(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 (< 5 cm H2O) guidelines for devices in the breathing system |
| Intended to moderate physiological response to cold (BP increase) | No specific quantitative performance data is provided for this claim. The device is considered substantially equivalent to a predicate device (RESPeRATE) for this indication. |
| Act as a respiratory gas humidifier and warmer | Device description states it "retains the heat and moisture exhaled by the wearer and warm and humidify the inhaled cold air." No specific quantitative performance data is provided for this claim. The device is considered substantially equivalent to a predicate device (Pegasus - PMH500) for this technology. |
Regarding the other requested information, the document unfortunately does not contain it:
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- If a multi-reader multi-case (MRMC) comparative effectiveness study was done, if so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not mentioned. This device is not an AI/software device, so such a study would not be applicable.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. This device is not an algorithm, so this is not applicable.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
- The sample size for the training set: Not mentioned. This device is not an algorithm, so a training set is not applicable.
- How the ground truth for the training set was established: Not mentioned. This device is not an algorithm, so a training set is not applicable.
In summary, the document provided is a regulatory submission demonstrating substantial equivalence to existing devices, not a detailed report of a clinical trial or performance study against pre-defined acceptance criteria for a new technology.
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Non-Confidential Summary of Safety and Effectiveness
Page 1 of 2 16-Apr-07
| Polar Wrap LLC6047 Executive Center Drive # 8Memphis, TN 38134 | Tel - 901-767-4171Fax - 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 - K020700RESPeRate - 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 expectedphysiological response to cold (i.e., increase in blood pressure). |
| Patient Population -- | Diagnosed hypertensives 18 years or older |
| Environment of Use -- | Outdoors |
| Contraindications -- | None |
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Non-Confidential Summary of Safety and Effectiveness Page 2 of 2 16-Apr-07
Device Attributes:
| Health Mask | |
|---|---|
| Attributes | |
| Intended useGeneral | To act as a respiratory gas humidifier to add moisture to, and sometimes to warm, the breathing gases for administration to the patient. |
| Intended useSpecific | 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(< 5 cm H2O) guidelines for devices in the breathing system |
Differences Between Other Legally Marketed Predicate Devices
The Health Mask is viewed as substantially equivalent to the following predicate devices -Pegasus - PMH500 Heated humidifier - K020700 for technology under CFR 868.5450 and RESPeRATE – K020399 for indications for use under CFR 882.5050, a non-invasive biofeedback device intended to lower blood pressure by guiding and monitoring patients breathing.
There are no significant differences that affect the safety or effectiveness of the intended device as compared to the predicate devices.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS) of the United States. The seal features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines representing the branches of government.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 7 2007
Polar Wrap LLC c/o Bruce McCormick, President 6047 Executive Center Drive #8 Memphis, TN 38134
Re: K070467
Trade/Device Name: Health Mask Regulation Number: 21 CFR 868.5450 Regulation Name: Respiratory gas humidifier Regulatory Class: Class II Product Code: OBN Dated: February 15, 2007 Received: February 16, 2007
Dear Mr. McCormick:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. McCormick
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
Page 1 of 1
510(k) Number: K070467
Device Name: Health Mask
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.
Prescription Use XX (Part 21 CFR 801 Subpart D) or
Over-the-counter use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Slan-Off) Division of Cardiovascular Devices 510(k) Number
§ 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).