(204 days)
No
The summary describes a mechanical oral device and does not mention any AI or ML components or functions.
Yes
The device is intended to alleviate or reduce obstructive sleep apnea and snoring, which are medical conditions, by holding the mandible in an advanced position to keep the airway open during sleep. This action directly addresses a health problem, qualifying it as therapeutic.
No
The device description clearly states its purpose is to reduce or alleviate snoring and sleep apnea by repositioning the mandible, which is a treatment function, not a diagnostic one.
No
The device description clearly states it is a "patient specific oral device" and describes its physical function of holding the mandible in an advanced position. The performance studies focus on mechanical properties and material biocompatibility, which are characteristic of a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Fuselier Intraoral Nighttime Device (FIND) is a physical device worn in the mouth. Its function is to mechanically reposition the mandible to keep the airway open. It does not analyze any biological samples.
- Intended Use: The intended use is to reduce or alleviate snoring and sleep apnea by physically altering the position of the jaw. This is a mechanical intervention, not a diagnostic test performed on a sample.
The information provided clearly describes a physical, patient-specific oral appliance used for treatment, not for analyzing biological samples for diagnostic purposes.
N/A
Intended Use / Indications for Use
A patient specific mandibular repositioning device intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea in adult patients 18 years or older.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
The Fuselier Intraoral Nighttime Device (FIND) is a patient specific oral device intended to mitigate night-time snoring and mild to moderate obstructive sleep apnea. The function of the FIND 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.
The principle of advancing a lower tray is to advance the mandible for the treatment of night-time snoring and / or mild to moderate obstructive sleep apnea.
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
18 years or 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)
Real-time Aging: The FIND has been used in a private dental practice for more than 1 year without device failures. The results of this experience support the substantial equivalence of the FIND for its proposed intended use to that of the predicate device. The observations support: Cleaning via rinsing with water and use of a toothbrush, Mechanical and durability after 1 year real-time use, Effects of aging do not alter the performance of the device.
Mechanical Performance: Flexural and breakage strength testing was performed on the subject device and the predicate. The construction and design performance were tested and found to be substantially equivalent. Flexural strength: Angle of deflection – 0.85 degrees, 77 lbs. to damage. Breakage Strength: 77 lbs. to damage. The comparative testing to the predicate demonstrated equivalence in performance.
Biocompatibility / Materials: The materials in contact with the patient have been cleared for the intended use of dental trays. The materials for the trays are identical to K896103 - IVOCap materials for the intended purpose of dental trays.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K972061 – Keith Thornton, DDS – Thornton Oral Appliance (TOA)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K090436 - Orthoplant Dental - Airwayease MAS, K896130 - Ivoclar Vivadent - SR Ivocap Polymer
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized image of a bird or eagle, formed by three overlapping profiles of human faces.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 7, 2017
Fuselier Enterprises, LLC Paul Dryden Consultant 2051 Mohican Trail Maitland, Florida 32751
Re: K161980 Trade/Device Name: Fuselier Intraoral Nighttime Device (find) 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
Dear Paul Dryden:
Dated: January 4, 2017 Received: January 6, 2017
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. 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 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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael J. Ryan -S
for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known)
K161980
Device Name
Fuselier Intraoral Nighttime Device
Indications for Use (Describe)
A patient specific mandibular repositioning device intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea in adult patients 18 years or 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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Fuselier Enterprises, LLC 2051 Mohican Trail Maitland, FL 32751
| Official Contact: | Brian Fuselier, Owner |
|---|---|
| Proprietary or Trade Name: | Fuselier Intraoral Nighttime Device |
| 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 | |
| Predicate Device: | K972061 – Keith Thornton, DDS – Thornton Oral Appliance |
| (TOA) | |
| Reference Devices: | K090436 - Orthoplant Dental - Airwayease MAS |
| K896130 - Ivoclar Vivadent - SR Ivocap Polymer |
Device Description:
The Fuselier Intraoral Nighttime Device (FIND) is a patient specific oral device intended to mitigate night-time snoring and mild to moderate obstructive sleep apnea. The function of the FIND 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.
The principle of advancing a lower tray is to advance the mandible for the treatment of night-time snoring and / or mild to moderate obstructive sleep apnea.
Indications for Use
A patient specific mandibular repositioning oral appliance intended to reduce or alleviate night-time snoring and mild to moderate obstructive sleep apnea in adult patients 18 years or older.
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 ●
- 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
Warnings
Use of this device may cause:
- tooth movement
- changes in dental occlusion ●
- gingival soreness
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510(k) Summary Page 2 of 6 4-Jan-17
- 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
Predicate Device Comparison:
We selected a predicate for the Fuselier Intraoral Nighttime Device and present the similarities in Table 1.
| Table 1 - Predicate Device Comparison | |||
|---|---|---|---|
| -- | -- | -- | --------------------------------------- |
| Subject Device | Predicate | |
|---|---|---|
| Fuselier Intraoral Nighttime Device | Thornton Oral Appliance (TOA) | |
| K972061 | ||
| 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 | ||
| Attributes | ||
| Indications for Use | A patient specific mandibular | |
| repositioning oral appliance intended | ||
| to reduce or alleviate night-time | ||
| snoring and mild to moderate | ||
| obstructive sleep apnea in adult | ||
| patients 18 years or older. | The TOA is intended to reduce or | |
| alleviate nighttime snoring and | ||
| obstructive sleep apnea, OSA. | ||
| 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 |
| Contraindications | have central sleep apnea have severe respiratory disorders have loose teeth or advanced periodontal disease are under 18 years of age | have central sleep apnea have severe respiratory disorders have loose teeth or advanced periodontal disease are under 18 years of age |
| Prescription | Prescription use | Prescription use |
| Single patient, multi-use | Yes | Yes |
| Principle of operation / means of | ||
| mandibular advancement | Adjustment of the relative position of | |
| the trays by the use of an adjustable | ||
| post 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 | Adjustment of the relative position of | |
| the trays by the use of hook which | ||
| pulls the mandible forward and | ||
| maintains mandibular advancement | ||
| thus enlarging the airway. The | ||
| vertical opening of the jaw is not fixed | ||
| in a single position |
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510(k) Summary Page 3 of 6
| 4-Jan-17 | ||
|---|---|---|
| Subject Device | ||
| Fuselier Intraoral Nighttime Device | Predicate | |
| Thornton Oral Appliance (TOA | ||
| K972061 | ||
| Design | ||
| Patient specific trays | Yes | Yes |
| Allows lateral and vertical movement | Yes | Yes |
| User can breathe through their mouth | Yes | Yes |
| Maximum adjustment by the user | 8 mm | 8 mm |
| Adjustment method for setting the | ||
| amount of protrusion | Adjustable screw/post holds the lower | |
| tray forward | Hook pulls the lower tray forward | |
| Works by holding lower jaw forward | Yes | Yes |
| Cleaned by simple rinsing with water | ||
| and toothbrush | Yes | Yes |
| Materials and Biocompatibility | Surface contact | |
| Mucosal | ||
| Prolonged duration per FDA Guidance | ||
| for intraoral appliances | Surface contact | |
| Mucosal | ||
| Prolonged duration per FDA | ||
| Guidance for intraoral appliances | ||
| Performance Testing | ||
| Material Properties | Performance testing related to torque | |
| and tensile strength was performed | ||
| and compared to the predicate | Use of standard dental tray material | |
| Flexural Strength | ||
| Breakage Strength | Angle of deflection – 0.85 degrees | |
| 77 lbs. to damage | Angle of deflection - 1.25 degrees | |
| 70 lbs. to damage | ||
| Cleaning and Effects of Aging | Private clinical practice of 1 year with | |
| 150 patients has demonstrated that the | ||
| FIND does not degrade with time, | ||
| cleaning or age | Data not available |
Discussion of Substantial Equivalence to the Predicate
The Fuselier Intraoral Nighttime Device is viewed as substantially equivalent to the predicate device because:
Indications - Similar to predicate - Thornton Oral Appliance - K972061. Indicated for treating nighttime 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 - Thornton Oral Appliance - K972061. Both devices use separate patient specific trays with a means to advance the mandible / lower jaw. Discussion - Both devices use separate patient specific 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 - Thornton Oral Appliance - K972061. 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 - Thornton Oral Appliance - K972061. 18 years and older
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510(k) Summary Page 4 of 6 4-Jan-17
Discussion - The patient population is identical and therefore they can be found as substantially equivalent.
Non-clinical performance testing
Real-time Aging
The FIND has been used in a private dental practice for more than 1 year without device failures. The results of this experience support the substantial equivalence of the FIND for its proposed intended use to that of the predicate device.
The observations support:
- Cleaning via rinsing with water and use of a toothbrush ●
- Mechanical and durability after 1 year real-time use
- Effects of aging do not alter the performance of the device ●
Mechanical Performance
We performed flexural and breakage strength testing on the subject device and the predicate and the construction and design performance were tested and found to be substantially equivalent. Discussion - We evaluated the strength of the tray materials and design based upon its intended use and flexural and breakage strength were the key factors to evaluate. Flexural strength saw the FIND to be slightly strong. less angular deflection under torque and the breakage strength – FIND had a slightly high force need before damage was observed. The comparative testing to the predicate demonstrated equivalence in performance.
Biocompatibility / Materials
The materials in contact with the patient have been cleared for the intended use of dental trays. The materials for the trays are identical to K896103 - IVOCap materials for the intended purpose of dental trays. In addition, the reference device, Orthoplant Dental Lab Airwayease MAS, K090436. utilizes the identical material for their oral appliance.
Clinical
Based upon Fuselier Intraoral Nighttime Device 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.
Discussion of Differences
The primary difference between the Fuselier Intraoral Nighttime Device and the predicate is the coupling system that holds the movable lower jaw in a forward position. This difference does not raise new concerns of substantial equivalence to the predicate device.
As presented in the above table, the proposed Fuselier Intraoral Nighttime Device is substantially equivalent to the identified predicate. The Fuselier Intraoral Nighttime Device and predicate are patient specific upper and lower trays, with a means of advancing the mandible to treat mild to moderate obstructive sleep apnea and snoring.
As indicated and discussed above, the fundamental features, indications for use, environment of use are identical to the predicates and thus the proposed Fuselier Intraoral Nighttime Device oral
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510(k) Summary Page 5 of 6 4-Jan-17
appliance can be found to be substantially equivalent to the listed predicate - Thornton Oral Appliance - K972061.
We have also included reference devices and Table 2 presents the comparison to the subject device.
| K896130 | K090436 | FIND | |
|---|---|---|---|
| Ivoclar Vivadent | Orthoplant Dental | Proposed Device | |
| SR Ivocap Polymer | Airwayease MAS | ||
| Intended Use | For the making of dental trays | The Airwayease MIAS is | |
| intended to reduce or alleviate | |||
| night time snoring and mild to | |||
| moderate obstructive sleep | |||
| apnea. | A patient specific mandibular | ||
| repositioning oral appliance | |||
| intended to reduce or alleviate | |||
| night-time snoring and mild to | |||
| moderate obstructive sleep apnea | |||
| in adult patients 18 years or older. | |||
| Population | No restrictions on population as | ||
| this is dental tray material only | Adult patients 18 years or older | ||
| who have a problem with | |||
| snoring or obstructive sleep | |||
| apnea. | Adult patients 18 years and older. | ||
| Environment of | |||
| Use | Dental applications | The device is initially fitted | |
| under the supervision of a | |||
| licensed practitioner (dentist or | |||
| physician) and is subsequently | |||
| used in either a home | |||
| environment or in a sleep | |||
| laboratory. | Home, dental and Physician | ||
| offices, Sleep laboratories | |||
| Materials | Material specifications sent | ||
| directly to FDA | The material composition of the | ||
| Airwayease MAS is identical to | |||
| the Ivocap Elastomer cleared in | |||
| K896130. No colorants or | |||
| additives have been added to | |||
| the originally cleared Ivocap | |||
| Elastomer. | The material composition of the | ||
| FIND is identical to the Ivocap | |||
| Elastomer cleared in K090436. No | |||
| colorants or additives have been | |||
| added to the originally cleared | |||
| Ivocap Elastomer. | |||
| Technological | |||
| features | This is material to make dental | ||
| trays so there are technological | |||
| features that relate to the subject | |||
| device except that the material is | |||
| intended for dental applications | |||
| such as the subject device | 2 trays which are adjustable to | ||
| act as a mandibular repositioner | 2 trays which are adjustable to act | ||
| as a mandibular repositioner |
Table 2 - Comparison of Reference Devices to Subject Device
Discussion of Reference Devices
We have selected reference devices which support the use of the intended materials for the intended use. K896130 is the Dental Tray material that has been used for many types of dental trays. K090436 specifically is an intra-oral appliance with the same intended use, patient population, and environment of use that utilizes the identical materials.
There are no differences between the reference devices and the subject device that would raise concerns of substantial equivalence.
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510(k) Summary Page 6 of 6 4-Jan-17
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 FIND is substantially equivalent to the predicate device.