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 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 re-applied. Nasal Ease is intended for topical use and provided non-sterile.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria	Reported Device Performance
Particle Size Distribution	99.4% of particles in the 5-500 micron (um) diameter range. Mean particle size of 118 um. No particles < 1.9 um detected. (This criterion aims to ensure particles are large enough for nasal deposition and not to reach the alveoli.)
Safety and Toxicology	HPMC is recognized as GRAS by the FDA and a food additive in the EU. Patty's Industrial Hygiene and Toxicology describes cellulose ethers (including HPMC) as "very low in toxicity." Feeding experiments in rats, dogs, and human volunteers showed a lack of toxic effect. Studies in volunteers revealed no serious adverse effects from taking the material as a snuff for several weeks. The quantity, grade, and route of administration of HPMC used in Nasal Ease do not present any serious toxicological risks.
Biocompatibility	Tested for cytotoxicity, sensitization, and irritation. Results demonstrated no biocompatibility concerns.
Stability and Shelf Life	Stability and shelf life testing results support a shelf life of at least 3 years at 40°C. Labeling directs consumer to use within 6 months of opening.
Allergen Blocking Capability (in vitro)	In vitro studies using a simulated barrier model validated that significant delay of allergen entry into the mucosa could be beneficial. A direct comparison to the predicate (NasalGuard) showed both Nasal Ease and NasalGuard significantly reduce the diffusion of pollen allergen in vitro for up to 6 hours.
Reduction of Allergic Rhinitis Symptoms	A prospective, randomized, placebo-controlled clinical validation study demonstrated significant reductions in severity scores for sneezing, running and stuffy nose, eye symptoms, and lower airway symptoms (all p<0.001) in patients using Nasal Ease compared to placebo. Reflective opinion of effect and guess on treatment at follow-up visits also confirmed effectiveness (both p<0.001). No clinically significant adverse effects were observed. The mean symptom scores for the active group were consistently lower than the placebo group across all assessed symptoms (e.g., Sneezing: 1.65 (Active) vs 2.31 (Placebo); Sum of All Symptoms: 8.19 (Active) vs 11.1 (Placebo)).
History of Safe and Effective Use	Registered as a Class I Medical Device with MHRA since 1991. Sold in over 50 countries worldwide for +20 years with no reports of any serious adverse events attributed to over 7,000,000 products sold.

Study Details: Clinical Validation Study

Sample size used for the test set and the data provenance:
- Sample Size: 54 active patients (Nasal Ease) and 53 placebo patients. (Total = 107 patients)
- Data Provenance: The study was a "prospective, randomized, placebo-controlled clinical validation study." While the explicit country of origin is not stated, the reference to "grass pollen season" and the dates in May 2013 suggest a Northern Hemisphere country, likely within a region where such studies are commonly conducted. The fact that Nasaleze is registered with MHRA (UK regulatory body) and sold in 50 countries suggests an international context for its development and testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the text. The ground truth (symptom severity scores) was established by the patients themselves via self-administration and daily recording of their symptoms.
Adjudication method for the test set:
- Adjudication methods like "2+1" or "3+1" are typically used when independent experts review cases to establish a definitive diagnosis or outcome. In this study, the "ground truth" was subjective patient-reported symptom scores. There is no mention of an adjudication method for these scores. The study design was randomized and placebo-controlled to mitigate bias in self-reporting.
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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving image interpretation by human readers, often assisted by AI. The Nasal Ease Allergy Blocker is a medical device for treating allergic symptoms and its clinical validation did not involve human readers interpreting diagnostic images.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is not an algorithm, but a physical product (HPMC powder administered as a nasal spray). The device's performance was evaluated both in vitro (standalone, without human physiological interaction in simulation) and in a clinical study with human use.
The type of ground truth used:
- The ground truth used for the clinical validation study was patient-reported symptom severity scores. Patients rated their own symptoms (sneezing, running nose, stuffy nose, eye symptoms, lower airways) on a scale of 1 (No Trouble At All) to 6 (Very Much Trouble).
The sample size for the training set:
- The text describes a single clinical validation study. There is no mention of a separate "training set" for an algorithm or a device performance model. The mentioned clinical study acts as the primary effectiveness evaluation.
How the ground truth for the training set was established:
- As there is no explicit "training set" described for an algorithm, this question is not applicable. The ground truth for the clinical validation study was established through patient self-assessment of symptom severity, recorded daily.

Summary

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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.369 Bayview AvenueAmityville, NY 11701Tel: 631-789-8228 / Fax: 631-881-9436
Name of Contact Person:	Gary AprilPresident, Healthcare Products DivisionHi-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

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

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 gradeHydroxypropyl Methylcellulose (HPMC)which has been formulated into amicronized powder of fine particles ofinert cellulose.	Water-based gel that contains cosmeticgrade ingredients that are commonly foundin commonly used lotions, creams, gels andother conditioners for the hair and skin.
APPLICATION	Administered by insufflation into thenose by spray bottle which enablespowder to be applied evenly as a finemist to the inside of the nasal cavity.	Nasal ointment is applied by finger or cottonswab to the outside of the nasal passages,around the nostrils and upper lip.
MODE OFACTION	When Nasal Ease powder comes intocontact with the moist surface of thenasal mucosa, it almost immediatelyforms a colorless, mucus-like fine gelwhich coats the inside of the nasal cavity-- acting as a mechanical barrier.	Utilizes a patented methodology that usesthe cationic properties of its ingredients tocreate an electrostatic filter that filtersairborne allergens before they enter thenasal 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 _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use X

(Per 21 CFR 801.109)

Regulation Number and Section

§ 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).