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 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.

AI/ML Overview

The provided text describes a 510(k) summary for the M2376A Device Link System. However, it does not contain any information about acceptance criteria, device performance metrics, or study details such as sample sizes, ground truth establishment, or expert involvement. The document primarily focuses on:

Submitter Information: Contact details for Agilent Technologies.
Device Name and Classification: M2376A Device Link System, common name HP Device Link, and a list of associated device regulations and pro codes.
Device Description: The system receives digital data from external devices, converts it to HL7 format, and transmits it to a Clinical Information System.
Intended Use: Electronic data collection and clinical information management; explicitly states it is not patient connected, for monitoring, or for controlling attached devices.
FDA Clearance Letter: A letter from the FDA confirming substantial equivalence to legally marketed predicate devices and outlining regulatory responsibilities.
Indications for Use: Reiterates its purpose for data collection and clinical information management, and specifies what it is not intended for.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text.

The document is a regulatory submission for a device that facilitates data transfer and management, not a diagnostic or therapeutic device whose performance would typically be evaluated with metrics like sensitivity, specificity, or accuracy against a ground truth. Its "performance" would likely be related to data integrity, successful transmission, and compatibility, which are implicitly covered by substantial equivalence in this context but not detailed in the provided summary.

Summary

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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.

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.: (978) 659-3173 Fax.: (978) 687-2651

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

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:

REGULATIONNUMBER	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, accessrecirculation monitoring	Gastro-urology	78 MQS
880.5725	Pump, infusion	Gnr'l Hospital	80 FRN
870.3535	System, balloon, intra-aortic andcontrol	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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KO11578 p.2/2

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.
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, (201) 594-1019. Traditionally, collance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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)

Regulation Number and Section

§ 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).