TD Clip

K190051 · Zephyr Sleep Technologies, Inc. · LRK · Jun 7, 2019 · Dental

Device Facts

• Record ID: K190051
• Device Name: TD Clip
• Applicant: Zephyr Sleep Technologies, Inc.
• Product Code: LRK · Dental
• Decision Date: Jun 7, 2019
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

TD Clip is a temporary mandibular repositioning device used to alleviate snoring and mild to moderate OSA while awaiting a custom oral appliance. The device consists of upper and lower dental titration trays custom-fitted with polyvinyl siloxane impression material; trays are fastened at a target therapeutic position using a clip assembly and pins. Used during sleep for a maximum of 30 nights. The workflow follows an OA Assessment study using the MATRx or MATRx plus system; the healthcare provider fastens the trays at the target protrusive position identified during the study. The patient inserts the device each evening. The device maintains mandibular protrusion to keep the airway open, potentially reducing apnea events and snoring. It is a prescription device fitted by a healthcare professional.

Clinical Evidence

No clinical data. Bench testing only. Testing included simulated aging, environmental conditions, and worst-case loading schemes to ensure structural integrity over 30 nights. Tray removal simulation confirmed 100% of users could remove the device safely. Biocompatibility testing performed per ISO 10993-1.

Technological Characteristics

Mandibular repositioning device; separate upper/lower trays; polyvinyl siloxane impression material; pin-based fastening system with serrated interface. Non-sterile. Biocompatibility per ISO 10993-1. Mechanical design allows for lateral/vertical jaw movement. Adjustable arch width.

Indications for Use

Indicated for adult patients (18+) with mild to moderate obstructive sleep apnea (OSA) and snoring. Contraindicated for patients with central sleep apnea, loose teeth, advanced periodontal disease, full dentures, dental implants, TMJ dysfunction syndrome, or severe respiratory disorders.

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

• Apnea Guard (K111110)

Reference Devices

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

Submission Summary (Full Text)

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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

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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 ([e-mail]) or phone [phone] 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

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# Indications for Use

510(k) Number (if known) K190051

Device Name TD Clip

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

| <div> <span> <span style="font-size: 20px;"><b> </b> </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
|-----------------------------------------------------------------------------------------------------------------------------------|
| <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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<br>Calgary, Alberta, Canada<br>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)<br>MATRx (K103704)<br>Brux-TMD QuickSplint (K111066) |

### 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.

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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.

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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<br>510(k) Number | Primary<br>Predicate | Reference Device | Subject Device | Substantial<br>Equivalence<br>Discussion |
| Manufacturer | | | | |
| | Apnea Guard<br>K111110 | MATRx plus<br>DEN170090 | TD Clip | |
| | Advanced Brain<br>Monitoring, Inc. | Zephyr Sleep<br>Technologies, Inc. | Zephyr Sleep<br>Technologies, Inc. | |
| Indications for Use | | | | |
| | The Apnea Guard<br>is a mandibular<br>repositioning<br>device intended to<br>reduce or alleviate<br>snoring and mild<br>to moderate<br>obstructive sleep<br>apnea (OSA) in<br>patients 18 years<br>and older. The<br>Apnea Guard is<br>intended to be<br>fitted with<br>assistance from a<br>healthcare<br>professional, and<br>used during sleep<br>for less than 30<br>nights. | The MATRx plus<br>device may also<br>be used with an<br>automated<br>mandibular<br>positioner that<br>uses feedback<br>control to record<br>changes in the<br>patient's<br>respiratory status<br>related to<br>repositioning of<br>the mandible<br>during an<br>overnight study.<br>MATRx plus uses<br>these recordings<br>to produce a<br>report for the HCP<br>that can be used to<br>prospectively<br>identify patients<br>with mild to<br>moderate<br>obstructive sleep<br>apnea who may be<br>suitable for<br>therapy with an<br>oral appliance and<br>to recommend a<br>target mandibular<br>position.<br>The use of the<br>device does not<br>replace the need<br>for follow-up<br>testing to<br>determine the<br>initial and<br>ongoing<br>effectiveness of<br>the therapy as<br>recommended by<br>clinical practice | The TD Clip is a<br>mandibular<br>repositioning<br>device intended to<br>reduce or alleviate<br>snoring and mild<br>to moderate<br>obstructive sleep<br>apnea (OSA) in<br>patients 18 years<br>and older. The<br>device is intended<br>to be fitted with<br>assistance from a<br>healthcare<br>professional and<br>used during sleep<br>for a total of less<br>than 30 nights. | The indications<br>for use of the<br>subject device are<br>identical to those<br>of the primary<br>predicate. |
| | #102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada | | | |
| | Primary<br>Predicate | Reference Device | Subject Device | |
| Proprietary Name | Apnea Guard | MATRx plus | TD Clip | Substantial |
| 510(k) Number | K111110 | DEN170090 | -- | Equivalence |
| Manufacturer | Advanced Brain<br>Monitoring, Inc. | Zephyr Sleep<br>Technologies,<br>Inc. | Zephyr Sleep<br>Technologies,<br>Inc. | Discussion |
| | | guidelines. | | |
| Use Environment | | | | |
| Intended for nighttime<br>use | | Yes | | Identical |
| Indicated for use at<br>home or in sleep<br>laboratories | | Yes | | |
| In-use claim | Less than 30 days | Duration of<br>Titration study<br>(max: 3 days) | Less than 30 days<br>(Including<br>titration study use) | Identical to<br>predicate - total<br>use < 30 days |
| Contraindications | | | | |
| | Missing, loose,<br>infected teeth,<br>temporary crowns<br>or fillings, TMJ<br>dysfunction<br>syndrome | Loose teeth, advanced periodontal<br>disease, full dentures/implants, TMJ<br>dysfunction syndrome, central sleep<br>apnea, severe respiratory disorders,<br>under 18 years of age | | Substantially<br>equivalent -<br>devices are<br>intended for use in<br>adults with mild<br>to moderate<br>obstructive sleep<br>apnea who have<br>sufficient<br>dentition and no<br>relevant<br>comorbidities |
| Technological Characteristics | | | | |
| Design | | | | |
| Operating Principle -<br>Mandibular<br>Advancement | | Yes | | |
| Separate upper and<br>lower tray pieces | | Yes | | |
| Placed in patient's<br>mouth each evening | | Yes | | |
| Mechanism of tray<br>fastening | | Same (Connected via brackets extending from the oral cavity<br>with directional guidance from rails) | | Identical |
| Permitted lateral and/or<br>vertical jaw movement | | Yes | | |
| Method of retention -<br>impression material | | Yes | | |
| Customized fit for each<br>patient | | Yes | | |
| | Primary<br>Predicate | Reference Device | Subject Device | Substantial<br>Equivalence<br>Discussion |
| Proprietary Name<br>510(k) Number | Apnea Guard<br>K111110 | MATRx plus<br>DEN170090 | TD Clip<br>-- | |
| Manufacturer | Advanced Brain<br>Monitoring, Inc. | Zephyr Sleep<br>Technologies,<br>Inc. | Zephyr Sleep<br>Technologies,<br>Inc. | |
| Method of fixing the<br>position | Pin connection<br>through one of<br>several slots | Pin connection to<br>a motorized<br>mandibular<br>positioner | Pin connection to<br>the TD clip<br>device; pin used<br>to fix in place | Substantially<br>equivalent - pin<br>used to secure<br>protrusive level |
| Dental tray shape | Same (Full arch, lingual and buccal walls to hold impression<br>material) | | | Identical |
| Dental tray sizing | One size fits all.<br>Adjustable arch<br>width. | Available in 2 sizes (medium and<br>large). Adjustable arch width. | | Substantially<br>equivalent –<br>multiple sizes in<br>subject device<br>accommodate full<br>range of arch<br>widths |
| Fastening resolution | 1.0 mm | 0.5 mm | | Substantially<br>equivalent –<br>ability to fasten<br>trays at a<br>clinically<br>meaningful<br>resolution |
| Can be adjusted or refit | Yes – with assistance from a healthcare professional | | | Identical |
| Materials | |…