← Product Code [OHP](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/OHP) · K071560 # PROVENT NASAL DILATOR, MODEL BR2 (K071560) _Ventus Medical, Inc. · OHP · Feb 8, 2008 · Dental · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/OHP/K071560 ## Device Facts - **Applicant:** Ventus Medical, Inc. - **Product Code:** [OHP](/submissions/DE/subpart-f%E2%80%94therapeutic-devices/OHP.md) - **Decision Date:** Feb 8, 2008 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 872.5570 - **Device Class:** Class 2 - **Review Panel:** Dental - **Attributes:** Therapeutic ## Indications for 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. ## Regulatory 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](/device/K030440.md)) - EMS PEEP Valves ([K983920](/device/K983920.md)) ## Reference Devices - REMstar Auto M-Series with AFLEX Series CPAP System ([K063830](/device/K063830.md)) - Breas iSleep 20i System ([K063476](/device/K063476.md)) - BiPAP Synchrony ([K071509](/device/K071509.md), [K070328](/device/K070328.md), [K063533](/device/K063533.md)) - BiPAP Auto SV ([K063540](/device/K063540.md)) - BiPAP Focus ([K053168](/device/K053168.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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 (650) 632-4199 (phone) (650) 632-4198 (fax) Cindy Domecus, R.A.C. (US & EU) Contact: Domecus Consulting Services LLC (650) 343-4813 (phone) (650) 343-7822 (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) ● 10-1 24 {1}------------------------------------------------ ## 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
Device | Oasys Oral
Airway
System,
KO30440 | EMS PEEP
Valves,
K983920 | Intraoral
devices,
cervical
pillows,
CPAP/BiPAP
devices and
accessories,
RF, and laser
devices | |------------------------|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------| | Indications
for Use | The Provent
device is
indicated for
the treatment
of
obstructive
sleep apnea
(OSA). | The OASYS
Oral Airway
System is
intended to
reduce or
alleviate
snoring and
obstructive
sleep apnea,
OSA. | An accessory
to provide
positive end
expiratory
pressure
breathing
capabilities to
manual
resuscitator,
therapeutic
CPAP
systems,
ventilator
circuits... | As noted in
above tables,
all these device
categories have
been classified
as Class II and
cleared for use
in OSA via the
510(k) route. | | Product
Code | LWF, BZD,
MNT, MNS | LRK, LWF | BYE | LRK, LOZ,
MYB, BZD,
MNT, MNS,
GEX, GEI | 10-2 {2}------------------------------------------------ | | Provent
Device | Oasys Oral
Airway
System,
KO30440 | EMS PEEP
Valves,
K983920 | Intraoral
devices,
cervical
pillows,
CPAP/BiPAP
devices and
accessories,
RF, and laser
devices | |----------------------------------|----------------------------------------------|----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------| | Mechanism
of OSA
treatment | Expiratory
positive
airway
pressure | Nasal dilation
and
mandibular
advancement | Provides
positive end
expiratory
pressure
breathing
capabilities to
therapeutic
CPAP systems | Various | | Sterility | Not sterile | Not sterile | Not sterile | Varies | | Expiration
dating | None | None | Unknown | Varies | | Prescription
Use | Yes | Yes | Yes | Yes | | At Home
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. 10-3 2 ୧ {3}------------------------------------------------ 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. {4}------------------------------------------------ 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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 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 {5}------------------------------------------------ #### 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 --- **Source:** [https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/OHP/K071560](https://fda.innolitics.com/submissions/DE/subpart-f%E2%80%94therapeutic-devices/OHP/K071560) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com