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

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

Device Description

The Device Interfacing Solution (DIS) has the following key components: Device specific converter module, device specific cable, bus cable to another DIS converter module, if needed, and Datex-Ohmeda monitor bus cable.

External devices are connected to the monitoring system by using 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 S/5 Anesthesia Monitor, S/5 Critical Care Monitor, S/5 Compact Anesthesia Monitor, or S/5 Compact Critical Care Monitor.

The DIS converter module is connected to to the socket at the rear of the Datex-Ohmeda monitor with a bus cable. The bus cable is also used for connecting DIS converter modules to each other. Specific modules can be connected to the different type of external devices. Up to ten DIS converter modules can be connected in series. Each external device has its own specific DIS converter module that can be used only with that device. One DIS converter module is needed for interfacing one external device.

The use of a DIS system consists of making physical connections: connecting external devices to DIS and linking DIS modules together to make a complete bus, and sending the converted data to the S/5 monitoring system. The user can then select the source of measurement data for physiologic parameters displayed in the Datex-Ohmeda monitor.

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

The provided text describes a medical device, the "Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx," and its regulatory clearance process (510(k)). However, it does not contain information about acceptance criteria or a study proving the device meets specific performance criteria through empirical data (e.g., accuracy, sensitivity, specificity studies).

Instead, the document focuses on:

Substantial Equivalence: The primary assertion is that the device is substantially equivalent to a predicate device (AS/3 Interface Board, B-INT (K935477)).
Compliance with Standards: The study mentioned is a nonclinical one demonstrating compliance with various electrical safety, electromagnetic compatibility, mechanical, environmental tolerance, and software validation standards.
Functional Description: Details about what the device does (e.g., converts data, interfaces with external devices) and what it does not do (e.g., perform physiological measurements itself, transfer alarms).

Therefore, I cannot populate the requested table or answer most of the questions directly from the provided text. The document is a regulatory submission demonstrating safety and effectiveness based on equivalence and adherence to general engineering and safety standards, not a performance study as typically understood in the context of diagnostic or AI-driven medical devices.

Here's what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Specific performance metrics (e.g., accuracy, latency of data transfer, error rate for data conversion)	NOT PROVIDED in the document. The document states "Verification of compliance with the following mandatory and voluntary standards has been made" and lists several electrical and safety standards. It also mentions "software validation and verification of specifications," but no quantifiable performance specifications are given.
Compliance with EN 60601-1:1990 + Amdt 1:1993 + Amdt 2:1995 + Amdt 3:1996 (Medical electrical equipment Part 1: General requirements for safety)	Verified
Compliance with IEC 60601-1:1988 +Amdt 1:1991 + Amdt 2:1995	Verified
Compliance with CAN/CSA C22.2 No. 601.1-M90 + S1:1994 + Amdt 2:1998	Verified
Compliance with UL 2601-1, October 24, 1997	Verified
Compliance with IEC 60601-1-2:1993	Verified
Compliance with EN 980: 1996	Verified
Compliance with EN 1041 1998	Verified
Compliance with EN 60529	Verified
Electrical Safety	Compliant
Electromagnetic Compatibility	Compliant
Mechanical and Environmental Tolerance	Compliant
Software Validation	Verified
Verification of specifications	Verified (but no specific performance specifications are detailed)

2. Sample size used for the test set and the data provenance: Not applicable. The "study" refers to compliance testing against engineering standards, not a clinical or performance validation study with a "test set" of patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as there's no diagnostic performance study involving expert ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

5. 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: Not applicable. This device is a data converter, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The document describes "nonclinical testing" including "software validation and verification of specifications." This suggests some form of standalone testing was done for the software's functionality, but no specific performance metrics (like accuracy of data conversion, latency, error rates) are provided.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the nonclinical testing, the "ground truth" would be the expected output or behavior of the device as defined by its specifications and the requirements of the standards (e.g., correct data format conversion, adherence to electrical safety limits). There's no biological or clinical "ground truth" in this context.

8. The sample size for the training set: Not applicable. This device does not use machine learning or AI that would involve a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary

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NOV 0 2 2001

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K012531

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

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

COMPANY NAME/ADDRESS/PHONE/FAX:

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

NAME OF CONTACT: Mr. Joel Kent

DATE:

August 3, 2001

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

TRADE NAME:

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

COMMON NAME:

Medical device data converter

CLASSIFICATION NAME:

The following Class II classification appears applicable:

Transducer Signal amplifier and conditioner (per 21 CFR 870.2060)

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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 is substantially equivalent in safety and effectiveness to the legally marketed (predicate) AS/3 Interface Board, B-INT (K935477).

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

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.

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

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

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

The S/5TM Device Interfacing Solution is substantially equivalent in safety and effectiveness to the legally marketed (predicate) A.S/3 Interface Board, B-INT (K935477).

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 DIS does not perform any physiological measurements itself. It receives data from connected external devices and transfers it in to the S/5TM monitoring system. The Datex-Ohmeda S/5TM monitor displays, trends and uses data for calculations and transfers it to the record keeping system and network accordingly. In terms of overall function, the S/5TM Device Interfacing Solution connected to an S/5™ monitoring systems is substantially equivalent in safety and effectiveness to the Datex-Ohmeda AS/3™ Interface Board, B-INT (K935477).

The S/5™ Device Interfacing Solution, in terms of general function is identical to its predicate AS/37M Interfacing board, B-INT (K935477). The S/5TM DIS simply extends the capability to interface more devices simultaneously, allows interfacing of different device types and also allows transfer of event type of data.

The concept of the S/5TM Device Interfacing Solution is the same as the predicate but the implementation differs slightly.

The predicate AS/3™ Interfacing board, B-INT (K935477) is a circuit board located in the frame of the monitor. It interfaces external medical devices such as monitors and anesthesia machines. One B-INT board includes drivers for the whole device library. The predicate B-INT is able to transfer numerical, waveform and alarm data from the interfaced device.

The S/5TM Device Interfacing Solution is a module that can be placed close to the interfaced external device. It interfaces external medical devices such as monitors, ventilators, anesthesia machines, blood gas analyzers and heart-lung machines. 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 S/5TM Device Interfacing Solution does not transfer alarms.

In summary, the S/5TM Device Interfacing Solution described in this submission is substantially equivalent to the predicate device.

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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 complies with the safety standards below and is therefore safe and effective for the intended use. The device has been thoroughly tested including electrical safety, electromagnetic compatibility, mechanical and environmental tolerance, software validation and verification of specifications. Verification of compliance with the following mandatory and voluntary standards has been made:

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 60601-1-2:1993 .
. EN 980: 1996
. EN 1041 1998
EN 60529

Conclusion:

The summary above shows that there are no new questions of safety and effectiveness for the Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx as compared to the predicate device.

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines forming its body and wings, symbolizing health, services, and people. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 2 2001

Mr. Joel C. Kent Manager, Quality and Regulatory Affairs Datex Ohmeda 86 Pilgrim Road Needham. MA 02492

Re: K012531

Trade Name: Datex-Ohmeda S/5™ Device Interfacing Solution N-DISxxxx Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitors (including cardiotachometer and rate alarm) Regulatory Class: Class II (two) Product Code: 74 MSX Dated: August 3, 2001 Received: August 6, 2001

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 that FDA has made a determination that your device complies with other requirements of the Act of that FDA nas made a decemination that your control by other Federal agencies. You must comply with all the Act's requirements and regulations cammistered of to: registration and listing (21 CFR Part 807); all the Act STequirements, morading, bannoving practice requirements as set forth in the quality labeling (21 CFR Part 801), good management of 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) This letter will anow you to ogin mainening your antial equivalence of your device to a legally premits tourication: "The I DA midning of basisnation 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 IT you desire specific advice to: your avitro diagnostic devices), please contact the Office of Compliance at (301) 594-4645. Additionally, for questions on the promotion and advertising of Compliance at (301) 597 1045. The of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Tegulation citined, "Wisolanding of responsibilities under the Act may be obtained from the Division Other general information on Jour 19 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,

Qala Teth

mes 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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Kol 253 / 510(k) Number (if known): _

NOV 02 2001 Device Name: Datex-Ohmeda S/5 Device Interfacing Solution, N-DISxxxx

The devices are indicated for use by qualified medical personnel only.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) OR Prescription Use_ Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109) (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).