The O2Vent W is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The device is indicated for use during sleep to aid in the treatment of these conditions.

Device Description

The O2Vent W is an oral appliance and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The O2Vent W is made up of two parts: 1. The Upper Tray fitted over the upper teeth, with the breathing port at the front leading to the airways on each side to the rear of the appliance, is made from medical grade titanium (3D printed). The upper titanium tray has two side protrusions (wings) that extend vertically down to interface with the lower acrylic tray for titration of the device. The upper tray is lined with acrylic insert, and is customized to patient bite and impression. 2. The Lower Tray customized to the lower teeth, positions the lower jaw forward, preventing the soft tissue of the throat from collapsing and obstructing the airway. The lower tray features an adjuster assembly set into the acrylic, comprising of an adjuster block and also adjustment screws each located on either side of the lower arch. The adjuster block interfaces with the side protrusions on the upper tray to provide titration. The screws are adjusted with an Adjustment Key for mandibular adjustment to be set by the dentist and/or by the patient under the direction of the dentist.

AI/ML Overview

The provided text does not contain information about the acceptance criteria or a study proving that the O2Vent W device meets specific performance criteria. Instead, it is a 510(k) summary for the device, focusing on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study.

Here's what can be extracted from the document regarding testing, and why it doesn't align with the detailed request:

1. A table of acceptance criteria and the reported device performance
This information is not available in the provided text. The document focuses on comparing the O2Vent W to predicate devices based on design features, intended use, and materials.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
No clinical study with a test set is described. Non-clinical testing was performed, but sample sizes for these tests are not mentioned.

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, as no ground truth for a test set is described in the context of a clinical study for performance evaluation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.

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-assisted diagnostic tool involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable, as this is a medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. The document states that "Human clinical studies were not deemed necessary to evaluate the substantial equivalence of the O2Vent W".

8. The sample size for the training set
Not applicable, as no training set for an algorithm is discussed.

9. How the ground truth for the training set was established
Not applicable.

Information that is present regarding testing:

Summary of Non-Clinical Tests (Page 8):
- Scope: Risk assessment of physical properties and ability to achieve intended use.
- Preliminary Testing: Performed to confirm design can withstand forces during normal use and reasonable abuse (e.g., bruxing).
- Results: The O2Vent W "met the specifications set." (Specific specifications are not detailed).
- Materials: New materials (adjustment screws) are made of special grade stainless steel, have prior 510(k) approval, and are widely used in dental appliances, matching those in the predicate SOMNODENT CLASSIC device.
- Biocompatibility: An assessment was performed. No new materials were used; all materials are already in predicate devices (O2Vent T & OVENT). Biocompatibility testing of the adjustment screws was deemed not warranted due to their source, nature, and long history of safe use in the intraoral environment. The device is considered biocompatible based on similar materials to predicate devices (O2Vent T, OVENT & SOMNODENT CLASSIC).
Summary of Clinical Tests (Page 8):
- Conclusion: Human clinical studies were not deemed necessary for substantial equivalence due to:
  - Designs not dissimilar from predicate devices.
  - No new technologies different from legally-marketed intra-mandibular repositioning devices.
  - No deviation from indications for use of predicate devices (O2Vent T, OVENT, SOMNODENT CLASSIC).
- Risk Management: Risks and mitigating controls (e.g., potential for soreness) are addressed by advising patients and dentists in the "Instructions for Use," covering contraindications, warnings, precautions, storage, fitting, and adjustment.

In essence, the document confirms that the O2Vent W underwent non-clinical testing for usability and material safety, met its internal specifications for these tests, and was deemed not to require clinical studies for its 510(k) submission based on its substantial equivalence to existing devices. Specific quantitative acceptance criteria and detailed performance data from a clinical study are not provided.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 11, 2017

Oventus Manufacturing Pty Ltd % M.W. Andy Anderson, Ph.D., RAC Senior Principal Advisor Regulatory and Clinical Research Institute. Inc. 5353 Wayzata Boulevard, #505 Minneapolis, Minnesota 55416

Re: K171316

Trade/Device Name: O2Vent W 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 15, 2017 Received: June 16, 2017

Dear M.W. Andy Anderson:

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

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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 the quality systems (QS) 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,

Mary S. Runner -A

Lori Wiggins 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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Indications for Use

510(k) Number (if known) K171316

Device Name O2VENT W

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	X
Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/1 description: The image shows the logo for Oventus Medical Ltd. The logo features a stylized letter "O" in a gradient of blue, with a wave-like shape running through the center. Above the "O" are several small blue circles, arranged in a cluster. Below the symbol is the word "OVENTUS" in a sans-serif font, with the letters "VEN" in a lighter shade of blue.

510(k) SUMMARY FOR O₂VENT W

prepared in accordance to 21CFR 807.92 K171316

Date Prepared	June 29, 2017
510 (k) Owner DetailsName:	Oventus Manufacturing Pty Ltd
Address	1 Swann Road, Indooroopilly, QLD 4068, Australia.
Phone:	+61 7 3180 3196
Name of Contact Person	Hemangi Malde
Device Trade name	O2Vent W
Common Name	Oral Appliance – Anti-snoring device
Classification	Class II
Classification Name	Intraoral devices for snoring and obstructive sleep apnea forsnoring and obstructive sleep apnea.
Classification Code	LRK
Classification Regulation	21 CFR 872.5570
Device Model Number(s)	O2VWUS
Predicate Device	O2Vent T - Oventus Manufacturing Pty Ltd - PrimaryOVENT – Oventus Manufacturing Pty LtdSOMNODENT CLASSIC – Somnomed Inc.
Device Description	The O2Vent W is an oral appliance and is intended to reduce oralleviate snoring and mild to moderate obstructive sleep apnea(OSA).The O2Vent W is made up of two parts:1. The Upper Tray fitted over the upper teeth, with the breathingport at the front leading to the airways on each side to the rear ofthe appliance, is made from medical grade titanium (3D printed).The upper titanium tray has two side protrusions (wings) thatextend vertically down to interface with the lower acrylic trayfor titration of the device. The upper tray is lined with acrylicinsert, and is customized to patient bite and impression.
	2. The Lower Tray customized to the lower teeth, positions thelower jaw forward, preventing the soft tissue of the throat from
	collapsing and obstructing the airway. The lower tray features an
	adjuster assembly set into the acrylic, comprising of an adjusterblock and also adjustment screws each located on either side of
	the lower arch.
	The adjuster block interfaces with the side protrusions on theupper tray to provide titration. The screws are adjusted with anAdjustment Key for mandibular adjustment to be set by thedentist and/or by the patient under the direction of the dentist.
Indications for Use	The O 2 Vent W is a removable medical device that is fitted in thepatient's mouth and is intended to reduce or alleviate snoring andmild to moderate obstructive sleep apnea (OSA). The device isindicated for use during sleep to aid in the treatment of theseconditions.
Target Population	Adult patients 18 years and older.
Environment of Use	Home Use and Sleep laboratories.
Summary of Comparisonof TechnologicalCharacteristics of theDevice to Predicate Device	As mentioned in the following pages.

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Feature	O2Vent W	O2Vent T	OVENT	SOMNODENT CLASSIC
510k Number	K171316	K161832	K160234	K050592
Device Photo	Image: O2Vent W device	Image: O2Vent T device	Image: OVENT device	Image: SOMNODENT CLASSIC device
Indications for Use	The O2Vent W is aremovable medical devicethat is fitted in the patient'smouth and is intended toreduce or alleviate snoringand mild to moderateobstructive sleep apnea(OSA). The device isindicated for use duringsleep to aid in the treatmentof these conditions.	The O2Vent T is aremovable medical devicethat is fitted in the patient'smouth and is intended toreduce or alleviate snoringand mild to moderateobstructive sleep apnea(OSA). The device isindicated for use duringsleep to aid in the treatmentof these conditions.	The OVENT is a removablemedical device that is fittedin the patient's mouth and isintended to reduce oralleviate snoring and mildto moderate obstructivesleep apnea, OSA. Thedevice is indicated for useduring sleep to aid in thetreatment of theseconditions.	To intended to reduce nighttime snoring and mild tomoderate obstructive sleepapnea (OSA) in adults.
Product Codes	LRK	LRK	LRK	LRK
Regulation	21CFR 872.5570	21CFR 872.5570	21CFR 872.5570	21CFR 872.5570
Use of device	Removable intraoral device.Single patient multiple use.Prescription use only.	Removable intraoral device.Single patient multiple use.Prescription use only.	Removable intraoral device.Single patient multiple use.Prescription use only.	Removable intraoral device.Single patient multiple use.Prescription use only.
Target Population	People over 18 years of agewho snore and/or have sleepapnea.	People over 18 years of agewho snore and/or have sleepapnea.	People over 18 years of agewho snore and/or have sleepapnea.	People over 18 years of agewho snore and/or have sleepapnea.
Environment of Use	To be used in the patient'shome or in sleeplaboratories.	To be used in the patient'shome or in sleeplaboratories.	To be used in the patient'shome or in sleeplaboratories.	To be used in the patient'shome or in sleeplaboratories.
Feature	O2Vent W	O2Vent T	OVENT	SOMNODENT CLASSIC
Cleaning	Should be cleaned daily in	Should be cleaned daily in	Should be cleaned daily in	Should be cleaned daily in
Instructions	soap and water.	soap and water.	soap and water.	soap and water.
	Can be periodically cleaned	Can be periodically cleaned	Can be periodically cleaned	Cannot be cleaned in an
	in an ultrasonic cleaner with	in an ultrasonic cleaner with	in an ultrasonic cleaner with	ultrasonic cleaner.
	an effervescent denture	an effervescent denture	an effervescent denture
	cleaning tablet.	cleaning tablet.	cleaning tablet.
Device	Repositions the lower jaw	Repositions the lower jaw	Repositions the lower jaw	Repositions the lower jaw
Functionality	forward.	forward.	forward.	forward.
	Acts by increasing the	Acts by increasing the	Acts by increasing the	Acts by increasing the
	pharyngeal space to	pharyngeal space to	pharyngeal space to	pharyngeal space to
	improve the patient's ability	improve the patient's ability	improve the patient's ability	improve the patient's ability
	to exchange air.	to exchange air.	to exchange air.	to exchange air.
	Does not have a lingual	Does not have a lingual	Has a lingual flange for	Does not have a lingual
	flange for holding the	flange for holding the	holding the mandible	flange for holding the
	mandible forward.	mandible forward.	forward1.	mandible forward.
	Permits patient to breathe	Permits patient to breathe	Permits patient to breathe	Permits patient to breathe
	through their mouth2.	through their mouth2.	through their mouth2.	through their mouth2.
	Retains the top and bottom	Retains the top and bottom	Retains the top and bottom	Retains the top and bottom
	teeth using rigid trays.	teeth using rigid trays.	teeth with monobloc.	teeth using rigid trays.
Device Design	Customized for each patient	Customized for each patient	Customized for each patient	Customized for each patient
	in a dental laboratory.	in a dental laboratory.	in a dental laboratory.	in a dental laboratory.
	Upper and lower trays are	Upper and lower trays	No upper and lower trays.	Upper and lower trays
	separate.	separate.		separate.
	The upper tray have	The two trays are connected	The device is a one piece	The protrusions (wings) are
	protrusions (wings) at the	in the front of the device	assembly.	at the rear of the bottom
	rear on the titanium part to	with a screw assembly.		tray to interface with the
	interface with the adjuster			adjuster block in the upper
	block in the lower tray.			tray.
Feature	O₂Vent W	O₂Vent T	OVENT	SOMNODENT CLASSIC
Adjustment	Can be adjusted by the clinician and patient⁴.Lower jaw adjusted using titration of the adjustment screws equally on both sides with an adjustment key.	Can be adjusted by the clinician and patient⁴.Lower jaw adjusted using titration of the adjustment screw with an adjustment key.	Cannot be adjusted by the clinician or patient⁴.Lower jaw cannot be adjusted and there is no adjustment key.	Can be adjusted by the clinician and patient⁴.Lower jaw adjusted using titration of the adjustment screws equally on both sides with an adjustment key.
SuppliedSterile/Non-Sterile	Non-Sterile	Non-sterile	Non-sterile	Non-sterile
Materials Used - 1	Medical grade metal used⁵.	Medical grade metal used⁵.	Medical grade metals used⁵.	Medical grade metals used⁵.
Materials Used - 2	Dental plastic laminates and acrylics used for upper and lower trays which is in contact with the patient's teeth.	Dental plastic laminates and acrylics used for upper and lower trays which is in contact with the patient's teeth.	Dental plastic laminates and acrylics used for upper and lower trays which is in contact with the patient's teeth.	Dental acrylics used for upper and lower trays which is in contact with the patient's teeth.
Biocompatibility*	Not performed as the materials are identical as in the OVENT.	Not performed as the materials identical as in the OVENT.	Passes Part 5 and Part 10 of ISO10993.	Information could not be verified.

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This is assumed as the predicate devices are FDA 510(k) cleared and are currently on the OVENT device was tested as part of this submission. Biocompatibility was not performed on the O Vent W device as the materials used in the device were similar to that of OVENT.

Note (1) The OVENT has a choice of lingual flance (to be decided by the clinician) although for most cases adequate retention (in advanced position) is achieved by the molded polymer insert.

Note (2) The O2Vent W, Q2Vent T and OVENT all have a dedicated breathing port (delivering air to the mouth) to allow the user to breathe through their mouth if they want, the SOMNODENT CLASSIC allows users to open their mouth to a degree.

Note (4) The OVENT requires a new insert to be made for mandbular adjustment, the O2Vent W, O2Vent T and SOMNODENT CLASSIC device can be adjusted by the clinician or patient through the adjustment screws and the adjustment key.

Note (5) The OxVent W, O2Vent T and OVENT use 3D printed titanium trays and stainless steel screws (only for O2 Vent T) and the SOMNODENT CLASSIC uses stainless steel screws and ball clasps.

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Summary of Non ClinicalTests	The non-clinical testing included risk assessment of the physicalproperties of the O2Vent W and its ability to achieve its intendeduse.Preliminary testing was carried out to confirm that the designcan withstand forces applied during normal use and alsoreasonable abuse in cases such as bruxing. The O2Vent W metthe specifications set.
	The only new material that was incorporated in the O2Vent Ware the adjustment screws which have been granted prior 510(k)approval, made of special grade stainless steel and have beenwidely used in manufacturing of dental appliances. Thespecifications of the adjuster screws are same as in the predicateSOMNODENT CLASSIC device. No other risks are introducedin the device. The O2Vent W met the specifications as set.
	A biocompatibility assessment of the device was performed. Thepurpose of the biocompatibility assessment was to ensure thatbiocompatibility had been established for the device.No new materials are being used in the device; all materials arealready used in the predicate devices (O2Vent T & OVENT).No new risks are introduced in the new device apart from thetwo adjustment screws on the lower tray, which are not presentin the predicate O2Vent T & OVENT devices, however arepresent in the SOMNODENT CLASSIC predicate device. Thesescrews have been granted prior 510(k) approval, made of specialgrade stainless steel and have been widely used in themanufacturing of dental appliances.
	Our conclusion is that biocompatibility testing of the adjustmentscrews is not warranted due to the source and nature of thecomponent, it has long been used in intraoral environment (i.e.mucosal, gingival, and palatal) with prolonged contact and hasbeen widely used in the manufacturing of dental appliances.
	The device is deemed to be biocompatible, based on thesimilarity of the materials of constructions to the predicatedevices (O2Vent T, OVENT & SOMNODENT CLASSIC).
Summary of Clinical Tests	Human clinical studies were not deemed necessary to evaluatethe substantial equivalence of the O2Vent W, as the O2Vent Wdoes not:• Use designs dissimilar from the predicate device and otherpreviously-cleared devices under a 510(k);
	• Use new technologies different from legally-marketed intra-mandibular repositioning devices for snoring and/or obstructivesleep apnea;
	• Deviate from the indications for use identified in the predicatedevices: the O2Vent T, OVENT and SOMNODENT CLASSIC.In lieu of human clinical testing, the risks and mitigatingcontrols associated with the use of mandibular repositioningdevices, as identified by the FDA, have been addressed in the"Risk Assessment". The function of mandibular repositioningdevices required that the prescribing dentist be aware of thepotential for soreness caused by mandibular advancement.Management of these risks is achieved by advising the patientsand dentists in the "Instructions for Use". The contraindications,warnings, precautions, storage, fitting and adjustment directionsare written to avoid potential problems from arising or persistingcaused by Mandibular Advancement Devices.
Differences between theproposed and predicatedevice(s).	As discussed in the comparison chart above, the main functionaldifference between the proposed O2Vent W and predicate devicesO2Vent T & OVENT is the method of adjustment:• O2Vent W allows protrusion of the mandible from theoriginal treatment position via use of adjuster assemblylocated on both sides of the lower arch, whereas O2Vent Tallows protrusion via a single screw mechanism in the frontof the device and additional impressions or laboratoryprocedures are required for OVENT.• The adjustments can be made by the clinician or by thepatient under the direction of the clinician for the O2VentW and O2Vent T device, however it is not possible in caseof the OVENT device.
	• Additionally, in order to facilitate the titration of the device,the O2Vent W have a separate upper tray with sideprotrusions (wings) and lower tray with the adjusterassembly on both the side that interface with theprotrusions, while O2Vent T has separate upper and lowertrays connected via the screw mechanism in the front of thedevice, and the OVENT has a monobloc design.
	No new risks are introduced in the new device apart from the wingsand two adjustment screws, which are not present in the predicateO2Vent T and OVENT device, however are present in theSOMNODENT CLASSIC predicate device.
	The treatment outcomes for O2Vent W, O2Vent T and OVENT areexpected to be equivalent as the final levels of mandibularprotrusion and the provision for oral breathing via the customizedairway is same for each device.
	The difference between the proposed O2Vent W and predicatedevice SOMNODENT CLASSIC is the location of the wings and

	titration blocks, which is switched between the upper and lowertrays. The purpose of the wings and the titration blocks is tostabilize the mandible in a more advanced position and thus be ableto advance the mandible forward incrementally to reduce airwaycollapse during sleep. The fact that the wing is on the top part ofthe device as opposed to the bottom is inconsequential as itachieves the same purpose of mandibular advancement in thisregard.
	Hence the differences mentioned are unlikely to adversely orotherwise affect the expected clinical outcomes for patients usingthe O2Vent W device as compared to those using the predicatedevices, thus not affecting the substantial equivalency of theproposed device.
Conclusion on Non Clinicaland Clinical Tests	The O2Vent W is considered to be substantially equivalent to thepredicate devices based on the following:• It has the same intended use and is indicated for the same userpopulation.· It has equivalent technological characteristics to the predicates.· The device is as safe, as effective and performs as well as orbetter than the legally marked devices identified above.

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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.”