CS/3 ARRHYTHMIA WORKSTATION

K974747 · Datex-Engstrom, Inc. · DSI · Apr 23, 1998 · Cardiovascular

Device Facts

• Record ID: K974747
• Device Name: CS/3 ARRHYTHMIA WORKSTATION
• Applicant: Datex-Engstrom, Inc.
• Product Code: DSI · Cardiovascular
• Decision Date: Apr 23, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1025
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The CS/3™ Arrythmia Workstation (ARRWS) is indicated for centralized monitoring, arrhythmia analysis and detection, waveform data storage and patient data storage in hospitalized patients connected to Datex-Engstrom monitors. The system is intended for use by qualified medical personnel only.

Device Story

CS/3 Arrhythmia Workstation (ARRWS) provides centralized monitoring and arrhythmia analysis for hospitalized patients. Device receives waveform and patient data inputs from connected Datex-Engstrom monitors. System performs arrhythmia detection and stores waveform/patient data. Operated by qualified medical personnel in clinical settings. Output allows clinicians to review patient status and arrhythmia events to support clinical decision-making and patient management.

Technological Characteristics

Centralized monitoring workstation for arrhythmia analysis and data storage. Interfaces with Datex-Engstrom patient monitors.

Indications for Use

Indicated for hospitalized patients connected to Datex-Engstrom monitors requiring centralized monitoring, arrhythmia analysis, and data storage. Intended for use by qualified medical personnel.

Regulatory Classification

Identification

The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.

Special Controls

*Classification.* Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.

Submission Summary (Full Text)

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

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around a symbol. The symbol is a stylized representation of three human profiles facing to the right, with flowing lines suggesting movement or connection.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 23 1998

Mr. Joel C. Kent Datex-Engstrom, Inc. 2 Highwood Drive Tewksbury, MA 01876

K974747 Re: CS/3™ Arrthymia Workstation Regulatory Class: III (three) Product Code: 74 DSI December 18, 1997 Dated: December 19, 1997 Received:

Dear Mr. Kent:

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, 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 either class II (Special Controls) or 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 requirements, 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 the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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

## Page 2 - Mr. Joel C. Kent

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 requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion 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,
Thomas J. Callihan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

510(k) Number (if known): __

Device Name: Datex-Engstrom CS/3 Arrhythmia Workstation

Indications For Use:

The CS/3™ Arrythmia Workstation (ARRWS) is indicated for centralized monitoring, arrhythmia analysis and detection, waveform data storage and patient data storage in hospitalized patients connected to Datex-Engstrom monitors.

The system is intended for use by qualified medical personnel only.

ﺼﺔ، ﻓ

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
(Per 21 CFR 801.109)

OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

*Division Sign-Off*

Division of Cardiovascular, Respiratory, and Neurological Devices

510(k) Number_