(183 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 is substantially equivalent to the following currently marketed device: Datex-Ohmeda Aestiva/5, with 7100 Ventilator, Anesthesia System - Class II -21CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K000706 Datex-Ohmeda Excel 3000 (Aestiva), with 7900 Ventilator, Anesthesia System -Class II - 21CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K973896 Datex-Ohmeda AS/3 Anesthesia Delivery Unit (ADU) - Class II -- 21CFR868.5160, which has been the subject of a cleared 510(k) with FDA log number K973985 The Datex-Ohmeda S/5 Avance Anesthesia System was designed to comply with the applicable portions of the following voluntary standards; - 1. UL 2601 General requirements for Medical Electrical Equipment - 2. EN 740 Anesthetic Work Stations - 3. EN/IEC 60601-1: General requirements for Medical Electrical Equipment - 4. EN/IEC 60601-1-2: 1998 Medical Electrical Equipment Electromagnetic Compatibility - 5. EN 475 Electrically Generated Alarm Signals - 6. ASTM F1463-93 Standard Specification for Alarm Signals - 7. ASTM F1208-94 Anesthesia Breathing Circuit Standard - 8. ASTM F1101-90 -- Standard Specification for Ventilators Intended for Use During Anesthesia - 9. ISO 5358 Anesthetic Gas Machines The Datex-Ohmeda S/5 Avance Anesthesia System and the currently marketed device are The Datest of Interious in design concepts, technologies and materials. The Datex-Ohmeda S/5 Substance Anesthesia System has been validated through rigorous testing that, in part, supports the I compliance of S/5 Avance Anesthesia System to the standards listed above.
This 510(k) premarket notification describes the Datex-Ohmeda S/5 Avance Anesthesia System. The submission establishes substantial equivalence to previously cleared devices rather than presenting a de novo study with explicit acceptance criteria for performance. Therefore, the information requested regarding a standalone study, multi-reader multi-case study, and detailed ground truth provenance is not explicitly available in this document.
Here's an analysis based on the provided text, focusing on how the device meets applicable standards rather than specific quantifiable acceptance criteria within a clinical performance study.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission based on substantial equivalence, the "acceptance criteria" are primarily established by compliance with recognized voluntary standards and the performance of predicate devices. The document does not provide specific numerical performance metrics for the S/5 Avance Anesthesia System that would typically be found in a clinical study report. Instead, performance is implied by its adherence to these standards.
| Acceptance Criteria (Implied by Standards Compliance) | Reported Device Performance (Implied by Standards Compliance) |
|---|---|
| Safe electrical operation (UL 2601, EN/IEC 60601-1) | Device designed to comply with these standards. |
| Anesthetic workstation functionality (EN 740) | Device designed to comply with this standard. |
| Electromagnetic compatibility (EN/IEC 60601-1-2) | Device designed to comply with this standard. |
| Alarm signal generation (EN 475, ASTM F1463-93) | Device designed to comply with these standards. |
| Anesthesia breathing circuit standards (ASTM F1208-94) | Device designed to comply with this standard. |
| Ventilator standards for anesthesia (ASTM F1101-90) | Device designed to comply with this standard. |
| Anesthetic gas machine standards (ISO 5358) | Device designed to comply with this standard. |
| General inhalation anesthesia and ventilatory support (Indications for Use) | Intended to provide general inhalation anesthesia and ventilatory support to a wide range of patients for volume or pressure control ventilation. |
| Substantial equivalence to predicate devices (Datex-Ohmeda Aestiva/5, Excel 3000, AS/3 ADU) | Stated as substantially equivalent in design concepts, technologies, and materials to the listed predicate devices. Validated through rigorous testing to support compliance. |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This 510(k) submission does not describe a clinical test set in the traditional sense with patient data. The "testing" mentioned is primarily related to engineering and system verification for compliance with voluntary standards.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. The submission focuses on device design and compliance with standards, not on establishing ground truth for a clinical dataset. Expert review would have been part of the regulatory body's assessment rather than part of the manufacturer's testing described here.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
Not applicable. This device is an anesthesia system, not an AI-assisted diagnostic or treatment planning tool that would typically involve an MRMC study.
6. Standalone Performance Study (Algorithm Only)
Not applicable. This is a medical device (anesthesia system), not an algorithm or AI product. Its performance is integrated into its physical and functional operation, demonstrated through compliance with engineering and safety standards.
7. Type of Ground Truth Used
The "ground truth" in this context is the fulfillment of requirements outlined in recognized national and international voluntary standards (e.g., UL, EN, IEC, ASTM, ISO) for electrical safety, performance, and functionality of anesthesia systems and ventilators. This is not clinical ground truth in terms of diagnoses or outcomes but rather engineering and safety compliance.
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI device that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable. See above.
§ 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).