The Datex-Ohmeda S/5™ Network and Central transfers information between networked Datex-Ohmeda devices in the Datex-Ohmeda monitor network. It also allows information transfer between several Centrals. Within one Datex-Ohmeda monitor network it allows a networked device to display, store, print and otherwise process information received from other networked devices.

The Datex-Ohmeda S/5™ Central maintains the network connections between the Datex-Ohmeda bedside monitors and other networked devices in Datex-Ohmeda monitor network. Furthermore, it coordinates the transfer of information between devices in the Datex-Ohmeda S/5™ Network as well as between the Datex-Ohmeda Network and Hospital Information Systems (HIS).

The Datex-Ohmeda S/5™ Central can be used for remote monitor management, storing, printing, viewing or otherwise processing of information from several bedside monitors or other networked devices.

The Datex-Ohmeda S/5™ ViewStation can be used for remote monitor management, printing, viewing or otherwise processing of information from several bedside monitors or other networked devices.

The Datex-Ohmeda S/5™ Network will be used for patients in the hospital and it is meant for continuous use.

The device is for use by qualified personnel only.

Device Description

The Datex-Ohmeda S/5 Network (also referred as D-O Network in the related documentation) is a system, which consists of networked devices (which have separate 510k clearance) and the actual networking hardware. The networked devices are Datex-Ohmeda products containing a network adapter for physical access to the D-O Network as well as software modules supporting network access.

Examples of currently available networked devices are:

Datex-Ohmeda S/5 Anesthesia Monitor
Datex-Ohmeda S/5 Compact Anesthesia Monitor
Datex-Ohmeda S/5 Critical Care Monitor
Datex-Ohmeda S/5 Compact Critical Care Monitor
Datex-Ohmeda S/5 Light Monitor
Datex-Ohmeda S/5 Cardiocap 5 Monitor
Datex-Ohmeda S/5 Network and Central, included in this 510(k)
Datex-Ohmeda S/5 Telemetry System

The DeioRecorder for Anesthesia (formerly named as Datex-Ohmeda AS/3 Record Keeper.) is also related to the D-O Network as an application using the services provided by the D-O Network.

No changes must be made to the Datex-Ohmeda S/5 Network and Central itself due to a new type of networked device.

The Datex-Ohmeda S/5 Central (also referred to as D-O Central in the related documentation) is the primary maintainer of communication between other networked devices and is, thus, an essential part of the network. The structure and functionality of the revised network corresponds to the structure and functionality of the substantially equivalent predicate device Datex-Ohmeda Network and Central (510(k) number: K000647).

The Datex-Ohmeda Network will be used for real-time communication between devices, for record keeping and for data management in a hospital. Practical examples of currently available features are:

O Transmission and display of measured values and alarms in the Datex-Ohmeda S/5 Central screen (central monitoring) and on the screen of another networked monitor (monitor-to-monitor communication).

O Anesthesia record keeping.

[ Storing and transferring of trend and record keeping data in the network. When the patient is moved from one monitor to another, the data can be transferred with the patient. This feature includes also transferring data from/to an external system (HIS, laboratory, etc.) to/from Datex-Ohmeda S/5 Network.

D Printing of anesthesia records, ICU reports, trend printouts, spirometry loop printouts, waveform snapshot printouts, etc.

The actual networking hardware consists of cabling, patch panels, racks, connectors, repeaters, etc. The networking hardware is similar to the networking hardware of the substantially equivalent predicate device Datex-Ohmeda Network and Central (510(k) number: K000647).

The Datex-Ohmeda S/5 ViewStation is a D-0 Central version that can show real-time curves and numeric information from any monitor residing in the Datex-Ohmeda Network. It also allows printing to laser printer or recording to a strip-chart recorder. The Datex-Ohmeda S/5 ViewStation does not store patient data, or provide any other network services than display and printing services. The ViewStation uses the same hardware and a subset of the software used by the main Central.

The Datex-Ohmeda S/5 Telemetry System Network is a computer-based system for monitoring patients using telemetry. It consists of a PC based Central Station including moments patients assurence as and up to 16 telemetry transmitters per station. The central station supports arrhythmia monitoring, and measuring and trending of ST changes. An Station Jupports arres has been developed to enable connection of Telemetry central to D-O STS TeleNot I ackage enables transfer of ECG waveforms, ECG related parameters and archythmia information to the D-O Network. Also bed-to-bed services from telemetry sessions to bedside monitors are made available.

The new version of Datex-Ohmeda S/5 Network and Central adds the following features: Commercial hardware: The display driver is a commercial board instead of D-O proprietary boards. The proprietary keyboard is not used anymore, instead there is a commercial keyboard with dedicated "EasyAccess" keys

O User Interface is now mouse controlled in addition to keyboard controlled O Numerical and graphical trends have been added

O Alarm management functionality has been extended: remotely silencing of bedside alarms and changing alarm limits from Datex-Ohmeda S/5 Central or ViewStation have been added

□ Monitor disconnection warning on Central has been added

□ Possibility to start a network recorder from a bedside monitor has been added D TeleNet Package to enable connection of Datex-Ohmeda S/5 Telemetry System to D-O Network

AI/ML Overview

The provided text is a 510(k) summary for the Datex-Ohmeda S/5 Network and Central '01. This document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with acceptance criteria and device performance metrics in the way often seen for novel AI/ML devices. Therefore, many of the requested categories of information are not directly available or applicable in this type of submission.

Here's an analysis of what can be extracted and what is not applicable:

1. A table of acceptance criteria and the reported device performance

Not Applicable in the traditional sense for a 510(k) substantial equivalence submission for this type of device. The document does not define specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds) and then report performance against them. Instead, it demonstrates compliance with safety standards and outlines technological similarities and differences to a predicate device to argue for substantial equivalence.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable (or not reported for clinical evaluation). The submission describes non-clinical testing focused on compliance with safety standards (e.g., EN60950, EN 55022, IEC 801-3, EN 1441). These standards involve tests for electrical safety, electromagnetic compatibility, risk analysis, and alarm signals. These types of tests do not rely on a "test set" of patient data in the way an AI/ML diagnostic algorithm would. No clinical test set or data provenance is mentioned.

3. 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 there's no clinical "test set" of patient data for a diagnostic algorithm, there's no requirement or mention of experts establishing a ground truth for such a set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. No clinical test set requiring adjudication is described.

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 is a system for networking and central monitoring of physiological monitors, not a diagnostic AI device intended to assist human readers in interpreting clinical cases. Therefore, an MRMC study is not relevant.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not Applicable. This device is a network and central station for existing physiological monitors, not a standalone diagnostic algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not Applicable. No clinical ground truth is established or used for the evaluation presented in this 510(k) summary. The "truth" in this context comes from adherence to established engineering and safety standards.

8. The sample size for the training set

Not Applicable. As this is not an AI/ML device relying on a training set of data for algorithm development, no training set size is mentioned.

9. How the ground truth for the training set was established

Not Applicable. No training set ground truth applies.

Summary of Device Evaluation in the Document:

The evaluation for the Datex-Ohmeda S/5 Network and Central '01 is primarily a non-clinical safety and performance evaluation demonstrating compliance with a list of mandatory and voluntary standards:

Compliance with Safety Standards:
- EN60950: 1995 (IEC950 2nd edition) - Safety of information technology equipment
- EN 55022: 1994 (IEC-CISPR 22) - Information technology equipment Radio disturbance characteristics
- IEC 801-3, IEC 801-4 - Electromagnetic compatibility Generic immunity standard
- EN 1441 - Medical devices Risk analysis
- EN 475 - Medical devices Electrically-generated alarm signals
- ISO 9703-1, ISO 9703-2 - Anesthesia and respiratory care alarm signals
- IEC 60601-1-4
- CAN/CSA-C22.2 No 950 - Information Technology Equipment Including Electrical Business Equipment
- UL1950 - Information Technology Equipment Including Electrical Business Equipment
- ISO/IEC 8802-3 (ANSI/IEEE 802.3), EIA/TIA-568, EIA/TIA-TSB40 - International network cabling standards
Software Validation and Verification of Specifications: Mentioned as part of the thorough testing, but without specific test results or methodologies detailed in this summary.
Environmental Tolerance Testing: Mentioned as part of the thorough testing.

The conclusion drawn from this non-clinical testing is that the device "complies with the safety standards below and is therefore safe and effective for the intended use" and that "there are no new questions of safety and effectiveness for the Datex-Ohmeda S/5 Network and Central as compared to the predicate device."

In essence, the "acceptance criteria" are compliance with the listed international and national safety and performance standards for medical electrical equipment and information technology equipment, and the "study" is the battery of tests conducted to ensure this compliance, along with a comparison to a legally marketed predicate device (K000647) to demonstrate substantial equivalence.

Summary

{0}------------------------------------------------

DEC 1 1 2001

Image /page/0/Picture/1 description: The image is a black and white logo. The logo consists of a large circle with a white letter "D" inside. There is a small square in the upper right corner of the circle.

Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5 Network and Central '01

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:

September 25, 2001

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

TRADE NAME:

Datex-Ohmeda S/5 Network and Central '01

COMMON NAME:

Clinical network and central station

CLASSIFICATION NAME:

The following Class III classification appears applicable:

System, network and communication, physiological monitors 870.2910

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

The Datex-Ohmeda S/5 Network and Central '01 is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda S/5 Network and Central and Information Center (510(k) number: K000647).

K013246 Page 1 of 5

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

Examples of currently available networked devices are:

Datex-Ohmeda S/5 Anesthesia Monitor
Datex-Ohmeda S/5 Compact Anesthesia Monitor
Datex-Ohmeda S/5 Critical Care Monitor
Datex-Ohmeda S/5 Compact Critical Care Monitor
Datex-Ohmeda S/5 Light Monitor
Datex-Ohmeda S/5 Cardiocap 5 Monitor
Datex-Ohmeda S/5 Network and Central, included in this 510(k)
Datex-Ohmeda S/5 Telemetry System

The DeioRecorder for Anesthesia (formerly named as Datex-Ohmeda AS/3 Record Keeper.) is also related to the D-O Network as an application using the services provided by the D-O Network.

No changes must be made to the Datex-Ohmeda S/5 Network and Central itself due to a new type of networked device.

The Datex-Ohmeda Network will be used for real-time communication between devices, for record keeping and for data management in a hospital. Practical examples of currently available features are:

O Transmission and display of measured values and alarms in the Datex-Ohmeda S/5 Central screen (central monitoring) and on the screen of another networked monitor (monitor-to-monitor communication).

O Anesthesia record keeping.

D Printing of anesthesia records, ICU reports, trend printouts, spirometry loop printouts, waveform snapshot printouts, etc.

{2}------------------------------------------------

than display and printing services. The ViewStation uses the same hardware and a subset of the software used by the main Central.

O User Interface is now mouse controlled in addition to keyboard controlled O Numerical and graphical trends have been added

O Alarm management functionality has been extended: remotely silencing of bedside alarms and changing alarm limits from Datex-Ohmeda S/5 Central or ViewStation have been added

□ Monitor disconnection warning on Central has been added

□ Possibility to start a network recorder from a bedside monitor has been added D TeleNet Package to enable connection of Datex-Ohmeda S/5 Telemetry System to D-O

Network

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

The Datex-Ohmeda S/5 Network and Central is intended to be used with Datex-Ohmeda devices for displaying, storing, printing and otherwise processing information received from other networked devices.

The Datex-Ohmeda S/5TM Network and Central transfers information between networked Datex-Ohmeda devices in the Datex-Ohmeda monitor network. It also allows information transfer between several Centrals. Within one Datex-Ohmeda monitor network it allows a networked device to display, store, print and otherwise process information received from other networked devices.

The Datex-Ohmeda S/5TM Central maintains the network connections between the Datex-Ohmeda bedside monitors and other networked devices in Datex-Ohmeda monitor network. Furthermore, it coordinates the transfer of information between devices in the Datex-Ohmeda S/5TM Network as well as between the Datex-Ohmeda Network and Hospital Information Systems (HIS).

The Datex-Ohmeda S/5TM Central can be used for remote monitor management, storing, printing, viewing or otherwise processing of information from several bedside monitors or other networked devices.

The Datex-Ohmeda S/5TM ViewStation can be used for remote monitor management, printing, viewing or otherwise processing of information from several bedside monitors or other networked devices.

The Datex-Ohmeda S/5TM Network will be used for patients in the hospital and it is meant for continuous use.

The device is for use by qualified personnel only.

{3}------------------------------------------------

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

The Datex-Ohmeda S/5 Network and Central is substantially equivalent in safety and effectiveness to the Datex-Ohmeda S/5 Network and Central and Information Center (510(k) number: K000647).

Similarities:

The indications for use is the same as in predicate except that "remote monitor management" has been expressed in the statement.

The structure and functionality of the Datex-Ohmeda S/5 Network and Central '01 closely corresponds to the structure and functionality of the Datex-Ohmeda Network and Central '99 (predicate). The basic architecture of Datex- Ohmeda S/5 Network and Central '01 is the same as that of Datex-Ohmeda Network and Central '99 (predicate).

The user interface uses the same basic functionality: Single patient view and multiple patient views are similar to the predicate. Alarm indications are similar.

The ability to have audible alarm indications only on the Central is similar to the predicate.

Differences:

The hardware platform now uses commercial graphics controller and normal PC keyboard instead of D-O proprietary versions.

The user interface can now also be controlled with a mouse. The Central uses a PC keyboard that has labeled special "Easy Access" keys. The earlier keyboard was proprietary with special keys.

Remote monitor management adds the option to silence bedside monitor alarms from the Central and to adjust monitor alarm limits. These functions are by default disabled. They can be activated by the system administrator and activation is password protected.

Numerical and graphical trend display has been added to the Central.

Monitor disconnection warning has been added since Central may in some cases be used for monitoring alarms.

Possibility to start a network recorder from monitor has been added to support work methods of e.g. some intensive care units.

A SW package to enable S/5 Telemetry system integration to the D-O Network has been developed. It uses similar connection to the network as the Central.

Summary:

In summary, the new Datex-Ohmeda S/5 Network and Central, described in this submission is substantially equivalent to the predicate (K000647) device.

{4}------------------------------------------------

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

The Datex-Ohmeda S/5 Network and Central '01 complies with the safety standards below and is therefore safe and effective for the intended use. The device has been thoroughly and is therefore safe and orietr. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . environmental tolerance, software validation and verification of specifications. environmental toloration, solling following mandatory and voluntary standards has been made:

EN60950: 1995 (IEC950 2nd edition) Safety of information technology equipment, 그 including electrical business equipment
EN 55022: 1994 (IEC-CISPR 22) -- Information technology equipment Radio 내 disturbance characteristics. Limits and methods of measurement
distance characteristics is not 2011-3, IEC 801-4) -- Electromagnetic compatibility -. Generic immunity standard
EN 1441, Medical devices Risk analysis l
EN 475, Medical devices Electrically-generated alarm signals l
ISO 9703-1, ISO 9703-2, Anesthesia and respiratory care alarm signals l
. IEC 60601-1-4
CAN/CSA-C22.2 No 950: Information Technology Equipment Including Electrical 미 Business Equipment
UL1950: Information Technology Equipment Including Electrical Business Equipment 1
ISO/IEC 8802-3 (ANSI/IEEE 802.3), EIA/TIA-568, EIA/TIA-TSB40, international 내 network cabling standards

Conclusion:

The summary above shows that there are no new questions of safety and effectiveness for the Datex-Ohmeda S/5 Network and Central as compared to the predicate device.

{5}------------------------------------------------

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

: 上一篇

DEC 1 1 2001

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

Re: K013246

Trade Name: Datex-Ohmeda S/5 Network and Central '01 Regulation Number: 21 CFR 870.2300 Regulation Name: Network and Communication Physiological System Regulatory Class: Class II (two) Product Code: MSX Dated: September 26, 2001 Received: September 28, 2001

Dear Mr. Kent:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave to to wowed your becally is the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate 101 use stated in the encreatinent date of the Medical Device Amendments, or to conninered pror to that 2011-17-11, in accordance with the provisions of the Federal Food, Drug, devices that have been recuired in assee approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I ou may, dicrorolo, mance 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 If your device is olassified (600 we controls. Existing major regulations affecting your device can may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

{6}------------------------------------------------

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 or any Federal statutes and regulations administered by other Federal agencies. You must or any I odetar band 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 Of A rat 0077, accesses (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 premarket notineated. "The sification 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 11 Jou desire specific and 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,

Doulla Teth

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

Enclosure

{7}------------------------------------------------

510(k) Number (if known): __

Device Name: Datex-Ohmeda S/5 Network and Central '01

K013246

Indications For Use:

The Datex-Ohmeda S/5™ Network and Central transfers information The Datex-Ohmeda 3/5 - Network dha Sossia Costex-Ohmeda monitor
between networked Datex-Ohmeda devices in the Datex-Ohmeda between lietworked Dutox Onation transfer between several Centrals.
It also allows information transfer between severalsed des network. It also anows information namses it allows a networked device Within one DateX-Onmedia monitor news.
to display, store, print and otherwise process information received from other networked devices.

The Datex-Ohmeda S/5™ Central maintains the network connections The Datex-Onmeda S/3 - Gentral manitors and other networked devices
between the Datex-Ohmeda bedside monitors and other networth o between the Datex-Ohmeda society. Furthermore, it coordinates the in Datex-Olimeda monitor noen of ices in the Datex-Olimeda S/5™
transfer of information between devices in the Datex-Olimed Hooped Hoose transfer of Information between the Datex-Ohmeda Network and Hospital Information Systems (HIS).

The Datex-Ohmeda S/5™ Central can be used for remote monitor The Datex-Onlineuu 0/0 - - Ong, viewing or otherwise processing of management, storing, printing, viowing or other networked devices.
information from several bedside monitors or other networked devices.

The Datex-Ohmeda S/5™ ViewStation can be used for remote monitor The Datex-Onlineda 0/3 - - V101 One of otherwise processing of information management, printing, "citions" or other networked devices.

. The Datex-Olimeda S/5™ Network will be used for patients in the hospital and it is meant for continuous use.

The device is for use by qualified personnel only.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use	X
(Per 21 CFR 801.109)

Over-The-Counter Use _

(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Devices
510(k) Number K013246

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).