M2376 DEVICELINK SYSTEM

K021912 · Philips Medical Systems, Inc. · MWI · Jun 24, 2002 · Cardiovascular

Device Facts

• Record ID: K021912
• Device Name: M2376 DEVICELINK SYSTEM
• Applicant: Philips Medical Systems, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Jun 24, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended Use

The M2376A Device Link System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. The M2376A is not intended for monitoring purposes, nor is the M2376A intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.

Device Story

M2376A Device Link System acts as data gateway; receives digital data from external bedside medical devices via device-specific cables; converts data to HL7 format; transmits to networked Clinical Information Systems. Device is not patient-connected; does not perform monitoring; does not control source devices. Used in clinical settings; operated by healthcare staff. Facilitates centralized clinical information management by integrating disparate bedside device data into hospital networks.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Communication gateway; converts proprietary digital signals to HL7 format for network transmission. Standalone hardware unit connecting to bedside devices via specific cables. Does not perform physiological monitoring or device control.

Indications for Use

Indicated for electronic data collection and clinical information management via connection to independent bedside devices. Not for patient monitoring or remote control of source devices.

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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# JUN 2 4 2002

## 510(k) Summary.

# 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. §.807.92.

1. The submitter of this premarket notification is:

Denise Haley Quality and Regulatory Engineer Philips Medical Systems 3000 Minuteman Road MS 0490 Andover, MA 01810-1099 Tel.: [phone] Fax.: [phone]

This summary was prepared on November 9, 1998, and updated on April 26, 2002.

2. The name of this device is the M2376A Device Link System. The common name is Device Link. Current Classification is (74) Cardiovascular MWI, classification names for the externally connected devices are as follows:

| REGULATION<br>NUMBER | CLASSIFICATION NAME | PANEL | PROCODE |
|----------------------|----------------------------------------------------------|------------------|---------|
| | | | |
| 870.1110 | Computer, blood pressure | Cardiovascular | 74 DSK |
| 870.1100 | Alarm, blood pressure | Cardiovascular | 74 DSJ |
| 870.1130 | System, measurement, blood pressure,<br>noninvasive | Cardiovascular | 74 DXN |
| 870.2300 | Monitor, cardiac | Cardiovascular | 74 DRT |
| 876.1800 | Urinometer | Gastro-urology | 78 EXS |
| 876.5820 | System, hemodialysis, access<br>recirculation monitoring | Gastro-urology | 78 MQS |
| 880.5725 | Pump, infusion | Gnr'l Hospital | 80 FRN |
| 870.3535 | System, balloon, intra-aortic and<br>control | Cardiovascular | 74 DSP |
| 868.5895 | Continuous ventilator | Anesthesiology | 73 CBK |
| 868.1730 | Computer, oxygen uptake | Anesthesiology | 73 BZL |
| 876.5860 | Dialyzer | Gastroenterology | 78 KDI |
| 870.2700 | Oximeter | Cardiovascular | 74 DQA |
| 868.1400 | Carbon Dioxide Gas Analyzer | Anesthesiology | 73 CCK |
| 870.1915 | Thermodilution probe | Cardiovascular | 74 QGL |
| 882.1400 | Electroencephalograph | Neurological | 84GWQ |
| 868.2375 | Breathing Frequency Monitor | Anesthesiology | 73 BZQ |
| 880.5400 | Neonatal incubator | General Hospital | 80 FMZ |
| 870.4360 | Cardiopulmonary Bypass Blood Pump | Cardiovascular | 74 KFM |

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K021912
page 2 of 2

3. The M2376A Device Link System receives digital data produced by external devices through device specific cables, converts that data into the HL7 format and transmits that information to any networked Clinical Information System.

4. When connected to a bedside device, the M2376A Device Link System is intended for electronic data collection and clinical information management. Device Link is neither patient connected, nor does it remotely control the attached source device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

JUN 2 4 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Medical Systems c/o Ms. Denise Haley Quality and Regulatory Engineer 3000 Minuteman Road Andover, MA 01810

Re: K021912

Trade Name: M2376A Device Link System Regulation Number: 21 CFR 870.2300 Regulation Name: Network and Communication Physiological System Regulatory Class: Class II (two) Product Code: MWI Dated: June 10, 2002 Received: June 11, 2002

### Dear Ms. Haley:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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) that do not require approval of a premarket approval application (PMA). 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. Iisting 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Denise Haley

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Donna-Bea Tillman, Ph.D.
Acting Director
Division of Cardiovascular
and Respiratory Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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# Page

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: M2376A Device Link System

Indications for Use:

The M2376A Device Link System is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices.

The M2376A is not intended for monitoring purposes, nor is the M2376A intended to control any of the clinical devices (independent bedside devices / information systems) it is connected to.

# (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Division of Cardio
510(k) Number K02192

Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR x (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)