(133 days)
The Aespire View 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 Aespire View (version 7) anesthesia system with 7900 ventilator is intended to provide general inhalation anesthesia and ventilator support to a wide range of patients. The system is to be used only by trained and qualified medical professionals.
The Aespire View (version 7) supplies set flows of medical gases to the breathing system (predicate device cleared via 510k submissions K092864 and K122445). A large selection of frames, gases, and vaporizers are available to give the user control of the system configuration. It is available in trollev and pendant models, with two or three gases, two vaporizer positions and up to three cylinder connections. All models connect to oxygen and can additionally connect with up to two optional gases (air and N2O). The Aespire View system accepts Tec 6+ and Tec 7 vaporizers on a Selectatec manifold. Safety features are designed to decrease the risk of hypoxic mixtures, agent mixtures and complete power or sudden gas supply failures. The Aespire View provides optional electronic Total Fresh Gas Flow (TFS) monitoring. The Aespire View also features a color display.
The Datex-Ohmeda 7900 Anesthesia Ventilator is used in the Aespire View anesthesia machine. 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, bellow 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 using the ComWheel. 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 Control (VCV) Mode, Pressure Control (PCV) Mode (Optional), Synchronized Intermittent Mandatory Ventilation with Pressure Support Ventilation (SIMV/PSV) Mode, Pressure Support with Apnea Backup (PSVPro) Mode (Optional), Synchronized Intermittent Mandatory Ventilation with Pressure Control (SIMV-PC) Mode (Optional), and Pressure Control Ventilation- Volume Guaranteed (PCV-VG) mode (Optional).
The provided text describes a 510(k) premarket notification for the "Aespire View" anesthesia system. This device is an updated version of a previously cleared predicate device. The document explicitly states that clinical testing was NOT required for this submission. Therefore, the information requested regarding acceptance criteria and studies proving the device meets those criteria, specifically concerning performance metrics usually derived from clinical studies (like accuracy, sensitivity, specificity, or reader improvement with AI), is not available in this document.
The submission focuses on non-clinical testing to demonstrate substantial equivalence to the predicate device, primarily due to software and hardware modifications and updated standards compliance.
Here's an analysis based on the provided text, focusing on the absence of clinical performance data:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable in the context of clinical performance for this submission. The "acceptance criteria" discussed are related to compliance with standards (e.g., IEC 60601-1) and verification/validation activities for software and hardware changes. No specific clinical performance metrics (e.g., accuracy, sensitivity) with corresponding acceptance thresholds are mentioned because clinical testing was not deemed necessary.
2. Sample size used for the test set and the data provenance:
Not applicable for a clinical test set. The document refers to "testing on unit level," "integration testing," and "performance testing" but does not specify sample sizes in terms of patient data as there was no clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable as no clinical ground truth was established for a clinical test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable as no clinical test set requiring adjudication was used.
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 device is an anesthesia system, not an AI-assisted diagnostic tool. No MRMC study was performed.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is not an algorithm for diagnostic interpretation in a standalone capacity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable for clinical ground truth. The "ground truth" in this context would be defined by engineering specifications and standards against which the device's functional performance was verified.
8. The sample size for the training set:
Not applicable as no machine learning model was developed or trained for this submission in a way that would involve a "training set" of clinical data.
9. How the ground truth for the training set was established:
Not applicable for the same reasons as above.
Summary of Non-Clinical Testing and "Acceptance Criteria" for this submission:
The document outlines a series of non-clinical tests and standards compliance achieved by the Aespire View (version 7). These form the basis for its "acceptance" and determination of substantial equivalence.
| Acceptance Criteria (Non-Clinical) | Reported Device Performance (Compliance/Verification) |
|---|---|
| Software Functionality and Enhancements | Software Version 7 introduced with enhancements and updates for standards compliance. |
| Electrical Safety Standards Compliance | Dual compliant to AAMI / ANSI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012 (FDA Recognized) and IEC 60601-1:2005 (3rd Edn). Verification testing included electrical safety. |
| Electromagnetic Compatibility (EMC) | Compliant with IEC 60601-1-2 Edition 3: 2007 (FDA Recognized). Verification testing included electromagnetic compatibility. |
| Specific Anesthesia System Standards Compliance | Compliant with IEC 60601-2-13 Edition 3.1: 2009 (FDA Recognized) and ISO 80601-2-13 Edition 1: 2011 (Not FDA Recognized). |
| Alarm System Compliance | Compliant with 60601-1-8 and 80601-2-13 3rd Edition, including updates to audio pause and alarm inhibit symbols. |
| Environmental and Operational Conditions (BTPS/STPD Units) | Includes option for service-authorized user to change ventilator flow measurements between STPD and BTPS units. |
| User Interface Improvements (Real Time Clock, ACGO, PEEP, Waveforms, Loops) | Includes real-time clock. More visible ACGO message and graphical illustration. Display of measured PEEP numeric value. Colored spontaneous breaths in waveform. Two flow waveforms (Paw and flow). Option to display spirometry loops. |
| Mechanical Design and Safety (Central Brake, Cylinder Kit) | Added a single central brake lever. Updates to large cylinder kit option for compliance with 60601-1 3rd Edition tip testing and sliding clauses. |
| Biocompatibility (Lubricant Material Change) | Lubricant material change on pneumatic connectors tested for volatile organic compounds (VOCs). Results demonstrated no increased biocompatibility risk. |
| Risk Management | Risk Analysis performed. |
| Design Control and Verification/Validation | Requirements/Specification Reviews, Design Reviews, Testing on unit level (Module verification), Integration testing (System verification), Performance Testing (Verification), Materials Testing, Verification Testing, Simulated Use/User Requirements Testing (Validation) were applied. |
In conclusion, this FDA 510(k) submission for the Aespire View anesthesia system did not involve a clinical study or generate clinical performance data against acceptance criteria, as the modifications were deemed to not require clinical testing to establish substantial equivalence. The "study" that proves the device meets (non-clinical) acceptance criteria involved extensive engineering verification and validation, along with adherence to recognized international standards.
§ 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).