(274 days)
AllerBlock Junior is intended for use in adults and children (8 years or older) 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 AllerBlock Junior produces a mucous-like gel barrier that evenly coats the nasal membranes and acts to block inhaled allergens within the nasal cavity.
AllerBlock Junior is composed of pharmaceutical grade Hydroxypropyl Methylcellulose (HPMC; 97%) and high quality strawberry scent (3%) which has been formulated into a micronized powder of fine particles of inert cellulose. AllerBlock Junior 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 the 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 (AR) symptoms.
The provided text is a 510(k) summary for AllerBlock Junior, a medical device intended to alleviate mild allergic symptoms. The document focuses on demonstrating substantial equivalence to a predicate device and extending its indications for use to include pediatric patients (8 years or older).
Here's an analysis of the acceptance criteria and the study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state "acceptance criteria" as a set of predefined quantitative thresholds that the device must meet for clearance. Instead, it presents summaries of clinical studies to demonstrate the device's safety and effectiveness, especially for the extended pediatric indication. The "reported device performance" is largely qualitative, focusing on symptom reduction and safety.
| Aspect | Acceptance Criteria (Implied) | Reported Device Performance (from Clinical Studies) |
|---|---|---|
| Safety | No serious toxicological risks; biocompatible; low incidence of adverse effects. | - Components: HPMC and strawberry scent flavoring are recognized as GRAS in the US. HPMC is "remarkably safe when given orally." |
- Biocompatibility: Tests (cytotoxicity, sensitization, irritation) showed "no biocompatibility concerns."
- Adverse Effects in Children (5 studies, N=219 total pediatric patients): "reported adverse effects and complications were few in number (2-15%) and mild in level of severity." |
| Effectiveness (Pediatric) | Alleviation of mild allergic symptoms (nasal irritation, itchy, runny, congested nasal passages). Reduced allergen exposure via mechanical barrier. | - Mechanism: Produces a mucous-like gel barrier that coats nasal membranes, blocking inhaled allergens. - Study 1 (Mucociliary Clearance): "Significant decrease of clearance observed in children... after treatment (especially those with mean value > 31 minutes) is due to the effect of cellulose." This implies the formation of the barrier.
- Studies 2-5 (AR Symptom Scores): "all showed consistent reductions in AR symptoms including nasal congestion and discharge, sneezing, nasal and ocular itching." This directly supports alleviation of mild allergic symptoms. |
| Shelf Life/Stability | Device maintains functionality and safety over its intended storage and use duration. | - Stability/Shelf Life Testing: "results support a shelf life of ≥ 3 yrs at 40°C." |
| Product Formulation | New formulation (strawberry scent, 3%) should maintain safety and effectiveness comparable to predicate. | - Ingredients: HPMC Powder 97%, Strawberry Powder 3%. Strawberry scent recognized as GRAS. - Particle Size: "Powder particle size remains essentially unchanged."
- Conclusion: "This change continues to support product safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance:
- Total Pediatric Patients Across 5 Studies: N=219.
- Study 1: N=100 children
- Study 2: N=23 children
- Study 3: N=25 children
- Study 4: N=30 children
- Study 5: N=41 children
- Data Provenance: Not explicitly stated regarding the country of origin for each study. However, the author names (e.g., Aivazis V, Bourli E; Zakharzhevskaya T, Sidorenko I; Aberg N, Dahl A, Benson M; Geppe N, Snegotskaya M; Chen X, Guan WJ, Sun SX) suggest a mix of international (possibly European, Russian, Chinese) origins for the studies. The studies are described as "clinical studies," implying they are prospective, designed trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- The document does not mention the use of experts to establish a "ground truth" for the test set in the context of diagnostic interpretation.
- The "ground truth" for these studies is based on clinical outcomes:
- Mucociliary clearance measurements (Study 1).
- Patient-reported daily symptom scores for allergic rhinitis (Studies 2-5).
- Clinical assessment of adverse events by study investigators.
- The qualifications of the clinicians/investigators conducting these studies are not detailed.
4. Adjudication Method for the Test Set:
- Adjudication methods (like 2+1 or 3+1 for discordance resolution) are typically used in studies involving expert interpretation of images or other subjective data to establish a definitive ground truth.
- These clinical studies primarily relied on objective measurements (mucociliary clearance) and patient-reported outcomes (symptom scores). There is no mention of an adjudication method in this context. Adverse events would be reported and managed by the study investigators.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:
- No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done.
- MRMC studies are typically used to assess the impact of AI on human reader performance, usually in image-based diagnostic tasks. The AllerBlock Junior device is a physical barrier product, not an AI diagnostic tool.
- The comparative effectiveness in the provided studies refers to comparing the device to placebo or standard of care (oral medications, nasal steroids in Study 4 and 5).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done:
- This question is not applicable. AllerBlock Junior is a physical device, not an algorithm, and does not have a "standalone" algorithmic performance. Its performance is directly tied to its physical application and effect on the user.
7. The Type of Ground Truth Used:
- Clinical Ground Truth:
- Mucociliary Clearance: An objective physiological measurement.
- Patient-Reported Outcomes (PROs): Daily symptom scores for allergic rhinitis (e.g., nasal congestion, discharge, sneezing, itching). These are subjective but are standard clinical endpoints for allergy studies.
- Adverse Event Reporting: Clinical observation and reporting of adverse effects by study participants and investigators.
8. The Sample Size for the Training Set:
- The document does not describe a "training set" in the context of machine learning. The clinical studies described are for validation of the device's safety and effectiveness.
- The device's formulation (HPMC with strawberry scent) is based on established knowledge of HPMC as a safe and effective barrier and strawberry as a GRAS flavoring, not derived from training on a dataset.
9. How the Ground Truth for the Training Set Was Established:
- This question is not applicable as there is no "training set" in the machine learning sense for this device. The underlying principles for the device (HPMC forming a barrier) are based on scientific understanding and prior uses of these materials.
§ 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).