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.

AI/ML Overview

The Oravan OSA device, an anti-snoring and mild to moderate sleep apnea treatment, established substantial equivalence through non-clinical data rather than through a study proving it meets specific acceptance criteria based on patient outcomes.

The submission does not include a table of acceptance criteria and reported device performance in the typical sense for a clinical study comparing an AI device to a ground truth. Instead, the focus is on demonstrating that the materials used in the device meet existing standards.

Here's a breakdown of the information that can be extracted from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance (Material Properties)
ISO 20795-2:2005 - Dentistry -- Base polymers -- Part 2: Orthodontic base polymers (Requirements and limits for physical properties)	The physical properties of the Orthodontic Acrylic material used in the Oravan OSA are in accordance with this standard.

2. Sample size used for the test set and the data provenance

Sample size for the test set: Not applicable. No clinical test set was used for performance evaluation of the device's therapeutic effectiveness. The "test set" here refers to the material samples evaluated against the ISO standard. The size of this material sample set is not specified.
Data provenance: Not explicitly stated, but implicitly derived from manufacturer testing of their raw materials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts: Not applicable. The "ground truth" for the material properties was established by adherence to the objective criteria outlined in the ISO standard, not by expert consensus on clinical outcomes.

4. Adjudication method for the test set

Adjudication method: Not applicable for clinical endpoints. For material properties, the "adjudication" is based on whether the measured physical properties of the orthodontic acrylic met the specifications of ISO 20795-2:2005.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC study: No. This is not an AI device, and no MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone performance: Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

Type of ground truth: For the material safety and performance, the ground truth was established by compliance with an international standard (ISO 20795-2:2005) for orthodontic base polymers. There was no clinical ground truth established for the device's effectiveness in reducing snoring or sleep apnea as no clinical testing was performed or required for substantial equivalence.

8. The sample size for the training set

Sample size for the training set: Not applicable. This is not an AI device that requires a training set.

9. How the ground truth for the training set was established

How the ground truth for the training set was established: Not applicable. This is not an AI device.

Study Proving Acceptance Criteria:

The study proving the device meets its "acceptance criteria" (in the context of this 510(k) submission) is a non-clinical study evaluating the physical properties of the Orthodontic Acrylic material.

Methodology: The submission states that the physical properties of the orthodontic acrylic material used in the Oravan OSA were tested against the requirements and limits specified in the international standard ISO 20795-2:2005 - Dentistry -- Base polymers -- Part 2: Orthodontic base polymers.
Outcome: The manufacturer reported that these physical properties were "in accordance with" the specified requirements and limits of the standard. This demonstrates that the material used is suitable for its intended purpose and meets established safety and performance benchmarks for dental materials.

The entire 510(k) submission relies on demonstrating substantial equivalence to existing predicate devices (Somnomed MAS RxA K050592 and The Moses Appliance K093710) by comparing their indications for use, technological characteristics, design, and materials. The non-clinical material testing supports the safety of the chosen material (orthodontic acrylic) by confirming its compliance with a relevant ISO standard. No clinical data or performance studies on the device's effectiveness in patients were submitted or required for this clearance.

Summary

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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:

4. Indications for Use:

Oravan OSA is intended to reduce snoring and mild to moderate sleep apnea in adults

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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 DeviceK093710	Predicate DeviceK050592
	Oravan OSA	The Moses Appliance	Somnomed MAS RxA
	New Jersey SnoringSolutions	Allen J. Moses, DDS,Ltd.	Somnomed Ltd.
Characteristics/ Features
Indications forUse	Oravan OSA is intendedto reduce snoring andmild to moderate sleepapnea in adults	The Moses appliance isintended for use onadult patients 18 years ofage and older as an aidfor the reduction and/oralleviation of snoringand mild to moderateobstructive sleep apnea.	The SomnoMed MASRxA is intended toreduce night timesnoring and mild tomoderate obstructivesleep apnea (OSA) inadults.
Prescription /OTC Use	Prescription onlyNote: Custom-fitted toeach patient, based ondental impressions	Prescription onlyNote: Custom-fitted toeach patient, based ondental impressions	Prescription onlyNote: Custom-fitted toeach patient, based ondental impressions
Devicecomponents/parts	Orthodontic Acrylic traysExpansion ScrewsWire with Ball clasp	Orthodontic Acrylic trayExpansion ScrewsWire with Ball clasp	Orthodontic Acrylic traysExpansion ScrewsWire with Ball clasp
Deviceconfiguration	Two-piece design:Upper acrylic traycovers top posteriorteethLower acrylic traycovers bottom posteriorteeth	One-piece design:Acrylic tray covers topand bottom posteriorteethIn addition, a retainer isused for the top anteriorteeth. No such retaineris required for thebottom anterior teeth	Two-piece design:Upper acrylic traycovers top teeth (bothposterior and anterior)Lower acrylic traycovers bottom teeth(both posterior andanterior)
	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

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. .

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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.

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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.

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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

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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:

Page 1 of 1

Page 22 of 84

Regulation Number and Section

§ 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.”