MODIFICATION TO M2376A DEVICELINK SYSTEM

K041401 · Philips Medical Systems · MWI · Jun 4, 2004 · Cardiovascular

Device Facts

• Record ID: K041401
• Device Name: MODIFICATION TO M2376A DEVICELINK SYSTEM
• Applicant: Philips Medical Systems
• Product Code: MWI · Cardiovascular
• Decision Date: Jun 4, 2004
• 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 correctly 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

DeviceLink System receives digital data from external bedside medical devices via device-specific cables; converts data into HL7 format; transmits data to networked Clinical Information Systems. Used in clinical environments; operated by healthcare professionals. Device is not patient-connected; does not perform monitoring; does not control source devices. Facilitates electronic data collection and clinical information management by integrating disparate bedside device data into hospital networks.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Data gateway system; receives digital inputs via device-specific cables; performs data format conversion to HL7; transmits data to networked clinical information systems. Standalone hardware unit; non-patient contacting.

Indications for Use

Indicated for clinical data collection and information management in healthcare settings via connection to independent bedside devices. Not for patient monitoring or remote control of connected devices. Prescription use only.

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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KO414-01

## JUN - 4 2004

Philips Medical Systems

## 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:

Herbert van Dyk Quality and Regulatory Engineer Philips Medical Systems Hewlett-Packard Str. 2 D71034 Böblingen, Germany Tel .: [phone] Fax.: [phone]

This summary was prepared on November 9, 1998, and updated on November 19, 2003.

2. The name of this device is the M2376A DeviceLink System. The common Current Classification is (74) Cardiovascular MWI, name is DeviceLink. 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 recirculation<br>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 |
| 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 | 74QGL |
| 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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3. The M2376A DeviceLink 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 DeviceLink System is intended for electronic data collection and clinical information management. DeviceLink is neither patient connected, nor does it remotely control the attached source device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN = 4 2004

Philips Medical Systems c/o Mr. Herbert van Dyk Quality and Regulatory Engineer Cardiac and Monitoring Systems 3000 Minuteman Road, Mail Stop 0490 Andover, MA 01810-1099

Re: K041401

Trade Name: M2376A DeviceLink System Regulation Number: 21 CFR 870.2300 Regulation Number: 21 CFN 870.2500
Regulation Name: Cardiac Monitor (including Cardiotachometer and Rate Alarm) Regulatory Class: II (two) Product Code: MWI Dated: May 24, 2004 Received: May 26, 2004

Dear Mr. Van Dyk:

We have reviewed your Section 510(k) premarket notification of intent to market the the indicati We have reviewed your Section 9 ro(x) premained is substantially equivalent (for the indications
referenced above and have determined the device is substantial in interstate relerenced above and nave decembled the enclicate devices marketed in interstate for use stated in the encrosulty manation promotion Device Amendments, or to commerce prior to May 20, 1976, the enaothor with the provisions of the Federal Food, Drug, devices that have been recialsmod in acceraarse wear at also premarket approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a previsions of the and Cosment Act (Act) that do not require approvine as a controls provisions of the Act. The You may, therefore, market the devices, boyse to annual registration, listing of
general controls provisions of the Act include requirements for annual registration, listing general controls provisions of the fist here in a 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 (sec above) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such adultional controls. Existing and be found in the Code of Featur regarning your device in the Federal Register.

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Page 2 – Mr. Herbert van Dyk

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuated of a states complies with other requirements of the Act that FDA has made a determination and Journer Federal agencies. You must or any Pederal Statutes and regulations daminibers but not limited to: registration and listing (21 comply with an the Act stequirements, moraaling, and manufacturing practice requirements as set CFK Part 807), labeling (21 CFR Part 820); and if applicable, the electronic form in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control provisions (Sections over device as described in your Section 5 10(k)
This letter will allow you to begin marketing your device as described in your i his letter will anow you to begin manically your maneting of your device to a legally premarket nothleadon: "The PDA maing of baction 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), please If you desire specific advice for Jour as [phone]. Also, please note the regulation entitled, Colliact the Office of Compullier at (SST) 31 (SFR Part 807.97). You may obtain Misoranuing of Icrerches to prenazionalibilities under the Act from the Division of Small other general informational 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,

Aefae Myp

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

Enclosure

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Philips Medical Systems

Page of ___________________________________________________________________________________________________________________________________________________________________________

## Indications for Use

510(k) Number (if known):

Device Name: M2376A DeviceLink System

## Indications for Use:

The M2376A DeviceLink System is indicated for use in data collection and clinical information management either correctly 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.

.

AND / OR

Over-The-Counter Use No (part 21 CFR 801 Subpart C)

Prescription Use Yes (part 21 CFR 801 Subpart D)

> (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Office of Device Evaluation (ODE)

Mera Maya for BD2

(Division/Sign-Off)
Division of Cardiovascular Devices
K041401
(Posted November 13, 2003)

(Optional Format 3-10-98)

| Special 510(k) M2376A | Company confidential | page 26 of 26 |
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