The Datex-Ohmeda S/5™ Compact Airway Module, E-CAiOVX family is intended to be used TIE Datex-Ohmeda 07-5 - Oct plant in monitors for monitoring respiratory, ventilatory and gas exchange parameters of hospitalized patients.

The Datex-Ohmeda S/5™ Compact Airway Module, E-CAiOVX family is indicated for The Date.x-Onlineda 075 - Comparation (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiration rate) ventilation (airway pressure, volume and flow) and gas luchange status (Oxygen Consumption VO2, Carbon Dioxide production VCO2, Respiratory Cxchange status (Oxygon Octountiples, EE). Gas exchange status monitoring is not indicated in the Quottent RQ, and Energy Expendhadevice is indicated for use by qualified medical personnel only.

Device Description

The Datex-Ohmeda S/5™ Compact Airway Module, E-CAiOVX is a double-width plug-in parameter module for monitoring respiratory (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiration rate), ventilatory (airway pressure, volume and flow) and gas exchange parameters (Oxygen Consumption VO2, Carbon Dioxide production VCO2, Respiratory Quotient RQ, and Energy Expenditure, EE). The E-CAiOVX is a Compact Airway measuring module for a modular monitoring system.

The E-CAiOVX module consists of:

AOVA infrared measuring sensor for measuring CO2, N2O and anaesthetic agents
Paramagnetic O2 sensor .
Side-Stream Spirometry measurement .
Gas Exchange measurement
Halothane, Sevoflurane, Isoflurane and Desflurane).

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the Datex-Ohmeda S/5™ Compact Airway Module (model family E-CAiOVX). This is a submission to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than a study designed to prove the device meets specific acceptance criteria based on performance metrics.

Therefore, many of the requested details about acceptance criteria, study design, ground truth, and sample sizes for training and test sets are not explicitly present in this type of regulatory document. The document focuses on demonstrating that the new device is fundamentally the same as a previously approved device.

Here's an attempt to answer the questions based on the provided text, noting where information is not available:

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

The document does not explicitly present a table of acceptance criteria with corresponding performance results. Instead, it asserts that "The Customer and parameter specifications are the same, except for one minor modification" as compared to the predicate device. This implies that the acceptance criteria are essentially those already established for the predicate device, and the new device meets them by virtue of being substantially equivalent.

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. This document describes a 510(k) submission which relies on demonstrating substantial equivalence to a predicate device, rather than a clinical trial with a test set of data. The "nonclinical testing" mentioned refers to verification and validation of specifications, not typically a "test set" in the context of AI/ML performance.

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 this is not a study involving expert-established ground truth for a test set, this information is not provided.

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

Not applicable. No test set requiring expert adjudication is mentioned.

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. The device described is an airway gas and spirometry monitoring module, not an AI-assisted diagnostic tool that would typically undergo an MRMC study.

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

This refers to a standalone performance evaluation of the device's measurement capabilities. The document states "The Datex-Ohmeda S/5TM Compact Airway Module... have been assessed against... thoroughly tested through validation and verification of specifications." This implies standalone testing was performed to ensure the device meets its specified performance parameters. However, specific results of this standalone performance are not detailed in this summary.

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

For the "nonclinical testing" (verification and validation), the "ground truth" would be established by reference standards or highly accurate measurement techniques for the various physiological parameters (CO2, O2, anesthetic agents, pressure, volume, flow, etc.) the device is designed to measure. This is inherent in the "validation and verification of specifications" against recognized standards (e.g., ISO, ASTM).

8. The sample size for the training set

Not applicable. This device is not an AI/ML model that would have a "training set" in the conventional sense. The software enhancements are described as "mostly improvements simplifying manufacturing and tests during manufacturing," implying maintenance and optimization rather than a machine learning training process.

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

Not applicable, as there is no mention of a training set for an AI/ML model.

Summary

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MAY 2 5 2005

KOS1092

Premarket Notification 510(k) Summary As required by section 807.92 Datex-Ohmeda S/5TM Compact Airway Module (model family E-CAIOVX) E-CAiOVX, E-CAiOV, E-CAiOV, E-CAiO, E-COVX, E-COV, E-CO and accessories.

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:

April 19, 2005

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

TRADE NAME:

Datex-Ohmeda S/5™ Compact Airway Module (model family E-CAiOVX) E-CAiOVX, E-CAiOV, E-CAiO, E-COVX, E-COV, E-CO and accessories.

COMMON NAME:

Airway gas, pressure and volume, anesthetic agent and agent identification and gas exchange monitor. Airway gas and Patient Spirometry accessories.

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CLASSIFICATION NAME:

The following Class II classifications appear applicable:

Product Code	Classification Name	CFR Section
CCK	Analyzer, Gas, Carbon-Dioxide, Gaseous-phase	868.1400
CCL	Analyzer, Gas, Oxygen, Gaseous-phase	868.1720
BZK	Spirometer, Monitoring (W/WO alarm)	868.1850
CAP	Monitor, Airway Pressure (Includes gauge and/or alarm)	868.2600
CBR	Analyzer, Gas, Nitrous-Oxide, Gaseous-phase (Anesthetic co)	868.1700
BZL	Computer, Oxygen-uptake	868.1730
CBQ	Analyzer, Gas, Enflurane, Gaseous-phase (Anesthetic conc.)	868.1500
CBS	Analyzer, Gas, Halothane Gaseous-phase (Anesthetic conc.)	868.1500
NHO	Analyzer, Gas, Desflurane, Gaseous-phase (Anesthetic conc.)	868.1500
NHQ	Analyzer, Gas, Isoflurane Gaseous-phase (Anesthetic conc.)	868.1500
NHP	Analyzer, Gas, Sevoflurane, Gaseous-phase (Anesthetic conc)	868.1500

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™ Compact Airway Module family, E-CAiOVX is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M-CAiOVX Module (K001814).

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

The intended use for the modified device is the same as for the predicate, Datex-Ohmeda M-CAiOVX module (K001814) The indications for use are also the same.

There has been no change to the basic technology from the predicate. The E-CAiOVX module is a facelifted version of the predicate M-CAiOVX module. The module cover and mechanics have changed, but the fundamental scientific technology is the same as in the predicate device M-CAiOVX (K001814). The electronic measurement boards are the same in E-CAiOVX and M-CAiOVX, except for one component type change (EEPROM), and the software is basically the same, although both the software code and revision has changed during the five years since the predicate submission. Software changes include mostly improvements simplifying manufacturing and tests during manufacturing. There are also some enhancements in the mechanics of the E-CAiOVX modulc compared with the predicate M-CAiOVX, e.g. EMC cover is better implemented into the mechanics. The EMC specifications for the E-CAiOVX and M-CAiOVX modules are the same. The Datex-Ohmeda Compact Airway Module module, E-CAiOVX can be used with the following Datex-Olımeda modular monitors with any monitor software (*)

S/5TM Anesthesia Monitor (AM) with monitor software S-STD93 or newer (*)

. S/5™ Compact Anesthesia Monitor (CAM) with monitor software S-STD93 or newer (*)

. S/5TM Critical Care Monitor (CCM) with monitor software S-ICU97 or newer (*)

S/5TM Compact Critical Care Monitor (CCCM).with monitor software S ICU97 or newer (*)

(*) The Gas exchange measurement works only with software versions 99 or newer. All monitors can be upgraded to software version 99 by using the U-LIFE U-xxx99(A).

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The E-CAiOVX module consists of:

AOVA infrared measuring sensor for measuring CO2, N2O and anaesthetic agents
Paramagnetic O2 sensor .
Side-Stream Spirometry measurement .
Gas Exchange measurement

. Halothane, Sevoflurane, Isoflurane and Desflurane).

Harothalle, Sevonurane, Isofturane and Decritical).
The E-CAiOVX module uses the same measurement technology and accessories as the predicate I he E-CAIOVX (K001814). The main accessories include airway gas sampling lines, D-fend device, M- CAIO + A (1001011). In tubing and D-lite sensors. The sampling line and the water traps, Spironicily measurement table connectors. The monitor is switched on and the gas spirometry tube and the spirometry tube is attached to the D-lite™ airway adapter. The D-lite™ is sampling the and the spironionly tace is that and moisture exchanger (HIME) of the patient's intubation tube. The monitor displays measurements from the E-CAiOVX's and subtype modules intubation table. The moment and loops. All the calculated paraneters can be selected on in the form of numeric values, our res, and view on the E-CAiOVX moduels are taken the usplay, and action. And for wear interface for alarms in Datex-Ohmeda S/5 patient care of by the nost monitor and forlow the asser merines. There are auditory and visual alarms and user adjustable limits for the gas measurement variables.

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

Intended use:

Indications for use:

The Datex-Ohmeda S/5M Compact Airway Module, E-CAiOVX family is indicated for The Date.x-Onlineda 075 - Comparation (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiration rate) ventilation (airway pressure, volume and flow) and gas luchange status (Oxygen Consumption VO2, Carbon Dioxide production VCO2, Respiratory Cxchange status (Oxygon Octountiples, EE). Gas exchange status monitoring is not indicated in the Quottent RQ, and Energy Expendhadevice 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 Datex-Ohmeda S/5™ Compact Airway Module family, E-CAiOVX is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M-CAiOVX Module (K001814).

The E-CAiOVX module has the following similarities compared to the predicate M-CAiOVX (K001814):

identical intended use and indications for use .
identical fundamental scientific technology .
same electronic measurement board (EEPROM type changed) .
same module software (version changed from 891977-3.2 to 8001805-4.5) .
same algorithms for respiratory, ventilatory and gas exchange parameter calculation .
use the same operating principle ●
use largely the same accessories ●
have the same user interface at the monitor and alarms (can be used with the same . monitor software)
the Customer and parameter specifications are the same, except for one minor . modification
have the same safety and effectiveness .
are manufactured using the same processes t

The main differences between the new E-CAiOVX and the predicate M-CAiOVX (K001814) is primarily due to fact that the new E-CAiOVX module has the following changes:

new color and shape and thus differing mechanics .
The front panel and labeling have changed .
The connector for gas return (front panel and accessories) have changed to be ◆ incompatible with female Luer Lock connectors.
The EEPROM type on the electronic measurement boards have changed .
The module software has been enhanced and revised several times. Most new revisions . include enhancements for manufacturing and testing during manufacturing.
The EMC is better implemented into the mechanics, e.g. some module materials changed . and shielding EMC foam was used.

Based on the analysis and other documentation included in this 510(k) notification and Dused on the and you and of the main features and indications for use of the Datex-Ohmeda S/STM Compact Airway Module, E-CAiOVX are substantially equivalent to the predicate Datex-Ohmeda M-CAiOVX Module (K001814).

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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 Compact Airway Module (model family E-CAiOVX) E-CAiOVX, E-The Datex-Onlineda S75 - Compact In-CO and accessories have been assessed against the CAIOV, L-CAIO, L-CO P.R. B OC T, B OO T, E oo oughly tested through validation and verification of specifications.

FDA/DCRND Reviewer Guidance for Premarket Notification Submissions, November 1993 .
I DriDCRISD 110101 1:1991 + Amdt. 2:1995 (Part 1: General requirements for safety) .
IEC 00001-1:1990+ A1:1993 + A13:1996 + A2:1995 (identical to IEC60601-1:1988 + Amdt. . 1:1991 + Amdt. 2:1995)
1:1994 Aind. 2:1993601.1-M90 + S1:1994 (Canadian deviations to IEC 60601-1:1988 + ◆ Amdt. 1:1991) + S2:1998 (=IEC Amdt 2:1995)
Amdt. 1:1971) SE: 27997 (U.S. deviations to IEC 60601-1:1988 + Amdt. 1:1991+ Amdt. . 2:1995)
IEC 60601-1-2:2001 (Electromagnetic compatibility Requirements and tests) .
IEC 60601-1-4:2000 (Programmable medical systems) ◆
ISO 9918 (1993) / EN 864 (1996): Capnometers for use with Humans Requirements .
ISO 7767:1997 Oxygen monitors for monitoring breathing mixtures. .
EN 12598:1999 Oxygen monitors for monitoring breathing mixtures. .
ISO 11196:1995 + Corr. 1:1997 /EN ISO 19996 (1997) Anaesthetic gas monitors ◆
ASTM F-1456 (2001) Standard specification for Capnometers .
ADAM I 150 (2007) Datent of Premarket Submission for Software Contained in Medical . Devices. Version 1.0. (May, 29, 1998)

CONCLUSION:

The summary above shows that there are no new questions of safety and effectiveness for the The summal y a 010 client module (model family E-CAiOVX) E-CAiOVX) E-CAiOVX, E-Datex-Olmedal 8-5-COVX, E-COV, E-CO and accessories as compared to the predicate device.

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Image /page/5/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized depiction of an eagle or bird symbol, composed of three curved lines that suggest the shape of a bird in flight. The logo is encircled by the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAY 2 5 2005

Mr. Joel Kent Manager, Quality and Regulatory Affairs GE Healthcare 86 Pilgrim Road Needham, Massachusetts 02492

Re: K051092

Trade/Device Name: Datex-Ohmeda S/5™ Compact Airway Module (model family E-CAiOVX) E-CAiOVX, E-CAiOV, E-CAiOV, E-CAiO, E-COVX, E-COV, E-CO and Accessories Regulation Number: 21 CFR 868.1400 Regulation Name: Carbon Dioxide Gas Analyzer Regulatory Class: II Product Code: CCL, BZK, CAP, CBR, BZL, CBQ, CBS, NHO, NHQ, NHP Dated: April 27, 2005 Received: April 28, 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 approvin uppression (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 (1 Nr.), it hay of base of Federal Regulations, Title 21, Parts 800 to 898. In your device ear or roublish further announcements concerning your device in the Eederal Register.

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Page 2 -- Mr. 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. or the Fet of all the Act's requirements, including, but not limited to: registration 1 od intilet 021 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice and instills (21 er retries in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet ronic 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 tetter "Hiffication. The FDA finding of substantial equivalence of your device to a premaired predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specifical of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the may obtain 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/industry/support/index.html.

Sincerely yours,

Chiu Lin, Ph.D.

Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: Datex-Ohmeda S/5™ Compact Airway Module (model family E-CAiOVX) E-CAiOVX, E-CAiOV, E-CAiO, E-CAiO, E-COVX, E-COV, E-CO and accessories.

Indications for Use:

The Datex-Ohmeda S/5™ Compact Airway Module, E-CAiOVX family is indicated for monitoring hospital patient´s respiration (CO2, O2, N2O, anesthetic agents, anesthetic agent identification and respiration rate) ventilation (airway pressure, volume and flow) and gas exchange status (Oxygen Consumption VO2, Carbon Dioxide production VCO2, Respiratory Quotient RQ, and Energy Expenditure, EE). Gas exchange status monitoring is not indicated in the presence of N2O+O2 mixtures. The device is indicated for use by qualified medical personnel only.

Over-The-Counter Use 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 NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Cluis Ls

Page _ of

(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Device

510(k) Number: K051042

Regulation Number and Section

§ 868.1720 Oxygen gas analyzer.

(a)
Identification. An oxygen gas analyzer is a device intended to measure the concentration of oxygen in respiratory gases by techniques such as mass spectrometry, polarography, thermal conductivity, or gas chromatography. This generic type of device also includes paramagnetic analyzers.(b)
Classification. Class II (performance standards).