ECHOVACS

K971776 · Vmi Technologies · LLZ · Jul 14, 1997 · Radiology

Device Facts

• Record ID: K971776
• Device Name: ECHOVACS
• Applicant: Vmi Technologies
• Product Code: LLZ · Radiology
• Decision Date: Jul 14, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

Intended Use

EchoVACS™ is indicated for the capture, archiving, retrieval and display of echocardiography images. It permits annotation of images as well as recording and analysis of workload statistics. It also permits report generation from a comprehensive internal lexicon of anatomic and diagnostic terms covering adult, pediatric and fetal echocardiography.

Device Story

EchoVACS™ is an all-digital networked PACS for echocardiography departments. System comprises three modules: Capture station, Review station, and Database server. Capture station connects to ultrasound machines to acquire exams; images compressed using MPEG (ISO/IEC 11172) standard. Database server provides centralized storage for patient demographics and exams. Review station allows clinicians to view exams, annotate images, and generate reports using an internal lexicon of anatomic/diagnostic terms. System facilitates workflow management through workload statistics recording. Used in clinical settings by healthcare providers to support diagnostic decision-making and patient record management.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

All-digital networked system. Image compression: MPEG (ISO/IEC 11172). Architecture: Capture station, Review station, and Database server. Connectivity: Networked system.

Indications for Use

Indicated for capture, archiving, retrieval, and display of echocardiography images in adult, pediatric, and fetal patient populations. Includes image annotation, workload statistics analysis, and report generation.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• ALI UltraPACS system (K963610)

Submission Summary (Full Text)

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

Image /page/0/Picture/0 description: The image shows the logo for VMI Technologies. The logo consists of the letters "VMI" in a bold, sans-serif font, with the word "Technologies" in a smaller, regular font to the right. A curved line extends over the letters, with a dot above the "V", creating a modern and professional look.

Tel:[phone] Fax:[phone]-ECHOVACS (toll-free) 1-888-324-6822

K971776

JUL 1 4 1997

ﻣﺴﺴﺴﺴﺴ

Section 5

# 5. 510(k) Summary

## Submitter

Douglas Seaborn Chief Executive Officer VMI Technologies 412-126 York Street Ottawa, Ontario Canada K1N 5T5

Telephone: [phone] x22 [phone] Fax:

#### Device Name

EchoVACS™ Trade name:

- Picture archiving and communications system (PACS) Common name: (ultrasound)
Classification name: Picture archiving and communications system (PACS)

## Intended Use

EchoVACS™ is indicated for the capture, archiving, retrieval and display of echocardiography images. It permits annotation of images as well as recording and analysis of workload statistics. It also permits report generation from a comprehensive internal lexicon of anatomic and diagnostic terms covering adult, pediatric and fetal echocardiography.

## Device Description

EchoVACS™ is an all-digital networked system that is intended to give the echocardiography department a solution for the capture, storage, retrieval and reporting of full-length echocardiograms. EchoVACS™ consists of three modules:

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

- Capture station this is connected to the ultrasound machine and . acquires the patient's echo exam. The images are compressed using MPEG (Moving Pictures Expert Group) which is an ISO standard (ISO/IEC 11172). Once captured, the exam is available to any station on the network.
- Review station this is connected to the network and is used to both view . echo exams and to generate the physician's report.
- Database server this supports the Capture and Review stations by . providing centralized functionality such as the storage of patient demographics.

EchoVACS™ is substantially equivalent to the ALI UltraPACS system (K963610).

## Comparisons to Predicate Device

The user features of EchoVACS™ and ALI UltraPACS system (K963610) are very similar.

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

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 1 4 1997

Doug Seaborn Chief Executive Officer VMI Technologies, Inc ............ 412-126 York Street Ottawa, Ontario Canada K1N 5T5

#### Re: K971776 EchoVacs™ (Picture Archiving and Communications Systems (PACS) ----Dated: May 9, 1997

Dear Mr. Seaborn:

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 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 general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

Received: May 13, 1997

Procode: 90 LLZ

Regulatory class: Unclassified

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 (OS) 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 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 (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours.

W.Liau Yu

Lillian Yin, 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

:

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

| 510(k) Number (if known) | K971776 |
|--------------------------|---------|
| Device Name: | ECHENKS |

Indications For Usc:

EchoVACS™ is indicated for the capture, archiving, retrieval and display of EchovACS Js indicated for the oupters, annotation of images as well as recording echocardiography imagos. It permits report generation from a and analysis of wonkloud clails.ret and diagnostic terms covering adult, pediatric and fetal echocardiography.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Rati Phillips
(Division Sign-Off)

Division of Reproductive, Abdominal, ENT, and Radiologica! Device 71776 510(k) Number

Prescription Use
(Per 21 CFR 801.109)

ાર

Over-The-Counter Use

(Optional Foruct 1-2-Xi)