(60 days)
The Health Mask is intended to moderate the expected physiological response to cold (i.e., increase in blood pressure). For diagnosed hypertensives 18 years or older.
The Health mask is a device worn by an individual outdoors when the air is cold. It is designed to retain the heat and moisture exhaled by the wearer and warm and humidify the inhaled cold air. The wearer breathes through a thermal medium which retains and returns the heat and moisture in the breathed air. The Thermal medium is placed inside a fabric mask which the wearer places over their mouth and nose. The mask is held in place with an elastic band.
The provided text describes a medical device called the "Health Mask" but does not contain any information about acceptance criteria or a study proving that the device meets such criteria.
The document is a 510(k) Premarket Notification from the FDA, which focuses on demonstrating substantial equivalence to predicate devices, rather than presenting de novo clinical study results against specific performance criteria.
Therefore, I cannot provide the requested information. The document focuses on:
- Device Description: What the Health Mask is and how it works (retaining heat and moisture from exhaled air to warm and humidify inhaled cold air).
- Intended Use: To moderate the expected physiological response to cold (increase in blood pressure) in diagnosed hypertensives aged 18 years or older, when used outdoors.
- Device Attributes: Materials, design, and a single performance metric (resistance to work of breathing).
- Predicate Devices: Identification of legally marketed devices to which the Health Mask is claimed to be substantially equivalent.
- FDA Clearance: The agency's determination of substantial equivalence.
Here's what I can extract based on the limited performance information provided, though it's not framed as "acceptance criteria" against which a study directly proved compliance:
Acceptance Criteria and Reported Device Performance (Based on available attributes and predicate device comparison)
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Low resistance to work of breathing or flow | 1.6 cm H2O at 60 Lpm, less than typical resistance to flow ( |
§ 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).