M2376A DEVICELINK SYSTEM, MODEL M2376A

K011578 · Agilent Technologies, Inc. · MWI · Jun 8, 2001 · Cardiovascular

Device Facts

• Record ID: K011578
• Device Name: M2376A DEVICELINK SYSTEM, MODEL M2376A
• Applicant: Agilent Technologies, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Jun 8, 2001
• 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 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 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 data integration and management for healthcare providers.

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. No patient-contacting components.

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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### 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,<br>noninvasive | Cardiovascular | 74 DXN |
| 870.2300 | Monitor, cardiac | Cardiovascular | 74 DRT |
| 876.1800 | Urinometer | Gastro-urology | 78 EXS |
| 876.5820 | System, hemodialysis, access<br>recirculation monitoring | Gastro-urology | 78 MQS |
| 880.5725 | Pump, infusion | Gnr'l Hospital | 80 FRN |
| 870.3535 | System, balloon, intra-aortic and<br>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 format 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. Device Link is neither patient connected, nor does it remotely control the attached source device.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN - 8 2001

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

Re: K011578

Trade Name: M2376A Agilent Technologies Device Link System Regulation Number: 870.2300 Regulatory Class: II (two) Product Code: 74 MWI Dated: May 21, 2001 Received: May 22, 2001

#### Dear Mr. Hudon:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have hove have determined the device is substantially equivalent (for the indications for use above and we norte dollarmarketed predicate devices marketed in interstate commerce stated in the onerosale/ to regarry in date of the Medical Device Amendments, or to devices that provision in the provisions with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general control Cosmone Act. The Act. The general control provisions of the Act include requirements for annual provisions of the Fee. - 110 general and 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 remarket / iphortal), it may of Federal Regulations, Title 21, Parts 800 to allecting your device can of readerermination assumes compliance with the Current Good 893. TT substainmily oquirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition,

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## Page 2 - Mr. Mike Hudon

FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you note: 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 nothleation. The I Drice results in 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 CFF Part 801 and If you desire specific actice for your actic devices), please contact the Office of Compliance at additionally 607.10 for in This allestions on the promotion and advertising of your device, [phone]. Traditionally, collance 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 mormation on your responsive at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Oala Teh

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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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 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 Cardiovascular & Respiratory Devices
510(k) Number K011578

Prescription Use x (Per 21 CFR 801.109)

OR Over-The-Counter Use

(Optional Format 1-2-96)