DATEX-ENGSTROM NETWORK

K974101 · Datex-Engstrom, Inc. · MSX · Feb 6, 1998 · Cardiovascular

Device Facts

• Record ID: K974101
• Device Name: DATEX-ENGSTROM NETWORK
• Applicant: Datex-Engstrom, Inc.
• Product Code: MSX · Cardiovascular
• Decision Date: Feb 6, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended Use

The Datex-Engstrom Network transfers information between networked Datex-Engstrom devices. It allows a networked device to display, store, print and otherwise process information received from other networked devices. The Datex-Engstrom Information Centre maintains the network connections between the Datex-Engstrom bedside monitors and other networked devices in Datex-Engstrom Network. Furthermore, it coordinates the transfer of information between devices in the Datex-Engstrom Network as well as between the Datex-Engstrom Network and Hospital Information Systems (HIS). The Datex-Engstrom Information Centre can be used for storing, printing, viewing or otherwise processing of information from several bedside monitors or other networked devices. The Datex-Engstrom Network will be used for patients in the hospital and it is meant for continuous use.

Device Story

Datex-Engstrom Network functions as a communication infrastructure for hospital bedside monitors; enables data transfer, storage, printing, and viewing across networked devices and Hospital Information Systems (HIS). The Information Centre acts as the central hub maintaining network connections and coordinating information flow. Used in clinical hospital settings; operated by healthcare professionals. System allows centralized monitoring of multiple patients; facilitates clinical decision-making by providing consolidated patient data access. Benefits include improved workflow efficiency and continuous patient data availability.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Network communication system for medical devices; facilitates data integration between bedside monitors and HIS. Operates as a central information hub. Connectivity via proprietary network architecture. No specific materials or energy sources defined beyond standard electronic networking hardware.

Indications for Use

Indicated for hospital patients requiring continuous monitoring; facilitates data transfer, storage, display, and processing between bedside monitors and Hospital Information Systems (HIS).

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

FEB -6 K

Mr. Joel C. Kent Manager, Quality and Regulatory Affairs Datex-Engstorm, Inc. 2 Highwood Drive Tewksbury, MA 01876

K974101 Re: Trade Name: Datex-Engstorm Network Regulatory Class: II (two) Product Code: 74 MSX January 28,1998 Dated: January 29,1998 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory 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.

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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 regulation (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. Callahan Ph.D.

Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: Datex-Engstrom Network

Indications For Use:

The Datex-Engstrom Network transfers information between networked Datex-Engstrom devices. It allows a networked device to display, store, print and otherwise process information received from other networked devices.

The Datex-Engstrom Information Centre maintains the network connections between the Datex-Engstrom bedside monitors and other networked devices in Datex-Engstrom Network. Furthermore, it coordinates the transfer of information between devices in the Datex-Engstrom Network as well as between the Datex-Engstrom Network and Hospital Information Systems (HIS).

The Datex-Engstrom Information Centre can be used for storing, printing, viewing or otherwise processing of information from several bedside monitors or other networked devices.

The Datex-Engstrom Network will be used for patients in the hospital and it is meant for continuous use.

(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

Danielle

(Optional Format 1-2-96)

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