O2Vent W

K171316 · Oventus Manufacturing Pty, Ltd. · LRK · Jul 11, 2017 · Dental

Device Facts

• Record ID: K171316
• Device Name: O2Vent W
• Applicant: Oventus Manufacturing Pty, Ltd.
• Product Code: LRK · Dental
• Decision Date: Jul 11, 2017
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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 Story

O2Vent W is a custom-fitted, removable intraoral mandibular repositioning device; used at home or in sleep labs by patients under dentist direction. Device consists of two parts: 3D-printed medical-grade titanium upper tray with side protrusions (wings) and a lower acrylic tray. Principle of operation: lower tray positions mandible forward to increase pharyngeal space, preventing soft tissue collapse and airway obstruction. Titration achieved via adjustment screws on both sides of lower arch; interface between wings and adjuster blocks allows incremental mandibular advancement. Dentist or patient (under direction) uses adjustment key to set protrusion. Output is physical stabilization of the jaw; benefits patient by reducing snoring and OSA symptoms. No electronic or software components.

Clinical Evidence

No clinical data. Substantial equivalence supported by non-clinical bench testing, risk assessment, and comparison of technological characteristics to legally marketed predicates.

Technological Characteristics

Materials: 3D-printed medical-grade titanium, dental plastic laminates, acrylics, and stainless steel adjustment screws. Form factor: Two-piece intraoral appliance with bilateral titration wings and adjuster blocks. Energy source: None (mechanical). Connectivity: None. Sterilization: Non-sterile.

Indications for Use

Indicated for adult patients 18 years and older with snoring and mild to moderate obstructive sleep apnea (OSA).

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• O2Vent T (K161832)
• OVENT (K160234)
• SOMNODENT CLASSIC (K050592)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|--------------------------------------------|
| Prescription Use (Part 21 CFR 801 Subpart D) | <div style="display:inline-block;">X</div> |
| Over-The-Counter Use (21 CFR 801 Subpart C) | <div style="display:inline-block;"></div> |

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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 Details<br>Name: | Oventus Manufacturing Pty Ltd |
| Address | 1 Swann Road, Indooroopilly, QLD 4068, Australia. |
| Phone: | [phone] |
| 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 for<br>snoring 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 - Primary<br>OVENT – Oventus Manufacturing Pty Ltd<br>SOMNODENT CLASSIC – Somnomed Inc. |
| Device Description | The O2Vent W is an oral appliance and is intended to reduce or<br>alleviate snoring and mild to moderate obstructive sleep apnea<br>(OSA).<br>The O2Vent W is made up of two parts:<br>1. The Upper Tray fitted over the upper teeth, with the breathing<br>port at the front leading to the airways on each side to the rear of<br>the appliance, is made from medical grade titanium (3D printed).<br>The upper titanium tray has two side protrusions (wings) that<br>extend vertically down to interface with the lower acrylic tray<br>for titration of the device. The upper tray is lined with acrylic<br>insert, and is customized to patient bite and impression. |
| | 2. The Lower Tray customized to the lower teeth, positions the<br>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<br>block and also adjustment screws each located on either side of |
| | the lower arch. |
| | The adjuster block interfaces with the side protrusions on the<br>upper tray to provide titration. The screws are adjusted with an<br>Adjustment Key for mandibular adjustment to be set by the<br>dentist and/or by the patient under the direction of the dentist. |
| Indications for Use | The <i>O</i> 2 <i>Vent W</i> is a removable medical device that is fitted in the<br>patient's mouth and is intended to reduce or alleviate snoring and<br>mild to moderate obstructive sleep apnea (OSA). The device is<br>indicated for use during sleep to aid in the treatment of these<br>conditions. |
| Target Population | Adult patients 18 years and older. |
| Environment of Use | Home Use and Sleep laboratories. |
| Summary of Comparison<br>of Technological<br>Characteristics of the<br>Device 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 a<br>removable medical device<br>that is fitted in the patient's<br>mouth and is intended to<br>reduce or alleviate snoring<br>and mild to moderate<br>obstructive sleep apnea<br>(OSA). The device is<br>indicated for use during<br>sleep to aid in the treatment<br>of these conditions. | The O2Vent T is a<br>removable medical device<br>that is fitted in the patient's<br>mouth and is intended to<br>reduce or alleviate snoring<br>and mild to moderate<br>obstructive sleep apnea<br>(OSA). The device is<br>indicated for use during<br>sleep to aid in the treatment<br>of these conditions. | The OVENT is a removable<br>medical device that is fitted<br>in the patient's mouth and is<br>intended to reduce or<br>alleviate snoring and mild<br>to moderate obstructive<br>sleep apnea, OSA. The<br>device is indicated for use<br>during sleep to aid in the<br>treatment of these<br>conditions. | To intended to reduce night<br>time snoring and mild to<br>moderate obstructive sleep<br>apnea (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.<br>Single patient multiple use.<br>Prescription use only. | Removable intraoral device.<br>Single patient multiple use.<br>Prescription use only. | Removable intraoral device.<br>Single patient multiple use.<br>Prescription use only. | Removable intraoral device.<br>Single patient multiple use.<br>Prescription use only. |
| Target Population | People over 18 years of age<br>who snore and/or have sleep<br>apnea. | People over 18 years of age<br>who snore and/or have sleep<br>apnea. | People over 18 years of age<br>who snore and/or have sleep<br>apnea. | People over 18 years of age<br>who snore and/or have sleep<br>apnea. |
| Environment of Use | To be used in the patient's<br>home or in sleep<br>laboratories. | To be used in the patient's<br>home or in sleep<br>laboratories. | To be used in the patient's<br>home or in sleep<br>laboratories. | To be used in the patient's<br>home or in sleep<br>laboratories. |
| 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.<br>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.<br>Lower jaw adjusted using titration of the adjustment screw with an adjustment key. | Cannot be adjusted by the clinician or patient⁴.<br>Lower jaw cannot be adjusted and there is no adjustment key. | Can be adjusted by the clinician and patient⁴.<br>Lower jaw adjusted using titration of the adjustment screws equally on both sides with an adjustment key. |
| Supplied<br>Sterile/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 Clinical<br>Tests | The non-clinical testing included risk assessment of the physical<br>properties of the O2Vent W and its ability to achieve its intended<br>use.<br>Preliminary testing was carried out to confirm that the design<br>can withstand forces applied during normal use and also<br>reasonable abuse in cases such as bruxing. The O2Vent W met<br>the specifications set. |
|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The only new material that was incorporated in the O2Vent W<br>are the adjustment screws which have been granted prior 510(k)<br>approval, made of special grade stainless steel and have been<br>widely used in manufacturing of dental appliances. The<br>specifications of the adjuster screws are same as in the predicate<br>SOMNODENT CLASSIC device. No other risks are introduced<br>in the device. The O2Vent W met the specifications as set. |
| | A biocompatibility assessment of the device was performed. The<br>purpose of the biocompatibility assessment was to ensure that<br>biocompatibility had been established for the device.<br>No new materials are being used in the device; all materials are<br>already used in the predicate devices (O2Vent T & OVENT).<br>No new risks are introduced in the new device apart from the<br>two adjustment screws on the lower tray, which are not present<br>in the predicate O2Vent T & OVENT devices, however are<br>present in the SOMNODENT CLASSIC predicate device. These<br>screws have been granted prior 510(k) approval, made of special<br>grade stainless steel and have been widely used in the<br>manufacturing of dental appliances. |
| | Our conclusion is that biocompatibility testing of the adjustment<br>screws is not warranted due to the source and nature of the<br>component, it has long been used in intraoral environment (i.e.<br>mucosal, gingival, and palatal) with prolonged contact and has<br>been widely used in the manufacturing of dental appliances.…