The M2376A Device Link 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

This device is a data collection and clinical information management system, and as such, the typical performance metrics like sensitivity, specificity, or AUC as seen with diagnostic AI devices are not applicable. Instead, its "performance" is primarily defined by its ability to accurately receive, convert, and transmit data without loss or corruption, and its compatibility with various external medical devices.

No specific acceptance criteria or a study proving the device meets those criteria are explicitly detailed, but based on the nature of the device (a data link system), the implicit acceptance criteria would revolve around:

Implicit Acceptance Criteria (in the absence of explicit values):

Data Integrity: The device must accurately transmit all data received from external devices without alteration or loss.
Data Format Conversion: The device must correctly convert proprietary data formats from external devices into the HL7 standard.
Connectivity: The device must successfully connect to and receive data from a defined list of external medical devices.
Interoperability: The device must successfully transmit HL7 formatted data to networked Clinical Information Systems.
Reliability/Stability: The device should operate consistently without errors or system crashes over extended periods.

Study Information (Based on the Provided Text):

The provided text does not describe a specific clinical study with quantitative performance metrics for the M2376A Device Link System. The document is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed performance study results with statistical outputs.

The primary "evidence" for this type of device typically comes from:

Bench Testing/Verification & Validation (V&V): This would involve extensive testing to ensure accurate data parsing, conversion, and transmission with various connected devices under different operating conditions. This V&V would likely cover the "acceptance criteria" outlined above. Such testing is typically performed by the manufacturer's engineers.
Compatibility Testing: Verifying that the M2376A Device Link System effectively communicates with all the listed external medical devices (e.g., blood pressure monitors, cardiac monitors, infusion pumps) and various Clinical Information Systems.

Since no specific study is detailed to quantify performance, most of the requested information cannot be directly extracted. However, based on the nature of the device and the 510(k) process, we can infer what would have been necessary.

Here's a breakdown of the requested information, acknowledging the limitations of the provided text:

A table of acceptance criteria and the reported device performance

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred/Implicit)
Data Integrity: Accurate transmission of all data.	The device "receives digital data produced by external devices... converts that data into the HL7 format and transmits that information..." (K021912, page 2 of 2). This implies accurate and complete processing.
Data Format Conversion: Correct conversion to HL7.	The device "converts that data into the HL7 format." This function is central to its purpose and would have been verified through V&V testing.
Connectivity: Successful connection to specified devices.	The device is "connected to a bedside device" and supports a range of external devices listed in the table (e.g., blood pressure, cardiac monitor). Compatibility testing would confirm this.
Interoperability: Successful transmission to CIS.	The device "transmits that information to any networked Clinical Information System." This suggests successful integration and data transfer.
Reliability/Stability	Not explicitly stated, but standard for medical devices; would have been assessed during V&V.

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. For a device link system, the "test set" would likely be a combination of various types of data signals/messages from a range of connected devices, and the number of test cases run through the system. This would be part of engineering V&V rather than a clinical trial with patient data.
- Data Provenance: Not applicable in the context of a clinical study. The "data" would be test data generated from medical devices in a lab environment.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable as this is a data integration device, not a diagnostic one requiring expert interpretation of medical images or patient conditions for ground truth. Ground truth for this device would be established by comparing the output of the Device Link System (HL7 data) with the known input data from the external device, which is an engineering verification task. Engineers and IT specialists with expertise in HL7 and medical device communication protocols would verify the system's output.
Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. Adjudication methods are typically used when there's subjective interpretation involved, such as in image reading. For a data transmission device, the "correctness" is objective (did the data transmit accurately, completely, and in the correct format?).
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. An MRMC study is completely irrelevant for this type of device. This device does not involve human "readers" interpreting output for diagnostic purposes, nor does it incorporate AI for diagnostic assistance. It is a data conduit.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The device is essentially "standalone" in its function as an algorithm-only component that receives, converts, and transmits data. Its performance would inherently be evaluated without human-in-the-loop interaction for its core function. The "human-in-the-loop" would be the clinician interacting with the clinical information system where the data ends up, but not with the Device Link itself for its data transfer function.
The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Engineering Ground Truth: The ground truth would be the original digital data generated by the connected external medical devices, which would then be compared bit-for-bit or field-for-field with the HL7 output from the M2376A Device Link System. This ensures no data loss or corruption and correct formatting.
The sample size for the training set
- Not applicable. This device is not an AI/machine learning device that requires a "training set." It performs deterministic data conversion and transmission based on programmed rules and protocols.
How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device.

Summary

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JUN 2 4 2002

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:

Denise Haley Quality and Regulatory Engineer Philips Medical Systems 3000 Minuteman Road MS 0490 Andover, MA 01810-1099 Tel.: (978) 659-2701 Fax.: (978) 685-5624

This summary was prepared on November 9, 1998, and updated on April 26, 2002.

The name of this device is the M2376A Device Link System. The common name is 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
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	74 QGL
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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K021912
page 2 of 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three stylized lines.

JUN 2 4 2002

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Medical Systems c/o Ms. Denise Haley Quality and Regulatory Engineer 3000 Minuteman Road Andover, MA 01810

Re: K021912

Trade Name: M2376A Device Link System Regulation Number: 21 CFR 870.2300 Regulation Name: Network and Communication Physiological System Regulatory Class: Class II (two) Product Code: MWI Dated: June 10, 2002 Received: June 11, 2002

Dear Ms. Haley:

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 - Ms. Denise Haley

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,

Donna-Bea Tillman, Ph.D.
Acting Director
Division of Cardiovascular
and Respiratory Devices
Office of Device Evaluation
Center for Devices and
Radiological Health

Enclosure

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Page

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: M2376A Device Link System

Indications for Use:

The M2376A Device Link 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 Cardio
510(k) Number K02192

Prescription Use _____________________________________________________________________________________________________________________________________________________________ OR x (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).