(267 days)
V80 Anesthetic Vaporizer is used to enrich the fresh gas flow of an anesthesia delivery system with controllable desflurane vapour.
V80 Anesthetic Vaporizer is intended to be operated only by licensed clinicians and qualified anesthesia personnel who have received adequate training in its use. Anyone unauthorized or untrained must not perform any operation on the anesthetic vaporizer.
V80 Anesthetic Vaporizer cannot be used in mobile vehicles, airplanes, helicopters or ships.
V80 Anesthetic Vaporizer is not suitable for use in an MRI environment.
V80 Anesthetic Vaporizer is used to provide desflurane vapour with controllable concentration.
The provided text is a 510(k) Summary for the Mindray V80 Anesthetic Vaporizer. It focuses on demonstrating substantial equivalence to a predicate device (D-Vapor Anesthetic Vaporizer) by comparing technical characteristics and performance data, mainly through bench testing and compliance with various standards.
Crucially, this document does not describe a study that uses a test set, ground truth established by experts, or measures human reader performance with or without AI assistance. The device in question is an anesthetic vaporizer, which is a piece of hardware, not an AI/software device that interprets medical images or diagnoses conditions. Therefore, many of the requested elements of your query (e.g., sample size for test set, number of experts, MRMC study, standalone performance for an algorithm, training set details) are not applicable to this type of medical device submission.
However, I can extract the relevant information from the document regarding its acceptance criteria and the type of studies conducted to prove it meets those criteria, specifically concerning its performance and other safety/effectiveness aspects.
Here's a breakdown of the requested information based on the provided document:
1. A table of acceptance criteria and the reported device performance
The document presents a comparison table between the subject device (V80 Anesthetic Vaporizer) and the primary predicate device (D-Vapor Anesthetic Vaporizer), essentially demonstrating that the acceptance criteria for the subject device are met by matching or exceeding the performance and specifications of the predicate.
| Technical Characteristics (Acceptance Criteria Based on Predicate) | Subject device V80 Anesthetic Vaporizer (Reported Performance) | Primary predicate D-Vapor Anesthetic Vaporizer (Benchmark/Acceptance Target) |
|---|---|---|
| Performance | ||
| Concentration setting range | 2vol.% to 18 vol.% | 2vol.% to 18 vol.% |
| Calibrated setting concentration | ±0.5vol.% or ±15%rel, the larger value applies in each case | ±0.5vol.% or ±15%rel, the larger value applies in each case |
| Other setting concentration (0.2-2 L/min) | ±0.9Vol.% or ±30% rel, which is greater | ±0.9Vol.% or ±30% rel, which is greater |
| Other setting concentration (2-8 L/min) | ±0.9Vol.% or ±20% rel, which is greater | ±0.9Vol.% or ±20% rel, which is greater |
| Other setting concentration (8-15 L/min) | ±0.9Vol.% or ±30% rel, which is greater | ±0.9Vol.% or ±30% rel, which is greater |
| Flow range | 0.2 to 15L/min | 0.2 to 15L/min |
| Maximum tilt angle during working | 10° | 10° |
| Warm-up time at 22 °C | within 6 min | within 6 min |
| User Interface Indicators | ||
| Display Panel Indicators | Operational, No Output, Delivery Low, Fill Up, Battery | Operational, No Output, Delivery Low, Fill Up, Battery |
| Glass tube liquid level indicator | A sight glass on the front to visually indicate the level of agent | A sight glass on the front to visually indicate the level of agent |
| Audio Paused | 120s | 120s |
| Connection to anesthesia delivery system | Selectatec®-compatible plug-in connectors | Selectatec®-compatible plug-in connectors |
| Filling system | Saf-T-Fill™ | Saf-T-Fill™ |
| Filling volume | Total: 320 mL | Total: 300 mL |
| Anesthetic agent loss (24 hours in storage, 22°C) | ≤0.5mL | ≤0.5mL |
| Anesthetic agent loss (24 hours in work, 22°C) | ≤2.5mL | ≤2.5mL |
| Filling time for 240 mL Desflurane (22°C, not warmed up) |
§ 868.5880 Anesthetic vaporizer.
(a)
Identification. An anesthetic vaporizer is a device used to vaporize liquid anesthetic and deliver a controlled amount of the vapor to the patient.(b)
Classification. Class II (performance standards).