SleepTight Mouthpiece STZ

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December 11, 2019 Michael D Williams DDS PA Michael Williams President 10991 Sw 42nd Pl Davie, Florida 33328 Re: K191618 Trade/Device Name: SleepTight Mouthpiece STZ 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: May 29, 2019 Received: June 18, 2019 Dear Michael Williams: 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 {1}------------------------------------------------ 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 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, for Srinivas Nandkumar. Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K191618 / S1 Device Name Sleep Tight Mouthpiece STZ Indications for Use (Describe) The SleepTight Mouthpiece (STZ) is intended for use by adult patients 18 years of age or older as an aid to reduce snoring. Type of Use (Select one or both, as applicable) | Prescription Use (Part 21 CFR 801 Subpart D) X 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 aspect 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." {3}------------------------------------------------ ### SPONSOR/APPLICANT Name: Michael D. Williams, DDS PA` 10991 SW 42nd Place Davie, FL 33328, USA Contact person Dr. Mike Williams Email: drmikewilliams@qmail.com Phone: 954-475-9154 Summary Preparation date: December 10, 2019 This document was prepared per 807.92(a)(1). ### DEVICE NAME- DEVICE TRADE NAME(S): SleepTight Mouthpiece STZ DEVICE CLASS: II COMMON NAME: Snoring mouthpiece DEVICE CLASSIFICATION NAME: Intraoral devices for snoring and/or obstructive sleep apnea REGULATIONS: 21 CFR 872.5570 PRODUCT CODES: LRK- Anti-Snoring Device ## 8.1 Identification of Predicate Devices(s) Primary Predicate: SnoreRx K170825 manufactured by Apnea Sciences Corporation. This over the counter Primary Predicate Device is the most similar in indications and technology to the STZ - Reference Device #1: SleepTight Mouthpiece STM K132506 manufactured by . Michael D. Williams DDS PA. This Rx Reference Device Predicate supports the scientific methodology of the STZ. - . Reference Device #2: ZQuiet K180124 manufactured by Sleeping Well, LLC. This over the counter Reference Device Predicate also supports the scientific methodology of the STZ. {4}------------------------------------------------ #### 8.2 Device description Purpose: The SleepTight Mouthpiece (STZ) is intended for use by adult patients 18 years of age or older as an aid to reduce snoring. #### Mechanism of Action The STZ advances and holds the lower jaw forward during sleep which enlarges and stiffens the airway to alleviate or reduce snoring. The STZ attaches to both upper and lower teeth which maintains a properly opened airway. #### Material The STZ utilizes a biocompatible thermoplastic mouthpiece material to treat snoring. The raw material is ethylene-vinyl acetate (EVA). ### Fitting The STZ uses the common boil and bite technique familiar to athletes who heat and mold their mouth guard to fit their teeth. ln this process the user softens the mouthpiece in hot water according to detailed directions provided with packaging. The user bites into the softened plastic and compresses the softened material to their teeth and gums while holding the jaw slightly forward until the material cools and stiffens. ## Therapeutic Function After cooling, the device maintains its shape and is used to hold the jaw open and forward during sleep to alleviate or reduce snoring. ## 8.3 Indication for Use The SleepTight Mouthpiece (STZ) is intended for use by adult patients 18 years of age or older as an aid to reduce snoring. ## 8.4 Substantial Equivalence Discussion. The STZ has the same indications for use as the OTC SnoreRx and the OTC ZQuiet. The proposed STZ is technologically identical in design, function and material composition to the FDA cleared prescription SleepTight Mouthpiece (STM). The STM is proposed to be renamed STZ for its use as an over-thecounter device. The STZ alleviates snoring by moving and holding the jaw forward in the identical manner as the predicates. The STZ can be self-fitted by the user by simply softening the device in hot water and then compressing the device to fit the mouth (also known as the "boil and bite" process) in a similar manner as the predicates SnoreRx and STM. With the supplied Adequate Use Directions, the STZ will be available for Over the Counter (OTC) use for legal {5}------------------------------------------------ adults. The STZ is not indicated for the treatment of central apnea nor any form of Obstructive Sleep Apnea (OSA) or other respiratory disorders. The STZ is substantially equivalent to the OTC SnoreRx and technologically identical to the FDA cleared SleepTight Mouthpiece STM device as seen in the chart below. The STZ is substantially equivalent to the reference predicates SnoreRx and ZQuiet in terms of its home use and over the counter use (OTC) as seen in the Table below. # Table 1: Comparison of SleepTight Mouthpiece (STZ) with Predicates | Device<br>Description | OTC Proposed<br>Device | OTC Primary<br>Predicate Device | Rx Reference<br>Device Predicate #1 | OTC Reference<br>Device Predicate #2 | |-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------| | Name of Device | STZ<br>Image: STZ device | SnoreRx<br>Image: SnoreRx device | STM<br>Image: STM device | ZQuiet<br>Image: ZQuiet device | | K number | K191618 | K170825 | K132506 | K180124 | | Class | II | II | II | II | | Product Code | LRK | LRK | LRK | LRK | | Classification<br>Name | Anti-Snoring<br>Device | Anti-Snoring<br>Device | Anti-Snoring<br>Device | Anti-Snoring<br>Device | | How Sold | Over the counter, proposed | Over the counter | Prescription | Over the counter | | Indications for<br>Use | The SleepTight<br>Mouthpiece<br>(STZ) is<br>intended for use<br>by adult patients<br>18 years of age<br>or older as an<br>aid to reduce<br>snoring. | "The SnoreRx is<br>intended for use<br>on adult patients<br>18 years of age<br>or older as an<br>aid for the<br>reduction of<br>snoring". | The Sleep Tight<br>Mouthpiece<br>(STM) is an<br>intraoral<br>mandibular<br>advancement<br>device<br>intended to be<br>used for the<br>treatment of<br>snoring and<br>mild to<br>moderate<br>obstructive<br>sleep apnea in<br>adults. | ZQuiet is<br>intended as an<br>aid in the<br>reduction of<br>snoring for<br>adults at least<br>18 years old. | | Device | STZ | SnoreRx | STM | ZQuiet | | | | | | Section 8 510(k) 191618 Summary<br>Traditional 510k | | | | | | SleepTight Mouthpiece (STZ) | | Device<br>Description | OTC Proposed<br>Device | OTC Primary<br>Predicate<br>Device | Rx Reference<br>Device<br>Predicate #1 | OTC Reference<br>Device Predicate<br>#2 | | | | | | | | <b>Technology &amp;<br/>Method of Use</b> | | | | | | Target population:<br>Adults | Yes | Yes | Yes | Yes | | mandibular<br>advancement<br>device | Yes | Yes | Yes | Yes | | Intra oral device | Yes | Yes | Yes | Yes | | Indicated to<br>reduce snoring | Yes | Yes | Yes | Yes | | Used at home | Yes | Yes | Yes | Yes | | User self-fitted | Yes | Yes | Yes | Yes | | | | | | | | Boil and Bite<br>custom fitting | Yes | Yes | Yes | No | | Single user<br>design | Yes | Yes | Yes | Yes | | <b>Material</b> | | | | | | Thermoplastic<br>elastomer<br>(Ethylene Vinyl<br>Acetate) | Yes | Yes | Yes | Yes | | Biocompatible | Yes | Yes | Yes | Yes | | <b>Design</b> | | | | | | "Horseshoe"<br>shape | Yes | Yes | Yes | No | | Single piece<br>monoblock | Yes | No | Yes | Yes | | Fits both upper<br>and lower teeth | Yes | Yes | Yes | Yes | | Adjustable after<br>fitting | Yes | Yes | Yes | No | | Dual laminate<br>materials | Yes | Yes | Yes | No | | <b>Safety</b> | | | | | | | | | | | | Device | STZ | SnoreRx | STM | ZQuiet | {6}------------------------------------------------ Section 8 510(k) 191618 Summary {7}------------------------------------------------ Section 8 510(k) 191618 Summary Traditional 510k | | | | SleepTight Mouthpiece (STZ) | | |---------------------------------------------------------------------------|----------------------------|-------------------------------------|-----------------------------------------|------------------------------------------| | Device<br>Description | OTC Proposed<br>Device | OTC Primary<br>Predicate<br>Device | Rx Reference<br>Device<br>Predicate #1 | OTC Reference<br>Device Predicate<br>#2 | | | Image: OTC Proposed Device | Image: OTC Primary Predicate Device | Image: Rx Reference Device Predicate #1 | Image: OTC Reference Device Predicate #2 | | Adequate Use<br>Directions STOP-<br>Bang<br>Questionnaire<br>with package | Yes | Yes | Yes | Yes | | Front breathing<br>opening | Yes | Yes | Yes | Yes | | FDA Compliant<br>labeling | Yes | Yes | Yes | Yes | ## 8.5 Non-Clinical Data - Performance Specifications The STZ, Substantial equivalence is based on non-clinical data as it relates to the historical use of cleared intraoral devices that reposition the jaw forward to alleviate or reduce snoring and to historical and ongoing documented scientific research confirming mandibular advancement devices to treat snoring. Multiple snoring mouthpiece prescription devices, like the identical predicate, SleepTight Mouthpiece STM, have been cleared for OTC use. Additional non-clinical testing was not performed for this submission as the performance of the STZ is identical to the previously cleared primary predicate STM. Physical properties testings have been demonstrated in the previously cleared submission. Certain FDA identified risks including: Intraoral gingival, palatal, or dental soreness; Temporomandibular Joint (TMJ) Dysfunction Syndrome; obstruction of oral breathing and loosening or flaring of lower anterior teeth or general tooth movement are mitigated by appropriate labeling updates and adequate instructions for use for the proposed STZ. The sponsor has mitigated the risks raised in the FDA quidance document Class II Special Controls Guidance Document: "Intraoral Devices for Snoring and/or Obstructive Sleep Apnea ... " Risks identified by the FDA for snoring mouthpieces are mitigated for the STZ in a similar fashion as the SnoreRx primary OTC predicate and the technologically identical STM prescription predicate device and have been addressed through labelling, and thorough instructions for use. As such, the STZ proposed product labeling now includes the STOPBang screening questionnaire which will advise the user to consult a physician, if their responses indicate the potential presence of sleep apnea or other respiratory disorder. The validated STOPBang questionnaire contains appropriate warnings and directing the lav {8}------------------------------------------------ user to a physician in such cases identified, for the device to be used without a prescription. The OTC predicates SnoreRx and ZQuiet, also uses the same STOPBang sleep health survey, included with their packaging, to help the user determine if their snoring is associated with a more serious medical condition, such as Obstructive Sleep Apnea (OSA) or other respiratory disorder. The STOPBang screening questionnaire can be found as included currently in these commercialized devices and have identical information to allow for safe and effective over the counter use to alleviate snoring. In terms of its over the counter use, the STZ is substantially equivalent to the currently marketed reference predicate devices Snore Rx K170825 and ZQuiet who also uses the STOPBang questionnaire. Improved labeling with adequate use directions and inclusion of the STOPBang Questionnaire allow for STZ OTC use as compared to the prescription status found in the primary predicate STM. # 8.6 Biocompatibility The Sleep Tight Mouthpiece (STZ), Sleep Tight Mouthpiece (STM), and the SnoreRx are manufactured with the same material, Ethylene Vinyl Acetate (EVA). Since the materials and methods of manufacture of the STZ are identical to the materials utilized in the STM K132506 predicate, no additional biocompatibility testing is provided. The STZ and STM are identical in terms of biocompatibility. ## 8.7 Prescription Status The proposed SleepTight Mouthpiece STZ is intended to be sold over the counter. Therefore, the product labeling has been modified to eliminate the prescription requirement. There have been no changes related to warnings or contraindications between the primary predicate STM and the proposed STZ. The proposed STZ product labeling now includes the STOPBang screening questionnaire in order to advise the user to consult a physician before product use if responses indicate a potential presence of sleep apnea or respiratory disorder. The reference predicate devices SnoreRx and ZQuiet already have a clearance for over-the-counter use. Dr. Michael Williams DDS PA believes that through the updated labeling, including placing warning and precautions prominently on the outer packaging and instructions for use, and by providing the STOPBang Questionnaire to alert the user for the potential presence of complicating factors, the STZ is as safe and as effective as the OTC reference devices SnoreRx and ZQuiet, which use the same questionnaire. Therefore, there is no impact on safety and effectiveness between the proposed STZ and the primary predicate and reference devices. ## 8.8 Summary Conclusion The STZ has a similar indication for use as the OTC cleared SnoreRx and ZQuiet. The STZ is technologically identical to the STM. The STZ is composed of the identical {9}------------------------------------------------ materials and was made with the same configuration as the STM. The STZ incorporates identical fitting, directions, functions, and mechanism of action as the STM and now adds labeling and safety information for OTC use. The STZ is substantially equivalent to the currently marketed reference predicate devices Snore Rx and ZQuiet, in its application for over the counter use.