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510(k) Data Aggregation
(219 days)
OPT96X Model: The F&P Optiflow+ Duet is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (10 years and up) and adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway. This device is designed to be used in a hospital, sub-acute facility, or long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional.
MYDUETXXX Model: The F&P Optiflow+ Duet is a nasal cannula patient interface for use with specified respiratory gas humidifiers to treat spontaneously breathing pediatric (10 years and up) and adult patients who would benefit from receiving high flow warmed and humidified respiratory gases to the upper airway. This device is designed to be used in a long-term care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional.
The F&P Optiflow+ Duet Nasal Cannula is a nasal cannula interface for use with a respiratory gas humidifier and flow generator to deliver Nasal High Flow (NHF) therapy to spontaneously breathing patients. The F&P Optiflow+ Duet Nasal Cannula is a prescription-only device, provided in a non-sterile state and intended to be used in a hospital, sub-acute facility, or long-term (managed) care facility by appropriately qualified healthcare professionals, or in the home by lay users operating the device as prescribed by a healthcare professional. The device is single patient use only for up to 14 days in the hospital and up to 30 days in the home/long-term care facilities.
This document is a 510(k) Premarket Notification from the FDA regarding a medical device, the F&P Optiflow+ Duet Nasal Cannula. It focuses on demonstrating the device's substantial equivalence to a legally marketed predicate device, rather than proving that an AI/ML powered device meets specific acceptance criteria.
Therefore, the requested information regarding acceptance criteria, study details for AI/ML performance, sample sizes for test/training sets, expert consensus for ground truth, and MRMC studies for AI assistance cannot be extracted from this document, as it pertains to a different type of device and regulatory submission.
The document provides information on the non-clinical performance tests conducted for the F&P Optiflow+ Duet Nasal Cannula to demonstrate its substantial equivalence to its predicate device (F&P Optiflow+ Nasal Cannula OPT94X, K162553).
Here's an analysis based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
This document does not present acceptance criteria in a quantitative table format that shows a direct "acceptance criteria vs. reported performance" for the device's primary function in terms of a specific output (like an AI model's accuracy, sensitivity, or specificity). Instead, the "performance" is demonstrated through compliance with various international standards and general performance specifications like flow ranges.
However, we can infer some "performance" aspects from the comparison table on pages 6-7, although they are mostly qualitative or specify operating ranges.
| Characteristic / Test | Acceptance Criteria (Implied by Predicate & Standards) | Reported Device Performance (F&P Optiflow+ Duet Nasal Cannula) |
|---|---|---|
| Product Code | BTT (Same as predicate) | BTT |
| Device Classification | 21 CFR §868.5450 (Same as predicate) | 21 CFR §868.5450 |
| Classification Panel | Anesthesiology (Same as predicate) | Anesthesiology |
| Indications for Use (General Equivalence) | Equivalent to predicate | More specific than predicate, but within its scope |
| Availability | Prescription Use (Same as predicate) | Prescription Use |
| Patient Population | Pediatric (10+) to Adult (More specific than predicate) | Pediatric (10 years and up) to adult. |
| Patient Acuity | Spontaneously breathing (Same as predicate) | Spontaneously breathing patients. |
| Patient Monitoring | Appropriate monitoring required (Same as predicate) | Appropriate patient monitoring must be used at all times. |
| Use Environment | Home, Hospital, sub-acute, long-term care facilities | Home and Hospital environment, sub-acute facilities, long-term (managed) care facilities (OPT96X Series); Home and long-term (managed) care facilities (MYDUET Series) |
| Reusability | Single patient-use only, |
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(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 |
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