(381 days)
No
The description focuses on the mechanical design and function of a mandibular advancement device, with no mention of AI or ML technologies.
Yes
The device is indicated for the treatment of snoring and mild to moderate obstructive sleep apnea, which are medical conditions, and its mechanism of action involves a physical intervention (mandibular advancement) to alleviate these conditions.
No
The device description states it is a "Mandibular advancement device" used for treatment, not for diagnosis. The Intended Use/Indications for Use section confirms it is "indicated in the treatment of snoring and/or mild to moderate obstructive sleep apnea."
No
The device description clearly states it is an "intraoral device" composed of "injection molded thermoplastic trays" and "interconnecting rods," which are physical hardware components.
Based on the provided information, the Oniris device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "treatment of snoring and/or mild to moderate obstructive sleep apnea in adults." This is a therapeutic treatment, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is an intraoral mandibular advancement device. Its mechanism of action is physical (increasing upper airway opening) and it is used during sleep. This is a physical intervention, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening.
Therefore, the Oniris device is a therapeutic medical device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Oniris device is indicated in the treatment of snoring and/or mild to moderate obstructive sleep apnea in adults.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
The Oniris Mandibular advancement device is an intraoral device for use during up to 8 hours of sleep, and composed of two injection molded thermoplastic trays overmoulded with thermoforming resin and customized to fit over the patient's teeth. The trays are attached and articulated through interconnecting rods to allow for mandibular advancement in relation to the maxilla up to 11 mm of protrusion. Mandibular advancement is the mechanism of action to increase upper airway opening to reduce snoring and mild to moderate sleep apnea.
The Oniris device is formed to upper and lower teeth without the need of taking a patient's dental impressions. Oniris device is a "boil-&-bite" device, the trays are customizable.
This mandibular advancement device maintains performance for 12 to 24 months depending on its conditions of use and maintenance as well as the patient's salivary composition.
Oniris mandibular device is proposed in two sizes to be adapted to different sizes of jaw (size 2 in the same box). The practitioner/dentist has to choose the most comfortable size for the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults
Intended User / Care Setting
Prescription Use (Part 21 CFR 801 Subpart D)
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)
In a one arm pilot study investigating the use of Oniris device in patients with moderate sleep apnea demonstrated a reduction of apnea index and oxygen desaturation index and was subjectively evaluated by patients to provide positive impact on snoring, morning fatigue and sleep quality.
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.
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.
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/1 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 to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 21, 2016
SAS Oniris Mr. Thibault Vincent CEO 704 Avenue Roger Salengro Chaville, 92370 France
Re: K150566 Trade/Device Name: Oniris 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 8, 2016 Received: February 10, 2016
Dear Mr. Vincent:
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.
1
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 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 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
2
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | |
|---|---|
| Food and Drug Administration | |
| Indications for Use |
| Form Approved: | OMB No. 0910-0120 |
|---|---|
| Expiration Date: | January 31, 2017 |
| See PRA Statement below. |
| 510(k) Number (if known) | K150566 |
|---|---|
| Device Name | ONIRIS |
Indications for Use (Describe)
The Oniris device is indicated in the treatment of snoring and/or mild to moderate obstructive sleep apnea in adults.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/14)
Page 1 of 1
PSC Publishing Services (30) 443-6740 EF
3
510(k) Summary K150566
Device Trade Name : Oniris
Submitter:
SAS Oniris 147 avenue Paul Doumer 92500 RUEIL-MALMAISON FRANCE
Phone: +33 1 47 16 17 17 Fax: +1 47 16 20 11
Contact person: Thibault Vincent
Device Common Name : Mandibular advancement device
Date summary prepared : 18/03/2016
Device Classification Name : Intraoral Devices for snoring and obstructive sleep apnea
Device classification : Class II Product Classification : 872.5570 Product Code : LRK
Predicate devices:
Primary predicate : SomnoGuard® SP Soft. K121761 Reference predicates : Zquiet® Mouthpiece. K093407 SomnoGuard Series (SomnoGuard, 2.0, AP, and AP Pro). K061688
Description of the device :
The Oniris Mandibular advancement device is an intraoral device for use during up to 8 hours of sleep, and composed of two injection molded thermoplastic trays overmoulded with thermoforming resin and customized to fit over the patient's teeth. The trays are attached and articulated through interconnecting rods to allow for mandibular advancement in relation to the maxilla up to 11 mm of protrusion. Mandibular advancement is the mechanism of action to increase upper airway opening to reduce snoring and mild to moderate sleep apnea.
Image /page/3/Picture/14 description: The image shows a clear plastic oral appliance. The appliance consists of two parts: a horseshoe-shaped piece that fits over the upper teeth and a rectangular piece that fits over the lower teeth. The two pieces are connected by two small plastic arms. The appliance is designed to be worn at night to help prevent teeth grinding and clenching.
The Oniris device is formed to upper and lower teeth without the need of taking a patient's dental impressions. Oniris device is a "boil-&-bite" device, the trays are customizable.
This mandibular advancement device maintains performance for 12 to 24 months depending on its conditions of use and maintenance as well as the patient's salivary composition.
4
Oniris mandibular device is proposed in two sizes to be adapted to different sizes of jaw (size 2 in the same box). The practitioner/dentist has to choose the most comfortable size for the patient.
Intended use:
The Oniris device is indicated in the treatment of snoring and/or mild to moderate obstructive sleep apnea in adults.
Technological characteristics compared to predicates
The principle of mandibular advancement for treatment of snoring/or obstructive sleep apnea is well known and there are a number of predicate devices. The advancement of the lower jaw, enables opening the upper airway and reduce snoring.
The Oniris Mandibular advancement device has the same technical characteristics as the primary predicate devices as summarized in table. Reference predicates supports substantial equivalence for the protrusion up to 11 mm and the possibility to mouth breath during device wearing.
| | Oniris mandibular
advancement
K150566 | SomnoGuard® SP
Soft
K121761 | Zquiet ®
K093407
Reference predicate | SomoGuard AP®
K061688
Reference predicate |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | The Oniris device is
indicated in the
treatment of snoring
and/or mild to
moderate obstructive
sleep apnea in adults. | The SomnoGuard®
SP Soft is intended
for the treatment of
night-time snoring
and mild to
moderate
obstructive sleep
apnea (OSAS) in
adults. | The ZQuiet
mandibular
advancement
device is intended
for the treatment of
nighttime
snoring in adults 1
8 years are older. | The SomnoGuard series
of mandibular
advancement devices is
intended for the
treatment of night-time
snoring and mild to
moderate obstructive
sleep apnea (OSAS)
in adults. |
| Dental impressions | « Boil & bite »
appliance | « Boil & bite »
appliance | | « Boil & bite »
appliance : |
| Mandibular
advancement | Oniris Device comes
with 9 connectors of
different length
enables up to 11mm
protusion | SomnoGuard® SP
Soft with 6
connectors of
different length
enables up to 10
mm protusion | ZQuiet® employs a
buccal cam
mechanism | SomnoGuard AP
comprises two-part
titratable enables up to
12 mm protusion. |
| Sterility | Non sterile | Non sterile | Non sterile | Non sterile |
| Design | Two independent
thermoplastic trays
linked to each other
by a coupling
protrusion
mechanism. | Two independent
thermoplastic trays
linked to each other
by a coupling
protrusion
mechanism. | Upper and lower
dental orthotics
with a buccal cam
mechanism. | SomnoGuard AP
consists of two
independent
thermoplastic trays,
both parts are linked to
each other by a coupling
protusion mechanism |
| Single patient use | X | X | X | X |
| Cleaned with water
and toothbrush daily | X | X | X | X |
| Interchangeable rods | Fixed by pressure on
lower tray; angular
rotation on pin tray | Fixed by pressure
on lower and upper
tray. | | |
5
The thermoplastic material used for tray is different, and the connecting mechanism of interchangeable rods Oniris device presents some differences compared to the primary predicate. The difference consists on larger shape stopper on lower tray to decrease the possibility of rod detachment. A slot has been added on the shape stopper to facilitate the fitting by pressure. The change of this rod is possible after angular rotation of the rod along its axis. This angular rotation is impossible to reproduce when wearing in mouth, and is a security to avoid detachment of rod during wearing.
On upper tray the rod is fitting like a key system, the rod rotate around the axis in order to reach the functional location, while the rod is fixed by pressure on the lower tray primary predicate.
The submission includes physical property specifications for materials used in the fabrication of the device, including density, tensile strain, tensile modulus, impact strength, softening temperature, melt flow rate, and Vicar Softening Point.
Clinical Data
In a one arm pilot study investigating the use of Oniris device in patients with moderate sleep apnea demonstrated a reduction of apnea index and oxygen desaturation index and was subjectively evaluated by patients to provide positive impact on snoring, morning fatigue and sleep quality.
Conclusions :
The Oniris device function is a similar manner to other comparative predicate devices and the intended use is the same. All are prescription devices indicated for patients suffering and/or mild to moderate obstructive apnea.
The information in this 510(k) submission demonstrate the Oniris device are substantially equivalent to the predicate devices. Fundamental scientific technology of the device is identical to the referenced predicate device. Rationale discussion on design differences of interchangeable rod has been conducted in the 510(k) Submission.