← Product Code [NUP](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NUP) · K213114 # BentrioTM Allergy Blocker (K213114) _Altamira Therapeutics, Inc. · NUP · Jun 24, 2022 · General Hospital · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NUP/K213114 ## Device Facts - **Applicant:** Altamira Therapeutics, Inc. - **Product Code:** [NUP](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NUP.md) - **Decision Date:** Jun 24, 2022 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 880.5045 - **Device Class:** Class 2 - **Review Panel:** General Hospital - **Attributes:** Therapeutic ## 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. ## Device Story Bentrio is a thixotropic, water-based gel emulsion delivered via a manually activated metered-dose nasal spray. Upon shaking, the formulation liquefies for administration; upon contact with nasal mucosa, it reverts to a gel state. This gel creates a physical, mucous-like barrier that coats nasal membranes, traps inhaled allergens (pollen, dust, animal hair), and facilitates their clearance. Used by patients (OTC) for self-protection against allergic rhinitis symptoms. The device is non-medicated (no antihistamines/steroids) and non-preserved. It is cleared from the nasal cavity into the throat and eliminated via the digestive tract. The barrier effect provides up to four hours of protection, alleviating nasal irritation and congestion. ## Clinical Evidence Clinical evidence includes an open-label, randomized, cross-over study (n=36) in a pollen allergen chamber (ACC) comparing Bentrio to the predicate. Results showed non-inferiority in mean Total Nasal Symptom Score (TNSS) over 240 minutes. A separate multicenter, randomized, open-label study (n=25) compared Bentrio to saline control over two weeks; Bentrio showed a reflective TNSS reduction of 1.9 points vs. 0.86 points for saline. Residence time study (n=8) confirmed gel presence in nasal turbinates for up to 240 minutes. ## Technological Characteristics Thixotropic water-based gel emulsion; GRAS inactive ingredients. Metered-dose nasal spray delivery. Non-sterile. Mechanical barrier principle. Shelf life 9 months at 25°C; 3-month in-use stability. ## Regulatory 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. ## Predicate Devices - Nasal Ease Allergy Blocker ([K132520](/device/K132520.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {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) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {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. --- **Source:** [https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NUP/K213114](https://fda.innolitics.com/submissions/EN/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/NUP/K213114) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com