(68 days)
O2Vent T, OVENT, SOMNODENT CLASSIC
Not Found
No
The device description and performance studies focus on the mechanical design and material properties of the oral appliance. There is no mention of AI, ML, image processing, or data-driven algorithms for diagnosis, treatment planning, or device function.
Yes
The device is intended to "reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA)" and is described as being indicated for "treatment of these conditions," which aligns with the definition of a therapeutic device.
No
The device description indicates that the O2Vent W is an oral appliance intended to "reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA)." It is a treatment device that works by positioning the lower jaw forward to prevent airway obstruction, rather than diagnosing a condition. Its function is to aid in the treatment of conditions, not to identify or measure them.
No
The device description clearly states it is a removable medical device fitted in the patient's mouth, made of physical components like titanium and acrylic, and includes mechanical adjustment mechanisms. This indicates it is a physical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce or alleviate snoring and mild to moderate obstructive sleep apnea by being fitted in the patient's mouth during sleep. This is a therapeutic and mechanical function, not a diagnostic one.
- Device Description: The device is an oral appliance that physically positions the jaw to open the airway. It does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of Diagnostic Elements: There is no mention of the device performing any tests, measurements, or analyses of biological samples or physiological parameters for diagnostic purposes.
- Anatomical Site: The device is used in the mouth, which is consistent with a physical appliance for airway management, not a diagnostic test.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The O2Vent W is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The device is indicated for use during sleep to aid in the treatment of these conditions.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
The O2Vent W is an oral appliance and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA).
The O2Vent W is made up of two parts:
- The Upper Tray 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, is made from medical grade titanium (3D printed). The upper titanium tray has two side protrusions (wings) that extend vertically down to interface with the lower acrylic tray for titration of the device. The upper tray is lined with acrylic insert, and is customized to patient bite and impression.
- The Lower Tray customized to the lower teeth, positions the lower jaw forward, preventing the soft tissue of the throat from collapsing and obstructing the airway. The lower tray features an adjuster assembly set into the acrylic, comprising of an adjuster block and also adjustment screws each located on either side of the lower arch.
The adjuster block interfaces with the side protrusions on the upper tray to provide titration. The screws are adjusted with an Adjustment Key for mandibular adjustment to be set by the dentist and/or by the patient under the direction of the dentist.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's mouth
Indicated Patient Age Range
Adult patients 18 years and older.
Intended User / Care Setting
Home Use and Sleep laboratories.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non Clinical Tests: The non-clinical testing included risk assessment of the physical properties of the O2Vent W and its ability to achieve its intended use. Preliminary testing was carried out to confirm that the design can withstand forces applied during normal use and also reasonable abuse in cases such as bruxing. The O2Vent W met the specifications set.
The only new material that was incorporated in the O2Vent W are the adjustment screws which have been granted prior 510(k) approval, made of special grade stainless steel and have been widely used in manufacturing of dental appliances. The specifications of the adjuster screws are same as in the predicate SOMNODENT CLASSIC device. No other risks are introduced in the device. The O2Vent W met the specifications as set.
A biocompatibility assessment of the device was performed. The purpose of the biocompatibility assessment was to ensure that biocompatibility had been established for the device. No new materials are being used in the device; all materials are already used in the predicate devices (O2Vent T & OVENT). No new risks are introduced in the new device apart from the two adjustment screws on the lower tray, which are not present in the predicate O2Vent T & OVENT devices, however are present in the SOMNODENT CLASSIC predicate device. These screws have been granted prior 510(k) approval, made of special grade stainless steel and have been widely used in the manufacturing of dental appliances. Our conclusion is that biocompatibility testing of the adjustment screws is not warranted due to the source and nature of the component, it has long been used in intraoral environment (i.e. mucosal, gingival, and palatal) with prolonged contact and has been widely used in the manufacturing of dental appliances. The device is deemed to be biocompatible, based on the similarity of the materials of constructions to the predicate devices (O2Vent T, OVENT & SOMNODENT CLASSIC).
Summary of Clinical Tests: Human clinical studies were not deemed necessary to evaluate the substantial equivalence of the O2Vent W, as the O2Vent W 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 intra-mandibular repositioning devices for snoring and/or obstructive sleep apnea;
- Deviate from the indications for use identified in the predicate devices: the O2Vent T, OVENT and SOMNODENT CLASSIC.
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". The function of mandibular repositioning devices required that the prescribing dentist be aware of the potential for soreness caused by mandibular advancement. Management of these risks is achieved by advising the patients and dentists in the "Instructions for Use". The contraindications, warnings, precautions, storage, fitting and adjustment directions are written to avoid potential problems from arising or persisting caused by Mandibular Advancement Devices.
Conclusion on Non Clinical and Clinical Tests: The O2Vent W is considered to be substantially equivalent to the predicate devices based on the following:
- It has the same intended use and is indicated for the same user population.
- It has equivalent technological characteristics to the predicates.
- The device is as safe, as effective and performs as well as or better than the legally marked devices identified above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
O2Vent T - Oventus Manufacturing Pty Ltd, OVENT – Oventus Manufacturing Pty Ltd, SOMNODENT CLASSIC – Somnomed Inc.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
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Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, resembling a bird-like shape.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 11, 2017
Oventus Manufacturing Pty Ltd % M.W. Andy Anderson, Ph.D., RAC Senior Principal Advisor Regulatory and Clinical Research Institute. Inc. 5353 Wayzata Boulevard, #505 Minneapolis, Minnesota 55416
Re: K171316
Trade/Device Name: O2Vent W Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices For Snoring And Intraoral Devices For Snoring And Obstructive Sleep Apnea Regulatory Class: Class II Product Code: LRK Dated: June 15, 2017 Received: June 16, 2017
Dear M.W. Andy Anderson:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply
1
with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (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,
Mary S. Runner -A
Lori Wiggins Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K171316
Device Name O2VENT W
Indications for Use (Describe)
The O2Vent W is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The device is indicated for use during sleep to aid in the treatment of these conditions.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | X |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the logo for Oventus Medical Ltd. The logo features a stylized letter "O" in a gradient of blue, with a wave-like shape running through the center. Above the "O" are several small blue circles, arranged in a cluster. Below the symbol is the word "OVENTUS" in a sans-serif font, with the letters "VEN" in a lighter shade of blue.
510(k) SUMMARY FOR O₂VENT W
prepared in accordance to 21CFR 807.92 K171316
| Date Prepared | June 29, 2017 |
|---|---|
| 510 (k) Owner Details | |
| 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 W |
| Common Name | Oral Appliance – Anti-snoring device |
| Classification | Class II |
| Classification Name | Intraoral devices for snoring and obstructive sleep apnea for |
| snoring and obstructive sleep apnea. | |
| Classification Code | LRK |
| Classification Regulation | 21 CFR 872.5570 |
| Device Model Number(s) | O2VWUS |
| Predicate Device | O2Vent T - Oventus Manufacturing Pty Ltd - Primary |
| OVENT – Oventus Manufacturing Pty Ltd | |
| SOMNODENT CLASSIC – Somnomed Inc. | |
| Device Description | The O2Vent W is an oral appliance and is intended to reduce or |
| alleviate snoring and mild to moderate obstructive sleep apnea | |
| (OSA). | |
| The O2Vent W is made up of two parts: |
- The Upper Tray 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, is made from medical grade titanium (3D printed).
The upper titanium tray has two side protrusions (wings) that
extend vertically down to interface with the lower acrylic tray
for titration of the device. The upper tray is lined with acrylic
insert, and is customized to patient bite and impression. |
| | 2. The Lower Tray customized to the lower teeth, positions the
lower jaw forward, preventing the soft tissue of the throat from |
| | collapsing and obstructing the airway. The lower tray features an |
| | adjuster assembly set into the acrylic, comprising of an adjuster
block and also adjustment screws each located on either side of |
| | the lower arch. |
| | The adjuster block interfaces with the side protrusions on the
upper tray to provide titration. The screws are adjusted with an
Adjustment Key for mandibular adjustment to be set by the
dentist and/or by the patient under the direction of the dentist. |
| Indications for Use | The O 2 Vent W is a removable medical device that is fitted in the
patient's mouth and is intended to reduce or alleviate snoring and
mild to moderate obstructive sleep apnea (OSA). The device is
indicated for use during sleep to aid in the treatment of these
conditions. |
| Target Population | Adult patients 18 years and older. |
| Environment of Use | Home Use and Sleep laboratories. |
| Summary of Comparison
of Technological
Characteristics of the
Device to Predicate Device | As mentioned in the following pages. |
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5
| Feature | O2Vent W | O2Vent T | OVENT | SOMNODENT CLASSIC |
|---|---|---|---|---|
| 510k Number | K171316 | K161832 | K160234 | K050592 |
| Device Photo | Image: O2Vent W device | Image: O2Vent T device | Image: OVENT device | Image: SOMNODENT CLASSIC device |
| Indications for Use | The O2Vent W is a | |||
| 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 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. | The OVENT 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. | To intended to reduce night | |||
| time snoring and mild to | ||||
| moderate obstructive sleep | ||||
| apnea (OSA) in adults. | ||||
| Product Codes | LRK | LRK | LRK | LRK |
| Regulation | 21CFR 872.5570 | 21CFR 872.5570 | 21CFR 872.5570 | 21CFR 872.5570 |
| Use of device | Removable intraoral device. | |||
| Single patient multiple use. | ||||
| Prescription use only. | Removable intraoral device. | |||
| Single patient multiple use. | ||||
| Prescription use only. | Removable intraoral device. | |||
| Single patient multiple use. | ||||
| Prescription use only. | Removable intraoral device. | |||
| Single patient multiple use. | ||||
| Prescription use only. | ||||
| Target Population | People over 18 years of age | |||
| who snore and/or have sleep | ||||
| apnea. | People over 18 years of age | |||
| who snore and/or have sleep | ||||
| apnea. | People over 18 years of age | |||
| who snore and/or have sleep | ||||
| apnea. | People over 18 years of age | |||
| who snore and/or have sleep | ||||
| apnea. | ||||
| Environment of Use | To be used in the patient's | |||
| home or in sleep | ||||
| laboratories. | To be used in the patient's | |||
| home or in sleep | ||||
| laboratories. | To be used in the patient's | |||
| home or in sleep | ||||
| laboratories. | To be used in the patient's | |||
| home or in sleep | ||||
| laboratories. | ||||
| Feature | O2Vent W | O2Vent T | OVENT | SOMNODENT CLASSIC |
| Cleaning | Should be cleaned daily in | Should be cleaned daily in | Should be cleaned daily in | Should be cleaned daily in |
| Instructions | soap and water. | soap and water. | soap and water. | soap and water. |
| Can be periodically cleaned | Can be periodically cleaned | Can be periodically cleaned | Cannot be cleaned in an | |
| in an ultrasonic cleaner with | in an ultrasonic cleaner with | in an ultrasonic cleaner with | ultrasonic cleaner. | |
| an effervescent denture | an effervescent denture | an effervescent denture | ||
| cleaning tablet. | cleaning tablet. | cleaning tablet. | ||
| Device | Repositions the lower jaw | Repositions the lower jaw | Repositions the lower jaw | Repositions the lower jaw |
| Functionality | forward. | forward. | forward. | forward. |
| Acts by increasing the | Acts by increasing the | Acts by increasing the | Acts by increasing the | |
| pharyngeal space to | pharyngeal space to | pharyngeal space to | pharyngeal space to | |
| improve the patient's ability | improve the patient's ability | improve the patient's ability | improve the patient's ability | |
| to exchange air. | to exchange air. | to exchange air. | to exchange air. | |
| Does not have a lingual | Does not have a lingual | Has a lingual flange for | Does not have a lingual | |
| flange for holding the | flange for holding the | holding the mandible | flange for holding the | |
| mandible forward. | mandible forward. | forward1. | mandible forward. | |
| Permits patient to breathe | Permits patient to breathe | Permits patient to breathe | Permits patient to breathe | |
| through their mouth2. | through their mouth2. | through their mouth2. | through their mouth2. | |
| Retains the top and bottom | Retains the top and bottom | Retains the top and bottom | Retains the top and bottom | |
| teeth using rigid trays. | teeth using rigid trays. | teeth with monobloc. | teeth using rigid trays. | |
| Device Design | Customized for each patient | Customized for each patient | Customized for each patient | Customized for each patient |
| in a dental laboratory. | in a dental laboratory. | in a dental laboratory. | in a dental laboratory. | |
| Upper and lower trays are | Upper and lower trays | No upper and lower trays. | Upper and lower trays | |
| separate. | separate. | separate. | ||
| The upper tray have | The two trays are connected | The device is a one piece | The protrusions (wings) are | |
| protrusions (wings) at the | in the front of the device | assembly. | at the rear of the bottom | |
| rear on the titanium part to | with a screw assembly. | tray to interface with the | ||
| interface with the adjuster | adjuster block in the upper | |||
| block in the lower tray. | tray. | |||
| Feature | O₂Vent W | O₂Vent T | OVENT | SOMNODENT CLASSIC |
| Adjustment | Can be adjusted by the clinician and patient⁴. | |||
| Lower jaw adjusted using titration of the adjustment screws equally on both sides with an adjustment key. | Can be adjusted by the clinician and patient⁴. | |||
| Lower jaw adjusted using titration of the adjustment screw with an adjustment key. | Cannot be adjusted by the clinician or patient⁴. | |||
| Lower jaw cannot be adjusted and there is no adjustment key. | Can be adjusted by the clinician and patient⁴. | |||
| Lower jaw adjusted using titration of the adjustment screws equally on both sides with an adjustment key. | ||||
| Supplied | ||||
| Sterile/Non-Sterile | Non-Sterile | Non-sterile | Non-sterile | Non-sterile |
| Materials Used - 1 | Medical grade metal used⁵. | Medical grade metal used⁵. | Medical grade metals used⁵. | Medical grade metals used⁵. |
| Materials Used - 2 | Dental plastic laminates and acrylics used for upper and lower trays which is in contact with the patient's teeth. | Dental plastic laminates and acrylics used for upper and lower trays which is in contact with the patient's teeth. | Dental plastic laminates and acrylics used for upper and lower trays which is in contact with the patient's teeth. | Dental acrylics used for upper and lower trays which is in contact with the patient's teeth. |
| Biocompatibility* | Not performed as the materials are identical as in the OVENT. | Not performed as the materials identical as in the OVENT. | Passes Part 5 and Part 10 of ISO10993. | Information could not be verified. |
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7
- This is assumed as the predicate devices are FDA 510(k) cleared and are currently on the OVENT device was tested as part of this submission. Biocompatibility was not performed on the O Vent W device as the materials used in the device were similar to that of OVENT.
Note (1) The OVENT has a choice of lingual flance (to be decided by the clinician) although for most cases adequate retention (in advanced position) is achieved by the molded polymer insert.
Note (2) The O2Vent W, Q2Vent T and OVENT all have a dedicated breathing port (delivering air to the mouth) to allow the user to breathe through their mouth if they want, the SOMNODENT CLASSIC allows users to open their mouth to a degree.
Note (4) The OVENT requires a new insert to be made for mandbular adjustment, the O2Vent W, O2Vent T and SOMNODENT CLASSIC device can be adjusted by the clinician or patient through the adjustment screws and the adjustment key.
Note (5) The OxVent W, O2Vent T and OVENT use 3D printed titanium trays and stainless steel screws (only for O2 Vent T) and the SOMNODENT CLASSIC uses stainless steel screws and ball clasps.
8
| Summary of Non Clinical
Tests | The non-clinical testing included risk assessment of the physical
properties of the O2Vent W and its ability to achieve its intended
use.
Preliminary testing was carried out to confirm that the design
can withstand forces applied during normal use and also
reasonable abuse in cases such as bruxing. The O2Vent W met
the specifications set. |
|-----------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The only new material that was incorporated in the O2Vent W
are the adjustment screws which have been granted prior 510(k)
approval, made of special grade stainless steel and have been
widely used in manufacturing of dental appliances. The
specifications of the adjuster screws are same as in the predicate
SOMNODENT CLASSIC device. No other risks are introduced
in the device. The O2Vent W met the specifications as set. |
| | A biocompatibility assessment of the device was performed. The
purpose of the biocompatibility assessment was to ensure that
biocompatibility had been established for the device.
No new materials are being used in the device; all materials are
already used in the predicate devices (O2Vent T & OVENT).
No new risks are introduced in the new device apart from the
two adjustment screws on the lower tray, which are not present
in the predicate O2Vent T & OVENT devices, however are
present in the SOMNODENT CLASSIC predicate device. These
screws have been granted prior 510(k) approval, made of special
grade stainless steel and have been widely used in the
manufacturing of dental appliances. |
| | Our conclusion is that biocompatibility testing of the adjustment
screws is not warranted due to the source and nature of the
component, it has long been used in intraoral environment (i.e.
mucosal, gingival, and palatal) with prolonged contact and has
been widely used in the manufacturing of dental appliances. |
| | The device is deemed to be biocompatible, based on the
similarity of the materials of constructions to the predicate
devices (O2Vent T, OVENT & SOMNODENT CLASSIC). |
| Summary of Clinical Tests | Human clinical studies were not deemed necessary to evaluate
the substantial equivalence of the O2Vent W, as the O2Vent W
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 intra-
mandibular repositioning devices for snoring and/or obstructive
sleep apnea; |
| | • Deviate from the indications for use identified in the predicate
devices: the O2Vent T, OVENT and SOMNODENT CLASSIC.
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". The function of mandibular repositioning
devices required that the prescribing dentist be aware of the
potential for soreness caused by mandibular advancement.
Management of these risks is achieved by advising the patients
and dentists in the "Instructions for Use". The contraindications,
warnings, precautions, storage, fitting and adjustment directions
are written to avoid potential problems from arising or persisting
caused by Mandibular Advancement Devices. |
| Differences between the
proposed and predicate
device(s). | As discussed in the comparison chart above, the main functional
difference between the proposed O2Vent W and predicate devices
O2Vent T & OVENT is the method of adjustment:
• O2Vent W allows protrusion of the mandible from the
original treatment position via use of adjuster assembly
located on both sides of the lower arch, whereas O2Vent T
allows protrusion via a single screw mechanism in the front
of the device and additional impressions or laboratory
procedures are required for OVENT.
• The adjustments can be made by the clinician or by the
patient under the direction of the clinician for the O2Vent
W and O2Vent T device, however it is not possible in case
of the OVENT device. |
| | • Additionally, in order to facilitate the titration of the device,
the O2Vent W have a separate upper tray with side
protrusions (wings) and lower tray with the adjuster
assembly on both the side that interface with the
protrusions, while O2Vent T has separate upper and lower
trays connected via the screw mechanism in the front of the
device, and the OVENT has a monobloc design. |
| | No new risks are introduced in the new device apart from the wings
and two adjustment screws, which are not present in the predicate
O2Vent T and OVENT device, however are present in the
SOMNODENT CLASSIC predicate device. |
| | The treatment outcomes for O2Vent W, O2Vent T and OVENT are
expected to be equivalent as the final levels of mandibular
protrusion and the provision for oral breathing via the customized
airway is same for each device. |
| | The difference between the proposed O2Vent W and predicate
device SOMNODENT CLASSIC is the location of the wings and |
| | |
| | titration blocks, which is switched between the upper and lower
trays. The purpose of the wings and the titration blocks is to
stabilize the mandible in a more advanced position and thus be able
to advance the mandible forward incrementally to reduce airway
collapse during sleep. The fact that the wing is on the top part of
the device as opposed to the bottom is inconsequential as it
achieves the same purpose of mandibular advancement in this
regard. |
| | Hence the differences mentioned are unlikely to adversely or
otherwise affect the expected clinical outcomes for patients using
the O2Vent W device as compared to those using the predicate
devices, thus not affecting the substantial equivalency of the
proposed device. |
| Conclusion on Non Clinical
and Clinical Tests | The O2Vent W is considered to be substantially equivalent to the
predicate devices based on the following:
• It has the same intended use and is indicated for the same user
population.
· It has equivalent technological characteristics to the predicates.
· The device is as safe, as effective and performs as well as or
better than the legally marked devices identified above. |
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