(234 days)
Not Found
No
The device is a topical nasal cream that acts as a mechanical barrier. There is no mention of any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended to alleviate mild allergic symptoms and has demonstrated effectiveness in clinical studies for treating and preventing allergic rhinitis symptoms, which are therapeutic actions.
No
The device is a cream intended to act as a mechanical barrier to reduce allergic symptoms, not to diagnose a condition.
No
The device is a topical nasal cream, which is a physical substance applied to the body, not a software program.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to alleviate mild allergic symptoms by acting as a mechanical barrier in the nasal passages. This is a physical action on the body, not a test performed on a sample taken from the body to diagnose a condition or provide information about a physiological state.
- Device Description: The device is a topical nasal cream that acts as a mechanical barrier. It does not involve any reagents, assays, or analysis of biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes (proteins, genes, metabolites, etc.)
- Providing diagnostic information about a disease or condition
The device functions as a physical barrier to prevent allergens from reaching the nasal mucosa, which is a therapeutic or prophylactic action, not a diagnostic one.
N/A
Intended Use / Indications for Use
The Alergol Pollen Blocker Cream 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.
Product codes
NUP
Device Description
Alergol Pollen Blocker Cream is a viscous topical nasal cream consisting of highly refined aliphatic long-chain hydrocarbons for prophylaxis and therapy of allergic rhinitis caused by airborne allergens. The product is applied by finger or cotton swab to the inside surface of the nasal vestibule in the region of the nose flap where it acts as a mechanical barrier to reduce the adverse effects of inhaled allergens. Proper application of the cream makes it more difficult for inhaled allergens to come into contact with the skin in the nasal interior, and thus reduces the intensity of allergic rhinitis symptoms.
The hydrocarbon gel is chemically inert to the body and nasal membranes, and contains no additives. On average, protection lasts for 3 to 5 hours before the cream has to be reapplied. The Alergol Pollen Blocker cream is intended for topical use and provided non-sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal vestibule, nose flap
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)
The safety and effectiveness of the Alergol Pollen Blocker Cream has been demonstrated in several clinical studies including two multicenter, prospective, randomized, double-blind, placebo-controlled crossover studies (N=50; N=91) of the anti-allergic effectiveness of the Alergol Pollen Blocker nasal cream in treating patients suffering from allergic rhinitis.
Both studies demonstrate the safety and effectiveness of the product. Symptom scores decreased significantly for patients treated with the Alergol Pollen Blocker Cream by up to 40% (p = 0.001) and nasal airflow resistance went down by approximately 50%.
In a clinical investigation (S. Schwetz et al. Arch Otolaryngol Head Neck Surgery. 2004;130:979-984) Dr. Theiss Alergol Pollen Blocker Cream was found to be effective for the prophylaxis of symptoms in patients with seasonal or perennial allergic rhinitis. In this double-blind, randomized, placebo-controlled, crossover study, ninety-one patients were randomly assigned to receive pollen blocker cream (n=43) or carboxymethylcellulose gel (placebo) (n=48). The efficacy of treatment was assessed by means of nasal provocation testing. The investigators assessed the nasal symptom severity scores (range 0-6) and the changes in nasal airflow after allergen challenge.
Results: Dr. Theiss Alergol Pollen Blocker Cream was significantly more effective than placebo and reduced the typical symptoms of allergic rhinitis in response to nasal challenge with allergen by nearly 60% (placebo reduced symptoms by 25%). The increase in airflow in response to treatment was approximately 20% in the Blocker Cream group compared to 10% in the placebo group.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Symptom scores decreased significantly for patients treated with the Alergol Pollen Blocker Cream by up to 40% (p = 0.001).
Nasal airflow resistance went down by approximately 50%.
Dr. Theiss Alergol Pollen Blocker Cream reduced the typical symptoms of allergic rhinitis by nearly 60% (placebo reduced symptoms by 25%).
The increase in airflow in response to treatment was approximately 20% in the Blocker Cream group compared to 10% in the placebo group.
| Patient Group | Number of Patients | Percent of Patients | Symptom Score |
|---|---|---|---|
| High Responders | 46 | 51% | Decrease >2 |
| Responders | 22 | 24% | Decrease = 1 or 2 |
| Non-Responders | 23 | 25% | Decrease |
§ 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
MAY 1 6 2005
510(k) Summary
Name of Device
| Trade Name: | Alergol Pollen Blocker Cream |
|---|---|
| Common Name: | Pollen Blocker |
| Classification Name: | Unclassified |
Predicate Devices
| 510(K) | MANUFACTURER | DEVICE | APPROVAL DATE |
|---|---|---|---|
| K981841 | RespirAid | BREATHE EASY | 10-13-98 |
| K032948 | Medpak | Elastic Skin Liquid Bandage | 06-25-04 |
Device Description
Alergol Pollen Blocker Cream is a viscous topical nasal cream consisting of highly refined aliphatic long-chain hydrocarbons for prophylaxis and therapy of allergic rhinitis caused by airborne allergens. The product is applied by finger or cotton swab to the inside surface of the nasal vestibule in the region of the nose flap where it acts as a mechanical barrier to reduce the adverse effects of inhaled allergens. Proper application of the cream makes it more difficult for inhaled allergens to come into contact with the skin in the nasal interior, and thus reduces the intensity of allergic rhinitis symptoms.
The hydrocarbon gel is chemically inert to the body and nasal membranes, and contains no additives. On average, protection lasts for 3 to 5 hours before the cream has to be reapplied. The Alergol Pollen Blocker cream is intended for topical use and provided non-sterile.
Intended Use
The Alergol Pollen Blocker Cream 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.
Pharmaceutical and Physical and Characteristics
The Alergol Pollen Blocker (5 g nasal ointment) contains only a special pharmaceutical Vaseline (100%), no preservatives, no odoriferous substances, and pharmer substances. The physical characteristics of the Dr. Theiss Alergol Pollen no other Cream is similar to the Kos Polyglycol Cream, a packing material for use in ear surgical procedures. Both creams maintain their consistency for 4-6 hours. The our bargroal product to commercially-available pharmaceutical vaseline products.
1
Safety Testing
By using longer carbon chains, a greater product viscosity is achieved which is an important factor regarding product safety. There have been no reports of any adverse effects during the past 40 years with the use of such products for topical purposes, even in the nasal cavity.
Laboratory and Testing
Appropriate toxicology and pharmacology testing demonstrates that the Alergol Pollen Blocker is safe for topical use as described in the product labelling. The biocompatibility of the Alergol Pollen Blocker cream is consistent with the results of the toxicology and safety performance testing. The Alergol Pollen Blocker does not contain any materials which are subject to the risk of transmission of bovine spongiform encephalitis (BSE). Stability and packaging materials testing demonstrate that the product has a shelf-life of over 5 years at room temperature. The pollen blocker cream is intended for topical use and provided non-sterile.
Summary of Clinical Results
The safety and effectiveness of the Alergol Pollen Blocker Cream has been demonstrated in several clinical studies including two multicenter, prospective, randomized, double-blind, placebo-controlled crossover studies (N=50; N=91) of the anti-allergic effectiveness of the Alergol Pollen Blocker nasal cream in treating patients suffering from allergic rhinitis.
Both studies demonstrate the safety and effectiveness of the product. Symptom scores decreased significantly for patients treated with the Alergol Pollen Blocker Cream by up to 40% (p = 0.001) and nasal airflow resistance went down by approximately 50%. Treated patients reported that the blocker cream was welltolerated and no side-effects occurred as a result of application of the nasal cream.
The methylcellulose control also provided treatment and is not, therefore, strictly a placebo. However, the treatment effect for patients treated with the Alergol Pollen Blocker Cream was more significant than for those treated with the control therapy.
Results from Clinical Trials
In a clinical investigation (S. Schwetz et al. Arch Otolaryngol Head Neck Surgery. 2004;130:979-984) Dr. Theiss Alergol Pollen Blocker Cream was found to be effective for the prophylaxis of symptoms in patients with seasonal or perennial allergic rhinitis.
In this double-blind, randomized, placebo-controlled, crossover study, ninety-one patients were randomly assigned to receive pollen blocker cream (n=43) or carboxymethylcellulose gel (placebo) (n=48).
2
The efficacy of treatment was assessed by means of nasal provocation testing. The investigators assessed the nasal symptom severity scores (range 0-6) and the changes in nasal airflow after allergen challenge.
Results:
Dr. Theiss Alergol Pollen Blocker Cream was significantly more effective than placebo and reduced the typical symptoms of allergic rhinitis in response to nasal challenge with allergen by nearly 60% (placebo reduced symptoms by 25% *)
The increase in airflow in response to treatment was approximately 20% in the Blocker Cream group compared to 10% in the placebo group.
| Patient Group | Number of Patients | Percent of Patients | Symptom Score |
|---|---|---|---|
| High Responders | 46 | 51% | Decrease >2 |
| Responders | 22 | 24% | Decrease = 1 or 2 |
| Non-Responders | 23 | 25% | Decrease |