AllerBlock Junior is intended for use in adults and children (8 years or older) 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 environmental pollens, house dust, animal hairs, and dust mites.

Application of AllerBlock Junior produces a mucous-like gel barrier that evenly coats the nasal membranes and acts to block inhaled allergens within the nasal cavity.

Device Description

AllerBlock Junior is composed of pharmaceutical grade Hydroxypropyl Methylcellulose (HPMC; 97%) and high quality strawberry scent (3%) which has been formulated into a micronized powder of fine particles of inert cellulose. AllerBlock Junior 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 the 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 skin in the nasal interior, and thus reducing the intensity of allergic rhinitis (AR) symptoms.

AI/ML Overview

The provided text is a 510(k) summary for AllerBlock Junior, a medical device intended to alleviate mild allergic symptoms. The document focuses on demonstrating substantial equivalence to a predicate device and extending its indications for use to include pediatric patients (8 years or older).

Here's an analysis of the acceptance criteria and the study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" as a set of predefined quantitative thresholds that the device must meet for clearance. Instead, it presents summaries of clinical studies to demonstrate the device's safety and effectiveness, especially for the extended pediatric indication. The "reported device performance" is largely qualitative, focusing on symptom reduction and safety.

Aspect	Acceptance Criteria (Implied)	Reported Device Performance (from Clinical Studies)
Safety	No serious toxicological risks; biocompatible; low incidence of adverse effects.	- Components: HPMC and strawberry scent flavoring are recognized as GRAS in the US. HPMC is "remarkably safe when given orally."- Biocompatibility: Tests (cytotoxicity, sensitization, irritation) showed "no biocompatibility concerns."- Adverse Effects in Children (5 studies, N=219 total pediatric patients): "reported adverse effects and complications were few in number (2-15%) and mild in level of severity."
Effectiveness (Pediatric)	Alleviation of mild allergic symptoms (nasal irritation, itchy, runny, congested nasal passages). Reduced allergen exposure via mechanical barrier.	- Mechanism: Produces a mucous-like gel barrier that coats nasal membranes, blocking inhaled allergens. - Study 1 (Mucociliary Clearance): "Significant decrease of clearance observed in children... after treatment (especially those with mean value > 31 minutes) is due to the effect of cellulose." This implies the formation of the barrier. - Studies 2-5 (AR Symptom Scores): "all showed consistent reductions in AR symptoms including nasal congestion and discharge, sneezing, nasal and ocular itching." This directly supports alleviation of mild allergic symptoms.
Shelf Life/Stability	Device maintains functionality and safety over its intended storage and use duration.	- Stability/Shelf Life Testing: "results support a shelf life of ≥ 3 yrs at 40°C."
Product Formulation	New formulation (strawberry scent, 3%) should maintain safety and effectiveness comparable to predicate.	- Ingredients: HPMC Powder 97%, Strawberry Powder 3%. Strawberry scent recognized as GRAS. - Particle Size: "Powder particle size remains essentially unchanged." - Conclusion: "This change continues to support product safety and effectiveness."

2. Sample Size Used for the Test Set and Data Provenance:

Total Pediatric Patients Across 5 Studies: N=219.
- Study 1: N=100 children
- Study 2: N=23 children
- Study 3: N=25 children
- Study 4: N=30 children
- Study 5: N=41 children
Data Provenance: Not explicitly stated regarding the country of origin for each study. However, the author names (e.g., Aivazis V, Bourli E; Zakharzhevskaya T, Sidorenko I; Aberg N, Dahl A, Benson M; Geppe N, Snegotskaya M; Chen X, Guan WJ, Sun SX) suggest a mix of international (possibly European, Russian, Chinese) origins for the studies. The studies are described as "clinical studies," implying they are prospective, designed trials.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

The document does not mention the use of experts to establish a "ground truth" for the test set in the context of diagnostic interpretation.
The "ground truth" for these studies is based on clinical outcomes:
- Mucociliary clearance measurements (Study 1).
- Patient-reported daily symptom scores for allergic rhinitis (Studies 2-5).
- Clinical assessment of adverse events by study investigators.
The qualifications of the clinicians/investigators conducting these studies are not detailed.

4. Adjudication Method for the Test Set:

Adjudication methods (like 2+1 or 3+1 for discordance resolution) are typically used in studies involving expert interpretation of images or other subjective data to establish a definitive ground truth.
These clinical studies primarily relied on objective measurements (mucociliary clearance) and patient-reported outcomes (symptom scores). There is no mention of an adjudication method in this context. Adverse events would be reported and managed by the study investigators.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
MRMC studies are typically used to assess the impact of AI on human reader performance, usually in image-based diagnostic tasks. The AllerBlock Junior device is a physical barrier product, not an AI diagnostic tool.
The comparative effectiveness in the provided studies refers to comparing the device to placebo or standard of care (oral medications, nasal steroids in Study 4 and 5).

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:

This question is not applicable. AllerBlock Junior is a physical device, not an algorithm, and does not have a "standalone" algorithmic performance. Its performance is directly tied to its physical application and effect on the user.

7. The Type of Ground Truth Used:

Clinical Ground Truth:
- Mucociliary Clearance: An objective physiological measurement.
- Patient-Reported Outcomes (PROs): Daily symptom scores for allergic rhinitis (e.g., nasal congestion, discharge, sneezing, itching). These are subjective but are standard clinical endpoints for allergy studies.
- Adverse Event Reporting: Clinical observation and reporting of adverse effects by study participants and investigators.

8. The Sample Size for the Training Set:

The document does not describe a "training set" in the context of machine learning. The clinical studies described are for validation of the device's safety and effectiveness.
The device's formulation (HPMC with strawberry scent) is based on established knowledge of HPMC as a safe and effective barrier and strawberry as a GRAS flavoring, not derived from training on a dataset.

9. How the Ground Truth for the Training Set Was Established:

This question is not applicable as there is no "training set" in the machine learning sense for this device. The underlying principles for the device (HPMC forming a barrier) are based on scientific understanding and prior uses of these materials.

Summary

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March 26, 2021

Nasaleze International Ltd Matt Duxbury Export Director Old Castletown Road Douglas, Isle of Man Im2 1qa Isle Of Man

Re: K201734

Trade/Device Name: AllerBlock Junior Regulation Number: 21 CFR 880.5045 Regulation Name: Medical recirculating air cleaner Regulatory Class: Class II Product Code: NUP Dated: February 23, 2021 Received: February 25, 2021

Dear Matt Duxbury:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. 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 of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shu-Chen Peng, Ph.D. Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K201734

Device Name AllerBlock Junior

Indications for Use (Describe)

Application of AllerBlock Junior produces a mucous-like gel barrier that evenly coats the nasal membranes and acts to block inhaled allergens within the nasal cavity.

Type of Use (Select one or both, as applicable)
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Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY

Contact Information

Submitter's Name and Address:	Nasaleze International LtdNunnery Mills, Old Castletown RoadDouglas, Isle of Man, IM2 1QA, British IslesTEL + 44 (0) 1624 611 050
Name of Contact Person:	Matt Duxbury, Export DirectorNasaleze International Ltd.
Date Summary was Prepared:	March 25, 2021
Name of Device
Name of the Device:	AllerBlock Junior
Regulatory Name:Regulation	Topical Nasal Cream -- Mechanical Allergen Particle Barrier21 CRF 880.5045 / NUP / Class II

Predicate Device

K170848 Alzair Allergy Blocker Cleared 06-14-17

Basis for Submission

1. Expanded the Indications for Use to include pediatric patients (8 years or older).
1. Substituted Strawberry Powder for Mint -- strawberry scent is preferable for children.
1. Updated the product labeling as follows:
- Includes specific Instructions for children and a new Package Insert ●
- Designates that AllerBlock Junior is indicated for Over-the-Counter (OTC) use ●

Product Description

Indications for Use

AllerBlock Junior is intended for use in adults and children (8 years or older) 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 AllerBlock Junior produces a mucous-like gel barrier that evenly coats the nasal membranes and acts to block inhaled allergens within the nasal cavity.

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Comparison to Predicate

The table below provides a high level summary of the similarities and differences between the Predicate and Subject products.

	PREDICATE DEVICE	SUBJECT DEVICE
510(K)	K170848	K201734
PRODUCT	Alzair Allergy Blocker	AllerBlock Junior
INDICATION	Adult Patients	Adults and Children (8 years or older)
INGREDIENTS	HPMC Powder 98.5%Peppermint Powder 1.5%	HPMC Powder 97%Strawberry Powder 3%
OTC vs. Rx Use	Rx Use	OTC
REGULATION	880.5045 / NUP	SAME

Safety and Performance Testing

Safety Testingand Toxicology	HPMC and strawberry scent flavoring are recognized as GRAS in the US. HPMC isremarkably safe when given orally. The quantity, grade, and route of administrationof HPMC used in AllerBlock Junior do not present any serious toxicological risks.
Biocompatibility	Biocompatibility testing included cytotoxicity, sensitization, and irritation. The resultsdemonstrated that there are no biocompatibility concerns with AllerBlock Junior.
Stability / Shelf Life	Stability and shelf life testing results support a shelf life of ≥ 3 yrs at 40°C. Once thebottle is opened, labeling directs the consumer to use the product within 6 months.

Clinical Studies in Children

The safety and effectiveness of AllerBlock Junior (HPMC + Mint) has been clinically investigated in 5 Clinical Studies comprising N=219 pediatric patients as summarized below. The study results are summarized on the next page -- followed by a discussion of the treated patient population, study design, effectiveness and safety results reference to adverse effects and complications), and the basis for determination of substantial equivalence.

	STUDY 1	STUDY 2	STUDY 3	STUDY 4	STUDY 5
YEAR	2005	2009	2010	2010	2019
AUTHORS	Aivazis V, Bourli E,Maratou E, Mavroudi A	Zakharzhevskaya T,Sidorenko I, Treskunov V	Aberg N, Dahl A, Benson M	Geppe N, Snegotskaya M,Kolosova N, Konopelko O	Chen X, Guan WJ, Sun SX,Zheng PY, Sun LH, et al
STUDY TITLE	Study of MucociliaryClearance in Children withAR: Before & After 6Weeks of Therapy withNatural Cellulose Powder	Efficacy and Safety ofNasaleze in Prevention andTreatment of Persistent ARin Adults and Children	Nasally Applied CellulosePowder Reduces SARSymptoms: Double-Blind,Placebo-Controlled Trial inChildren & Adolescents	Intranasal Inert CellulosePowder in PreventingSeasonal Allergic Rhinitis inChildren	Effects of IntranasalCellulose Powder inChildren with AllergicRhinitis -- Randomized-Controlled Trial
TREATMENT	Nasaleze	Nasaleze	RandomizedNasaleze vs. Placebo	Randomized - Nasaleze vs.Standard of Care Oral Meds	Randomized - Nasaleze vs.Nasal Steroids vs. Placebo
DURATION	6 weeks	4 weeks	4 weeks	4 weeks	8 weeks
PT POPULATION	Allergic Rhinitis	Persistent Allergic Rhinitis	History of SAR (in Spring)	Seasonal Allergic Rhinitis	Perennial Allergic Rhinitis
· Total Enrollment	Total EnrollmentN=100	Total EnrollmentN=48	Total EnrollmentN=53	Total EnrollmentN=110	Total EnrollmentN=121
· Children Treated	Children TreatedN=100	Children TreatedN=23	Children TreatedN=25	Children TreatedN=30	Children TreatedN=41
· Age Range + Mean	Ages 1½ - 8 yrs	Ages 2 - 18 yrs11 yrs	Ages 8 - 18 yrs11 yrs	Ages 4 - 14 yrs8 yrs	Ages 6 - 11 yrs8 yrs
PATIENTDEMOGRAPHICINFORMATION	Male/FemaleN=53/47	Duration of AR 6 yrs (1-15)	NASALEZEN = 2515/10	NASALEZEN = 303.1 yrs50%67%	NASALEZEN = 413.4 yrs100%71%
	Skin Test Positive N=78/93	Skin Test Positive 80%Pollenosis (Hay Fever) 80%

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Image /page/5/Figure/3 description: The image shows the text "Clinical Studies in Children (continued)". The text is in bold font. The words are arranged on a single line.

Image /page/5/Figure/4 description: This image contains efficacy and safety results from a clinical study. The efficacy results show nasal mucous clearance and allergic rhinitis symptom severity scores. The safety results include tolerability, adverse effects, and side effects, with specific data on non-serious adverse events for steroids, nasaleze, and placebo treatments. Several graphs are included to show allergic rhinitis symptoms, C-ACT scores, FEV1, nasal discharge, nasal congestion, nasal itching, and ocular symptoms.

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Clinical Studies in Children (continued)

Discussion

· Study Design

All 5 studies were well-controlled clinical studies in which pediatric patients either acted as their own control (Pre vs. Post-Treatment with AllerBlock Junior) or were randomized to receive AllerBlock Junior vs. Placebo.

· Treated Patient Population

AllerBlock Junior is indicated to treat both adults and children (8 years or older) while the predicate was intended for use in adults only. The specified minimum age of 8 years is based on pooling the age distributions from the 5 clinical studies and observing that approximately half of the patients treated with the Nasaleze product were children 8 years or younger.

· Effectiveness Results

= Study 1 Assessed mucociliary clearance as measure of treatment effectiveness. Significant decrease of clearance observed in children in this study after treatment (especially those with mean value > 31 minutes) is due to the effect of cellulose -- since the children received no other therapy.
= Study 2-5 Evaluated allergic rhinitis daily symptom scores as reported by subjects. These studies all showed consistent reductions in AR symptoms including nasal congestion and discharge, sneezing, nasal and ocular itching.

· Safety Results

In all 5 studies of children, the reported adverse effects and complications were few in number (2-15%) and mild in level of severity. These results from N=219 pediatric patients treated with AllerBlock Junior demonstrate product safety.

· Basis for Determination of Substantial Equivalence

= Product Formulation Strawberry scent flavoring (3%) has been substituted for mint (1.5%): and Ingredients
- Strawberry scent flavoring is recognized as GRAS in the US
- Powder particle size remains essentially unchanged

This change continues to support product safety and effectiveness.

· Clinical Equivalence For the Pediatric Studies, the product investigated was the Allergy Blocker formulation. Since AllerBlock Junior is so similar to Allergy Blocker (see above), this difference does not impact the application of the safety and effectiveness results to support clinical equivalence.

Conclusions

By virtue of its physical characteristics, intended use, and performance testing, AllerBlock Junior is substantially equivalent to Alzair Allergy Blocker. AllerBlock Junior poses no safety risk to users, and has been shown to significantly block allergen entry into the nasal mucosa. Clinical studies of children have demonstrated that AllerBlock Junior'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.

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).