(45 days)
The OVENT is a removable medical device that is fitted in the patient is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea, OSA. The device is indicated for use during sleep to aid in the treatment of these conditions.
The OVENT is for prescription use only.
The OVENT device is for the treatment of snoring and/or obstructive sleep apnea and is comprised of:
• A titanium bimaxillary oral appliance which comprises, in one device, a lower tray fitted over the lower teeth and an upper tray fitted over the upper teeth.
• A dental polymer material in each tray which is in contact with and retaining in position, the user's top and bottom teeth.
• The lower jaw is retained in an advanced position to help open up the natural airway and alleviate the user's snoring condition.
• A breathing port at the front of the appliance with an enclosed airway on each side which passes between the teeth and the cheek. Each airway delivers the air at the rear of the mouth typically between the last teeth. The airways allow the user to breathe with the mouth closed.
The provided text, a 510(k) summary for the OVENT device, does not describe any clinical studies conducted to prove the device meets acceptance criteria. Instead, it explicitly states:
"Human clinical studies were not deemed necessary to evaluate the performance of the device to determine substantial equivalence as the OVENT does not:
- Use designs dissimilar from the predicate device and other previously-cleared devices under a 510(k);
- Use new technologies different from legally-marketed intramandibular repositioning devices for snoring and/or obstructive sleep apnea;
- Deviate from the indications for use identified in the predicate devices: the TAPIII and the LISA."
Therefore, I cannot provide the requested information regarding the acceptance criteria and the study that proves the device meets them, as no such study is detailed in this document.
The document does include non-clinical tests performed, such as biocompatibility and peel/bond strength testing. These tests had certain acceptance criteria, but they are not clinical performance measures.
Here's a summary of the non-clinical test information:
Non-Clinical Acceptance Criteria and Reported Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| Cytotoxicity (ISO-10993 Part 5) | Passed |
| Skin Sensitization (ISO-10993 Part 10) | Passed |
| Intraoral Mucosa Irritation (ISO-10993) | Passed |
| Intracutaneous Reactivity (ISO-10993) | Passed |
| Peel/Bond Strength: | |
| Bond Strength (Titanium to Acrylic) | Pass/fail criterion: 1N/mm or 10N overall strength for a 10mm interface length. The OVENT materials before and after aging had peak strengths greater than 1N/mm (>10N for a 10mm wide sample), meeting the criterion. |
| Peel Strength (Acrylic to Dental Laminate) | Pass/fail criterion: 1N/mm or 10N overall strength for a 10mm interface length (tested as per DD253-2001). The key objective was to ensure that any degradation at the interfaces did not result in oral fluid ingression. |
Regarding Clinical Studies:
- Sample size for the test set and data provenance: Not applicable, no clinical test set described.
- Number of experts used to establish the ground truth for the test set and qualifications: Not applicable, no clinical test set described.
- Adjudication method for the test set: Not applicable, no clinical test set described.
- Multi reader multi case (MRMC) comparative effectiveness study: Not applicable, no clinical study described.
- Standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, device is a physical intraoral appliance, not an algorithm.
- The type of ground truth used: Not applicable, no clinical ground truth established.
- Sample size for the training set: Not applicable, no algorithm or clinical device training described.
- How the ground truth for the training set was established: Not applicable, no algorithm or clinical device training described.
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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three faces in profile, stacked on top of each other. The faces are facing to the right. The image is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 17, 2016
Oventus Manufacturing Pty. LTD c/o Mr. Mark Job Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, MN 55313
Received: March 2, 2016
Re: K160234 Trade/Device Name: OVENT Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea Regulatory Class: II Product Code: LRK Dated: February 23, 2016
Dear Mr. Job:
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.
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Page 2 - Mr. Mark Job
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 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 device-related 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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Tina Kiang
-S
for Erin I. Keith, M.S. 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) K160234
Device Name
OVENT
Indications for Use (Describe)
The OVENT is a removable medical device that is fitted in the patient is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea, OSA. The device is indicated for use during sleep to aid in the treatment of these conditions.
The OVENT is for prescription use only.
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) |
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Image /page/3/Picture/0 description: The image is a logo for a company called "Oventus". The logo features a stylized blue circle with a wave-like design inside. Above the circle are several blue dots of varying sizes, arranged in a semi-circular pattern. The company name "Oventus" is written in a sans-serif font below the circle, with the letters "N" and "T" in a slightly lighter shade of blue.
OVENT 510(k) Summary
| Date Prepared: | 25th January 2016 |
|---|---|
| Owner Information [807.92(b)(1)] | Oventus Pty. Ltd.Suite 8, Level 17, 141 Queen Street,Brisbane QLD 4000 AUSTRALIATel +61 7 3210 2913 Fax +61 7 3229 9949Official Contact: Neil Anderson |
| Device Name [807.92(b)(2)] | |
| Proprietary or Trade Name:Common / Usual Name:Regulation:Classification:Classification Name:Product codes:Device: | OVENTOral Appliance - anti snoring device.21 CFR 872.5570IIIntraoral devices for snoring and/or obstructive sleepapnea.LRK Anti-Snoring DeviceOventus OVENT Device |
| Predicate Device [807.92(b)(3)] | • Airway Management - TAP III - K062951• Dynaflex – LISA - K103076 |
| Device Description [807.92(b)(4)] | The OVENT device is for the treatment of snoringand/or obstructive sleep apnea and is comprised of:• A titanium bimaxillary oral appliance whichcomprises, in one device, a lower tray fitted over thelower teeth and an upper tray fitted over the upperteeth.• A dental polymer material in each tray which is incontact with and retaining in position, the user's topand bottom teeth.• The lower jaw is retained in an advanced position tohelp open up the natural airway and alleviate theuser's snoring condition.• A breathing port at the front of the appliance with anenclosed airway on each side which passes betweenthe teeth and the cheek. Each airway delivers the airat the rear of the mouth typically between the lastteeth. The airways allow the user to breathe with themouth closed. |
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Image /page/4/Picture/0 description: The image shows a logo for a company called Oventus. The logo features a stylized blue circle with a wave-like design inside, and a cluster of blue dots above it. The company name "Oventus" is written in a simple font below the circle.
| Intended Use [807.92(b)(5)]Indicated Use: | The OVENT is a removable medical device that isfitted in the patient's mouth and is intended to reduce oralleviate snoring and mild to moderate obstructive sleepapnea, OSA. The device is indicated for use duringsleep to aid in the treatment of these conditions.The OVENT is for prescription use only. |
|---|---|
| Target population: | Adult patients 18 years and older |
| Environment of Use: | Home Use and sleep laboratories |
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Image /page/5/Picture/0 description: The image shows a logo for a company called "Oventus". The logo features a stylized blue circle with a wave-like design inside, suggesting water or movement. Above the circle are several smaller blue circles, arranged in a way that gives the impression of droplets or a splash. The company name "Oventus" is written in a modern, sans-serif font below the circle.
| Comparison to Predicate Devices | |||
|---|---|---|---|
| --------------------------------- | -- | -- | -- |
| Feature | OVENT(Oventus) | TAPIII(Airway Management | LISA(Dynaflex) |
|---|---|---|---|
| 510(k) Number | This application | K062951 | K103076 |
| Photo | Image: OVENT | Image: TAPIII | Image: LISA |
| Intended Use | The OVENT is aremovable medical devicethat is fitted in thepatient's mouth and isintended to reduce oralleviate snoring and mildto moderate obstructivesleep apnea, OSA. Thedevice is indicated for useduring sleep to aid in thetreatment of theseconditions. | To reduce or alleviatenight time snoring andmild to moderateobstructive sleep apnea(OSA). | Dynaflex® Anti-Snoring& Sleep Apnea Devicesare intended to reducenight time snoring andmild to moderateobstructive sleep apnea(OSA) in adults. |
| Product Codes | LRK | LRK | LRK |
| Regulation | 21 CFR 872.5570 | 21 CFR 872.5570 | 21 CFR 872.5570 |
| Use of device | Removable intraoraldevice. Multiple use.Prescription use only. | Removable intraoraldevice. Multiple use.Prescription use only. | Removable intraoraldevice. Multiple use.Prescription use only. |
| Target population | People over 18 years ofage who snore and/orhave sleep apnea | People over 18 years ofage who snore and/orhave sleep apnea | People over 18 years ofage who snore and/orhave sleep apnea |
| Environment of use | To be used in the patient'shome or in sleeplaboratories | To be used in the patient'shome or in sleeplaboratories | To be used in the patient'shome or in sleeplaboratories |
| Should be cleaned dailyin soap and water. | Should be cleaned dailyin soap and water. | Should be cleaned dailyin soap and water. | |
| CleaningInstructions | Can be periodicallycleaned in an ultrasoniccleaner with aneffervescent denturecleaning tablet | Can be periodicallycleaned in an ultrasoniccleaner with aneffervescent denturecleaning tablet | Can be periodicallycleaned in an ultrasoniccleaner with aneffervescent denturecleaning tablet |
| Feature | OVENT(Oventus) | TAPIII (AirwayManagement Repositions | LISA(Dynaflex) |
| Device Functionality | Repositions the lower jawforward. | the lower jawforward. | Repositions the lower jawforward. |
| 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 toimprove the patient'sability to exchange air. | |
| Has a lingual flange forholding the mandibleforward1. | Does not have a lingualflange for holding themandible forward1. | Has a lingual flange forholding the mandibleforward1. | |
| Permits patient to breathethrough their mouth2. | Permits patient to breathethrough their mouth2. | Does not permit patient tobreathe through theirmouth2. | |
| Retains the top andbottom teeth using rigidtrays3. | Retains the top andbottom teeth using rigidtrays3. | Does not retain the topand bottom teeth usingrigid trays3. | |
| Device Design | Custom made for eachpatient in a dentallaboratory. | Custom made for eachpatient in a dentallaboratory. | Custom made for eachpatient in a dentallaboratory. |
| Adjustment | Cannot be adjusted by theclinician or patient4. | Can be adjusted by theclinician or patient4. | Cannot be adjusted by theclinician or patient4. |
| Supplied Sterile/Non-sterile | Non-sterile | Non-sterile | Non-sterile |
| Medical grade metalsused5 | Medical grade metalsused5 | No metal parts used5. | |
| Materials Used | Dental plastic laminatesand acrylics used forupper and lower trayswhich is in contact withthe patient's teeth. | Dental plastic laminatesand acrylics used forupper and lower trayswhich is in contact withthe patient's teeth. | Dental plastic laminatesand acrylics used forupper and lower trayswhich is in contact withthe patient's teeth. |
| Biocompatibility* | Passses Part 5 and Part 10of ISO 10993 | Passes Part 5 and Part 10of ISO10993. | Passes Part 5 and Part 10of ISO10993. |
| Mechanical safety* | Can withstandmechanical forceswithout significantdegradation | Can withstandmechanical forceswithout significantdegradation | Can withstandmechanical forceswithout significantdegradation |
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Image /page/6/Picture/0 description: The image shows the logo for Oventus Medical. The logo features a stylized blue circle with a wave-like line running through it, and several blue dots above the circle. The word "Oventus" is written in a stylized font below the circle, with the "E" in Oventus represented by three horizontal lines.
- 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.
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 moulded polymer insert, the LISA relies on the lingual component for holding the mandible forward.
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Image /page/7/Picture/0 description: The image shows a logo for a company called "Oventus". The logo features a stylized blue circle with a wave-like shape inside, suggesting water or movement. Above the circle are several small blue dots that appear to be moving away from the circle. The company name "Oventus" is written in a simple, sans-serif font below the circle, with a trademark symbol to the right.
Note (2) The OVENT has 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 allows users to open their mouth to a degree, whereas for the LISA, if the user opens their mouth the lingual structure no longer supports the mandible and the lower jaw moves back.
Note (3) The OVENT and the TAP retain the top and bottom teeth in rigid trays whereas the LISA only retains the top teeth
Note (4) The OVENT requires a new insert to be made for mandibular adjustment, the TAP device can be adjusted by the clinician or patient and the LISA requires a whole new device to be made
Note (5) The OVENT uses titanium, the TAP stainless steel and the LISA has no metal parts
Non-Clinical Tests Performed [807.92(b)(1)]
- a. Biocompatibility testing was performed as outlined in the FDA-modified "Use of International Standard ISO-10993, Biological Evaluation of Medical Devices Part-1: Evaluation and Testing" for a surface device that contacts intraoral (i.e., mucosal, gingival, and palatal) surfaces for prolonged contact. Testing was conducted as described in Parts 5 and 10 of ISO-10993 the standard at a certified, independent laboratory. The OVENT passed all 4 tests as per the pass/fail criteria of the standards - cytotoxicity, skin sensitization, intraoral mucosa irritation and intracutaneous reactivity.
- b. Peel/Bond strength was determined for the titanium to the acrylic and the acrylic to the dental laminate materials before and after accelerated aging in an oral simulation solution. Aging duration was calculated to be equivalent to 1 year of nightly use. The bond strength pass/fail criterion was set at 1N/mm or 10N overall strength for a 10mm interface length. The peel strength was tested as per DD253-2001: Mouth guards for use in sport and recreation - Requirements and test methods. All the OVENT materials before and after aging - had peak strengths greater than 1N/mm (>10N for a 10mm wide sample) and consequently have suitable bond strengths for the device application**.
** The key objective was to ensure that any degradation at the interfaces did not result in oral fluid ingression. All strengths were well above the set value and no fluid ingression resulted. If the inserts were removable for cleaning rather adhered to the titanium - mechanical retention would be required and the peel strength would be substantially less.
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Image /page/8/Picture/0 description: The image shows a logo for a company called "Oventus". The logo features a stylized blue circle with a wave-like shape inside. Above the circle are several smaller blue circles that appear to be ascending in size. The company name "Oventus" is written in a simple font below the circle.
Clinical Tests Performed [807.92(b)(2)]
Human clinical studies were not deemed necessary to evaluate the performance of the device to determine substantial equivalence as the OVENT does not:
- Use designs dissimilar from the predicate device and other previously-cleared devices under a 510(k);
- . Use new technologies different from legally-marketed intramandibular repositioning devices for snoring and/or obstructive sleep apnea;
- Deviate from the indications for use identified in the predicate devices: the TAPIII and the LISA.
In lieu of human clinical testing, the risks and mitigating controls associated with the use of mandibular repositioning devices, as identified by the FDA, have been addressed in the "Risk Assessment". In addition, adequate warnings and precautions are found in the "Instructions for Use".
Conclusion [807.92(b)(3)]
The OVENT is considered to be substantially equivalent to the predicate devices based on the following:
- . Differences in the wording of intended uses between the subject and predicate devices are not critical to the intended therapeutic use of the device.
- It has equivalent technological characteristics to the predicates.
- The device is as safe, as effective and performs as well as than the legally marked . devices identified above.
§ 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.”