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.

AI/ML Overview

The provided text is a 510(k) summary for the M2376A DeviceLink System. It primarily focuses on regulatory information, device description, and indications for use. It does not contain information regarding acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment for a performance study.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is a regulatory submission for market clearance, not a technical performance study report.

The DeviceLink System is described as a device that "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." Its function is for electronic data collection and clinical information management, and it is explicitly stated that it 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." This suggests its primary function is data transfer and formatting, rather than generating clinical insights or diagnoses that would typically require validation against medical performance metrics.

Summary

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SEP 1 7 2002

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:

Barry Wyshogrod Quality and Regulatory Engineer Philips Medical Systems 3000 Minuteman Road MS 0490 Andover, MA 01810-1099 Tel.: (978) 659-7383 Fax .: (978) 685-5624

This summary was prepared on November 9, 1998, and updated on September 3, 2002.

The name of this device is the M2376A DeviceLink System. The common Current Classification is (74) Cardiovascular MWI, name is DeviceLink. 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, access recirculationmonitoring	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
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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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.
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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DEPARTMENT OF HEALTH & HUMAN SERVICES

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 features a stylized eagle or bird-like figure with three curved lines forming its body and wings. The bird is oriented diagonally, facing upwards and to the right. Encircling the bird is text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

p 1 7 2002

Philips Medical Systems c/o Mr. Barry Wyshogrod Quality and Regulatory Engineer 3000 Minuteman Road Andover, MA 01810-1099

Re: K022920

Trade Name: M2376A DeviceLink System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor Regulatory Class: Class II (two) Product Code: MWI Dated: September 3, 2002 Received: September 4, 2002

Dear Mr. Wyshogrod:

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. Iisting 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. Barry Wyshogrod wi

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply 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 forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control 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 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,

Delta Ten

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _ of _

KO22920 510(k) Number (if known): __

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)

Seal Th
Division of Cardiovascular & Respiratory Devices
510(k) Number K022920

Prescription Use x OR (Per 21 CFR 801.109)

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).