INVENT SNORING DEVICE

K120665 · Ventus Medical, Inc. · LWF · Jun 12, 2012 · Ear, Nose, Throat

Device Facts

• Record ID: K120665
• Device Name: INVENT SNORING DEVICE
• Applicant: Ventus Medical, Inc.
• Product Code: LWF · Ear, Nose, Throat
• Decision Date: Jun 12, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.3900
• Device Class: Class 1
• Attributes: Therapeutic

Intended Use

The InVent Snoring Device is intended to reduce or eliminate snoring.

Device Story

InVent Snoring Device is an external nasal dilator placed over patient's nostrils to reduce or eliminate snoring. Device functions by creating expiratory positive airway pressure (EPAP) and directing expiratory flow through selected pathways to dilate and maintain nasal airway patency. Used by patients for self-application. Output is mechanical dilation of nasal passages; helps maintain airway pressure during expiration. Benefits include reduction or elimination of snoring.

Clinical Evidence

Bench testing confirmed device meets pre-defined specifications. Clinical testing supports safety and effectiveness for the intended use.

Technological Characteristics

External nasal dilator; utilizes expiratory resistance mechanism to create EPAP. Materials and dimensions modified from predicate. No electronic components, software, or energy source.

Indications for Use

Indicated for individuals seeking to reduce or eliminate snoring. Available for over-the-counter use.

Regulatory Classification

Identification

A nasal dilator is a device intended to provide temporary relief from transient causes of breathing difficulties resulting from structural abnormalities and/or transient causes of nasal congestion associated with reduced nasal airflow. The device decreases airway resistance and increases nasal airflow. The external nasal dilator is constructed from one or more layers of material upon which a spring material is attached, with a skin adhesive applied to adhere to the skin of the nose; it acts with a pulling action to open the nares. The internal nasal dilator is constructed from metal or plastic and is placed inside the nostrils; it acts by pushing the nostrils open or by gently pressing on the columella.

Predicate Devices

• BR2 Nasal Dilator

Submission Summary (Full Text)

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120665'

JUN 1 2 2012

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# 510(k) Summary

Date Summary Prepared: June 12, 2012

| 510(k) Owner: | Ventus Medical, Inc. |
|----------------------|-------------------------------------------------|
| | 101 Metro Drive, Suite 620 |
| | San Jose, CA 95110 |
| | Phone: [phone] |
| | Fax: [phone] |
| | [e-mail] |
| Contact Person: | Cindy Domecus, R.A.C. (US & EU) |
| | Principal, Domecus Consulting Services LLC |
| | Consultant to Ventus Medical, Inc. |
| | [phone] |
| Trade Name: | InVent Snoring Device |
| Common Name: | Nasal Dilator |
| Classification Name: | 21 CFR 874.3900 Nasal Dilator; Product Code LWF |
| Predicate Device: | BR2 Nasal Dilator |

## Device Description:

As with the predicate device, the subject device is a nasal dilator intended to reduce or eliminate snoring. While the predicate device is an internal nasal dilator, the subject device is an external nasal dilator in which the device is placed over the patient's nostrils. As with the predicate device, the subject device creates dilating pressure or expiratory positive airway pressure (EPAP) to dilate and open the nasal airway. The device directs expiratory flow though selected pathways, which maintain nasal airway pressure and help maintain nasal passage dilation.

Intended Use:

The InVent Snoring Device is intended to reduce or eliminate snoring.

## Technological Characteristics Comparison:

The predicate device and subject device have the same mechanism of action – expiratory resistance. Minor changes have been made to the dimensions and materials.

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## Performance Data:

Bench testing of the subject device confirms that it meets pre-defined specifications and is substantially equivalent to the predicate device. Clinical testing also supports that the device is safe and effective for its intended use.

# Conclusion:

The InVent Snoring Device is substantially equivalent to the BR2 predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Ventus Medical, Incorporated % Ms. Cindy Domecus, R.A.C. (US & EU) Principal Domecus Consulting Services LLC 1171 Barroilhet Drive Hillsborough, CA 94010

Re: K120665

Trade/Device Name: InVent Snoring Device Regulation Number: 21 CFR 874.3900 Regulation Name: Nasal dilator Regulatory Class: Class I Product Code: LWF Dated: May 2, 2012 Received: May 3, 2012

Dear Ms. Domecus:

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.

We note that your device exceeded the Limitations of exemptions from section 510(k) of the Federal Food. Drug. and Cosmetic Act (21 CFR Part 874.9), and therefore required the submission and clearance of a premarket notification prior to commercial distribution in the United States. Future devices of this same type that meet the exemption criteria and do not exceed the limitations of exemptions found in 21 CFR Part 874.9 will be exempt from the premarket notification requirements of the Act.

JUN 1 2 2012

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#### Page 2- Ms. Cindy Domecus

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); medical device reporting (reporting of medical device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Tou thay 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,

Affang for

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ventus Medical, Inc.

#### Indications for Use Statement 1.

### Indications for Use Form

Indications for Use 510(k) Number (if known): Device Name: InVent Snoring Device

Indications for Use:

The InVent Snoring Device is intended to reduce or eliminate snoring.

Prescription Use (Part 21 CFR 801 Subpart D)

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AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C) X

1

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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