AllerBlock Junior

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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 {1}------------------------------------------------ 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 {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K201734 Device Name AllerBlock Junior #### Indications for Use (Describe) 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. | Type of Use (Select one or both, as applicable) | |-------------------------------------------------| |-------------------------------------------------| Prescription Use (Part 21 CFR 801 Subpart D) X Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # 510(K) SUMMARY # Contact Information | Submitter's Name and Address: | Nasaleze International Ltd<br>Nunnery Mills, Old Castletown Road<br>Douglas, Isle of Man, IM2 1QA, British Isles<br>TEL + 44 (0) 1624 611 050 | |--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------| | Name of Contact Person: | Matt Duxbury, Export Director<br>Nasaleze International Ltd. | | Date Summary was Prepared: | March 25, 2021 | | Name of Device | | | Name of the Device: | AllerBlock Junior | | Regulatory Name:<br>Regulation | Topical Nasal Cream -- Mechanical Allergen Particle Barrier<br>21 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). - 2. Substituted Strawberry Powder for Mint -- strawberry scent is preferable for children. - 3. 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 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. ### 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. {4}------------------------------------------------ # 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 | <b>AllerBlock Junior</b> | | INDICATION | Adult Patients | Adults and Children (8 years or older) | | INGREDIENTS | HPMC Powder 98.5%<br>Peppermint Powder 1.5% | HPMC Powder 97%<br><b>Strawberry Powder 3%</b> | | OTC vs. Rx Use | Rx Use | <b>OTC</b> | | REGULATION | 880.5045 / NUP | SAME | ### Safety and Performance Testing | Safety Testing<br>and Toxicology | HPMC and strawberry scent flavoring are recognized as GRAS in the US. HPMC is<br>remarkably safe when given orally. The quantity, grade, and route of administration<br>of HPMC used in AllerBlock Junior do not present any serious toxicological risks. | |----------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Biocompatibility | Biocompatibility testing included cytotoxicity, sensitization, and irritation. The results<br>demonstrated 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 the<br>bottle 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,<br>Maratou E, Mavroudi A | Zakharzhevskaya T,<br>Sidorenko I, Treskunov V | Aberg N, Dahl A, Benson M | Geppe N, Snegotskaya M,<br>Kolosova N, Konopelko O | Chen X, Guan WJ, Sun SX,<br>Zheng PY, Sun LH, et al | | STUDY TITLE | Study of Mucociliary<br>Clearance in Children with<br>AR: Before & After 6<br>Weeks of Therapy with<br>Natural Cellulose Powder | Efficacy and Safety of<br>Nasaleze in Prevention and<br>Treatment of Persistent AR<br>in Adults and Children | Nasally Applied Cellulose<br>Powder Reduces SAR<br>Symptoms: Double-Blind,<br>Placebo-Controlled Trial in<br>Children & Adolescents | Intranasal Inert Cellulose<br>Powder in Preventing<br>Seasonal Allergic Rhinitis in<br>Children | Effects of Intranasal<br>Cellulose Powder in<br>Children with Allergic<br>Rhinitis -- Randomized-<br>Controlled Trial | | TREATMENT | Nasaleze | Nasaleze | Randomized<br>Nasaleze vs. Placebo | Randomized - Nasaleze vs.<br>Standard of Care Oral Meds | Randomized - Nasaleze vs.<br>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 Enrollment<br>N=100 | Total Enrollment<br>N=48 | Total Enrollment<br>N=53 | Total Enrollment<br>N=110 | Total Enrollment<br>N=121 | | · Children Treated | Children Treated<br>N=100 | Children Treated<br>N=23 | Children Treated<br>N=25 | Children Treated<br>N=30 | Children Treated<br>N=41 | | · Age Range + Mean | Ages 1½ - 8 yrs | Ages 2 - 18 yrs<br>11 yrs | Ages 8 - 18 yrs<br>11 yrs | Ages 4 - 14 yrs<br>8 yrs | Ages 6 - 11 yrs<br>8 yrs | | PATIENT<br>DEMOGRAPHIC<br>INFORMATION | Male/Female<br>N=53/47 | Duration of AR 6 yrs (1-15) | NASALEZE<br>N = 25<br>15/10 | NASALEZE<br>N = 30<br>3.1 yrs<br>50%<br>67% | NASALEZE<br>N = 41<br>3.4 yrs<br>100%<br>71% | | | Skin Test Positive N=78/93 | Skin Test Positive 80%<br>Pollenosis (Hay Fever) 80% | | | | {5}------------------------------------------------ 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. {6}------------------------------------------------ # 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.