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.

AI/ML Overview

The provided text describes a 510(k) submission for the Provent™ Professional Sleep Apnea Therapy device. While it mentions that "Bench and clinical performance data were submitted to support the 510(k) Notification" and that "The bench and clinical testing demonstrated that the device is safe and effective for its intended use," it does not provide specific acceptance criteria or details of the study that proves the device meets those criteria.

The document primarily focuses on establishing substantial equivalence to predicate devices based on indications for use, product codes, mechanism of action, and other general characteristics.

Therefore, I cannot populate the requested table and information based on the provided text.

Specifically, the following information is missing from the provided text:

A table of acceptance criteria and the reported device performance: No specific performance metrics or acceptance thresholds are mentioned.
Sample sized used for the test set and the data provenance: No details on the number of patients/subjects, their demographics, or where the data came from (e.g., country, retrospective/prospective).
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: There is no mention of expert involvement or ground truth establishment for a test set.
Adjudication method: Not applicable as no expert review process is described.
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: This device is a therapeutic device, not an AI-powered diagnostic tool, so an MRMC study is not relevant in this context.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable as this is a physical therapeutic device.
The type of ground truth used: No ground truth is mentioned.
The sample size for the training set: This refers to a machine learning context, which is not applicable here.
How the ground truth for the training set was established: Not applicable.

Summary

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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 (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) ●

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Device Description

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.

	ProventDevice	Oasys OralAirwaySystem,KO30440	EMS PEEPValves,K983920	Intraoraldevices,cervicalpillows,CPAP/BiPAPdevices andaccessories,RF, and laserdevices
Indicationsfor Use	The Proventdevice isindicated forthe treatmentofobstructivesleep apnea(OSA).	The OASYSOral AirwaySystem isintended toreduce oralleviatesnoring andobstructivesleep apnea,OSA.	An accessoryto providepositive endexpiratorypressurebreathingcapabilities tomanualresuscitator,therapeuticCPAPsystems,ventilatorcircuits...	As noted inabove tables,all these devicecategories havebeen classifiedas Class II andcleared for usein OSA via the510(k) route.
ProductCode	LWF, BZD,MNT, MNS	LRK, LWF	BYE	LRK, LOZ,MYB, BZD,MNT, MNS,GEX, GEI

10-2

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	ProventDevice	Oasys OralAirwaySystem,KO30440	EMS PEEPValves,K983920	Intraoraldevices,cervicalpillows,CPAP/BiPAPdevices andaccessories,RF, and laserdevices
Mechanismof OSAtreatment	Expiratorypositiveairwaypressure	Nasal dilationandmandibularadvancement	Providespositive endexpiratorypressurebreathingcapabilities totherapeuticCPAP systems	Various
Sterility	Not sterile	Not sterile	Not sterile	Varies
Expirationdating	None	None	Unknown	Varies
PrescriptionUse	Yes	Yes	Yes	Yes
At HomeUse	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

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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 (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

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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

Regulation Number and Section

§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.

(a)
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.(b)
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.”