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.

AI/ML Overview

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Device Performance for Winx Sleep Therapy System (Winx+ Mouthpiece)

1. Table of Acceptance Criteria and Reported Device Performance

The provided 510(k) summary focuses on demonstrating substantial equivalence of the Winx+ mouthpiece to the predicate Winx mouthpiece, rather than setting entirely new, independent acceptance criteria for the Winx+ system. However, specific performance targets and safety metrics were evaluated.

Clinical Performance Acceptance Criteria (derived implicitly from non-inferiority claims):

Performance Metric	Acceptance Criteria (for Winx+ to be non-inferior to Winx)	Reported Device Performance (Winx+ Mouthpiece)
Effectiveness (Primary Endpoint):
Clinical Success Rate (First Night)	Non-inferiority to Winx mouthpiece, defined as AHI reduction of >50% compared to control PSG AND treatment AHI < 20 events per hour, with a delta (margin) set at -0.20 (i.e., Winx+ success rate should not be more than 20% lower than Winx, with statistical significance)	63.3% (19 of 30 subjects met clinical success criteria) against Winx's 40.0%. P<0.0001 for non-inferiority vs. Winx (with delta = -0.20).
Clinical Success Rate (Last Treatment Night - Long-term)	Non-inferiority to a proportion of 40% (likely the predicate's established performance based on previous studies), with a delta (margin) of -0.20. (This implies that for extended use, the Winx+ should maintain a success rate not more than 20% lower than the predicate's established long-term performance).	78.3% (18 of 23 subjects met clinical success criteria). P<0.001 for non-inferiority against a proportion of 40% (with delta = -0.20).
Safety:	No new safety issues identified. No serious or severe adverse events (AEs) related to the device. Minimal, self-resolving adverse events with no need for medical intervention or prescription medication.	No serious or severe AEs reported. 75% of AEs were mild, 25% moderate. All AEs resolved without medical intervention or prescription medication. Mean duration of AEs: 8.4 ± 9.3 days.

Non-Clinical Performance Criteria (for Winx Sleep Therapy System using Winx+ Mouthpiece):

Test	Acceptance Criteria	Reported Performance
Design Verification	Meet engineering specifications (performance, strength, reliability, life, component compatibility)	Pass
Electrical Safety	Pass IEC 60601-1 and 60601-1-2	Pass
Biocompatibility	Pass ISO 10993-1 (cytotoxicity, sensitization, oral irritation)	Pass
Environmental	Pass environmental testing	Pass
Shipping	Pass D4169-09	Pass
Acoustics	Pass ISO 7779	Pass

2. Sample Size Used for the Test Set and Data Provenance

The "test set" refers to the subjects enrolled in the clinical studies evaluating the Winx+ mouthpiece.

Randomization Study (comparing Winx+ vs. Winx):
- Sample Size: 30 subjects for each mouthpiece type (implied, as 12 of 30 for Winx and 19 of 30 for Winx+ are reported).
- Data Provenance: Not explicitly stated, but clinical studies for FDA submissions typically involve data from within the US or compliant international sites. The lack of specific country information points to a standard clinical trial setting. The study design (randomized, crossover) indicates a prospective collection of data.
Extension Study (long-term Winx+ follow-up):
- Sample Size: 23 subjects (18 of 23 achieved success). This study was a 30-day extension of subjects who likely participated in the initial phase or were new enrollees for long-term evaluation. 24 of 29 subjects completed the 30-day home-use period.
- Data Provenance: Not explicitly stated regarding country, but likely the same as the Randomization Study. This was also a prospective collection of data, following subjects over time.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

The primary endpoint (Clinical Success) was based on objective physiological measurements: Apnea-Hypopnea Index (AHI) determined by Polysomnography (PSG).

Number of Experts: Not explicitly stated how many experts reviewed each PSG. However, PSG studies are typically scored by trained and certified sleep technologists, often overseen or interpreted by a Board-Certified Sleep Physician. The document does not specify if multiple independent scorers were used for adjudication.
Qualifications of Experts: Assumed to be qualified sleep technologists and/or sleep physicians who are experts in interpreting PSG data according to established clinical guidelines for OSA diagnosis and severity. Specific years of experience are not mentioned.

4. Adjudication Method for the Test Set

The ground truth was established by Polysomnography (PSG) readings, with the primary endpoint being "Clinical Success" defined by specific AHI criteria (AHI reduction > 50% and treatment AHI < 20 events per hour).

The document does not explicitly describe an adjudication method for disagreements in PSG scoring if multiple scorers were used. It is standard practice for PSG labs to have quality control and review processes in place, but a formal (e.g., 2+1 or 3+1) adjudication method for the study's ground truth derivation is not detailed. The AHI is an objective metric derived from PSG parameters, generally reducing the need for subjective adjudication found in image-based diagnoses.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done.

This type of study is more common for diagnostic imaging devices where human readers interpret medical images with and without AI assistance. The Winx Sleep Therapy System is a treatment device, and its effectiveness was measured by objective physiological outcomes (AHI from PSG) rather than human interpretation of data. The "comparison" was between two device configurations (Winx vs. Winx+ mouthpiece) in treating patients, not a comparison of human reader performance.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study was Done

The Winx Sleep Therapy System is a medical device, not an AI algorithm. Therefore, the concept of a "standalone" study for an algorithm does not directly apply here.

The device itself operates autonomously, generating negative pressure. The "study" evaluated the device's performance when used by patients, with outcomes measured by clinicians using standard diagnostic tools (PSG). The comparison was between two versions of the device's mouthpiece (Winx vs. Winx+), effectively testing one device (Winx+) in a "standalone" therapeutic capacity against its predicate (Winx).

7. The Type of Ground Truth Used

The ground truth for evaluating effectiveness was based on objective physiological data from Polysomnography (PSG).

Specifics: The primary endpoint, "Clinical Success," was defined by an Apnea-Hypopnea Index (AHI) reduction of >50% (comparing treatment PSG to control PSG) and a treatment AHI of <20 events per hour. This is a widely accepted clinical metric for Obstructive Sleep Apnea (OSA) severity and treatment success.

8. The Sample Size for the Training Set

The document does not describe a "training set" in the context of an AI algorithm development. The Winx Sleep Therapy System is a physical device.

If we interpret "training set" broadly as the data used to initially develop or refine the device design before the pivotal clinical studies, that information is not provided. The provided text focuses on the clinical studies (Randomization and Extension) used for regulatory submission and demonstrating substantial equivalence.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a "training set" for an AI algorithm, or detailed information about the early development data for the physical device, this information is not available in the provided text. The non-clinical performance data (design verification, electrical, biocompatibility, etc.) were conducted to evaluate the device against engineering specifications and regulatory standards, which serve as foundational "ground truths" for safe and effective device design.

Summary

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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 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.

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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.

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operation	pharyngeal airway and oral tissuesurges soft palate and tongue anteriorlyout of airway. Airway remains atambient pressure while sealed oralcavity is maintained at lower pressure.Negative oral pressure supplied by theWinx Sleep Therapy System isdelivered via the mouthpiece to thepatient's mouth.
Anatomical sites	Intraoral	Same
Where used	Home	Same
Energy used ordelivered	Negative 25 inches of H2O at pump tomaintain negative 20 inches of H2O inoral cavity	Negative 20 inches of H2Oat pump to maintainnegative 20 inches of H2Oin 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
Storageconditions	-20° to 60°C, 15% to 95% relativehumidity	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 engineeringspecifications, including performance, strength,reliability, life, and component compatibility.	Pass
Electrical	Verify console passes electrical safety and EMCtesting per IEC 60601-1 and 60601-1-2. Safetytesting includes leakage currents, dielectricstrength, mechanical strength, excessivetemperatures, fire prevention, liquid overflow,and interruption of the power supply. EMCtesting includes conducted and radiatedemissions, electrostatic discharge, radiatedimmunity, and surge.	Pass

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Biocompatibility	Verify mouthpiece passes biocompatibilitytesting per ISO 10993-1. Specifically,cytotoxicity, sensitization, and oral irritation.	Pass
Environmental	Verify system passes environmental testing.	Pass
Shipping ·	Verify system passes shipping testing perD4169-09.	Pass
Acoustics	Verify system passes acoustics testing per ISO7779.	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 < 20 events per hour.

Randomization Study Subiects Meeting Clinical Success on First Treatment Night

Measure	Winx Mouthpiece	Winx+ Mouthpiece
Clinical Success Subjects	12 of 30	19 of 30
Success Rate	40.0%	63.3%*

*P<0001 for the test of non-inferiority of Winx+ against Winx based on the two-sample one-sided Z test for two proportions against delta=-0.20.

Extension Study Subjects Meeting Clinical Success on Last Treatment Night

Measure	Winx+, Last Night
Clinical Success Subjects	18 of 23
Success Rate	78.3%*

*P<0.001 for the test of non-inferiority against the proportion of 40% with delta of -0.20.

Safety

During treatment with the Winx+ mouthpiece, there were no serious or severe adverse events (AEs) reported. Seventy-five percent (75%) of the AEs were classified as mild in severity

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Winx Sleep Therapy System

(awareness of sign or symptom but easily tolerated; for example, a noted transient redness on tongue after removal of device) and twenty-five percent (25%) of the AEs were classified as moderate in severity (discomfort enough to cause interference with usual activity; for example, a subject with a sore mouth who had discomfort/difficulty drinking orange juice).

· Ten (10) events (oral tissue irritations/discomforts and dental discomforts) were treated with over-the-counter medication. One (1) subject had gum inflammation that was self-treated by gargling salt water. All AEs resolved without need of medical intervention or prescription medication. The mean duration of device-related AEs was 8.4+9.3 days (mean±SD), median (Q1, Q3) of 6 (3, 8) with a range of 1-38 days.

Listing of Device-Related Adverse Events for Winx+ Mouthpiece

Oral Tissue Irritation with Discomfort
Oral Tissue Irritation without Discomfort
Oral Tissue Discomfort without Irritation
Dental Discomfort
Dry Mouth
Excessive Salivation
Jaw Discomfort
Headache
Nasal congestion
Other
Cold Tight and numb feeling in mouth Mouth felt stretched out Tooth sensitivity Color of tongue Excessive mucous Sore neck Diminished sense of taste Jaw alignment change

Discussion

The objective of the Randomization and Extension Studies was to demonstrate that the safety and effectiveness of the Winx+ mouthpiece when used with the Winx Sleep Therapy System is substantially equivalent to the safety and effectiveness of the predicate Winx mouthpiece when used with the Winx Sleep Therapy System. The thirty-day home-use period was completed by 24 of 29 subjects who initiated it. No new safety issues were identified, there were no serious or severe AEs. and no medical interventions for AEs were required.

The effectiveness endpoints were met with p<0.001, demonstrating the non-inferiority of the effectiveness of the Winx+ mouthpiece during the first and last treatment nights when compared

ApniCure, Inc.

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Winx Sleep Therapy System

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to the Winx mouthpiece evaluated during the first treatment night in the Randomization Study and after a twenty-eight-day home-use period in the pivotal study of the predicate device.

Conclusion

The safety and effectiveness of the Winx Sleep Therapy System using the Winx+ mouthpiece were evaluated and found to be substantially equivalent to the Winx mouthpiece used with the Winx Sleep Therapy System previously cleared by FDA.

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/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure embracing a globe or sphere.

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

June 13, 2014

ApniCure, Inc. Chris Daniel Executive Vice President, Operations 900 Chesapeake Drive Redwood City, CA 94063

Re: K132003

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: May 15, 2014 Received: May 16, 2014

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.

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Page 2 - Mr. Chris 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 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 (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/or 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/ReportalProblem/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.

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

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Enclosure

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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)

K132003

Image /page/8/Picture/13 description: The image shows the logo for the Food and Drug Administration (FDA). The logo is made up of the letters "FDA" in a stylized font. The letters are outlined with a thick black line. The logo is simple and recognizable.

Anya C. Harry -S 2014.06.13 06:36:57 -04'00'

Regulation Number and Section

§ 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.”