(200 days)
No
The description mentions a microprocessor and electronic control, but no terms or functionalities indicative of AI/ML are present.
No
The device provides mechanical ventilation to patients during surgery, which is a supportive rather than a therapeutic function in this context.
No
This device is described as an anesthesia ventilator, providing mechanical ventilation and monitoring patient parameters during surgery. While it monitors parameters, its primary function is respiratory support, not the diagnosis of medical conditions.
No
The device description clearly outlines hardware components such as a microprocessor, sensors, bellows, and an RS-232 port, indicating it is not a software-only device.
Based on the provided information, the Ohmeda 7900 Anesthesia Ventilator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is to provide mechanical ventilation for patients during surgery and monitor patient parameters. This involves direct interaction with the patient's respiratory system, not the analysis of samples taken from the body (which is the core of IVD).
- Device Description: The description details a ventilator that delivers breathing gases and monitors physiological parameters like oxygen, airway pressure, and exhaled volume. This is consistent with a life support and monitoring device used in vivo (within the living body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
Therefore, the Ohmeda 7900 Anesthesia Ventilator falls under the category of a medical device used for patient support and monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Ohmeda 7900 Anesthesia Ventilator provides mechanical ventilation for patients during surgery, as well as adiustment and monitoring various patient parameters-
Patient breathing waveform during volume mode or pressure mode VE Exhaled minute volume VTE Exhaled tidal volume O2 Percent of oxygen inspired fimin Units of breath rate per minute Pmax Maximum airway pressure during a patient breath Pmean Mean airway pressure, calculated every patient breath or 10 seconds whichever occurs first Pplateau Airway pressure measured at the end of inspiratory pause time.
Product codes
73CBK
Device Description
The 7900 Anesthesia Ventilator is a microprocessor based, electronically driven ventilator with a built in monitoring system for inspired oxygen, ainway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well as measure inspired oxygen concentration. This allows for compensation of compression losses, fresh gas contribution, and small leakage in the breathing absorber, bellows and system. User settings and microprocessor calculations catterns. User interface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices.
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
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Ohmeda 7800 Anesthesia Ventilator
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the word "OHMEDA" in bold, black letters. A symbol resembling a snake is placed below the letters "OHM". The letters are closely spaced together, and the overall impression is one of a bold, vintage-style logo or heading.
THE BOC GROUP
February 29, 1996
Ohmeda Inc Ohmeda Drive PO Box 7550 Madison WI 53707-7550 608 221 1551
.
| 606 22 | |
|---|---|
| Subject: | 510(k) Summary of Safety and Effectiveness Information |
| for the Ohmeda 7900 Anesthesia Ventilator. | |
| Proprietary: | Ohmeda 7900 Anesthesia Ventilator |
| Common: | Continuous Ventilator |
| Classification: | Ventilator, Continuous Class II - 21CFR868.5895 - 73CBK |
The 510(k) summary of safety and effectiveness information is accordance with the requirements of SMDA 1990 and 1992.
The Ohmeda 7900 Anesthesia Ventilator is substantially equivalent to the currently marketed Ohmeda 7800 Anesthesia Ventilator.
The Ohmeda 7900 Anesthesia Ventilator provides mechanical ventilation for patients during surgery, as well as adiustment and monitoring various patient parameters-
Patient breathing waveform during volume mode or pressure mode VE Exhaled minute volume VTE Exhaled tidal volume O2 Percent of oxygen inspired fimin Units of breath rate per minute Pmax Maximum airway pressure during a patient breath Pmean Mean airway pressure, calculated every patient breath or 10 seconds whichever occurs first Pplateau Airway pressure measured at the end of inspiratory pause time.
The 7900 Anesthesia Ventilator is a microprocessor based, electronically driven ventilator with a built in monitoring system for inspired oxygen, ainway pressure and exhaled volume. Sensors in the breathing circuit are used to control and monitor patient ventilation as well as measure inspired oxygen concentration. This allows for compensation of compression losses, fresh gas contribution, and small leakage in the breathing absorber, bellows and system. User settings and microprocessor calculations catterns. User interface keeps settings in memory. The user may change settings with a simple and secure setting sequence. A bellows contains breathing gasses to be delivered to the patient. Positive End Expiratory Pressure (PEEP) is regulated electronically. Positive pressure is maintained in the breathing system so that any leakage that occurs is outward. An RS-232 serial digital communications port connects to and communicates with external devices.
The software for the Ohmeda 7900 Anesthesia Ventilator has been developed following a rigorous software development process and has been fully specified and validated by Ohmeda.
The Ohmeda 7900 Anesthesia Ventilator complies with the following standards:
- ASTM F1101 Sections 5.2, 5.3.2, 5.4.3, 5.5, 5.7.1, 6.2.2, 6.2.3, 6.6 and 6.8.1 1.
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- ISO 10651 - Sections 50.3.1, 51.10 and 51.7
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- IEC 601-1 - 1988, EN 60601-1
- IEC 601-1-2, EN 60601-1-2 4.
- CISPR 11 Group 1 (EN55011) ●
- . EN 55011: "Limits and Methods of Measurement of Radio Interference Characteristics of Industrial, Scientific and Medical (ISM) Equipment"
- IEC 801-2, 8kV air, 3kV contact
- IEC 801-3, 3V/m
- IEC 801-4, 2kV power line
- IEC 801-5, 2kV line to earth, 1 kV line to line
-
- EN 60601-1-4
- ર. DIN 13252/06 - 1984
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- E-DIN 132252/01 - 1991
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- prEN 740/12 - 1994
- UL 2601 1994 9.
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- IEC 68-2-3 Test Ca, IEC 68-2-1 Test Ab-Cold, IEC 68-2-2 Test Bb-Hot, IEC 68-2-34, IEC 68-2-34, IEC 68-2-37
The Ohmeda 7800 Anesthesia Ventilator and the Ohmeda 7900 Anesthesia Ventilator are substantially equivalent in technological characteristics, theory of operation and measurement methods. The Ohmeda 7900 Anesthesia Ventilator is the next generation of ventilator, utilizing the technological advances of today to bring Ohmeda ventilators to the next century.