Twilite Appliance

K190687 · Stephen J Harkins, Dds, PC · LRK · Jul 2, 2019 · Dental

Device Facts

• Record ID: K190687
• Device Name: Twilite Appliance
• Applicant: Stephen J Harkins, Dds, PC
• Product Code: LRK · Dental
• Decision Date: Jul 2, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Twilite Appliance ® is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years and older.

Device Story

Twilite Appliance is a customized intraoral device used at home, in dental offices, or sleep laboratories. It consists of custom-milled trays that hold the mandible in an advanced position to prevent tongue compression against the oropharyngeal wall, keeping the airway open during sleep. The device is operated by the patient. A dentist adjusts the posts on the lower tray to a pre-determined distance to maintain mandibular advancement. The device allows for lateral and vertical jaw movement and mouth breathing. By maintaining airway patency, the device aims to reduce snoring and mild to moderate OSA symptoms. Healthcare providers use the device to manage patient sleep-disordered breathing; output is the physical maintenance of jaw position.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on design, principle of operation, performance specifications, and bench testing of materials.

Technological Characteristics

Customized intraoral dental trays milled from dental-grade polymers (identical to K153490). Features adjustable posts for mandibular advancement. Mechanical device; no energy source or software. Biocompatibility per ISO 10993-1. Performance testing includes flexural strength and fracture toughness.

Indications for Use

Indicated for adults 18+ with mild to moderate obstructive sleep apnea (OSA) and snoring. Contraindicated for patients with central sleep apnea, severe respiratory disorders, loose teeth, advanced periodontal disease, loose dental work, oral conditions adversely affected by dental appliances, or full denture users.

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

• Prosomnus [CA] Sleep and Snore Device (K172859)

Reference Devices

• Dental Direkt – DD Biosplint P (K153490)

Submission Summary (Full Text)

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July 2, 2019

Stephen J Harkins, DDS, PC % Paul Dryden Consultant Stephen J Harkins, DDS, PC c/o ProMedic, LLC 131 Bay Point Dr NE St. Petersburg, Florida 33704

Re: K190687

Trade/Device Name: Twilite Appliance 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: June 5, 2019 Received: June 6, 2019

Dear Paul Dryden:

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.

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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) 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 531-542 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 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. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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# Food and Drug Administration Indications for Use

DEPARTMENT OF HEALTH AND HUMAN SERVICES

510(k) Number (if known) K190687

Device Name

### Twilite Appliance ®

Indications for Use (Describe)

The Twilite Appliance ® is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years and older.

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

XX Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Page 1 of 1

FORM FDA 3881

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EF

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| Stephen J Harkins, DDS, PC<br>4781 E. Camp Lowell Dr. #101<br>Tucson, AZ 85712 | Tel - 520-465-7203 |
|--------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Contact: | Stephen Harkins, DDS |
| Submission Correspondent: | Paul Dryden |
| | ProMedic, LLC |
| | 131 Bay Point Dr. NE |
| | St. Petersburg, FL 33704 |
| Proprietary or Trade Name: | Twilite Appliance ® |
| Common/Usual Name: | Device, Anti-Snoring |
| Classification Name: | LRK - Device, anti-snoring, Intraoral devices for snoring and<br>intraoral devices for snoring and obstructive sleep apnea<br>21 CFR 872.5570, Class 2 |
| Primary Predicate:<br>Reference Device: | K172859 - Prosomnus [CA] Sleep and Snore Device<br>K153490 - Dental Direkt – DD Biosplint P |

### Device Description:

The Twilite Appliance ® is a customized oral device intended to mitigate night-time snoring and mild to moderate obstructive sleep apnea. The Twilite Appliance ® is to continuously hold the mandible in an advanced position to prevent the tongue from compressing against the oropharyngeal wall keeping the airway open during sleep.

### Indications for Use

The Twilite Appliance ® is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

#### Contraindications

The following contraindications are noted in the labeling. These are typical of oral appliances for the proposed indications for use and suggested by FDA's guidance document.

The device is contraindicated for patients who:

- have central sleep apnea ●
- have severe respiratory disorders
- o have loose teeth or advanced periodontal disease
- have loose dental work
- oral conditions which would be adversely affected by wearing dental appliances ●
- o full denture user
- o are under 18 years of age

#### Warnings

Use of this device may cause:

- tooth movement
- changes in dental occlusion

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- gingival soreness
- tooth soreness
- pain or soreness to the temporomandibular joint
- obstruction of oral breathing
- excessive salivation
- excessive dry mouth
- loosening of dental restorations ●
- . loosening of teeth

Environment of Use Home, Dental offices, and Sleep laboratories

## Primary Predicate Comnarison:

We selected a predicate for the Twilite Appliance ® and present the similarities in Table 1.

| Table 1 - Primary Predicate Comparison | | |
|----------------------------------------|--|--|
|----------------------------------------|--|--|

| | Subject Device<br>Twilite Appliance ® | Primary Predicate<br>Prosomnus [CA] Sleep and Snore<br>Device - K172859 |
|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Classification | LRK - device, anti-snoring<br>Intraoral devices for snoring and intraoral<br>devices for snoring and obstructive sleep<br>apnea | LRK - device, anti-snoring<br>Intraoral devices for snoring and intraoral<br>devices for snoring and obstructive sleep<br>apnea |
| CFR | 872.5570 | 872.5570 |
| Attributes | | |
| Indications for Use | The Twilite Appliance ® is intended to<br>reduce nighttime snoring and mild to<br>moderate obstructive sleep apnea (OSA)<br>in adults. | The Prosomnus [CA] Sleep and Snore<br>Device is intended to reduce night time<br>snoring and mild to moderate obstructive<br>sleep apnea (OSA) in adults.<br>The DentiTrac® micro-recorder is<br>completely embedded into the Prosomnus<br>[CA] Sleep and Snore appliance. The<br>microrecorder is intended to measure<br>patient compliance to the oral appliance<br>therapy in combination with the<br>DentiTrac® System |
| Environments of use | Home, Dental and Physician offices,<br>Sleep laboratories | Home, Dental and Physician offices, Sleep<br>laboratories |
| Patient Population | Adult patients 18 years and older | Adult patients 18 years and older |
| 1-July-19 | | |
| | Subject Device<br>Twilite Appliance ® | Primary Predicate<br>Prosomnus [CA] Sleep and Snore<br>Device - K172859 |
| Contraindications | have central sleep apnea have severe respiratory disorders have loose teeth or advanced periodontal disease have loose dental work oral conditions which would be adversely affected by wearing dental appliances full denture user are under 18 years of age | have central sleep apnea have severe respiratory disorders have loose teeth or advanced periodontal disease have loose dental work oral conditions which would be adversely affected by wearing dental appliances full denture user are under 18 years of age |
| Prescription | Prescription use | Prescription use |
| Single patient, multi-use | Yes | Yes |
| Limitation of duration of use | No limitation | No limitation |
| Principle of operation / means<br>of mandibular advancement | Adjustment of the relative position of the<br>trays by the use of an elastic bands that<br>holds the mandible forward and maintains<br>mandibular advancement thus enlarging<br>the airway. The vertical opening of the<br>jaw is not fixed in a single position | The Prosomnus [CA] Sleep and Snore<br>device series consists of one or multiple<br>lower device(s) together with one or<br>multiple mated-post upper device(s) that<br>are manufactured to the dentist<br>prescriber's requested advancement<br>positions up to 11mm to provide a<br>selection of gentle adjustments according<br>to patient comfort and need. |
| Design | | |
| Customized trays | Yes | Yes |
| Allows lateral and vertical<br>movement | Yes | Yes |
| User can breathe through their<br>mouth | Yes | Yes |
| Adjustment method for setting<br>the Amount of protrusion | Posts on the lower tray are adjusted to<br>hold the lower jaw forward at a dentists<br>pre-determined distance | Multiple lower trays can be made where<br>each has greater protrusion up to 11 mm<br>User can substitute different lower trays<br>to advance the jaw |
| Works by holding lower jaw<br>forward | Yes | Yes |
| Cleaned by simple rinsing with<br>water and toothbrush | Yes | Yes |
| Single patient, multi-use | Yes | Yes |
| Principle of operation / means<br>of mandibular advancement | Fixed posts on the lower tray hold the<br>lower jaw forward. | Fixed posts on the lower tray hold the<br>lower jaw forward. |
| Adjustment method for setting<br>the amount of protrusion | Fixed posts on the lower tray hold the<br>lower jaw forward. | Fixed posts on the lower tray hold the<br>lower jaw forward. |
| | The dentist adjusts the posts for the<br>required amount of protrusion | The dentist adjusts the posts for the<br>required amount of protrusion |
| 1-July-19 | | |
| | Subject Device<br>Twilite Appliance ® | Primary Predicate<br>Prosomnus [CA] Sleep and Snore<br>Device - K172859 |
| Materials and Biocompatibility | Surface contact<br>Mucosal<br>Prolonged duration per FDA Special<br>Controls for intraoral appliances<br>Material is identical to K153490. | Surface contact<br>Mucosal<br>Prolonged duration per FDA Special<br>Controls for intraoral appliances |
| Material Properties | Use of standard dental tray materials<br>Material is identical to K153490 | Use of standard dental tray materials |
| Performance Testing | • Flexural strength / Fracture<br>Toughness<br>• Water absorption / solubility<br>• Mechanical / Tensile testing | Compression and Shear Torsion Testing |

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# 510(k) Summary

### Discussion of Substantial Equivalence

The Twilite Appliance ® is viewed as substantially equivalent to the predicate device because:

### Indications -

Similar to predicate - Prosomnus [CA] Sleep and Snore Device - K172859. Indicated for treating night-time snoring and mild to moderate obstructive sleep apnea (OSA).

### Discussion -

The indications for use between the subject device and predicate are similar and therefore they can be found as substantially equivalent.

## Technology / Principle of Operation -

Similar to predicate - Prosomnus [CA] Sleep and Snore Device - K172859. Both devices use separate customized trays with a means to advance the mandible / lower jaw.

### Discussion -

Both devices use separate customized trays with a means to advance the mandible / lower jaw are similar and therefore they can be found as substantially equivalent.

### Environment of Use -

Similar to predicate - Prosomnus [CA] Sleep and Snore Device - K172859. They are used in Home, Dental and Physician offices, Sleep laboratories.

### Discussion -

Both devices have the same environments of use and therefore they can be found as substantially equivalent.

### Patient Population -

Identical to predicate – Prosomnus [CA] Sleep and Snore Device – K172859. 18 years and older. Discussion -

The patient population is identical and therefore they can be found as substantially equivalent.

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# 510(k) Summary

1-July-19

#### Non-clinical performance testing

### Bench Testing

The materials for the trays are made from materials cleared for use as dental trays. In additions to the materials meeting dental standards, we performed testing after manufacture and aging for:

- . Flexural strength / Fracture Toughness
### Biocompatibility / Materials

The materials in contact with the patient have been cleared for the intended use of dental trays. The materials are dental tray materials cleared under K153490.

### Clinical

Based upon Twilite Appliance ® design concept, it was determined that no clinical testing would be required as we are identical in this principle of operation and technology as well as performance specification, namely maximum advancement distance. Also, the specifications of the ability to advance the lower tray are the same and the maximum advancement is similar to the predicate.

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### Discussion of Substantial Equivalence to Reference

### Table 2 - Comparison of the Subject Device vs. the Reference K153490

| | Subject Device<br>Twilite Appliance ® | Reference<br>Dental Direkt<br>DD BioSplint P |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Classification | LRK - device, anti-snoring<br>Intraoral devices for snoring and intraoral<br>devices for snoring and obstructive sleep<br>apnea | EBG, MQC |
| | | Temporary crown and bridge resin |
| CFR | 872.5570 | 872.3770 |
| 510(k) | K190687 | K153490 |
| | Attributes | |
| Indications for Use | The Twilite Appliance ® is intended to<br>reduce nighttime snoring and mild to<br>moderate obstructive sleep apnea (OSA)<br>in adults. | DD medical polymers are indicated for<br>temporary (< 12 months) crowns, bridges<br>and bite splints. Applications include both<br>anterior and posterior structures. |
| Environments of use | Home, Dental and Physician offices,<br>Sleep laboratories | Home, Dental offices |
| Patient Population | Adult patients 18 years and older | No patient limitations |
| Contraindications | • have central sleep apnea<br>• have severe respiratory disorders<br>• have loose teeth or advanced<br>periodontal disease<br>• are under 18 years of age | No noted contraindications |
| Prescription | Prescription use | Prescription use |
| Single patient, multi-use | Yes | Yes |
| Limitation of duration of use | No limitation | Less than 12 months |
| | Design | |
| Customized trays | Yes | Yes |
| Single patient, multi-use | Yes | Yes |
| Materials and Biocompatibility | Surface contact<br>Mucosal<br>Prolonged duration per FDA Special<br>Controls for intraoral appliances<br>Identical to K153490 | Tested per ISO 10993-1<br>ISO 10477:2004 – Polymer-based Crown<br>and Bridge Materials<br>ISO 20795-1:2013 Dentistry - Base<br>Polymers - Denture |
| Material Properties | Use of standard dental tray materials<br>Material is identical to K153490 | Crowns, bridges, bile splints |
| Performance Testing | • Flexural strength / Fracture<br>Toughness<br>• Mechanical / Tensile testing<br>Identical material to K153490 | • Flexural strength<br>• Flexural modulus<br>• Residual MMA monomer<br>• Water sorption<br>• Solubility |

The Twilite Appliance ® is viewed as substantially equivalent for the applicable performance to the reference device because:

### Indications -

The reference is indicated for use for crowns, bridges and bite splints. The subject device is a form of dental tray similar to a bite splint.

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The difference in indications for use does not raise new or different concerns that haven't been addressed by the predicate.

### Technology / Principle of Operation -

Similar to reference the subject device is a customized tray that can be used by a patient. The material is identical and is provided in a block which is then milled to the patient's specific shape. This is the identical intended method of the reference, K153490.

Discussion - The reference is a tray form that can be used as needed. The difference does not raise new or different concerns that can't be addressed by the predicate.

### Patient Population -

Discussion - The patient population is not identified in the reference, but the general population are people who require a dental tray.

### Non-clinical performance testing

### Bench Testing

The materials for the trays are made from reference tested materials that have been tested and the data provided in K153490. In addition to the materials meeting dental standards, we performed testing after manufacture and aging for:

- Flexural strength / Fracture Toughness .
### Biocompatibility / Materials

The materials in contact with the patient are identical to the reference K153490. There are no differences.

### Discussion of Differences and Substantial Equivalence Conclusion

There are few differences between the Twilite Appliance ® and the predicate. These are discussed above.

For the reference comparison, the materials are identical, but the reference was only cleared for crowns, bridges and bite splints for use of less than 12 months. However, the clinical experience for the proposed device has shown that it can be used for greater than 12 months based upon the indications for use. All differences have been addressed via performance testing and has demonstrated substantial equivalence to the primary predicate device.

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### Substantial Equivalence Conclusion

Based upon the performance testing and comparison to the legally marketed predicate device for indications for use, technology, and performance we have demonstrated that the Twilite Appliance ® is substantially equivalent the predicate device.