(204 days)
No
The description focuses on the mechanical design and function of a physical oral appliance, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA), indicating its use in treating medical conditions.
No
The device is described as 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)." It is a treatment device, not one that diagnoses conditions.
No
The device description clearly outlines physical components (upper tray, lower tray, connector bands) made of specific materials (PA2200, thermoplastic polyurethane/cured elastomer) that are fitted in the patient's mouth. This indicates a hardware-based medical device, not a software-only one.
Based on the provided information, the O2Vent Optima is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens from the human body. The O2Vent Optima is a physical device fitted in the mouth to treat snoring and sleep apnea. It does not analyze any biological samples.
- The intended use and device description clearly state its function as a mechanical device. It works by repositioning the jaw to open the airway, not by performing diagnostic tests on samples.
- There is no mention of any laboratory analysis or testing of biological materials.
Therefore, the O2Vent Optima falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The O2Vent Optima is a removable medical device that is fitted in the patient's mouth and is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA). The device is indicated for use during sleep to aid in the treatment of these conditions.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
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.
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
Environment of Use: Home Use and Sleep laboratories.
Use of device: Prescription use only.
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)
Not Found
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.
K171316 O₂Vent W – Oventus Manufacturing Pty Ltd
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.
K143244 The Panthera Anti-Snoring Device – Panthera Dental Inc, K971794 EMA Appliance – Myerson LLC
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.”
0
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
1
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 Ltd |
| The primary predicate was chosen as it has the same principal design | |
| features as the O₂Vent Optima and indications for use | |
| Reference Device(s) | K143244 The Panthera Anti-Snoring Device – Panthera Dental Inc |
| This reference device was chosen as the material is the same as that | |
| used in the O₂Vent Optima | |
| K971794 EMA Appliance – Myerson LLC | |
| This reference device was chosen for the straps/bands | |
| Device Description | 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 jawThe 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 | |
| Indications for Use | The O2Vent Optima is a removable oral appliance that is fitted in the mouth and is intended to reduce or alleviate snoring and mild to moderate OSA. The Optima is indicated for use during sleep to aid in the treatment of these conditions. |
| Target Population | Adult patients 18 years and older. |
| Environment of Use | Home Use and Sleep laboratories. |
| Summary of Comparison of | |
| Technological Characteristics | |
| of the Device to Predicate | |
| Device | The following table displays a comparison between the O2Vent Optima and the O2Vent W (predicate) and reference devices |
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| Feature | O₂Vent Optima | Primary Predicate
O₂Vent W | Reference Device
The Panthera Anti-
Snoring Device | Reference Device
Elastic Mandibular
Advancement (EMA)
Appliance | Compared to
Subject
Device |
|----------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510k Number | K190236 | K171316 | K143244 | K971794 | |
| Device Photo | Image: O2Vent Optima | Image: O2Vent W | Image: The Panthera Anti-Snoring Device | Image: Elastic Mandibular Advancement (EMA) Appliance | |
| Indications for Use | The O₂Vent Optima is a
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 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 Panthera anti snoring
device is Intended to
reduce or alleviate
snoring and mild to
moderate obstructive
sleep apnea (OSA) in
adults. | Treatment of nasal
respiratory
dysfunction of
obstructive sleep
apnea and snoring in
those patients where
repositioning of the
mandible and opening
the bite can increase
the patients air space | Similar to
predicates |
| Product Codes | LRK | LRK | LRK | LRK | Same for all |
| Regulation | 21CFR 872.5570 | 21CFR 872.5570 | 21CFR 872.5570 | 21CFR 872.5570 | Same for all |
| Common Name | Intraoral devices for
snoring and intraoral
devices for snoring and
obstructive sleep apnea | Intraoral devices for snoring
and intraoral devices for
snoring and obstructive sleep
apnea | Intraoral devices for
snoring and intraoral
devices for snoring and
obstructive sleep apnea | Intraoral devices for
snoring and intraoral
devices for snoring
and obstructive sleep
apnea | 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 |
| Feature | O2Vent Optima | Primary Predicate
O2Vent W | Reference Device
The Panthera Anti-
Snoring Device | Reference Device
Elastic Mandibular
Advancement (EMA)
Appliance | Compared to
Subject
Device |
| 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. | Adults | Not indicated | Same or
similar |
| Device Functionality
(Please note trays and
splints are
synonymous) | Repositions the lower
jaw forward. | Repositions the lower jaw
forward. | A mandibular
repositioner, maintaining
the lower jaw in a
forward position during
sleep. | Advance the mandible
to an anterior and
inferior position with
regard to the maxilla. | Description
similar for all
devices |
| Acts by increasing the
pharyngeal space to
improve the patient's
ability to exchange air. | Acts by increasing the
pharyngeal space to
improve the patient's
ability to exchange air. | Acts by increasing the
pharyngeal space to improve
the patient's ability to
exchange air. | This mechanical
protrusion acts to
increase the patient's
pharyngeal space,
improving their ability to
exchange air during
sleep. | Repositioning of the
mandible pulls the
tongue forward and
increased the patient's
airspace thereby
decreasing upper
airway obstruction. | Same as
predicate,
similar to
references |
| Permits patient to
breathe through their
mouth via a proprietary
built in airway | Permits patient to
breathe through their
mouth via a proprietary
built in airway | Permits patient to breathe
through their mouth via a
proprietary built in airway | NA | NA | Same as
primary
predicate |
| Retains the top and
bottom teeth using rigid
trays. | Retains the top and
bottom teeth using rigid
trays. | Retains the top and bottom
teeth using rigid trays. | The upper and lower
splints are adapted for the
upper and lower teeth,
respectively | Upper and lower trays
for tooth retention | Same as
primary
predicate;
similar for
references |
| Upper and lower trays
are separate. | Upper and lower trays
are separate. | Upper and lower trays are
separate. | Two customized splints
that fit separately over
the upper and lower teeth
inside the mouth. | Upper and lower trays
are separate | Same as
primary,
similar for
references |
| Feature | O2Vent Optima | Primary Predicate
O2Vent W | Reference Device
The Panthera Anti-Snoring Device | Reference Device
Elastic Mandibular
Advancement (EMA)
Appliance | Compared to
Subject
Device |
| Device Design and
Principle of
Operation | The trays have
protrusions (lugs) at the
side of the upper and
lower parts with a
connector between the
upper and lower parts to
stabilize and/or advance
the lower jaw. | The upper tray has protrusions
(wings) at the rear on the
titanium part to interface with
the adjuster block in the lower
tray. | The lower splint contains
a triangular protrusion,
allowing the splints to
engage by means of
interlocking rods on the
sides | Removable
replacement
adjustable bands
which attach by
protrusions to the side
of the upper and lower
trays | Same as
reference
devices,
similar to
predicate
device |
| Means of advancing
the mandible | Lower jaw adjusted by
attaching connectors of
varying lengths | Lower jaw adjusted using
titration of the adjustment
screws equally on both sides
with an adjustment key. | Adjusted via the use of
interlocking rods placed
on the sides of the splints.
The shorter the rod, the
further the mandible is
advanced
The length of the rods
can vary from 19 to 36
mm and can be adjusted
in 0.5-mm increments for
a highly accurate and
customized advancement | Lower jaw adjusted by
attaching connectors
of varying lengths | Same as
reference
devices;
similar to
predicate
device |
| Adjustment | Can be adjusted by the
clinician and patient. | Can be adjusted by the
clinician and patient. | The dentist/patient can
simply select a shortened
connecting rod until
optimal advancement is
achieved | Can be adjusted by the
clinician and patient. | Same for all |
| Feature | O2Vent Optima | Primary Predicate
O2Vent W | Reference Device
The Panthera Anti-
Snoring Device | Reference Device
Elastic Mandibular
Advancement (EMA)
Appliance | Compared to
Subject
Device |
| Design
CAD/CAM | Customized for each
patient in a dental
laboratory located at the
manufacturing site based
on the dentist
prescription
Use of computer aided
design (CAD) and
computer aided
manufacturing (CAM)
and is made through
additive manufacturing
using laser sintering of
PA2200 Polymide 12
nylon material.
The use of these
technologies provides for
customization according
to the unique
characteristics of the
patient oral anatomy
based on the prescription
provided by the clinician | Customized for each patient
in a dental laboratory based
on the dentist prescription.
Use of computer aided design
(CAD) and computer aided
manufacturing (CAM). Dental
plastic laminates and acrylics
are used for upper and lower
trays.
The titanium component of
the device is 3D printed using
the additive manufacturing.
EBM (Electron Bean Melting)
method of 3D printing.
The use of these technologies
provides for customization
according to the unique
characteristics of the patient
oral anatomy based on the
prescription provided by the
clinician | The device is a
prescription customized
for each patient and has
an adjustment mechanism
enabling the amount of
mandibular advancement
to be set by the dentist or
physician at the time of
fitting the device.
Use of computer aided
design (CAD) and
computer aided
manufacturing (CAM).
Uses CAD that enables a
high degree of
customization according
to the physician or dentist
prescription to
accommodate complex
dental anatomy of
individual patients. The
CAM and selective laser
sintering guarantees
precision, accuracy and
consistency for each
patient | This custom oral
appliance is available
to dental and medical
professionals through
authorized dental
laboratories. | Same as for
reference
device;
similar to the
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 |
| Supplied Sterile/Non-
Sterile | Non-Sterile | Non-Sterile | Non-sterile. | Non-Sterile | Same for all |
| Feature | O2Vent Optima | Primary Predicate
O2Vent W | Reference Device
The Panthera Anti-
Snoring Device | Reference Device
Elastic Mandibular
Advancement (EMA)
Appliance | Compared to
Subject
Device |
| Materials of
construction:
Components
Top and Bottom
trays | Made from polymers
(100% polyamide type
12 [aka Nylon])
Highly resilient and
durable biocompatible
polymer material | Medical grade titanium (top
air channel only)
Dental plastic laminates and
acrylics used for upper and
lower trays which are in
contact with the patient's
teeth. Erkoloc-pro Dual
Laminate and Orthocryl
(Bottom and top trays only) | Made from polymers
(polyamide type 12 [aka
Nylon]),
Highly resilient and
durable biocompatible
polymer material. | Proprietary
thermoplastic polymer
that delivers superior
impact strength to
acrylic. | Same as the
reference
device;
different from
predicate as
subject device
uses additive
manufacturing
for teeth
contact
materials |
| Materials of
construction
Component.
Connectors/straps | 100% thermoplastic
Polyurethane/cured
elastomer | NA | Same as above per
labeling | 100% thermoplastic
Polyurethane/cured
elastomer | Same as the
reference
devices |
| Cleaning Instructions | Clean the device daily in
lukewarm water with a
soft toothbrush. Rinse,
dry, and store in the case
provided. | Clean the device with a soft
clean toothbrush (not the
same toothbrush you use to
brush your teeth as toothpaste
can damage the device). Rinse
well with lukewarm water. | Clean the device daily in
lukewarm water with a
soft toothbrush. Rinse,
dry, and store in the case
provided. | Clean your appliance
every morning in cool
or lukewarm water
with a denture
toothbrush and
toothpaste. We
suggest using denture
toothpaste such as
DentuCreme® or
Fresh 'N Brite; If
white film begins to
form on the appliance
or if it
picks up odors, soak it
in a denture cleaning
solution such as
Polident® or
Efferdent® in
warm, not hot, water | Same as
reference
device and
similar to
predicate |
| Feature | O₂Vent Optima | Primary Predicate
O₂Vent W | Reference Device
The Panthera Anti-
Snoring Device | Reference Device
Elastic Mandibular
Advancement (EMA)
Appliance | Compared to
Subject
Device |
| | Clean twice a week with
chlorine free
antibacterial cleanser | Clean twice a week with an
effervescent denture cleaning
tablet. | Twice weekly use
chlorine free antibacterial
orthodontic cleaning
solution. | Once per week clean
the device with a
commercial denture
cleaner in cool water. | Same as
reference;
similar to
predicate |
| Biocompatibility -
Passes Part 5 and
Part 10 of ISO 10993 | Yes, passed all tests | Not performed as the
materials are identical as in
the OVENT T (K160234). | Information could not be
verified.
Statement in K143244
"The device is
biocompatible, based on
the similarity of the
materials of construction
to the predicate device
(Narval CC) marketed by
ResMed" | Information could not
be verified. | Same as
predicate and
reference
devices per
available
information |
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8
9
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| Differences between
the proposed device,
predicate device and
reference device(s). | As summarized above, the main functional differences between the subject
(O2Vent Optima) and predicate (O2Vent W) and/or reference devices (The
Panthera Anti-Snoring Device and Elastic Mandibular Advancement (EMA)
Appliance) are: |
|---------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | - Predicate: The predicate device does not use PA2200 in the additive
manufacturing process
- Reference: The Panthera Anti-Snoring Device and the Elastic
Mandibular Advancement (EMA) Appliances do not contain an airway |
| Conclusion on Non-
Clinical and Clinical
Tests | The O2Vent Optima is considered to be substantially equivalent to the predicate
and reference 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 predicate or
reference devices. - The device is as safe, as effective and performs comparatively to the |