(315 days)
Indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen to a conscious, spontaneously breathing patient.
The device will be available in two models: (Details below) FLOWSTAR TOUCH DIGITAL MIXER FLOWMETER 50 %, and FLOWSTAR TOUCH DIGITAL MIXER FLOWMETER 70 %.
50% and 70% represent the maximum nitrous oxide concentration. The FlowStar Touch O2- N₂O Mixer for Analgesia is a device which can precisely dose a mixture of medical oxygen and medical nitrous oxide, depending on the adjusted mixture, for the sedation of patients in hospitals and at the dentist. The operator, a doctor or a dentist is able to adjust the total flow and the concentration of nitrous oxide of this flow. Depending on these settings the level of sedation of the patient can be controlled by the operator. The Baldus® Touch O2- N2O Mixer for Analgesia device has been created with the following safety features. The total flow emitted can consist of a maximum of 70 % nitrous oxide, the mix up of gas types is prevented by mechanical encodings and the flow of pure nitrous oxide in the absence of a missing oxygen supply is prevented by a fail-safe device. An integrated Touch pad is used to select the desired N₂O /O2 gas mixture. The total flow can consist of between 0 (100% O2) and 70 (30% O2) percent N₂O. The minimum output of 30 % O2 prevents from a hypoxic mixture for the patient. The FlowStar TouchO2- N2O Mixer for Analgesia device has an integrated O2 Flush function which delivers at least 30 l/min of pure oxygen to flush the N20 out of the patient circuit after the treatment. The FlowStar TouchO2- N₂O Mixer for Analgesia device has an alarm system which generates an alarm in the case of an insufficient O2 supply. The device will shut off the sedation when the O2 supply reaches a critical level. The gas mixture output of the FlowStar TouchO2- N2O Mixer for Analgesia device is connected to the Bag T. The Bag T is a device with two inputs and two outputs. One input is the gas mixture from the mixing device. The other input is a valve which opens when the adjusted total flow is too low for the patient. The gas mixture is then enriched with additional ambient air. The first output of the Bag T is for the connected breathing bag which is filled when the patient exhales and is emptied when the patient inhales. The second output leads the gas mixture to the scavenger system and finally to the patient. The main accessories for the proposed device are a Breathing Bag and a Double Mask Scavenger System.
The device includes a microprocessor-controlled valve system that precisely meters Oxygen and Nitrous Oxide gases for analgesic purposes. The inputs of the touchpad influence the gas flow inside of the device. The firmware is considered to be of a moderate level of concern.
Here's an analysis of the provided text regarding the acceptance criteria and supporting studies for the FlowStar Touch Digital Mixer Flowmeter:
1. Table of Acceptance Criteria & Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in a tabulated format with specific numerical targets. Instead, it focuses on demonstrating substantial equivalence to a predicate device (Accutron Digital Ultra K052335) through comparisons of characteristics and compliance with recognized standards. The "performance" is implicitly demonstrated by meeting the standards and showing similar or improved characteristics compared to the predicate.
Below is a table summarizing the characteristics where performance could be inferred or compared:
| Characteristic | Acceptance Criteria (Inferred from predicate/standards) | Reported Device Performance (FlowStar Touch Digital Mixer Flowmeter) |
|---|---|---|
| Intended Use | Administer adjustable mixture of Nitrous Oxide and Oxygen to a conscious, spontaneously breathing patient. | Indicated for administering an adjustable mixture of Nitrous Oxide analgesic gas and Oxygen to a conscious, spontaneously breathing patient. (Functionally identical) |
| Max N2O Concentration | 70% (for 70% model) | 70% (FlowStar Touch Digital Mixer Flowmeter 70%) |
| Min O2 Concentration | 30% | 30% (Prevents hypoxic mixture for patient) |
| Oxygen Flush | Minimum 20 LPM | 40-55 l/min (Improved/Higher) |
| Oxygen Flow | 1.0 LPM - 9.9 LPM | 1.0 - 18 l/min (Wider Range/Improved) |
| Oxygen Resuscitator Flow | Minimum 100 LPM | 100 - 250 l/min (Wider Range/Improved) |
| Nitrous Oxide Flow | 0 - 6.9 LPM | 0 - 12.6 l/min (Wider Range/Improved) |
| Mixed Gas Flow | 1.0 - 9.9 LPM | 3 – 18 l/min (Wider Range/Improved) |
| Power Source | 100-240 V AC, 50/60 Hz | 110-230 V 50-60 Hz (Essentially the same) |
| Controls | Touch Panel | Touch Panel (Same) |
| Safety Standards Compliance | IEC 60601-1, IEC 60601-1-2 | IEC 60601-1, IEC 60601-1-2 (SAME), ISO 11195, CGA V-5, CGA C-9, ISO 5356-1 |
| Alarms (O2 Fail-Safe) | O₂ ceases if O₂ supply interrupted/reduced; alarm sounds, N₂O flow ceases. | If no oxygen supplied, visual/acoustic signals emitted. Unit shuts off sedation if O2 reaches critical level. (Equivalent) |
| Alarms (N2O Supply) | Alarm if N₂O supply cannot keep up; alarm sounds, flow switches to 100% O2. | If no nitrous oxide supplied, visual/acoustic signals emitted (including low pressure or measurement failure). (Equivalent) |
| Alarms (Mixed Gas Flow) | Alarm if mixed gas line pressure obstructed. | O₂ minimum flow 3 l/min (visual/acoustic signals if |
§ 868.5330 Breathing gas mixer.
(a)
Identification. A breathing gas mixer is a device intended for use in conjunction with a respiratory support apparatus to control the mixing of gases that are to be breathed by a patient.(b)
Classification. Class II (performance standards).