(147 days)
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.
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.
The acceptance criteria and study proving the device meets them are described below for the TD Clip.
1. Table of Acceptance Criteria and Reported Device Performance:
| Test | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intraoral Material Performance | No presence or increased risk of breakage that could lead to unacceptable harm over the maximal study length (30 nights of use). | Evaluated under simulated aging, including environmental conditions and representative worst-case loading schemes. The device met the implied acceptance criteria. (Specific quantitative results or detailed findings are not provided in this summary, but the conclusion is that the device is safe and effective). |
| TD Clip Performance | Maintained the set protrusive positioning over 30 nights of use. | Evaluated under repeated use and exposed to normal sleep forces over 30 nights of use, including static and cyclic loading under worst-case use. The device met the implied acceptance criteria. (Specific quantitative results or detailed findings are not provided in this summary, but the conclusion is that the device is safe and effective). |
| Tray Removal Simulation | 100% of users were able to remove the Titration Trays from their mouth quickly and without causing injury to themselves or the Titration Trays. | Evaluated to ensure users could remove the trays quickly and without injury. The device met the implied acceptance criteria. (Specific quantitative results or detailed findings are not provided in this summary, but the conclusion is that the device is safe and effective). |
| Biocompatibility Testing | Materials in contact with mucosal membrane adhere to ISO 10993-1 and associated FDA guidance. | All materials in contact with the mucosal membrane were assessed and tested in accordance with ISO 10993-1 and the associated FDA guidance. The device met the implied acceptance criteria. |
| Risk Management | No unacceptable risks identified. | During risk management and performance testing, no new risks were identified. The risk management concluded that the TD Clip had no unacceptable risks. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified for any of the performance tests. The document only mentions "mechanical and environmental use conditions" and "repeated use and exposed to normal sleep forces over 30 nights of use".
- Data Provenance: The tests described are "Bench testing" and "simulated mechanical and environmental use conditions," indicating these were laboratory/engineering tests rather than human clinical trials. Thus, there is no country of origin or retrospective/prospective distinction for data provenance in the traditional sense; the data is from an engineering test setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications:
- Not applicable. The ground truth for these performance tests would be based on engineering specifications and direct measurements against those specifications, rather than expert interpretation of medical data. The evaluation was for mechanical and material performance.
4. Adjudication Method for the Test Set:
- Not applicable. Adjudication methods like 2+1 or 3+1 are used for clinical studies with human evaluators to establish ground truth for ambiguous cases. These were bench tests against predetermined engineering criteria.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and its effect size:
- No MRMC comparative effectiveness study was done. Clinical testing was explicitly stated as "not performed as the device has no technological differences from the predicate."
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. The TD Clip is a physical medical device (an intraoral appliance) and not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm doesn't apply here. The performance tests focused on the physical integrity and function of the device itself.
7. The Type of Ground Truth Used:
- The ground truth for the performance testing was based on engineering specifications and predefined performance limits (e.g., no breakage, maintenance of protrusive positioning, quick and injury-free removal, adherence to biocompatibility standards). This is a form of objective, empirical measurement and adherence to established material and mechanical standards.
8. The Sample Size for the Training Set:
- Not applicable. As a physical medical device undergoing bench testing, there is no "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable, as there is no training set.
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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 (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
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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)
| 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.
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 SECalgary, Alberta, CanadaT2H-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 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 Name510(k) Number | PrimaryPredicate | Reference Device | Subject Device | SubstantialEquivalenceDiscussion |
| Manufacturer | ||||
| Apnea GuardK111110 | MATRx plusDEN170090 | TD Clip | ||
| Advanced BrainMonitoring, Inc. | Zephyr SleepTechnologies, Inc. | Zephyr SleepTechnologies, Inc. | ||
| Indications for Use | ||||
| The Apnea Guardis a mandibularrepositioningdevice intended toreduce or alleviatesnoring and mildto moderateobstructive sleepapnea (OSA) inpatients 18 yearsand older. TheApnea Guard isintended to befitted withassistance from ahealthcareprofessional, andused during sleepfor less than 30nights. | The MATRx plusdevice may alsobe used with anautomatedmandibularpositioner thatuses feedbackcontrol to recordchanges in thepatient'srespiratory statusrelated torepositioning ofthe mandibleduring anovernight study.MATRx plus usesthese recordingsto produce areport for the HCPthat can be used toprospectivelyidentify patientswith mild tomoderateobstructive sleepapnea who may besuitable fortherapy with anoral appliance andto recommend atarget mandibularposition.The use of thedevice does notreplace the needfor follow-uptesting todetermine theinitial andongoingeffectiveness ofthe therapy asrecommended byclinical practice | The TD Clip is amandibularrepositioningdevice intended toreduce or alleviatesnoring and mildto moderateobstructive sleepapnea (OSA) inpatients 18 yearsand older. Thedevice is intendedto be fitted withassistance from ahealthcareprofessional andused during sleepfor a total of lessthan 30 nights. | The indicationsfor use of thesubject device areidentical to thoseof the primarypredicate. | |
| #102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada | ||||
| PrimaryPredicate | Reference Device | Subject Device | ||
| Proprietary Name | Apnea Guard | MATRx plus | TD Clip | Substantial |
| 510(k) Number | K111110 | DEN170090 | -- | Equivalence |
| Manufacturer | Advanced BrainMonitoring, Inc. | Zephyr SleepTechnologies,Inc. | Zephyr SleepTechnologies,Inc. | Discussion |
| guidelines. | ||||
| Use Environment | ||||
| Intended for nighttimeuse | Yes | Identical | ||
| Indicated for use athome or in sleeplaboratories | Yes | |||
| In-use claim | Less than 30 days | Duration ofTitration study(max: 3 days) | Less than 30 days(Includingtitration study use) | Identical topredicate - totaluse < 30 days |
| Contraindications | ||||
| Missing, loose,infected teeth,temporary crownsor fillings, TMJdysfunctionsyndrome | Loose teeth, advanced periodontaldisease, full dentures/implants, TMJdysfunction syndrome, central sleepapnea, severe respiratory disorders,under 18 years of age | Substantiallyequivalent -devices areintended for use inadults with mildto moderateobstructive sleepapnea who havesufficientdentition and norelevantcomorbidities | ||
| Technological Characteristics | ||||
| Design | ||||
| Operating Principle -MandibularAdvancement | Yes | |||
| Separate upper andlower tray pieces | Yes | |||
| Placed in patient'smouth each evening | Yes | |||
| Mechanism of trayfastening | Same (Connected via brackets extending from the oral cavitywith directional guidance from rails) | Identical | ||
| Permitted lateral and/orvertical jaw movement | Yes | |||
| Method of retention -impression material | Yes | |||
| Customized fit for eachpatient | Yes | |||
| PrimaryPredicate | Reference Device | Subject Device | SubstantialEquivalenceDiscussion | |
| Proprietary Name510(k) Number | Apnea GuardK111110 | MATRx plusDEN170090 | TD Clip-- | |
| Manufacturer | Advanced BrainMonitoring, Inc. | Zephyr SleepTechnologies,Inc. | Zephyr SleepTechnologies,Inc. | |
| Method of fixing theposition | Pin connectionthrough one ofseveral slots | Pin connection toa motorizedmandibularpositioner | Pin connection tothe TD clipdevice; pin usedto fix in place | Substantiallyequivalent - pinused to secureprotrusive level |
| Dental tray shape | Same (Full arch, lingual and buccal walls to hold impressionmaterial) | Identical | ||
| Dental tray sizing | One size fits all.Adjustable archwidth. | Available in 2 sizes (medium andlarge). Adjustable arch width. | Substantiallyequivalent –multiple sizes insubject deviceaccommodate fullrange of archwidths | |
| Fastening resolution | 1.0 mm | 0.5 mm | Substantiallyequivalent –ability to fastentrays at aclinicallymeaningfulresolution | |
| Can be adjusted or refit | Yes – with assistance from a healthcare professional | Identical | ||
| Materials | ||||
| Biocompatibilitytesting | Same (Testing according to 10993-1) | Identical | ||
| Impression materialcomposition | Polyvinyl siloxane impression material | Substantiallyequivalent –standard dentalimpressionmaterial | ||
| Patient instructions forcleaning | Same (cleaned by rinsing with water) | Identical | ||
| Single-patient multi-use | Yes | Identical | ||
| Sterility | Same (not provided sterile) | Identical | ||
| Performance Specification | ||||
| Holds mandible inprotrusion for theduration of the night | Same | Identical | ||
| Adjustment range | 26 mm (8 mmretrognathic to 18mm prognathic) | 20 mm (6 mm retrognathic to 14 mmprognathic) | Substantiallyequivalent;identical toreference device.Adjustment rangeof subject deviceis identical to that | |
| #102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada | ||||
| PrimaryPredicate | Reference Device | Subject Device | ||
| Proprietary Name | Apnea Guard | MATRx plus | TD Clip | SubstantialEquivalenceDiscussion |
| 510(k) Number | K111110 | DEN170090 | -- | |
| Manufacturer | Advanced BrainMonitoring, Inc. | Zephyr SleepTechnologies,Inc. | Zephyr SleepTechnologies,Inc. | |
| available in theOA Assessmentstudy. |
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Image /page/6/Picture/0 description: The image shows the logo for Zephyr Sleep Technologies. The logo includes the word "ZEPHYR" in a large, bold font, with the words "Sleep Technologies" underneath in a smaller font. To the right of the text is a graphic of a crescent moon with a star. The address "#102, 701-64th Avenue SE, Calgary, AB, T2H 2C3, Canada" is printed below the logo.
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Image /page/7/Picture/0 description: The image shows the logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in a large, bold, teal font, with the words "Sleep Technologies" in a smaller font underneath. To the right of the company name is a graphic of a crescent moon with a star. Below the logo is the address "#102, 701 - 64th Avenue SE, Calgary, AB, T2H 2C3, Canada".
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Image /page/8/Picture/0 description: The image shows the logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in large, bold, teal letters, with the words "Sleep Technologies" in a smaller font underneath. To the right of the text is a graphic of a crescent moon with a star above it, also in teal. The logo is clean and modern, suggesting a company focused on sleep-related technology.
The subject and predicate devices have equivalent indications for use, target populations, in-use claims, and contraindications. Both devices are prescription use and are fitted with assistance from a healthcare professional. Both the subject and predicate device operate by providing mandibular advancement to the patient via separate upper and lower travs that are placed in the mouth by the patient each evening. Both devices use brackets that extend from the oral cavity. The tray design, use of polyvinyl siloxane impression material, and instructions for cleaning are equivalent between the subject and predicate devices. The Titration Trays and impression material used in the TD Clip device are the same as those previously cleared for use for the MATRx (K103704) and MATRx plus (DEN170090) devices. The adjustment range of the TD Clip device, though smaller than that of the predicate, is identical to that of the reference device.
While the fastening system of both devices rely on pins, the design differs slightly between the two devices. The Apnea Guard predicate device uses pin connections through one of several slots, while the TD Clip uses a pin to connect the clip to the Titration Trays, and a pin in combination with a serrated interface to hold the position.
Performance Testing
All materials in contact with the mucosal membrane were assessed and tested in accordance with ISO 10993-1 and the associated FDA guidance. Use of International Standard ISO 10993-1, 'Biological Evaluation of Medical Devices – Part 1 Evaluation and Testing within a Risk Management Process" issued June 16, 2016.
Bench testing of the assembled device simulating mechanical and environmental use conditions was conducted to ensure that the device performs as intended and is safe and effective. The following bench testing was conducted:
| Test | Test Description |
|---|---|
| Intraoral MaterialPerformance | The trays and impression material were evaluated under simulatedaging, including environment conditions and representative worst-case loading schemes to ensure there was no presence or increasedrisk of breakage that could lead to an unacceptable harm over themaximal study length (30 nights of use). |
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Image /page/9/Picture/0 description: The image is a logo for Zephyr Sleep Technologies. The logo features the word "ZEPHYR" in large, bold, teal letters, with the words "Sleep Technologies" in a smaller font underneath. To the right of the text is a graphic of three curved lines emanating from a star, also in teal. The logo is clean and modern, and the teal color gives it a calming and professional feel.
| TD ClipPerformance | 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 RemovalSimulation | 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. The risk management concluded that the TD Clip had no unacceptable risks.
Conclusion:
Based on the information provided in this 510(k) premarket notification, the TD Clip is substantially equivalent in terms of safety and efficacy to the predicate device identified above.
§ 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.”