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510(k) Data Aggregation
(141 days)
Nasal Ease 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 Nasal Ease produces a mucous-like gel barrier that evenly coats the nasal membranes and acts to block inhaled allergens within the nasal cavity.
Nasal Ease Allergy Blocker is composed of 100% pharmaceutical grade Hydroxypropyl Methylcellulose (HPMC) which has been formulated into a micronized powder of fine particles of inert cellulose. Nasal Ease 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 Nasal Ease 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 nasal interior, and thus reducing the intensity of allergic rhinitis symptoms.
One bottle squeeze releases around 3.2mg of powder. The maximum usual dose is around 3 puffs/day into each nostril, giving a total of 19mg/day.
The cellulose gel is considered inert and does not penetrate the dermal layer of the skin. On average, protection lasts for 4-6 hours before the gel has to be re-applied. Nasal Ease is intended for topical use and provided non-sterile.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Particle Size Distribution | 99.4% of particles in the 5-500 micron (um) diameter range. Mean particle size of 118 um. No particles < 1.9 um detected. (This criterion aims to ensure particles are large enough for nasal deposition and not to reach the alveoli.) |
| Safety and Toxicology | HPMC is recognized as GRAS by the FDA and a food additive in the EU. Patty's Industrial Hygiene and Toxicology describes cellulose ethers (including HPMC) as "very low in toxicity." Feeding experiments in rats, dogs, and human volunteers showed a lack of toxic effect. Studies in volunteers revealed no serious adverse effects from taking the material as a snuff for several weeks. The quantity, grade, and route of administration of HPMC used in Nasal Ease do not present any serious toxicological risks. |
| Biocompatibility | Tested for cytotoxicity, sensitization, and irritation. Results demonstrated no biocompatibility concerns. |
| Stability and Shelf Life | Stability and shelf life testing results support a shelf life of at least 3 years at 40°C. Labeling directs consumer to use within 6 months of opening. |
| Allergen Blocking Capability (in vitro) | In vitro studies using a simulated barrier model validated that significant delay of allergen entry into the mucosa could be beneficial. A direct comparison to the predicate (NasalGuard) showed both Nasal Ease and NasalGuard significantly reduce the diffusion of pollen allergen in vitro for up to 6 hours. |
| Reduction of Allergic Rhinitis Symptoms | A prospective, randomized, placebo-controlled clinical validation study demonstrated significant reductions in severity scores for sneezing, running and stuffy nose, eye symptoms, and lower airway symptoms (all p<0.001) in patients using Nasal Ease compared to placebo. Reflective opinion of effect and guess on treatment at follow-up visits also confirmed effectiveness (both p<0.001). No clinically significant adverse effects were observed. The mean symptom scores for the active group were consistently lower than the placebo group across all assessed symptoms (e.g., Sneezing: 1.65 (Active) vs 2.31 (Placebo); Sum of All Symptoms: 8.19 (Active) vs 11.1 (Placebo)). |
| History of Safe and Effective Use | Registered as a Class I Medical Device with MHRA since 1991. Sold in over 50 countries worldwide for +20 years with no reports of any serious adverse events attributed to over 7,000,000 products sold. |
Study Details: Clinical Validation Study
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Sample size used for the test set and the data provenance:
- Sample Size: 54 active patients (Nasal Ease) and 53 placebo patients. (Total = 107 patients)
- Data Provenance: The study was a "prospective, randomized, placebo-controlled clinical validation study." While the explicit country of origin is not stated, the reference to "grass pollen season" and the dates in May 2013 suggest a Northern Hemisphere country, likely within a region where such studies are commonly conducted. The fact that Nasaleze is registered with MHRA (UK regulatory body) and sold in 50 countries suggests an international context for its development and testing.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the text. The ground truth (symptom severity scores) was established by the patients themselves via self-administration and daily recording of their symptoms.
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Adjudication method for the test set:
- Adjudication methods like "2+1" or "3+1" are typically used when independent experts review cases to establish a definitive diagnosis or outcome. In this study, the "ground truth" was subjective patient-reported symptom scores. There is no mention of an adjudication method for these scores. The study design was randomized and placebo-controlled to mitigate bias in self-reporting.
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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:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices involving image interpretation by human readers, often assisted by AI. The Nasal Ease Allergy Blocker is a medical device for treating allergic symptoms and its clinical validation did not involve human readers interpreting diagnostic images.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- This is not applicable as the device is not an algorithm, but a physical product (HPMC powder administered as a nasal spray). The device's performance was evaluated both in vitro (standalone, without human physiological interaction in simulation) and in a clinical study with human use.
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The type of ground truth used:
- The ground truth used for the clinical validation study was patient-reported symptom severity scores. Patients rated their own symptoms (sneezing, running nose, stuffy nose, eye symptoms, lower airways) on a scale of 1 (No Trouble At All) to 6 (Very Much Trouble).
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The sample size for the training set:
- The text describes a single clinical validation study. There is no mention of a separate "training set" for an algorithm or a device performance model. The mentioned clinical study acts as the primary effectiveness evaluation.
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How the ground truth for the training set was established:
- As there is no explicit "training set" described for an algorithm, this question is not applicable. The ground truth for the clinical validation study was established through patient self-assessment of symptom severity, recorded daily.
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