The Datex-Ohmeda Tonometry module , E-TONO is intended to be used with Datex-Ohmeda modular monitoring systems for gastrointestinal tonometry measurements.

Indications for use:

The Datex-Ohmeda Tonometry Module is indicated for monitoring gastrointestinal CO2 (PgCO2) and calculation of various gastrointestinal tonometry parameters (gastrointestinal -arterial PCO2 difference, gastrointestinal -end-tidal PCO2 difference and intramucosal pH) when used with a Datex-Ohmeda modular monitoring system. It is indicated for use in hospital patients.

The Tonometry module is indicated for use by qualified medical personnel only.

Device Description

The Datex-Ohmeda Tonometry module, E-TONO is a single-width plug-in parameter module for a Datex-Ohmeda modular monitoring system. The Datex-Ohmeda Tonometry module, E-TONO can be used with the following Datex-Ohmeda modular monitors:

S/5TM Anesthesia Monitor (AM), S/5TM Compact Anesthesia Monitor (CAM), S/5TM Critical Care Monitor (CCM), or S/5TM Compact Critical

Care Monitor (CCCM), with monitor software versions 99 or newer.

The tonometry module measures the gastrointestinal PCO2 (PgCO2) every 10 minutes utilizing a tonometry catheter placed into the patient's stomach or intestine. Initially the module fills the balloon of the Tonometrics catheter with ambient air, then repeatedly every 10 min deflates the balloon, analyzes and displays the PgCO2, and inflates the balloon again.

All the calculated parameters can be selected on the display, and trended. Alarms for Tonometry are taken care of by the host monitor and follow the user interface for alarms in Datex-Ohmeda S/5 patient monitors. There are auditory and visual alarms and user adjustable limits for Tonometry variables. The accessories are the same for the E-TONO module and the predicate device, the M-TONO (K993656).

AI/ML Overview

This 510(k) summary for K052167 describes a medical device, not an AI/ML powered device, and therefore does not contain the specific information requested in the prompt. The document focuses on demonstrating substantial equivalence to a predicate device, rather than proving device performance against detailed acceptance criteria through a study with ground truth data.

However, I can extract the relevant information regarding the device itself and its equivalence claim:

Acceptance Criteria and Device Performance (Based on Substantial Equivalence Claim)

This submission establishes substantial equivalence to a predicate device (Datex-Ohmeda M-TONO Module, K993656) rather than defining specific acceptance criteria for performance metrics. The underlying assumption is that if the new device is substantially equivalent to a legally marketed predicate, it meets the inherent performance standards of that predicate.

1. Table of "Acceptance Criteria" (Implied) and Reported Device Performance

Since this is a substantial equivalence submission, the "acceptance criteria" are not explicitly stated as numerical targets but are implied through the characteristics of the predicate device. The "reported device performance" is essentially the claim of identical characteristics to the predicate in key areas.

Characteristic	Implied "Acceptance Criteria" (from Predicate M-TONO)	Reported Device Performance (E-TONO)
Intended Use & Indications for Use	Identical to M-TONO: monitoring gastrointestinal CO2 (PgCO2) and calculation of various gastrointestinal tonometry parameters in hospital patients by qualified medical personnel.	Identical to M-TONO.
Fundamental Scientific Technology	Identical to M-TONO.	Identical to M-TONO.
Electronic Measurement Board	Identical to M-TONO.	Identical to M-TONO.
Module Software (Core Functionality)	Functionally equivalent to M-TONO (version 1.0).	Same module software (version changed from 1.0 to 1.1), minor modification to module software. Implications are that core functionality remains equivalent.
Operating Principle	Identical to M-TONO.	Identical to M-TONO.
Accessories	Identical to M-TONO.	Identical to M-TONO.
User Interface at the Monitor and Alarms	Identical to M-TONO (can be used with the same monitor software).	Identical to M-TONO.
Customer and Parameter Specifications	Identical to M-TONO.	Identical to M-TONO.
Safety and Effectiveness	Identical to M-TONO.	Identical to M-TONO.
Manufacturing Processes	Identical to M-TONO.	Identical to M-TONO.
Physical Design (Color, Shape, Size, Mechanics)	Not directly compared as "acceptance criteria," but noted as the primary difference.	New color, shape, and size, thus differing mechanics. Front panel and labeling changed.

Study Information (Non-AI/ML Device)

The document describes a regulatory submission (510(k)) based on substantial equivalence, and not a study with the characteristics typically associated with AI/ML device validation. Therefore, many of the requested fields are not applicable or cannot be extracted from this document.

2. Sample size used for the test set and the data provenance: Not applicable. This document does not describe a clinical study with a test set of patient data to evaluate performance metrics for an AI/ML device. The evaluation is based on engineering and design comparisons to a predicate device and adherence to safety standards.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. See point 2.

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

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 not an AI/ML device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an AI/ML device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. See point 2. The "ground truth" in this context is the safety and effectiveness profile of the legally marketed predicate device (K993656) and adherence to recognized standards.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable. See point 8.

Summary of Nonclinical Testing and Conclusions:

The document states that the Datex-Ohmeda S/5™ Tonometry Module, E TONO and accessories has been assessed against the following standards:

COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices
FDA/DCRND Reviewer Guidance for Premarket Notification Submissions, November 1993
IEC 60601-1:1988 + Amdt. 1:1991 + Amdt. 2:1995 (Part 1: General requirements for safety)
EN 60601-1:1990+ A1:1993 + A13:1996 + A2:1995 (identical to IEC60601-1:1988 + Amdt. 1:1991 + Amdt. 2:1995)
CAN/CSA C22.2 No. 601.1-M90 + S1:1994 + S2:1998 (Canadian deviations to IEC 60601-1)
UL 2601-1, October 24, 1997 (U.S. deviations to IEC 60601-1)
IEC 60601-1-2:2001 (Electromagnetic compatibility Requirements and tests)

Conclusion: The device has been "thoroughly tested through validation and verification of specifications" to these standards, and there are "no new questions of safety and effectiveness" compared to the predicate device. This implies that testing demonstrated compliance with these general safety and performance standards for medical devices.

Summary

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K052167
PAGE 1 OF 3

SEP - 8 2005

Page 1 of 3

Premarket Notification 510(k) Summary As required by section 807.92

Datex-Ohmeda S/5TM Tonometry Module, E TONO 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:

September 1, 2005

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

TRADE NAME: Datex-Ohmeda S/5TM Tonometry Module, E TONO and accessories COMMON NAME: Regional capnometer CLASSIFICATION NAME: The following Class II classification appears applicable: Product Code Classification Name CFR Section CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-phase 868.1400

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/5TM Tonometry Module, E-TONO is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M-TONO Module (K993656).

Page 2 of 3

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

S/5TM Anesthesia Monitor (AM), S/5TM Compact Anesthesia Monitor (CAM), S/5TM Critical Care Monitor (CCM), or S/5TM Compact Critical

Care Monitor (CCCM), with monitor software versions 99 or newer.

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The accessories have also been cleared separately under (K992181), (K993296), (K983366), and (K980384).

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

Intended Use:

The Datex-Ohmeda Tonometry module , E-TONO is intended to be used with Datex-Ohmeda modular monitoring systems for gastrointestinal tonometry measurements.

Indications for use:

The Tonometry module is indicated for use by qualified medical personnel only. SUMMARY OF TECHNOLOGICAL CHARACTERITICS OF DEVICE COMPARED

TO THE PREDICATE DEVICE as required by 807.92(a)(6)

The Datex-Ohmeda S/5TM Tonometry Module, E-TONO is substantially equivalent in safety and effectiveness to the legally marketed (predicate) Datex-Ohmeda M-TONO Module (K993656).

The E-TONO module has the following similarities compared to the predicate M-TONO (K993656):

· identical intended use and indications for use
· identical fundamental scientific technology
· identical electronic measurement board
· same module software (version changed from 1.0 to 1.1)
· use the same operating principle
· identical 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
· have the same safety and effectiveness
· are manufactured using the same processes

Page 3 of 3

The main differences between the new E-TONO and the predicate M-TON() (K993656) is primarily due to fact that the new E-TONO module has the following changes:

· new color, shape, and size and thus differing mechanics
The front panel and labeling have changed
· Minor modification to module software

Based on the analysis and other documentation included in this 510(k) notification and attachments it is evident that the main features and indications for use of the Datex-Ohmeda S/5TM Tonometry Module, E-TONO are substantially equivalent to the predicate Datex-Ohmeda M-TONO Module (K993656).

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

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Datex-Ohmeda S/5™ Tonometry Module, E TONO and accessories has been assessed against the standards below. The device has been thoroughly tested through validation and verification of specifications.

COUNCIL DIRECTIVE 93/42/EEC of 14 June 1993 concerning medical devices
· FDA/DCRND Reviewer Guidance for Premarket Notification Submissions, November 1993
IEC 60601-1:1988 + Amdt. 1:1991 + Amdt. 2:1995 (Part 1: General requirements for safety)
· EN 60601-1:1990+ A1:1993 + A13:1996 + A2:1995 (identical to IEC60601-1:1988 + Amdt. 1:1991 + Amdt. 2:1995)
· CAN/CSA C22.2 No. 601.1-M90 + S1:1994 (Canadian deviations to IEC 60601-1:1988 + Amdt. 1:1991) + S2:1998 (=IEC Amdt 2:1995)
· UL 2601-1, October 24, 1997 (U.S. deviations to IEC 60601-1:1988 + Amdt. 1:1991+ Amdt. 2:1995)
IEC 60601-1-2:2001 (Electromagnetic compatibility Requirements and tests)

CONCLUSION:

The summary above shows that there are no new questions of safety and effectiveness for the Datex-Ohmeda S/5TM Tonometry Module, E-TONO when compared to the legally marketed (predicate) Datex-Ohmeda M-TONO Module (K993656).

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SEP - 8 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MI) 20050

Mr. Joel C. Kent Manager, Quality and Regulatory Affairs GE Healthcare 86 Pilgrim Road NEEDHAM MA 02492

Re: K052167

Trade/Device Name: Datex-Ohmeda S/5" Tonometry Module, E TONA and accessories Regulation Number: 21 CFR §868.1400 Regulation Name: Carbon dioxide gas analyzer Regulatory Class: II Product Code: CCK Dated: August 5, 2005 Received: August 9, 2005

Dear Mr. Kent:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 (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.

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This letter will allow you to begin marketing your device as described in your Section 5 10(k) I his letter will anow you to begin manketing your accession of your device to a legally premarket nothication. THC PDA midnig of sacchanial of your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please if you desire specific advice for your do rout with to be of the regulation numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification the Also, please note the regulation entitled, "Wisolarians on your responsibilities under the Act from the 190 807.97). You may outlin other general information on J. S. J. S. J. S. S. J. S. S. Stance 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,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K052167_____________________________________________________________________________________________________________________________________

Device Name: Datex-Ohmeda S/5™ Tonometry Module, E TONO and accessories.

Indications for use:

The Datex-Ohmeda Tonometry Module is indicated for monitoring gastrointestinal CO2 (PgCO2) and calculation of various gastrointestinal tonometry parameters (gastrointestinal - arterial PCO2 difference, qastrointestinal - end-tidal PCO2 difference and intramucosal pH) when used with a Datex-Ohmeda modular monitoring system. It is indicated for use in hospital patients.

The Tonometry module is indicated for use by qualified medical personnel only.

Over-The-Counter Use _ Prescription Use _____________________________________________________________________________________________________________________________________________________________ AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C Brogdon

Page _ of _

510(k) Number

Regulation Number and Section

§ 868.1400 Carbon dioxide gas analyzer.

(a)
Identification. A carbon dioxide gas analyzer is a device intended to measure the concentration of carbon dioxide in a gas mixture to aid in determining the patient's ventilatory, circulatory, and metabolic status. The device may use techniques such as chemical titration, absorption of infrared radiation, gas chromatography, or mass spectrometry.(b)
Classification. Class II (performance standards).