(94 days)
No
The device description and lack of mention of AI/ML terms or performance studies indicate it is a mechanical device without AI/ML.
No.
A therapeutic device is intended to treat a disease, injury, or medical condition. While the Snore Bandit is intended to reduce snoring, which can be a symptom of a medical condition (like sleep apnea), its primary function as described is an 'aid to reduce snoring' by mechanical means, rather than directly treating a disease. The predicate device listed (K191618 Sleep Tight Mouthpiece STZ) also appears to be a snoring aid and not explicitly categorized as a therapeutic device for a disease.
No
The Snore Bandit is described as an aid to reduce snoring by advancing and holding the lower jaw forward, which is a therapeutic action. Its "Intended Use / Indications for Use" section specifies reducing snoring, not diagnosing it. There is no mention of it being used to identify, measure, or monitor any condition or disease.
No
The device description clearly states it is a physical appliance that uses a 'boil-and-bite' technique to mold to the user's mouth and hold the jaw forward. This is a hardware device, not software.
Based on the provided information, the Snore Bandit is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The Snore Bandit is a physical appliance worn in the mouth. It does not analyze blood, urine, tissue, or any other biological sample.
- The intended use is to reduce snoring. This is a physical intervention to address a physiological issue, not a diagnostic test to identify a disease or condition.
- The device description details a physical molding process and mechanical action. It describes how the device is shaped and how it physically holds the jaw forward. This is characteristic of a medical device, not a diagnostic test.
Therefore, the Snore Bandit falls under the category of a medical device, specifically a dental appliance, rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Snore Bandit is intended for use by adult patients (18 years or older) as an aid to reduce snoring.
Product codes
LRK
Device Description
The Snore Bandit Anti-Snoring Appliance advances and holds the lower jaw forward during sleep which enlarges and stiffens the airway to alleviate or reduce snoring. The Snore Bandit 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. After cooling, the device maintains its shape and is used to hold the jaw open and forward during sleep to alleviate or reduce snoring. The product is non-sterile and provided in a sealed box with instructions.
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
18 years or older
Intended User / Care Setting
Not Found
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
No clinical testing was performed in association with this submission.
Key Metrics
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). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
July 1, 2021
SnoreBandit LLC % Colette Cozean Regulatory Consultant The EyeDeas Company 21581 Midcrest Dr. Lake Forest, California 92630
Re: K210910
Trade/Device Name: Snore Bandit 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 24, 2021 Received: May 26, 2021
Dear Colette Cozean:
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.
1
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 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 mediation-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.
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210910
Device Name Snore Bandit Anti-Snoring Appliance
| Indications for Use (Describe) |
|---|
| Snore Bandit is intended for use by adult patients (18 years or older) as an aid to reduce snoring. |
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
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3
- 510(k) Summary
510(k) Summary
| Applicant: | Snore Bandit LLC
8176 Merlewood Ave
Las Vegas, NV 89117
Phone: 702-283-3557 |
|------------------------------|---------------------------------------------------------------------------------------------------------------------|
| Contact person: | Colette Cozean, Ph,D.
21581 Midcrest Dr.
Lake Forest, CA 92603 USA
949-855-2885
colettecozean@gmail.com |
| Date Prepared: | March 24, 2021 |
| Proprietary Name: | Snore Bandit ™ Anti-Snoring Appliance |
| Common name: | Intraoral Device for Snoring |
| Classification Name: | Device, anti-snoring
(Class II, 21 CFR 872.5570, Product Code LRK) |
| Primary Predicate Device: | Sleep Tight Mouthpiece STZ (K191618)-OTC Reference |
| Reference Predicate Devices: | Pure Sleep (K190058) – Over the Counter Reference |
Description of the Device
The Snore Bandit Anti-Snoring Appliance advances and holds the lower jaw forward during sleep which enlarges and stiffens the airway to alleviate or reduce snoring. The Snore Bandit 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. After cooling, the device maintains its shape and is used to hold the jaw open and forward during sleep to alleviate or reduce snoring. The product is non-sterile and provided in a sealed box with instructions.
4
Indications for Use
Snore Bandit is intended for use by adults (18 years or older) as an aid to reduce snoring.
A. Technological Characteristics
The appliance is equivalent in design and functionality to the primary predicate, Sleep Tight Mouthpiece (STZ) device (K191618). Both devices work by advancing the mandible and allows the patient to breathe through their mouth and nose utilizing space between the upper and lower teeth. Both are custom fit for comfort to the individual user by a standard 'boil and bite' method. Both use an ethylene vinyl acetate material. Both are manufactured via a molding process. Both devices are provided non-sterile. The main difference between the subject device and the primary predicate device is a multi-layered breathing space design rather than a singlelayer breathing space design in the primary predicate device. This opens the airway and allows maximum airflow and prevents the patient's lips from blocking the breathing ports.
| | Subject | OTC Primary
Predicate | OTC Reference
Predicate | OTC Reference
Predicate |
|----------------------------------------|------------------------------------------------------------------------------------------------------|---------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------|
| Name | Snore Bandit | STZ | PureSleep | ZQuiet |
| Classification
name | Device, anti-snoring | Device, anti-snoring | Intraoral
Device for
Snoring and
Obstructive
Sleep Apnea | Device, anti-snoring |
| 510(k) Number | K210910 | K191618 | K190058 | K180124 |
| Class | II | II | II | II |
| Product Code | LRK | LRK | LRK | LRK |
| 21 CFR | 872.5570 | 872.5570 | 872.5570 | 872.5570 |
| Technology &
Mechanism of
Action | Mandibular
advancement
design to
increase
pharyngeal
space to
alleviate
snoring | Mandibular
advancement | Mandibular
repositioning
device (MRD)
that advances
the lower jaw
to increase
pharyngeal
space and
alleviate
snoring | Mandibular
advancement |
Comparison to Predicate Devices
5
| Indications for
use | "Snore Bandit
is intended
for use on
adults 18
years of age
or older as an
aid to reduce
snoring" | "Sleep Tight
Mouthpiece
STZ is
intended for
use on adult
patients 18
years of age
or older as an
aid to reduce
snoring" | Adults | "ZQuiet is intended
as an aid in the
reduction of snoring
for adults at least 18
years old." |
|------------------------|------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
| Prescription
Status | OTC | OTC | OTC | OTC |
| Provided Sterile | NO | NO | NO | NO |
| Materials | Ethylene Vinyl
Acetate (EVA)
Copolymer,
no colorant | Thermoplastic
Elastomer
(Ethyl Vinyl
Acetate) | Polypropylene
homopolymer
and Ethylene
Vinyl Acetate
(EVA) | Thermoplastic
Elastomer with a
colorant |
B. Technology - Mechanism of Action
The subject device and primary predicate device (K191618) are identical in the mechanism of action. They both work by utilizing an intraoral mouthpiece to advance the lower mandible and create space between the upper and lower teeth (breathing spaces) giving the patient the ability to breathe through their mouth and nose.
The mechanism of action for the other two OTC reference predicate devices, the PureSleep and ZQuiet, is solely advancing the mandible. With an intraoral device that alters the mandible position, mandibular changes can lead to pain or discomfort in the temporomandibular joint (TMJ). The subject device has no new risks regarding mandibular advancement.
Utilizing the same mechanism of action as the predicate devices (primary and reference), the subject device raises no new concerns regarding the effectiveness or safety as compared to the other predicate devices.
6
C. Indication for Use
The subject device uses language for the indication for use in substance to previously approved OTC devices for the reduction of snoring. The subject device is "intended for use by adults (18 years or older) as an aid to reduce snoring."
This is almost identical to the indications for use for the primary predicate devices, and the two reference devices, the Sleep Tight Mouthpiece (STZ) is intended for use by adult patients 18 years of age as an aid to reduce snoring, PureSleep is an intraoral mandibular repositioning device used on adults as an aid during sleep to reduce snoring and ZQuiet, whose indications is "intended as an aid in the reduction of snoring for adults at least 18 years old" respectively.
As the indications for use are identical, there are no new concerns regarding safety as compared to predicate devices (primary and reference).
D. Prescription Status
The subject device is intended to be sold over-the-counter. All of the predicate devices (primary and reference), STZ, PureSleep, and ZQuiet have clearance for over-the-counter use. The subject labeling specifically states that the device does not treat obstructive sleep apnea and the STOP-BANG questionnaire is included in the labeling to help mitigate the risk of undiagnosed OSA among potential Snore Bandit users.
Substantial equivalent labeling and instructions for use to that of the over-the-counter predicate devices, there are no new concerns regarding effectiveness or safety as compared to predicate devices (primary and reference).
E. Labeling
The subject appliance has similar labeling as the OTC reference predicate devices (primary and reference), Sleep Tight Mouthpiece (STZ), PureSleep, and ZQuiet. It utilizes a validated questionnaire to access the risk of sleep apnea and contains the appropriate warnings and labeling for the device to be used without requiring a prescription.
F. Technology - Materials
To support this application, the sponsor has included Biocompatibility testing results demonstrating the subject device is biocompatible under ISO 10993, including cytotoxicity, sensitization, and irritation testing. The device was shown to meet the requirements of the ISO 10993 guidelines for each of these tests. Other biocompatibility tests recommended for permanent mucosal contact were not conducted because all materials used in the device are certified USP Class VI and used in many other currently marketed medical devices, including another mouthguard called Somnos Anti-Snoring Mouth Guard (K201484) made by the same manufacturer that makes Snore Bandit.
7
Because the same materials and manufacturing processes are used in the primary predicate device, there are no new concerns regarding effectiveness or safety as compared to the predicate devices.
G. Biocompatibility
The materials and manufacturing process are similar to the predicate devices (primary and reference). One hundred percent of the Snore Bandit is made of Elvax. There is no added colorant in Snore Bandit.
Testing results have been include cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10), and irritation (ISO 10993-10). As all the materials used in the device are certified USP Class VI and used in many other currently marketed medical devices, no additional biocompatibility testing was conducted.
Clinical Testing
No clinical testing was performed in association with this submission.
Conclusions
The results of the comparison of design, materials, intended use, labeling, and technological characteristics demonstrate the subject device is substantially equivalent in safety and efficacy to the legally marketed predicate devices, both the primary and reference predicates. Therefore, the sponsor concludes the proposed Snore Bandit device is substantially equivalent to the identified predicate devices.