Sleeping Well, LLC June 12, 2018

℅ 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 (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);

U.S. Food & Drug Administration

10903 New Hampshire Avenue Doc ID# 04017.02.11
Silver Spring, MD 20993
www.fda.gov
Page 2 - William Mclain K180124

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 ([email protected]) or phone
(1-800-638-2041 or 301-796-7100).

Sincerely,
y
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

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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: (802) 985-3013
Fax: (802) 985-9298
Email: [email protected]

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: (717) 656-9656
Fax: (717) 656-3434
Email: [email protected]

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

1
 • 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 trays 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.

2
 Table 1: Substantial Equivalence Table

Feature ZQuiet - K180124 ZQuiet - K093407 - Pred- ZQuiet - K090503 - Pred- SnoreRx - K170825 -
icate Device (Primary) icate Device (Reference) Predicate Device (Refer-
ence)

Product Code LKR LRK LRK LRK

Product Classifi- Class II Class II Class II Class II
cation
Classification Anti-Snoring Device Anti-Snoring Device Anti-Snoring Device Anti-Snoring Device
Name
Proprietary ZQuiet ZQuiet ZQuiet SnoreRx
Name
Technology - Mandibular advance- Mandibular advance- Mandibular advance- Mandibular advance-
3

Mode of Action ment to increase pharyn- ment to increase pharyn- ment to increase pharyn- ment to increase pharyn-
geal space. geal space. geal space. geal space.
Indication for ZQuiet is intended as an The ZQuiet mandibular The ZQuiet mandibular The SnoreRx is intended
Use aid in the reduction of advancement device is advancement device is for use on adult patients
snoring for adults at least intended for the treat- intended for the treat- 18 years of age or older as
18 years old. ment of nighttime snor- ment of nighttime snor- an aid for the reduction
ing in adults 18 years or ing in adults. of snoring.
older.
 Table 1: (continued)

Feature ZQuiet - Proposed De- ZQuiet - K093407 - Pred- ZQuiet - K090503 - Pred- SnoreRx - K170825 -
vice icate Device (Primary) icate Device (Reference) Predicate Device (Refer-
ence)

Design Principle An upper and lower tray An upper and lower tray An upper and lower tray An upper and lower tray
constructed in one piece constructed in once piece constructed in once piece that are adjustable in
and joined by a flexible and joined by a flexible and joined by a flexible 1mm increments. The
hinge. The lower tray hinge. The lower tray hinge. The lower tray rigid trays are lined with
protrudes the mandible protrudes the mandible protrudes the mandible softer polymer that is
to widen the upper air- to widen the upper air- to widen the upper air- molded to take the shape
way. way. way. of the upper and lower
teeth using a “boil and
bite” approach.
Prescription OTC Prescription Prescription OTC
4

Status
Materials Thermoplastic Elas- Thermoplastic Elas- Thermoplastic Elas- The materials of con-
tomer with Blue Col- tomer with Blue Col- tomer with Blue Col- struction are unknown.
orant orant orant
 The following sections provide a more detailed summary of the technological character-
istics as compared to the predicate devices.

10.1 Technology - Mode of Action

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 product as 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 ad-
vancement 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

5
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 Snor-
eRx 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 label-
ing 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 pred-
icate 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-

6
struction are unknown.

11 Non-Clinical Testing
Non-clinical testing was not performed for this submission. However, Sleeping Well con-
ducted 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 Guid-
ance 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 biocompati-
bility testing was conducted.

13 Clinical Testing
No clinical testing was performed in association with this submission.

14 Conclusions
The results of the comparison of design, materials, intended use and technological character-
istics 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 de-
vice. Therefore, Sleeping Well, LLC concludes that the proposed ZQuiet is substantially
equivalent to the identified predicate devices.