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510(k) Data Aggregation
(150 days)
COMFORTGEL NASAL MASK
The ComfortGel Blue Nasal Mask is intended to provide an interface for application of CPAP or bi-level therapy to patients. The mask is for single patient use in the home or multi-patient use in the hospital/institutional environment. The mask is to be used by patients (>66lbs/30kg) for whom CPAP or bi-level therapy has been prescribed.
The Respironics ComfortGel Blue Nasal Mask consists of a polycarbonate faceplate with a gel cushion encapsulated in a polyester seal for the face. The mask includes integrated exhalation features on the elbow. It is an accessory for use with CPAP and bi-level devices in the home (single patient use) and hospital/institution (multi-patient use).
The ComfortGel Blue Nasal mask covers the patient's nose only. It is strapped to the patient's face using headgear which connects to the mask via slots in the forehead bracket at the top, and via ball clip headgear attachments, which fit into sockets in the mask faceplate at the bottom. The mask is connected to the CPAP or bi-level flow generator via standard 22mm patient tubing. Positive pressure ventilation is then able to be applied to the lungs in a non-invasive way.
The provided text describes a 510(k) summary for the ComfortGel Blue Nasal Mask. This document focuses on demonstrating substantial equivalence to predicate devices for a medical device rather than presenting a performance study with acceptance criteria and results in the typical sense of an AI/ML device study.
Therefore, many of the requested categories for AI/ML performance studies are not applicable to the information contained within this 510(k) summary. I will answer the questions to the best of my ability based on the provided text, indicating where information is not available or not relevant for this type of submission.
Here's a breakdown based on your request:
1. A table of acceptance criteria and the reported device performance
The 510(k) summary does not explicitly list "acceptance criteria" and "reported device performance" in the context of a statistical study with metrics like sensitivity, specificity, accuracy, etc., as would be common for AI/ML devices. Instead, it compares the technical characteristics and performance of the subject device to predicate devices to demonstrate substantial equivalence. The "acceptance criteria" in this context would implicitly be that the subject device's performance characteristics (e.g., leak rates, pressure drop, dead space) are comparable to or within acceptable limits of the predicate devices and do not raise new safety or effectiveness concerns.
| Performance Characteristic | Predicate Device (ComfortGel Full Face Mask - K073600) | Predicate Device (Reusable Contour II Nasal Mask - K991648) | Subject Device (ComfortGel Blue Nasal Mask) | Implied "Acceptance Criteria" (Substantial Equivalence) | Reported Performance (Post-testing) |
|---|---|---|---|---|---|
| Intended Use | Provides interface for CPAP/bi-level therapy; multi-patient use (home/hospital); patients >66lbs/30kg; full face | Provides interface for CPAP/bi-level therapy; single patient use (home/hospital); patients >30kg; nasal mask | Provides interface for CPAP/bi-level therapy; single patient use (home) / multi-patient use (hospital); patients >66lbs/30kg; nasal mask | Same intended use, patient population, environment of use. | Substantially equivalent to predicates. |
| Mask Deadspace | Small - 210 cc, Medium - 260 cc, Large - 300 cc | Small: ~95 cc, Medium: ~123 cc, Large: ~123 cc | Petite: 76 cc, Small: 97 cc, Medium: 99 cc, Large: 118 cc | Comparable to nasal mask predicate. | New sizes introduced, values provided. |
| Intentional Leak | > 9.5 SLPM @ 2.5 cm H2O, > 15 SLPM @ 5 cm H2O, |
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