PureSleep (OTC use)

K190058 · Sleep Science Partners, Inc. · LRK · Apr 11, 2019 · Dental

Device Facts

• Record ID: K190058
• Device Name: PureSleep (OTC use)
• Applicant: Sleep Science Partners, Inc.
• Product Code: LRK · Dental
• Decision Date: Apr 11, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic, Real-World Evidence

Real-World Evidence

Submission	Device	Sponsor	RWD Sources	RWE Use Summary	Key Tags
K190058 · Apr 11, 2019	PureSleep (OTC use)	Sleep Science Partners, Inc.	Real-world data from actual use of the predicate device (PureSleep Rx, K113022)	The sponsor utilized real-world data from the predicate device's history of use to support the transition of the device to an OTC environment and to inform the adaptation of labeling and instructions for use.	Predicate device history; OTC transition; Labeling adaptation

Clinical Evidence

Study Design	Population	Comparator	Key Endpoints
Real-world data from predicate device (K113022); Retrospective analysis of real-world use	Adults using the PureSleep Rx device	Not applicable for this study	Safety and effectiveness in routine use

Indications for Use

PureSleep® (OTC) is indicated for use for adults 18 years and above as an aid in the reduction of snoring during hours of sleep

Device Story

PureSleep® is an intraoral mandibular repositioning device (MRD) for over-the-counter (OTC) use. It consists of two dental trays—an outer structural shell and an inner heat-sensitive lining—that are custom-molded to the user's teeth via a 'boil and bite' method. The device is worn in the mouth during sleep to advance the lower jaw, increasing pharyngeal space and reducing air turbulence to alleviate snoring. Users perform self-fitment and can adjust the jaw advancement position in three settings (4mm apart anteriorly) with 9mm inferior placement. The device is intended for single-user, multi-use application at home. It provides a non-invasive mechanical intervention for snoring reduction.

Clinical Evidence

No clinical trials were conducted. Evidence consists of real-world data from the predicate device (K113022) and a Human Factors and Usability Engineering (HFE/UE) study. The HFE/UE study demonstrated that users can safely and effectively fit and use the device in an OTC environment without dental professional assistance. Biocompatibility testing confirms compliance with ISO 10993.

Technological Characteristics

Materials: Polypropylene homopolymer and ethylene vinyl acetate copolymer. Principle: Mandibular repositioning via custom-molded 'boil and bite' dental trays. Form factor: Two-piece intraoral tray system. Connectivity: None. Sterilization: Non-sterile. Biocompatibility: Meets ISO 10993-1 for prolonged mucosal contact. Adjustability: Three-position jaw advancement.

Indications for Use

Indicated for adults 18+ as an aid in the reduction of snoring during sleep.

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

• PureSleep® (Rx use), Sleep Science Partners, Inc. (K113022)

Reference Devices

• SnoreRx®, Apnea Sciences, Inc. (K170825)

Submission Summary (Full Text)

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# 510(k) Summary

#### Submitted by:

| Owner's Name: | Sleep Science Partners, Inc. |
|---------------|--------------------------------------------------------------|
| Address: | 900 Larkspur Landing Circle, Suite 207 Larkspur CA 94939 USA |
| Contact: | Noel P. Lindsay |
| Title: | Chairman & CEO |
| Tel: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |

Contact Person:

| Name: | Valerie Followell |
|--------|---------------------------------------------|
| Title: | Senior RA & QA Consultant at Lean RAQA, LLC |
| Tel: | [phone] |
| Email: | [e-mail] |

| Date Prepared: | January 10, 2019 |
|----------------------|-------------------------------------------------------------|
| Trade Name: | PureSleep® |
| Common Name: | Antisnoring device |
| Classification Name: | Intraoral devices for snoring and obstructive sleep apnea |
| Classification: | Class II |
| Product Code: | LRK |
| Regulation Number: | 872.5570 |
| Predicate Device: | PureSleep® (Rx use), Sleep Science Partners, Inc. (K113022) |
| Reference Device: | SnoreRx®, Apnea Sciences, Inc. (K170825) |

#### DEVICE DESCRIPTION:

The PureSleep® device for Over-the-Counter (OTC) use is an intraoral mandibular repositioning device that increases the pharyngeal space to improve the user's ability to exchange air and to decrease air turbulence, a causative factor in snoring. The device consists of two dental trays designed to conform to the shape of the upper and lower jaws.

#### INTENDED USE:

PureSleep® (OTC) is indicated for use for adults 18 years and above as an aid in the reduction of snoring during hours of sleep

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# COMPARISSION OF TECHNOLOGICAL CHARACTERISTICS:

The proposed OTC device and the PureSleep® (Rx) predicate device are identical in all their technological characteristics (design, materials, functionality, principles of operations, etc.). Both the PureSleep® for OTC use and its predicate device consist of intraoral mouth pieces that are molded to the user's teeth using a standard 'boil and bite' method and allows slight adjustment of the jaw to the user's comfort. The PureSleep® for OTC use is provided non-sterile and uses the same packaging system as the Rx predicate device, except for adapted product documentation (Instructions for Use and package labeling) for the retail consumers. The table below compares the indications for use and technological aspects of the proposed device against the predicate as well as a reference device that FDA had cleared that has a similar technology with OTC indications.

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| | | Proposed device | Predicate device | Reference device |
|-------------------------|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Proprietary Name | | PureSleep® | PureSleep® | SnoreRx® |
| Manufacturer | | Sleep Science Partners, Inc. | Same | Apnea Sciences, Inc. |
| 510(k) | | K190058 | K113022 | K170825 |
| Classification | Regulation<br>Product<br>Code | LABELING<br>21 CFR 872.5570 | | |
| | LRK | Same | Same | |
| | Class.<br>Name | Intraoral Device for Snoring and<br>Obstructive Sleep Apnea | Same | Same |
| | | An intraoral mandibular repositioning<br>device used on adults as an aid during | An intraoral mandibular repositioning<br>device used during sleep to reduce | Intended for use on adult<br>patients 18 years of age<br>or older as an aid for the |
| Intended use | | sleep to reduce snoring. | snoring and treat mild to moderate<br>obstructive sleep apnea in adults. | reduction of snoring. |
| Indication for<br>use | Rx or OTC<br>Patient<br>population | OTC<br>Adults | Rx<br>Same | OTC<br>Same |
| Labeling | | Language, visuals and structure have<br>been adapted for OTC use based on | Instructions divided into 1)<br>instructions for use for the dentist to | |
| | | FDA guidance documents, HFE/UE<br>study and RWD gained with K113022. | prepare and fit the device and 2)<br>patient information on use and care. | Similar contraindications<br>and warnings |
| | | TECHNOLOGY | | |
| | | | | |
| Mode of action | | Mandibular repositioning device<br>(MRD) that advances the lower jaw to<br>increase pharyngeal space and<br>alleviate snoring | Same | Same |
| Environment | | During sleep, at home | Same | Same |
| Placement of device | | In the mouth, on the lower and upper<br>jaws | Same | Same |
| Preparation / Set-up | | Connect upper and lower parts per<br>bite type. | Same | Squeeze mouthpiece in a<br>'C' position and adjust. |
| Molding / Fitment | | Custom impression to each<br>individual's mouth using a "boil and<br>bite" approach and thermal setting<br>(heat sensitive) resins. Molded to the<br>entire upper and lower arch of teeth. | Same | Same |
| Design | | Consists of an upper and lower tray.<br>Outer shell provides with structural<br>support and inner shell is lined with<br>softer material that is heat sensitive<br>and thus allows for custom fitting. | Same | Same |
| Adjustments | | • Adjustable jaw advancement<br>position.<br>• Adjustably positions the mandible<br>forward in three positions, 4mm<br>apart anteriorly, while maintaining a<br>9mm inferior placement for user<br>comfort | Same | Similar<br>• Adjustable jaw advancement<br>position.<br>• Ability to reset the adjustment.<br>• The upper and lower trays are<br>adjustable in 1mm increments<br>up to 6mm. |
| Single Use / Reusable | | Single user, multi-use | Same | Same |
| Cleaning instructions | | Clean/rinse daily with toothbrush and<br>toothpaste or with effervescent oral<br>device cleaning tablets. Deep clean<br>once per week. | Same but recommended frequency is<br>less prescriptive (i.e. periodic<br>cleaning) | Clean/rinse daily. Deep<br>clean every two weeks. |
| Sterile | | No | Same | Same |
| Materials | | Polypropylene homopolymer and<br>ethylene vinyl acetate copolymer | Same | The specific materials are<br>unknown. |
| Biocompatibility | | Meets ISO 10993-1 for a surface<br>device contacting mucosal membrane<br>for a prolonged contact duration (><br>24h to 30 days): cytotoxicity,<br>sensitization and irritation | Same | Same |

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#### NON-CLINICAL TESTING

The materials and methods of manufacture of the product are biocompatible and meet the applicable requirements of ISO 10993.

A Human Factors and Usability Engineering (HFE/UE) study was performed for the use of PureSleep® in the OTC environment that support the safe and effective use of the product without assistance from a dental professional.

Documentation provided by Sleep Science Partners, Inc. presents real-world data gleaned from actual use of the PureSleep® Rx predicate device, along with the HFE/UE study which support the conclusion that the proposed device is clinically safe for OTC use.

Finally, Sleep Science Partners, Inc. conducted a risk analysis on the proposed device in accordance with ISO 14971:2007 and by considering the issues raised in the FDA quidance document "Class // Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea" (November 12, 2002). All identified risks have been addressed through device design, verification/validation or through documentation (labeling and Instructions for Use) provided to the consumer.

### CLINICAL PERFORMANCE TESTING

Real-world data is included in support of this submission.

### CONCLUSION

Based upon the similarities in technology and in intended use, as well as indications for use similar to the reference predicate, together with performance testing, we believe that PureSleep® for OTC use is substantially equivalent to the predicate devices.

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April11, 2019

Sleep Science Partners, Inc % Valerie Followell Senior RA & QA Consultant Lean RAQA, LLC 12602 North Summerwind Drive Marana, Arizona 85658

Re: K190058

Trade/Device Name: PureSleep (OTC use) 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: January 10, 2019 Received: January 11, 2019

Dear Valerie Followell:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 and Part 809; medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Tina Kiang, Ph.D. for Acting 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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# Indications for Use

510(k) Number (if known) K190058

Device Name PureSleep® (OTC use)

#### Indications for Use (Describe)

PureSleep® (OTC) is indicated for use for adults 18 years and in the reduction of snoring during hours of sleep

| 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) | <div> </div> |

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