O2Vent Optima

K190236 · Oventus Manufacturing Pty, Ltd. · LRK · Aug 29, 2019 · Dental

Device Facts

• Record ID: K190236
• Device Name: O2Vent Optima
• Applicant: Oventus Manufacturing Pty, Ltd.
• Product Code: LRK · Dental
• Decision Date: Aug 29, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The O2Vent Optima 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

Removable intraoral appliance; custom-fitted to patient teeth via CAD/CAM and additive manufacturing (laser sintering of PA2200 nylon). Device consists of upper and lower trays connected by thermoplastic polyurethane/cured elastomer bands. Principle of operation: mandibular advancement; stabilizes lower jaw in forward position to increase pharyngeal space and prevent airway collapse during sleep. Features integrated breathing port for mouth breathing. Used in home or sleep lab settings; prescribed by dentists/physicians. Patient adjusts advancement by selecting connector bands of varying lengths (13-21mm). Output is mechanical stabilization of mandible; benefits patient by reducing snoring and OSA severity.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 (Parts 5 and 10). No clinical data presented.

Technological Characteristics

Materials: PA2200 (Polyamide 12/Nylon) for trays; 100% thermoplastic polyurethane/cured elastomer for connector bands. Additive manufacturing (laser sintering). Non-sterile. Mechanical sensing/actuation via mandibular advancement. No energy source. Dimensions adjustable via 13-21mm bands.

Indications for Use

Indicated for adult patients 18 years and older with snoring and mild to moderate obstructive sleep apnea (OSA). Used during sleep to reduce or alleviate symptoms.

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 W (K171316)

Reference Devices

• The Panthera Anti-Snoring Device (K143244)
• EMA Appliance (K971794)

Submission Summary (Full Text)

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August 29, 2019

Oventus Manufacturing PTY LTD % M.W. (Andy) Anderson Regulatory Consultant for Oventus Medical Regulatory and Clinical Research Institute 5353 Wayzata Blvd, Ste 505 Minneapolis, Minnesota 55416

Re: K190236

Trade/Device Name: O2Vent Optima 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: July 31, 2019 Received: August 1, 2019

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Srinivas Nandkumar, Ph.D. Acting Assistant Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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## Indications for Use

510(k) Number (if known) K190236

Device Name O2 Vent Optima

Indications for Use (Describe)

The O2Vent Optima 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) |
|-------------------------------------------------|
|-------------------------------------------------|

| <span style="text-decoration: overline;">X</span> Reproduction Use (Part 21 CFR 601 Subpart D) | <input checked="true" type="checkbox"/> |
|------------------------------------------------------------------------------------------------|-----------------------------------------|
| Sponsor-Type Use (21 CFR 601 Subpart C) | <input type="checkbox"/> |

A Prescription Use (Part 21 CFR 801 Subpart D)

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

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## 510(k) SUMMARY FOR O2VENT OPTIMA

K190236

prepared in accordance to 21CFR 807.92

| Date Prepared | July 31,2019 |
|---------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510 (k) Owner Details | |
| Name: | Oventus Manufacturing Pty Ltd |
| Address | 1 Swann Road, Indooroopilly, QLD 4068, Australia. |
| Phone: | [phone] |
| Name of Contact Person | Robyn Woidtke |
| Device Trade name | O₂Vent Optima |
| Common Name | Oral Appliance - Anti snoring device |
| Classification | Class II |
| Classification Name | Intraoral devices for snoring and obstructive sleep apnea. |
| Classification Code | LRK |
| Classification Regulation | 21 CFR 872.5570 |
| Device Model Number(s) | O2VB |
| Primary Predicate Device | K171316 O₂Vent W – Oventus Manufacturing Pty Ltd<br>The primary predicate was chosen as it has the same principal design<br>features as the O₂Vent Optima and indications for use |
| Reference Device(s) | K143244 The Panthera Anti-Snoring Device – Panthera Dental Inc<br>This reference device was chosen as the material is the same as that<br>used in the O₂Vent Optima<br>K971794 EMA Appliance – Myerson LLC<br>This reference device was chosen for the straps/bands |
| Device Description | The O₂Vent Optima is a removable medical device that is fitted in the<br>patient's mouth and is intended to reduce or alleviate snoring and mild<br>to moderate obstructive sleep apnea (OSA).<br>The O₂Vent Optima consists of the following parts:<br>Upper tray (upper teeth)<br>Lower tray (lower teeth)<br>Connector bands<br>The upper tray is fitted over the upper teeth, with the breathing<br>port at the front leading to the airways on each side to the rear<br>of the appliance. The upper nylon tray has two side<br>protrusions (lugs) that engage a connector that when attached,<br>extends to the lower tray and attaches to a similar lug<br>stabilizing and advancing the lower jawThe lower tray, is customized to the bottom teeth, which when<br>attached to the same connector via a side protrusion (lug) |
| | preventing the tongue and soft tissues of the throat from collapsing and obstructing the airway. In order to adjust the trays to the specific needs of the user, various length bands (13-21mm) are used to move the lower jaw (i.e. adjust the trays) forward or backward The shorter the connector band, the further the lower jaw is moved forwards. The O2Vent Optima is delivered fully assembled with the 19mm connector band as the recommended starting titration length for all new users. The upper and lower trays of the O2Vent Optima are made with PA2200 (i.e. Nylon) The straps which connect the upper and lower trays together are made of 100% thermoplastic polyurethane/cured elastomer |
| Indications for Use | The O2Vent Optima is a removable oral appliance that is fitted in the mouth and is intended to reduce or alleviate snoring and mild to moderate OSA. The Optima 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<br>Technological Characteristics<br>of the Device to Predicate<br>Device | The following table displays a comparison between the O2Vent Optima and the O2Vent W (predicate) and reference devices |

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| Feature | O₂Vent Optima | Primary Predicate<br>O₂Vent W | Reference Device<br>The Panthera Anti-<br>Snoring Device | Reference Device<br>Elastic Mandibular<br>Advancement (EMA)<br>Appliance | Compared to<br>Subject<br>Device |
|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k Number | K190236 | K171316 | K143244 | K971794 | |
| Device Photo | Image: O2Vent Optima | Image: O2Vent W | Image: The Panthera Anti-Snoring Device | Image: Elastic Mandibular Advancement (EMA) Appliance | |
| Indications for Use | The O₂Vent Optima is a<br>removable medical<br>device that is fitted in the<br>patient's mouth and is<br>intended to reduce or<br>alleviate snoring and<br>mild to moderate<br>obstructive sleep apnea<br>(OSA). The device is<br>indicated for use during<br>sleep to aid in the<br>treatment of these<br>conditions.. | The O₂Vent W is a removable<br>medical device that is fitted in<br>the patient's mouth and is<br>intended to reduce or alleviate<br>snoring and mild to moderate<br>obstructive sleep apnea<br>(OSA). The device is<br>indicated for use during sleep<br>to aid in the treatment of these<br>conditions. | The Panthera anti snoring<br>device is Intended to<br>reduce or alleviate<br>snoring and mild to<br>moderate obstructive<br>sleep apnea (OSA) in<br>adults. | Treatment of nasal<br>respiratory<br>dysfunction of<br>obstructive sleep<br>apnea and snoring in<br>those patients where<br>repositioning of the<br>mandible and opening<br>the bite can increase<br>the patients air space | Similar to<br>predicates |
| Product Codes | LRK | LRK | LRK | LRK | Same for all |
| Regulation | 21CFR 872.5570 | 21CFR 872.5570 | 21CFR 872.5570 | 21CFR 872.5570 | Same for all |
| Common Name | Intraoral devices for<br>snoring and intraoral<br>devices for snoring and<br>obstructive sleep apnea | Intraoral devices for snoring<br>and intraoral devices for<br>snoring and obstructive sleep<br>apnea | Intraoral devices for<br>snoring and intraoral<br>devices for snoring and<br>obstructive sleep apnea | Intraoral devices for<br>snoring and intraoral<br>devices for snoring<br>and obstructive sleep<br>apnea | Same for all |
| Classification | Class II | Class II | Class II | Class II | Same for all |
| Use of device | Removable intraoral<br>device. Single patient<br>multiple use.<br>Prescription use only. | Removable intraoral device.<br>Single patient multiple use.<br>Prescription use only. | Removable intraoral<br>device.<br>Multiple use.<br>Prescription use only. | Removable intraoral<br>device. Single patient<br>multiple use.<br>Prescription use only. | Similar or<br>same for all |
| Feature | O2Vent Optima | Primary Predicate<br>O2Vent W | Reference Device<br>The Panthera Anti-<br>Snoring Device | Reference Device<br>Elastic Mandibular<br>Advancement (EMA)<br>Appliance | Compared to<br>Subject<br>Device |
| Target Population | People over 18 years of<br>age who snore and/or<br>have sleep apnea. | People over 18 years of age<br>who snore and/or have sleep<br>apnea. | Adults | Not indicated | Same or<br>similar |
| Device Functionality<br>(Please note trays and<br>splints are<br>synonymous) | Repositions the lower<br>jaw forward. | Repositions the lower jaw<br>forward. | A mandibular<br>repositioner, maintaining<br>the lower jaw in a<br>forward position during<br>sleep. | Advance the mandible<br>to an anterior and<br>inferior position with<br>regard to the maxilla. | Description<br>similar for all<br>devices |
| Acts by increasing the<br>pharyngeal space to<br>improve the patient's<br>ability to exchange air. | Acts by increasing the<br>pharyngeal space to<br>improve the patient's<br>ability to exchange air. | Acts by increasing the<br>pharyngeal space to improve<br>the patient's ability to<br>exchange air. | This mechanical<br>protrusion acts to<br>increase the patient's<br>pharyngeal space,<br>improving their ability to<br>exchange air during<br>sleep. | Repositioning of the<br>mandible pulls the<br>tongue forward and<br>increased the patient's<br>airspace thereby<br>decreasing upper<br>airway obstruction. | Same as<br>predicate,<br>similar to<br>references |
| Permits patient to<br>breathe through their<br>mouth via a proprietary<br>built in airway | Permits patient to<br>breathe through their<br>mouth via a proprietary<br>built in airway | Permits patient to breathe<br>through their mouth via a<br>proprietary built in airway | NA | NA | Same as<br>primary<br>predicate |
| Retains the top and<br>bottom teeth using rigid<br>trays. | Retains the top and<br>bottom teeth using rigid<br>trays. | Retains the top and bottom<br>teeth using rigid trays. | The upper and lower<br>splints are adapted for the<br>upper and lower teeth,<br>respectively | Upper and lower trays<br>for tooth retention | Same as<br>primary<br>predicate;<br>similar for<br>references |
| Upper and lower trays<br>are separate. | Upper and lower trays<br>are separate. | Upper and lower trays are<br>separate. | Two customized splints<br>that fit separately over<br>the upper and lower teeth<br>inside the mouth. | Upper and lower trays<br>are separate | Same as<br>primary,<br>similar for<br>references |
| Feature | O2Vent Optima | Primary Predicate<br>O2Vent W | Reference Device<br>The Panthera Anti-Snoring Device | Reference Device<br>Elastic Mandibular<br>Advancement (EMA)<br>Appliance | Compared to<br>Subject<br>Device |
| Device Design and<br>Principle of<br>Operation | The trays have<br>protrusions (lugs) at the<br>side of the upper and<br>lower parts with a<br>connector between the<br>upper and lower parts to<br>stabilize and/or advance<br>the lower jaw. | The upper tray has protrusions<br>(wings) at the rear on the<br>titanium part to interface with<br>the adjuster block in the lower<br>tray. | The lower splint contains<br>a triangular protrusion,<br>allowing the splints to<br>engage by means of<br>interlocking rods on the<br>sides | Removable<br>replacement<br>adjustable bands<br>which attach by<br>protrusions to the side<br>of the upper and lower<br>trays | Same as<br>reference<br>devices,<br>similar to<br>predicate<br>device |
| Means of advancing<br>the mandible | Lower jaw adjusted by<br>attaching connectors of<br>varying lengths | Lower jaw adjusted using<br>titration of the adjustment<br>screws equally on both sides<br>with an adjustment key. | Adjusted via the use of<br>interlocking rods placed<br>on the sides of the splints.<br>The shorter the rod, the<br>further the mandible is<br>advanced<br>The length of the rods<br>can vary from 19 to 36<br>mm and can be adjusted<br>in 0.5-mm increments for<br>a highly accurate and<br>customized advancement | Lower jaw adjusted by<br>attaching connectors<br>of varying lengths | Same as<br>reference<br>devices;<br>similar to<br>predicate<br>device |
| Adjustment | Can be adjusted by the<br>clinician and patient. | Can be adjusted by the<br>clinician and patient. | The dentist/patient can<br>simply select a shortened<br>connecting rod until<br>optimal advancement is<br>achieved | Can be adjusted by the<br>clinician and patient. | Same for all |
| Feature | O2Vent Optima | Primary Predicate<br>O2Vent W | Reference Device<br>The Panthera Anti-<br>Snoring…