The S/5™ Critical Care Monitor is a patient monitor, which displays the measurement of patient physiological parameters in the hospital setting. The measurement of patient physiological parameters is accomplished by specialized measurement modules which, when plugged into the frame, allow the modules to communicate with the monitor. The care giver can select from a variety of available measurements (parameters) and apply those parameters that are best suited to patient care. Modules perform the functions of parameter measurement and minor data processing. The S/5TM Critical Care Monitor displays parameters on screen, signals alarms and performs advanced data processing. There are two software options available for the S/5 Critical Care Monitor with L-ICU02 and L-ICU02A.

L-ICU02A is equipped with extended arrhythmia analysis capability. Other than arrhythmia analysis capabilities, this software option is identical to L-ICU02.

The modifications to the device are:

Improved Central Processing Unit Board, B-CPU5, with increased memory capability.
Improved Universal Peripheral Interface Board, B-UPI4NET, which is a combination of the previous B-UPI and B-NET boards.
Rotating of the "ComWheel" now scrolls through different trend pages.
Technical alarms such as "SpO2 probe off", "Leads off" (ECG), and "Px No transducer" (InvBP) transferred to the Central Station.
Changed to include support for alarm silencing and alarm limits adjustment from Central Station.
The alarm priority of "X module removed" message has been increased from note level to yellow level.
Software can additionally send request for recording to Central Station.
Standby information is additionally sent to Central Station.
Snapshot printing speed 25 mm/s has been added.
Mean Arterial Pressure value replaces O2 F1 value in vital parameters numerical trend.
The NMT cycle time selections have been changed to be: 20 s / 1 min / 5 min / 15 min / 30 min / 60 min / 120 min.
Lifetime of an old NIBP value has been changed from 60 min to 245 min.
Support for M-BIS (Bispectral Index) module has been added. M-BIS is the subject of a separate 510(k) premarket notification
Support for the M-miniC (CO2 module) module has been added. The Mini CO2 module M-miniC is the subject of a separate 510(k) premarket notification.
Support for the N-DIS external device interfacing modules for interfacing of the following device categories: ventilators/anesthesia machines, stand-alone monitors, blood gas analyzers and heart-lung machines has been added. The N-DIS modules is the subject of a separate 510(k) premarket notification.
Uses arrhythmia analysis version which has an improved vfib algorithm compared to arthythmia analysis version submitted in the predicate 510(k).

The S/5™ Critical Care Monitor with L-ICU02 and L-ICU02A uses several types of plugin measurement modules. Modules are the subject of separate 510(k)'s and are not part of this notification.

The S/5™ Critical Care Monitor with L-ICU02 and L-ICU02A is typically furnished with a module that measures BCG, invasive and non-invasive blood pressures, pulse oximerry and temperature. Modules are placed in the S/5™ monitor frame and are automatically recognized by the monitor. The patient cables are connected to the module plug in jacks and then monitoring can begin. The S/5TM Critical Care Monitor with L-ICU02 and L-ICU02A can display measurements in the form of numeric values, traces and trends. Audible and visual alarms are used to indicate patient status. The priority profile of an alarm depends on the parameter. The S/5TM Critical Care Monitor with L-ICU02 and L-ICU02A is overated by a kevboard. Typically pressing a key results in a pop up menu appearing on the screen. Selections can then be made easily from the menu using a unique ergonomically designed pointing device on the keyboard called a ComWheel™. The software L-ICU02 and L-ICU02A perform some module related tasks like arrhythmia analysis, ST-values calculation, heart rate calculation, impedance and respiration rate calculation, energy expenditure calculation, drug calculation, EEG spectrum analysis and evoked potential response averaging. All the module communication is also handled in the main software. There are various optional types of keyboards, some are like standard keyboards and another is a hand-held Remote controller (K-REMCO) which is still directly connected to the S/5TM Critical Care Monitor via a long cord but provides more flexibility in controlling the monitor while the doctor or nurse is handling other patient care needs. The S/5™ Critical Care Monitor can be in a stand-alone or networked configuration. If networked, measurements are sent to the network for central station or monitor-to-monitor viewing. Trends can also be sent via a network to a central computer for archiving.

AI/ML Overview

The provided text does not contain specific acceptance criteria or a detailed study proving device performance against such criteria. Instead, it describes a Premarket Notification 510(k) Summary for a modified patient monitor, the Datex-Ohmeda S/5™ Critical Care Monitor with L-ICU02 and L-ICU02A software.

This document focuses on demonstrating substantial equivalence to a predicate device (Datex-Ohmeda CS/3™ Critical Care Monitor with S-ICU99(A) software, K000168), rather than presenting a standalone performance study with defined acceptance criteria for the new device.

The "Summary of Nonclinical Testing" section (Page 4) lists compliance with various safety standards (e.g., IEC 60601-1, ANSI/AAMI EC57). This implies that the device meets the requirements set forth in these standards, but it doesn't provide specific performance metrics or thresholds for clinical accuracy or efficacy.

Therefore, many of the requested details about acceptance criteria, specific performance numbers, sample sizes, expert involvement, and ground truth for a performance study are not available in the provided text.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Compliance with various safety standards (e.g., IEC 60601-1, EN 60601-1, CAN/CSA-C22.2 No.601.1-M90, IEC 60601-2-27, ANSI/AAMI EC57, etc.)	The device "complies with the safety standards below and is therefore safe and effective for the intended use." Specific performance metrics (e.g., accuracy, sensitivity, specificity for arrhythmia detection, ST-segment analysis, etc.) against these standards are not explicitly stated in terms of numerical thresholds or observed values. The document asserts compliance, indicating that the device's performance, as evaluated against these standards, met their requirements.
Substantial Equivalence to predicate device (Datex-Ohmeda CS/3™ Critical Care Monitor with S-ICU99(A) software K000168) in terms of intended use, indications for use, and technological characteristics.	The document repeatedly states that the new device is "substantially equivalent" to the predicate. It specifically mentions that the "arrhythmia analysis functionality of the S/5™ Critical Care Monitor with L-ICU02A is substantially equivalent to the functionality of the predicate device CS/3™ Critical Care Monitor with S-ICU99A (K000168)." No specific performance data (e.g., improved vfib algorithm performance) is quantified to demonstrate this equivalence beyond stating an improvement in the vfib algorithm.

Acceptance Criteria

Reported Device Performance

Compliance with various safety standards (e.g., IEC 60601-1, EN 60601-1, CAN/CSA-C22.2 No.601.1-M90, IEC 60601-2-27, ANSI/AAMI EC57, etc.)

The device "complies with the safety standards below and is therefore safe and effective for the intended use." Specific performance metrics (e.g., accuracy, sensitivity, specificity for arrhythmia detection, ST-segment analysis, etc.) against these standards are not explicitly stated in terms of numerical thresholds or observed values. The document asserts compliance, indicating that the device's performance, as evaluated against these standards, met their requirements.

Substantial Equivalence to predicate device (Datex-Ohmeda CS/3™ Critical Care Monitor with S-ICU99(A) software K000168) in terms of intended use, indications for use, and technological characteristics.

The document repeatedly states that the new device is "substantially equivalent" to the predicate. It specifically mentions that the "arrhythmia analysis functionality of the S/5™ Critical Care Monitor with L-ICU02A is substantially equivalent to the functionality of the predicate device CS/3™ Critical Care Monitor with S-ICU99A (K000168)." No specific performance data (e.g., improved vfib algorithm performance) is quantified to demonstrate this equivalence beyond stating an improvement in the vfib algorithm.

2. Sample size used for the test set and the data provenance

The document describes "nonclinical testing" including "software validation and verifications," and compliance with standards. It does not specify a "test set" in the context of a clinical performance study with human subjects or a dataset for evaluating an AI algorithm.
Data provenance: Not applicable as a clinical or AI-specific dataset is not described. The testing described is primarily in vitro/bench testing for compliance with engineering and safety standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. The document doesn't describe a study involving expert-established ground truth for performance evaluation of an AI algorithm or clinical device.
The "compliance with standards" implies that the device's technical specifications and functional performance were verified against established norms, likely by engineers and testers, rather than clinical experts providing ground truth for diagnostic accuracy.

4. Adjudication method for the test set

Not applicable as there is no specific "test set" and ground truth establishment process described that would require adjudication.

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

No MRMC comparative effectiveness study is described. This device is a patient monitor, not an AI diagnostic standalone or assistive tool in the modern sense. The "AI" mentioned in the prompt's question for this section (human readers improve with AI) is not relevant to this type of device and its submission. The closest mention of "AI" in the document is the "improved vfib algorithm," which is an internal processing algorithm, not an AI system for human reader assistance.

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

The document implies that the device, including its software and algorithms (like the "arrhythmia analysis version which has an improved vfib algorithm"), underwent "software validation and verifications." This could be interpreted as standalone testing of the algorithm's performance against specifications derived from standards or predicate device performance. However, no specific standalone performance results (e.g., sensitivity, specificity for vfib detection) are provided. The focus is on compliance and substantial equivalence rather than detailed performance reporting.

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

Not explicitly stated for performance evaluation. For compliance with standards, the ground truth would be the requirements defined by those standards (e.g., an alarm must trigger within X seconds of a simulated event, a measurement must be accurate within Y tolerance).
For the "improved vfib algorithm," the ground truth would likely be established through a combination of simulated cardiac signals, annotated ECG databases, or comparison to established, validated arrhythmia detection methods. However, no specifics are given.

8. The sample size for the training set

Not applicable. The document does not describe the development of a machine learning or AI model that would typically involve a "training set." The "improved vfib algorithm" is mentioned, suggesting algorithmic development and verification, but details of datasets used for its development or validation are not provided.

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

Not applicable, as no training set for an AI model is described.

Summary

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JUL 2 4 2002

K021376

Page 1 of 5

Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5™ Critical Care Monitor with L-ICU02 and L-ICU02A software

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:

July 20, 2002

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

TRADE NAME:

Datex-Ohmeda S/5TM Critical Care Monitor with L-ICU02 and L-ICU02A software

COMMON NAME:

Patient Monitor

CLASSIFICATION NAME:

The following Class III classification appears applicable:

DSI	Arrhythmia detector & alarm	870.1025
	MLD Monitor ST-segment & alarm	870.1025

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

The Datex-Ohmeda S/5TM Critical Care Monitor with L-ICU02 and L-ICU02A software is substantially equivalent to the predicate Datex-Ohmeda CS/31M Cricical Care Mouitwawth S-ICU99(A) software (K000168).

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

The intended use and indications for use for the modified device, Datex-Obmeda S/STM Critical Care Monitor with L-ICU02 and L-ICU02A software is similar as the predicate Datex-Ohmeda CS/3TM Critical Care Monitor with S-ICU99(A) software (K000168).

There has been no change to the fundamental scientific technology from the predicate.

The device description of the Datex-Ohmeda S/5 TM Critical Care Monitor with L-ICU02 and L-ICU02A software is as follows:

L-ICU02A is equipped with extended arrhythmia analysis capability. Other than arrhythmia analysis capabilities, this software option is identical to L-ICU02.

The modifications to the device are:

Improved Central Processing Unit Board, B-CPU5, with increased memory 1. capability.
Improved Universal Peripheral Interface Board, B-UPI4NET, which is a 2. combination of the previous B-UPI and B-NET boards.
Rotating of the "ComWheel" now scrolls through different trend pages. 3.
1. Technical alarms such as "SpO2 probe off", "Leads off" (ECG), and "Px No transducer" (InvBP) transferred to the Central Station.
1. Changed to include support for alarm silencing and alarm limits adjustment from Central Station.
1. The alarm priority of "X module removed" message has been increased from note level to yellow level.
1. Software can additionally send request for recording to Central Station.
Standby information is additionally sent to Central Station. 8.
Snapshot printing speed 25 mm/s has been added. 9.
Mean Arterial Pressure value replaces O2 F1 value in vital parameters numerical 10. trend.
1. The NMT cycle time selections have been changed to be:
- 20 s / 1 min / 5 min / 15 min / 30 min / 60 min / 120 min.
1. Lifetime of an old NIBP value has been changed from 60 min to 245 min.
Support for M-BIS (Bispectral Index) module has been added. M-BIS is the 13. subject of a separate 510(k) premarket notification
1. Support for the M-miniC (CO2 module) module has been added. The Mini CO2 module M-miniC is the subject of a separate 510(k) premarket notification.

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Support for the N-DIS external device interfacing modules for interfacing of the 15. following device categories: ventilators/anesthesia machines, stand-alone monitors, blood gas analyzers and heart-lung machines has been added. The N-DIS modules is the subject of a separate 510(k) premarket notification.
Uses arrhythmia analysis version which has an improved vfib algorithm 16. compared to arthythmia analysis version submitted in the predicate 510(k).

The S/5™ Critical Care Monitor with L-ICU02 and L-ICU02A uses several types of plugin measurement modules. Modules are the subject of separate 510(k)'s and are not part of this notification.

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

Intended use:

The $/5"M Critical Care Monitor with L-ICU02 and L-ICU02A is intended for multiparameter patient monitoring.

Indications for use:

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

The Datex-Ohmeda S/5TM Critical Care Monitor with L-ICU02 and L-ICU02A software is substantially equivalent to the predicate Datex-Ohmeda CS/37M Critical Care Monitor with S-ICU99(A) software (K000168).

The S/5TM Critical Care Monitor with L-ICU02 and L-ICU02A software is indicated for monitoring of hemodynamic (including arrhythmia and ST-segment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), and neurophysiological status of all hospital patients. The S/5TM Critical Care Monitor with L-ICU02 and L-ICU02A software when using BIS is for monitoring the state of the brain by data acquisition and processing of electroencephalograph signals and may be used as an aid in monitoring the effects of certain anesthetic agents* (*Gan TJ, Glass P, Windsor A, Pavne F. Rosow C. Sebel P. Manberg P. Bispectral Index Monitoring Allows Faster Emergence and Improved Recovery from Propofol. Alfentanil and Nitrous Oxide Anesthesia. Anesthesiology, October 1997; (4) 87:308-15.) The S/5TM Critical Care Monitor with L-ICU02 and L-ICU02A software is indicated for use by qualified medical personnel only. There are two software options available for the S/5TM Critical Care Monitor: L-ICU02 and L-ICU02A (collectively referred to as L-ICU02(A) ). (Note: Lrefers to software license). Only one software can be used at any given time in the monitor. The software is preloaded in the factory. The new device with different software options, S/5TM Critical Care Monitor with L-ICU02 and L-ICU02A, is compared to predicates as outlined below. The basic model of the monitor is the S/5TM Critical Care Monitor with L-ICU02, which is a new revision of the predicate devices, CS/37M Critical Care Monitor with S-ICU99 (K000168). The S/5TM Critical Care Monitor with L-ICU02 may be equipped with extended bedside arrhythmia analysis capability and in this case the monitor is called S/51M Critical Care Monitor with L-ICU02A. The arrhythmia analysis functionality of the S/5TM Critical Care Monitor with L-ICU02A is substantially equivalent to the functionality of the predicate device CS/3™ Critical Care Monitor with S-ICU99A (K000168). The S/5TM Critical Care Monitor with L-ICU02 and L-ICU02A is a modular multiparameter patient monitor providing connections to measurement modules. The general construction, indications for use and intended use of the S/57M Critical Care Monitor with L-ICU02 and L-ICU02A are similar compared to the predicate CS/3TM Critical Care Monitor with S-ICU99(A) (K000168).

Based on the above and a detailed analysis in other documentation included in this 510(k) notification it is evident that the main features and indications for use of the S/504 Critical Care Monitor with L-ICU02 and L-ICU02A software is substantially equivalent to the predicate CS/3TM Critical Care Monitor with S-ICU99(A) software (K000168) ..

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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/5TM Critical Care Monitor with L-ICU02 and L-ICU02A software 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 verifications. Verifications. Verification of compliance with the following mandatory and voluntary standards has been made:

. IEC 60601-1:1988+ Amdt .: 1:1991 + Amdt. 2:1995
EN 60601-1: 1990 + A1:1993+A2:1995+A13:1996 .
CAN/CSA-C22.2 No.601.1-M90 +S1:1994+Amdt. 2:1998 .
IEC 60601-2-27:1994/EN 60601-2-27:1994 .
IEC 60601-2-30:1995/EN 60601-2-30:1995 .
IEC 60601-2-34:1994/EN 60601-2-34:1994 .
IEC 60601-2-40:1998 .
IEC 60601-1-2(1993)/EN 60601-1-2 .
IEC 60601-1-4: 1996+Amdt. 1:1999/EN 60601-1-4 .
. ISO 9918:1993/EN 864:1996
ISO 9919:1992/EN865:1997 .
ISO 7767:1997/EN12598:1999 .
IEC 601-2-10:1987/HD 395.2.10:1988 + Am 1:2000 .
IEC 60601-2-26:1994/EN60601-2-26 ●
IEC 60068-2 .
. UL 2601-1:1997
. ANSI/AAMI ES-1:1993
ANSI/AAMI EC57:1998 .
FDA 21 CFR 898.12 .

Conclusion:

The summary above shows that there are no new questions of safety and effectiveness for the Datex-Ohmeda S/5™ Critical Care Monitor with L-ICU02 and L-ICU02A software as compared to the predicate device.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 6 2002

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

Re: K021376

Trade Name: Datex-Ohmeda S/5™ Critical Care Monitor with L-ICU02 and L-ICU02A Software Regulation Name: Arrhythmia Detector and Alarm Regulation Number: 21 CFR 870.1025 Regulatory Class: Class III (three) Product Code: DSI Dated: April 29, 2002 Received: May 1, 2002

Dear Mr. Kent:

This letter corrects our substantially equivalent letter of July 24, 2002, regarding the incorrect Indications for Use.

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.

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Page 2 - Mr. Joel C. Kent

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.

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 (OS) 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 80) 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 vou

Elias Mallés

Image /page/6/Picture/7 description: The image shows a close-up of a handwritten signature. The signature appears to be in cursive and is written with a dark ink on a white background. The signature is somewhat stylized and difficult to read, but it seems to start with a loop and then continues with a series of connected strokes.

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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K021376 510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Datex-Ohmeda S/5™ Critical Care Monitor with L-ICU02 and L-ICU02A software

Indications For Use:

The S/5™ Critical Care Monitor with L-ICU02 and L-ICU02A software is indicated for monitoring of hemodynamic (including arrhythmia and STsegment analysis), respiratory, ventilatory, gastrointestinal/regional perfusion, Bispectral index (BIS), and neurophysiological status of all hospital patients.

The S/5™ Critical Care Monitor with L-ICU02 and L-ICU02A software when using BIS is for monitoring the state of the brain by data acquisition and processing of electroencephalograph signals and may be used as an aid in monitoring the effects of certain anesthetic agents.

The S/5TM Critical Care Monitor with L-ICU02 and L-ICU02A software is 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)

Prescription Use √
(Per 21 CFR 801.109)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Optional Format 1-2-96)

Division of Cardiovascular & Respiratory Doctor:
Group Number	K021375

Regulation Number and Section

§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).

(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.