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 the HP Viridia Anesthesia Component Monitoring System (ACMS) and the HP Viridia 24 HP model 1204A through a digital interface (RS232). The monitoring system is known as the HP Model M1166A Component Monitoring System. 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

The provided text doesn't contain detailed acceptance criteria or a specific study proving the device meets those criteria in a quantitative sense as might be expected for an AI/ML device. The document is a 510(k) summary for a medical device (Hewlett Packard M1026A Anesthetic Gas Monitor), focusing on demonstrating substantial equivalence to a predicate device rather than presenting a performance study with acceptance criteria in the typical AI/ML validation context.

However, based on the provided text, I can extract information related to the device's intended function and regulatory classification. I will infer "acceptance criteria" from the device's function and regulatory classification categories, and "reported device performance" from the statement of substantial equivalence to a predicate device that has already met regulatory standards.

Here's the information structured to best fit your request, with explicit notes about what information is not present in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a conventional medical device (anesthetic gas monitor) and not an AI/ML diagnostic tool, the "acceptance criteria" within this 510(k) context are implicitly tied to its ability to accurately measure and monitor anesthetic gas contents, respiratory gases, and signal alarms, consistent with the performance of its predicate device. The "reported device performance" is primarily the assertion of substantial equivalence.

Acceptance Criteria Category (Inferred from device function & classification)	Reported Device Performance (from 510(k) Summary)
Accuracy of Gas Measurement:	Substantially Equivalent to Predicate Device: The device utilizes the Andros Inc. Model 4700 MGM Multi Gas Module for concentration calculation by non-dispersive infrared analysis and a Servomex PM1111 D/E paramagnetic transducer for fast O2 measurement. The 510(k) states: "The above device is substantially equivalent to the HP M1026A Option A01 marketed pursuant to K951127." This implies its accuracy meets the established performance of the predicate.
Measurement and Display of Respiratory Gases:	Substantially Equivalent to Predicate Device: "When coupled with the above ACMS, the device will measure and display respiratory gases and anesthetic agents of ventilated patients." Performance is considered equivalent to the predicate device, which has already cleared regulatory hurdles for this function.
Measurement and Display of Anesthetic Agents:	Substantially Equivalent to Predicate Device: "When coupled with the above ACMS, the device will measure and display respiratory gases and anesthetic agents of ventilated patients." Specific unclassified gas analyzers (desflurane, isoflurane, sevoflurane) were previously cleared under a prior 510(k) (K951127) for the original M1026A AGM, implying their equivalence to classified agents like enflurane and halothane.
Alarm Functionality:	Substantially Equivalent to Predicate Device: "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." The expectation is that this alarm functionality is comparable to the predicate.
Intended Use Compatibility:	Substantially Equivalent to Predicate Device: "The device has the same intended use as the legally marketed predicate device. When connected to the ACMS, it is intended for measuring the airway gases of ventilated patients within the anesthesia environment during the induction and maintenance of, and emergence from, anesthesia." This includes monitoring adult, pediatric, and neonate patients. Performance for these patient populations is assumed equivalent to the predicate.
Interoperability (RS232 Digital Interface):	Substantially Equivalent to Predicate Device: The device "operates with the HP Viridia Anesthesia Component Monitoring System (ACMS) and the HP Viridia 24 HP model 1204A through a digital interface (RS232)." Its compatibility and reliable data transfer are implied to be equivalent to the predicate.
Technological Characteristics:	Same or Similar to Predicate Device: "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." This statement underpins the assertion of substantial equivalence.

Note: The 510(k) summary emphasizes the substantial equivalence of the new device to a legally marketed predicate device (HP M1026A Option A01, K951127). For conventional devices like gas monitors, validation typically involves demonstrating that the new device meets performance specifications (e.g., accuracy, precision, response time) that are equivalent to or better than the predicate, often through bench testing and, in some cases, limited clinical validation if new indications or significant technological changes are introduced. This summary does not provide specific numerical performance metrics, test protocols, or raw data from such validation steps; it relies on the regulatory pathway of substantial equivalence.

Detailed Information as Requested (with caveats):

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

Information Not Provided: The text does not detail any specific "test set" in the context of data used for algorithm validation. This device is a hardware monitoring system, and its approval is based on substantial equivalence to a predicate device, implying its performance validation (e.g., accuracy, reliability) was likely based on internal testing and comparison to the predicate's established performance, rather than a data-driven "test set" as seen with AI/ML.

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)

Information Not Provided: As there is no "test set" in the context of an AI/ML algorithm requiring expert ground truth labeling mentioned, this information is not applicable and not present.

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

Information Not Provided: Not applicable, as no algorithm test set 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

Information Not Provided: This device is an anesthetic gas monitor, not an AI-assisted diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human "readers" and AI assistance is not relevant or described.

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

Information Not Provided: Not applicable. This is a hardware device; no "algorithm only" performance is described in the context of an AI/ML system.

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

Inferred based on device type: For a gas monitor, "ground truth" would typically refer to the "true" concentration of gases, established by highly accurate calibration gases or reference analytical methods. However, the document does not specify the exact methods or certifications for this, largely relying on the substantial equivalence and the use of commercially available, validated gas analysis modules.

8. The sample size for the training set

Information Not Provided: Not applicable, as this is not an AI/ML device with a "training set."

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

Information Not Provided: Not applicable, as this is not an AI/ML device with a "training set."

In summary, the provided document is a regulatory submission for a conventional medical device, focused on demonstrating substantial equivalence. It does not contain the specific performance study details, datasets, or expert review processes commonly described for AI/ML-based diagnostic devices. The "acceptance criteria" are implicitly met by demonstrating that the device functions as intended and is substantially equivalent to a previously cleared device.

Summary

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AUG 1 2 1998

5.0 510(k) Summary.

510(k) Summary

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.

The submitter of this premarket notification is:

Elisabeth M. George Quality and Regulatory Affairs Manager Hewlett-Packard Company Patient Monitoring Division Medical Products Group 3000 Minuteman Road Andover, MA 01810-1099 Tel .: (978) 659-4663 Fax .: (978) 685-5624

This summary was prepared on July 22, 1998.

The name of this device is the Hewlett Packard M1026A Anesthetic Gas Monitor Option A02 for use with the HP Model M1166A Component Monitoring System (CMS) and Viridia 24 HP Model 1204A. The common name is the HP Anesthesia Gas Monitor. Classification names are as follows:

REGULATIONNUMBER	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

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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.

The above device is substantially equivalent to the HP M1026A Option A01 marketed pursuant to K951127.
The above device operates with the HP Viridia Anesthesia Component Monitoring System (ACMS) and the HP Viridia 24 HP model 1204A through a digital interface (RS232). The monitoring system is known as the HP Model M1166A Component Monitoring System. 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.
The device has the same intended use as the legally marketed predicate device. When connected to the ACMS, it is intended for measuring the airway gases of ventilated patients within the anesthesia environment during the induction and maintenance of, and emergence from, anesthesia.
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.

110

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 2 1998

Ms. Elisabeth M. George Hewlett-Packard Company Medical Products Group 3000 Minuteman Road Andover, MA 01810

K982619 Re: HP Anesthesia Gas Monitor with Water Trap Regulatory Class: II (two) Product Code: 73 CCL Dated: July 24, 1998 Received: July 27, 1998

Dear Ms. George:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 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 requlation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory 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 for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Elisabeth M. George

This letter will allow you to begin marketing your device as described in your 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 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. 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 requlation entitled, "Misbranding by reference to premarket notification"(21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

Thomas J. Callahan

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page _ of _

510(k) Number (if known): K982619

Device Name: Hewlett Packard 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 Compatibilitiy Statement: The Hewlett Packard M1026A is not intended for use in a MRI magnetic field.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark Kraus

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

(Optional Format 1-2-96)

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).