(176 days)
No
The device description and performance studies focus on the physical mechanism of jaw repositioning and material properties, with no mention of AI or ML.
Yes
The device is intended to alleviate or reduce snoring, which is a physiological condition, thus it serves a therapeutic purpose.
No.
The SleepTight Mouthpiece is intended as an aid to reduce snoring by physically altering the jaw position, not by diagnosing a condition.
No
The device description clearly states it is a "mouthpiece" made of "biocompatible thermoplastic mouthpiece material" (ethylene-vinyl acetate) that the user heats and molds to their teeth. This is a physical, hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reduce snoring" by physically repositioning the jaw. This is a mechanical action, not a diagnostic test performed on biological samples.
- Device Description: The description details a physical mouthpiece that is molded to the user's teeth and holds the jaw forward. It does not involve any reagents, instruments, or procedures for examining specimens from the human body.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological sample. There are no references to diagnostic markers, assays, or laboratory procedures.
IVD devices are used to examine specimens from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease or injury. The SleepTight Mouthpiece does not fit this definition. It is a physical device intended to address a physiological issue (snoring) through mechanical means.
N/A
Intended Use / Indications 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.
Product codes
LRK
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. In 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients 18 years of age or older
Intended User / Care Setting
Over-The-Counter Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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)
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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
Description | OTC Proposed
Device | OTC Primary
Predicate Device | Rx Reference
Device Predicate #1 | OTC Reference
Device Predicate #2 |
|-----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| Name of Device | STZ
Image: STZ device | SnoreRx
Image: SnoreRx device | STM
Image: STM device | ZQuiet
Image: ZQuiet device |
| K number | K191618 | K170825 | K132506 | K180124 |
| Class | II | II | II | II |
| Product Code | LRK | LRK | LRK | LRK |
| Classification
Name | Anti-Snoring
Device | Anti-Snoring
Device | Anti-Snoring
Device | Anti-Snoring
Device |
| How Sold | Over the counter, proposed | Over the counter | Prescription | Over the counter |
| Indications 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. | "The SnoreRx is
intended for use
on adult patients
18 years of age
or older as an
aid for the
reduction of
snoring". | The Sleep Tight
Mouthpiece
(STM) is an
intraoral
mandibular
advancement
device
intended to be
used for the
treatment of
snoring and
mild to
moderate
obstructive
sleep apnea in
adults. | ZQuiet is
intended as an
aid in the
reduction of
snoring for
adults at least
18 years old. |
| Device | STZ | SnoreRx | STM | ZQuiet |
| | | | | Section 8 510(k) 191618 Summary
Traditional 510k |
| | | | | SleepTight Mouthpiece (STZ) |
| Device
Description | OTC Proposed
Device | OTC Primary
Predicate
Device | Rx Reference
Device
Predicate #1 | OTC Reference
Device Predicate
#2 |
| | | | | |
| Technology &
Method of Use | | | | |
| Target population:
Adults | Yes | Yes | Yes | Yes |
| mandibular
advancement
device | Yes | Yes | Yes | Yes |
| Intra oral device | Yes | Yes | Yes | Yes |
| Indicated to
reduce snoring | Yes | Yes | Yes | Yes |
| Used at home | Yes | Yes | Yes | Yes |
| User self-fitted | Yes | Yes | Yes | Yes |
| | | | | |
| Boil and Bite
custom fitting | Yes | Yes | Yes | No |
| Single user
design | Yes | Yes | Yes | Yes |
| Material | | | | |
| Thermoplastic
elastomer
(Ethylene Vinyl
Acetate) | Yes | Yes | Yes | Yes |
| Biocompatible | Yes | Yes | Yes | Yes |
| Design | | | | |
| "Horseshoe"
shape | Yes | Yes | Yes | No |
| Single piece
monoblock | Yes | No | Yes | Yes |
| Fits both upper
and lower teeth | Yes | Yes | Yes | Yes |
| Adjustable after
fitting | Yes | Yes | Yes | No |
| Dual laminate
materials | Yes | Yes | Yes | No |
| Safety | | | | |
| | | | | |
| 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 | ||||
| Description | OTC Proposed | |||
| Device | OTC Primary | |||
| Predicate | ||||
| Device | Rx Reference | |||
| Device | ||||
| Predicate #1 | OTC Reference | |||
| Device Predicate | ||||
| #2 | ||||
| Image: OTC Proposed Device | Image: OTC Primary Predicate Device | Image: Rx Reference Device Predicate #1 | Image: OTC Reference Device Predicate #2 | |
| Adequate Use | ||||
| Directions STOP- | ||||
| Bang | ||||
| Questionnaire | ||||
| with package | Yes | Yes | Yes | Yes |
| Front breathing | ||||
| opening | Yes | Yes | Yes | Yes |
| FDA Compliant | ||||
| 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.