(16 days)
No
The document describes a standard anesthesia gas monitoring device that measures and displays physiological data and triggers alarms based on preset limits. There is no mention of AI, ML, or any related concepts like image processing, training sets, or performance metrics typically associated with AI/ML devices.
No.
The device is for monitoring and providing data to support clinical decision-making, not for providing therapy or treatment.
Yes
The device measures and monitors anesthesia gas contents to provide data for the support of clinical decision making, which aligns with the definition of a diagnostic device (providing information to assist in determining the nature of a condition).
No
The device description explicitly states it is a "Anesthesia Gas Module" and operates with a "Component Monitoring System" through a "digital interface (RS232)". This indicates the presence of hardware components beyond just software.
Based on the provided information, the M1026A Anesthesia Gas Module is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a patient's health.
- Device Function: The M1026A Anesthesia Gas Module measures and monitors gases in the ventilation circuitry of a patient. This is measuring gases within the patient's breathing system, not analyzing a specimen taken from the patient's body.
- Intended Use: The intended use is to monitor anesthesia gas contents in the ventilation circuitry and provide data to healthcare professionals for clinical decision making. This aligns with monitoring physiological parameters during a medical procedure, not performing a diagnostic test on a biological sample.
Therefore, the device falls under the category of a patient monitoring device, not an IVD.
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
73 CCL
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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:
| 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 |
1
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.
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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 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 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)
OR
Mark Kraus
Prescription Use (Per 21 CFR 801.109)
Over-The-Counter Use
(Optional Format 1-2-96)