(193 days)
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No
The description details a device that uses infrared light absorption and proprietary software algorithms for calculation, but there is no mention of AI or ML technologies.
No.
The device is a monitor that measures concentrations of anesthetic gases, not a device that administers treatment or delivers therapy itself.
Yes
The device monitors the concentration of anesthetic gases, which is a measurement used to inform medical decisions regarding patient care during anesthesia administration.
No
The device description explicitly details numerous hardware components including a benchtop instrument, pneumatic system, measurement chamber, optical bench assembly, infrared light source, optical filters, optical detector, analog circuit board, and digital circuit board. While software is mentioned as a functional subsystem, it is clearly integrated with and dependent on this extensive hardware.
Based on the provided information, the Ohmeda Model 5330 Anesthetic Agent Monitor is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Ohmeda Model 5330 monitors the concentration of anesthetic gases in a patient's anesthesia circuit. This is a measurement of gases being administered to the patient, not an analysis of a biological specimen taken from the patient.
- Intended Use: The intended use is to monitor anesthetic gas concentrations during anesthesia administration, which is a real-time measurement of the environment the patient is in, not a diagnostic test on a biological sample.
Therefore, the device falls under the category of a patient monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Ohmeda Model 5330 Anesthetic Agent Monitor is intended for general hospital or clinical use by medical professionals whenever it is desired to monitor concentrations of anesthetic gas. The agents monitored include isoflurane, endoflurane, halothane, desflurane and sevoflurane. The need to monitor these anesthetic agents is most commonly encountered in the operating room during administration of anesthesia. It is available for sale only by or on the order of a licensed medical practitioner
Product codes
73CBO, 73CBS
Device Description
The Ohmeda Model 5330 Anesthetic Agent Monitor is a benchtop instrument which draws a continuous flow of sample gas from a patient's anesthesia circuit. The sample is then drawn through a measurement chamber where agent concentration is measured. Measured values are displayed as numbers and as a graph on the illuminated display panel on the front of the unit is operated by push buttons on the front panel . The major functional subsystems of the device are the power supply, the pneumatic system, the measurement chamber, the electronics and the software. Power is supplied by a power cord connected to the AC line. There is no internal battery. AC power is conditioned internally by the power supply subassembly. The pneumatic system draws sample gas into the device through a moisture collection system. The sample then enters the measurement chamber, which is a cavity within the optical bench assembly. The sample is then exhausted out the back of the unit. The measurement cavity allows infrared light to be passed through the sample so a detector on the other side of the sample can measure the amount of absorption. The infrared light source consists of a coiled resistive metal element which radiates a relatively wide spectrum of infrared. Two infrared optical filters rotate on a wheel in the optical path, providing alternating wavelengths of illumination through the sample. The amount of transmitted infrared light is measured with an optical detector. By using the detected levels of transmitted infrared light at the two alternating wavelengths, anesthetic agent concentrations can be calculated. The electronic system consists of an analog circuit board and a digital circuit board . The analog board takes electrical signals from the measurement chamber and conditions them so measurement calculations can be performed. The digital circuit board digitizes the conditioned analog signals and performs measurement calculations. Proprietary software algorithms are used to calculate measured concentrations of anesthetic agent in the sample gas.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
medical professionals / general hospital or clinical use, operating room
Description of the training set, sample size, data source, and annotation protocol
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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
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§ 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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JAN 7 1997
510(k) Summary of Safety and Effectiveness
July 3,1996
Submitter Information
Ohmeda Inc. Medical Systems Division 1315 W. Century Drive Louisville, CO. 80027 303-673-1392 Contact: Bill Curnan
Product Name
Ohmeda Model 5330 Anesthetic Agent Monitor Proprietary: Common: Anesthetic Gas Analyzer Classification: Anesthetic Gas Analyzer, enflurane -(73CBO/21CFR868.1500 Class II) Anesthetic Gas Analyzer, halothane -(73CBS/21CFR868.1620 Class II)
Predicate Devices
The predicate device is the current version of the same device, the Ohmeda Model 5330 Anesthetic Agent Monitor (4 agent version), 510 (k) # K931439, and the previous version which was the Ohmeda Model 5330 Anesthetic Agent Monitor (3 agent version), 510(k) #K890606. These predicate devices have the same performance specifications as the five agent version being proposed, they just monitor fewer agents. Another predicate device is the Ohmeda Model 5250 RGM Monitor, # K920590, which features an anesthetic agent monitor. The 5250 can monitor sevoflurane. The Ohmeda Model 5330 Anesthetic Agent Monitor (4 agent version) has the hardware capability to monitor sevoflurane, but it is not enabled for the U.S. market. Additionally, the Ohmeda Model 5330 Anesthetic Agent Monitor (5 agent version) is commercially distributed outside the U.S., with emphasis in Europe and Japan.
Device Description
The Ohmeda Model 5330 Anesthetic Agent Monitor is a benchtop instrument which draws a continuous flow of sample gas from a patient's anesthesia circuit. The sample is then drawn through a measurement chamber where agent concentration is measured. Measured values are displayed as numbers and as a graph on the illuminated display panel on the front of the unit is operated by push buttons on the front panel . The major functional subsystems of the device
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are the power supply, the pneumatic system, the measurement chamber, the electronics and the software. Power is supplied by a power cord connected to the AC line. There is no internal battery. AC power is conditioned internally by the power supply subassembly. The pneumatic system draws sample gas into the device through a moisture collection system. The sample then enters the measurement chamber, which is a cavity within the optical bench assembly. The sample is then exhausted out the back of the unit. The measurement cavity allows infrared light to be passed through the sample so a detector on the other side of the sample can measure the amount of absorption. The infrared light source consists of a coiled resistive metal element which radiates a relatively wide spectrum of infrared. Two infrared optical filters rotate on a wheel in the optical path, providing alternating wavelengths of illumination through the sample. The amount of transmitted infrared light is measured with an optical detector. By using the detected levels of transmitted infrared light at the two alternating wavelengths, anesthetic agent concentrations can be calculated. The electronic system consists of an analog circuit board and a digital circuit board . The analog board takes electrical signals from the measurement chamber and conditions them so measurement calculations can be performed. The digital circuit board digitizes the conditioned analog signals and performs measurement calculations. Proprietary software algorithms are used to calculate measured concentrations of anesthetic agent in the sample gas.
Intended Use
The Ohmeda Model 5330 Anesthetic Agent Monitor is intended for general hospital or clinical use by medical professionals whenever it is desired to monitor concentrations of anesthetic gas. The agents monitored include isoflurane, endoflurane, halothane, desflurane and sevoflurane. The need to monitor these anesthetic agents is most commonly encountered in the operating room during administration of anesthesia. It is available for sale only by or on the order of a licensed medical practitioner
Technological Comparison to Predicate Device
No hardware changes are necessary for the addition of sevoflurane measurement capability. The existing measurement chamber configuration is sufficient to accommodate the measurement method. Therefore the five agent version will appear physically identical to the current four agent version as far as the user is concerned with the exception that the operating menu will now allow for sevoflurane measurement. All specifications for existing features on the current version will be unaffected by the addition of sevoflurane.
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