M2376A DEVICELINK SYSTEM, MODEL M2376A

K014181 · Philips Medical Systems, Inc. · MWI · Jan 15, 2002 · Cardiovascular

Device Facts

• Record ID: K014181
• Device Name: M2376A DEVICELINK SYSTEM, MODEL M2376A
• Applicant: Philips Medical Systems, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Jan 15, 2002
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2

Intended Use

The M2376A DeviceLink 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 a data gateway; receives digital data from external bedside medical devices via device-specific cables; converts data into HL7 format; transmits data to networked Clinical Information Systems. Device is not patient-connected; does not perform monitoring; does not control source devices. Used in clinical environments to facilitate centralized data management for healthcare providers. Benefits include streamlined clinical information flow and integration of bedside device data into hospital networks.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Data gateway system; receives digital input via device-specific cables; converts data to HL7 format for network transmission. Standalone hardware unit for clinical information management. Not patient-contacting.

Indications for Use

Indicated for electronic data collection and clinical information management in clinical settings by interfacing with independent bedside medical devices. Not for patient monitoring or remote control of connected 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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510(k) Summary.

K014181
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## JAN 1 5 2002 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:

Mike Hudon Regulatory Approvals Engineer Philips Medical Systems 3000 Minuteman Road Andover, MA 01810-1099 Tel .: [phone] Fax.: [phone]

This summary was prepared on November 9, 1998, and updated on December 18, 2001.

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 |
| 870.2700 | Oximeter | Cardiovascular | 74 DQA |
| 868.1400 | Carbon Dioxide Gas Analyzer | Anesthesiology | 73 CCK |
| 870.1915 | Thermodilution probe | Cardiovascular | 74QGL |
| 882.1400 | Electroencephalograph | Neurological | 84GWQ |
| 868.2375 | Breathing Frequency Monitor | Anesthesiology | 73 BZQ |
| 880.5400 | Neonatal incubator | General Hospital | 80 FMZ |

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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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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized eagle with three lines forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The text is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 5 2002

Mr. Mike Hudon Regulatory Approvals Engineer Philips Medical Systems 3000 Minuteman Road Andover, MA 01810-1099

Re: K014181

Trade Name: M2376A Philips Device Link System Regulation Number: 21 CFR 870. 2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: MWI Dated: December 18, 2001 Received: December 20, 2001

Dear Mr. Hudon:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becareer of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for ass barba in the encreated of the enactment date of the Medical Device Amendments, or to conninered prior to May 20, 1978, are excerdance 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 rod may, diereleve, mains 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 (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 - Mr. Mike Hudon

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that IDA's issualled of a budewice on the clearences of the Act
that FDA has made a determination that your device complies with of consection - You must that FDA has made a decidination administered by other Federal agencies. You must of any Federal statutes and regulations daminding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFR Part 807); rabeing (21 CFR Part on 1); good management (200); and if applicable, the electronic
forth in the quality systems (QS) regulation (2) CFR Part 820); and if app form in the quality systems (QS) regulations (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) I his letter will anow you to begin marketing your avine equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivale internet the premarket notification. THC PDF miding of basification 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 CFF Part 801 and If you desire specific advice for your dovice diagnostic devices), please contact the Office of additionally 21 CFN Patt 807.10 for mi The crimes on the promotion and advertising of
Compliance at [phone]. Additionally, for questions on the promotion and advertis Compliance at [phone]. Additionally, 10 - 11.
your device, please contact the Office of Compliance at [phone] - STD Box 97 your ucined, "Misbranding by reference to premarket notification" (21CFF Part 807.97).
regulation entitled, "Misbranding by reference to premarket in trained from the Other general information on your responsibilities under the Act may be obtained from the Other general miorination on your responsional 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,

A. Don Miller

Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known):

Device Name: M2376A Device Link System

Indications for Use:

The M2376A DeviceLink 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)

Darie Tiller

K014181

OR

x Prescription Use -(Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)