(130 days)
When used with a Neptune Heated Humidifier and Hudson RCI ventilator circuits, the ConchaSmart Column provides heated humidification for patients with and without an artificial airway in place.
The ConchaSmart Column is an accessory to the Neptune Heated Humidifier (K063758 and K131912). It is a single use, disposable humidifier cartridge which is intended for neonatal, infant, pediatric, and adult patients requiring heated humidification. The ConchaSmart Column is used by inserting the column into the center of the Neptune Heated Humidifier.
The provided document is a 510(k) summary for the ConchaSmart Column, a respiratory gas humidifier. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria in the context of an AI/algorithm-based medical device.
Therefore, the requested information categories related to acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are largely not applicable to this type of regulatory submission. This document describes a medical device, but not an AI-powered one that would typically undergo the kind of performance evaluation requested.
However, I can extract the information that is present and indicate where the requested information is not applicable (N/A) or not provided in this document.
1. A table of acceptance criteria and the reported device performance
The document presents a comparison to a predicate device based on technological characteristics and performance specifications rather than explicit acceptance criteria and a study proving device performance against those criteria in the way an AI device would be evaluated. The "reported device performance" in this context refers to its specifications alongside those of the predicate.
| Characteristic | Acceptance Criteria (Predicate) | Reported Device Performance (ConchaSmart Column) |
|---|---|---|
| Intended Use | Same as predicate (Fisher & Paykel MR290) | When used with a Neptune Heated Humidifier and Hudson RCI ventilator circuits, provides heated humidification for patients with and without an artificial airway in place. |
| Patient Population | Neonatal, Infant, Pediatric, Adult | Neonatal, Infant, Pediatric, Adult |
| Humidification Therapies | Invasive, Non-Invasive, High Flow Nasal Cannula Therapy | Invasive, Non-Invasive, High Flow Nasal Cannula Therapy |
| Humidity Output | ISO 8185:2007 | ISO 8185:2007 |
| - Subglottic mode | ≥33mg H2O /L | ≥33mg H2O /L |
| - Supraglottic mode | ≥10mg H2O /L | ≥10mg H2O /L |
| Enthalpy Limit |
§ 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).