AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE

K082762 · Aardvark Medical · JCX · Nov 12, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K082762
• Device Name: AARDVARK NASAL IRRIGATION AND ASPIRATION DEVICE
• Applicant: Aardvark Medical
• Product Code: JCX · General, Plastic Surgery
• Decision Date: Nov 12, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4780
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric, 3rd-Party Reviewed

Intended Use

The Aardvark Medical Device is intended for use in nasal and sinus lavage. The device facilitates instillation of saline into the nasal passage and provides powered suction to either 1) directly evacuate the nasal passage, or 2) to remove the fluid and effluent by aspirating from the opposite nostril in a maneuver similar to the Proetz displacement or aspiration irrigation maneuver. The device is used to treat conditions and disorders of the upper respiratory tract where homeostasis of the nasal mucosa is disturbed, resulting in symptoms such as catarrh and mucopurulent or crust sceretions. Such conditions and disorders include: Rhinitis (as a symptom of colds, allergies, etc.) and both acute and chronic Sinusitis It can also be used to collect mucus samples for subsequent testing. It is intended for use in adults and children in either the physician's office or in the home.

Device Story

Aardvark nasal irrigation and aspiration system facilitates saline instillation into nasal passages and provides mild powered suction for fluid/effluent removal. Operates via handheld, battery-powered unit with disposable tips; includes charger. Used in physician offices or home settings by clinicians or patients. Enables direct evacuation or Proetz displacement/aspiration irrigation maneuvers. Assists in treating rhinitis and sinusitis by clearing catarrh, mucopurulent, or crust secretions; also enables mucus sample collection for diagnostic testing. Clinical benefit derived from restoring nasal mucosa homeostasis.

Clinical Evidence

Bench testing only. Device verification testing performed under the company's Design Control Process confirmed conformance to specifications.

Technological Characteristics

Handheld, battery-operated powered suction device. Includes disposable tip portion and external charger. Mechanical suction principle. No software or complex electronics described.

Indications for Use

Indicated for adults and children with upper respiratory tract conditions where nasal mucosa homeostasis is disturbed, including rhinitis (colds, allergies) and acute/chronic sinusitis. Used for nasal/sinus lavage, mucus collection, and evacuation of secretions.

Regulatory Classification

Identification

A powered suction pump is a portable, AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. The device may be used during surgery in the operating room or at the patient's bedside. The device may include a microbial filter.

Predicate Devices

• Rhinoflow Micronized ENT Wash System (K973875)
• Orwell Fluid Collections and Disposal System (K989845)
• DeVilbiss Suction Device (K982304)
• The EMG suction Unit (K063448)

Submission Summary (Full Text)

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| | 510(k) Summary<br>Prepared August 30, 2008<br>Revised November 6, 2008<br>NOV 12 2008 |
|-----------------|----------------------------------------------------------------------------------------|
| Submitted by: | Aardvark Medical, Company<br>P.O. Box 1654<br>Ross, California 94957 |
| Contact Person: | Chris Baker M.D.<br>Telephone: [phone]<br>c-mail: [e-mail] |
| Product Name: | Aardvark nasal irrigation and aspiration device |
| Common Name: | Powered Nasal Irrigator and Aspirator |
| Classification: | Powered Nasal Aspirator 874.5550 Class I<br>Powered Portable Suction 878.4780 Class II |

## Predicate Devices:

| Device Name | Manufacturer | K Number |
|----------------------------------------------------|---------------------------|----------|
| Rhinoflow<br>Micronized ENT<br>Wash System | Respironics | K973875 |
| Orwell Fluid<br>Collections and<br>Disposal System | Cardinal Health | K989845 |
| DeVilbiss<br>Suction Device | Sunrise Medical | K982304 |
| The EMG<br>suction Unit | EMG Technology<br>Company | K063448 |

### Description of Device:

The Aardvark device is designed to make nasal and sinus lavage easy and convenient. The device facilitates instillation of salinc into the nasal passage. It then provides mild powered suction to remove the fluid from the nostril. Alternatively, it can bc used on the opposite nostril while intermittently occluding the sprayed nostril, i.e., the Proetz Displacement mancuver. The device consists of a hand held battery opcrated unit with a disposable tip portion. A charger is provided with the device.

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### Intended Use:

The Aardyark Medical Device is intended for use in nasal and sinus lavage. The device facilitates instillation of saline into the nasal passage and provides powered suction to either 1) directly evacuate the nasal passage, or 2) to remove the fluid and effluent by aspirating from the opposite nostril in a maneuver similar to the Proetz displacement or aspiration irrigation maneuver. The device is used to treat conditions and disorders of the upper respiratory tract where homeostasis of the nasal mucosa is disturbed, resulting in symptoms such as catarrh and mucopurulent or crust sceretions. Such conditions and disorders include: Rhinitis (as a symptom of colds, allergies, etc.) and both acute and chronic Sinusitis It can also be used to collect mucus samples for subsequent testing. It is intended for use in adults and children in either the physician's office or in the home.

### Comparison with Predicate Devices:

The submission device and the predicate devices have substantially equivalent intended use and technological specifications.

#### Performance:

The Aardvark device verification testing under the company's Design Control Process has confirmed the device's conformance with specifications. The specifications do not include any significant differences from those of the predicates.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Aardvark Medical Company c/o Marc Job Regulatory Technology Services, LLC 1394 25th Street NW Buffalo, MN 55313

NOV 1 2 2008

Re: K082762

Trade/Device Name: Aardvark Nasal Irrigation and Aspiration System Regulation Number: 21 CFR 878.4780 Regulation Name: Powered suction pump Regulatory Class: Class II Product Code: JCX Dated: October 28, 2008 Received: October 29, 2008

Dear Mr. Job:

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.

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 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); 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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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

M.B. Egerthans, mD

Malvina B. Eydelman, M.D. 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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510(k) Number (if known):

Device Name: Aardvark Nasal Irrigation and Aspiration System

Indications For Use:

The Aardvark Medical Device is intended for use in nasal and sinus lavage. The device facilitates instillation of saline into the nasal passage and provides powered suction to either 1) directly evacuate the nasal passage, or 2) to remove the fluid and effluent by aspirating from the opposite nostril in a maneuver similar to the Proetz displacement or Aspiration Irrigation Maneuver. The device is used to treat conditions and disorders of the upper respiratory tract where homeostasis of the nasal mucosa is disturbed, resulting in symptoms such as catarrh and mucopurulent or crust secretions. Such conditions and disorders include: Rhinitis (as a symptom of colds, allergies, etc.) and both acute and chronic Sinusitis. It can also be used to collect mucus samples for subsequent testing. It is intended for use in adults and children in either the physician's office or in the home.

X Prescription Use (Per 21CFR 801)

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Concurrence Of CDRH, Office Of Device Evaluation (ODE)

D.

Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devices

510(k) Number*K082762*