.
The system implements a dedicated algorithm to visualize biopsies with respect to . a single reference image of the prostate.
The system has no measurement features.

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K100793 - Page 3 of

Substantial Equivalence Comparison Chart

	KOELIS	EIGEN LLC
System:	3D PROSTATE SUITE	3-D Imaging Workstation
510(k) number:		K081093
Function	• 2D/3D image- acquisition- viewing/reviewing- processing- storage• Multi-Planar Reformatting (MPR)• Patient and clinical data management	• Volume rendering• Segmentation• Measurements
Function:	• Printing
Intended Use:	Process, visualize and record 3D digital ultrasoundimages of the prostate
Data Source:	3D TRUS scanners
Physical Characterization:	Software package- operates on off the shelf hardware- Windows operating system

Conclusion:

. .

The results of comparing the intended uses, functions and technological characteristics of the UROSTATION - 3D PROSTATE SUITE with its predicate devices shows that the system is as safe and as effective as its predicate device.

Therefore the UROSTATION - 3D PROSTATE SUITE is substantially equivalent to existing products currently on the market.

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Image /page/3/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an 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

Mr. Cecile Desmulie Quality Manager KOELIS 5, avenue du Grand Sablon La Tronche 38700 FRANCE

SEP 2 2 2010

Re: K100793

Trade Name: Urostation-3D Prostate Suite Regulation Number: 21 CFR $892.2050 . Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: September 17, 2010 Received: September 20, 2010

Dear Mr. Desmulie:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/cdrh/industry/support/index.html.

Sincerely yours.

Donald J. Hett

Donald J. St Pierre Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device · Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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Indications for Use

K10793

SEP 22 2010

510(k) Number (if known):

Unknown

Device Name:

UROSTATION 3D PROSTATE SUITE

Indications For Use:

Prescription Use X (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 of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Page 1 of 1

Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety

K100793
519K

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).