M2376A DEVICELINK SYSTEM

K041942 · Phillips Medical Systems · MWI · Jul 23, 2004 · Cardiovascular

Device Facts

• Record ID: K041942
• Device Name: M2376A DEVICELINK SYSTEM
• Applicant: Phillips Medical Systems
• Product Code: MWI · Cardiovascular
• Decision Date: Jul 23, 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 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 DeviceLink 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 settings to facilitate centralized data management; allows healthcare providers to view integrated data from multiple sources within a clinical information system; supports clinical decision-making by providing consolidated patient data.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Data gateway system; converts proprietary digital signals from bedside devices to HL7 format for network transmission. Standalone hardware unit; connects via device-specific cables to bedside monitors/pumps/ventilators. No patient-contacting components. Software-based data conversion and transmission.

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 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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JUL 2 3 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 July 14, 2004.

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

| REGULATION | CLASSIFICATION NAME | PANEL | PROCODE |
|------------|----------------------------------------------------------|------------------|---------|
| NUMBER | | | |
| 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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## Philips Medical Systems

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

JUL 2 3 2004

Phillips Medical Systems c/o Mr. Herbert van Dyk Quality and Regulatory Engineer Cardiac and Monitoring Systems Hewlett-Packard Str. 2 D710340 Böblingen GERMANY

Re: K041942

Trade Name: M23764A DeviceLink System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (including cardiotachometer and rate alarm) Regulatory Class: II (two) Product Code: MWI Dated: July 14, 2004 Received: July 19, 2004

Dear Mr. van Dyk :

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, 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. Herbert van Dyk

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I toase be actived that I be mination that your device complies with other requirements of the Act that 1 Dr Accomment and regulations administered by other Federal agencies. You must or any 1 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 OF A rat 607); adoming (21 CFR Part 820); and if applicable, the electronic forth in the quand 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 promated nonineted 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), please 11 you dome specific an enoliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act 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,

Neil R.P. Ogden

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

Enclosure

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K04194:

Philips Medical Systems

Page

## Indications for Use

510(k) Number (if known): K041942

Device Name: M2376A DeviceLink 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.

Neil R. Ogden
(Division Sign-Off)
Division of Cardiovascular Devices
frrBDZ

510(k) Number K041942

AND / OR

Prescription Use Yes (part 21 CFR 801 Subpart D)

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Posted November 13, 2003)

(Optional Format 3-10-98)