MAXAIR NASAL DILATOR SYSTEM

K982929 · Hnl Technologies · LWF · Sep 9, 1998 · Ear, Nose, Throat

Device Facts

• Record ID: K982929
• Device Name: MAXAIR NASAL DILATOR SYSTEM
• Applicant: Hnl Technologies
• Product Code: LWF · Ear, Nose, Throat
• Decision Date: Sep 9, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3900
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The MaxAir™ Nasal Dilator is intended to be used to enhance the flow of air through the nose. The nasal dilator is designed to pull on the outer lateral wall of the nasal passage which in turn will reduce the resistance to air flow through the nasal passage during breathing. The MaxAir™ Nasal Dilator's uses include, but are not limited to persons with temporary symptoms of nasal congestion which may be caused by colds, deviated septums, allergic rhinitis, and alar and valve insufficiency. The reduction of resistance to air flow in the nasal passage can also reduce the onset of snoring due to restrictions to air flow through the nasal passages.

Device Story

MaxAir Nasal Dilator is a mechanical device designed to enhance nasal airflow. It functions by physically pulling on the outer lateral wall of the nasal passage, thereby reducing resistance to airflow during breathing. The device is intended for over-the-counter use by individuals suffering from temporary nasal congestion or snoring related to nasal restriction. By decreasing airway resistance, the device aims to improve breathing and potentially reduce snoring. It is a non-powered, external or internal mechanical aid.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Mechanical nasal dilator; non-powered; designed for physical expansion of the nasal valve/lateral wall. No software or electronic components.

Indications for Use

Indicated for individuals experiencing nasal congestion due to colds, deviated septums, allergic rhinitis, or alar and valve insufficiency, and for individuals seeking to reduce snoring caused by nasal airflow restriction.

Regulatory Classification

Identification

A nasal dilator is a device intended to provide temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or transient causes of nasal congestion associated with reduced nasal airflow. The device decreases airway resistance and increases nasal airflow. The external nasal dilator is constructed from one or more layers of material upon which a spring material is attached, with a skin adhesive applied to adhere to the skin of the nose; it acts with a pulling action to open the nares. The internal nasal dilator is constructed from metal or plastic and is placed inside the nostrils; it acts by pushing the nostrils open or by gently pressing on the columella.

Submission Summary (Full Text)

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Public Health Service

Food and Drug Administration

9200 Corporate Boulevard Rockville MD 20850

9 1998 SEP

Hanford N. Lockwood, Jr. HNL Technologies 2222 Alameda De Las Pulgas San Mateo, CA 94403

Re:

K982929

Maxair Nasal Dilator System Dated: "August 10, 1998 Received: August 20, 1998 Regulatory class: Unclassified Procode: 77 LWF

Dear Mr. Lockwood:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Modical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number [phone] or [phone] or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".

Sincerely yours,

William Yin

Lillian Yin, Ph.D. Director, Division of Reproductive Abdominal, Ear, Nose and Throa and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of

510(k) NUMBER: K982929 DEVICE NAME: INDICATIONS FOR USE:

The MaxAir™ Nasal Dilator is intended to be used to enhance the flow of air through the nose. The nasal dilator is designed to pull on the outer lateral wall of the nasal passage which in turn will reduce the resistance to air flow through the nasal passage during breathing. The MaxAir™ Nasal Dilator's uses include, but are not limited to persons with temporary symptoms of nasal congestion which may be caused by colds, deviated septums, allergic rhinitis, and alar and valve insufficiency. The reduction of resistance to air flow in the nasal passage can also reduce the onset of snoring due to restrictions to air flow through the nasal passages.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED.)

| Concurrence of CDRH, Office of Device Evaluation (ODE) | | |
|--------------------------------------------------------------------|---------|---------------------------------------------------------------------------------------------------|
| (Division Sign-Off) | | |
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | | |
| 510(k) Number | K982929 | |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter-Use (Optional Format 1-2-96) <span style="text-decoration: overline;">✓</span> |