PROVENT PROFESSIONAL SLEEP APNEA THERAPY

K090398 · Ventus Medical, Inc. · OHP · Apr 3, 2009 · Dental

Device Facts

• Record ID: K090398
• Device Name: PROVENT PROFESSIONAL SLEEP APNEA THERAPY
• Applicant: Ventus Medical, Inc.
• Product Code: OHP · Dental
• Decision Date: Apr 3, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The PROVENT Professional Sleep Apnea Therapy Device - PROVENT 50 intended use is for the treatment of obstructive sleep apnea (OSA).

Device Story

PROVENT 50 is a nasal device placed inside nostrils. It directs expiratory flow through specific pathways to increase intranasal pressure, mimicking the expiratory phase of CPAP therapy. Used for obstructive sleep apnea treatment. Device operates passively via airflow resistance; no active power source or software. Patient-applied; used during sleep. Output is physiological pressure modulation during expiration, intended to maintain airway patency and reduce apnea events.

Clinical Evidence

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

Technological Characteristics

Intranasal device; passive airflow resistance mechanism; 50 cm H2O sec/liter resistance specification. No electronic components, software, or external power source.

Indications for Use

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

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)

Submission Summary (Full Text)

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K090398

### 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)<br>APR - 3 2009 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mary Rose, R.A.C.<br>Manager, Regulatory Affairs |
| Date Summary Prepared: | February 13, 2009 |
| Name of Device: | PROVENT™ Professional Sleep Apnea Therapy – 50 cm<br>H2O sec/liter |
| 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 Device: | Provent™ Professional Sleep Apnea Therapy, K071560 |

# 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 PROVENT 50 device to the predicate device when used according to its intended use.

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its body and wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ventus Medical c/o Mary Rose Manager, Regulatory Affairs 1301 Shoreway Road, Suite 425 Belmont, CA 94002

APR - 3 2009

Re: K090398 Trade/Device Name: PROVENT 50 Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea Regulatory Class: Class II Product Code: OHP Dated: February 13, 2009 Received: February 17, 2009

Dear Ms. Rose :

We have reviewed your Section 510(k) premarket notification of intent to market the device wf the reviews 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 econment of pror to recordance 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, atorely missions 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 or any i 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 CI K Far 607); adoling (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. Egolins, 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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Ventus Medical, Inc.

K050398

Special 510(k)

### Indications for Use

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

PROVENT Professional Sleep Apnea Therapy Device - PROVENT 50 Device Name: _ . Indications for Use:

The PROVENT Professional Sleep Apnea Therapy Device - PROVENT 50 intended use is for the treatment of obstructive sleep apnea (OSA).

Prescription Use × (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (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)

Luca T

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

510(k) Number

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