The Datex-Ohmeda S/5 Device Interfacing Solution, DIS, is intended to be used with a Datex-Ohmeda monitoring systems for transferring data between external devices and a monitor.

The Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx..01, is indicated for data transfer between stand-alone monitors, ventilators/anesthesia machines, blood gas analyzers, and heart-lung machines and Datex-Ohmeda bedside monitors for displaying and patient care information purposes. The device is indicated for use by qualified medical personnel only.

Device Description

External devices are connected to the monitoring system by using small plug-in converter modules that handle the communication between the device and S/5 monitoring system. These DIS converter modules convert the data coming from the connected device to a format that can be utilized in the Datex-Ohmeda S/5 Anesthesia Monitor, Datex-Ohmeda S/5 Critical Care Monitor, Datex-Ohmeda S/5 Compact Anesthesia Monitor. Datex-Ohmeda S/5 Compact Critical Care Monitor, or Datex-Ohmeda S/5 FM. The use of a DIS system consists of making the physical connections connecting external devices to DIS and linking DIS modules together to make a complete bus. Then the DIS transfers data between a device and the S/5 monitoring system. The user can then select the source of measurement data for physiologic parameters displayed on the Datex-Ohmeda monitor. The first DIS converter module is connected to the socket at the Datex-Ohmeda S/5 monitor. In S/5 Anesthesia Monitor, and S/5 Critical Care Monitor the DIS socket is located at the rear of the monitor and in $/5 Compact Anesthesia Monitor, $/5 Compact Critical Care Monitor, and S/5 FM monitor it is located in left hand side of the monitor. Additional DIS converter modules in a system are connected to each other with the bus cable. The external device is connected to the DIS converter module with a device specific cable. Up to ten DIS converter modules can be connected in the system. The maximum number of simultaneous interfaces is ten. The maximum length of interface cable is 10 meters (33ft). The number of DIS interfaces that can be used depend on the length of the interface cables and the particular monitor used. The Device Interfacing Solution supports interfacing of the following device categories: ventilators/anesthesia machines, stand-alone monitors, blood gas analyzers and heart-lung machines. The Device Interfacing Solution can interface numerical, waveform and event type of data from the external device. Alarms are not transferred. Interfaced data can be displayed on the monitor screen, trended, printed and used for record keeping purposes. Also, interfaced physiologic data is sent to the network to be viewed at the Central station monitor.

AI/ML Overview

Acceptance Criteria and Study for Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx..01

The provided documentation describes a 510(k) premarket notification for the Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx..01, and focuses on demonstrating substantial equivalence to a legally marketed predicate device (N-DISxxxx..00). As such, the "acceptance criteria" and "study" are framed within the context of demonstrating this equivalence rather than establishing the performance of a novel device against predefined clinical metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Demonstration of Equivalence to Predicate K012531)	Reported Device Performance (N-DISxxxx..01)
Intended Use: Identical intended use.	Intended Use: "The Datex-Ohmeda S/5 Device Interfacing Solution, DIS, is intended to be used with a Datex-Ohmeda monitoring systems for transferring data between external devices and a monitor." This is stated to be identical to the predicate.
Indications for Use: Nearly identical indications for use.	Indications for Use: "The Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx..01, is indicated for data transfer between stand-alone monitors, ventilators/anesthesia machines, blood gas analyzers, and heart-lung machines and Datex-Ohmeda bedside monitors for displaying and patient care information purposes. The device is indicated for use by qualified medical personnel only." Stated as "nearly identical" to the predicate.
Operating Principle: Same operating principle.	Operating Principle: The device converts data from external devices to a format usable by S/5 monitors and transfers it. This is stated as the "same operating principle" as the predicate.
Safety and Effectiveness: Same safety and effectiveness.	Safety and Effectiveness: The conclusion states "no new questions of safety and effectiveness" and that it is "substantially equivalent in safety and effectiveness" to the predicate, based on non-clinical testing.
Software: Essentially the same software.	Software: Stated as "essentially the same software" as the predicate.
User Interface: Same user interface at the monitor.	User Interface: Stated to "Have same user interface at the monitor" as the predicate.
Manufacturing Process: Manufactured using the same processes.	Manufacturing Process: Stated to "Are manufactured using the same processes" as the predicate.
Compliance with Recognized Standards: Meeting relevant electrical safety, EMC, and labeling standards.	Compliance with Recognized Standards: Assessed against and in compliance with EN 60601-1, IEC 60601-1, CAN/CSA C22.2 No. 601.1-M90, UL 2601-1, IEC 60601-1-2, EN 980, EN 1041, and EN 60529 (IPX1).
New Features (N-DISVENT module): Ability to transfer current clock time for synchronization with Datex-Ohmeda AiSys Carestation (only when no case open).	New Features: N-DISVENT module can transfer time from monitor to ventilator (only with Datex-Ohmeda AiSys Carestation) for time synchronization, but only when there is no case open.

2. Sample Size Used for the Test Set and Data Provenance

The documentation does not specify a "test set" sample size or data provenance in the way one might expect for a clinical performance study of an AI/ML device. The focus is on demonstrating substantial equivalence to a predicate device through non-clinical testing and comparison of technical characteristics.

The "testing" mentioned is likely internal validation and verification activities against engineering specifications and recognized standards. No patient data (retrospective or prospective) is mentioned for a "test set" for the purpose of evaluating data transfer accuracy or clinical performance.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This section is not applicable as there is no mention of a "test set" requiring expert-established ground truth in the context of clinical performance for this device. The device's function is data transfer, not diagnostic or predictive, which typically requires expert interpretation for ground truth establishment.

4. Adjudication Method for the Test Set

This section is not applicable as there is no mention of a "test set" and thus no adjudication method for establishing ground truth for such a set.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not done. This type of study is typically used for diagnostic or screening devices where human reader performance is being evaluated, often with or without AI assistance. The Datex-Ohmeda S/5 Device Interfacing Solution is a data transfer device and does not involve human interpretation of medical images or data in a way that an MRMC study would be relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The device is a hardware and software system for data transfer. Its "performance" is inherently standalone in the sense that it automatically converts and transfers data. There is no "human-in-the-loop" for the primary function of data conversion and transfer; it's a device that facilitates the display and use of data by humans, but its core function is automated.

The "study" that proves the device meets its "acceptance criteria" (i.e., substantial equivalence) is the "summary of nonclinical testing for the device" which includes:

Validation and verification of specifications: This refers to internal testing conducted by the manufacturer to ensure the device performs as designed.
Assessment against recognized standards: The device was tested for compliance with specific electrical safety, electromagnetic compatibility (EMC), and labeling standards (e.g., EN 60601-1, IEC 60601-1-2).

These non-clinical tests serve as the "standalone" performance evaluation, demonstrating that the device functions correctly and safely in its intended environment.

7. The Type of Ground Truth Used

For the non-clinical testing and substantial equivalence claim, the "ground truth" would be:

Engineering Specifications: The design and functional requirements of the device itself.
Standard Requirements: The explicit requirements outlined in the referenced electrical safety, EMC, and labeling standards.
Predicate Device Characteristics: The known, legally marketed characteristics and performance of the predicate device (N-DISxxxx..00), against which the new device (N-DISxxxx..01) is compared for equivalence.

8. The Sample Size for the Training Set

This section is not applicable. The Datex-Ohmeda S/5 Device Interfacing Solution is a data transfer device, not an AI/ML algorithm that requires a "training set" of data to learn or develop its capabilities. Its functionality is based on pre-programmed logic for converting data formats.

9. How the Ground Truth for the Training Set Was Established

This section is not applicable as no training set is used for this device.

Summary

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JUL 1 9 2005

Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx..01

GENERAL COMPANY INFORMATION as required by 807.92(a)(1)

COMPANY NAME/ADDRESS/PHONE/FAX:

GE Healthcare 86 Pilgrim Road Needham, MA 02492 USA Tel: 781-449-8685 Fax: 781-433-1344

NAME OF CONTACT:

Mr. Joel Kent

DATE:

June 17, 2005

DEVICE NAME as required by 807.92(a)(2)

TRADE NAME:

Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx..01.

COMMON NAME:

Medical device data converter

CLASSIFICATION NAME:

The following Class II classification appears applicable:

Product Code	Classification Name	CFR Section
MSX	System, Network And Communication, PhysiologicalMonitors	870.2300

NAME OF LEGALLY MARKETED DEVICE FOR WHICH A CLAIM OF SUBSTANTIAL EQUIVALENCE IS MADE as required by 807.92(a)(3)

The S/5TM Device Interfacing Solution, N-DISxxxx..01 is substantially equivalent in safety and effectiveness to the legally marketed (predicate) S/5TM Device Interfacing Solution, N-DISxxxx..00 (K012531).

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DEVICE DESCRIPTION as required by 807.92(a)(4)

INTENDED USE as required by 807.92(a)(5)

Intended Use:

. .

The Datex-Ohmeda S/5 Device Interfacing Solution, DIS, is intended to be used with a Datex-Ohmeda monitoring systems for transferring data between external devices and a monitor.

Indications for use:

The Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx..01, is indicated for data transfer between stand-alone monitors, ventilators/anesthesia machines, blood gas analyzers, and heartlung machines and Datex-Ohmeda bedside monitors for displaying and patient care information purposes. The device is indicated for use by qualified medical personnel only.

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SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED TO THE PREDICATE DEVICE as required by 807.92(a)(6)

The S/5™ Device Interfacing Solution, N-DISxxxx..01 is substantially equivalent in safety and effectiveness to the legally marketed (predicate) S/5TM Device Interfacing Solution, N-DISxxxx..00 (K012531).

The S/5TM Device Interfacing Solution (later referred to as DIS) is an additional part of a Datex-Ohmeda modular S/5TM monitoring system. The Device Interfacing Solution enables connection of external medical bedside devices such as stand-alone monitors, ventilators/anesthesia machines, blood gas analyzers and heart-lung machines to the monitoring systems.

The S/5™ Device Interfacing Solution is a module that can be placed close to the interfaced external device. The module is device specific: a separate DIS module is needed to interface each external device. The DIS is able to transfer numerical, waveform and event type of data such as ventilator settings, laboratory results and heart-lung machine settings.

The N-DISxxxx..01 like the predicate N-DISxxxx..00 (K12531) does not perform any physiological measurements itself. It transfers data between connected external devices and S/5™ monitoring system. The Datex-Ohmeda S/5™ monitor displays, trends and uses data for calculations and transfers it to the record keeping system and network accordingly. The N-DISxxxx..01, in terms of general function is identical to its S/5™ Device Interfacing Solution, N-DISxxxx..00 (K012531). The N-DISxxxx..01 simply extends capability of Interfacing Solution to the Datex-Ohmeda S/5TM monitor. Neither the Device Interfacing Solution, N-DISxxxx..01 nor the predicate N-DISxxxx..00 transfer alarms. A new feature of the N-DISVENT module is that it can transfer a current clock time from the monitor to the Datex-Ohmeda AiSys Carestation (only this ventilator). This synchronization is done to have same clock time both in the ventilator and monitor. The same clock time in both devices is important for the record keeping purposes. This clock time transfer (time synchronization) is done only when there is no case open in the the monitor/ventilator. The comparison above as well as supporting data and analysis shows that there are no new questions of safety and effectiveness for the S/5™ Device Interfacing Solution or accessories.

The N-DISxxxx..01 has following similarities compared to the predicate N-DISxxxx..00 (K012531).

·Identical intended use and nearly identical indications for use .
. ·The same (improved) electronic board
. ·Essentially the same software.

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·Uses same operating principle .
. ·Have same user interface at the monitor
·Have the same safety and effectiveness
· Are manufactured using the same processes .

The main differences between the new N-DISxxxx..01 and the predicate N-DISAxxxx..00 (K0124531) are as follows:

· Electronic board uses various voltage comparing the old board. With FM monitor DIS . uses a 15Vdc power supply instead of old DIS modules which use 8Vdc. New board supports both voltages and automatically selects the correct voltage.
. · A new N-DISVENT module can communicate also with other Datex-Ohmeda ventilators and it will replace the N-DISAEST module,
. ·N-DISVENT can transfer time from monitor to ventilator (only with Datex-Ohmeda AiSys Carestation). This is used for time synchronization.

Based on the analysis and other documentation included in this 510(k) notification and attachments it is evident that the main features and indications for use of the S/5™ Device Interfacing Solution, N-DISxxxx.01 is substantially equivalent to the predicate S/5TM Device Interfacing Solution, N-DISxxxx..00 (K012531).

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SUMMARY OF NONCLINICAL TESTING FOR THE DEVICE and CONCLUSIONS as required by 807.92(b)(1)(3)

The Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx..01. has been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications.

EN 60601-1:1990 + Amdt 1:1993 + Amdt 2:1995 + Amdt 3:1996 Medical electrical equipment Part . 1: General requirements for safety
IEC 60601-1:1988 +Amdt 1:1991 + Amdt 2:1995 .
. CAN/CSA C22.2 No. 601.1-M90 + S1:1994 + Amdt 2:1998
. UL 2601-1,October 24, 1997
. IEC 60601-1-2:2001
Electromagnetic compatibility Requirements and tests .
EN 980: 1996 Terminology, symbols and information provided with medical devices- Graphical . symbols for use in the labeling of medical devices
EN 1041 1998 Terminology, symbols and information provided with medical devices; information . supplied by the manufacturer with medical devices.
. Protection against ingress of liquid: EN 60529 (IPX1):1992

CONCLUSION:

. .

The summary above shows that there are no new questions of safety and effectiveness for the S/5TM Device Interfacing Solution, N-DISxxxx..01 and it is substantially equivalent in safety and effectiveness to the legally marketed (predicate) S/5TM Device Interfacing Solution, N-DISxxxx.00 (K012531).

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/4/Picture/2 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features the department's name encircling a stylized eagle emblem. The eagle is depicted with three lines forming its body and wings, and two curved lines representing its legs.

JUL 1 9 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Healthcare c/o Mr. Joel C. Kent Manager, Quality and Regulatory Affairs 86 Pilgrim Road Needham, MA 02492

Re: K051634

Trade Name: Datex-Ohmeda S/5 Device Interfacing Solution N-DISxxxx..01 Regulation Number: 21 CFR 870.2300 Regulation Name: Physiological Network and Communication System Regulatory Class: Class II (two) Product Code: MSX Dated: June 17, 2005 Received: June 20, 2005

Dear Mr. Kent:

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, listing 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. Joel C. Kent

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast be advisou that I Dr wintion that your device complies with other requirements of the Act that I Dri has intacts and regulations administered by other Federal agencies. You must or any I cacal statuted and registements, including, but not limited to: registration and listing (21 Comply with an the 110 - 510 and manufacturing practice requirements as set CFR Part 8077, adoning (21 CFR Part 820); and if applicable, the electronic form in the qualis (Sections (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation come of pro herem (evice as described in your Section 510(k) rins letter wilf anow your to organization of substantial equivalence of your device to a legally prematice notification: "The President on 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), please If you desire specific acreoliance at (301) 594-4646. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Whoording of reservir on your responsibilities under the Act may be obtained from the Other general mionmation on Journational 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,

Bfimmermon for

S. R. Zimmerman, M.D.

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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Indications for Use

510(k) Number (if known): __ K05 | 634

Device Name: Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx..01

Indications for Use:

The device is indicated for use by qualified medical personnel only.

Over-The-Counter Use _ X Prescription Use __ AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (Please do not write below this line-continue on another page of neëoed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page __ of ___________________________________________________________________________________________________________________________________________________________________

B.H. Harrison

(Division Sign-OHJ
Division of Cardiovascular Devices
510(k) Number K05/454

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).