WINX SLEEP THERAPY SYSTEM

K130538 · Apnicure, Inc. · OZR · May 22, 2013 · Dental

Device Facts

• Record ID: K130538
• Device Name: WINX SLEEP THERAPY SYSTEM
• Applicant: Apnicure, Inc.
• Product Code: OZR · Dental
• Decision Date: May 22, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The Winx Sleep Therapy System is indicated for home use in the treatment of obstructive sleep apnea (OSA) in adults.

Device Story

Winx Sleep Therapy System treats obstructive sleep apnea (OSA) via intraoral negative pressure. System components: bedside console, soft polymer mouthpiece, flexible tubing, and data management software. Patient wears mouthpiece during sleep; console generates gentle negative pressure delivered to oral cavity, holding tongue and soft palate forward to maintain airway patency. Console records usage time and pressure data. Clinicians use Winx Data Management Software on laboratory computers to download usage data and generate reports. Optional laboratory console version integrates with polysomnography (PSG) systems for real-time pressure monitoring by sleep technicians. Sizing determined via bite wax impressions and sizing templates or iPhone application. Device intended for home use by adult patients.

Clinical Evidence

Bench testing only.

Technological Characteristics

Intraoral pressure gradient device. Components: electronic bedside console, soft polymer mouthpiece, flexible polymer tubing. Console generates negative pressure; monitors pressure and usage time. Connectivity: data download to PC via software; optional laboratory console integrates with PSG systems. Sizing: bite wax impressions with template or iPhone application.

Indications for Use

Indicated for home treatment of obstructive sleep apnea (OSA) in adults.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• Winx Sleep Therapy System (K111549)
• Winx Sleep Therapy System (K122130)

Submission Summary (Full Text)

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### Winx Sleep Therapy System

Special 510(k) Notification

#### 2. 510(K) SUMMARY

MAY 2 2 2013

Date Prepared: February 6, 2013

# 510(k) Owner Information:

ApniCure, Inc. 900 Chesapeake Drive Redwood City, CA 94063

# Contact Person

Chris Daniel Executive Vice President, Operations [phone] Phone Number: Fax Number: [phone]

### 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 saliya, 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.

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# Mouthpiece

The 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 |
| | | K122130 |

# Performance Data:

Results of bench testing demonstrate that the Winx Sleep Therapy System is safe and effective for its intended use and substantially equivalent to the predicate.

#### Summary:

Based on the indications for use and product performance provided in this notification, the subject device has been shown to be substantially equivalent to the currently marketed predicate device.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle or bird symbol, with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.

#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

# May 22, 2013

Mr. Chris Daniel Executive Vice President Apnicure, Inc. 900 Chesapeake Drive Redwood City, California 94063

Re: K130538

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: Class II Product Code: OZR Dated: April 22, 2013

Received: April 23, 2013

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.

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

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Page 2 - Mr. Daniel

CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Kwame.O.Ulmer -S . for

Anthony D. Watson, B.S., M.S., M.B.A. Director

Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Winx Sleep Therapy System

Special 510(k) Notification

#### INDICATIONS FOR USE STATEMENT 1.

510(k) Number (if known):

K130538

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)

Amy K. Lieve 2013.05 21 36:57 -04'00'

(Division Sign-Off) (Division of Anesthesiology, General Hospital Infection Control, Dental Devices

510(k) Number:

ApniCure, Inc.

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