(141 days)
Not Found
Not Found
No
The device description and intended use focus on a mechanical barrier created by a cellulose gel, with no mention of AI or ML technologies.
Yes
The device is intended to treat hay fever and allergy symptoms by creating a physical barrier against allergens in the nasal cavity, and clinical study results show significant reduction in symptom severity, fulfilling the definition of a therapeutic device.
No
The device is intended to treat symptoms of allergies by forming a physical barrier against allergens, not to diagnose any condition.
No
The device is a physical product (powder and spray bottle) that forms a gel barrier, not a software application.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro) to diagnose, monitor, or screen for diseases or conditions.
- Nasal Ease Function: Nasal Ease Allergy Blocker works by creating a physical barrier within the nasal cavity to block allergens from entering. It is applied topically to the nasal membranes and does not perform any diagnostic tests on bodily samples.
- Intended Use: The intended use is to treat mild allergic symptoms by physically blocking allergens, not to diagnose or monitor a condition through testing of bodily fluids or tissues.
- Device Description: The description focuses on the physical properties of the powder and how it forms a gel barrier. There is no mention of reagents, test strips, or any components typically associated with diagnostic testing.
Therefore, Nasal Ease Allergy Blocker is a therapeutic device that acts as a physical barrier, not an in vitro diagnostic device.
N/A
Not Found
§ 880.5045 Medical recirculating air cleaner.
(a)
Identification. A medical recirculating air cleaner is a device used to remove particles from the air for medical purposes. The device may function by electrostatic precipitation or filtration.(b)
Classification. Class II (performance standards).
0
HI-TECH PHARMACAL
NASAL EASE ALLERGY BLOCKER DEC 3 1 2013
510(K) SUMMARY
| Submitter's Name and Address: | Hi-Tech Pharmacal, Inc.
369 Bayview Avenue
Amityville, NY 11701
Tel: 631-789-8228 / Fax: 631-881-9436 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------|
| Name of Contact Person: | Gary April
President, Healthcare Products Division
Hi-Tech Pharmacal, Inc. |
| Date Summary was Prepared: | December 30, 2013 |
| Name of Device | |
| Name of the Device: | Nasal Ease Allergy Blocker |
| Trade or Proprietary Name: | Nasal Ease Allergy Blocker |
| Common or Usual Name: | Topical Nasal Cream -- Mechanical Allergen Particle Barrier |
| CFR Reference | 21 CRF 880.5045 |
| Product Code | NUP |
| Regulatory Class | Class II |
Predicate Devices
| CODE | 510(K) | MANUFACTURER | DEVICE |
|---|---|---|---|
| NUP | K053625 | Turtech | NasalGuard Allergen Blocker |
| KCL | Preamendment | DeVilbiss | Model 175 Glass Powder Blower |
Intended Use
Nasal Ease Allergy Blocker is intended to treat hay fever and allergy sufferers by promoting alleviation of mild allergic symptoms (i.e. mild nasal irritation including itchy, runny, or congested nasal passages) triggered by the inhalation of various airborne allergens including indoor and outdoor environmental pollens, house dust, animal hairs and dust mites.
Application of Nasal Ease produces a mucous-like gel barrier that evenly coats the nasal membranes and acts to block inhaled allergens within the nasal cavity.
Product Description
Nasal Ease Allergy Blocker is composed of 100% pharmaceutical grade Hydroxypropyl Methylcellulose (HPMC) which has been formulated into a micronized powder of fine particles of inert cellulose. Nasal Ease is administered by insufflation into the nose using a proprietary spray bottle which enables the powder to be applied evenly as a fine mist to the inside of the nasal cavity.
When Nasal Ease powder comes into contact with the moist surface of the nasal mucosa, it almost immediately forms a colorless, mucus-like fine gel which coats the inside of the nasal cavity. The inert gel acts as a mechanical barrier ~ making it more difficult for inhaled allergens to come into contact with the nasal interior, and thus reducing the intensity of allergic rhinitis symptoms.
One bottle squeeze releases around 3.2mg of powder. The maximum usual dose is around 3 puffs/day into each nostril, giving a total of 19mg/day.
The cellulose gel is considered inert and does not penetrate the dermal layer of the skin. On average, protection lasts for 4-6 hours before the gel has to be reapplied. Nasal Ease is intended for topical use and provided non-sterile.
510(K) SUMMARY
1
Comparison to Predicate
| PARAMETER | · Nasal Ease Allergy Blocker | NasalGuard Allergen Blocker |
|---|---|---|
| DESCRIPTION | HPMC Powder | Glycerin-Based Gel |
| COMPOSITION | 100% pharmaceutical grade | |
| Hydroxypropyl Methylcellulose (HPMC) | ||
| which has been formulated into a | ||
| micronized powder of fine particles of | ||
| inert cellulose. | Water-based gel that contains cosmetic | |
| grade ingredients that are commonly found | ||
| in commonly used lotions, creams, gels and | ||
| other conditioners for the hair and skin. | ||
| APPLICATION | Administered by insufflation into the | |
| nose by spray bottle which enables | ||
| powder to be applied evenly as a fine | ||
| mist to the inside of the nasal cavity. | Nasal ointment is applied by finger or cotton | |
| swab to the outside of the nasal passages, | ||
| around the nostrils and upper lip. | ||
| MODE OF | ||
| ACTION | When Nasal Ease powder comes into | |
| contact with the moist surface of the | ||
| nasal mucosa, it almost immediately | ||
| forms a colorless, mucus-like fine gel | ||
| which coats the inside of the nasal cavity | ||
| -- acting as a mechanical barrier. | Utilizes a patented methodology that uses | |
| the cationic properties of its ingredients to | ||
| create an electrostatic filter that filters | ||
| airborne allergens before they enter the | ||
| nasal passages. |
Particle Size Distribution
Particle size distribution has been analytically characterized with 99.4% of particles in the 5-500 micron (um) diameter range and a mean particle size of 118 um.
Particle Deposition -- It is well recognized that nasally inhaled particles are deposited in the respiratory tract according to size. Particles larger than 5um are deposited in the nasopharynx, whereas particles ranging in size from 1-5 um are typically deposited in the trachea, bronchial, and bronchiolar region. Only particles typically ≤ 1 um in diameter are observed in the alveoli.
For Nasal Ease, no particles 100 seasonal allergic rhinitis patients, Nasal Ease was demonstrated to provide significant protection against all SAR symptoms from both upper and lower airways during the grass pollen season in an adult population. The magnitude and scope of efficacy support the use of the product as an early choice in the treatment of allergic rhinitis.
Study Limitations -- included a lack of evaluation in subjects with severe symptoms; and lack of pollen counts measurements during the study.
History of Safe and Effective Use
Nasaleze has been registered as a Class I Medical Device with MHRA since 1991 and is currently sold in more than 50 countries worldwide
During this +20 year period, there have been no reports of any serious adverse events attributed to Nasaleze by consumers who have safely used over 7,000,000 products sold.
Conclusions
By virtue of its physical characteristics, intended use, and performance testing, Nasal Ease is equivalent to products legally cleared to be marketed in the US, specifically NasalGuard.
Nasal Ease poses no safety risk to users, and has been shown to significantly block allergen entry into the nasal mucosa. Clinical studies have demonstrated that Nasal Ease's mucous-like gel barrier is beneficial to hay fever sufferers through the reduction of nasal allergen exposure and consequently a reduction in symptoms from seasonal allergic rhinitis.
4
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines representing its wings or body. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
December 31, 2013
Hi-Tech Pharmacal, Inc % Gary April, President, Healthcare Products Division, Hi-Tech Pharmacal, Inc. 369 Bayview Avenue Amityville, NY 11701
Re: K132520
Trade/Device Name: Nasal Ease Allergen Blocker Regulation Number: 21 CFR 880.5045 Regulation Name: Medical recirculating air cleaner Regulatory Class: Class II Product Code: NUP Dated: November 26, 2013 Received: November 27, 2013
Dear Mr. April:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
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.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
5
Page 2 - Mr. Gary April
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-204) or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevjces/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
http://www.fda.gov/MedicalDevices/ResourcesforYourIndustry/default.htm
Sincerely yours,
Bradley S. Cunningham -S
for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use Statement
Nasai Ease Allergy Blocker Device Name:
510(k) Number: K132520
.. : :...
Indications for Use: Nasal Ease Allergy Blocker is intended to treat hay fever and allergy sufferers by promoting alleviation of mild allergic symptoms (i.e. mild nasal irritation including itchy, runny, or congested nasal passages) triggered by the inhalation of various airborne allergens including indoor and outdoor environmental pollens, house dust, animal hairs and dust mites.
Application of Nasal Ease produces a mucous-like gel barrier that evenly coats the nasal membranes and acts to block inhaled allergens within the nasal cavity.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
CONCURRENCE OF CDRH, OFFICE OF DEVICE EVALUATION
Sageev George -S 2013.12.29 22:32:44 -05'00'
Prescription Use _____________________________________________________________________________________________________________________________________________________________
OR
Over-The-Counter Use X
(Per 21 CFR 801.109)