MODIFICATION TO M2376A DEVICELINK SYSTEM

K013470 · Philips Medical Systems, Inc. · MWI · Nov 14, 2001 · Cardiovascular

Device Facts

• Record ID: K013470
• Device Name: MODIFICATION TO M2376A DEVICELINK SYSTEM
• Applicant: Philips Medical Systems, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Nov 14, 2001
• 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

The M2376A Device Link System acts as a data gateway for clinical information management. It receives digital data from external bedside medical devices via device-specific cables; transforms this data into HL7 format; and transmits it to clinical information systems. The device is used in clinical environments where it facilitates data collection and management. It does not perform patient monitoring, nor does it control the connected bedside devices. Healthcare providers use the output to manage clinical information, which supports documentation and data integration workflows. The device benefits patients by enabling centralized, efficient management of clinical data collected from various bedside monitors and therapeutic devices.

Clinical Evidence

Bench testing only.

Technological Characteristics

The system consists of hardware interfaces for connecting to bedside devices via device-specific cables. It performs data conversion to HL7 standards for network transmission. It is a non-monitoring, non-control data management system.

Indications for Use

Indicated for use in clinical settings for the collection and management of data from independent bedside medical devices. Not intended for patient monitoring or 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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K013470

### 510(k) Summary.

## NOV 1 4 2001

#### 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted
Safety and China Safe of the Safe Medical Devices Act of 1990 This summary of 510(K) safety and enectiveness in offectively and enough and of 1990
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 October 16, 2001

2. The name of this device is the M2376A Device Link System. The common name is Device is this bevice is the Nizer (res 74) Cardiovascular
common name is Device Link. Current Classification is (74) Cardiovascular common name is Device Link. Current Olassinoation is (1)
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, noninvasive | Cardiovascular | 74 DXN |
| 870.2300 | Monitor, cardiac | Cardiovascular | 74 DRT |
| 876.1800 | Urinometer | Gastro-urology | 78 EXS |
| 876.5820 | System, hemodialysis, access recirculation monitoring | Gastro-urology | 78 MQS |
| 880.5725 | Pump, infusion | Gnr'l Hospital | 80 FRN |
| 870.3535 | System, balloon, intra-aortic and 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 3. The M2376A Device Link System Feesves, convents that data into the HL7
external devices through device specific cables, convents that data into the HL7 external devices through device specific cables, oblivery and the comments of the System.

4. When connected to a bedside device, the M2376A Device Link System
1988 to the time the collection and clinical information management. 4. When connected to a beasies and clinical incornation management.
is intended for electronic data collection and clinical information management.
The managed for election c is intended for electronic data collection and clinion information in the Device Link is ne attached source device.

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# DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/2 description: The image shows a circular logo with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a symbol consisting of three curved lines that resemble a stylized human figure. The logo is black and white and appears to be a seal or emblem.

#### Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

#### NOV 1 4 2001

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

Re: K013470

K013470
Trade Name: M2376A Philips Device Link System Trade Namo: umber: 21 CFR 870. 2300 Regulation Number: 21 CHK 8 /0. 2500
Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm)
Regulation Name: Cardiac Monitor (including cardiotachome Regulatory Class: Class II (two) Product Code: MWI Dated: October 16, 2001 Received: October 18, 2001

Dear Mr. Hudon:

We have reviewed your Section 510(k) premarket notification of intent to market the device the indication We have reviewed your Section 500(K) prematics is substantialy equivalent (for the indications for referenced above and have determined institutions marketed in interstate commerce
use stated in the enclosure) to legally marketed prediced in interstate on to devices that use stated in the enclosure) to legally maked previse annoments, or to devices that
prior to May 28, 1976, the enactment date of the Federal Food. Drug, and Cosmetic prior to May 28, 1976, the enactment date of the provisions of the Federal Food, Drug, and Cosmetic
have been reclassified in accordance with the provision of the Peneralian have been reclassified in accordance will use provisions of an application (PMA). You may,
Act (Act) that do not require approval of a premarks approval application of the g Act (Act) that do not require apptoval of a premate approvizions of the Act. The general
therefore, market the device, subject to the general controls provisions of the gene therefore, market the device, subject to the general concess as registration, listing of devices, good
controls provisions of the Act include requirements for and adulteratio controls provisions of the Act mende requirements for and adulteration.
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 If your device is classified (see above) inte Euro may regulations affecting your device can be
may be subject to such additional controls. Exista 21 to sed. In addition, FDA may be subject to such additions, Title 21, Parts 800 to 898 108. addition, FDA may publish
found in the Code of Federal Regulations, Title 21, Parts 800 to 898 In addition found in the Code of I coloral roggination 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
ts of the Actively and section the treass device complies with other requiremen Please be advised that FDA's issuance of a substantial equives with other requirements of the Act or
that FDA has made a determination adveries complies with other requiremen that FDA has made a determination that your device columns will sensies. You must comply with
any Federal statutes and regulations administed by other Federal on clisting ( any Federal statutes and regulations and limited to registerion and listing (21 CFR Pat 807);
all the Act's requirements, including, but the regulies requirements s set forth all the Act's requirements, including but not immed to: registianon and the quality
labeling (21 CFR Part 801); good manufacturing practice requirements as sex form in the qu labeling (21 CFR Part 801); good manufacturing placity, the electronic product radiation
systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product systems (QS) regulation (21 CFR Fall 620), and 820), and 820, 21 CFR 1000-1050.
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)
and the supportunity and Chiling of substantial equivalence of vour device to a This letter will allow you to begin marketing your device of your device to a legally
premarket notification. The FDA inning of substantial equivalerice to a legally premarket notification. The FDA finding of substantial equivalice of 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 CPR Part 801 and If you desire specific advice for your device diron in documents devices, please contact the Office of
additionally 21 CFR Part 809.10 for in the consumers on the organism an additionally 21 CFR Part 809. I for minto urisons on the province and advertising of
Compliance at [phone]. Additionally, for questions on the protion and advertising Compliance at [phone]. Addinblany, Inc. questions on also. Also, please note the your device, please contact the Office of Coultination' (21CFR Patt 807.97).
regulation entitled, "Misbranding by reference to premarket not its interned from the Division regulation entitled, "Misbranding on responsibilities under the Act may be obtained from the Division
Other general information on your responsibilities under the Activenes o Other general information on your responsibilities under the rise and its toll-free number (800)
of Small Manufacturers, International and Consumer Assistance at its toll-fre 638-2041 or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Darlu Wills

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

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Enclosure

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NOV 1 ◀ 2001

KUI-TIC

Page 1 of 1

510(k) Number (if known): K013476

Device Name: M2376A Device Link System

Indications for Use:

The M2376A DeviceLink System is indicated for use in data collection and The M2376A DeviceLink System is indicated for use in ual occuration in the more
clinical information management either directly or through networks with independent bedside devices.

The M2376A is not intended for monitoring purposes, nor is the M2376A
reas and intended to belocies of independent bedside devices / infor The M2376A is not intended for molutioning parposes, as as as as a levices / information
intended to control any of the clinical devices (independent bedside devices / inform systems) it is connected to.

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

O.R. Teth
Division of Cardiovascular & Respiratory Devices
510(k) Number R013470

Prescription Use X (Per 21 CFR 801.109)

Over-The-Counter Use OR

(Optional Format 1-2-96)

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