PROVENT NASAL DILATOR, MODEL BR2

K071560 · Ventus Medical, Inc. · OHP · Feb 8, 2008 · Dental

Device Facts

• Record ID: K071560
• Device Name: PROVENT NASAL DILATOR, MODEL BR2
• Applicant: Ventus Medical, Inc.
• Product Code: OHP · Dental
• Decision Date: Feb 8, 2008
• 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 is indicated for use in the treatment of obstructive sleep apnea (OSA).

Device Story

Provent device; nasal-placed; directs expiratory flow through specific pathways; increases intranasal pressure during expiration; mimics expiratory portion of CPAP breathing cycle; used at home by patients; prescription-only; non-invasive treatment for OSA; provides positive end-expiratory pressure without external power or machine.

Clinical Evidence

Bench and clinical performance data submitted. Testing demonstrated device safety and effectiveness for the treatment of obstructive sleep apnea.

Technological Characteristics

Nasal-placed device; provides expiratory positive airway pressure; non-sterile; prescription use; home-use capable; mechanical design; no external energy source.

Indications for Use

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

• Oasys Oral Airway System (K030440)
• EMS PEEP Valves (K983920)

Reference Devices

• REMstar Auto M-Series with AFLEX Series CPAP System (K063830)
• Breas iSleep 20i System (K063476)
• BiPAP Synchrony (K071509, K070328, K063533)
• BiPAP Auto SV (K063540)
• BiPAP Focus (K053168)

Submission Summary (Full Text)

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K071560
FEB - 8 2008

# 510(K) SUMMARY

510(k) Applicant: Ventus Medical, Inc. 1301 Shoreway Road, Suite 340 Belmont, CA 94002 Menlo Park, CA 94025 [phone] (phone) [phone] (fax)

Cindy Domecus, R.A.C. (US & EU) Contact: Domecus Consulting Services LLC [phone] (phone) [phone] (fax)

Date Summary Prepared: February 7, 2008

Provent™ Professional Sleep Apnea Therapy Name of Device:

Intraoral device Common Name:

Classification Name: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea (21 CFR 872.5570)

Predicate devices included in the 510(k) Notification are Predicate Device: noted in the below table of comparison to predicate devices. A few examples are cited below.

- Oasys Oral Airway System, K030440 .
- REMstar Auto M-Series with AFLEX Series CPAP System (K063830) ●
- Breas iSleep 20i System (K063476) .
- BiPAP Synchrony (K071509, K070328, K063533) .
- BiPAP Auto SV (K063540) .
- BiPAP Focus (K053168) ●

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## 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).

## Comparison to Predicate Devices:

The below table shows a comparison of the Provent device to its predicates.

| | Provent<br>Device | Oasys Oral<br>Airway<br>System,<br>KO30440 | EMS PEEP<br>Valves,<br>K983920 | Intraoral<br>devices,<br>cervical<br>pillows,<br>CPAP/BiPAP<br>devices and<br>accessories,<br>RF, and laser<br>devices |
|------------------------|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications<br>for Use | The Provent<br>device is<br>indicated for<br>the treatment<br>of<br>obstructive<br>sleep apnea<br>(OSA). | The OASYS<br>Oral Airway<br>System is<br>intended to<br>reduce or<br>alleviate<br>snoring and<br>obstructive<br>sleep apnea,<br>OSA. | An accessory<br>to provide<br>positive end<br>expiratory<br>pressure<br>breathing<br>capabilities to<br>manual<br>resuscitator,<br>therapeutic<br>CPAP<br>systems,<br>ventilator<br>circuits... | As noted in<br>above tables,<br>all these device<br>categories have<br>been classified<br>as Class II and<br>cleared for use<br>in OSA via the<br>510(k) route. |
| Product<br>Code | LWF, BZD,<br>MNT, MNS | LRK, LWF | BYE | LRK, LOZ,<br>MYB, BZD,<br>MNT, MNS,<br>GEX, GEI |

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| | Provent<br>Device | Oasys Oral<br>Airway<br>System,<br>KO30440 | EMS PEEP<br>Valves,<br>K983920 | Intraoral<br>devices,<br>cervical<br>pillows,<br>CPAP/BiPAP<br>devices and<br>accessories,<br>RF, and laser<br>devices |
|----------------------------------|----------------------------------------------|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Mechanism<br>of OSA<br>treatment | Expiratory<br>positive<br>airway<br>pressure | Nasal dilation<br>and<br>mandibular<br>advancement | Provides<br>positive end<br>expiratory<br>pressure<br>breathing<br>capabilities to<br>therapeutic<br>CPAP systems | Various |
| Sterility | Not sterile | Not sterile | Not sterile | Varies |
| Expiration<br>dating | None | None | Unknown | Varies |
| Prescription<br>Use | Yes | Yes | Yes | Yes |
| At Home<br>Use | Yes | Yes | Yes | Varies |

### Performance Data

.

Bench and clinical performance data were submitted to support the 510(k) Notification. The bench and clinical testing demonstrated that the device is safe and effective for its intended use.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/2 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, facing right. The eagle is composed of three thick, curved lines. Encircling the eagle is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.

FEB -- 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ventus Medical, Inc. c/o Cindy Domecus, R.A.C. Regulatory Consultant 1171 Barroilhet Drive Hillsborough, CA 94010

Re: K071560 Trade/Device Name: Provent™ Professional Sleep Apnea Therapy 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: January 23, 2008 Received: January 24, 2008

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.

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. Egleston, myD

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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#### INDICATIONS FOR USE

510(k) Number (if known): K071560

Device Name: Provent™ Professional Sleep Apnea Therapy

Indications for Use:

The Provent™ Professional Sleep Apnea Therapy device is indicated for use in the treatment of obstructive sleep apnea (OSA).

Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Karen H. Baker

510(k) Number K071560