PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)

K102404 · Ventus Medical, Inc. · OHP · Dec 2, 2010 · Dental

Device Facts

• Record ID: K102404
• Device Name: PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 80); PROVENT PROFESSIONAL SLEEP APNEA THERAPY (PROVENT 50)
• Applicant: Ventus Medical, Inc.
• Product Code: OHP · Dental
• Decision Date: Dec 2, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The PROVENT® Sleep Apnea Therapy Device is indicated for use in the treatment of obstructive sleep apnea (OSA).

Device Story

PROVENT Sleep Apnea Therapy (PROVENT 80/PROVENT 50) is a nasal device placed inside nostrils. It functions by directing expiratory flow through specific pathways to increase intranasal pressure, mimicking the expiratory phase of CPAP therapy. Used by patients for OSA treatment. Device provides mechanical resistance to expiration to maintain airway patency during sleep. No electronic components, software, or algorithms involved.

Clinical Evidence

Non-clinical and clinical testing demonstrated substantial equivalence to predicate devices. No specific metrics or study details provided in the summary.

Technological Characteristics

Intraoral/nasal device. Mechanical resistance mechanism to increase intranasal pressure during expiration. No energy source, software, or connectivity.

Indications for Use

Indicated for treatment of obstructive sleep apnea (OSA) in patients requiring therapy.

Regulatory Classification

Identification

Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.

Special Controls

*Classification.* Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”

Predicate Devices

• Provent™ Professional Sleep Apnea Therapy (K071560)
• Provent™ Professional Sleep Apnea Therapy (K090398)

Submission Summary (Full Text)

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### 510(k) Summary

| 510(k) Applicant: | Ventus Medical, Inc.<br>1301 Shoreway Road, Suite 425<br>Belmont, CA 94002<br>[phone] (phone)<br>[phone] (fax) |
|------------------------|------------------------------------------------------------------------------------------------------------------------------|
| | DEC 9 2010 |
| Contact: | Mike Nevares<br>Director, Quality & Regulatory |
| Date Summary Prepared: | August 20, 2010 |
| Name of Device: | PROVENT® Sleep Apnea Therapy:<br>• PROVENT 80 (PROVENT HR)<br>• PROVENT 50 (PROVENT SR) |
| Common Name: | Intraoral device |
| Classification Name: | Intraoral devices for snoring and intraoral devices for<br>snoring and obstructive sleep apnea (21 CFR 872.5570) |
| Product Code: | OHP |
| Predicate Devices: | Provent™ Professional Sleep Apnea Therapy, K071560<br>Provent™ Professional Sleep Apnea Therapy, K090398 |

# Device Description

The PROVENT device is placed just inside the nostrils. The device directs expiratory flow through selected pathways, which increases intranasal pressure similar to the expiratory portion of the breathing cycle during CPAP use.

# Indications for Use

For the treatment of obstructive sleep apnea (OSA).

## Performance Data

Non-clinical and clinical testing demonstrated substantial equivalence of the modified devices to the predicate devices when used according to the intended use.

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Image /page/1/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract design of an eagle with three lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle emblem.

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

Ventus Medical Incorporated c/o Mr. Michael P. Nevares Director, Quality and Regulatory 1301 Shoreway Road, Suite 425 Belmont, CA 94002

DEC 2 2010

Re: K102404 Trade/Device Name: PROVENT® Sleep Apnea Therapy

Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring, and Intraoral Devices for Snoring and Obstructive Sleep Apnea

Obstructive Sleep Apnea
Class II

Regulatory Class: Class II Product Code: OHP Dated: August 27, 2010 Received: September 30, 2010

Dear Mr. Nevares:

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.

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Page 2 - Mr. Michael P. Nevares

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 (OS) 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/CDRH/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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

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

Sincerely yours,

Quk. Then mf

Malvina B. Eydelman, M 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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K102404

Ventus Medical, Inc.

Special 510(k)

#### Indications for Use

510(k) Number (if known):

Device Name: PROVENT® Sleep Apnea Therapy:

- . PROVENT 80
- PROVENT 50 .

Indications for Use:

The PROVENT® Sleep Apnea Therapy Device is indicated for use in the treatment of obstructive sleep apnea (OSA).

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Anakut

(Division S Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

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Confidential

510(k) Number K102404

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