(347 days)
Not Found
No
The description focuses on hardware components, software for data management, and clinical study results, with no mention of AI or ML algorithms for diagnosis, treatment adjustment, or other functions.
Yes
The device is stated to be indicated for "treatment of obstructive sleep apnea (OSA) in adults," which classifies it as a therapeutic device.
No
The Winx Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA), not for diagnosis. While it has software to download usage data and generate patient reports, this is for monitoring treatment effectiveness, not for initial diagnosis.
No
The device description clearly lists multiple hardware components: a bedside console, a mouthpiece, and a flexible tube. While it includes software applications, it is not solely software.
Based on the provided information, the Winx Sleep Therapy System is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is "treatment of obstructive sleep apnea (OSA) in adults." This describes a therapeutic device, not a device used to examine specimens derived from the human body for the purpose of providing information for diagnosis, monitoring, or treatment.
- Device Description: The description details a system with a bedside console, mouthpiece, tube, and software for data management. These are components of a physical therapy system, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other elements typically associated with in vitro diagnostics.
The device is clearly intended to physically treat OSA by increasing airway patency, not to diagnose or monitor the condition through laboratory 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 and two (2) sizing methods. The components are: 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 sizing methods include: a sizing template and an iPhone sizing application (Winx Mouthpiece Sizing Application).
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
Two versions of the mouthpiece are provided - Winx and Winx+. The Winx+ mouthpiece includes a tonque pocket. Each mouthpiece is provided in ten (10) discrete sizes. Sleep technicians use a bite wax to obtain an impression of each patient's teeth and a sizing template or iPhone application to determine the best mouthpiece size.
Tubing
The tubing connects to the console and to the mouthpiece with custom connectors.
Winx Data Management Software Application
The Winx Data Management Software application resides on a sleep laboratory computer and allows clinicians to download usage data from the console and generate patient usage reports.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intraoral
Indicated Patient Age Range
Adults
Intended User / Care Setting
Home use
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)
Subjects were enrolled in two studies to evaluate the effectiveness and safety of the Winx+ mouthpiece.
- Study 1: Randomized, crossover study comparing first night effectiveness and safety after four nights of home use between the Winx+ mouthpieces using subjects who were naive to both treatments (Randomization Study).
Sample Size: 30 subjects
Key Result: Clinical Success Subjects: 19 of 30, Success Rate: 63.3% for Winx+ Mouthpiece vs. 12 of 30 Clinical Success Subjects, 40.0% Success Rate for Winx Mouthpiece. P 50% comparing treatment PSG to control PSG and treatment AHI
§ 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.”
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Winx Sleep Therapy System
510(k) Notification
510(K) SUMMARY 2.
JUN 1 3 2014
Date Prepared: June 9, 2014
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 Fax Number: . (650) 361-9399
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 and two (2) sizing methods. The components are: 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 sizing methods include: a sizing template and an iPhone sizing application (Winx Mouthpiece Sizing Application).
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.
ApniCure. Inc.
1
Mouthpiece
Two versions of the mouthpiece are provided - Winx and Winx+. The Winx+ mouthpiece includes a tonque pocket. Each mouthpiece is provided in ten (10) discrete sizes. Sleep technicians use a bite wax to obtain an impression of each patient's teeth and a sizing template or iPhone application to determine the best mouthpiece size.
Tubing
The tubing connects to the console and to the mouthpiece with custom connectors.
Winx Data Management Software Application
The Winx Data Management Software application resides on a sleep laboratory computer and allows clinicians 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 pressure, which is delivered through the mouthpiece into the oral cavity and holds the tongue and soft palate out of the airway. The console records patient usage data (e.g., hours 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:
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 | 510(k) # |
|---|---|---|
| Winx Sleep Therapy System | ApniCure | K111549 |
Technological Characteristics:
| Characteristic | Winx Sleep Therapy System (Predicate) | Winx+ |
|---|---|---|
| K Number | K111549 | K132003 |
| Intended Use | Treatment of obstructive sleep apnea (OSA). | Same |
| Indications for Use | The Winx Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults. | Same: |
| Target population | Adults who have obstructive sleep apnea. | Same |
| Mode of | Pressure gradient developed between | Same |
ApniCure, Inc.
2
| operation | pharyngeal airway and oral tissues
urges soft palate and tongue anteriorly
out of airway. Airway remains at
ambient pressure while sealed oral
cavity is maintained at lower pressure.
Negative oral pressure supplied by the
Winx Sleep Therapy System is
delivered via the mouthpiece to the
patient's mouth. | |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|
| Anatomical sites | Intraoral | Same |
| Where used | Home | Same |
| Energy used or
delivered | Negative 25 inches of H2O at pump to
maintain negative 20 inches of H2O in
oral cavity | Negative 20 inches of H2O
at pump to maintain
negative 20 inches of H2O
in oral cavity |
| Patient | Polymers (polycarbonate, | Same |
| Contacting | thermoplastic elastomer, Tygon | |
| Materials | tubing), adhesive | |
| Biocompatibility | Meets ISO 10993 | Same |
| Sterility | Non-sterile | Same |
| Electrical Safety | Meets IEC 60601-1 and 60601-1-2 | Same |
| Operating | 5° to 40°C, 15% to 95% relative | Same |
| conditions | humidity | |
| Storage
conditions | -20° to 60°C, 15% to 95% relative
humidity | Same |
| Vacuum area | Flat bar with multiple vacuum ports | Curved bar with 1 vacuum |
| shape | | port |
| Lip seal shape | No tongue pocket | Tongue pocket |
Non-Clinical Performance Data:
Design verification & validation testing were performed on the Winx Sleep Therapy System using the Winx+ Mouthpiece.
The test protocols were developed based on product requirements, specifications, and risk analyses. ApniCure uses a Failure Mode and Effect Analysis (FMEA) to assess the impact of proposed device modifications. Non-clinical testing is summarized below.
| Test | Test Method Summary | Results |
|---|---|---|
| Design verification | Verify system meets its engineering | |
| specifications, including performance, strength, | ||
| reliability, life, and component compatibility. | Pass | |
| Electrical | Verify console passes electrical safety and EMC | |
| testing per IEC 60601-1 and 60601-1-2. Safety | ||
| testing includes leakage currents, dielectric | ||
| strength, mechanical strength, excessive | ||
| temperatures, fire prevention, liquid overflow, | ||
| and interruption of the power supply. EMC | ||
| testing includes conducted and radiated | ||
| emissions, electrostatic discharge, radiated | ||
| immunity, and surge. | Pass |
3
| Biocompatibility | Verify mouthpiece passes biocompatibility
testing per ISO 10993-1. Specifically,
cytotoxicity, sensitization, and oral irritation. | Pass |
|------------------|------------------------------------------------------------------------------------------------------------------------------------------|------|
| Environmental | Verify system passes environmental testing. | Pass |
| Shipping · | Verify system passes shipping testing per
D4169-09. | Pass |
| Acoustics | Verify system passes acoustics testing per ISO
7779. | Pass |
Results of non-clinical testing demonstrate that the Winx Sleep Therapy System using the Winx+ Mouthpiece is as safe and as effective for its intended use and substantially equivalent to the predicate.
Clinical Performance Data:
Materials, Methods, and Study Population
Subjects were enrolled in two studies to evaluate the effectiveness and safety of the Winx+ mouthpiece. The first study was a randomized, crossover study comparing first night effectiveness and safety after four nights of home use between the Winx+ mouthpieces using subjects who were naive to both treatments (Randomization Study). The second study was a thirty-day extension using the Winx+ mouthpiece at home followed by a second treatment PSG and safety evaluation (Extension Study).
The subject population included otherwise healthy subjects with OSA. Male and female subjects between the ages of 18 and 80 were included without discrimination by gender, and subjects of all races and ethnicities were equally eligible to participate in the studies.
Results
Effectiveness
The Primary Endpoint was defined as Clinical Success on treatment night determined by apnea-hypopnea index (AHI) and defined as AHI reduction of > 50% comparing treatment PSG to control PSG and treatment AHI Sincerelv vours. FOR
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
.
.
.
.
Enclosure
8
INDICATIONS FOR USE STATEMENT 1.
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 X (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)
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Anya C. Harry -S 2014.06.13 06:36:57 -04'00'