SnoreRx

K170825 · Apnea Sciences Corporation · LRK · Aug 18, 2017 · Dental

Device Facts

• Record ID: K170825
• Device Name: SnoreRx
• Applicant: Apnea Sciences Corporation
• Product Code: LRK · Dental
• Decision Date: Aug 18, 2017
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SnoreRx is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.

Device Story

SnoreRx is an intraoral mandibular repositioning device; repositions jaw anteriorly to increase pharyngeal space; reduces air turbulence causing snoring. Device consists of two custom-fitted trays; molded to patient teeth via 'boil and bite' method; allows adjustable jaw advancement up to 6 mm. Used in home environment; patient self-operates. Device is reusable; non-sterile. Benefits patient by reducing snoring through mechanical airway management.

Clinical Evidence

No clinical efficacy trials were performed. Evidence includes a retrospective study on user experience with the predicate device (tooth movement, breakage, side effects), a human factors assessment for OTC use, and a usability study confirming that OTC consumers can correctly prepare, fit, and adjust the device per labeling instructions.

Technological Characteristics

Materials: Polycarbonate resin and ethylene vinyl acetate copolymer. Biocompatibility: ISO 10993. Physical testing: ISO 178 (flexural modulus/strength), ISO 527 (stress/strain), ISO 62 (water absorption), ISO 3146 (melting point), ISO 1183 (density/melt flow). Form factor: Two-tray intraoral device. Mechanism: Mechanical mandibular advancement up to 6 mm. Sterilization: Non-sterile.

Indications for Use

Indicated for adult patients 18 years of age or older as an aid for the reduction of snoring.

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

• SnoreRx (K153200)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an image of three stylized human profiles facing to the right, with a stylized eagle above them.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - W 066-G609 Silver Spring, MD 20993-0002

August 28, 2017

Apnea Sciences Corporation James Smith, Ph.D. 24982 Barclay Lane Laguna Niguel, California 92677

Re: K170285 Trade/Device Name: SnoreRx 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: LRK Dated: July 17, 2017 Received: July 18, 2017

Dear Dr. Smith:

This letter corrects our substantially equivalent letter of August 18, 2017.

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 Actinclude 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device

{1}------------------------------------------------

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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

# Michael J. Ryan -S

for Lori A. Wiggins, MPT, CLT Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

#### Indications for Use

510(k) Number (if known)

Device Name SnoreRx

Indications for Use (Describe)

The SnoreRx is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.

Type of Use (Select one or both, as applicable)

_ Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other spect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

FORM FDA 3881 (8/14)

EF

PSC Publishing Scrvices [phone]

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for Apnea Sciences. The logo consists of the words "APNEA" and "SCIENCES" in a gold sans-serif font, separated by a crescent moon shape. Below the logo is the tagline "Advancing the Science of Sleep Medicine" in a smaller, italicized font.

### 510(k) SUMMARY

### Submitted by:

| Owner's Name: | Apnea Sciences Corporation |
|---------------|-----------------------------------------------------------|
| Address: | 27121 Aliso Creek Road, Ste. 140<br>Aliso Viejo, CA 92656 |
| Contact: | James Fallon, President/CEO |
| Telephone: | [phone] |
| Fax: | [phone] |
| E-mail: | [e-mail] |

### Contact Person:

| Name | James Smith, Ph.D. |
|----------------|-----------------------------------------------|
| Address | 24982 Barclay Lane<br>Laguna Niguel, CA 92677 |
| Telephone | 949-340-7261 |
| Fax: | 949-340-7141 |
| E-mail: | [e-mail] |
| Date Prepared: | March 16, 2017 |

## Trade Name :

SnoreRx

Common Name : Classification Name : Device Class: Product Code: Regulation No.

Mandibular repositioning device Anti-Snoring Device Class II LRK 21 CFR 872.5570

Predicate Device: SnoreRx (Apnea Sciences Corporation) Predicate 510(k) #: K153200

De vice Description: The SnoreRx is an intraoral device that repositions the jaw anteriorly in order to increase the patient's pharyngeal space, which improves the ability to exchange air and decreases air turbulence, a causative factor in snoring. The device consists of two custom fabricated trays that fit separately over the upper and lower dental arches and engage each other in the anterior area of the mouth.

Intended Use : The SnoreRx is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.

Technology Comparison: The devices are identical in design and functionality. Both the SnoreRx and its predicate consist of intraoral mouth

{4}------------------------------------------------

Image /page/4/Picture/0 description: The image is a logo for Apnea Sciences. The logo consists of a gold rectangle with the word "APNEA" on the left and "SCIENCES" on the right, separated by a crescent moon shape. Below the rectangle is the tagline "Advancing the Science of Sleep Medicine" in a smaller font.

pieces that are molded to the patient's teeth using a standard 'boil and bite' method, and allows slight adjustment of the anterior positioning of the jaw to the patient's comfort. The SnoreRx is provided non-sterile and uses the same packaging system as the predicate device. The table below compares the technological aspects of the new and predicate devices.

| Subject Area | New Device | Predicate | Differences |
|------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------|
| Product Code | LRK | LRK | |
| Product Classification | Class II | Class II | |
| Classification Name | Anti-Snoring Device | Anti-Snoring Device | |
| Proprietary Name | SnoreRx | SnoreRx | |
| Technological Features | Mandibular<br>repositioning device<br>that advances the<br>lower jaw to increase<br>pharyngeal space. | Mandibular<br>repositioning device<br>that advances the<br>lower jaw to increase<br>pharyngeal space. | |
| Intended Use | Minimize air<br>turbulence that causes<br>snoring. Device is<br>intended for Over-<br>The-Counter use. | Minimize air<br>turbulence that causes<br>snoring. Device is<br>intended for<br>prescription use. | Product labeling has been<br>developed to ensure<br>appropriate Instructions<br>for Use are provided to<br>OTC consumers. |
| Materials | Polycarbonate resin<br>Ethylene vinyl acetate<br>copolymer | Polycarbonate resin<br>Ethylene vinyl acetate<br>copolymer | |
| Desirable Characteristics | Home use, heat<br>sensitive / moldable,<br>adjustable jaw<br>advancement position | Home use, heat<br>sensitive / moldable,<br>adjustable jaw<br>advancement position | |
| Specifications:<br>- Physical:<br>- Mechanical:<br>- Single use: | Custom-fitted<br>intraoral device<br>Repositions mandible<br>anteriorly up to 6 mm<br>Reusable | Custom-fitted<br>intraoral device<br>Repositions mandible<br>anteriorly up to 6 mm<br>Reusable | |
| Sterility | Non-sterile | Non-sterile | |
| Biocompatibility | ISO 10993 | ISO 10993 | |

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the logo for Apnea Sciences. The logo consists of the words "APNEA" and "SCIENCES" in white font on a gold bar, separated by a white crescent moon. Below the gold bar is the text "Advancing the Science of Sleep Medicine" in a smaller, gold font.

| Nonclinical Testing: | The SnoreRx materials were tested for cytotoxicity, irritation, and sensitization and were determined to be biocompatible in accordance with ISO 10993. Biocompatibility test reports have been submitted as part of this filing. |
|----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Device materials were tested for various physical properties. The tray material was tested for flexural modulus and strength (ISO 178), stress and strain at break (ISO 527), and water absorption (ISO 62). The liner material was tested for melting point (ISO 3146), and density and melt flow rate (ISO 1183). All materials met device specifications. |
| Clinical Testing: | A retrospective study was conducted to gain insight on the user's experience with the predicate device, including incidence of tooth movement, breakage, and other side effects typically experienced by users of intraoral devices. |
| | A human factors assessment was also performed for the use of SnoreRx in the OTC environment. |
| | Additionally, a usability study was performed to assess the OTC consumer's understanding of the device labeling and instructions for use, and to demonstrate that the OTC consumer can appropriately prepare, fit, and adjust the SnoreRx without assistance from a dental professional. |
| | Conclusion of Comparison: SnoreRx and its predicate are technologically identical and there are no differences in design and materials. The SnoreRx is fitted by the 'boil-and-bite' method that is equivalent to that used for multiple OTC devices. The OTC indication for use does not raise substantial new questions of safety or effectiveness. Therefore, the new device (SnoreRx) is determined to be substantially equivalent to the predicate device. |