(30 days)
The Datex-Ohmeda S/5 Avance Anesthesia System is intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients. The device is intended for volume or pressure control ventilation. The S/5 Avance is not suitable for use in a MRI environment.
The Datex-Ohmeda S/5 Avance Anesthesia System supplies set flows of medical gases to the breathing system using electronic gas mixing. Gas flows are selected by the user using the keypad and rotary controller on the main display unit and then displayed as electronic flow meters on the system display unit. The Avance is equipped with a pneumatic back-up O2 delivery system and traditional flow tube, as well. A large selection of frames, gases, and vaporizers are available to give the user control of the system configuration. The S/5 Avance is also available in wall-mount and pendant models. It is available with two or three gases, up to two vaporizer positions and up to three cylinder connections. All models have O2. The S/5 Avance comes with up to two optional gases (air, N2O). The S/5 Avance systems accept Tec 4, Tec 5, Tec 6, and Tec 7 vaporizers on a Selectatec manifold. Safety features and devices within the S/5 Avance are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. The Avance system is available with optional integrated respiratory gas monitoring. When supplied as an option, the integrated respiratory gas monitoring is provided via the Datex-Ohmeda M-Gas Module (M-CAiO and M-CAiOV software revision 3.2 and above K# 001814) which is physically integrated into the Avance, receives electronic power from the Avance and communicates measured values to the Avance for Cisplay on the system display unit.
The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the S/5 Avance Anesthesia System. 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 as 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. The 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. Ventilator modes for the device include Volume Mode, Pressure Control Mode, Pressure Support with Apnea Backup Ventilation (Optional) and Synchronized Mandatory Intermittent Ventilation(SIMV) (Optional) Mode. Ventilator parameters and measurements are displayed on the system display unit.
This looks like a 510(k) premarket notification for a medical device, which typically focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific clinical study results or acceptance criteria in the way a clinical trial report would.
Based on the provided text, here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define acceptance criteria in terms of specific performance metrics (e.g., accuracy, sensitivity, specificity) for a clinical outcome or diagnostic task. Instead, the "acceptance criteria" appear to be compliance with relevant medical device standards and the demonstration of substantial equivalence to predicate devices.
| Acceptance Criteria (Inferred from Document) | Reported Device Performance (Summary) |
|---|---|
| Compliance with Voluntary Standards | The Datex-Ohmeda S/5 Avance Anesthesia System was designed to comply with the applicable portions of the following voluntary standards: |
- UL 2601 General requirements for Medical Electrical Equipment
- EN 740 Anesthetic Work Stations
- EN/IEC 60601-1: General requirements for Medical Electrical Equipment
- EN/IEC 60601-1-2: 1998 Medical Electrical Equipment Electromagnetic Compatibility
- EN 475 Electrically Generated Alarm Signals
- ASTM F1463-93 Standard Specification for Alarm Signals
- ASTM F1208-94 Anesthesia Breathing Circuit Standard
- ASTM F1101-90 Standard Specification for Ventilators Intended for Use During Anesthesia
- ISO 5358 Anesthetic Gas Machines |
| Substantial Equivalence to Predicate Devices | The Datex-Ohmeda S/5 Avance Anesthesia System is stated to be substantially equivalent to the Datex-Ohmeda S/5 Avance Anesthesia System (K032803) and Datex-Ohmeda 7900 Ventilator Enhancements (K023366). The document explicitly states: "The Datex-Ohmeda S/5 Avance Anesthesia System and the currently marketed device are substantially equivalent in design concepts, technologies and materials." The FDA's letter confirms: "We have determined the device is substantially equivalent... to legally marketed predicate devices." |
| Safety Features | The S/5 Avance includes "Safety features and devices...designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures." (This is a design intent, not a quantified performance measure in this document). |
| Integrated Monitoring Performance | When supplied as an option, "the integrated respiratory gas monitoring is provided via the Datex-Ohmeda M-Gas Module (M-CAiO and M-CAiOV software revision 3.2 and above K# 001814) which is physically integrated into the Avance, receives electronic power from the Avance and communicates measured values to the Avance for display on the system display unit." (Performance of this module is referenced by its own 510(k) and software revision, not detailed here.) |
| Ventilator Monitoring Performance | 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 as 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." (Statements of functionality, not quantified performance here). |
2. Sample Size Used for the Test Set and the Data Provenance
The document does not describe a specific clinical "test set" in the context of an algorithm or diagnostic device. The "rigorous testing" mentioned is referred to as demonstrating compliance with standards and supporting substantial equivalence, which typically involves bench testing, engineering verification, and validation (V&V) activities. There is no mention of patient data (e.g., country of origin, retrospective/prospective).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable/provided as the document describes a hardware anesthesia system and ventilator, not a diagnostic algorithm requiring ground truth established by experts for a test set. The validation focuses on engineering and regulatory standards compliance.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable/provided for the same reasons as point 3.
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
This information is not applicable/provided. The device is an anesthesia system, not an AI-assisted diagnostic or decision-support tool that would involve human readers interpreting cases.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This information is not applicable/provided. The device is an integrated anesthesia system, not a standalone algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable/provided as the validation is based on engineering and performance specifications against established standards and equivalence to predicate devices, not on a ground truth related to clinical outcomes or diagnostic accuracy in the context of an AI/diagnostic algorithm.
8. The Sample Size for the Training Set
This information is not applicable/provided. There is no mention of a "training set" as this is not an AI/machine learning device in the context of diagnostic algorithms.
9. How the Ground Truth for the Training Set was Established
This information is not applicable/provided for the same reasons as point 8.
In summary:
This 510(k) summary focuses on demonstrating that the Datex-Ohmeda S/5 Avance Anesthesia System is substantially equivalent to legally marketed predicate devices and complies with relevant safety and performance standards. It achieves this through rigorous engineering and validation testing against those standards and by comparing its design and technology to existing cleared devices. The document does not describe clinical studies involving patient data or the performance of a diagnostic algorithm in the way the questions are framed.
§ 868.5160 Gas machine for anesthesia or analgesia.
(a)
Gas machine for anesthesia —(1)Identification. A gas machine for anesthesia is a device used to administer to a patient, continuously or intermittently, a general inhalation anesthetic and to maintain a patient's ventilation. The device may include a gas flowmeter, vaporizer, ventilator, breathing circuit with bag, and emergency air supply.(2)
Classification. Class II (performance standards).(b)
Gas machine for analgesia —(1)Identification. A gas machine for analgesia is a device used to administer to a patient an analgesic agent, such as a nitrous oxide-oxygen mixture (maximum concentration of 70 percent nitrous oxide).(2)
Classification. Class II (performance standards).