STATNET

K970525 · Gorca Systems, Inc. · IZI · Apr 16, 1997 · Radiology

Device Facts

• Record ID: K970525
• Device Name: STATNET
• Applicant: Gorca Systems, Inc.
• Product Code: IZI · Radiology
• Decision Date: Apr 16, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1600
• Device Class: Class 2
• Attributes: Software as a Medical Device

Indications for Use

StatNet is intended for the storage, distribution to any of several work stations, viewing, interpretation and annotation of X-ray of coronary anatomy that have been obtained in coronary catheterization laboratories and written on DICOM-3 CD-ROM media.

Device Story

StatNet is a PACS for cardiology departments; functions as a network of image display, processing, and archiving modules. Inputs consist of coronary angiographic X-ray images provided via DICOM-3 CD-ROM media. System utilizes general-purpose PC hardware, digital communication hardware, and proprietary software integrated with third-party medical image analysis tools. Operators (clinicians) use workstations to perform cine-like review, pan/zoom, frame rate control, window/level adjustments, image inversion, and real-time digital edge enhancement. System supports vessel measurements using NIH Image software. Output is displayed on high-resolution monitors (up to 1024x1024 pixels) to assist physicians in interpreting coronary anatomy and generating reports. Benefits include efficient digital storage, distribution, and review of cardiac studies compared to traditional film-based workflows.

Clinical Evidence

Bench testing only. No clinical data provided. Equivalence established through comparative analysis of functional specifications, image processing capabilities, and technical performance metrics against predicate devices.

Technological Characteristics

System comprises general-purpose PC hardware and digital communication hardware. Supports DICOM 3.0 standard for image interchange. Display resolutions: 512x512, 512x1024, and 1024x1024 pixels. Features real-time digital edge enhancement. Connectivity via digital fiber network. Software includes proprietary integration modules and third-party medical image analysis tools (NIH Image).

Indications for Use

Indicated for the storage, distribution, viewing, interpretation, and annotation of coronary angiographic X-ray images obtained in catheterization laboratories.

Regulatory Classification

Identification

An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

Predicate Devices

• Camtronics Archium (K934496)

Reference Devices

• IMACS
• EIGEN

Submission Summary (Full Text)

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GORCA MEDICAL TECHNOLOGIES K970525

510(k) Summary

APR 16 1997

for GORCA Medical Technologies StatNet

Prepared February 6, 1997

Submitted by: GORCA Medical Technologies
300 West Route 38
Moorestown, NJ 08057

Contact Person: Donald G. Herzog
Vice President, Medical Technologies

Device Trade Name: StatNet.

Common name: Picture Archiving and Communication System (PACS)
for cardiology departments.

Classification: Accessory to angiographic X-ray system (892.1600) or PACS, product code LLZ, consisting of a combination of medical image storage devices, product code LMB, and medical image communication devices, product code LMD, to which image processing and display functions have been added.

Predicate Device: Camtronics Archium manufactured by Camtronics Ltd., 900 Walnut Ridge Drive, Hartland, WI (K934496).

Description of Device:

StatNet is a network of image display, processing, and archiving modules composed of general purpose, personal computer level, digital hardware; commercial, general purpose digital communication hardware; general purpose operating systems and communications software; medical image analysis and processing software developed by others; and proprietary software modules developed by GORCA that integrate the preceding components into a complete system. Images enter the network on DICOM-3 CD-ROM media.

Intended Use of Device:

StatNet is intended for the storage, distribution to any of several work stations, viewing, interpretation and annotation of X-ray of coronary anatomy that have been obtained in coronary catheterization laboratories and written on DICOM-3 CD-ROM media.

GORCA Proprietary Information 5-1

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# Statement of Substantial Equivalence

| | | | Predicate | | |
| --- | --- | --- | --- | --- | --- |
| | Function or Variable | STATnet | IMACS | EIGEN | Camtronics |
| 1 | Electronic Equivalent of Cine Review | Yes | Yes | Yes | Yes |
| 2 | Cine-like Control Techniques | Pan and Zoom, Frame Rate Control, Window and Level Adjustments, Image Inversion | Pan and Zoom, Frame Rate Control, Window and Level Adjustments, Image Inversion | Pan and Zoom, Frame Rate Control, Window and Level Adjustments, Image Inversion | Pan and Zoom, Frame Rate Control, Window and Level Adjustments, Image Inversion |
| 3 | Vessel Measurements | Yes, Using NIH Image Software | Yes, Under Proprietary Method | Yes, Under Proprietary Method | Yes, Under Proprietary Method |
| 4 | Display Resolution | 512x512, 512x1024, and 1024x1024 Pixels | 512x512 and 512x1024 Pixels | 512x512, 512x1024, and 1024x1024 Pixels | 512x512, 512x1024, and 1024x1024 Pixels |
| 5 | Image Enhancement | Real-Time Digital Edge Enhancement While Displaying | Real-Time Digital Edge Enhancement While Displaying | Real-Time Digital Edge Enhancement While Displaying | Real-Time Digital Edge Enhancement While Displaying |
| 6 | Case Storage Technique | As a Single Patient Record | As a Single Patient Record | As a Single Patient Record | As a Single Patient Record |
| 7 | Interchange of Cardiac Angiographic Studies | CDR DICOM 3.0 Formatted Disk | CDR DICOM 3.0 Formatted Disk | CDR DICOM 3.0 Formatted Disk | CDR DICOM 3.0 Formatted Disk |
| 8 | Network Link | Digital Fiber | Digital Fiber | None (Dual-Path Digital Optical Disk as Input to all Review Stations and Archives) | Digital Fiber |
| 9 | Image Acquisition into System | DICOM 3 Formatted CDR Disk | CDR DICOM 3.0 Formatted Disk and Analog Acquisition From Cath Lab Camera | Analog Acquisition From Cath Lab Camera | CDR DICOM 3.0 Formatted Disk and Analog Acquisition From Cath Lab Camera |
| 10 | Demographics-Based Case Selection Menu | Yes | Yes | Yes | Yes |
| 11 | Archive Storage Format | Digital | Digital | Digital | Digital |
| 12 | Selected Frames Separately Stored for Use in Report Generation | Yes | Yes | Yes | Yes |

FDA Equivalence-1 copy 2/6/97