(158 days)
Not Found
No
The document describes a standard anesthesia gas module that measures and displays physiological data and triggers alarms based on preset limits. There is no mention of AI, ML, or any related concepts in the intended use, device description, or other sections.
No
The device measures and monitors anesthesia gas, provides data, and signals alarms for clinical decision-making support. It does not actively treat a condition or restore function, which are characteristics of a therapeutic device.
No
The device measures and monitors anesthesia gas contents, providing data to support clinical decision-making, but it does not directly diagnose a condition or disease.
No
The device description explicitly states it is an "Anesthesia gas Module" and operates with other hardware components (Agilent Technologies Anesthesia Component Monitoring System and Viridia 24 Agilent Technologies Model 1204A) through a digital interface. This indicates it is a hardware device with integrated software, not a software-only medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The device measures and monitors anesthesia gas in the ventilation circuitry of a patient. This is a measurement of gases within the patient's breathing system, not a test performed on a sample taken from the patient's body (like blood, urine, or tissue).
- Device Description: The description reinforces that it measures respiratory gases and anesthetic agents of ventilated patients.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or performing tests on specimens outside of the body.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information about a physiological or pathological state. This device is monitoring gases within a patient's breathing circuit, which falls under the category of patient monitoring rather than in vitro diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
868.1400, 868.1500, 868.1620, 868.1700, 868.1720, 868.2375, CBQ, CBS
Device Description
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. 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. 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
airway
Indicated Patient Age Range
adult, pediatric and neonate
Intended User / Care Setting
health care professionals in health care facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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- 510(K) SUMMARY
MAY 1 9 2000
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.
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- 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 submitter of this premarket notification is :
The summary was prepared on December 6, 1999.
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- 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
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- 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.
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- 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.
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- 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 5Agld
| Tifle: |
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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 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.
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)