(105 days)
Not Found
No
The summary describes a mechanical system for treating sleep apnea and a software application for data management, with no mention of AI or ML capabilities.
Yes
The device is clearly indicated for the treatment of obstructive sleep apnea (OSA) in adults.
No
The device is used for treatment of obstructive sleep apnea (OSA) by increasing airway patency, not for diagnosis.
No
The device description clearly states that the system consists of four main components, including a bedside console, mouthpiece, and flexible tube, in addition to the software application. This indicates the presence of significant hardware components.
Based on the provided information, the Winx Sleep Therapy System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the treatment of obstructive sleep apnea (OSA) in adults. 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 description details a system that physically interacts with the patient (mouthpiece, tube, console) to increase airway patency. It does not involve the analysis of biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
The Winx Sleep Therapy System is a therapeutic device used to treat a medical condition, not a diagnostic device used to identify or monitor a condition through the analysis of biological samples.
N/A
Intended Use / Indications for Use
The Winx Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults.
Product codes
OZR
Device Description
The Winx Sleep Therapy System consists of four (4) main components: a small electronic bedside console, a soft polymer mouthpiece, a flexible polymer tube that connects the mouthpiece to the console, and a physicians' software application (Winx Data Management Software) that allows clinicians to download usage data from the console and generate patient usage reports.
The mouthpiece is an intraoral device that is worn during sleep. The system is designed to increase airway patency and decrease airway obstruction.
Console
The console generates a gentle negative pressure, collects excess saliva, records patient use time, and monitors pressure. The console is provided with a power cord. which connects to a standard electrical outlet. An optional laboratory console is available for use in a sleep laboratory. The laboratory console includes wires that extend from the console. The wires connect to the sleep laboratory's polysomnography (PSG) system, allowing the sleep technicians to view the console's pressure on the same monitor as the other PSG channels.
Mouthpiece
The mouthpiece is provided in ten (10) discrete sizes. Sleep technicians use a bite rne mouthplood is pression of each patient's teeth and a sizing template to determine the best mouthpiece size.
Tubing
r ubing
The tubing connects to the console by screwing into the console base and to the mouthpiece with luer connectors.
Winx Data Management Software Application
The Winx Data Management Software application resides on a sleep laboratory The Winx Buta Manageniaans to download usage data from the console and generate patient usage reports.
Use
The patient connects the system and places the mouthpiece in his or her mouth. The mouthpiece is worn during sleep. The console generates a gentle, negative rne mouthplood to worn canning ough the mouthpiece into the oral cavity and holds pressure, which to usingte out of the airway. The console records patient usage data the tongue and days of use, oral cavity pressure). Clinicians can download patient usage data from the console to review usage and generate usage reports.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity
Indicated Patient Age Range
adults
Intended User / Care Setting
Home use, sleep laboratory
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)
Performance Data:
r chornance been hesting demonstrate that the Winx Sleep Therapy System is safe and effective for its intended use and substantially equivalent to the predicate.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 V 222136 2.
Date Prepared: July 16, 2012
OCT 3 1 2012
510(k) Owner Information:
ApniCure. Inc. 900 Chesapeake Drive Redwood City, CA 94063
Contact Person
Chris Daniel Executive Vice President. Operations Phone Number: (650) 361-9300 (650) 361-9399 Fax Number:
Device Information:
Trade Name: Common Name: Classification: Classification Name: Winx Sleep Therapy System Intraoral Pressure Gradient Device Class II . Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea (21 CFR 872.5570, Product Code OZR)
Physical Description:
The Winx Sleep Therapy System consists of four (4) main components: a small electronic bedside console, a soft polymer mouthpiece, a flexible polymer tube that connects the mouthpiece to the console, and a physicians' software application (Winx Data Management Software) that allows clinicians to download usage data from the console and generate patient usage reports.
The mouthpiece is an intraoral device that is worn during sleep. The system is designed to increase airway patency and decrease airway obstruction.
Console
The console generates a gentle negative pressure, collects excess saliva, records patient use time, and monitors pressure. The console is provided with a power cord. which connects to a standard electrical outlet. An optional laboratory console is available for use in a sleep laboratory. The laboratory console includes wires that extend from the console. The wires connect to the sleep laboratory's polysomnography (PSG) system, allowing the sleep technicians to view the console's pressure on the same monitor as the other PSG channels.
1
Mouthpiece
The mouthpiece is provided in ten (10) discrete sizes. Sleep technicians use a bite rne mouthplood is pression of each patient's teeth and a sizing template to determine the best mouthpiece size.
Tubing
r ubing
The tubing connects to the console by screwing into the console base and to the mouthpiece with luer connectors.
Winx Data Management Software Application
The Winx Data Management Software application resides on a sleep laboratory The Winx Buta Manageniaans to download usage data from the console and generate patient usage reports.
Use
The patient connects the system and places the mouthpiece in his or her mouth. The mouthpiece is worn during sleep. The console generates a gentle, negative rne mouthplood to worn canning ough the mouthpiece into the oral cavity and holds pressure, which to usingte out of the airway. The console records patient usage data the tongue and days of use, oral cavity pressure). Clinicians can download patient usage data from the console to review usage and generate usage reports.
Indications for Use:
muleations for 560.
The Winx Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults.
Substantial Equivalence:
The Winx Sleep Therapy System is substantially equivalent in intended use, indications for use, and technological characteristics to the following device:
| Name | .
. Manufacturer
| STATE AND STATES AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND AND A BROAD AND A BREACH AND A BREACH AND A BREACH AN
510(k) # |
|----------------------------------------|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| ' Attune Sleep Apnea System ApniCure | | K111549 |
Performance Data:
r chornance been hesting demonstrate that the Winx Sleep Therapy System is safe and effective for its intended use and substantially equivalent to the predicate.
Summary:
Gased on the indications for use and product performance provided in this notification, the Dasca on the Indications for also and substantially equivalent to the currently marketed predicate device.
2
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
OCT 31 2012
ApniCure, Incorporated Mr. Chris Daniel Executive Vice President 900 Chesapeake Drive Redwood City, California 94063
Re: K122130
Trade/Device Name: Winx Sleep Therapy System Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II
Product Code: OZR Dated: September 28, 2012 Received: October 1, 2012
Dear Mr. Daniel:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.
3
Page 2- Mr. Daniel
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing (repertice 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Th. for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
INDICATIONS FOR USE STATEMENT 1.
K122130 510(k) Number (if known):
Device Name: Winx Sleep Therapy System
Indications for Use:
The Winx Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
L. Schult
Division Sign-(Division Sign-Off)
Division of Anesthesiology, General Hospital
Division of Anesthesiology, General Devices Division Control, Dental Device
510(k) Number:
CONFIDENTIAL