NASALGUARD

K053625 · Trutek Corp · NUP · Feb 22, 2006 · General Hospital

Device Facts

• Record ID: K053625
• Device Name: NASALGUARD
• Applicant: Trutek Corp
• Product Code: NUP · General Hospital
• Decision Date: Feb 22, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5045
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

NasalGuard® 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.

Device Story

NasalGuard is a water-based, non-sterile topical gel composed of GRAS cosmetic-grade ingredients. Applied by the user to the skin around the nostrils and upper lip, the gel utilizes cationic properties to attract and trap airborne allergens before they enter the nasal passages. The product is intended for over-the-counter use, with reapplication required every 4-6 hours. By physically blocking allergens, the device aims to alleviate mild allergic symptoms such as nasal irritation, congestion, and rhinorrhea. It does not penetrate the dermal layer. Clinical efficacy was evaluated in a double-blind, crossover study comparing symptom reduction against a predicate control.

Clinical Evidence

Double-blind, crossover study of 43 subjects with allergic rhinitis. Primary endpoint: reduction of allergic symptoms compared to active control (Alergol). Results showed 79% of subjects were responders (high responders + responders) for NasalGuard vs 75% for Alergol. Chi-square test p-value = 0.7974, indicating no statistically significant difference between treatments. Bench testing demonstrated NasalGuard captured mold spores approximately three times more effectively than a silicon gel control.

Technological Characteristics

Water-based gel; GRAS cosmetic-grade ingredients; topical application; non-sterile; non-penetrating; physical allergen-trapping mechanism via cationic properties; 7g ointment form factor.

Indications for Use

Indicated for individuals experiencing mild allergic rhinitis symptoms, including itchy, runny, or congested nasal passages, triggered by environmental allergens such as pollen, house dust, animal hair, and dust mites.

Regulatory Classification

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

• Dr.Theiss Alergol Pollen Blocker Cream (K042610)

Submission Summary (Full Text)

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K053625

NasalGuard® 510(k)

FEB 2 2 2006

#### 510(k) Summary 16.0

Name of Device

Trade Name: NasalGuard Allergen Blocker Gel Common Name: NasalGuard Classification Name: Unclassified

Predicate Device

| 510(K) | Manufacturer | Device | Approval<br>Date |
|---------|----------------------------------------|-------------------------------------------|------------------|
| K042610 | Dr. Theiss Naturwaren<br>Gmbh, Germany | Dr.Theiss Alergol<br>Pollen Blocker Cream | 05/16/2005 |

#### Device Description

NasalGuard is a water-based gel consisting of common, GRAS cosmetic grade ingredients. The product is applied by finger or cotton swab to the outside of the masal passages, around the nostrils and upper lip. NasalGuard utilizes a patented methodology that uses the cationic properties of its ingredients to create an memodology that assess the causens ne allergens before they enter the nasal passages.

The gel is considered innocuous and does not penetrate the dermal layer of the skin. The get is concrease on lasts for 4-6 hours before the gel has to be reapplied. NasalGuard is intended for topical use and provided non-sterile.

#### Intended Use

NasalGuard® is intended to promote alleviation of mild allergic symptoms (i.e. mild I wasal 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 Characteristics

NasalGuard (7g nasal ointment) is a water-based gel that contains cosmetic grade ivasarQuard 72 habar ommonly found in commonly used lotions, creams, gels and other conditioners for the hair and skin.

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#### Safety Testing

By using a water-based gel that contains only GRAS cosmetic grade ingredients, Dy doing a wa maintained as an innocuous and safe product. There have been no Nusured is maints adverse effects resulting from its use by over 20,000 users.

### Laboratory Testing

Leberco Testing Inc. has tested NasalGuard for primary dermal irritation, primary eye irritation, gingival irritation and acute oral toxicity. The findings indicate NasalGuard milution, gingirdi invicological standards. NasalGuard poses no health risks or as innocabab from tomesalGuard is intended for topical use and provided non-sterile.

### Summary of Clinical Results

A double blind, crossover study of 43 subjects with known allergic rhinitis condition r r double of the use of NasalGuard showed significant efficant efficacy during the trial in reducing allergic rhinitis symptoms compared with an active control.

These test data has been statistically analyzed as per the Alergol clinical study criteria.

The chi-square test has p-value = 0.7974, which indicates that no statistically significant difference exists between these two treatments. However, the results indicate a somewhat more efficacious trend for the NasalGuard compared with Alergol.

| | Device | |
|------------------------------------------|------------|---------|
| Patient Percentage | NasalGuard | Alergol |
| High Responders | 56% | 51% |
| Responders | 23% | 24% |
| Non-Responders | 21% | 25% |
| High Responders &<br>Responders Combined | 79% | 75% |

The comparative responses of the patients are classified as follows:

# Proof of Substantial Equivalency of NasalGuard to Alergol

The Predicate device Alergol data is used as a control and Statistical Analysis of the data proves that NasalGuard is equally efficient as the predicate device in reducing the symptoms of Allergic Rhinitis.

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The Asthma Center conducted a Mold and Pollen Spore counting bench test. The Astimal Contor Coapturing capacity of NasalGuard, Alergol with Silicon gel. Comparing the ponen captaring caparting capard on average captured mold spores approximately three times more than the control, Silicon Gel.

## Conclusions:

By virtue of its physical characteristics and intended use, the NasalGuard Allergy Dy virtue of its physical enarcessively cleared to be marketed to be marketed in the United States; specifically Alergol.

NasalGuard poses no safety threat to users and has been demonstrated to attract airborne allergens and work as intended.

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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 2 2006

Denison Pharmaceuticals, Inc. c/o Mr. Ashok L. Wahi Trutek Corporation 80 West End Ave. Somerville, NJ 08876

Re: K053625

Trade/Device Name: NasalGuard® Regulation Number: 21 CFR 880.5045 Regulation Name: Medical recirculating air cleaner Regulatory Class: Class II Product Code: NUP Dated: December 22, 2005 Received: December 29, 2005

Dear Mr. Wahi:

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 for woo battle in 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 I ou may, alere, mains of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can may be subject to back as a leaderal 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 that I Dri has Intatutes and regulations administered by other Federal agencies. You must or uny 1 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

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## Page 2 - Mr. Ashok L. Wahi

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will anow you to oegin maneting of substantial equivalence of your device to a legally premits that it and in the PDA miams of basistically for your device and thus, permits your device to proceed to the market.

- If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you desire specific advice for your ac 110 - 110 - 110 - 11 - 11 - 11 - 11 - 11 - 11 Conact the Office of Complance as (est notification" (21CFR Part 807.97). You may obtain Misoranding by reference to premailso international in the Act from the Division of Small other general information on Jour respective Assistance at its toll-free number (800) 638-204) or Manufacturers, International and Consultion of Consumers of the news of the new learners himl.
Sincerely yours,

MB Egblew, and

Malvina B. Eydelman, M.D. Acting Division 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 Statement 13.0

Device Name: NasalGuard

KOS3625 510(k) Number:

Indications for Use:

NasalGuard® is intended to promote alleviation of mild allergic symptoms (i.e. Nusal Onara - 13 menaca id pro itchy, runny or congested nasal passages) mita nusul in hation including arious allergens including environmental pollens, house dust, animal hairs and dust mites.

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) OR

Over-The-Counter-Use J________________________________________________________________________________________________________________________________________________________ (Optional format)

Karen H. Lober
(Division Sign-Off)

Division of Ophth Nose and Throat Do

510(k) Number K053625