The M1026A Anesthesia gas Module is intended to measure and monitor anesthesia gas contents in the ventilation circuitry of a patient and to provide this data to health care professionals in form readings, waves and alarms, via the Component Monitoring System, for the support of clinical decision making.

The device is indicated for use in health care facilities by health care professionals whenever there is a need for adult, pediatric and neonate patient anesthesia gas monitoring.

Device Description

The above device operates with Agilent Technologies Anesthesia Component Monitoring System (ACMS) and the Viridia 24 Agilent Technologies Model 1204A through a digital interface (RS232). The monitoring system is known as the Model M1166A Component Monitoring System (CMS). When coupled with the above ACMS, the device will measure and display respiratory gases and anesthetic agents of ventilated patients. The device will signal physiological alarms and document deviations when preset limits are exceeded. An INOP ("inoperative") alarm is triggered and a message is displayed in the event of malfunction, lack of detectable breath, power disconnects, and other inoperative states.

AI/ML Overview

This 510(k) summary does not contain the kind of detailed information typically found in a study proving a device meets acceptance criteria, particularly for AI/Machine Learning devices. This document is for a medical device that measures physiological parameters. Therefore, many of the requested fields are not applicable or cannot be extracted from the provided text.

Here is an analysis based on the provided text, indicating where information is not present:

Acceptance Criteria and Device Performance Study for Agilent Technologies M1026A Anesthetic Gas Monitor Option C05

This 510(k) submission describes the Agilent Technologies M1026A Anesthetic Gas Monitor Option C05, intended for measuring and displaying respiratory gases and anesthetic agents. The submission primarily focuses on demonstrating substantial equivalence to previously cleared devices (K951127 and K982619) rather than a de novo study against specific acceptance criteria for performance metrics like sensitivity, specificity, or agreement.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not include a table of acceptance criteria or specific performance metrics (e.g., accuracy, precision, bias) for the M1026A Anesthetic Gas Monitor. Such performance data would typically be found in test reports or validation studies, which are not part of this 510(k) summary. The submission asserts that the device operates with similar technological characteristics to its predicate device. It states concentrations are calculated by non-dispersive infrared analysis and O2 measurement by a paramagnetic transducer.

Performance Metric (Hypothetical)	Acceptance Criteria (Hypothetical)	Reported Device Performance (Not Provided)
Accuracy for CO2 concentration	Within X% of reference standard	Not specified in provided document
Accuracy for Enflurane concentration	Within Y% of reference standard	Not specified in provided document
Accuracy for O2 concentration	Within Z% of reference standard	Not specified in provided document
Response time	< A seconds	Not specified in provided document
Alarm efficacy	> B% detection of out-of-range values	Not specified in provided document

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

The document does not mention a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective/prospective). Substantial equivalence claims for physiological monitoring devices typically rely on bench testing, comparison to predicate devices, and sometimes animal or human volunteer studies, but details are not included here.

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

This information is not applicable and not provided. This device is a measurement device for gas concentrations, not a diagnostic imaging or AI-based system requiring expert interpretation or ground truth establishment in the traditional sense for diagnostic accuracy studies. Ground truth for such devices is usually established through validated reference gas mixtures or laboratory equipment.

4. Adjudication method for the test set

This information is not applicable and not provided for the same reasons as point 3.

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

An MRMC study is not applicable and not mentioned. This device is a gas monitor, not an AI-assisted diagnostic tool for human readers.

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

This concept is not applicable in the context of this device. The device itself is a "standalone" monitor in that it measures and displays physiological data; it is not an algorithm that requires separate standalone performance testing in the way an AI diagnostic algorithm would. Its performance characteristics are inherent to its sensors and processing.

7. The type of ground truth used

The document does not explicitly state the type of ground truth used. For gas analyzers, ground truth would typically be established using:

Certified reference gas mixtures (NIST-traceable): Precisely known concentrations of the target gases used for calibration and accuracy verification.
Validated laboratory reference instruments: High-precision gas analyzers used to establish true concentration values.

8. The sample size for the training set

This information is not applicable and not provided. This device is a physiological monitor based on established measurement principles (non-dispersive infrared analysis, paramagnetic transduction), not a machine learning or AI algorithm that requires a "training set" in the computational sense.

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

This information is not applicable and not provided for the reasons stated in point 8.

Summary

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510(K) SUMMARY

MAY 1 9 2000

K994188

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 C.F.R. § 807.92.

1. The submitter of this premarket notification is :
  Herbert van Dyk Quality and Regulatory Senior Engineer Agilent Technologies Deutschland GmbH Patient Monitoring Division Health Care Solution Group Herrenbergerstr. 130 71120 Boeblingen Germany Phone: (+49) 7031 464 2854 Fax: (+49) 7031 464 4297 e-mail: herbert_v_dyk@agilent.com

The summary was prepared on December 6, 1999.

1. The name of this device is the Agilent Technologies M1026A Anesthetic Gas Monitor Option C05 for use with the Agilent Technologies Model M1166A Component Monitoring System (CMS) and Viridia 24 Agilent Technologies Model 1204A. The common name is the Agilent Technologies Anesthesia Gas Monitor. Classification names are as follows:

Regulation number	Classification name
868.1400	Carbon dioxide gas analyzer
868.1500	Enflurane gas analyzer
868.1620	Halothane gas analyzer
868.1700	Nitrous oxide gas analyzer
868.1720	Oxygen gas analyzer
868.2375	Breathing frequency monitor
Unclassified	Desflurane gas analyzer
Unclassified	Isoflurane gas analyzer
Unclassified	Sevoflurane gas analyzer

The unclassified gas analyzers for desflurane, isoflurane and sevoflurane are similar to the gases classified under 868.1500, enflurane, and 868.1620, halothane. Analysis of these gases has been cleared under the original M1026A AGM 510(k) no. K951127 and K982619

1. The above device is substantially equivalent to the Agilent Technologies M1026A marketed pursuant to K951127 and K982619.

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1. The above device operates with Agilent Technologies Anesthesia Component Monitoring System (ACMS) and the Viridia 24 Agilent Technologies Model 1204A through a digital interface (RS232). The monitoring system is known as the Model M1166A Component Monitoring System (CMS). When coupled with the above ACMS, the device will measure and display respiratory gases and anesthetic agents of ventilated patients. The device will signal physiological alarms and document deviations when preset limits are exceeded. An INOP ("inoperative") alarm is triggered and a message is displayed in the event of malfunction, lack of detectable breath, power disconnects, and other inoperative states.
1. The device has the same intended use as the legally marketed predicate device. When connected to the ACMS, it is the intended for measuring the airway gases of ventilated patients within the anesthesia environment during the induction and maintenance of, and emergence from, anesthesia.
1. The technological characteristics are the same or similar to those found with the predicate device. Using the Andros Inc. Model 4700 MGM Multi Gas Module, the concentration of respiratory and anesthetic gases is calculated for patients under anesthesia by non-dispersive infrared analysis. Fast O2 measurement is done using the Servomex PM1111 D/E paramagnetic transducer.

Special 510{k} M1026A 5AgldTifle:
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol resembling an abstract eagle or bird-like figure with three wavy lines beneath it, possibly representing water or movement.

Public Health Service

MAY 1 9 2000

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Herbert van Dyk Quality and Regulatory Senior Engineer Agilent Technologies, GMBH Healthcare Solution Group Herrenberger Straße 130 - 71034 Böblingen Germany

K994188 Re: Anesthesia Gas Monitor M1026A Regulatory Class: II (two) Product Code: CBQ, CBS Dated: April 18, 2000 Received: April 20, 2000

Dear Mr. Van Dyk:

We have reviewed your Section 510(k) notification of intent to market we nave reviews from and we have determined the device is che device forcerenced and for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in encrobare, co regally in to May 28, 1976, the enactment date of the Incercato ocaments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and In accordante with a You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls che general conclude 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. aegulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act obrigation you might .Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. Herbert van Dyk

This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The Finding of substantial in your 310(x) premarket notification marketed predicate device equivalence of your device co a royal device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling II you desire specific advice for for for for for in vitro regulation (21 CFN fare over and act the Office of Compliance at diagnostic devices) productions on the promotion and (301) 394-4046. Addrefonally, 2017-10-11 the Office of Compliance at advertising of your doviee, provettion entitled, (301) 394-4037. AISO) premarket notification" (21 CFR 807.97).
"Misbranding by reference to premarket notification" (21 may "Misbranding by reference to promaticilities under the Act may Ocher general information of Small Manufacturers Assistance at its be obtained from the Britison.
toll-free number (800) 638-2041 or (301) 443-6597, ar at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

James E. Dillard III Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of

9941888 510(k) Number (if known):

Device Name: Agilent Technologies M1026A Anesthesia Gas Monitor

Indications for Use:

The device is indicated for use in health care facilities by health care professionals whenever there is a need for adult, pediatric and neonate patient anesthesia gas monitoring.

MRI Compatibility Statement: The M1026A is not intended for use in a MRI magnetic field

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

Concurence of CDRH, Office of Device Evaulation (ODE)

for Mardi N. Mulhern

(Posted July 1, 1998)

(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devic 510(k) Number

(Optional Format 3-10-98)

Regulation Number and Section

§ 868.1500 Enflurane gas analyzer.

(a)
Identification. An enflurane gas analyzer is a device intended to measure the concentration of enflurane anesthetic in a gas mixture.(b)
Classification. Class II (performance standards).