(60 days)
Not Found
No
The summary describes a passive physical device (a mask with a thermal medium) and does not mention any computational or data-driven components indicative of AI/ML.
Yes
The device is intended to moderate a physiological response (increase in blood pressure due to cold) in diagnosed hypertensives, indicating a therapeutic purpose.
No
The device description states its purpose is to moderate a physiological response (increase in blood pressure due to cold) and warm/humidify inhaled air, not to identify or diagnose a condition.
No
The device description clearly describes a physical mask with a thermal medium and fabric, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Health Mask is a physical device worn externally to modify the temperature and humidity of inhaled air. It does not analyze any biological samples from the patient.
- Intended Use: The intended use is to moderate a physiological response to cold, not to diagnose or detect a condition based on in vitro analysis.
The device description and intended use clearly indicate that it is a therapeutic or preventative device worn externally, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
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.
Product codes
OBN
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
18 years or older / 18+ years old
Intended User / Care Setting
Outdoors
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Pegasus - PMH500 Heated humidifier - K020700, RESPeRATE - K020399
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 16-Apr-07
| Polar Wrap LLC
6047 Executive Center Drive # 8
Memphis, TN 38134 | Tel - 901-767-4171
Fax - 901-767-8594 | APR 17 2007 |
|------------------------------------------------------------------------|---------------------------------------------------------------------|-------------|
| Official Contact: | Bruce McCormick, President | |
| Proprietary or Trade Name: | Health Mask | |
| Common/Usual Name: | Respiratory humidifier mask (direct patient interface) | |
| Classification Name: | Respiratory humidifier mask (direct patient interface) | |
| Device: | Health Mask | |
| Predicate Devices: | Pegasus - PMH500 Heated humidifier - K020700
RESPeRate - K020399 | |
| Device Description: | | |
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.
Image /page/0/Picture/6 description: The image shows a side view of a person wearing a face mask. The mask covers the nose and mouth and is secured with straps around the ears. The person's head is outlined with a dotted line, and the mask is shaded in gray.
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.
| Indications for Use: | |
|---|---|
| Indicated Use -- | The Health Mask is intended to moderate the expected |
| physiological response to cold (i.e., increase in blood pressure). | |
| Patient Population -- | Diagnosed hypertensives 18 years or older |
| Environment of Use -- | Outdoors |
| Contraindications -- | None |
1
Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 16-Apr-07
Device Attributes:
| Health Mask | |
|---|---|
| Attributes | |
| Intended use | |
| General | To act as a respiratory gas humidifier to add moisture to, and sometimes to warm, the breathing gases for administration to the patient. |
| Intended use | |
| Specific | To moderate the expected physiological response to cold (i.e., increase in blood pressure). |
| Environments of use | Outdoors |
| Patient Population | 18+ years old, diagnosed hypertensives |
| Contraindications | None |
| Prescription | Prescription |
| Design | |
| External device covering patient to reduce heat loss | Placed over the mouth and worn like a mask |
| Retains heat to be returned to patient | Yes |
| Materials | |
| Thermal medium | Wire (copper) mesh |
| Housing / HME Mask Shell | Wrap - polypropylene and polyester with elastic band to hold the device around the head |
| Air Chamber Shell | Polypropylene |
| Performance | |
| Low resistance to work of breathing or flow | 1.6 cm H2O at 60 Lpm, less than typical resistance to flow |
| ( |