ZQuiet

K180124 · Sleeping Well, LLC · LRK · Jun 12, 2018 · Dental

Device Facts

• Record ID: K180124
• Device Name: ZQuiet
• Applicant: Sleeping Well, LLC
• Product Code: LRK · Dental
• Decision Date: Jun 12, 2018
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

ZQuiet is intended as an aid in the reduction of snoring for adults at least 18 years old.

Device Story

ZQuiet is an intraoral appliance consisting of upper and lower trays joined by a flexible hinge. The device is worn by the user during sleep to maintain anterior positioning of the mandible, which widens the pharyngeal airway to prevent occlusion and reduce snoring. It is intended for over-the-counter use by adults. The device is manufactured in varying protrusive sizes (2mm and 6mm) to accommodate different user anatomies. Users select the appropriate size to achieve mandibular advancement. The device includes the STOP-Bang screening questionnaire in its labeling to advise users to consult a physician if they exhibit signs of sleep apnea or other respiratory disorders.

Clinical Evidence

No clinical data. Bench testing was not performed; equivalence was established through comparison of design, materials, and intended use, supported by a risk analysis conducted in accordance with ISO 14971:2007 and FDA guidance for intraoral devices.

Technological Characteristics

Intraoral mandibular advancement device; one-piece construction with flexible hinge; thermoplastic elastomer (clear or blue-tinted). Dimensions vary by protrusive size (2mm or 6mm). Non-electronic, mechanical device. No software or connectivity.

Indications for Use

Indicated for adults at least 18 years old as an aid in the reduction of snoring.

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

• ZQuiet (K093407)
• ZQuiet (K090503)
• SnoreRx (K170825)

Submission Summary (Full Text)

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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 & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

Sleeping Well, LLC % Mr. William McLain President and Principal Consultant Keystone Regulatory Services, LLC 342 E. Main Street, Suite 207 Leola, Pennsylvania 17540

### Re: K180124

Trade/Device Name: ZQuiet 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 11, 2018 Received: May 14, 2018

Dear William McLain:

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

June 12, 2018

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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 medical devices and radiation-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.

# Mary S. Runner -S

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

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## Indications for Use

510(k) Number (if known)

### K180124

Device Name ZQuiet

Indications for Use (Describe)

ZQuiet is intended as an aid in the reduction of snoring for adults at least 18 years old.

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)

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### 510(k) Summary (K180124)

#### 1 Submission Owner

Mr. Daniel Webster Vice President Sleeping Well, LLC P.O. Box 1240 5247 Shelburne, Rd, #204 Shelburne, VT 05482 Phone: [phone] Fax: [phone] Email: [e-mail]

#### 2 Submission Correspondent

Mr. William G. McLain President and Principal Consultant Keystone Regulatory Services, LLC 342 E. Main Street Suite 207 Leola, PA 17540 Phone: [phone] Fax: [phone] Email: [e-mail]

#### 3 Date Summary Prepared

May 11, 2018

#### 4 Device Trade Name

ZQuiet

#### 5 Device common name

Intraoral Device for Snoring

#### 6 Device classification name

Device, Anti-Snoring, 21 CFR 872.5570, LRK, Class II

#### 7 Legally Marketed Device To Which The Device Is Substantially Equivalent

- · Primary Predicate ZQuiet , K093407

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- · Reference Predicate ZQuiet , K090503
- · Reference Predicate SnoreRx , K170825

#### 8 Description Of The Device

The ZQuiet is an oral appliance comprised of an upper and lower tray constructed in one piece and joined by a flexible hinge. The travs engage with the maxillary and mandibular dentition and the device maintains an anterior positioning of the mandible which widens the pharyngeal airway to prevent occlusion. The device is presented in varying protrusive sizes allowing the user to try different degrees of mandibular advancement to reduce snoring.

#### 9 Intended Use

ZQuiet is intended as an aid in the reduction of snoring for adults at least 18 years old.

#### 10 Technological Characteristics

The proposed ZQuiet has identical technical characteristics to the predicate ZQuiet, K090503. A comparison of technological characteristics is presented in Table 1 below with additional narrative following.

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| Feature | ZQuiet - K180124 | ZQuiet - K093407 - Pred-<br>icate Device (Primary) | ZQuiet - K090503 - Pred-<br>icate Device (Reference) | SnoreRx - K170825 -<br>Predicate Device (Refer-<br>ence) |
|--------------------------------|-----------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Product Code | LKR | LRK | LRK | LRK |
| Product Classifi-<br>cation | Class II | Class II | Class II | Class II |
| Classification<br>Name | Anti-Snoring Device | Anti-Snoring Device | Anti-Snoring Device | Anti-Snoring Device |
| Proprietary<br>Name | ZQuiet | ZQuiet | ZQuiet | SnoreRx |
| Technology<br>- Mode of Action | Mandibular<br>advance-<br>ment to increase pharyn-<br>geal space. | Mandibular<br>advance-<br>ment to increase pharyn-<br>geal space. | Mandibular<br>advance-<br>ment to increase pharyn-<br>geal space. | Mandibular<br>advance-<br>ment to increase pharyn-<br>geal space. |
| Indication<br>for<br>Use | ZQuiet is intended as an<br>aid in the reduction of<br>snoring for adults at least<br>18 years old. | The ZQuiet mandibular<br>advancement device is<br>intended for the treat-<br>ment of nighttime snor-<br>ing in adults 18 years or<br>older. | The ZQuiet mandibular<br>advancement device is<br>intended for the treat-<br>ment of nighttime snor-<br>ing in adults. | The SnoreRx is intended<br>for use on adult patients<br>18 years of age or older as<br>an aid for the reduction<br>of snoring. |

Table 1: Substantial Equivalence Table

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| | Feature | ZQuiet - Proposed De-<br>vice | ZQuiet - K093407 - Pred-<br>icate Device (Primary) | ZQuiet - K090503 - Pred-<br>icate Device (Reference) | SnoreRx - K170825 -<br>Predicate Device (Refer-<br>ence) |
|---|------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Design Principle | An upper and lower tray<br>constructed in one piece<br>and joined by a flexible<br>hinge.<br>The lower tray<br>protrudes the mandible<br>to widen the upper air-<br>way. | An upper and lower tray<br>constructed in once piece<br>and joined by a flexible<br>hinge.<br>The lower tray<br>protrudes the mandible<br>to widen the upper air-<br>way. | An upper and lower tray<br>constructed in once piece<br>and joined by a flexible<br>hinge.<br>The lower tray<br>protrudes the mandible<br>to widen the upper air-<br>way. | An upper and lower tray<br>that are adjustable in<br>1mm increments.<br>The<br>rigid trays are lined with<br>softer polymer that is<br>molded to take the shape<br>of the upper and lower<br>teeth using a "boil and<br>bite" approach. |
| 4 | Prescription<br>Status | OTC | Prescription | Prescription | OTC |
| | Materials | Thermoplastic<br>Elas-<br>tomer with Blue Col-<br>orant | Thermoplastic<br>Elas-<br>tomer with Blue Col-<br>orant | Thermoplastic<br>Elas-<br>tomer with Blue Col-<br>orant | The materials of con-<br>struction are unknown. |

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The following sections provide a more detailed summary of the technological characteristics as compared to the predicate devices.

#### Technology - Mode of Action 10.1

The proposed and predicate devices are highly similar in terms of technology or mode of action as they are all intraoral devices intended for the purpose of reduction of snoring.

#### 10.2 Indication for Use

### Comparison of the Proposed ZQuiet device to the Predicate ZQuiet Devices

While there are minor differences in specific wording, the most substantial difference is in the use of the words "aid in the reduction of snoring" for the proposed device as compared to "treatment of snoring" for the ZQuiet predicates. This change reflects the consumer-oriented focus of reducing snoring as compared to someone who may need to be under a physician's or dentist's care. The proposed and predicate ZQuiet devices are all intended for adults. The proposed and K093407 predicate both additionally indicate that the minimum age of use is 18 years. The K090503 predicate does not mention a minimum adult age of use. The more recently cleared predicate and the proposed device differ in the identification of the device. The proposed device more simply mentions the product name "ZQuiet", where the K093407 predicate describes the "ZQuiet mandibular advancement device". None of the difference described effect the safety or performance of the device. Therefore, there is no negative impact on safety and effectiveness.

### Comparison of the Proposed ZQuiet Device to the SnoreRx, K170825

The proposed ZQuiet device has an indication of use that states "ZQuiet is intended as an aid in the reduction of snoring for adults at least 18 years old." The predicate SnoreRx device has an indication for use that states "The SnoreRx is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring." There are no differences in the patient population and in the function which is aiding in the reduction of snoring. Therefore, there is no negative impact on safety and effectiveness related to the indications for use.

#### 10.3 Design Principle

### Comparison of the Proposed ZQuiet device to the Predicate ZQuiet Devices

The proposed and predicate ZQuiet devices are identical in design with the only difference being the degree of mandibular advancement. Both of the predicate devices had 6mm of mandibular advancement. The proposed ZQuiet has 2mm and 6mm of mandibular advancement to give the user the opportunity to find a device that works with their particular anatomy. The degree of mandibular advancement does not exceed the original cleared 6mm. Therefore, the proposed ZQuiet device is substantially equivalent to the predicate device in

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terms of the basic design and mandibular advancement and there is no negative impact on safety and effectiveness.

### Comparison of the Proposed ZQuiet Device to the SnoreRx, K170825

The proposed ZQuiet device and predicate SnoreRx device are designed differently, but function similarly. The proposed device is molded in one piece from a material that is sufficiently stiff to retain the lower mandible in position throughout the night yet sufficiently pliable to allow small degrees of lateral movement of the mandible and remain comfortable for the user. To achieve different degrees of mandibular advancement, ZQuiet uses different molds to manufacture devices with different dimensions.

The predicate SnoreRx device uses a rigid outer tray and that contains a soft polymer that the user molds to the shape of their teeth using a boil and bite approach. The SnoreRx device uses an intra-device ratcheting mechanism to adjust the degree of mandibular advancement.

Despite the difference in the approach to achieving the degree in mandibular advance ment, the end result is the same. The mandible is advanced and the pharyngeal space is increased. Therefore, there is no negative impact on safety and effectiveness.

#### 10.4 Prescription Status

The proposed ZQuiet is intended to be sold over-the-counter. Therefore, the product labeling has been modified to eliminate prescribing information. There have been no changes related to warnings or contraindications. The proposed product labeling now includes the STOP-Bang 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 predicate SnoreRx, K170825 has a clearance for over-the-counter use. Sleeping Well believes that through the redesign of the packaging by placing the warnings and precautions prominently on the outer packaging and instructions for use, and by providing the STOP-Bang Questionnaire to alert the user for the potential presence of complicating factors, the labeling is as safe and as effective as the OTC predicate, K170825. Therefore, there is no negative impact on safety and effectiveness.

#### 10.5 Materials

The proposed ZQuiet device will be made with either clear or blue-tinted thermoplastic elastomer. These materials are identical to those referenced in the two Sleeping Well predicate devices with the following exception. Sleeping Well, LLC intends to be able to vary the amount of tint to aid in product differentiation. The proposed and predicate ZQuiet devices, are therefore, considered to be substantially equivalent in terms of materials and there is no negative impact on safety and effectiveness.

A comparison to the predicate SnoreRx is not possible because the materials of con-

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struction are unknown.

#### Non-Clinical Testing 11

Non-clinical testing was not performed for this submission. However, Sleeping Well conducted a risk analysis on the device in accordance with ISO 14971:2007 and by 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 through communication with the user through the instructions for use.

#### 12 Biocompatibility

Since the materials and methods of manufacture are identical to the materials and/or the base materials utilized in the K093407 and K090503 predicates, no additional biocompatibility testing was conducted.

#### Clinical Testing 13

No clinical testing was performed in association with this submission.

#### 14 Conclusions

The results of the comparison of design. materials, intended use and technological characteristics demonstrate that the device is as safe and effective as the legally marketed predicate devices. The packaging and labeling has been redesigned to provide sufficient information to the consumer to ensure the safe and effective over-the-counter use of the proposed device. Therefore, Sleeping Well, LLC concludes that the proposed ZQuiet is substantially equivalent to the identified predicate devices.