(312 days)
Not Found
No
The description focuses on the mechanical design and materials of a custom oral appliance, with no mention of AI, ML, or any computational analysis of data.
Yes
The device is described as "treatment for mild to moderate obstructive sleep apnea" and is intended to "reduce snoring and mild to moderate sleep apnea." These descriptions indicate a therapeutic purpose.
No
The device description clearly states it is for "treatment of mild to moderate obstructive sleep apnea" and "reduce snoring." It does not mention any function for diagnosing conditions.
No
The device description clearly states it is made of "two unique acrylic pieces" and "orthodontic acrylic," indicating it is a physical, hardware-based device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Oravan OSA Function: The Oravan OSA is a physical device (an oral appliance) that is worn by the patient to treat a condition (sleep apnea and snoring). It does not analyze biological samples or provide diagnostic information based on such analysis.
- Intended Use: The intended use clearly states it is "intended to reduce snoring and mild to moderate sleep apnea." This is a therapeutic or treatment function, not a diagnostic one.
- Device Description: The description details a physical appliance made of acrylic that fits over the teeth. This is consistent with a medical device used for treatment, not an IVD.
The Oravan OSA is a medical device, specifically an oral appliance used for the treatment of sleep apnea and snoring.
N/A
Intended Use / Indications for Use
Oravan OSA is intended to reduce snoring and mild to moderate sleep apnea in adults
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
The Oravan OSA has been developed for the treatment of mild to moderate obstructive sleep apnea. Each Oravan device is made for each individual patient. There are two unique acrylic pieces that fit over the top and bottom teeth. The Oravan is fully adjustable for maximum benefit to treat the symptoms of obstructive sleep apnea and snoring. The Oravan sleek design allows for comfortable mandibular movement. The Oravan is made of orthodontic acrylic. Each device is warranted for 2 full years against breakage from everyday use.
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
Not Found
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)
The submission does not rely on any clinical data; therefore no clinical testing was performed
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.
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.”
0
1121285
MAR 0 8 2013
10(K) SUMMARY
Submitter's Name and Contact Information 1.
Company Name: Address:
New Jersey Snoring Solutions 769 Northfield Avenue, Ste 154 West Orange, NJ 07052
Contact Person:
Deborah Stein Vice President, New Jersey Snoring Solutions
Email: Telephone: Fax:
debbie481@comcast.net 973-886-6855 973-325-6442
Summary Preparation Date: January 14, 2013
2. Device Identification:
| Proprietary Name: | Oravan OSA |
|---|---|
| Common Name: | Anti-snoring device |
| Classification: | Class II |
| Product Code: | LRK |
| Regulation Number: | 21 CFR 872.5570 |
| Review Panel: | Dental |
3. Description of the Device:
The Oravan OSA has been developed for the treatment of mild to moderate obstructive sleep apnea. Each Oravan device is made for each individual patient. There are two unique acrylic pieces that fit over the top and bottom teeth. The Oravan is fully adjustable for maximum benefit to treat the symptoms of obstructive sleep apnea and snoring. The Oravan sleek design allows for comfortable mandibular movement. The Oravan is made of orthodontic acrylic. Each device is warranted for 2 full years against breakage from everyday use.
4. Indications for Use:
Oravan OSA is intended to reduce snoring and mild to moderate sleep apnea in adults
1
5. Predicate Devices:
The Oravan OSA is substantially equivalent to the following devices:
- Somnomed MAS RxA (by Somnomed Ltd.), cleared under K050592 i.
- The Moses Appliance (by Allen J. Moses, DDS, Ltd.), cleared under ii. K093710
Summary of Similar Technological Characteristics 6.
The proposed 'Oravan OSA' and the predicate devices are Anti-snoring devices intended to reduce snoring and mild to moderate sleep apnea in adults. Their fundamental scientific technology, design,t echnological characteristics and materials are also comparable, as outlined in the following table:
| | Subject Device | Predicate Device
K093710 | Predicate Device
K050592 |
|-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Oravan OSA | The Moses Appliance | Somnomed MAS RxA |
| | New Jersey Snoring
Solutions | Allen J. Moses, DDS,
Ltd. | Somnomed Ltd. |
| Characteristics
/ Features | | | |
| Indications for
Use | Oravan OSA is intended
to reduce snoring and
mild to moderate sleep
apnea in adults | The Moses appliance is
intended for use on
adult patients 18 years of
age and older as an aid
for the reduction and/or
alleviation of snoring
and mild to moderate
obstructive sleep apnea. | The SomnoMed MAS
RxA is intended to
reduce night time
snoring and mild to
moderate obstructive
sleep apnea (OSA) in
adults. |
| Prescription /
OTC Use | Prescription only
Note: Custom-fitted to
each patient, based on
dental impressions | Prescription only
Note: Custom-fitted to
each patient, based on
dental impressions | Prescription only
Note: Custom-fitted to
each patient, based on
dental impressions |
| Device
components/
parts | Orthodontic Acrylic trays
Expansion Screws
Wire with Ball clasp | Orthodontic Acrylic tray
Expansion Screws
Wire with Ball clasp | Orthodontic Acrylic trays
Expansion Screws
Wire with Ball clasp |
| Device
configuration | Two-piece design:
Upper acrylic tray
covers top posterior
teeth
Lower acrylic tray
covers bottom posterior
teeth | One-piece design:
Acrylic tray covers top
and bottom posterior
teeth
In addition, a retainer is
used for the top anterior
teeth. No such retainer
is required for the
bottom anterior teeth | Two-piece design:
Upper acrylic tray
covers top teeth (both
posterior and anterior)
Lower acrylic tray
covers bottom teeth
(both posterior and
anterior) |
| | Subject Device | Predicate Device K093710 | Predicate Device K050592 |
| | Oravan OSA | The Moses Appliance | Somnomed MAS RxA |
| | New Jersey Snoring Solutions | Allen J. Moses, DDS, Ltd. | Somnomed Ltd. |
| Characteristics / Features | | | |
| Device Functionality | The device allows for increase in the patient's pharyngeal opening, improving their ability to exchange air during sleep and reduce vibrations. | The device allows for increase in the patient's pharyngeal opening, improving their ability to exchange air during sleep and reduce vibrations. | The device allows for increase in the patient's pharyngeal opening, improving their ability to exchange air during sleep and reduce vibrations. |
| | Works by mandibular advancement using component advancement screws. | Works by mandibular advancement using component advancement screws. | Works by mandibular advancement using component advancement screws. |
| | Extension wings hold maxillary and mandibular sections in relative approximation once advancement is fixed | Extension wings hold maxillary and mandibular sections in relative approximation once advancement is fixed | Extension wings hold maxillary and mandibular sections in relative approximation once advancement is fixed |
| | Ball clasps hold the device on teeth | Ball clasps hold the device on teeth | Ball clasps hold the device on teeth |
| | Lower jaw advancement is adjustable using a supplied adjustment key | Lower jaw advancement is adjustable using a supplied adjustment key | Lower jaw advancement is adjustable using a supplied adjustment key |
| Mandibular Advancement range | Up to 6 mm | Up to 6 mm | Up to 6 mm |
| Materials | | | |
| · Orthodontic Acrylic | Two part Polymethylmethacrylate; supplied by Dentaurum; (Medical grade, biocompatible) | Two part Polymethylmethacrylate; supplied by Dentaurum; (Medical grade, biocompatible) | Two part Polymethylmethacrylate; supplied by Dentaurum; (Medical grade, biocompatible) |
| · Colorants | No colorants | Blue | Pink |
| · Screws
· Wire and ball clasp | Medical Grade Stainless Steel | Medical Grade Stainless Steel | Medical Grade Stainless Steel |
2
:
.
. .
3
Non-Clinical Data 7.
The submission includes data regarding the physical properties of the Orthodontic Acrylic material used in the Oravan OSA. These physical properties are in accordance with the requirements and limits specified in standard ISO 20795-2:2005 - Dentistry -- Base polymers -- Part 2: Orthodontic base polymers.
8. Clinical Testing
The submission does not rely on any clinical data; therefore no clinical testing was performed
9. Conclusion:
Based on the intended use, design, technological characteristics and non-clinical information provided in the submission; the proposed 'Oravan OSA' is substantially equivalent to the predicate device, and does not raise any new concerns of safety of effectiveness.
/
4
Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three overlapping, curved lines representing its wings or feathers.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
March 8, 2013
Ms. Deborah Stein Vice President New Jersey Snoring Solutions 769 Northfield Avenue, Suite 154 WEST ORANGE NJ 07052
Re: K121285
Trade/Device Name: Oravan OSA 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: January 16, 2013 Received: February 7, 2013
Dear Ms. Stein:
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.
5
Page 2 - Ms. Stein
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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Kwame O Ulmer for
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K12|285
Device Name:
Oravan OSA
Indications for Use:
Oravan OSA is intended to reduce snoring and mild to moderate sleep apnea in adults
Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
AND/OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
Mary S. Runner -S 013:03.07 12:48:04 COLLIA 18 5'00'> 0 0
(Division Sign-Off) Division of Anesthesiology, General Hospital fection Control, Dental Devices
510(k) Number:
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