(204 days)
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.
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 O₂Vent Optima consists of the following parts:
Upper tray (upper teeth)
Lower tray (lower teeth)
Connector bands
The upper tray is 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. The upper nylon tray has two side protrusions (lugs) that engage a connector that when attached, extends to the lower tray and attaches to a similar lug stabilizing and advancing the lower jaw. The lower tray, is customized to the bottom teeth, which when 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.
Here's a summary of the O2Vent Optima's acceptance criteria and the study information, based on the provided FDA 510(k) summary:
1. Acceptance Criteria and Reported Device Performance:
The document provided (an FDA 510(k) summary) acts as a substantial equivalence determination, not a full clinical study report with explicit acceptance criteria and corresponding reported performance metrics (like sensitivity, specificity, accuracy, or specific reductions in AHI).
Instead, the submission argues for substantial equivalence by comparing the technological characteristics of the O2Vent Optima to predicate and reference devices. The "performance" is implicitly demonstrated through this comparison, indicating that the device is "as safe, as effective and performs comparatively" to the predicate and reference devices that are already legally marketed.
Therefore, the table below reflects the characteristics that were compared to establish substantial equivalence rather than numerical acceptance criteria and performance data.
| Feature Compared | O2Vent Optima Characteristics | Primary Predicate (O2Vent W) Characteristics | Reference Device 1 (Panthera Anti-Snoring Device) Characteristics | Reference Device 2 (EMA Appliance) Characteristics | Conclusion (Implicit Acceptance) |
|---|---|---|---|---|---|
| Indications for Use | Reduce/alleviate snoring, mild to moderate OSA. For use during sleep. | Reduce/alleviate snoring, mild to moderate OSA. For use during sleep. | Reduce/alleviate snoring, mild to moderate OSA | Treatment of nasal respiratory dysfunction of OSA and snoring, where repositioning of mandible and opening bite increases airspace. | Similar to predicates/references |
| 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 |
| Classification | Class II | Class II | Class II | Class II | Same for all |
| Use of Device | Removable intraoral device, single patient multiple use, prescription use only. | Removable intraoral device, single patient multiple use, prescription use only. | Removable intraoral device, multiple use, prescription use only. | Removable intraoral device, single patient multiple use, prescription use only. | Similar or same for all |
| Target Population | Adults 18+ who snore and/or have sleep apnea. | Adults 18+ who snore and/or have sleep apnea. | Adults | Not indicated (for this specific comparison) | Same or similar |
| Device Functionality | Repositions lower jaw forward, acts by increasing pharyngeal space, permits mouth breathing via built-in airway, retains teeth using rigid trays (separate upper/lower). | Repositions lower jaw forward, acts by increasing pharyngeal space, permits mouth breathing via built-in airway, retains teeth using rigid trays (separate upper/lower). | Mandibular repositioner, maintains lower jaw forward, acts to increase pharyngeal space, retains teeth using customized splints (separate upper/lower). | Advance mandible to anterior/inferior position, pulls tongue forward, increases airspace, decreases obstruction, upper/lower trays for tooth retention (separate). | Description similar for all devices; Airway feature same as primary predicate, different from some references. |
| Mandibular Advancement | Adjusted by attaching connectors of varying lengths. | Adjusted using titration of adjustment screws. | Adjusted via interlocking rods. | Adjusted by attaching connectors of varying lengths. | Same as reference devices; similar to predicate. |
| Adjustment | Clinician and patient adjustable. | Clinician and patient adjustable. | Clinician/patient can select shortened connecting rod. | Clinician and patient adjustable. | Same for all |
| Design (CAD/CAM) | Customized per patient (CAD/CAM, additive manufacturing, laser sintering of PA2200). | Customized per patient (CAD/CAM, plastic laminates/acrylics for main trays, titanium component 3D printed via EBM). | Customized per patient (CAD/CAM, selective laser sintering). | Custom oral appliance available through dental labs. | Same as for reference device; similar to predicate. |
| Adjustment Accessory | Replacement/re-supply connectors (13-21 mm). | NA | Replacement/re-supply connectors (19-36 mm). | Replacement/re-supply connectors. | Similar to reference devices. |
| Sterility | Non-Sterile | Non-Sterile | Non-Sterile | Non-Sterile | Same for all |
| Materials of Construction (Trays) | Polyamide type 12 (Nylon). | Medical grade titanium (air channel), dental plastic laminates and acrylics. | Polyamide type 12 (Nylon). | Proprietary thermoplastic polymer. | Same as reference device; different from predicate due to additive manufacturing. |
| Materials of Construction (Connectors) | 100% thermoplastic Polyurethane/cured elastomer. | NA | Same as above per labeling (assumed same as trays). | 100% thermoplastic Polyurethane/cured elastomer. | Same as reference devices. |
| Biocompatibility | Yes, passed all tests (ISO 10993 Parts 5 & 10). | Not performed (materials identical to K160234). | Statement in K143244: biocompatible based on similarity to predicate. | Information could not be verified. | Same as predicate and reference devices per available information. |
2. Sample Size Used for the Test Set and Data Provenance:
The provided document (510(k) summary) does not describe a clinical study of the O2Vent Optima that would involve a "test set" and a specific sample size for performance evaluation. Instead, it relies on demonstrating substantial equivalence to already cleared devices through a comparison of technological characteristics. Therefore, there is no information on sample size or data provenance from a specific test set.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
As no specific clinical performance study with a test set is described, there's no information regarding experts used to establish ground truth.
4. Adjudication Method for the Test Set:
Not applicable, as no described test set or clinical performance study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study is mentioned or summarized in the provided document. The submission focuses on device characteristics, not reader performance with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study:
Not applicable. The O2Vent Optima is an intraoral medical device, not an AI algorithm.
7. Type of Ground Truth Used:
Not applicable. The submission focuses on comparing the physical and functional characteristics of the device and its materials to predicate devices rather than validating an algorithm against a ground truth. Biocompatibility testing was done to established standards (ISO 10993).
8. Sample Size for the Training Set:
Not applicable. This is a physical medical device, not an AI algorithm.
9. How the Ground Truth for the Training Set was Established:
Not applicable.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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) |
|---|
| ------------------------------------------------- |
| X Reproduction Use (Part 21 CFR 601 Subpart D) | |
|---|---|
| Sponsor-Type Use (21 CFR 601 Subpart C) |
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
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: | +61 7 3180 3196 |
| 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 LtdThe primary predicate was chosen as it has the same principal designfeatures as the O₂Vent Optima and indications for use |
| Reference Device(s) | K143244 The Panthera Anti-Snoring Device – Panthera Dental IncThis reference device was chosen as the material is the same as thatused in the O₂Vent OptimaK971794 EMA Appliance – Myerson LLCThis reference device was chosen for the straps/bands |
| Device Description | The O₂Vent Optima is a removable medical device that is fitted in thepatient's mouth and is intended to reduce or alleviate snoring and mildto moderate obstructive sleep apnea (OSA).The O₂Vent Optima consists of the following parts:Upper tray (upper teeth)Lower tray (lower teeth)Connector bandsThe upper tray is fitted over the upper teeth, with the breathingport at the front leading to the airways on each side to the rearof the appliance. The upper nylon tray has two sideprotrusions (lugs) that engage a connector that when attached,extends to the lower tray and attaches to a similar lugstabilizing and advancing the lower jawThe lower tray, is customized to the bottom teeth, which whenattached 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 ofTechnological Characteristicsof the Device to PredicateDevice | 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 PredicateO₂Vent W | Reference DeviceThe Panthera Anti-Snoring Device | Reference DeviceElastic MandibularAdvancement (EMA)Appliance | Compared toSubjectDevice |
|---|---|---|---|---|---|
| 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 aremovable medicaldevice that is fitted in thepatient's mouth and isintended to reduce oralleviate snoring andmild to moderateobstructive sleep apnea(OSA). The device isindicated for use duringsleep to aid in thetreatment of theseconditions.. | The O₂Vent W is a removablemedical device that is fitted inthe patient's mouth and isintended to reduce or alleviatesnoring and mild to moderateobstructive sleep apnea(OSA). The device isindicated for use during sleepto aid in the treatment of theseconditions. | The Panthera anti snoringdevice is Intended toreduce or alleviatesnoring and mild tomoderate obstructivesleep apnea (OSA) inadults. | Treatment of nasalrespiratorydysfunction ofobstructive sleepapnea and snoring inthose patients whererepositioning of themandible and openingthe bite can increasethe patients air space | Similar topredicates |
| 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 forsnoring and intraoraldevices for snoring andobstructive sleep apnea | Intraoral devices for snoringand intraoral devices forsnoring and obstructive sleepapnea | Intraoral devices forsnoring and intraoraldevices for snoring andobstructive sleep apnea | Intraoral devices forsnoring and intraoraldevices for snoringand obstructive sleepapnea | Same for all |
| Classification | Class II | Class II | Class II | Class II | Same for all |
| Use of device | Removable intraoraldevice. Single patientmultiple use.Prescription use only. | Removable intraoral device.Single patient multiple use.Prescription use only. | Removable intraoraldevice.Multiple use.Prescription use only. | Removable intraoraldevice. Single patientmultiple use.Prescription use only. | Similar orsame for all |
| Feature | O2Vent Optima | Primary PredicateO2Vent W | Reference DeviceThe Panthera Anti-Snoring Device | Reference DeviceElastic MandibularAdvancement (EMA)Appliance | Compared toSubjectDevice |
| Target Population | People over 18 years ofage who snore and/orhave sleep apnea. | People over 18 years of agewho snore and/or have sleepapnea. | Adults | Not indicated | Same orsimilar |
| Device Functionality(Please note trays andsplints aresynonymous) | Repositions the lowerjaw forward. | Repositions the lower jawforward. | A mandibularrepositioner, maintainingthe lower jaw in aforward position duringsleep. | Advance the mandibleto an anterior andinferior position withregard to the maxilla. | Descriptionsimilar for alldevices |
| Acts by increasing thepharyngeal space toimprove the patient'sability to exchange air. | Acts by increasing thepharyngeal space toimprove the patient'sability to exchange air. | Acts by increasing thepharyngeal space to improvethe patient's ability toexchange air. | This mechanicalprotrusion acts toincrease the patient'spharyngeal space,improving their ability toexchange air duringsleep. | Repositioning of themandible pulls thetongue forward andincreased the patient'sairspace therebydecreasing upperairway obstruction. | Same aspredicate,similar toreferences |
| Permits patient tobreathe through theirmouth via a proprietarybuilt in airway | Permits patient tobreathe through theirmouth via a proprietarybuilt in airway | Permits patient to breathethrough their mouth via aproprietary built in airway | NA | NA | Same asprimarypredicate |
| Retains the top andbottom teeth using rigidtrays. | Retains the top andbottom teeth using rigidtrays. | Retains the top and bottomteeth using rigid trays. | The upper and lowersplints are adapted for theupper and lower teeth,respectively | Upper and lower traysfor tooth retention | Same asprimarypredicate;similar forreferences |
| Upper and lower traysare separate. | Upper and lower traysare separate. | Upper and lower trays areseparate. | Two customized splintsthat fit separately overthe upper and lower teethinside the mouth. | Upper and lower traysare separate | Same asprimary,similar forreferences |
| Feature | O2Vent Optima | Primary PredicateO2Vent W | Reference DeviceThe Panthera Anti-Snoring Device | Reference DeviceElastic MandibularAdvancement (EMA)Appliance | Compared toSubjectDevice |
| Device Design andPrinciple ofOperation | The trays haveprotrusions (lugs) at theside of the upper andlower parts with aconnector between theupper and lower parts tostabilize and/or advancethe lower jaw. | The upper tray has protrusions(wings) at the rear on thetitanium part to interface withthe adjuster block in the lowertray. | The lower splint containsa triangular protrusion,allowing the splints toengage by means ofinterlocking rods on thesides | Removablereplacementadjustable bandswhich attach byprotrusions to the sideof the upper and lowertrays | Same asreferencedevices,similar topredicatedevice |
| Means of advancingthe mandible | Lower jaw adjusted byattaching connectors ofvarying lengths | Lower jaw adjusted usingtitration of the adjustmentscrews equally on both sideswith an adjustment key. | Adjusted via the use ofinterlocking rods placedon the sides of the splints.The shorter the rod, thefurther the mandible isadvancedThe length of the rodscan vary from 19 to 36mm and can be adjustedin 0.5-mm increments fora highly accurate andcustomized advancement | Lower jaw adjusted byattaching connectorsof varying lengths | Same asreferencedevices;similar topredicatedevice |
| Adjustment | Can be adjusted by theclinician and patient. | Can be adjusted by theclinician and patient. | The dentist/patient cansimply select a shortenedconnecting rod untiloptimal advancement isachieved | Can be adjusted by theclinician and patient. | Same for all |
| Feature | O2Vent Optima | Primary PredicateO2Vent W | Reference DeviceThe Panthera Anti-Snoring Device | Reference DeviceElastic MandibularAdvancement (EMA)Appliance | Compared toSubjectDevice |
| DesignCAD/CAM | Customized for eachpatient in a dentallaboratory located at themanufacturing site basedon the dentistprescriptionUse of computer aideddesign (CAD) andcomputer aidedmanufacturing (CAM)and is made throughadditive manufacturingusing laser sintering ofPA2200 Polymide 12nylon material.The use of thesetechnologies provides forcustomization accordingto the uniquecharacteristics of thepatient oral anatomybased on the prescriptionprovided by the clinician | Customized for each patientin a dental laboratory basedon the dentist prescription.Use of computer aided design(CAD) and computer aidedmanufacturing (CAM). Dentalplastic laminates and acrylicsare used for upper and lowertrays.The titanium component ofthe device is 3D printed usingthe additive manufacturing.EBM (Electron Bean Melting)method of 3D printing.The use of these technologiesprovides for customizationaccording to the uniquecharacteristics of the patientoral anatomy based on theprescription provided by theclinician | The device is aprescription customizedfor each patient and hasan adjustment mechanismenabling the amount ofmandibular advancementto be set by the dentist orphysician at the time offitting the device.Use of computer aideddesign (CAD) andcomputer aidedmanufacturing (CAM).Uses CAD that enables ahigh degree ofcustomization accordingto the physician or dentistprescription toaccommodate complexdental anatomy ofindividual patients. TheCAM and selective lasersintering guaranteesprecision, accuracy andconsistency for eachpatient | This custom oralappliance is availableto dental and medicalprofessionals throughauthorized dentallaboratories. | Same as forreferencedevice;similar to thepredicate |
| AdjustmentAccessory | Replacement/re-supplyconnectors (13-21 mm) | NA | Replacement/re-supplyconnectors (19-36 mm) | Replacement/re-supply connectors | Similar toreferencedevices |
| Supplied Sterile/Non-Sterile | Non-Sterile | Non-Sterile | Non-sterile. | Non-Sterile | Same for all |
| Feature | O2Vent Optima | Primary PredicateO2Vent W | Reference DeviceThe Panthera Anti-Snoring Device | Reference DeviceElastic MandibularAdvancement (EMA)Appliance | Compared toSubjectDevice |
| Materials ofconstruction:ComponentsTop and Bottomtrays | Made from polymers(100% polyamide type12 [aka Nylon])Highly resilient anddurable biocompatiblepolymer material | Medical grade titanium (topair channel only)Dental plastic laminates andacrylics used for upper andlower trays which are incontact with the patient'steeth. Erkoloc-pro DualLaminate and Orthocryl(Bottom and top trays only) | Made from polymers(polyamide type 12 [akaNylon]),Highly resilient anddurable biocompatiblepolymer material. | Proprietarythermoplastic polymerthat delivers superiorimpact strength toacrylic. | Same as thereferencedevice;different frompredicate assubject deviceuses additivemanufacturingfor teethcontactmaterials |
| Materials ofconstructionComponent.Connectors/straps | 100% thermoplasticPolyurethane/curedelastomer | NA | Same as above perlabeling | 100% thermoplasticPolyurethane/curedelastomer | Same as thereferencedevices |
| Cleaning Instructions | Clean the device daily inlukewarm water with asoft toothbrush. Rinse,dry, and store in the caseprovided. | Clean the device with a softclean toothbrush (not thesame toothbrush you use tobrush your teeth as toothpastecan damage the device). Rinsewell with lukewarm water. | Clean the device daily inlukewarm water with asoft toothbrush. Rinse,dry, and store in the caseprovided. | Clean your applianceevery morning in coolor lukewarm waterwith a denturetoothbrush andtoothpaste. Wesuggest using denturetoothpaste such asDentuCreme® orFresh 'N Brite; Ifwhite film begins toform on the applianceor if itpicks up odors, soak itin a denture cleaningsolution such asPolident® orEfferdent® inwarm, not hot, water | Same asreferencedevice andsimilar topredicate |
| Feature | O₂Vent Optima | Primary PredicateO₂Vent W | Reference DeviceThe Panthera Anti-Snoring Device | Reference DeviceElastic MandibularAdvancement (EMA)Appliance | Compared toSubjectDevice |
| Clean twice a week withchlorine freeantibacterial cleanser | Clean twice a week with aneffervescent denture cleaningtablet. | Twice weekly usechlorine free antibacterialorthodontic cleaningsolution. | Once per week cleanthe device with acommercial denturecleaner in cool water. | Same asreference;similar topredicate | |
| Biocompatibility -Passes Part 5 andPart 10 of ISO 10993 | Yes, passed all tests | Not performed as thematerials are identical as inthe OVENT T (K160234). | Information could not beverified.Statement in K143244"The device isbiocompatible, based onthe similarity of thematerials of constructionto the predicate device(Narval CC) marketed byResMed" | Information could notbe verified. | Same aspredicate andreferencedevices peravailableinformation |
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| Differences betweenthe proposed device,predicate device andreference device(s). | As summarized above, the main functional differences between the subject(O2Vent Optima) and predicate (O2Vent W) and/or reference devices (ThePanthera Anti-Snoring Device and Elastic Mandibular Advancement (EMA)Appliance) are: |
|---|---|
| - Predicate: The predicate device does not use PA2200 in the additivemanufacturing process- Reference: The Panthera Anti-Snoring Device and the ElasticMandibular Advancement (EMA) Appliances do not contain an airway | |
| Conclusion on Non-Clinical and ClinicalTests | The O2Vent Optima is considered to be substantially equivalent to the predicateand reference devices based on the following: |
| - It has the same intended use and is indicated for the same userpopulation.- It has equivalent technological characteristics to the predicate orreference devices.- The device is as safe, as effective and performs comparatively to the |
§ 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.”