Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary mentions "medical image analysis and processing software developed by others" and "proprietary software modules developed by GORCA," but there is no explicit mention of AI, ML, deep learning, or any related terms. The description focuses on standard image processing, networking, and archiving functionalities.

Therapeutic

No
The device is described as a system for storage, distribution, viewing, interpretation, and annotation of X-ray images, primarily for diagnostic purposes. It does not perform any therapeutic function.

Diagnostic

No
The device is intended for the storage, distribution, viewing, interpretation, and annotation of X-ray images, but it does not perform a diagnosis itself. Interpretation and annotation are functions performed by a human user, not the device.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is 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". This indicates it includes hardware components in addition to software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is NOT an IVD (In Vitro Diagnostic).

Here's why:

IVD devices are used to examine specimens (like blood, urine, tissue) taken from the human body to provide information about a person's health.
StatNet's intended use is for the storage, distribution, viewing, interpretation, and annotation of X-ray images of coronary anatomy. X-ray images are generated externally to the body and are not specimens taken from the body.

The device is clearly focused on handling and processing medical images obtained through an imaging modality (X-ray), not on analyzing biological samples.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes

LLZ, LMB, LMD

Device Description

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.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

coronary anatomy

Indicated Patient Age Range

Not Found

Intended User / Care Setting

cardiology departments, coronary catheterization laboratories

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K934496

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 892.1600 Angiographic x-ray system.

(a)
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.(b)
Classification. Class II.

Summary

0

K 970525 GORCA MEDICAL TECHNOLOGIES

510(k) Summary for GORCA Medical Technologies StatNet Prepared February 6, 1997

APR 1 6 1997

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

Donald G. Herzog Contact Person: Vice President, Medical Technologies
Device Trade Name: StatNet.
Picture Archiving and Communication System (PACS) Common name: for cardiology departments.
Accessory to angiographic X-ray system (892.1600) or PACS, product code Classification: 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.

1

Statement of Substantial Equivalence

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	Function or Variable	STATnet	Predicate
			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

空室

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