MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A

K012094 · Agilent Technologies, Inc. · MWI · Jul 20, 2001 · Cardiovascular

Device Facts

• Record ID: K012094
• Device Name: MODIFICATION TO DEVICE LINK SYSTEM, MODEL M2376A
• Applicant: Agilent Technologies, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Jul 20, 2001
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The M2376A DeviceLink System is indicated for use in data collection and 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 Device Link System acts as a data gateway; receives digital data from external bedside medical devices via device-specific cables; converts data into HL7 format; transmits information to networked Clinical Information Systems. Used in clinical settings; operated by healthcare staff. Device does not perform patient monitoring; does not provide remote control of source devices. Benefits include automated data collection and integration into hospital information systems, reducing manual documentation requirements.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Data gateway system; connects to bedside devices via device-specific cables; converts proprietary digital signals to HL7 standard; networked connectivity to Clinical Information Systems; software-based data processing.

Indications for Use

Indicated for electronic data collection and clinical information management from bedside medical devices. Not intended for patient monitoring or remote control of connected source 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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KOI 2094 p. 1/2

## "JUL 2 0 2001

510(k) Summary.

## 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:

Mike Hudon Regulatory Approvals Engineer Agilent Technologies Patient Monitoring Division Healthcare Solutions Group 3000 Minuteman Road Andover, MA 01810-1099 Tel.: [phone] Fax.: [phone]

This summary was prepared on November 9, 1998, and updated on May 16, 2001.

2. The name of this device is the M2376A Device Link System. The common name is the HP Device Link. 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, 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 |

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3. The M2376A Device Link System receives digital data produced by external devices through device specific cables, converts that data into the HL7 External and transmits that information to any networked Clinical Information System.

4. When connected to a bedside device, the M2376A Device Link System is intended for electronic data collection and clinical information management. lo intonuou for enotient connected, nor does it remotely control the attached source device.

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular emblem with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of what appears to be an eagle or a similar bird, with its wings spread and head facing to the right.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 0 2001

Mr. Mike Hudon Regulatory Approvals Engineer Agilent Technologies, Inc. Healthcare Solutions Group 3000 Minuteman Road Andover, MA 01810-1099

Re: K012094

K012094
Trade Name: M2376A Agilent Technologies Device Link System
Trade Name: M2376A Agilent 2000 Regulation Number: 21 CFR 870.2300 Regulatory Class: II (two) Product Code: 74 MWI Dated: July 3, 2001 Received: July 5, 2001

Dear Mr. Hudon:

We have reviewed your Section 510(k) notification of intent to market the device referenced above We have reviewed your Section 510(K) intention of the indications for use stated in
and we have determined the device is substantially equivalies indications for use stated i and we have determined the device is sticated devices marketed interstate commerce prior to
the enclosure) to legally marketed predicated in Desice Amondments, or to devices the enclosure) to legally marketed predical Device Amendments, or to devices that have been
May 28, 1976, the enactment date of the Medical Device Amend Cosmetic Act (Act). May 28, 1976, the enactment date of the Federal Food, Drug, and Cosmetic Act (Act).
reclassified in accordance with the provisions of the Feceral control movisions of the Act reclassified in accordance with the provisions of the ecters l cource in any and You may, therefore, market the device, sudject to the general registration, listing of devices,
general control provisions of the Act include requirements for annual programm general control provisions of the Acc melude requirements for allinous and adulteration.
good manufacturing practice, labeling, and prohibitions against misbranding and adult

If your device is classified (see above) into either class II (Special Controls) or class III (Prematket If your device is classified (see above) litic emicr etails major regulations affecting your
Approval), it may be subject to such additions Title 21 Barts and to 895 A Approval), it may be subject to such additions. Title 21, Parts 800 to 895. A substantially
device can be found in the Code of Federal Regulations, Title 21, Parts 800 to device can be found in the Code of Peachartes with the Current Good Manufacturing Practice
equivalent determination assumes collines with the Current (GS) for Medical Devices equivalent determination assumes collipitalicy with the cancer of on Medical Devices: General
requirements, as set forth in the Quality System Regulation (the Rood and Drug requirements, as set form in the Quality System resultated (* 2) pecialisms the Food and Drug
regulation (21 CFR Part 820) and that, through periodic QS inspections, with the regulation (21 CFR Part 820) and may, unough periodio QB asportions.
Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation
t Administra may result in regulatory action. In addition,

may result in regulatory action. In adinom,
FDA may publish further announcements a vice in the Federal Register. Please FDA may publish further announcentents concerning your avves and affect any obligation you

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Page 2 - Mr. Mike Hudon

might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Vark Tuth

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

Enclosure

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Page **_ of _**

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: M2376A Device Link System

Indications for Use:

The M2376A DeviceLink System is indicated for use in data collection and 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 Cardiovascular & Respiratory Devices
510(k) Number K012094

OR

Prescription Use _____________________________________________________________________________________________________________________________________________________________ x (Per 21 CFR 801.109)

Over-The-Counter Use _

(Optional Format 1-2-96)