(85 days)
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.
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.
The provided FDA 510(k) summary for the Alzair Allergy Blocker does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria, as one would typically find for a diagnostic or imaging device.
This document is a 510(k) premarket notification for a Class II medical device, which generally relies on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than comprehensive clinical trials with detailed performance metrics and sample sizes like a PMA application would require.
Here's an analysis of the available information based on your requested categories:
1. A table of acceptance criteria and the reported device performance
No explicit "acceptance criteria" (e.g., sensitivity, specificity, accuracy thresholds) or corresponding "reported device performance" metrics are provided in this document. The device is not a diagnostic tool where such metrics would be typical. Its performance is described in terms of its mechanism of action and historical safety.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Test set sample size: Not applicable and not provided. The substantial equivalence argument relies on the physical characteristics and intended use being similar to the predicate device, along with safety and biocompatibility testing. There isn't a "test set" in the sense of a set of patient data being evaluated against a ground truth.
- Data provenance: Not directly applicable to a performance study for this type of device. The historical safety data mentioned is global, as the predicate device has been sold in "more than 50 countries worldwide."
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no "ground truth" establishment by experts for a test set described in this submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No test set requiring expert adjudication is described.
5. 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
Not applicable. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a topical nasal powder, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The document focuses on demonstrating the device's physical properties, biocompatibility, and history of safe use, rather than accuracy against a ground truth for a diagnostic claim. The "clinical studies" mentioned in the conclusion refer to previous work for the predicate device, demonstrating reduction of nasal allergen exposure and symptoms, which would be a form of clinical outcomes data.
8. The sample size for the training set
Not applicable. This device is not a machine learning model.
9. How the ground truth for the training set was established
Not applicable. This device is not a machine learning model.
Summary of available information regarding performance and proof:
- Device Name: Alzair Allergy Blocker
- Intended Use: 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. It forms a mucous-like gel barrier to block inhaled allergens.
Proof of Performance (as described in the 510(k) Summary):
The proof provided is primarily based on substantial equivalence to a predicate device (K132520 - Allergy Blocker, Nasal Eze International) and supporting evidence for safety and mechanism of action.
- Mechanism of Action: When Alzair Allergy Blocker powder comes into contact with the moist nasal mucosa, it forms a colorless, mucus-like fine gel that coats the inside of the nasal cavity. This inert gel acts as a mechanical barrier, making it more difficult for inhaled allergens to contact the nasal lining, thereby reducing the intensity of allergic rhinitis symptoms.
- Safety Testing & Toxicology: HPMC and peppermint are recognized as GRAS (Generally Recognized As Safe) in the US. The concentration, grade, and route of administration are considered safe and below known toxicological levels.
- Biocompatibility: Testing included cytotoxicity, sensitization, and irritation, with results demonstrating no biocompatibility concerns.
- Stability and Shelf Life: Testing supports a shelf life of at least 3 years at 40°C.
- History of Safe and Effective Use (Predicate Device): The predicate, Nasaleze Allergy Blocker (with identical formulation), has been registered as a Class I Medical Device since 1991 and sold in over 50 countries for more than 25 years. During this period, over 7,000,000 products have been sold with no reports of serious adverse events.
- Clinical Studies (Predicate Device): The summary states, "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." No specifics of these studies (e.g., sample size, design, results) are provided in this document, as the FDA typically would have reviewed these as part of the predicate's original submission.
In conclusion, for this specific device, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to a predicate, along with safety (toxicology, biocompatibility) and stability data, and referencing previously established clinical benefits of the predicate device's formulation. There are no quantitative performance metrics like sensitivity/specificity or sample sizes for an independent test set in this 510(k) submission.
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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, Shu-Chen.Peng@fda.hhs.gov.
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 (800) 638-2041 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" (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 (800) 638-2041 or (301) 796-7100 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) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | 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 DuxburyExport DirectorNasaleze 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%Peppermint Powder 1.5% | SAME |
| INDICATIONS | See previous page. | SAME | |
| PRESCRIPTIONDESIGNATION | 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.
§ 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).