Alzair Allergy Blocker

K170848 · Nasaleze International, Ltd. · NUP · Jun 14, 2017 · General Hospital

Device Facts

• Record ID: K170848
• Device Name: Alzair Allergy Blocker
• Applicant: Nasaleze International, Ltd.
• Product Code: NUP · General Hospital
• Decision Date: Jun 14, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5045
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Alzair 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 airbone allergens including indoor 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

Topical nasal powder; administered via proprietary spray bottle insufflation. Input: micronized powder (98.5% HPMC, 1.5% peppermint). Mechanism: powder contacts nasal mucosa; forms colorless, mucus-like gel barrier. Function: mechanical barrier blocks inhaled allergens from contacting nasal interior; reduces allergic rhinitis symptoms. Used by patients for self-administration. Benefits: reduction in nasal allergen exposure and associated symptoms. Safety supported by 25+ year history of predicate use and GRAS status of ingredients.

Clinical Evidence

No new clinical trials conducted for this submission. Evidence relies on the established history of safe and effective use of the predicate device (identical formulation), which has been marketed globally for over 25 years with over 7,000,000 units sold without serious adverse events. Previous clinical studies demonstrated the gel barrier's efficacy in reducing nasal allergen exposure and symptoms of seasonal allergic rhinitis.

Technological Characteristics

Micronized powder formulation consisting of 98.5% Hydroxypropyl Methylcellulose (HPMC) and 1.5% peppermint. Delivered via proprietary insufflation spray bottle. Mechanical barrier principle of operation. Biocompatibility testing (cytotoxicity, sensitization, irritation) performed. Shelf life: 3 years at 40°C; 6 months post-opening.

Indications for Use

Indicated for hay fever and allergy sufferers experiencing mild nasal irritation (itchy, runny, or congested nasal passages) due to inhaled airborne allergens including indoor/outdoor pollens, house dust, animal hair, and dust 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

• Allergy Blocker, Nasal Eze International (K132520)

Submission Summary (Full Text)

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July 28, 2021

Nasaleze International Ltd Matt Duxbury Export Director, Nunnery Mills Old Castletown Road Douglas, Isle of Man, IM2 1QA British Isles

Re: K170848

Trade/Device Name: Alzair Allergy Blocker Regulation Number: 21 CFR 880.5045 Regulation Name: Medical recirculating air cleaner Regulatory Class: Class II Product Code: NUP

Dear Matt Duxbury:

The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated June 14, 2017. Specifically, FDA is updating this SE Letter because the signature was omitted from the original letter, as an administrative correction.

Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Shu-Chen Peng, Ph.D., OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Devices, 301-796-6481, [e-mail].

Sincerely,

# Srinivas Nandkumar -S

Srinivas Nandkumar, Ph.D. Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 14, 2017

Nasaleze International Ltd Mr. Matt Duxbury Export Director. Nunnery Mills Old Castletown Road Douglas, Isle of Man, IM2 1QA British Isles

Re: K170848

Trade/Device Name: Alzair Allergy Blocker Regulation Number: 21 CFR 880.5045 Regulation Name: Medical Recirculating Air Cleaner Regulatory Class: Class II Product Code: NUP Dated: March 15, 2017 Received: March 21, 2017

Dear Mr. 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. 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

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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); 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 Industry and Consumer Education at its toll-free number [phone] or [phone] 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" (21 CFR 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/MedicalDevices/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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

for Malvina 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

510(k) Number (if known) K170848

Device Name Alzair Allergy Blocker

#### Indications for Use (Describe)

Alzair 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 airbone allergens including indoor 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.

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------|----------------------------------------------------------------|
| <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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## 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<br>Export Director<br>Nasaleze International Ltd. |
| Date Summary was Prepared: | May 18, 2017 |
| Name of Device | |
| Name of the Device: | Alzair Allergy Blocker |
| Trade or Proprietary Name: | Alzair Allergy Blocker for Prescription Use |
| 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 Device

K132520 -- Allergy Blocker, Nasal Eze International (31-DEC-14)

### Basis for Submission

The changes to the product are the addition of the Prescription Use identifier in the labeling and the new brand for US marketing, "Alzair Allergy Blocker".

### Product Description

Alzair Allergy Blocker is composed of pharmaceutical grade Hydroxypropyl Methylcellulose (HPMC; 98.5%) and high quality peppermint (1.5%) which has been formulated into a micronized powder of fine particles of inert cellulose. Alzair Allergy Blocker 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 Alzair Allergy Blocker 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 symptoms.

### Indications for Use

Alzair 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 Alzair Allergy Blocker 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

| | PREDICATE DEVICE | ADD-TO-FILE DEVICE | SUBJECT DEVICE |
|-----------------------------|----------------------|---------------------------------------------|------------------------|
| 510(K) | K132520 | N/A | K170848 |
| PRODUCT | Allergy Blocker | Allergy Blocker (with Mint) | Alzair Allergy Blocker |
| INGREDIENTS | HPMC Powder 100% | HPMC Powder 98.5%<br>Peppermint Powder 1.5% | SAME |
| INDICATIONS | See previous page. | | SAME |
| PRESCRIPTION<br>DESIGNATION | OVER-THE-COUNTER USE | | PRESCRIPTION USE |
| PRODUCT CODE | NUP | | SAME |
| REGULATION | 880.5045 | | SAME |
| DATE CLEARED | 12-31-14 | Letter to file 04-02-15 | PENDING |

### Safety Testing & Toxicology

HPMC and spearmint are recognized as GRAS in the US. Overall, HPMC is a remarkably safe material when given orally in gram quantities. The quantity, grade, and route of administration of HPMC used in Alzair Allergy Blocker do not present any serious toxicological risks.

Combining HPMC with Mint flavoring is most unlikely to cause any toxicological hazards as all the ingredients are rated non-hazardous and the quantities ingested are well below any known recommended unconditional daily acceptance level.

### Biocompatibility

Biocompatibility testing included cytotoxicity, sensitization, and irritation. The results demonstrated that there are no biocompatibility concerns with Alzair Allergy Blocker.

### Stability and Shelf Life

Stability and shelf life testing results support a shelf life of at least 3 yrs at 40°C. Once the bottle is opened, labeling directs the consumer to use the product within 6 months.

### History of Safe and Effective Use

The predicate, Nasaleze Allergy Blocker (which has an identical formulation), 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 +25 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, Alzair Allergy Blocker (K170848) is equivalent to Nasaleze Allergy Blocker (K132520).

Alzair Allergy Blocker poses no safety risk to users, and has been shown to significantly block allergen entry into the nasal mucosa. Clinical studies have demonstrated that the allergy blocker'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.

K170848