(106 days)
No
The summary describes a mechanical oral appliance and does not mention any AI/ML components or related performance metrics.
Yes
The device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea, which are medical conditions, and it physically manipulates the mandible to keep the airway open for therapeutic purposes.
No
The device description and intended use state that the device is intended to treat snoring and sleep apnea by repositioning the jaw, not to diagnose the conditions. It does not mention any diagnostic functions, performance metrics typical of diagnostic devices, or input imaging.
No
The device description clearly states it is a "customized oral device" and mentions bench testing for physical properties like flexural strength and water absorption, indicating it is a physical hardware device.
Based on the provided information, the Twilite Appliance ® is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce snoring and mild to moderate obstructive sleep apnea by physically repositioning the mandible. This is a therapeutic intervention, not a diagnostic test performed on samples from the human body.
- Device Description: The description clearly states it's an oral device that holds the mandible in an advanced position to keep the airway open. This is a mechanical action, not a diagnostic process.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for the diagnosis, monitoring, or treatment of a disease or condition based on the analysis of samples.
The Twilite Appliance ® is a medical device, specifically an oral appliance used for the treatment of snoring and sleep apnea.
N/A
Intended Use / Indications for 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.
Product codes
LRK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Adults 18 years and older.
Intended User / Care Setting
Home, Dental offices, and Sleep laboratories
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K172859 - Prosomnus [CA] Sleep and Snore Device
Reference Device(s)
K153490 - Dental Direkt – DD Biosplint P
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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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
EF
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| Stephen J Harkins, DDS, PC
4781 E. Camp Lowell Dr. #101
| 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 |
| intraoral devices for snoring and obstructive sleep apnea | |
| 21 CFR 872.5570, Class 2 | |
| Primary Predicate: | |
| Reference Device: | K172859 - Prosomnus [CA] Sleep and Snore Device |
| 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
4
- 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
Twilite Appliance ® | Primary Predicate
Prosomnus [CA] Sleep and Snore
Device - K172859 |
|-------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Classification | LRK - device, anti-snoring
Intraoral devices for snoring and intraoral
devices for snoring and obstructive sleep
apnea | LRK - device, anti-snoring
Intraoral devices for snoring and intraoral
devices for snoring and obstructive sleep
apnea |
| CFR | 872.5570 | 872.5570 |
| Attributes | | |
| Indications for Use | The Twilite Appliance ® is intended to
reduce nighttime snoring and mild to
moderate obstructive sleep apnea (OSA)
in adults. | The Prosomnus [CA] Sleep and Snore
Device is intended to reduce night time
snoring and mild to moderate obstructive
sleep apnea (OSA) in adults.
The DentiTrac® micro-recorder is
completely embedded into the Prosomnus
[CA] Sleep and Snore appliance. The
microrecorder is intended to measure
patient compliance to the oral appliance
therapy in combination with the
DentiTrac® System |
| Environments of use | Home, Dental and Physician offices,
Sleep laboratories | Home, Dental and Physician offices, Sleep
laboratories |
| Patient Population | Adult patients 18 years and older | Adult patients 18 years and older |
| 1-July-19 | | |
| | Subject Device
Twilite Appliance ® | Primary Predicate
Prosomnus [CA] Sleep and Snore
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
of mandibular advancement | Adjustment of the relative position of the
trays by the use of an elastic bands that
holds the mandible forward and maintains
mandibular advancement thus enlarging
the airway. The vertical opening of the
jaw is not fixed in a single position | The Prosomnus [CA] Sleep and Snore
device series consists of one or multiple
lower device(s) together with one or
multiple mated-post upper device(s) that
are manufactured to the dentist
prescriber's requested advancement
positions up to 11mm to provide a
selection of gentle adjustments according
to patient comfort and need. |
| Design | | |
| Customized trays | Yes | Yes |
| Allows lateral and vertical
movement | Yes | Yes |
| User can breathe through their
mouth | Yes | Yes |
| Adjustment method for setting
the Amount of protrusion | Posts on the lower tray are adjusted to
hold the lower jaw forward at a dentists
pre-determined distance | Multiple lower trays can be made where
each has greater protrusion up to 11 mm
User can substitute different lower trays
to advance the jaw |
| Works by holding lower jaw
forward | Yes | Yes |
| Cleaned by simple rinsing with
water and toothbrush | Yes | Yes |
| Single patient, multi-use | Yes | Yes |
| Principle of operation / means
of mandibular advancement | Fixed posts on the lower tray hold the
lower jaw forward. | Fixed posts on the lower tray hold the
lower jaw forward. |
| Adjustment method for setting
the amount of protrusion | Fixed posts on the lower tray hold the
lower jaw forward. | Fixed posts on the lower tray hold the
lower jaw forward. |
| | The dentist adjusts the posts for the
required amount of protrusion | The dentist adjusts the posts for the
required amount of protrusion |
| 1-July-19 | | |
| | Subject Device
Twilite Appliance ® | Primary Predicate
Prosomnus [CA] Sleep and Snore
Device - K172859 |
| Materials and Biocompatibility | Surface contact
Mucosal
Prolonged duration per FDA Special
Controls for intraoral appliances
Material is identical to K153490. | Surface contact
Mucosal
Prolonged duration per FDA Special
Controls for intraoral appliances |
| Material Properties | Use of standard dental tray materials
Material is identical to K153490 | Use of standard dental tray materials |
| Performance Testing | • Flexural strength / Fracture
Toughness
• 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.
8
Discussion of Substantial Equivalence to Reference
Table 2 - Comparison of the Subject Device vs. the Reference K153490
| | Subject Device
Twilite Appliance ® | Reference
Dental Direkt
DD BioSplint P |
|--------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Product Classification | LRK - device, anti-snoring
Intraoral devices for snoring and intraoral
devices for snoring and obstructive sleep
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
reduce nighttime snoring and mild to
moderate obstructive sleep apnea (OSA)
in adults. | DD medical polymers are indicated for
temporary (