(86 days)
The indication for FLOW-i Anesthesia System is administering inhalation Anesthesia while controlling the entire ventilation of patients with no ability to breathe, as well as in supporting patients with a limited ability to breathe. The system is intended for use on neonatal to adult patient populations. The system is intended for use in hospital environments, except MRI environment, by healthcare professionals trained in inhalation Anesthesia administration.
The modified FLOW-i Anesthesia System version 3.0 is an Anesthesia System designed to meet the many ventilatory challenges within Anesthesia, as well as to provide inhalation Anesthesia. It is intended to serve a wide range of patients from neonatal to adult. FLOW-i Anesthesia System is a software-controlled semi-closed system for inhalation Anesthesia (Sevoffurane, Desflurane, Isofturane and/or nitrous oxide). The most important performance features of the FLOW-i Anesthesia System are: - a ventilator whose functionality is based on ICU-ventilator technology, o - the volume reflector technology, o - the electronically controlled injector vaporizers and o - the ergonomic design. o
The provided 510(k) summary describes modifications to an Anesthesia System and claims substantial equivalence to a predicate device. It specifically states that no clinical investigation was needed or performed to validate the changes. Therefore, the device does not have a study with acceptance criteria in the traditional sense, as it relies on non-clinical testing and substantial equivalence.
However, the document does list technical specifications for various parameters, which can be interpreted as the performance criteria that the device (and its modifications) must continue to meet. The "study" that proves the device meets these criteria is the non-clinical testing and performance activities.
Here's an attempt to structure the information based on the request, interpreting the provided text accordingly:
1. Table of Acceptance Criteria and Reported Device Performance
Since no specific "acceptance criteria" for a study are explicitly stated, the technical specifications from the "Specifications from FLOW-i User's Manual, section 14 Technical Specifications" are used as the inherent performance criteria the device is expected to meet. The document states that "Design verification and validation has demonstrated that the FLOW-i Anesthesia System performs within its specifications."
| Parameter | Acceptance Criteria (Predicate Device Specification) | Reported Device Performance (Subject Device Specification) |
|---|---|---|
| Fresh gas oxygen conc | 21 - 100 % (O2/Air); 28- 100 % (O2/N2O) Accuracy: 21-59%: ±3 % v/v; 60-100%: ±5 % v/v | Same |
| Isoflurane conc | 0-5% Accuracy: ±15% of set value or ±5% of maximum possible setting (whichever is greater) | Same |
| Sevoflurane conc | 0-8% Accuracy: ±15% of set value or ±5% of maximum possible setting (whichever is greater) | Same |
| Desflurane conc | 0-10% (FG flow |
§ 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).