(85 days)
Not Found
No
The device description and intended use focus on a mechanical barrier created by a powder that forms a gel, with no mention of AI or ML technology.
Yes.
The device is intended to alleviate mild allergic symptoms by acting as a barrier to inhaled allergens, which classifies it as having a therapeutic effect.
No
Explanation: The device is intended to treat symptoms of allergies by forming a physical barrier in the nasal cavity, not to diagnose medical conditions or identify the presence of allergens.
No
The device description clearly states it is a powder composed of HPMC and peppermint, administered via a spray bottle, which forms a gel barrier. This is a physical substance and delivery mechanism, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "treat hay fever and allergy sufferers by promoting alleviation of mild allergic symptoms... triggered by the inhalation of various airborne allergens". This describes a therapeutic or preventative action within the body, not a diagnostic test performed on a sample taken from the body.
- Mechanism of Action: The device works by forming a physical barrier (a gel) within the nasal cavity to block allergens from contacting the nasal membranes. This is a mechanical action, not a chemical or biological reaction used to detect or measure something in a sample.
- Device Description: The description focuses on the composition of the powder and how it forms a gel barrier. There is no mention of reagents, assays, or any components typically associated with in vitro diagnostic tests.
- Lack of Diagnostic Language: The document uses terms like "treat," "alleviation," "block," and "reduce symptoms," which are indicative of a therapeutic device, not a diagnostic one.
In vitro diagnostics are tests performed on samples (like blood, urine, tissue) taken from the body to detect diseases, conditions, or infections. This device acts directly within the body to prevent the effects of allergens.
N/A
Intended Use / 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 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.
Product codes
NUP
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nasal cavity / nasal passages / nasal mucosa
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
Image /page/1/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with the profiles overlapping each other.
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
2
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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4
510(K) SUMMARY
Contact Information
| Submitter's Name and Address: | Nasaleze International Ltd
Nunnery Mills, Old Castletown Road
Douglas, Isle of Man, IM2 1QA, British Isles
TEL + 44 (0) 1624 611 050 |
|-------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Name of Contact Person: | Matt Duxbury
Export Director
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.
5
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 | |
| PRESCRIPTION | |||
| 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.