NASAL EASE ALLERGY BLOCKER
Device Facts
| Record ID | K132520 |
|---|---|
| Device Name | NASAL EASE ALLERGY BLOCKER |
| Applicant | Hi-Tech Pharmacal, Inc. |
| Product Code | NUP · General Hospital |
| Decision Date | Dec 31, 2013 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 880.5045 |
| Device Class | Class 2 |
| Attributes | Therapeutic, Real-World Evidence |
Real-World Evidence
| Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags |
|---|---|---|---|---|---|
| K132520 · Dec 31, 2013 | NASAL EASE ALLERGY BLOCKER | Hi-Tech Pharmacal, Inc. | Post-market surveillance/registry data; International regulatory registration records (MHRA) | The sponsor utilized over 20 years of international post-market surveillance data and sales history to support the safety profile of the device. | Post-market surveillance; Safety history; International regulatory registration |
Clinical Evidence
| Study Design | Population | Comparator | Key Endpoints |
|---|---|---|---|
| International Post-Market Surveillance; Post-market surveillance / observational safety reporting; Follow-up/Duration: 20+ years (since 1991); Study Period: 1991-2013 | General consumer population using the device globally; Sample Size: Over 7,000,000 products sold; Number of Sites: 50+ countries | Not applicable for this study | Incidence of serious adverse events |
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.
Device Story
Nasal Ease Allergy Blocker is a topical nasal powder composed of micronized Hydroxypropyl Methylcellulose (HPMC). Administered via proprietary spray bottle, the powder is insufflated into the nasal cavity. Upon contact with nasal mucosa, the powder forms a colorless, mucus-like gel barrier. This mechanical barrier prevents inhaled allergens from contacting the nasal interior, thereby reducing allergic rhinitis symptoms. Used by patients at home; reapplication required every 4-6 hours. Healthcare providers use clinical symptom scores to assess efficacy. The device provides a non-pharmacological, mechanical method to reduce allergen exposure and alleviate symptoms.
Clinical Evidence
Prospective, randomized, placebo-controlled clinical study (N=107; 54 active, 53 placebo) evaluated efficacy over 4 weeks during grass pollen season. Primary endpoints: daily symptom scores (sneezing, runny/stuffy nose, eye/lower airway symptoms). Results showed significant reduction in mean symptom scores for active group vs. placebo (p<0.001). No clinically significant adverse effects reported. Bench testing confirmed particle size distribution (mean 118 um) prevents alveolar deposition.
Technological Characteristics
Material: 100% pharmaceutical grade Hydroxypropyl Methylcellulose (HPMC). Form: Micronized powder. Delivery: Proprietary spray bottle for insufflation. Mechanism: Mechanical barrier formation via gelation upon contact with mucosal moisture. Non-sterile. Shelf life: 3 years at 40°C.
Indications for Use
Indicated for adults suffering from mild seasonal allergic rhinitis symptoms (sneezing, runny/stuffy nose, nasal irritation) triggered by airborne allergens (pollens, dust, animal hair, mites).
Regulatory Classification
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.
Predicate Devices
- NasalGuard Allergen Blocker (K053625)
- Model 175 Glass Powder Blower (Preamendment)
Submission Summary (Full Text)
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#### HI-TECH PHARMACAL
# NASAL EASE ALLERGY BLOCKER DEC 3 1 2013
### 510(K) SUMMARY
| Submitter's Name and Address: | Hi-Tech Pharmacal, Inc.<br>369 Bayview Avenue<br>Amityville, NY 11701<br>Tel: 631-789-8228 / Fax: 631-881-9436 |
|-------------------------------|----------------------------------------------------------------------------------------------------------------|
| Name of Contact Person: | Gary April<br>President, Healthcare Products Division<br>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.
K132520
510(K) SUMMARY
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### Comparison to Predicate
| PARAMETER | · Nasal Ease Allergy Blocker | NasalGuard Allergen Blocker |
|-------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DESCRIPTION | HPMC Powder | Glycerin-Based Gel |
| COMPOSITION | 100% pharmaceutical grade<br>Hydroxypropyl Methylcellulose (HPMC)<br>which has been formulated into a<br>micronized powder of fine particles of<br>inert cellulose. | Water-based gel that contains cosmetic<br>grade ingredients that are commonly found<br>in commonly used lotions, creams, gels and<br>other conditioners for the hair and skin. |
| APPLICATION | Administered by insufflation into the<br>nose by spray bottle which enables<br>powder to be applied evenly as a fine<br>mist to the inside of the nasal cavity. | Nasal ointment is applied by finger or cotton<br>swab to the outside of the nasal passages,<br>around the nostrils and upper lip. |
| MODE OF<br>ACTION | When Nasal Ease powder comes into<br>contact with the moist surface of the<br>nasal mucosa, it almost immediately<br>forms a colorless, mucus-like fine gel<br>which coats the inside of the nasal cavity<br>-- acting as a mechanical barrier. | Utilizes a patented methodology that uses<br>the cationic properties of its ingredients to<br>create an electrostatic filter that filters<br>airborne allergens before they enter the<br>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 < 1.9 um were detected. The results of this particle size distribution analysis provide evidence that essentially none of the HPMC reach the alveoli and that the whole quantity can be considered as swallowed (as described below).
Mucociliary Clearance -- Particles deposited in the nose and in the tracheo-bronchial airway are trapped in the mucous lining. The inert particles eventually travel with the downward mucous flow into the pharynx where they are swallowed and end up in the qut.
# Safety Testing & Toxicology
HPMC is recognized in the EU as a food additive and as GRAS by the FDA. Patty's Industrial Hygiene and Toxicology describes the cellulose ethers (including HPMC) as "all very low in toxicity" and "exposure of humans to the dust in manufacturing operations over many years has not led to any known adverse effects".
Feeding experiments in rats, dogs, and also human volunteers showed a lack of toxic effect. Studies in volunteers revealed no serious adverse effects of taking the material as a snuff for several weeks.
No studies of genotoxicity, or reproductive toxicity have been identified, but the chemistry of the materials, their recognized safety in food use, and lack of toxicity in feeding studies suggest that further studies are not necessary.
Overall, HPMC is a remarkably safe material when given orally in gram quantities. The quantity, grade, and route of administration of HPMC used in Nasal Ease do not present any serious toxicological risks.
K132520
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# HI-TECH PHARMACAL
# Biocompatibility
Biocompatibility testing included cytotoxicity, sensitization, and irritation. The results demonstrated that there are no biocompatibility concerns with Nasal Ease.
# Stability and Shelf Life
Stability and shelf life testing results support a shelf life of at least 3 vrs at 40°C. Once the bottle is opened, labeling directs the consumer to use the product within 6 months.
# In Vitro Studies
Several in vitro studies have been performed using a simulated barrier model to investigate and characterize the performance of Nasal Ease compared to several controls. The results of these studies validate in principle that significant delay of allergen entry into the mucosa could be beneficial to hay fever sufferers through the reduction of allergen exposure.
In addition, an in vitro study was performed directly comparing the allergen blocking capability of Nasal Ease to the predicate. NasalGuard. The study results demonstrate that Nasal Ease and NasalGuard significantly reduce the diffusion of pollen allergen in vitro for up to 6 hours.
# Clinical Study
Nasal Ease Allergy Blocker was demonstrated to significantly reduce symptoms of allergic rhinitis in a prospective, randomized, placebo-controlled clinical validation study. Patients with mild symptoms of seasonal allergic rhinitis to grass pollen self-administered either Nasal Ease or placebo (lactose powder with same particle size and appearance as Nasal Ease).
Over the course of 4 weeks during allergy season, 53 placebo patients and 54 active patients recorded their daily symptom scores including trouble with sneezing, running nose, stuffy nose, eye symptoms and lower airway symptoms. Short Message Service (SMS) on mobile phones was used for reminders of treatment times.
The study showed significant reductions of severity scores for sneezing, running and stuffy nose, and symptoms from eyes and lower airways -- both separately and together (all p<0.001). Reflective opinion of effect and guess on treatment at follow-up visits (both p<0.001) confirmed effectiveness. No clinically significant adverse effects were observed.
Image /page/2/Figure/13 description: The image is a graph titled "EFFECTIVENESS: Nasal Ease vs. Placebo". The y-axis is labeled "Sum of Daily Symptom Scores" and ranges from 0 to 8. The x-axis is labeled "Dates in May 2013" and is divided into four weeks. The graph shows two lines, one representing "Nasal Ease" and the other representing "Placebo", with the placebo line being higher than the nasal ease line. There is also a table that shows the statistical significance of daily group differences, with May 1 being "ns", May 2 being "p<0.05", and May 3-28 being "p<0.001".
Image /page/2/Figure/14 description: The image shows the title of a study, "EFFECTIVENESS: Nasal Ease vs. Placebo". The title suggests that the study is comparing the effectiveness of Nasal Ease, a nasal spray, to a placebo. The study is likely investigating whether Nasal Ease is more effective than a placebo in treating nasal congestion or other nasal symptoms. The image is a title for a study that is comparing the effectiveness of Nasal Ease to a placebo.
Dates in Mav 2013
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#### HI-TECH PHARMACAL
The figure on the previous page and the tables below summarize the effectiveness results from the clinical validation study.
| SCORE | SYMPTOMS SEVERITY |
|-------|---------------------|
| 1 | No Trouble At All |
| 2 | Little Trouble |
| 3 | Moderate Trouble |
| SCORE | SYMPTOMS SEVERITY |
| 4 | Rather Much Trouble |
| 5 | Much Trouble |
| 6 | Very Much Trouble |
| EFFECTIVENESS RESULTS ~ MEAN SYMPTOM SCORES | | |
|---------------------------------------------|---------------|----------------|
| SYMPTOM ASSESSMENT | ACTIVE / N=54 | PLACEBO / N=53 |
| Sneezing | 1.65 | 2.31 |
| Running Nose | 1.75 | 2.37 |
| Stuffy Nose | 1.76 | 2.32 |
| Eye Symptoms | 1.59 | 2.18 |
| Lower Airways | 1.44 | 1.92 |
| Sum of Nasal Symptoms | 5.16 | 6.99 |
| Sum of All Symptoms | 8.19 | 11.1 |
Clinical Summary -- In a randomized placebo-controlled clinical validation study of >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.
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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
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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
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# 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)
