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510(k) Data Aggregation
(130 days)
CONCHASMART COLUMN
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 |
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(253 days)
CONCHATHERM NEPTUNE HEATED HUMIDIFIER, COMFORT FLO HUMIDIFICATION SYSTEM, CONCHASMART COLUMN
ConchaTherm Neptune Heated Humidifier: The ConchaTherm® Neptune TM is a respiratory humidifier designed to heat and humidify respiratory gases delivered via endotracheal tubes, nasal cannula or face masks to adult, pediatric, infant and neonatal patients. This system may be used with either conventional (non-heated wire) breathing circuits or compatible (21-volt) Hudson Respiratory Care Incorporated (RCI) heated-wire circuits. The ConchaTherm® NeptuneTM can be used with ventilators, continuous flow systems, oxygen diluters and blenders, adjustable nebulizer adapters for aerosol therapy, or nonflammable anesthesia gases to help maintain patient body temperature.
ConchaSmart Column: When used with the Hudson RCI ConchaTherm Neptune Heated Humidifier and Hudson RCI ventilator circuits, the ConchaSmart Column provides heated humidification for patients with and without an artificial airway in place.
Comfort Flo Humidification System: To provide a continuous flow of heated and humidified gas to spontaneously breathing patients.
The ConchaTherm Neptune Heated Humidifier is an active heated humidifier designed to provide heat and moisture to the medical gases delivered to a patient through continuous flow, invasive ventilation or non-invasive ventilation. The ConchaSmart Column is an accessory to the ConchaTherm Neptune Heated Humidifier. 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 ConchaTherm Neptune. The Comfort Flo Humidification System is intended to deliver heated and humidified respiratory gases to spontaneously breathing patients. The Comfort Flo Humidification System is designed to be used in conjunction with the ConchaTherm Neptune Heated Humidifier for neonate/infant, pediatric, and adult populations. The Comfort Flo Humidification System includes a Heated Wire Breathing Circuit, a ConchaSmart Column, and various Class I exempt accessories.
The provided document is a 510(k) summary for a medical device (Teleflex Medical's ConchaTherm Neptune Heated Humidifier, ConchaSmart Column, and Comfort Flo Humidification System). It focuses on demonstrating substantial equivalence to predicate devices, primarily through technological characteristics and performance data related to safety standards.
It does not contain any information about acceptance criteria and studies related to AI/algorithm performance, human reader studies, ground truth establishment, or sample sizes for training/test sets for an AI device. The document is for a physical medical device (humidifier) and not an AI/ML software device.
Therefore, I cannot extract the requested information from the provided text.
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