RHINIX™ nasal filter for patients aged 6 years and older, with properties that allow unimpeded nasal breathing, is for the prevention or alleviation of seasonal allergic rhinitis (hay fever) and for seasonal or perennial allergies to other airborne allergens with a similar size fraction to grass pollen allergens.

Device Description

The device consists of a filtering membrane/media and a frame. The filtering membrane is a planar filter made of polypropylene non-woven fibers. The frame is made of medical grade SEBS compound which is a biocompatible polymer designed for human skin contact. Each filter section in each nostril is connected via the frame's u-shaped bridge. The device is made in multiple sizes.

The device is inserted in the nostrils and is in contact with unbroken skin in the anterior vestibule of the nostrils (non-invasive). The device functions as a filtering device (mechanical barrier) that removes particles (pollen) from the inhaled air. The filter allows adequate air movement while breathing through the nose. The device is single-use and should only be used when exposed to allergens.

AI/ML Overview

The provided document describes the Rhinix™ nasal filter and its substantial equivalence to predicate devices, supported by a clinical trial. However, it does not explicitly present acceptance criteria in a table format with reported device performance against those criteria. Instead, it discusses the findings of a clinical trial that serves to demonstrate the device's effectiveness.

Here's a breakdown of the information that can be extracted, and where details are missing, it will be noted:

1. A table of acceptance criteria and the reported device performance

The document does not provide a formal table of acceptance criteria. However, based on the clinical trial results, the implicit criteria can be inferred from the statistically significant improvements observed.

Acceptance Criteria (Implied)	Reported Device Performance
Significant reduction in daily symptoms of hay fever (Total TNSS).	Rhinix™ significantly reduced daily symptoms of hay fever as measured by total TNSS (p=0.049).
Significant reduction in specific symptoms (Sneezing, itching, rhinorrhea, throat irritation).	Sneezing, itching, rhinorrhea, and throat irritation were also significantly reduced compared to placebo.
No significant perception of increased nasal resistance compared to placebo.	There was no difference in perception of increased nasal resistance when wearing Rhinix™ compared to a placebo device.
Safety of use.	The study indicated that a Rhinix™ Nasal Filter is safe to use.
Allows unimpeded breathing.	Rhinix™ could thus be considered to allow unimpeded breathing (based on no perceived increase in nasal resistance compared to placebo).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: The document mentions a clinical trial (NCT01699165) which is a "randomized, double-blind, placebo-controlled crossover clinical trial." However, the specific number of participants (sample size) in this trial is not provided in the given text.
Data Provenance:
- Country of Origin: Not explicitly stated in the provided text.
- Retrospective or Prospective: The study is described as a "randomized, double-blind, placebo-controlled crossover clinical trial," which is a prospective study design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the document. For a self-administered device like a nasal filter for hay fever, ground truth on symptom reduction would typically be self-reported by patients using validated questionnaires or symptom scores. Expert consensus for ground truth on patient-reported outcomes is not usually applicable in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable/provided. Adjudication methods are typically used when there are subjective interpretations of medical images or other complex data requiring multiple expert reviewers. For a clinical trial assessing symptom reduction of a physical device, the outcome measures are usually direct patient reports or objective physiological measurements, not requiring adjudication in the sense of expert review of initial assessments.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging AI tools, not for a physical device like a nasal filter.
Effect Size of AI assistance: This is not applicable as there is no AI component described for this device.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance: Yes, in a way. The clinical trial investigated the performance of the Rhinix™ nasal filter as a standalone device in alleviating symptoms. It is a physical device, so "algorithm only" or "human-in-the-loop" are not directly applicable concepts in the same way they would be for a software device. The clinical trial assessed the device's efficacy on its own when used by individuals.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The ground truth for the clinical trial would be based on patient-reported outcomes data, specifically questionnaires or scales measuring symptoms of allergic rhinitis (e.g., Total Nasal Symptom Score - TNSS) and perception of nasal resistance.

8. The sample size for the training set

This information is not applicable/provided. A "training set" refers to data used to train machine learning models. The Rhinix™ nasal filter is a physical medical device, not a software algorithm that requires training data in the machine learning sense. The clinical trial described is for validation, not training.

9. How the ground truth for the training set was established

This information is not applicable/provided for the reasons stated in point 8.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

September 4, 2014

Rhinix Aps % Ms. Mette Munch OA Consultant Otto Ruds Gade 34, 2th DK-8200 Aarhus N Denmark

Re: K134003

Trade/Device Name: Rhinix™ nasal filter Regulation Number: 21 CFR 880.5045 Regulation Name: Medical recirculating air cleaner Regulatory Class: Class II Product Code: NUP Dated: Julv 8, 2014 Received: August 7, 2014

Dear Ms. Munch:

We have reviewed your 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. 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 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 (reporting of medical device

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related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Deborah L. Falls -

ഗ for Malvina Eydelman Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K134003

Device Name Rhinix™ nasal filter

Indications for Use (Describe)

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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K134003

Image /page/3/Picture/1 description: The image shows the logo for Rhinix Nasal Filters. The word "RHINIX" is in large, bold, sans-serif font on the top line. Below that, in a smaller font, are the words "NASAL FILTERS."

510(k) summary – Rhinix™ nasal filter

Administrative information:

Name:	Rhinix Aps
Address:	Otto Ruds Gade 34, 2thDK-8200 Aarhus NDenmark
Contact person:	Mette Munch, QA Consultant
Cell phone:	+45 29872000
E-mail:	mm@addaction.dk

Date of summary: 29-Aug-2014

Name of device:

Trade name: Rhinix Nasal Filter Common name: Nasal filter Classification name: Recirculating Air Filter (NUP)

Predicate devices:

510(k) or reg. no	Manufacturer	Device	Product Code
K120894	HayMaxTM Limited,Bedfordshire, UK	HaymaxTM OrganicDrug-Free PollenBarrier Balm	NUP
3007479155	Sam JoungInternational	Nosk Nose Filters	LWF
3007279871	Airware Holdings	Air Allergy AdvancedNasal Filter	LWF

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K134003

Image /page/4/Picture/1 description: The image shows the logo for Rhinix Nasal Filters. The word "RHINIX" is in bold, black letters on the top line, and the words "NASAL FILTERS" are in a smaller, gray font on the bottom line. The letters "TM" are in superscript in the upper right corner of the logo.

Device description:

Intended use:

Rhinix™ nasal filter for patients aged 6 years and older, with properties that allow unimpeded nasal breathing, is for the prevention or alleviation of seasonal allergic rhinitis (hay fever) and for seasonal or perennial allergies to other airborne allergens with a similar size fraction to grass pollen allergens.

Comparison to Predicate Device:

Table 1: Comparison between Rhinix™ nasal filter and K120894 – Haymax™ with respect to intended use:

	Rhinix™ nasal filter	K120894 – Haymax™
Intended use	Rhinix™ nasal filter forpatients aged 6 years and older,with properties that allowunimpeded nasal breathing, isfor the prevention oralleviation of seasonal allergicrhinitis (hay fever) and forseasonal or perennial allergiesto other airborne allergens witha similar size fraction to grasspollen allergens.	HayMax™ is intended topromote alleviation of mildallergic symptoms (i.e. mildnasal irritation, including itchy,runny, or congested nasalpassages), triggered by theinhalation of various airborneallergens including grass andtree pollen, house dust miteand animal dander. It isintended to be used by anyonewho experiences symptoms ofhayfever or allergic rhinitic. Asit is drug-free and organic it isalso considered suitable forchildren or pregnant women.

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Image /page/5/Picture/0 description: The image shows the logo for Rhinix Nasal Filters. The word "RHINIX" is in large, bold, black letters, with "TM" in a smaller font in the upper right corner. Below "RHINIX" is the phrase "NASAL FILTERS" in a smaller, lighter font.

Summary of technical characteristics of device compared to predicate devices:

Rhinix™ nasal filter and Haymax™ Pollen Barrier Palm achieve their intended use based on a similar principle, which is to introduce a barrier that reduces the pollen load in the nasal cavity. Haymax™ Pollen Barrier Palm achieves this using a drug free topical viscous balm applied around the nasal cavity. Rhinix™ achieves its intended use with a membrane just inside the entrance to the nasal cavity. It has been shown in bench tests that the membrane used in a Rhinix™ nasal filter has an airflow resistance below the level of perception. It has also been shown in bench tests that a Rhinix™ Nasal Filter membrane removes particles with a similar size distribution to pollens from the air stream. They are both provided non-sterile, non-prescriptive for over-the-counter use.

The comparison between Rhinix™ nasal filter and Nosk Nose Filter and Air Allergy Advanced Nasal Filter, respectively, is illustrated in figure 1 below. The comparison relates especially to the general design elements of the products. They all consist of three essential parts: a frame, a membrane and a connecting u-shaped bridge. Their contact with the nasal cavity is also equivalent as they all have to be inserted into the nostrils. Nosk Nose filters and Rhinix TM Nasal Filters both use a polypropylene membrane, which is non-toxic. The intended use of Nosk Nose Filter and Air Allergy Advanced Filter is as a nasal dilator, which is different from the intended use of the Rhinix™ Nasal Filter. This difference in intended use does not influence the safety of Rhinix™ when compared to Nosk Nose filter and Air Allergy Advanced Filter and does not influence the effectiveness of Rhinix™ in being placed in the anterior nasal cavity similar to the predicate devices. Rhinix™ uses a membrane that allows unimpeded breathing and that removes pollens sufficiently to reduce allergy symptoms (see below for clinical data).

Image /page/5/Picture/5 description: The image shows four different types of nasal dilators. The first dilator is blue and has a textured surface. The second dilator is orange and has a smooth surface. The third dilator is clear and has a smooth surface. All of the dilators are designed to be inserted into the nostrils to help open up the nasal passages.

Fig 1: Comparison of RhinixTM nasal filters with two LWF devices. Left: Nosk Nose Filters (Sam Joung International, reg no. 3007479155). Middle: Air Allergy Advanced Nasal Filer (Airware Holdings, reg. no. 3007279871) Right: Rhinix™M Nasal Filter.

Predicate devices and Rhinix™ Nasal Filter do not contain software and do not require EMC and Electrical Safety evaluation.

Summary of substantial equivalence based on clinical data Haymax™ Pollen Barrier Palm has been cleared for the intended use of alleviation of seasonal

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Image /page/6/Picture/0 description: The image shows the logo for Rhinix Nasal Filters. The word "RHINIX" is written in bold, black letters, with the letters "NASAL FILTERS" written in a smaller, gray font below. The letters "TM" are written in a small, black font in the upper right corner of the logo.

K134003

allergic rhinitis. The clinical trial (NCT01699165) reported in the Journal of Allergy and Clinical Immunology titled "Nasal filters for the treatment of allergic rhinitis: A randomized, double-blind, placebo-controlled crossover clinical trial" demonstrated that Rhinix™ significantly reduced daily symptoms of hav fever as measured by total TNSS (p=0.049). Sneezing, itching and rhinorrhea, as well as throat irritation were also significantly reduced compared to placebo. The study also showed that there was no difference in perception of increased nasal resistance when wearing Rhinix™ compared to a placebo device, and Rhinix™ could thus be considered to allow unimpeded breathing. Finally, the study indicated that a Rhinix™ Nasal Filter is safe to use.

Thus, based on the intended use of providing alleviation of seasonal allergic rhinitis, Rhinix™ is substantial equivalent to the predicate device Haymax™M Pollen Barrier Palm.

Conclusion on substantial equivalence based on technical comparison and clinical data:

Rhinix™ Nasal Filters pose no safety threat or health risk to users and has been demonstrated demonstrated to reduce symptoms related to seasonal allergic rhinitis and work as intended. Because of the physical/mechanical mode of action there are no known interactions with other medicines and it can be safely used complimentary to other forms of treatment of allergic rhinitis.

Thus, by virtue of the physical characteristics and intended use, the Rhinix™ nasal filter is substantially equivalent to devices legally cleared to be marketed in the United States.

Verification of Summary:

Rhinix ApS can verify that the summary includes only information that is also covered in the body of the 510(k). The summary does not contain any puffery or unsubstantiated labeling claims. The summary does not contain any raw data only summary data. The summary does not contain any trade secret or confidential commercial information. The summary does not contain any patient identification information.

Regulation Number and Section

§ 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).