(20 days)
None
Not Found
No
The description focuses on a mechanical device that physically alters the nasal passage and does not mention any computational or data-driven components indicative of AI/ML.
Yes
The device is intended to reduce symptoms of nasal congestion caused by various conditions, which aligns with the definition of a therapeutic device designed to treat or alleviate a medical condition.
No
The device is a nasal dilator intended to enhance airflow and reduce resistance, addressing symptoms like nasal congestion and snoring. It is a therapeutic or assistive device, not one used to diagnose medical conditions or provide diagnostic information.
No
The device description clearly states it is a "Nasal Dilator," which is a physical device designed to pull on the nasal passage walls. This indicates a hardware component, not a software-only device.
Based on the provided information, the MaxAir™ Nasal Dilator is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. This typically involves tests performed on blood, urine, tissue, or other bodily fluids to diagnose diseases or conditions.
- The MaxAir™ Nasal Dilator is a physical device applied externally to the nose. Its function is to mechanically alter the nasal passage to improve airflow. It does not involve the analysis of any biological specimens.
The intended use and device description clearly indicate a mechanical function to improve breathing, not a diagnostic test performed on a sample.
N/A
Intended Use / 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.
Product codes
77 LWF
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal passage
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.3900 Nasal dilator.
(a)
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.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
0
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:
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 (301) 594-4613. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. 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 (800) 638-2041 or (301) 443-6597 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
1
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) ✓ |