(150 days)
No
The device description and performance studies focus on the mechanical design and material properties of the oral appliance, with no mention of AI or ML technologies.
Yes.
The device is intended to reduce snoring, which is a medical condition and the device provides a therapeutic benefit.
No
This device is intended to reduce snoring, which is a therapeutic purpose, not a diagnostic one. It functions by keeping the tongue in place to prevent airway blockage.
No
The device description clearly states it is a "single piece tray system for intraoral use" and a "'boil-and-bite' device," indicating it is a physical, hardware-based medical device.
Based on the provided information, the Zyppah® device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Zyppah's Function: The Zyppah® device is an intraoral appliance designed to be worn in the mouth to reduce snoring. It works mechanically by positioning the tongue.
- No Specimen Analysis: The device does not involve the analysis of any biological specimens from the patient.
Therefore, the Zyppah® device falls under the category of a medical device, but not specifically an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
Zyppah® is intended for use by adult patients (18 years or older) as an aid to reduce snoring.
Product codes
LRK
Device Description
The Zyppah Anti-Snoring Appliance is a single piece tray system for intraoral use. The 'boil-and-bite' device is customized to each patient. It features an elastic strap that spans the device that is designed to keep the tongue in place during sleep, instead of blocking the airway and contributing to snoring. The product is non-sterile and provided in a sealed box with directions for use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intraoral
Indicated Patient Age Range
adult patients (18 years 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 tensile strength of the proposed OTC device was compared to the single-hole design of the cleared predicate in bench testing. It was found that using a two-hole the silicone strap in place increased the force the strap could withstand by 14% over that of a single-hole design used in the predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Dr. Greenburg's Hybrid Zyppah (K111680)
Reference Device(s)
ZQuiet (K180124), SnoreRX (K170825)
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 contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
January 24, 2019
Always More Marketing % Colette Cozean Regulatory Consultant EyeDeas Company 21581 Midcrest Drive Lake Forest, California 92630
Re: K182312
Trade/Device Name: Zyppah Anti-Snoring Device 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: December 14, 2018 Received: December 26, 2018
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mary S. Runner Runner Runner-S3 Digitally signed by Mary S. Date: 2019.01.24 14:05:59 -23
for
Tina Kiang, Ph.D. 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) K182312
Device Name Zyppah(R) Anti-Snoring Device
Indications for Use (Describe)
Zyppah(R) is intended for use by adult patients (18 years 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
510(k) Summary
K182312
| Applicant: | Always More Marketing, Inc.
24981 Palmilla Drive
Calabasas, CA 91302, USA
Phone: 818-414-4817 |
|-----------------------|---------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Colette Cozean, Ph.D.
21581 Midcrest Dr.
Lake Forest, CA 92603 USA
949-855-2885
ccozean@cox.net |
| Date Prepared: | January 21, 2019 |
| Proprietary Name: | Zyppah® Anti-Snoring Appliance |
| Common Name: | Intraoral Device for Snoring |
| Classification Name: | Device, anti-snoring
(Class II, 21 CFR 872.5570, Product Code LRK) |
| Predicate Device: | Dr. Greenburg's Hybrid Zyppah (K111680) – Prescription Predicate |
| Reference Predicates: | ZQuiet (K180124) – Over the Counter Reference Predicate
SnoreRX (K170825) - Over the Counter Reference Predicate |
8. Description of the Device
The Zyppah Anti-Snoring Appliance is a single piece tray system for intraoral use. The 'boil-and-bite' device is customized to each patient. It features an elastic strap that spans the device that is designed to keep the tongue in place during sleep, instead of blocking the airway and contributing to snoring. The predicate The product is non-sterile and provided in a sealed box with directions for use.
9. Indications for Use
4
Zyppah® is intended for use by adult patients (18 years or older) as an aid to reduce snoring.
10. Technological Characteristics
The appliance is equivalent in design and functionality to the prescription Zyppah device (K111680). Both devices work by depressing the tongue during sleep to open the airway and reduce the incidence of snoring, in addition to advancing the mandible. Both are customized to the individual patient by a standard 'boil and bite' method. Both use the same materials and manufacturing process. Both devices are provided non-sterile. The sole difference between the subject and predicate device is the use of double-hole retention for the silicone strap, rather than the single-hole retention in the predicate device. This adds additional strength to the binding to prevent any breakage or loosening of the strap.
The appliance has similar labeling as the OTC reference predicate devices, SnoreRx and ZQuiet. It utilizes a validated questionnaire to assess the risk of sleep apnea, and contains appropriate warnings and labeling for the device to be used without a prescription.
| | Subject | Prescription
Predicate | OTC Reference
Predicate | OTC Reference
Predicate |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------|
| Name | Zyppah® Anti-
Snoring Appliance | Dr. Greenburg's
Hybrid | SnoreRx | ZQuiet |
| Classification
Name | Device, anti-
snoring | Device, anti-
snoring | Device, anti-
snoring | Device, anti-
snoring |
| 510(k)
Number | K182312 | K111680 | K170825 | 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 | Repositioning the
tongue,
mandibular
advancement | Repositioning the
tongue,
mandibular
advancement | Mandibular
advancement | Mandibular
advancement |
| Indications for
use | Zyppah® is
intended for use
by adult patients
(18 years or
older) as an aid to
reduce snoring. | This appliance is
indicated for
persons 18 years
or older, who wish
to reduce the
incidence of
snoring and/or
mild to moderate
sleep apnea. | "SnoreRx is
intended for use
on adult
patients 18
years of age or
older as an aid
for the
reduction of
snoring" | "ZQuiet is
intended as an
aid in the
reduction of
snoring for
adults at least
18 years old." |
| Prescription
Status | OTC | Prescription | OTC | OTC |
5
| Provided
| Sterile | No | No | No | No |
|---|---|---|---|---|
| Materials | Hard outer shell | |||
| with | ||||
| thermoplastic | ||||
| filling material | ||||
| and elastic band | Hard outer shell | |||
| with thermoplastic | ||||
| filling material and | ||||
| elastic band | Thermoplastic | |||
| Elastomer with | ||||
| Colorant |
10.1 Technology - Mechanism of Action
The subject device and prescription predicate device (K111680) are identical in mechanism of action. They both work by utilizing an intraoral mouthpiece to reposition the tongue in conjunction with a slight advancement of the mandible.
The mechanism of action for the other two OTC predicate devices, the SnoreRx and ZQuiet, is solely advancing the mandible. With any 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 in regards to mandibular advancement.
Utilizing the same mechanism of action as the prescription predicate the subject device raises no new concerns regarding effectiveness or safety as compared to predicate devices.
10.2 Technology - Indication for Use
The subject device uses language for the indication for use that is identical in substance to previouslyapproved OTC devices for the reduction of snoring. The subject device is "intended for use by adult patients (18 years or older) as an aid to reduce snoring."
This is almost identical to the indications for use for the two OTC predicate devices, the SnoreRx and ZQuiet, whose indications for use are "SnoreRx is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring" and "ZQuiet 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 is no new concerns regarding effectiveness or safety as compared to predicate devices.
10.4 Technology - Prescription Status
The subject device is intended to be sold over-the-counter. Product labeling has therefore eliminated prescribing information. Two of the predicate devices, SnoreRx and ZQuiet, have clearance for over-thecounter use.
Warnings and contraindications are substantially equivalent to those of over-the-counter predicate devices. The labeling specifically states that the device does not treat obstructive sleep apnea, and includes the validated STOP-BANG questionnaire is included in the labeling to help mitigate the risk of undiagnosed OSA among potential Zyppah patients.
6
The similar predicate prescription device (Dr. Greenburg's Hybrid, K111680) has been on the market for more than seven years. Due to its postmarket record of substantially equivalent performance to other devices of this type and substantially 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.
10.5 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.
Because the same materials and manufacturing processes are used as the currently marketed predicate device, there are no new concerns regarding effectiveness or safety as compared to the predicate device.
11. Non-Clinical Testing
The tensile strength of the proposed OTC device was compared to the single-hole design of the cleared predicate in bench testing. It was found that using a two-hole the silicone strap in place increased the force the strap could withstand by 14% over that of a single-hole design used in the predicate device.
The sponsor conducted a risk analysis on the device in accordance with ISO 14971:2007, taking into account the issues raised in the FDA Guidance Document "Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea – Guidance for Industry and FDA." All identified risks have been addressed through device design or with communication with the user through the instructions for use.
12. Biocompatibility
The materials and manufacturing process are similar to the currently marketed materials in the prescription predicate device.
Testing results that have been include cytotoxicity (ISO 10993-5), sensitization (ISO 10993-10) and irritation (ISO 10993-10). As all 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.
Class VI certification is less stringent than 10993
13. Clinical Testing
7
No clinical testing was performed in association with this submission.
14. 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 the legally marketed predicate devices. Therefore, the sponsor concludes the proposed Zyppah® device is substantially equivalent to the identified predicate devices.