O2VENT T

{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<br>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<br>TAP-III – Airway Management | | Device Description | The O2Vent T is a removable medical device that is fitted in the<br>patient's mouth and is intended to reduce or alleviate snoring<br>and mild to moderate obstructive sleep apnea (OSA).<br>The O2Vent T is made up of three 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<br>2. The Lower Tray fitted over the lower teeth, positions the jaw<br>for mandibular advancement.<br>The Upper and Lower Trays have a "landing area" customized to<br>the patient's teeth and made from medical grade polymers. | | | 3. The Upper and Lower Trays are connected together with a<br>connector. A hook mechanism attached to the Upper Tray fits<br>into a socket attached to the Lower Tray and positions the lower<br>jaw forward, preventing the soft tissue of the throat from<br>collapsing and obstructing the airway. An Adjustment Key for<br>the <i>O</i> 2 <i>Vent T</i> allows the patient and their Clinician to adjust the<br>protrusion of the lower jaw to the most effective and<br>comfortable position. | | Intended Use of the Device | The <i>O</i> 2 <i>Vent T</i> is a removable medical device that is fitted in the<br>patient's mouth and is intended to reduce or alleviate snoring<br>and mild to moderate obstructive sleep apnea (OSA). The device<br>is 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. | {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<br>removable medical<br>device that is fitted in<br>the patient's mouth<br>and is intended to<br>reduce or alleviate<br>snoring and mild to<br>moderate obstructive<br>sleep apnea (OSA).<br>The device is<br>indicated for use<br>during sleep to aid in<br>the treatment of these<br>conditions. | The OVENT is a<br>removable medical<br>device that is fitted in<br>the patient's mouth and<br>is 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. | To reduce or alleviate<br>night time snoring and<br>mild to moderate<br>obstructive sleep apnea<br>(OSA). | | Product Codes | LRK | LRK | LRK | | Regulation | 21CFR 872.5570 | 21CFR 872.5570 | 21CFR 872.5570 | | Use of device | Removable intraoral<br>device. Multiple use.<br>Prescription use only. | Removable intraoral<br>device. Multiple use.<br>Prescription use only. | Removable intraoral<br>device. Multiple use.<br>Prescription use only. | | Target Population | People over 18 years<br>of age who snore<br>and/or have sleep<br>apnea. | People over 18 years<br>of age who snore<br>and/or have sleep<br>apnea. | People over 18 years<br>of age who snore<br>and/or have sleep<br>apnea. | | Environment of<br>Use | To be used in the<br>patient's home or in<br>sleep laboratories. | To be used in the<br>patient's home or in<br>sleep laboratories. | To be used in the<br>patient's home or in<br>sleep laboratories. | | Cleaning<br>Instructions | Should be cleaned<br>daily in soap and<br>water. | Should be cleaned<br>daily in soap and<br>water. | Should be cleaned<br>daily in soap and<br>water. | | | Can be periodically<br>cleaned in an<br>ultrasonic cleaner with<br>an effervescent<br>denture cleaning<br>tablet. | Can be periodically<br>cleaned in an<br>ultrasonic cleaner with<br>an effervescent<br>denture cleaning<br>tablet. | Can be periodically<br>cleaned in an<br>ultrasonic cleaner with<br>an effervescent<br>denture cleaning<br>tablet. | | Feature | O₂Vent T | OVENT | TAP-III | | Device<br>Functionality | Repositions the lower<br>jaw forward.<br>Acts by increasing the<br>pharyngeal space to<br>improve the patient's<br>ability to exchange air.<br>Does not have a<br>lingual flange for<br>holding the mandible<br>forward.<br>Permits patient to<br>breathe through their<br>mouth2.<br>Retains the top and<br>bottom teeth using<br>rigid trays. | Repositions the lower<br>jaw forward.<br>Acts by increasing the<br>pharyngeal space to<br>improve the patient's<br>ability to exchange air.<br>Has a lingual flange<br>for holding the<br>mandible forward1.<br>Permits patient to<br>breathe through their<br>mouth2.<br>Retains the top and<br>bottom teeth using<br>rigid trays. | Repositions the lower<br>jaw forward.<br>Acts by increasing the<br>pharyngeal space to<br>improve the patient's<br>ability to exchange air.<br>Does not have a<br>lingual flange for<br>holding the mandible<br>forward.<br>Permits patient to<br>breathe through their<br>mouth2.<br>Retains the top and<br>bottom teeth using<br>rigid trays. | | Device Design | Customized for each<br>patient in a dental<br>laboratory. | Customized made for<br>each patient in a dental<br>laboratory. | Customized made for<br>each patient in a dental<br>laboratory. | | Adjustment | Can be adjusted by the<br>clinician and patient4. | Cannot be adjusted by<br>the clinician or<br>patient4. | Can be adjusted by the<br>clinician and patient4. | | Supplied<br>Sterile/Non-Sterile | Non-Sterile | Non-sterile | Non-sterile | | Materials Use - 1 | Medical grade metal<br>used5. | Medical grade metal<br>used5. | Medical grade metals<br>used5. | | Materials Use - 2 | Dental plastic<br>laminates and acrylics<br>used for upper and<br>lower trays which is in<br>contact with the<br>patient's teeth. | Dental plastic<br>laminates and acrylics<br>used for upper and<br>lower trays which is in<br>contact with the<br>patient's teeth. | Dental plastic<br>laminates and acrylics<br>used for upper and<br>lower trays which is in<br>contact with the<br>patient's teeth. | | Biocompatibility* | Not performed as the<br>materials are identical<br>as in the OVENT. | Passes Part 5 and Part<br>10 of ISO10993. | Passes Part 5 and Part<br>10 of ISO10993. | | Mechanical safety | Can withstand<br>mechanical forces<br>without significant<br>degradation. | Can withstand<br>mechanical forces<br>without significant<br>degradation. | Can withstand<br>mechanical forces<br>without significant<br>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<br>properties of the O2Vent T and its ability to achieve its intended<br>use. The only new material that was incorporated in the O2Vent<br>T is the connector assembly made from special grade 316<br>stainless steel. The material and design specifications of the<br>connector assembly is already used in as the predicate TAP-III<br>device. No other risks are introduced in the device. The O2Vent<br>T met the specifications as set.<br>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. No new<br>materials are being used in the device; all materials are already<br>used in the predicate device (OVENT). No new risks are<br>introduced in the new device apart from the connector assembly,<br>which are not present in the predicate OVENT device, however<br>is present in the TAP-III predicate device and the new material<br>has no patient tissue contact in the new device.<br>The device is deemed to be biocompatible, based on the<br>similarity of the materials of constructions to the predicate<br>devices (OVENT & TAP-III). | |-----------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Summary of Clinical Tests | Human clinical studies were not deemed necessary to evaluate<br>the substantial equivalence of the O2Vent T as the O2Vent T<br>does not:<br>• Use designs dissimilar from the predicate device and other<br>previously-cleared devices under a 510(k);<br>• Use new technologies different from legally-marketed intra-<br>mandibular repositioning devices for snoring and/or obstructive<br>sleep apnea;<br>• Deviate from the indications for use identified in the predicate<br>devices: the OVENT and TAP-III.<br><br>In lieu of human clinical testing, the risks and mitigating<br>controls associated with the use of mandibular repositioning<br>devices, as identified by the FDA, have been addressed in the | | | | | | "Risk Assessment". The function of mandibular repositioning<br>devices required that the prescribing dentist be aware of the<br>potential for soreness caused by mandibular advancement.<br>Management of these risks is achieved by advising the patients<br>and dentists in the "Instructions for Use". The contraindications,<br>warnings, precautions, storage, fitting and adjustment directions<br>are written to avoid potential problems from arising or persisting<br>caused by Mandibular Advancement Devices. | | Differences between the<br>proposed and predicate<br>device(s). | As discussed in the comparison chart above, the main functional<br>difference between the proposed O2Vent T and predicate device<br>OVENT is the method of adjustment. O2Vent T allows protrusion<br>of the mandible from the original treatment position via a screw<br>mechanism without requiring additional impressions or laboratory<br>procedures as required for OVENT. The adjustments can be made<br>by the clinician or patient for the O2Vent T device, however it is<br>not possible in case of the OVENT device.<br>Additionally, in order to facilitate the ability to titrate the device,<br>the O2Vent T has separate upper and lower trays connected via the<br>screw mechanism, while the OVENT has a monobloc design.<br>No new risks are introduced in the new device apart from the<br>connector assembly and separate trays, which are not present in the<br>predicate OVENT device, however are present in the TAP-III<br>predicate device.<br>The treatment outcomes for O2Vent T and OVENT are expected to<br>be equivalent as the final levels of mandibular protrusion and the<br>provision for oral breathing via the customized airway is same for<br>each device.<br>Hence the differences mentioned are unlikely to adversely or<br>otherwise affect the expected clinical outcomes for patients using<br>the O2Vent T device as compared to those using the OVENT, thus<br>not affecting the substantial equivalency of the proposed device. | | Conclusion on Non Clinical<br>and Clinical Tests | The O2Vent T is considered to be substantially equivalent to the<br>predicate devices based on the following:<br>• It has the same intended use and is indicated for the same user<br>population.<br>• It has equivalent technological characteristics to the predicates.<br>• The device is as safe, as effective and performs as well as or<br>better than the legally marked devices identified above. | {8}------------------------------------------------