(56 days)
NasalGuard® is intended to promote alleviation of mild allergic symptoms (i.e. mild nasal irritation including itchy, runny or congested nasal passages) triggered by the inhalation of various allergens including environmental pollens, house dust, animal hairs and dust mites.
NasalGuard is a water-based gel consisting of common, GRAS cosmetic grade ingredients. The product is applied by finger or cotton swab to the outside of the nasal passages, around the nostrils and upper lip. NasalGuard utilizes a patented methodology that uses the cationic properties of its ingredients to create an electrostatic field that attracts and blocks airborne allergens before they enter the nasal passages. The gel is considered innocuous and does not penetrate the dermal layer of the skin. The gel is concentrated and lasts for 4-6 hours before the gel has to be reapplied. NasalGuard is intended for topical use and provided non-sterile.
Here's an analysis of the provided text regarding the NasalGuard device, focusing on the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit from Predicate Study) | Reported Device Performance (NasalGuard) |
|---|---|
| No statistically significant difference in efficacy compared to Alergol in reducing allergic rhinitis symptoms. | p-value = 0.7974 (chi-square test), indicating no statistically significant difference from Alergol. |
| Comparable responder rates to Alergol. | High Responders: NasalGuard 56% vs. Alergol 51% |
| Responders: NasalGuard 23% vs. Alergol 24% | |
| Non-Responders: NasalGuard 21% vs. Alergol 25% | |
| Combined High Responders & Responders: NasalGuard 79% vs. Alergol 75% | |
| Safe, innocuous, and meets toxicological standards. | No reported adverse effects in >20,000 users. Test findings indicate it meets toxicological standards. |
| Attracts airborne allergens (bench test). | Captured mold spores approximately three times more than the control (Silicon Gel). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 43 subjects for the clinical efficacy study.
- Data Provenance: Not explicitly stated, but the submission is from Denison Pharmaceuticals, Inc. c/o Trutek Corporation, with the device itself being "Unclassified." The predicate device is from Dr. Theiss Naturwaren Gmbh, Germany. The clinical study was likely conducted in the US, but this isn't clarified. The study was prospective (a "double blind, crossover study").
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- This information is not provided in the document for the clinical study. The "ground truth" for the clinical study would likely be the reported allergic symptoms of the subjects.
4. Adjudication Method for the Test Set
- The document states it was a "double blind, crossover study." This implies that neither the subjects nor the researchers administering the treatments and collecting data knew which treatment (NasalGuard or active control Alergol) was being given. However, a specific "adjudication method" for interpreting or validating clinical outcomes (e.g., by an independent panel) is not 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
- No, an MRMC comparative effectiveness study was not done. This device is a topical gel, not an AI-powered diagnostic or assistive tool for human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- No, this is not applicable. The device is a physical product (gel) and not an algorithm.
7. The Type of Ground Truth Used
- Clinical Efficacy Study: Self-reported allergic rhinitis symptoms by subjects, as observed during a double-blind, crossover study.
- Safety Testing: Observational data (no reported adverse effects) and laboratory toxicological standards/findings.
- Bench Test: Mold spore counting (presumably objective measurement).
8. The Sample Size for the Training Set
- This concept is not applicable as the device is a physical product (gel) and does not involve a machine learning model or algorithm with a "training set."
9. How the Ground Truth for the Training Set Was Established
- This concept is not applicable for the same reason as above.
§ 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).