(45 days)
The PROVENT Professional Sleep Apnea Therapy Device - PROVENT 50 intended use is for the treatment of obstructive sleep apnea (OSA).
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.
The provided 510(k) summary for K090398, "PROVENT™ Professional Sleep Apnea Therapy – 50 cm H2O sec/liter", does not contain the detailed information requested regarding acceptance criteria, study design for device performance, or human-in-the-loop studies.
Instead, the summary states:
"Non-clinical and clinical testing demonstrated substantial equivalence of the PROVENT 50 device to the predicate device when used according to its intended use."
This indicates that the submission relied on demonstrating the new device (PROVENT 50) was substantially equivalent to a previously cleared predicate device (Provent™ Professional Sleep Apnea Therapy, K071560), rather than presenting new, detailed performance study data against specific quantitative acceptance criteria or evaluating AI components. Since this device is not an AI/ML powered device, the questions regarding multi-reader multi-case studies, standalone algorithm performance, and ground truth establishment for AI models are not applicable.
Therefore, I cannot provide the requested information from the given text. A 510(k) summary typically provides a high-level overview and does not always include the exhaustive details of performance studies that would be found in the full 510(k) submission.
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510(k) Summary
| 510(k) Applicant: | Ventus Medical, Inc.1301 Shoreway Road, Suite 425Belmont, 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 cmH2O sec/liter |
| Common Name: | Intraoral device |
| Classification Name: | Intraoral devices for snoring and intraoral devices forsnoring 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.
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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.
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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. 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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§ 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.”