OHMEDA 7900 ANESTHESIA VENTILATOR

K960964 · Ohmeda Medical · CBK · Sep 27, 1996 · Anesthesiology

Device Facts

• Record ID: K960964
• Device Name: OHMEDA 7900 ANESTHESIA VENTILATOR
• Applicant: Ohmeda Medical
• Product Code: CBK · Anesthesiology
• Decision Date: Sep 27, 1996
• Decision: ST
• Submission Type: Traditional
• Regulation: 21 CFR 868.5895
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Ohmeda 7900 Anesthesia Ventilator provides mechanical ventilation for patients during surgery, as well as adjustment and monitoring various patient parameters- Patient breathing waveform during volume mode or pressure mode V₀ Exhaled minute volume V₇₅ Exhaled tidal volume O₂ Percent of oxygen inspired f/min 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.

Device Story

Microprocessor-based, electronically controlled, pneumatically driven anesthesia ventilator; used in OR by clinicians. Inputs: breathing circuit sensor data (airway pressure, exhaled volume, inspired oxygen). Operation: bellows delivers breathing gases; electronic regulation of PEEP; microprocessor calculates ventilation parameters (minute volume, tidal volume, breath rate, airway pressures) and compensates for compression losses, fresh gas contribution, and system leaks. Output: real-time patient breathing waveforms and numerical ventilation parameters displayed on user interface. Benefits: precise mechanical ventilation control and continuous monitoring of patient respiratory status during anesthesia.

Clinical Evidence

Bench testing only. Compliance with ASTM F1101, ISO 10651, IEC 601-1, IEC 601-1-2, EN 60601-1-4, DIN 13252, and UL 2601 standards. Environmental and mechanical stress testing performed per IEC 68-2 series.

Technological Characteristics

Microprocessor-based control; pneumatically driven bellows system. Features RS-232 serial digital communications port. Complies with ASTM F1101, ISO 10651, IEC 601-1, IEC 601-1-2, EN 60601-1-4, DIN 13252, and UL 2601. Environmental testing per IEC 68-2 series.

Indications for Use

Indicated for patients undergoing surgery requiring mechanical ventilation.

Regulatory Classification

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.

Predicate Devices

• Ohmeda 7800 Anesthesia Ventilator

Submission Summary (Full Text)

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SEP 27 1996
Ohmeda
THE BOC GROUP
K960964

February 29, 1996

Ohmeda Inc
Ohmeda Drive
PO Box 7550
Madison WI 53707-7550
608 221 1551

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 being submitted in 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 adjustment and monitoring various patient parameters-

Patient breathing waveform during volume mode or pressure mode
V₀ Exhaled minute volume
V₇₅ Exhaled tidal volume
O₂ Percent of oxygen inspired
f/min 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 controlled, pneumatically driven ventilator with a built in monitoring system for inspired oxygen, airway 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 control breathing patterns. 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:

1. 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
2. ISO 10651 - Sections 50.3.1, 51.10 and 51.7
3. IEC 601-1 - 1988, EN 60601-1
4. IEC 601-1-2, EN 60601-1-2
- 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
5. EN 60601-1-4
6. DIN 13252/06 - 1984
7. E-DIN 132252/01 - 1991
8. prEN 740/12 - 1994
9. UL 2601 - 1994
10. IEC 68-2-3 Test Ca, IEC 68-2-1 Test Ab-Cold, IEC 68-2-2 Test Bb-Hot, IEC 68-2-14, IEC 68-2-34, IEC 68-2-6, IEC 68-2-27

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.

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