Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical components and materials of a mechanical mandibular advancement device. There is no mention of software, algorithms, or data processing that would indicate the use of AI/ML.

Therapeutic

Yes
The device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea, which are medical conditions, and it is indicated for use during sleep to aid in the treatment of these conditions.

Diagnostic

No

The device is described as 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)." Its purpose is to treat conditions by repositioning the jaw, not to diagnose them.

SaMD (Software as a Medical Device)

No

The device description clearly outlines physical components made of medical-grade titanium and polymers, which are hardware. The summary also describes fitting and adjustment of these physical components.

IVD (In Vitro Diagnostic)

Based on the provided information, the O2Vent T is not an In Vitro Diagnostic (IVD) device.

Here's why:

IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
O2Vent T Function: The O2Vent T is a physical device that is fitted in the patient's mouth. Its function is to mechanically reposition the jaw to alleviate snoring and sleep apnea. It does not involve the analysis of biological specimens.

The description clearly indicates that the O2Vent T is a mechanical device used in vivo (within the living body) to treat a condition, rather than a device used in vitro (outside the living body) to analyze samples for diagnostic purposes.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes (comma separated list FDA assigned to the subject device)

LRK

Device Description

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 O2Vent T is made up of three parts:

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 O2 Vent T allows the patient and their Clinician to adjust the protrusion of the lower jaw to the most effective and comfortable position.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

patient's mouth, teeth, jaw, throat

Indicated Patient Age Range

Adult patients 18 years and older.

Intended User / Care Setting

Home Use 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)

Summary of Non Clinical Tests: The non-clinical testing included risk assessment of the physical properties of the O2Vent T and its ability to achieve its intended use. The only new material that was incorporated in the O2Vent T is the connector assembly made from special grade 316 stainless steel. The material and design specifications of the connector assembly is already used in as the predicate TAP-III device. No other risks are introduced in the device. The O2Vent T met the specifications as set. A biocompatibility assessment of the device was performed. The purpose of the biocompatibility assessment was to ensure that biocompatibility had been established for the device. No new materials are being used in the device; all materials are already used in the predicate device (OVENT). No new risks are introduced in the new device apart from the connector assembly, which are not present in the predicate OVENT device, however is present in the TAP-III predicate device and the new material has no patient tissue contact in the new device. The device is deemed to be biocompatible, based on the similarity of the materials of constructions to the predicate devices (OVENT & TAP-III).

Summary of Clinical Tests: Human clinical studies were not deemed necessary to evaluate the substantial equivalence of the O2Vent T as the O2Vent T does not:

Use designs dissimilar from the predicate device and other previously-cleared devices under a 510(k);
Use new technologies different from legally-marketed intra-mandibular repositioning devices for snoring and/or obstructive sleep apnea;
Deviate from the indications for use identified in the predicate devices: the OVENT and TAP-III.

In lieu of human clinical testing, the risks and mitigating controls associated with the use of mandibular repositioning devices, as identified by the FDA, have been addressed in the "Risk Assessment". The function of mandibular repositioning devices required that the prescribing dentist be aware of the potential for soreness caused by mandibular advancement. Management of these risks is achieved by advising the patients and dentists in the "Instructions for Use". The contraindications, warnings, precautions, storage, fitting and adjustment directions are written to avoid potential problems from arising or persisting caused by Mandibular Advancement Devices.

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.

K160234, K062951

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.

Not Found

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

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.”

Summary

0

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 stylized human figure with three faces in profile, representing the department's focus on people. The figure is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the figure.

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

1

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

2

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)

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.

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

3

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 snoring
and obstructive sleep apnea.
Classification Code	LRK
Classification Regulation	21 CFR 872.5570
Device Model Number(s)	O2VTDL, O2VTOV
Predicate Device	OVENT – Oventus Manufacturing Pty Ltd
TAP-III – Airway Management
Device Description	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 O2Vent T is made up of three parts:

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. |
| | 3. 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 O 2 Vent T allows the patient and their Clinician to adjust the
protrusion of the lower jaw to the most effective and
comfortable position. |
| Intended Use of the Device | The O 2 Vent 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. |
| Target Population | Adult patients 18 years and older. |
| Environment of Use | Home Use and Sleep laboratories. |
| Summary of Comparison
of Technological
Characteristics of the
Device to Predicate Device | As mentioned in the following pages. |

4

5

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 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.	The OVENT 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.	To reduce or alleviate
night time snoring and
mild to moderate
obstructive sleep apnea
(OSA).
Product Codes	LRK	LRK	LRK
Regulation	21CFR 872.5570	21CFR 872.5570	21CFR 872.5570
Use of device	Removable intraoral
device. Multiple use.
Prescription use only.	Removable intraoral
device. Multiple use.
Prescription use only.	Removable intraoral
device. Multiple use.
Prescription use only.
Target Population	People over 18 years
of age who snore
and/or have sleep
apnea.	People over 18 years
of age who snore
and/or have sleep
apnea.	People over 18 years
of age who snore
and/or have sleep
apnea.
Environment of
Use	To be used in the
patient's home or in
sleep laboratories.	To be used in the
patient's home or in
sleep laboratories.	To be used in the
patient's home or in
sleep laboratories.
Cleaning
Instructions	Should be cleaned
daily in soap and
water.	Should be cleaned
daily in soap and
water.	Should be cleaned
daily in soap and
water.
	Can be periodically
cleaned in an
ultrasonic cleaner with
an effervescent
denture cleaning
tablet.	Can be periodically
cleaned in an
ultrasonic cleaner with
an effervescent
denture cleaning
tablet.	Can be periodically
cleaned in an
ultrasonic cleaner with
an effervescent
denture cleaning
tablet.
Feature	O₂Vent T	OVENT	TAP-III
Device
Functionality	Repositions the lower
jaw forward.
Acts by increasing the
pharyngeal space to
improve the patient's
ability to exchange air.
Does not have a
lingual flange for
holding the mandible
forward.
Permits patient to
breathe through their
mouth2.
Retains the top and
bottom teeth using
rigid trays.	Repositions the lower
jaw forward.
Acts by increasing the
pharyngeal space to
improve the patient's
ability to exchange air.
Has a lingual flange
for holding the
mandible forward1.
Permits patient to
breathe through their
mouth2.
Retains the top and
bottom teeth using
rigid trays.	Repositions the lower
jaw forward.
Acts by increasing the
pharyngeal space to
improve the patient's
ability to exchange air.
Does not have a
lingual flange for
holding the mandible
forward.
Permits patient to
breathe through their
mouth2.
Retains the top and
bottom teeth using
rigid trays.
Device Design	Customized for each
patient in a dental
laboratory.	Customized made for
each patient in a dental
laboratory.	Customized made for
each patient in a dental
laboratory.
Adjustment	Can be adjusted by the
clinician and patient4.	Cannot be adjusted by
the clinician or
patient4.	Can be adjusted by the
clinician and patient4.
Supplied
Sterile/Non-Sterile	Non-Sterile	Non-sterile	Non-sterile
Materials Use - 1	Medical grade metal
used5.	Medical grade metal
used5.	Medical grade metals
used5.
Materials Use - 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.
Biocompatibility*	Not performed as the
materials are identical
as in the OVENT.	Passes Part 5 and Part
10 of ISO10993.	Passes Part 5 and Part
10 of ISO10993.
Mechanical safety	Can withstand
mechanical forces
without significant
degradation.	Can withstand
mechanical forces
without significant
degradation.	Can withstand
mechanical forces
without significant
degradation.

6

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.

7

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 physical
properties of the O2Vent T and its ability to achieve its intended
use. The only new material that was incorporated in the O2Vent
T is the connector assembly made from special grade 316
stainless steel. The material and design specifications of the
connector assembly is already used in as the predicate TAP-III
device. No other risks are introduced in the device. The O2Vent
T met the specifications as set.
A biocompatibility assessment of the device was performed. The
purpose of the biocompatibility assessment was to ensure that
biocompatibility had been established for the device. No new
materials are being used in the device; all materials are already
used in the predicate device (OVENT). No new risks are
introduced in the new device apart from the connector assembly,
which are not present in the predicate OVENT device, however
is present in the TAP-III predicate device and the new material
has no patient tissue contact in the new device.
The device is deemed to be biocompatible, based on the
similarity of the materials of constructions to the predicate
devices (OVENT & TAP-III). |
|-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of Clinical Tests | Human clinical studies were not deemed necessary to evaluate
the substantial equivalence of the O2Vent T as the O2Vent T
does not:
• Use designs dissimilar from the predicate device and other
previously-cleared devices under a 510(k);
• Use new technologies different from legally-marketed intra-
mandibular repositioning devices for snoring and/or obstructive
sleep apnea;
• Deviate from the indications for use identified in the predicate
devices: the OVENT and TAP-III.

In lieu of human clinical testing, the risks and mitigating
controls associated with the use of mandibular repositioning
devices, as identified by the FDA, have been addressed in the |
| | |
| | "Risk Assessment". The function of mandibular repositioning
devices required that the prescribing dentist be aware of the
potential for soreness caused by mandibular advancement.
Management of these risks is achieved by advising the patients
and dentists in the "Instructions for Use". The contraindications,
warnings, precautions, storage, fitting and adjustment directions
are written to avoid potential problems from arising or persisting
caused by Mandibular Advancement Devices. |
| Differences between the
proposed and predicate
device(s). | As discussed in the comparison chart above, the main functional
difference between the proposed O2Vent T and predicate device
OVENT is the method of adjustment. O2Vent T allows protrusion
of the mandible from the original treatment position via a screw
mechanism without requiring additional impressions or laboratory
procedures as required for OVENT. The adjustments can be made
by the clinician or patient for the O2Vent T device, however it is
not 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 the
screw mechanism, while the OVENT has a monobloc design.
No new risks are introduced in the new device apart from the
connector assembly and separate trays, which are not present in the
predicate OVENT device, however are present in the TAP-III
predicate device.
The treatment outcomes for O2Vent T and OVENT are expected to
be equivalent as the final levels of mandibular protrusion and the
provision for oral breathing via the customized airway is same for
each device.
Hence the differences mentioned are unlikely to adversely or
otherwise affect the expected clinical outcomes for patients using
the O2Vent T device as compared to those using the OVENT, thus
not affecting the substantial equivalency of the proposed device. |
| Conclusion on Non Clinical
and Clinical Tests | The O2Vent T is considered to be substantially equivalent to the
predicate devices based on the following:
• It has the same intended use and is indicated for the same user
population.
• It has equivalent technological characteristics to the predicates.
• The device is as safe, as effective and performs as well as or
better than the legally marked devices identified above. |

8