The O2Vent T 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 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
The Lower Tray fitted over the lower teeth, positions the jaw for mandibular advancement.
The Upper and Lower Trays have a "landing area" customized to the patient's teeth and made from medical grade polymers.
The Upper and Lower Trays are connected together with a connector. A hook mechanism attached to the Upper Tray fits into a socket attached to the Lower Tray and positions the lower jaw forward, preventing the soft tissue of the throat from collapsing and obstructing the airway. An Adjustment Key for the O2Vent T allows the patient and their Clinician to adjust the protrusion of the lower jaw to the most effective and comfortable position.

AI/ML Overview

The O2Vent T device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA).

1. Table of Acceptance Criteria and Reported Device Performance:

The document provided does not specify numerical acceptance criteria for clinical performance (e.g., reduction in AHI or snoring scores). Instead, the acceptance criteria are implicitly based on demonstrating substantial equivalence to predicate devices (OVENT and TAP-III) through non-clinical testing and shared intended use, technological characteristics, safety, and effectiveness.

Feature	Acceptance Criteria (Implied by Substantial Equivalence to Predicates)	Reported Device Performance (O2Vent T)
Intended Use	Reduce/alleviate snoring and mild to moderate OSA.	The O2Vent T is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA).
Target Population	Adults 18 years and older.	Adult patients 18 years and older.
Environment of Use	Home Use and Sleep Laboratories.	Home Use and Sleep Laboratories.
Device Functionality	Repositions lower jaw forward, increases pharyngeal space, permits oral breathing, retains teeth using rigid trays.	Repositions the lower jaw forward. Acts by increasing the pharyngeal space to improve the patient's ability to exchange air. Permits patient to breathe through their mouth. Retains the top and bottom teeth using rigid trays.
Device Design	Customized for each patient in a dental laboratory.	Customized for each patient in a dental laboratory.
Adjustment	Adjustable by clinician and/or patient.	Can be adjusted by the clinician and patient (via a screw mechanism, without requiring additional impressions or laboratory procedures, unlike some predicates).
Sterility	Non-sterile.	Non-sterile.
Biocompatibility	Meets ISO10993 Part 5 and Part 10 standards for patient contact materials.	Biocompatibility assessment performed. Materials are identical to or similar to those in the predicate OVENT device (which passes ISO10993 Part 5 and 10), and the new connector assembly material (special grade 316 stainless steel) has no patient tissue contact and is used in the TAP-III predicate. The device is deemed biocompatible.
Mechanical Safety	Can withstand mechanical forces without significant degradation.	Can withstand mechanical forces without significant degradation.

2. Sample Size and Data Provenance for Test Set:

Sample Size: The document explicitly states: "Human clinical studies were not deemed necessary to evaluate the substantial equivalence of the O2Vent T." Therefore, there is no "test set" in the traditional sense of a clinical trial patient cohort. The evaluation relied on non-clinical testing and comparison to predicate devices.
Data Provenance: Not applicable, as no dedicated clinical test set was used.

3. Number of Experts and Qualifications for Ground Truth:

Not applicable, as no clinical test set requiring expert ground truth was utilized. The assessment was based on non-clinical testing and regulatory comparison.

4. Adjudication Method for Test Set:

Not applicable, as no clinical test set requiring adjudication was utilized.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, an MRMC comparative effectiveness study was not performed. The submission explicitly states, "Human clinical studies were not deemed necessary." The device's approval is based on demonstrating substantial equivalence to existing legally marketed devices, not on proving improved effectiveness for human readers with or without AI assistance (as this is not an AI-assisted device).

6. Standalone (Algorithm Only) Performance Study:

No, a standalone algorithm performance study was not done. This device is a physical intraoral appliance, not a software algorithm, so the concept of "standalone algorithm performance" is not applicable.

7. Type of Ground Truth Used:

Not applicable in the context of a clinical test set. Instead, "ground truth" for the device's characteristics and safety was established through:
- Engineering specifications and material testing: Verifying the physical and mechanical properties of the device and its components.
- Biocompatibility testing/assessment: Ensuring materials meet safety standards (ISO10993) based on predicate device data and non-contact nature of new materials.
- Comparison to predicate devices: Establishing substantial equivalence in intended use, technological characteristics, and safety/effectiveness to previously cleared devices.

8. Sample Size for the Training Set:

Not applicable. This is a physical medical device, not an AI or machine learning model that requires a "training set."

9. How the Ground Truth for the Training Set was Established:

Not applicable. As above, this is not an AI/ML device requiring a training set and associated ground truth establishment.

Summary

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

September 23, 2016

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

Re: K161832

Trade/Device Name: O2 Vent T 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: August 23, 2016 Received: August 25, 2016

Dear Dr. M.W. 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

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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 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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Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K161832

Device Name O2VENT T

Indications for Use (Describe)

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

Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image shows the logo for Oventus Medical. The logo features a stylized blue circle with a wave-like design inside, suggesting a connection to breathing or airflow. Above the circle are several blue dots of varying sizes, arranged in a semi-circular pattern. Below the circle, the word "OVENTUS" is written in a stylized font.

510(k) SUMMARY FOR O₂VENT T

prepared in accordance to 21CFR 807.92

Date Prepared	23rd September 2016
510 (k) Owner Details
Name:	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 T
Common Name	Oral Appliance - Anti snoring device
Classification	Class II
Classification Name	Intraoral devices for snoring and intraoral devices for snoringand obstructive sleep apnea.
Classification Code	LRK
Classification Regulation	21 CFR 872.5570
Device Model Number(s)	O2VTDL, O2VTOV
Predicate Device	OVENT – Oventus Manufacturing Pty LtdTAP-III – Airway Management
Device Description	The O2Vent T is a removable medical device that is fitted in thepatient's mouth and is intended to reduce or alleviate snoringand mild to moderate obstructive sleep apnea (OSA).The O2Vent T is made up of three 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 titanium2. The Lower Tray fitted over the lower teeth, positions the jawfor mandibular advancement.The Upper and Lower Trays have a "landing area" customized tothe patient's teeth and made from medical grade polymers.
	3. The Upper and Lower Trays are connected together with aconnector. A hook mechanism attached to the Upper Tray fitsinto a socket attached to the Lower Tray and positions the lowerjaw forward, preventing the soft tissue of the throat fromcollapsing and obstructing the airway. An Adjustment Key forthe O 2 Vent T allows the patient and their Clinician to adjust theprotrusion of the lower jaw to the most effective andcomfortable position.
Intended Use of the Device	The O 2 Vent T is a removable medical device that is fitted in thepatient's mouth and is intended to reduce or alleviate snoringand mild to moderate obstructive sleep apnea (OSA). The deviceis indicated 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 T	OVENT	TAP-III
510k Number	Not yet received.	K160234	K062951
Device Photo	Image: O2Vent T device	Image: OVENT device	Image: TAP-III device
Intended Use	The O2Vent T is aremovable medicaldevice that is fitted inthe patient's mouthand is intended toreduce or alleviatesnoring and mild tomoderate obstructivesleep apnea (OSA).The device isindicated for useduring sleep to aid inthe treatment of theseconditions.	The OVENT is aremovable medicaldevice that is fitted inthe patient's mouth andis intended to reduce oralleviate snoring andmild to moderateobstructive sleep apnea,OSA. The device isindicated for use duringsleep to aid in thetreatment of theseconditions.	To reduce or alleviatenight time snoring andmild to moderateobstructive sleep apnea(OSA).
Product Codes	LRK	LRK	LRK
Regulation	21CFR 872.5570	21CFR 872.5570	21CFR 872.5570
Use of device	Removable intraoraldevice. Multiple use.Prescription use only.	Removable intraoraldevice. Multiple use.Prescription use only.	Removable intraoraldevice. Multiple use.Prescription use only.
Target Population	People over 18 yearsof age who snoreand/or have sleepapnea.	People over 18 yearsof age who snoreand/or have sleepapnea.	People over 18 yearsof age who snoreand/or have sleepapnea.
Environment ofUse	To be used in thepatient's home or insleep laboratories.	To be used in thepatient's home or insleep laboratories.	To be used in thepatient's home or insleep laboratories.
CleaningInstructions	Should be cleaneddaily in soap andwater.	Should be cleaneddaily in soap andwater.	Should be cleaneddaily in soap andwater.
	Can be periodicallycleaned in anultrasonic cleaner withan effervescentdenture cleaningtablet.	Can be periodicallycleaned in anultrasonic cleaner withan effervescentdenture cleaningtablet.	Can be periodicallycleaned in anultrasonic cleaner withan effervescentdenture cleaningtablet.
Feature	O₂Vent T	OVENT	TAP-III
DeviceFunctionality	Repositions the lowerjaw forward.Acts by increasing thepharyngeal space toimprove the patient'sability to exchange air.Does not have alingual flange forholding the mandibleforward.Permits patient tobreathe through theirmouth2.Retains the top andbottom teeth usingrigid trays.	Repositions the lowerjaw forward.Acts by increasing thepharyngeal space toimprove the patient'sability to exchange air.Has a lingual flangefor holding themandible forward1.Permits patient tobreathe through theirmouth2.Retains the top andbottom teeth usingrigid trays.	Repositions the lowerjaw forward.Acts by increasing thepharyngeal space toimprove the patient'sability to exchange air.Does not have alingual flange forholding the mandibleforward.Permits patient tobreathe through theirmouth2.Retains the top andbottom teeth usingrigid trays.
Device Design	Customized for eachpatient in a dentallaboratory.	Customized made foreach patient in a dentallaboratory.	Customized made foreach patient in a dentallaboratory.
Adjustment	Can be adjusted by theclinician and patient4.	Cannot be adjusted bythe clinician orpatient4.	Can be adjusted by theclinician and patient4.
SuppliedSterile/Non-Sterile	Non-Sterile	Non-sterile	Non-sterile
Materials Use - 1	Medical grade metalused5.	Medical grade metalused5.	Medical grade metalsused5.
Materials Use - 2	Dental plasticlaminates and acrylicsused for upper andlower trays which is incontact with thepatient's teeth.	Dental plasticlaminates and acrylicsused for upper andlower trays which is incontact with thepatient's teeth.	Dental plasticlaminates and acrylicsused for upper andlower trays which is incontact with thepatient's teeth.
Biocompatibility*	Not performed as thematerials are identicalas in the OVENT.	Passes Part 5 and Part10 of ISO10993.	Passes Part 5 and Part10 of ISO10993.
Mechanical safety	Can withstandmechanical forceswithout significantdegradation.	Can withstandmechanical forceswithout significantdegradation.	Can withstandmechanical forceswithout significantdegradation.

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This is assumed as the devices are FDA 510(k) cleared and are currently on the market. Only the OVENT device was tested as part of this submission. Biocompatibility was not performed on the O₂Vent T device as the materials used in the device were similar to that of OVENT.

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Note (1) The OVENT has a choice of lingual flange (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 T and OVENT both have a dedicated breathing port (delivering air to the rear of the mouth) to allow the user to breathe through their mouth if they want, the TAP-III allows users to open their mouth to a degree.

Note (4) The OVENT requires a new insert to be made for mandibular adjustment, the O2Vent T and TAP device can be adjusted by the clinician or patient.

Note (5) The O2Vent T and OVENT uses titanium and the TAP-III uses stainless steel.

Summary of Non Clinical Tests	The non-clinical testing included risk assessment of the physicalproperties of the O2Vent T and its ability to achieve its intendeduse. The only new material that was incorporated in the O2VentT is the connector assembly made from special grade 316stainless steel. The material and design specifications of theconnector assembly is already used in as the predicate TAP-IIIdevice. No other risks are introduced in the device. The O2VentT 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 newmaterials are being used in the device; all materials are alreadyused in the predicate device (OVENT). No new risks areintroduced in the new device apart from the connector assembly,which are not present in the predicate OVENT device, howeveris present in the TAP-III predicate device and the new materialhas no patient tissue contact in the new device.The device is deemed to be biocompatible, based on thesimilarity of the materials of constructions to the predicatedevices (OVENT & TAP-III).
Summary of Clinical Tests	Human clinical studies were not deemed necessary to evaluatethe substantial equivalence of the O2Vent T as the O2Vent Tdoes 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 OVENT and TAP-III.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 T and predicate deviceOVENT is the method of adjustment. O2Vent T allows protrusionof the mandible from the original treatment position via a screwmechanism without requiring additional impressions or laboratoryprocedures as required for OVENT. The adjustments can be madeby the clinician or patient for the O2Vent T device, however it isnot possible in case of the OVENT device.Additionally, in order to facilitate the ability to titrate the device,the O2Vent T has separate upper and lower trays connected via thescrew mechanism, while the OVENT has a monobloc design.No new risks are introduced in the new device apart from theconnector assembly and separate trays, which are not present in thepredicate OVENT device, however are present in the TAP-IIIpredicate device.The treatment outcomes for O2Vent T and OVENT are expected tobe equivalent as the final levels of mandibular protrusion and theprovision for oral breathing via the customized airway is same foreach device.Hence the differences mentioned are unlikely to adversely orotherwise affect the expected clinical outcomes for patients usingthe O2Vent T device as compared to those using the OVENT, thusnot affecting the substantial equivalency of the proposed device.
Conclusion on Non Clinicaland Clinical Tests	The O2Vent T 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.”