(270 days)
Not Found
No
The device is a physical gel formulation and its mechanism of action is purely mechanical (creating a barrier). There is no mention of any software, algorithms, or data processing that would suggest the use of AI/ML.
Yes.
The device is intended to treat hay fever and allergy sufferers by alleviating mild allergic symptoms. It also states that a clinical study was conducted to demonstrate non-inferiority of Bentrio to a predicate device in alleviating allergic rhinitis symptoms, which are therapeutic claims.
No
The device is intended to treat symptoms and provide a protective barrier, not to diagnose a condition.
No
The device description clearly states that Bentrio™ is a gel emulsion applied as a nasal spray, indicating it is a physical substance, not software.
Based on the provided information, Bentrio™ is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- Bentrio's Function: Bentrio™ is a nasal spray that creates a physical barrier within the nasal cavity to trap allergens. It acts directly on the nasal membranes and does not analyze or test any biological samples taken from the body.
- Intended Use: The intended use is to alleviate symptoms of hay fever and allergies by physically blocking allergens, not by diagnosing or monitoring a condition through laboratory analysis.
- Device Description: The description focuses on the physical properties of the gel and its mechanism of action as a barrier.
- Performance Studies: The studies described evaluate the device's ability to reduce allergy symptoms and its residence time in the nasal cavity, not its ability to accurately detect or measure substances in biological samples.
Therefore, Bentrio™ functions as a physical barrier device applied topically to the nasal passages, which falls outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Bentrio 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, animal hair and dust mites.
Application of Bentrio produces a mucous-like gel barrier that coats the nasal membranes, traps inhaled allergens within the nasal cavity and helps with their clearance.
Product codes
NUP
Device Description
BentrioTM is a gel emulsion which is applied as a nasal spray for self-protection. It is intended to help protect against allergens such as pollen, house dust, animal hair and dust mites, which are inhaled through your nose and may cause allergic reactions. BentrioTM is free of any medication such as antihistamines or steroids and does not contain any preservatives.
The gel formulation of BentrioTM has been designed for extended residence time within the nose. Upon shaking of the spray bottle, it turns liquid which allows for spraying into the nose. After contact with the nasal mucosa, the formulation returns to its gel state and creates the protective barrier. BentrioTM is cleared from the nasal cavities over time into the throat and eliminated via the digestive tract.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nasal membranes/cavities
Indicated Patient Age Range
Adults and children (12 years old and older)
Intended User / Care Setting
Over-The-Counter Use
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
An open-label, cross-over, randomized, single center clinical study was conducted to demonstrate non-inferiority of Bentrio to the predicate device, Nasal Ease Allergy Blocker, in alleviating the symptoms of allergic rhinitis. Thirty-six study subjects were exposed to pollen in a Fraunhofer Allergen Chamber (ACC) prior to treatment then randomized and crossed-over after treatment with Bentrio or Nasal Ease. The difference of mean Total Nasal Symptom Score (TNSS) over 240 min during pollen challenge in the ACC (0-240 min) between Bentrio and Nasal Ease supported a conclusion of substantial equivalence for Bentrio relative to Nasal Ease.
Extended nasal residence time of Bentrio Allergy Blocker was demonstrated study with fluorescein-stained formulation in 8 healthy volunteers. The formulation remained in the inferior turbinate and septum for up to 240 minutes and in the middle turbinate for up to 90 minutes. Those results are consistent with the protective effects of Bentrio Allergy Blocker observed in the ACC study, which lasted - as for the predicate device - for up to four hours.
Clinical performance of Bentrio Allergy Blocker over two weeks was demonstrated in a multicenter, randomized, open-label, study. 25 subjects with seasonal allergic rhinitis self-administered Bentrio Allergy Blocker or saline nasal spray three times per day or as needed.
Key Metrics
Reduction in reflective TNSS (worst symptoms over the previous 24 hours) from 6.81 points during Run-in to 4.95 points during the 2-week treatment period for Bentrio Allergy Blocker group. This compares against a reduction from 7.37 to 6.69 points in the saline control group. The reduction was -1.9 points in the Bentrio Allergy Blocker group vs. -0.86 points in the saline control group.
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
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a larger font size than the name. The name is written as "U.S. FOOD & DRUG ADMINISTRATION".
June 24, 2022
Altamira Therapeutics, Inc. % Patrick Johnson Regulatory Consultant DuVal & Associates, P.A. Medical Arts Building, Suite 1820 825 Nicollet Mall Minneapolis, Minnesota 55402
Re: K213114
Trade/Device Name: Bentrio™ Allergy Blocker Regulation Number: 21 CFR 880.5045 Regulation Name: Medical Recirculating Air Cleaner Regulatory Class: Class II Product Code: NUP Dated: May 24, 2022 Received: May 25, 2022
Dear Patrick Johnson:
We have reviewed vour 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies.combination product submissions. 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 or any Federal
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531 -542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shu-Chen Peng, Ph.D. Assistant 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
Enclosure
2
Indications for Use
510(k) Number (if known) K213114
Device Name Bentrio(TM) Allergy Blocker
Indications for Use (Describe)
Bentrio 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, animal hair and dust mites.
Application of Bentrio produces a mucous-like gel barrier that coats the nasal membranes, traps inhaled allergens within the nasal cavity and helps with their clearance.
| 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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3
510(K) SUMMARY - K213114
Administrative Information
Submitter's Name and Address:
Altamira Therapeutics, Inc. 8 The Green, Ste B Dover, DE 19901 USA TEL 302 200 8095 Name of Contact Person: Elena Cavallini, Sr. RA Manager
Date Summary was Prepared: June 24, 2022
Name of Device
Trade or Proprietary Name: Bentrio 110 Allergy Blocker Common or Usual Name: Allergy Blocker Nasal Spray Classification Name: Cream, Nasal, Topical, Mechanical Allergen Particle Barrier CFR Reference: 21 CFR 880.5045 Product Code: NUP Regulatory Class: Class II
Predicate Device
K132520 - Nasal Ease Allergy Blocker, Hi-Tech Pharmacal. Inc.
Product Description
Bentrio" is a gel emulsion which is applied as a nasal spray for self-protection. It is intended to help protect against allergens such as pollen, house dust, animal hair and dust mites, which are inhaled through your nose and may cause allergic reactions. Bentrio™ is free of any medication such as antihistamines or steroids and does not contain any preservatives.
The gel formulation of Bentriot 11 has been designed for extended residence time within the nose. Upon shaking of the spray bottle, it turns liquid which allows for spraying into the nose. After contact with the nasal mucosa, the formulation returns to its gel state and creates the protective barrier. Bentrio™ is cleared from the nasal cavities over time into the throat and eliminated via the digestive tract.
Indications for Use
Bentrio" 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 hair and dust mites.
Application of Bentrio™ produces a mucous-like gel barrier that coats the nasal membranes, traps inhaled allergens within the nasal cavity and helps with their clearance.
Comparison to Predicate
4
| Subject Device | Predicate | |
|---|---|---|
| Parameter | Bentrio™ Allergy Blocker | Nasal Ease Allergy |
| Blocker K132520 | ||
| Indication for Use | Bentrio™ 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 hair and dust | ||
| mites. | ||
| Application of Bentrio™ produces | ||
| a mucous-like gel barrier that coats | ||
| the nasal membranes, traps inhaled | ||
| allergens within the nasal | ||
| cavity and helps with their | ||
| clearance. | 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. | ||
| Type of Use (Rx / | ||
| OTC) | OTC | OTC |
| User | Adults and children (12 years old | |
| and older) | Adults and children (12 years old | |
| and older) | ||
| Mechanism of | ||
| Action | Acts to block inhaled allergens | |
| within the nasal cavity | Acts to block inhaled allergens | |
| within the nasal cavity | ||
| User Contact Type | Nasal mucosa | Nasal mucosa |
| User Interface | Manually activated nasal spray | Manually activated nasal spray |
| Key design | Thixotropic water- | HPMC powder delivered via nasal |
| parameters | based gel consisting of GRAS | |
| inactive ingredients delivered via | ||
| metered-dose nasal spray | spray | |
| Sterility | Non-sterile | Non-sterile |
Non-Clinical Performance
Safety Testing & Toxicology
Bentrio's ingredients are well characterized and specified for purity and compatibility and are commonly used in medicinal products, cosmetics or in medical devices. The quantity, grade, and route of administration of these ingredients do not present any serious toxicological risks and the quantities administered when used as directed are well below any known recommended daily acceptance levels.
Biocompatibility
5
Biocompatibility testing included cytotoxicity, acute irritation and sensitization (product formulation excluding vanillin), and irritation and repeated dose acute systemic toxicity of the final product formulation. The results demonstrated that there are no biocompatibility concerns with Bentrio™ for the indicated patient population.
Stability and Shelf Life
Stability and shelf-life testing results support a shelf life of 9 months at 25°C. Once opened, labeling directs the consumer to use the product within 3 months.
Clinical Performance
An open-label, cross-over, randomized, single center clinical study was conducted to demonstrate non-inferiority of Bentrio to the predicate device, Nasal Ease Allergy Blocker, in alleviating the symptoms of allergic rhinitis. Thirty-six study subjects were exposed to pollen in a Fraunhofer Allergen Chamber (ACC) prior to treatment then randomized and crossed-over after treatment with Bentrio or Nasal Ease. The difference of mean Total Nasal Symptom Score (TNSS) over 240 min during pollen challenge in the ACC (0-240 min) between Bentrio and Nasal Ease supported a conclusion of substantial equivalence for Bentrio relative to Nasal Ease.
Image /page/5/Figure/5 description: The image is a line graph titled "Mean TNSS Values for all Time Points by Treatment (ITT)". The x-axis is labeled "Minutes in ACC" and ranges from -10 to 240. The y-axis is labeled "Mean TNSS" and ranges from 0 to 8. There are three lines on the graph, representing different medical devices: AM-301, HPMC, and Visit 4.
Mean TNSS Values for all Time Points by Treatment (ITT)
Extended nasal residence time of Bentrio Allergy Blocker was demonstrated study with fluorescein-stained formulation in 8 healthy volunteers. The formulation remained in the inferior turbinate and septum for up to 240 minutes and in the middle turbinate for up to 90 minutes. Those results are consistent with the protective effects of Bentrio Allergy Blocker observed in the ACC study, which lasted - as for the predicate device - for up to four hours.
Clinical performance of Bentrio Allergy Blocker over two weeks was demonstrated in a multicenter, randomized, open-label, study.
25 subjects with seasonal allergic rhinitis self-administered Bentrio Allergy Blocker or saline nasal spray three times per day or as needed. Treatment with Bentrio Allergy Blocker showed a reduction in the reflective TNSS (worst symptoms over the previous 24 hours) from 6.81
6
points during Run-in to 4.95 points during the 2-week treatment period. This compares against a reduction from 7.37 to 6.69 points in the saline control group. The reduction was -1.9 points in the Bentrio Allergy Blocker group vs. -0.86 points in the saline control group. Both treatments were shown to be well-tolerated.
Conclusions
Based on the formulation, intended use, and performance testing, Bentrio™ (K213114) is substantially equivalent to Nasal Ease Allergy Blocker (K132520). 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 symptoms from seasonal allergic rhinitis.