(45 days)
Not Found
No
The summary describes a mechanical device that uses physical pathways to manage airflow, with no mention of AI/ML terms or data processing that would suggest such technology.
Yes
The device's intended use is for the "treatment of obstructive sleep apnea (OSA)", which is a therapeutic purpose.
No
The device is described as a "Therapy Device" used for "treatment" of obstructive sleep apnea (OSA) by directing expiratory flow to increase intranasal pressure, which is a therapeutic mechanism, not a diagnostic one.
No
The device description explicitly states it is a physical device placed inside the nostrils, which is a hardware component.
Based on the provided information, this 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)". This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is placed in the nostrils and affects airflow to treat a condition. It does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or any other processes typically associated with in vitro diagnostics.
IVDs are devices used to examine specimens taken from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device directly treats a condition by altering airflow.
N/A
Intended Use / Indications for Use
The PROVENT Professional Sleep Apnea Therapy Device - PROVENT 50 intended use is for the treatment of obstructive sleep apnea (OSA).
Product codes (comma separated list FDA assigned to the subject device)
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
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)
Non-clinical and clinical testing demonstrated substantial equivalence of the PROVENT 50 device to the predicate device when used according to 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.
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
510(k) Summary
| 510(k) Applicant: | Ventus Medical, Inc.
1301 Shoreway Road, Suite 425
Belmont, CA 94002
(650) 832-6118 (phone)
(650) 632-4198 (fax)
APR - 3 2009 |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact: | Mary Rose, R.A.C.
Manager, Regulatory Affairs |
| Date Summary Prepared: | February 13, 2009 |
| Name of Device: | PROVENT™ Professional Sleep Apnea Therapy – 50 cm
H2O sec/liter |
| Common Name: | Intraoral device |
| Classification Name: | Intraoral devices for snoring and intraoral devices for
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.
1
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.
2
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. 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.
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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