(139 days)
The inspired™ VHB20 Heated Humidifier is intended to be used to warm and add humidity to gases delivered to patients requiring mechanical ventilation or positive pressure breathing assistance or general medical gases.
The inspired TM VHB20 Heated Humidifier is indicated for use by trained personnel only within a hospital/institutional environment. It is compatible with the Fisher and Paykel MR290 Humidification Chamber (Single Use), RT380 Dual Heated Breathing Circuit and RT265 Dual Heated Infant Breathing Circuit.
The subject device, inspired™ VHB20 Heated Humidifier, is indicated to add humidity and heat to the breathing gasses delivered to patients requiring mechanical ventilation or positive pressure breathing assistance.
It consists of an electrically powered heat controlled with a microprocessor to provide software control of the heating element that transfers heat to the water in a chamber.
Breathing tubes enable the humidified gas to be transported to the patient which may also be electrically heated (if connected), by means of a heater-wire placed internally to the tubes, to minimize the loss of humidity. A passive electrical adaptor provides electrical energy from the humidifier to the heater-wire in the breathing circuit. Over-current protection is provided by the SMPS inside the inspired™ VHB20 Heated Humidifier, which incorporates an over-current protection that will be triggered (cut-out) if output power of the SMPS reaches 110% of the rating (100W). The SMPS will recover automatically after fault condition is removed, while the humidifier will restart. This safety feature protects the humidifier from short-circuits in the DC part of the circuit, and prevents voltage and current transients on the heater-wire.
The inspired™ VHB20 Heated Humidifier provides heated and humidified gas with flow rates of 5 to 60 lpm (invasive) and 5 to 120 lpm (non-invasive).
The inspired™ VHB20 Heated Humidifier is a mains powered device that complies with ES60601-1, IEC 60601-1-2, ISO 80601-2-74 and AIM 7351731.
The provided text describes a 510(k) premarket notification for a medical device, the "inspired™ VHB20 Heated Humidifier." This document focuses on demonstrating substantial equivalence to a predicate device, the Fisher & Paykel MR850 Respiratory Humidifier. The information provided is primarily for regulatory clearance based on equivalence, not a clinical study proving specific performance metrics against acceptance criteria in the way one might see for a novel AI/ML device.
Therefore, many of the requested items related to Acceptance Criteria and Study Design (e.g., sample size for test sets, ground truth establishment by experts, MRMC studies, standalone performance with effect sizes) are not applicable to this type of regulatory submission for a respiratory gas humidifier. The "acceptance criteria" here are based on demonstrating that the new device is as safe and effective as a legally marketed predicate device, primarily through bench testing comparing its performance specifications.
However, I can extract the relevant "acceptance criteria" (which are performance specifications) and the "reported device performance" from the provided Table 1, and comment on other requested points based on the available information.
Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this type of device are generally its performance specifications that demonstrate it operates within safe and effective parameters, comparable to a predicate device. The "reported device performance" is the measured performance of the proposed device.
Here's a table comparing the subject device's reported performance against the predicate's, which implicitly serves as the "acceptance criteria" for substantial equivalence:
| Performance Characteristic | Acceptance Criteria (Predicate: Fisher & Paykel MR850) | Reported Device Performance (Subject: inspired™ VHB20) | Comment (from document) |
|---|---|---|---|
| Heater plate over temperature cutout (hardware) | $118 \pm 6°C$ | $118 \pm 7°C$ | Similar |
| Safety cutoff temperature (software control) | $110°C$ | $105°C$ | Similar |
| Heater Wires power supply | 22V~, 2.73A max, 60W, 50/60Hz | 24VDC, 80VA | Similar |
| Temperature control settings (Airway Invasive) | Default: $40°C$, Range: $35-40°C$ (Versions 7.22) | Default: $39°C$, Range: $35-40°C$ | Similar |
| Temperature control settings (Airway Non-invasive) | Default: $34°C$, Range: $28-34°C$ (Versions 7.22) | Default: $34°C$, Range: $30-37°C$ | Similar |
| Temperature control settings (Chamber outlet Invasive) | Default: N/A, Range: $35.5-42°C$ (Versions 7.22) | Default: $36°C$, Range: $35-43°C$ | Similar |
| Temperature control settings (Chamber outlet Non-invasive) | Default: N/A, Range: $31-36°C$ (Versions 7.22) | Default: $31°C$, Range: $30-32°C$ | Similar |
| Display Accuracy | $\pm 0.3°C$ (in 25 to $45°C$ range) | $\pm 2°C$ | Similar |
| High temperature alarm (Invasive mode) | Displayed temp exceeds $41°C$ or Airway temp exceeds $43°C$ | Patient-side temperature exceeds $41°C$ | Similar |
| High temperature alarm (Non-invasive mode) | Displayed temp exceeds $41°C$ or Airway temp exceeds $43°C$ | Patient-side temperature exceeds $38°C$ | Similar |
| Low temperature alarm (Invasive mode) | After 10 min @ $29.5°C$ or 60 min @ $34.5°C$ | Patient-side temp 33mg/L | $\geq 33mg/L$ |
| Humidity Performance (Non-Invasive) | > 10 mg/L | $\geq 12 mg/L$ | Similar |
| Warm-up time | Less than 30 minutes |
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).