K Number
K041942
Device Name
M2376A DEVICELINK SYSTEM
Date Cleared
2004-07-23

(4 days)

Product Code
Regulation Number
870.2300
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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 Description
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.
More Information

Not Found

Not Found

No
The summary describes a data collection and conversion system, with no mention of AI or ML terms or functionalities.

No
The device is described as a data collection and management system that converts and transmits digital data. It explicitly states it is "not intended for monitoring purposes," "not intended to control any of the clinical devices," and its function is information management, not diagnosis, treatment, or prevention of disease.

No
Explanation: The device is indicated for data collection and clinical information management, converting data to HL7 format for transmission to a Clinical Information System. It is explicitly stated that it is "not intended for monitoring purposes," and its function does not involve diagnosing conditions.

No

The device description explicitly states it receives data through "device specific cables," indicating a hardware component is involved in the data acquisition process.

Based on the provided information, the M2376A DeviceLink System is not an IVD (In Vitro Diagnostic).

Here's why:

  • IVDs are used to examine specimens derived from the human body. The M2376A's intended use and description clearly state that it collects and manages data from independent bedside devices and transmits it to a Clinical Information System. It does not interact with or analyze biological samples.
  • The device's function is data management and conversion. It receives digital data, converts it to HL7 format, and transmits it. This is a data processing function, not a diagnostic test performed on a specimen.

Therefore, the M2376A DeviceLink System falls outside the scope of what is considered an In Vitro Diagnostic device.

N/A

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

MWI
DSK
DSJ
DXN
DRT
EXS
MQS
FRN
DSP
CBK
BZL
KDI
DQA
CCK
QGL
GWQ
BZQ
FMZ
KFM

Device Description

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Not Found

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

Not Found

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
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.(b)
Classification. Class II (performance standards).

0

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

This summary was prepared on November 9, 1998, and updated on July 14, 2004.

  1. 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:
REGULATIONCLASSIFICATION NAMEPANELPROCODE
NUMBER
870.1110Computer, blood pressureCardiovascular74 DSK
870.1100Alarm, blood pressureCardiovascular74 DSJ
870.1130System, measurement, blood pressure,
noninvasiveCardiovascular74 DXN
870.2300Monitor, cardiacCardiovascular74 DRT
876.1800UrinometerGastro-urology78 EXS
876.5820System, hemodialysis, access recirculation
monitoringGastro-urology78 MQS
880.5725Pump, infusionGnr'l Hospital80 FRN
870.3535System, balloon, intra-aortic and controlCardiovascular74 DSP
868.5895Continuous ventilatorAnesthesiology73 CBK
868.1730Computer, oxygen uptakeAnesthesiology73 BZL
876.5860DialyzerGastroenterology78 KDI
870.2700OximeterCardiovascular74 DQA
868.1400Carbon Dioxide Gas AnalyzerAnesthesiology73 CCK
870.1915Thermodilution probeCardiovascular74QGL
882.1400ElectroencephalographNeurological84GWQ
868.2375Breathing Frequency MonitorAnesthesiology73 BZQ
880.5400Neonatal incubatorGeneral Hospital80 FMZ
870.4360Cardiopulmonary Bypass Blood PumpCardiovascular74 KFM

1

Philips Medical Systems

  1. 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.

  2. 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.

2

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.

3

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 (301) 594-4648. 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 (800) 638-2041 or (301) 443-6597 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

4

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)