K Number
K071560
Device Name
PROVENT NASAL DILATOR, MODEL BR2
Date Cleared
2008-02-08

(246 days)

Product Code
Regulation Number
872.5570
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Provent™ Professional Sleep Apnea Therapy device is indicated for use in the treatment of obstructive sleep apnea (OSA).
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.
More Information

Not Found

No
The description focuses on a mechanical device that directs airflow and does not mention any computational or adaptive elements typically associated with AI/ML.

Yes
The device is specifically indicated for "treatment of obstructive sleep apnea (OSA)", directly stating its therapeutic purpose.

No
The device is indicated for "treatment of obstructive sleep apnea (OSA)," which means it is a therapeutic device, not a diagnostic one.

No

The device description clearly states it is a physical device placed inside the nostrils, indicating it is a hardware-based medical device.

Based on the provided information, the Provent™ Professional Sleep Apnea Therapy device is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use is for the treatment of obstructive sleep apnea (OSA). IVDs are used for the diagnosis or monitoring of diseases or conditions by examining samples taken from the human body (like blood, urine, tissue).
  • Device Description: The device is a physical device placed in the nostrils to affect airflow and pressure. It does not involve the analysis of biological samples.
  • Lack of IVD Indicators: The description does not mention any processes related to sample collection, analysis of biological markers, or laboratory testing, which are characteristic of IVDs.

The Provent device is a therapeutic device, not a diagnostic one.

N/A

Intended Use / Indications for Use

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

Product codes (comma separated list FDA assigned to the subject device)

LWF, BZD, MNT, MNS, OHP

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Nostrils (Inferred)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K030440, K063830, K063476, K071509, K070328, K063533, K063540, K053168

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

§ 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.”

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.

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