(217 days)
The Nasal Comfort Freedom provides a conduit such that airflow from a positive pressure source is directed to a patient's nose. The device is intended for adult patients (>66 lb/30kg) for whom positive airway pressure has been prescribed. The device is single-patient re-use, and is intended for use in a clinical or home-use environment.
The Nasal Comfort Freedom is a medical device that is capable of connection to a positive pressure source, and provides a conduit for delivery of an air flow to a patient's nose. The device is a single-patient re-use device supplied non-sterile by prescription. The Nasal Comfort Freedom interfaces with the patient by way of nasal pillows assembled into a breathing chamber. The nasal pillows and breathing chamber are soft and flexible to conform to the patient's nose. A rotating elbow is connected to the breathing chamber and incorporates a passive vent for exhaled gases to escape the device. The elbow is permanently connected at its distal end to a rotating connector. The Rotating Connector provides a means by which air supply may be connected and disconnected from the breathing mask via two clips incorporated into the Tubing Connector. The supplied tubing uses a standard conical fitting for connection to currently marketed 22mm fittings for use with CPAP ventilators and accessories. The Nasal Comfort Freedom is secured to the patient during use by way of a disposable adhesive strip that is fitted over the bridge of the patient's nose. The adhesive on the underside of the Nose Strip provides attachment to the patient's skin, while the outward facing layer of the strip features the loop side of a hook-and-loop fabric. The Breathing Chamber of the mask incorporates two hook fabric strips to be mated with the loop fabric of the Nose Strip. The patient may fit the nasal pillows into the nostrils, and then secure the hook strips over the loop strip on the nose to provide a snug fit of the device. Following each use, the Nose Strip may be removed and discarded by the patient.
The Lakeview Sleep Center, Nasal Comfort Freedom device underwent several non-clinical tests to establish substantial equivalence to predicate devices. These tests assessed device characteristics related to airflow, pressure, gas exhaustion, patient attachment, and material biocompatibility.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Nasal Comfort Freedom are implicitly set by matching or demonstrating comparable performance to the predicate devices, ResMed Swift FX (K090244) and Respironics GoLife Nasal Mask (K102502). The table below summarizes key performance attributes and how the Nasal Comfort Freedom's performance compares to these predicates.
| Attribute | Predicate Device (ResMed Swift FX) Reported Performance | Predicate Device (Respironics GoLife) Reported Performance | Lakeview Sleep Center Nasal Comfort Freedom Reported Performance | Acceptance Criteria (Implicit from Predicate Comparison) | Device Performance Meets Criteria? |
|---|---|---|---|---|---|
| A. Intended Use | |||||
| A.1 Indications for Use Statement | Adult patients (> 66 lb/30 kg) and single-patient re-use in home, multi-patient re-use in hospital/institutional. | Adult patients (> 66 lb/30 kg) and single-patient reuse in home, multi-patient multi-use in hospital/institutional. | Adult patients (>66 lb/30kg), single-patient re-use, clinical or home-use environment. | Comparable target population and usage environment. | Yes (more restrictive, thus safer) |
| A.2 Labeling | Equivalent in content | Label not available | Equivalent in content | Equivalent in content compared to Swift FX. | Yes |
| A.3 Target Population | Adult patients (>66 lbs) | Adult patients (>66 lbs) | Adult patients (>66 lbs) | Adult patients (>66 lbs). | Yes |
| B. Technology | |||||
| B.1 Patient contacting materials | Unknown | Hytrel, Silicone, Ethylene octane copolymer, Polycarbonate, Urethane | Silicone, Polycarbonate, Polyolefin, Polyethylene, Nylon, 3M 7331 adhesive | Biocompatible materials, comparable to predicates where known. | Yes (assumed through biocompatibility testing) |
| B.2 Design | Nasal pillow style mask with chamber, rotating elbow, tubing, nasal pillows, strap headgear. | Nasal pillow style mask with chamber, rotating elbow, tubing, nasal pillows, strap headgear. | Nasal pillow style mask with chamber, rotating elbow, tubing, nasal pillows, and straps for connection to patient's nose. | Similar design structure. | Yes |
| B.3 Length of connector tubing | 12 inches | Unknown | 12 inches | Comparable to Swift FX (12 inches). | Yes |
| B.4 Diameter | Connector tubing ID = 15mm; Min airway diameter 6mm | Connector tubing ID = 15mm | Connector tubing ID = 15mm; Min airway diameter 7mm | Connector tubing ID = 15mm; Min airway diameter at least 6mm. | Yes |
| B.5 Exhaust | Passive, 38 holes, 0.027" diameter ~ 0.022 sq in exhaust area. | Passive, dimensions unknown. | Passive, 36 holes, 0.031" +/- 0.003" diameter ~ min 0.022 sq in exhaust area. | Passive exhaust with comparable exhaust area. | Yes |
| B.6 Dead Space | 103 mL (per IFU) | * |
§ 868.5905 Noncontinuous ventilator (IPPB).
(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).