VIEW ARCHIVING STATION by ELECTROMED INTL., LTD.

The VIEW Archiving Station represents the first generation of Electromed International's vascular image archiving and communication stations. The VIEW Archiving Station is intended for vascular image archiving, processing, analysis, management, and communication as the Cinenet Cardiac Image Network with the exception of analysis which is available as an option with the Cardiac Image Management System (CIMS). Some of the features offered in the VIEW Archiving Station are: vascular image processing (zoom, panning, edge enhancement, contrast), analysis (left and right ventricular functions, quantitative coronary analysis), and communication (printing of reports and sending of exam information in DICOM or Electromed encapsulation over a local area network, including images). Images are acquired in real-time on both products.

The VIEW Archiving Station may be interfaced directly with the majority of image digitizers available in todays angiographic systems. It may be linked to video signals of 1249 lines at 25 images/sec or even 1049 lines at 30 images/sec. The video signal is then re-sampled in real time to yield a signal of 625 lines which then may be recorded on a laser video disc by the CRV.

The View Archiving Station is comprised of two principle assemblies: the Electronic Cabinet; and the User Console which is connected solely to the Electronic Cabinet. Unlike the Cinenet Cardiac Image Network which uses digital videocassettes as the archiving media, the VIEW Archiving Station archives it's images on laser video discs and the exam information on internal hard disks. Each uniquely numbered laser video disc holds approximately 48 minutes (24 per side) of recording time, 35-45 examinations. The internal hard disks encompasses records that contain patient and exam information along with the referenced video laser disk ID number, which in turn, contains the recorded images. Approximately 100,000 records can be maintained on the internal hard disks at the present time. The Cinenet Cardiac Image Network incorporates a Data Storage Library which contains anywhere from 84 to 1008 digital video cassettes for automatic retrieval, whereas the VIEW Archiving Station acts as a stand alone unit whereby the laser video discs are manually inserted when prompted.

The VIEW Archiving Station is to be connected to a 230V (±10%), 50/60Hz, 10A power source.

The configurable and add-on options being offered with the VIEW Archiving Station are: Room Loop Playback (the viewing of inages on a remote monitor in the orocedure room). Table Side Joystick (remote console in the procedure room to control the playback of recorded images); SVHS Copier (the recording of exams onto a SVHS tape); and a High Definition Printing of reports, including reference images at 1200cpi and 256 gray scale levels, via an ethernet local area network).

Since the VIEW Archiving Station can transmit information and images in a Dicom compliant format, via an ethernet local area network, a CD-R Station may be connected to record exams onto a transportable media (CD). The CD-R Station is not part of this 510(k) submission.

Since the options or combination of options, as stated above, are available as an integral part of the VIEW Archiving Station, the device will inevitably be offered in various configurations while maintaining the intended use and technological characteristics presented here within.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called "VIEW Archiving Station." It describes the device's intended use and claims substantial equivalence to previously marketed devices. However, this document does not contain specific acceptance criteria, details of a study proving the device meets acceptance criteria, or information on performance metrics, sample sizes, ground truth establishment, or expert involvement as requested in your prompt.

The document states: "The VIEW Archiving Station does not in any way raise new questions of safety or effectiveness, when used as labeled, in comparison to the predicate device." This is a general statement typical of a 510(k) submission, asserting that the device is substantially equivalent to existing devices and therefore does not require new studies to demonstrate safety and effectiveness.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and the reported device performance: This information is not present in the provided text.
Sample sized used for the test set and the data provenance: This information is not present.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not present.
Adjudication method for the test set: This information is not present.
If a multi reader multi case (MRMC) comparative effectiveness study was done: This information is not present.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: This information is not present.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): This information is not present.
The sample size for the training set: This information is not present.
How the ground truth for the training set was established: This information is not present.

The document focuses on describing the device's features, functionality, and comparison to predicate devices for the purpose of demonstrating substantial equivalence for regulatory approval. It does not include the detailed study results and performance metrics that would be associated with acceptance criteria.

Summary

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ELECTROMED INTERNATIONAL
2140 boul. industriel, St-Eustache (Quebec) Canada J7R 6R4

ustriel, St-Eustache (Quebec) Canada J7R SR4
01-2100 Fax: (514) 491-4138

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971176

510(k) NOTIFICATION (VIEW ARCHIVING STATION)

Page. 1

Sept. 3, 1997

February 17, 1997

(510(k) SUMMARY) APPENDIX B

510(k) SUMMARY

SUBMITTER: Electromed International 310 Industrial Blvd. St. Eustache, Quebec Canada J7R 5R4 Tel .: (514)-491-2100 Fax. (514)-491-4138

PREPARED BY: James Riedl

ﺘﻬ

Picture Archiving and Communication System, CFR 892.2050 (CLASS II) CLASSIFICATION NAME:

COMMON OR USUAL NAME: Vascular image archiving, and communications station

PROPRIETARY NAME:	VIEW ARCHIVING STATION( Vascular Integrated Electromed Workstation )
PREVIOUSLY MARKETED DEVICE TOWHICH SUBSTANTIAL EQUIVALENCEIS BEING CLAIMED:	Sony Medical System's"Cinenet Cardiac Image Network" (K924708)and Diagnostic Archive's "Cardiac Image ManagementSystem (CIMS)" (K925961)

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-Certified
ISO 9001
Certified

510(k) NOTIFICATION (VIEW ARCHIVING STATION)

Page: 2

APPENDIX B (510(k) SUMMARY)

approximately 48 minutes (24 per side) of recording time, 35-45 examinations. The internal hard disks encompasses records that contain patient and exam information along with the referenced video laser disk ID number, which in turn, contains the recorded images. Approximately 100,000 records can be maintained on the internal hard disks at the present time. The Cinenet Cardiac Image Network incorporates a Data Storage Library which contains anywhere from 84 to 1008 digital video cassettes for automatic retrieval, whereas the VIEW Archiving Station acts as a stand alone unit whereby the laser video discs are manually inserted when prompted.

The VIEW Archiving Station is to be connected to a 230V (±10%), 50/60Hz, 10A power source.

The VIEW Archiving Station does not in any way raise new questions of safety or effectiveness, when used as labeled, in comparison to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 3 1997

James Riedi Quality Director Electromed International 310 boul. Industriel St-Eustache (Quebec) Canada J7R 5R4

Re: K971176

View Archiving Station (Vascular Image Archiving and Communication Station) Dated: July 7, 1997 Received: July 9, 1997 Regulatory class: II 21 CFR 892.1600/Procode: 90 IZI

Dear Mr. Riedl:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.

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 (2) CFR Part 80) and additionally 809.10 for in yitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

h. Lillian Yiu, Ph.D.

Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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(INTENDED USE) APPENDIX C

Device:

Picture archiving and communications system, 21 CFR 892.2050, (CLASS II)

Model:

Intended Use:

VIEW ARCHIVING STATION

Vascular image archiving, processing, analysis, management and communication.

Note: For further details, please refer to the VIEW ARCHIVING STATION User Manual

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.