(364 days)
This version of the Datex-Ohmeda 7900 Ventilator is used in Datex-Ohmeda Aestiva/5 Anesthesia Systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped 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 measure inspired oxygen concentration. This allows for the compensation of compression losses, fresh gas contribution and small leakage in the breathing absorber, bellows and system. User setting 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 tot he 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. Ventilatory modes for the device, include Volume Mode, Pressure Control Mode, Synchronous Intermittent Mandatory Ventilation (optional), Pressure Support with Apnea Backup Ventilation (optional).
This version of the Datex-Ohmeda 7900 Ventilator is used in Datex-Ohmeda Aestiva/5 Anesthesia Systems. It is a microprocessor based, electronically controlled, pneumatically driven ventilator that provides patient ventilation during surgical procedures. The 7900 ventilator is equipped 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 measure inspired oxygen concentration. This allows for the compensation of compression losses, fresh gas contribution and small leakage in the breathing absorber, bellows and system. User setting 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 tot he 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. Ventilatory modes for the device, include Volume Mode, Pressure Control Mode, Synchronous Intermittent Mandatory Ventilation (optional), Pressure Support with Apnea Backup Ventilation (optional).
The Datex-Ohmeda 7900 Ventilator Enhancements to the Aestiva/5 Anesthesia System is a pneumatically driven, microprocessor-based, electronically controlled ventilator that provides patient ventilation during surgical procedures. The device includes a built-in monitoring system for inspired oxygen, airway pressure, and exhaled volume.
Here's an analysis of the acceptance criteria and supporting study information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text focuses on regulatory substantial equivalence based on compliance with voluntary standards and comparisons to predicate devices, rather than explicit performance-based acceptance criteria with specific numerical targets. The "reported device performance" in this context refers to its successful validation against these standards and its similar functionality to predicate devices.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Compliance with Voluntary Standards: | |
| UL 2601 General requirements for Medical Electrical Equipment | Validated through rigorous testing to support compliance. |
| EN 740 Anesthetic Work Stations | Validated through rigorous testing to support compliance. |
| EN/IEC 60601-1: General requirements for Medical Electrical Equipment | Validated through rigorous testing to support compliance. |
| EN/IEC 60601-1-2: 1998 Medical Electrical Equipment Electromagnetic Compatibility | Validated through rigorous testing to support compliance. |
| ASTM F1101-90 Standard Specification for Ventilators Intended for Use During Anesthesia | Validated through rigorous testing to support compliance. |
| ISO 5358 Anesthetic Gas Machines | Validated through rigorous testing to support compliance. |
| ASTM F1209-94 Anesthesia Breathing Circuit Standard | Validated through rigorous testing to support compliance. |
| EN 475 Electrically Generated Alarm Signals | Validated through rigorous testing to support compliance. |
| ASTM F1463-93 Standard Specification for Alarm Signals | Validated through rigorous testing to support compliance. |
| Substantial Equivalence to Predicate Devices: Design concepts, technologies, and materials should be similar. | The device is stated to be substantially equivalent in design concepts, technologies, and materials to the Ohmeda 7900 Anesthesia Ventilator (K960964), Ohmeda Excel 3000 Anesthesia Gas System (K973896), Datex-Engstrom AS/3 Anesthesia Delivery Unit (ADU) (K973985), and Puritan Bennett 7200 ICU Ventilator (K930017). Similar functionality, including microprocessor-based control, pneumatic drive, monitoring of inspired oxygen, airway pressure, exhaled volume, compensation for losses, and various ventilatory modes, is described. |
| Safety and Effectiveness for Intended Use: Providing patient ventilation during surgical procedures. | Demonstrated through substantial equivalence to legally marketed predicate devices and compliance with relevant safety and performance standards. The device is intended for use by trained and qualified medical professionals. |
2. Sample size used for the test set and the data provenance
The document does not detail specific "test sets" or "data provenance" in the context of clinical studies for performance metrics. The validation is described as "rigorous testing" to ensure compliance with voluntary standards. This suggests engineering and bench testing, rather than a clinical trial with a patient test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The document describes compliance with engineering and electrical safety standards, as well as functional equivalence to predicate devices, not interpretation of clinical data by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no mention of a clinical test set requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is a ventilation device; its approval does not involve AI assistance or MRMC studies.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
Not applicable. This is a medical device, and its performance is assessed against established engineering and safety standards, and functional equivalence, not as an algorithm's standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context is the successful demonstration of compliance with the detailed requirements outlined in the voluntary consensus standards (UL, EN/IEC, ASTM, ISO) and the functional specifications of the device itself, proving its substantial equivalence to the predicate devices. This involves engineering specifications, technical testing, and regulatory requirements rather than clinical ground truth from patient data.
8. The sample size for the training set
Not applicable. This device is not an AI/ML algorithm that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This device is not an AI/ML algorithm that requires a training set.
§ 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).