K Number

Device Name

TD Clip

Manufacturer

Zephyr Sleep Technologies, Inc.

Date Cleared

2019-06-07

(147 days)

Product Code

LRK

Regulation Number

872.5570

Intended Use

The TD Clip is intended to be used with MATRx or MATRx plus Titration Trays to form a mandibular repositioning device intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years and older. The device is intended to be fitted with assistance from a healthcare professional and used during sleep for a total of less than 30 nights.

Device Description

The TD Clip is a temporary oral appliance. The patient uses the temporary oral appliance to alleviate mild to moderate obstructive sleep apnea and/or snoring while waiting for a custom oral appliance to be manufactured. The dentist fabricates temporary titration trays consisting of upper and lower dental trays. The trays are custom fit to the patient using polyvinyl siloxane impression material. The healthcare provider may use the clip assembly to fasten the titration trays at the target therapeutic position to form the TD Clip temporary oral appliance. Patients may use the temporary oral appliance as treatment while waiting for their custom oral appliance. Adjustment of the position requires the setting of a new TD Clip by the healthcare professional.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

K111110

Reference Devices

DEN170090, K103704, K111066

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on a mechanical device for mandibular repositioning and does not mention any AI/ML components or capabilities.

Therapeutic

Yes
The device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea, which are medical conditions, and it is used as a temporary oral appliance for treatment.

Diagnostic

Explanation: The device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea, acting as a treatment rather than a diagnostic tool.

SaMD (Software as a Medical Device)

The device description clearly describes a physical oral appliance (temporary oral appliance, dental trays, clip assembly) and the performance studies focus on mechanical and material properties, indicating it is a hardware device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
Device Function: The TD Clip is a physical oral appliance used to reposition the mandible. It is a mechanical device that directly interacts with the patient's anatomy to alleviate symptoms of snoring and sleep apnea. It does not analyze biological samples.
Intended Use: The intended use clearly states it's a mandibular repositioning device to reduce or alleviate snoring and OSA. This is a therapeutic function, not a diagnostic one.
Device Description: The description details the physical components and how it's used as a temporary oral appliance. There is no mention of analyzing biological samples or providing diagnostic information.

Therefore, the TD Clip falls under the category of a medical device, but not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

LRK

Device Description

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Intraoral

Indicated Patient Age Range

18 years and older

Intended User / Care Setting

Fitted with assistance from a healthcare professional; used during sleep.

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)

Bench testing was conducted, including:

Intraoral Material Performance: The trays and impression material were evaluated under simulated aging, including environment conditions and representative worst-case loading schemes to ensure there was no presence or increased risk of breakage that could lead to an unacceptable harm over the maximal study length (30 nights of use).
TD Clip Performance: The TD Clip was evaluated under repeated use and exposed to normal sleep forces over 30 nights of use, including static and cyclic loading under worst-case use, to ensure that it maintained the set protrusive positioning.
Tray Removal Simulation: The TD Clip Titration Trays were evaluated to ensure that 100% of users were able to remove the Titration Trays from their mouth quickly and without causing injury to themselves or the Titration Trays.
Clinical testing was not performed as the device has no technological differences from the predicate. During risk management and performance testing, no new risks were identified.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K111110 (Apnea Guard)

Reference Device(s)

DEN170090 (MATRx plus), K103704 (MATRx), K111066 (Brux-TMD QuickSplint)

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 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.”

Summary

Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 7, 2019

Zephyr Sleep Technologies, Inc. Sabina Bruehlmann Director, Technology 102, 701 64 Ave SE Calgary, T2H 2C3 Ca

Re: K190051

Trade/Device Name: TD Clip 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: April 30, 2019 Received: May 1, 2019

Dear Sabina Bruehlmann:

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

542 of the Act); 21 CFR 1000-1050.

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-

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,

Srinivas Nandkumar, Ph.D. Assistant 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

Indications for Use

510(k) Number (if known) K190051

Device Name TD Clip

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image features the logo for Zephyr Sleep Technologies. The logo is in blue and includes the company name in a stylized font. Below the name is the company's address: #102, 701-64th Avenue SE, Calgary, AB, T2H 2C3, Canada.

K190051

Section 5 - 510k Summary - TD Clip

Date:	January 9, 2019
Manufacturer Name:	Zephyr Sleep Technologies, Inc.
Contact Name:	Sabina Bruehlmann, PhD
Title:	Director, Technology
Postal Address:	#102, 701 64th Ave SE
Calgary, Alberta, Canada
T2H-2C3
Phone Number:	587-332-0285
Fax Number:	587-332-0208
Establishment Registration Number:	3008960597
Device Proprietary Name:	TD Clip
Classification Name:	CFR 872.5570
Classification Code:	Class II
Product Code:	LRK (anti-snoring device)
Predicate Device:	Apnea Guard (K111110)
Reference Devices:	MATRx plus (DEN170090)
MATRx (K103704)
Brux-TMD QuickSplint (K111066)

Device Description:

The dentist fabricates temporary titration trays consisting of upper and lower dental trays. The trays are custom fit to the patient using polyvinyl siloxane impression material.

Image /page/4/Picture/0 description: The image shows the logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in a large, sans-serif font, with the words "Sleep Technologies" in a smaller font underneath. To the right of the text is a stylized image of a crescent moon and a star. Below the logo is the address "#102. 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada".

The healthcare provider may use the clip assembly to fasten the titration trays at the target therapeutic position to form the TD Clip temporary oral appliance. Patients may use the temporary oral appliance as treatment while waiting for their custom oral appliance. Adjustment of the position requires the setting of a new TD Clip by the healthcare professional.

In the expected workflow, the patient first completes an OA Assessment study with the MATRx or MATRx plus system. The healthcare provider then takes the titration trays used in the overnight OA Assessment study and fastens them at the intended target protrusive position for temporary treatment.

Indications for Use:

The TD Clip is a mandibular repositioning device intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in patients 18 years and older. The device is intended to be fitted with assistance from a healthcare professional and used during sleep for less than 30 nights.

Patient Population:

The TD Clip is intended to be used on adult patients upon referral from their healthcare provider.

Contraindications:

The device is contraindicated for patients who:

. have central sleep apnea
. have loose teeth or advanced periodontal disease
have full dentures or dental implants
have temporomandibular joint (TMJ) dysfunction syndrome
have severe respiratory disorders
are under 18 years of age ●

Comparison to Predicate Device:

The TD Clip is substantially equivalent to the predicate, Apnea Guard. The following table provides a comparison of the intended use and technological features of the subject. predicate, and reference devices.

Image /page/5/Picture/0 description: The image shows the logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in a large, bold, blue font, with the words "Sleep Technologies" in a smaller font underneath. To the right of the text is a stylized image of a crescent moon with a star.

#102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada
Proprietary Name
510(k) Number	Primary
Predicate	Reference Device	Subject Device	Substantial
Equivalence
Discussion
Manufacturer
	Apnea Guard
K111110	MATRx plus
DEN170090	TD Clip
	Advanced Brain
Monitoring, Inc.	Zephyr Sleep
Technologies, Inc.	Zephyr Sleep
Technologies, Inc.
Indications for Use
	The Apnea Guard
is a mandibular
repositioning
device intended to
reduce or alleviate
snoring and mild
to moderate
obstructive sleep
apnea (OSA) in
patients 18 years
and older. The
Apnea Guard is
intended to be
fitted with
assistance from a
healthcare
professional, and
used during sleep
for less than 30
nights.	The MATRx plus
device may also
be used with an
automated
mandibular
positioner that
uses feedback
control to record
changes in the
patient's
respiratory status
related to
repositioning of
the mandible
during an
overnight study.
MATRx plus uses
these recordings
to produce a
report for the HCP
that can be used to
prospectively
identify patients
with mild to
moderate
obstructive sleep
apnea who may be
suitable for
therapy with an
oral appliance and
to recommend a
target mandibular
position.
The use of the
device does not
replace the need
for follow-up
testing to
determine the
initial and
ongoing
effectiveness of
the therapy as
recommended by
clinical practice	The TD Clip is a
mandibular
repositioning
device intended to
reduce or alleviate
snoring and mild
to moderate
obstructive sleep
apnea (OSA) in
patients 18 years
and older. The
device is intended
to be fitted with
assistance from a
healthcare
professional and
used during sleep
for a total of less
than 30 nights.	The indications
for use of the
subject device are
identical to those
of the primary
predicate.
	#102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada
	Primary
Predicate	Reference Device	Subject Device
Proprietary Name	Apnea Guard	MATRx plus	TD Clip	Substantial
510(k) Number	K111110	DEN170090	--	Equivalence
Manufacturer	Advanced Brain
Monitoring, Inc.	Zephyr Sleep
Technologies,
Inc.	Zephyr Sleep
Technologies,
Inc.	Discussion
		guidelines.
Use Environment
Intended for nighttime
use		Yes		Identical
Indicated for use at
home or in sleep
laboratories		Yes
In-use claim	Less than 30 days	Duration of
Titration study
(max: 3 days)	Less than 30 days
(Including
titration study use)	Identical to
predicate - total
use