← Product Code [MWI](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWI) · K033680

# M2376A PHILIPS DEVICE LINK SYSTEM (K033680)

_Philips Medical Systems · MWI · Dec 11, 2003 · Cardiovascular · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWI/K033680

## Device Facts

- **Applicant:** Philips Medical Systems
- **Product Code:** [MWI](/submissions/CV/subpart-c%E2%80%94cardiovascular-monitoring-devices/MWI.md)
- **Decision Date:** Dec 11, 2003
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 870.2300
- **Device Class:** Class 2
- **Review Panel:** Cardiovascular
- **Attributes:** Software as a Medical Device

## 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.

## 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 environments to facilitate data integration and management for healthcare providers. Benefits include automated data collection and centralized information management, reducing manual entry and improving clinical workflow efficiency.

## 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; network connectivity for transmission to Clinical Information Systems; non-patient-connected; software-based data processing.

## Regulatory 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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DEC 1 1 2003

K033680
p.1/2

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.: +49 (7031) 463-1734 Fax .: +49 (7031) 463-2442

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 name is DeviceLink. 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 recirculation<br>monitoring | Gastro-urology   | 78 MQS  |
| 880.5725             | Pump, infusion                                           | Gnr'i 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

DEC 1 1 2003

Philips Medical Systems c/o Mr. Herbert van Dyk Quality and Regulatory Engineer Cardiac and Monitoring Systems Hewlett-Packard Str. 2 Boblingen D71034 Germany

Re: K033680

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: November 19, 2003 Received: November 24, 2003

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 Toast of Identifical that I Drive issuation over device complies with other requirements of the Act that I Dri has made a and regulations administered by other Federal agencies. You must or any I ederal battatoo the requirements, including, but not limited to: registration and listing Comply with an the Act 5 requirements, as 801); good manufacturing practice requirements as set (21 CFR Part 807), accems (QS) regulation (21 CFR Part 820); and if applicable, the electronic form in also quant) by econo (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation comi of provisions (Steting your device as described in your Section 510(k) I mis lower will and in your he FDA finding of substantial equivalence of your device to a legally premarket noticated 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), please n you desire of Compliance at (301) 594-4646. 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 may be obtained from the Outer general mioniation turers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely vours.

Oleandlthy

Bram D. Zuckerman, I 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

510(k) Number (if known): ____ K 0 3 368 O

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.

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

Division of Cardin ascular & Respiratory Devices 510(K) Numi

K033650
Q0476650
for boz 12/11/13

OR

Per 21 CFR 801.109)

Prescription Use _ × (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

Special 510(k) M2376A

Company confidential

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