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.

AI/ML Overview

The provided text describes the "Twilite Appliance®," an intraoral device for snoring and obstructive sleep apnea. However, it does not contain a study proving the device meets specific acceptance criteria in the manner of a clinical trial with reported performance metrics.

Instead, the document details a 510(k) Premarket Notification, which is a submission to the FDA demonstrating that the device is substantially equivalent to a legally marketed predicate device. This process primarily relies on comparing the new device's characteristics and performance to those of an already cleared device, rather than conducting new, extensive clinical studies with specific acceptance criteria that the device must "meet."

Therefore, the requested information elements related to a study proving the device meets acceptance criteria cannot be fully extracted from this document, as such a study (in the sense of a clinical trial with performance targets) was not conducted for substantial equivalence.

Here's an attempt to address your requests based on the provided text, highlighting where the information is absent due to the nature of a 510(k) submission:

1. A table of acceptance criteria and the reported device performance

This information is not present in the document in the format of specific, quantifiable acceptance criteria (e.g., "reduce AHI by X%") and corresponding measured device performance from a clinical trial. The document focuses on demonstrating substantial equivalence to a predicate device based on shared attributes, rather than proving a pre-defined performance against acceptance criteria. The performance testing mentioned is non-clinical (bench testing for material properties).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: Not applicable. No clinical "test set" in the context of a performance study is described. The submission relies on comparison to a predicate and non-clinical bench testing.
Data Provenance: Not applicable for a clinical test set. The non-clinical data (material testing) would be from laboratory settings, but geographic origin is not specified.
Retrospective/Prospective: Not applicable, as no clinical study is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. No clinical performance study requiring expert adjudication of a test set is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable. No clinical performance study requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an oral appliance, not an AI-powered diagnostic tool, and therefore MRMC studies are irrelevant to its evaluation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an oral appliance, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. No clinical study with ground truth establishment is described. The "truth" for this submission is substantial equivalence to a legally marketed device.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or complex algorithm development.

9. How the ground truth for the training set was established

Not applicable.

Summary of the Device's Evaluation (based on the provided text):

The Twilite Appliance® demonstrated substantial equivalence to the predicate device, Prosomnus [CA] Sleep and Snore Device (K172859), based on the following:

Identical Indications for Use: Both are intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Similar Technology/Principle of Operation: Both use separate customized trays with a means to advance the mandible/lower jaw.
Same Environment of Use: Home, Dental and Physician offices, Sleep laboratories.
Identical Patient Population: Adults 18 years and older.
Identical Contraindications: Listed contraindications are the same.
Similar Design and Features: Customized trays, allows lateral and vertical movement, user can breathe through the mouth, works by holding the lower jaw forward, cleaned by rinsing, "single patient, multi-use."
Similar Materials: The subject device uses materials identical to those cleared under K153490 (Dental Direkt DD BioSplint P) for dental trays and bite splints, and these materials meet dental standards.
Non-Clinical Performance Testing: Bench testing was performed after manufacture and aging for:
- Flexural strength / Fracture Toughness
- Water absorption / solubility (implied, by referencing K153490 which tested these properties for identical materials)
- Mechanical / Tensile testing (implied, by referencing K153490 which tested these properties for identical materials)
- Biocompatibility: Materials in contact with the patient are cleared for dental tray use and are identical to those in K153490.

The submission argues that no clinical testing was required because the Twilite Appliance® is identical in principle of operation, technology, and key performance specifications (like maximum advancement distance) to the predicate device. The differences in indications for use for the material reference (K153490) were deemed not to raise new safety or effectiveness concerns not addressed by the predicate.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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

PSC Publishing Services (301) 443-6740

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Stephen J Harkins, DDS, PC4781 E. Camp Lowell Dr. #101Tucson, 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 andintraoral devices for snoring and obstructive sleep apnea21 CFR 872.5570, Class 2
Primary Predicate:Reference Device:	K172859 - Prosomnus [CA] Sleep and Snore DeviceK153490 - Dental Direkt – DD Biosplint P

Device Description:

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 DeviceTwilite Appliance ®	Primary PredicateProsomnus [CA] Sleep and SnoreDevice - K172859
Product Classification	LRK - device, anti-snoringIntraoral devices for snoring and intraoraldevices for snoring and obstructive sleepapnea	LRK - device, anti-snoringIntraoral devices for snoring and intraoraldevices for snoring and obstructive sleepapnea
CFR	872.5570	872.5570
Attributes
Indications for Use	The Twilite Appliance ® is intended toreduce nighttime snoring and mild tomoderate obstructive sleep apnea (OSA)in adults.	The Prosomnus [CA] Sleep and SnoreDevice is intended to reduce night timesnoring and mild to moderate obstructivesleep apnea (OSA) in adults.The DentiTrac® micro-recorder iscompletely embedded into the Prosomnus[CA] Sleep and Snore appliance. Themicrorecorder is intended to measurepatient compliance to the oral appliancetherapy in combination with theDentiTrac® System
Environments of use	Home, Dental and Physician offices,Sleep laboratories	Home, Dental and Physician offices, Sleeplaboratories
Patient Population	Adult patients 18 years and older	Adult patients 18 years and older
1-July-19
	Subject DeviceTwilite Appliance ®	Primary PredicateProsomnus [CA] Sleep and SnoreDevice - 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 / meansof mandibular advancement	Adjustment of the relative position of thetrays by the use of an elastic bands thatholds the mandible forward and maintainsmandibular advancement thus enlargingthe airway. The vertical opening of thejaw is not fixed in a single position	The Prosomnus [CA] Sleep and Snoredevice series consists of one or multiplelower device(s) together with one ormultiple mated-post upper device(s) thatare manufactured to the dentistprescriber's requested advancementpositions up to 11mm to provide aselection of gentle adjustments accordingto patient comfort and need.
Design
Customized trays	Yes	Yes
Allows lateral and verticalmovement	Yes	Yes
User can breathe through theirmouth	Yes	Yes
Adjustment method for settingthe Amount of protrusion	Posts on the lower tray are adjusted tohold the lower jaw forward at a dentistspre-determined distance	Multiple lower trays can be made whereeach has greater protrusion up to 11 mmUser can substitute different lower traysto advance the jaw
Works by holding lower jawforward	Yes	Yes
Cleaned by simple rinsing withwater and toothbrush	Yes	Yes
Single patient, multi-use	Yes	Yes
Principle of operation / meansof mandibular advancement	Fixed posts on the lower tray hold thelower jaw forward.	Fixed posts on the lower tray hold thelower jaw forward.
Adjustment method for settingthe amount of protrusion	Fixed posts on the lower tray hold thelower jaw forward.	Fixed posts on the lower tray hold thelower jaw forward.
	The dentist adjusts the posts for therequired amount of protrusion	The dentist adjusts the posts for therequired amount of protrusion
1-July-19
	Subject DeviceTwilite Appliance ®	Primary PredicateProsomnus [CA] Sleep and SnoreDevice - K172859
Materials and Biocompatibility	Surface contactMucosalProlonged duration per FDA SpecialControls for intraoral appliancesMaterial is identical to K153490.	Surface contactMucosalProlonged duration per FDA SpecialControls for intraoral appliances
Material Properties	Use of standard dental tray materialsMaterial is identical to K153490	Use of standard dental tray materials
Performance Testing	• Flexural strength / FractureToughness• Water absorption / solubility• 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 DeviceTwilite Appliance ®	ReferenceDental DirektDD BioSplint P
Product Classification	LRK - device, anti-snoringIntraoral devices for snoring and intraoraldevices for snoring and obstructive sleepapnea	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 toreduce nighttime snoring and mild tomoderate obstructive sleep apnea (OSA)in adults.	DD medical polymers are indicated fortemporary (< 12 months) crowns, bridgesand bite splints. Applications include bothanterior and posterior structures.
Environments of use	Home, Dental and Physician offices,Sleep laboratories	Home, Dental offices
Patient Population	Adult patients 18 years and older	No patient limitations
Contraindications	• have central sleep apnea• have severe respiratory disorders• have loose teeth or advancedperiodontal disease• 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 contactMucosalProlonged duration per FDA SpecialControls for intraoral appliancesIdentical to K153490	Tested per ISO 10993-1ISO 10477:2004 – Polymer-based Crownand Bridge MaterialsISO 20795-1:2013 Dentistry - BasePolymers - Denture
Material Properties	Use of standard dental tray materialsMaterial is identical to K153490	Crowns, bridges, bile splints
Performance Testing	• Flexural strength / FractureToughness• Mechanical / Tensile testingIdentical material to K153490	• Flexural strength• Flexural modulus• Residual MMA monomer• Water sorption• 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.

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.”