The Oravan Herbst is intended to reduce snoring and mild to moderate sleep apnea in adults. It is made of orthodontic acrylic trays and herbst assembly. It has two acrylic pieces - the upper acrylic tray that fits over the top posterior teeth and the lower acrylic tray that fits over the bottom posterior teeth. The herbst assembly provides a standard titration mechanism and enables mandibular advancement. With this design, the Oravan Herbst allows the physician to increase the patient's pharyngeal opening, improving their ability to exchange air during sleep and reduce vibrations. Each Oravan Herbst device is patient-specific (customized for each patient).

AI/ML Overview

The device in question is the Oravan Herbst, an intraoral device intended to reduce snoring and mild to moderate sleep apnea in adults.

Here's an analysis based on the provided text, addressing the points requested:

1. A table of acceptance criteria and the reported device performance

The document does not explicitly present specific acceptance criteria in terms of clinical performance metrics (e.g., AHI reduction, success rate) or a "reported device performance" in a clinical context. Instead, the substantial equivalence relies on:

Acceptance Criteria Category	Specific Criteria (Implicitly Met)	Reported Device Performance (as demonstrated for substantial equivalence)
Intended Use	Reduction of snoring and mild to moderate sleep apnea in adults.	Oravan Herbst is intended for this use, matching predicate devices.
Technological Characteristics	Similar fundamental scientific technology, design, and materials to predicate devices (SomnoDent Herbst K130558 and Oravan OSA K121285). The key difference in adjustment mechanism (Herbst style vs. expansion screws) is deemed minor and not raising new concerns for equivalence, as both achieve mandibular advancement.	Device Components/Parts: Orthodontic Acrylic trays, Herbst Assembly, Wire with ball clasps, Allen key (Matches SomnoDent Herbst).Device Configuration: Two-piece design, upper and lower acrylic trays covering posterior teeth (Matches both predicates).Device Functionality: Mandibular advancement to increase pharyngeal opening, improve air exchange, reduce vibrations (Matches both predicates).Mandibular Advancement Range: Up to 5mm for Oravan Herbst (Matches SomnoDent Herbst, Oravan OSA is 6mm, considered minor difference).Materials: Medical grade Polymethylmethacrylate, Medical Grade Stainless Steel for wire with ball clasps and Herbst assembly (Matches both predicates). No colorants used.
Non-Clinical Data	Physical properties of orthodontic acrylic material in accordance with ISO 20795-2:2005. Risk analysis performed per ISO 14971, with acceptable hazards.	Physical properties of orthodontic acrylic material meet ISO 20795-2:2005 (same as K121285). Risk analysis demonstrates hazards are acceptable based on biocompatible materials, well-characterized design, labeling, and performance testing.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The submission states, "The submission does not rely on any clinical data; therefore no clinical testing was performed." This means there was no test set of patient data used to evaluate the device clinically. The evaluation was based on non-clinical data and comparison to predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Since no clinical data or clinical testing was performed, there was no test set requiring ground truth established by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as no clinical test set was used.

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

Not applicable. This device is an intraoral appliance, not an AI-powered diagnostic tool, and no MRMC study was mentioned.

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

Not applicable, as this is a physical medical device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable, as no clinical studies were performed. The "ground truth" for substantial equivalence was primarily based on established standards (e.g., ISO for materials) and the characteristics of legally marketed predicate devices.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device, so there is no concept of a "training set."

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

Not applicable, as there is no training set.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

October 29, 2015

OravanOSA, LLC Ms. Deborah Stein Vice President 769 Northfield Avenue, Suite 160 West Orange, New Jersey 07052

Re: K152159 Trade/Device Name: Oravan Herbst 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: July 22, 2015 Received: August 3, 2015

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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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

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Indications for Use

510(k) Number (if known)

к152159

Device Name Oravan Herbst

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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SECTION 5 510(k) Summary

Submitter's Name and Contact Information 1.

Company Name:	OravanOSA, LLC
Address:	769 Northfield Avenue, Suite 160West Orange, NJ 07052
Contact Person:	Deborah SteinVice President, OravanOSA LLC
Email:	debbie481@comcast.net
Telephone:	973-886-6855
Fax:	973-325-6442

Summary Preparation Date: July 15, 2015

2. Device Identification:

Proprietary Name:	Oravan Herbst
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:

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4. Indications for Use:

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

5. Predicate Devices:

The Oravan Herbst is substantially equivalent to the following devices:

SomnoDent Herbst (by SomnoMed Inc.), K130558 i.
Oravan OSA (by New Jersey Snoring Solutions), K121285 ii.

Summary of Similar Technological Characteristics 6.

The proposed 'Oravan Herbst' 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, technological characteristics and materials are also comparable, as outlined in the following table:

	Subject Device	Predicate DeviceK121285	ReferencePredicate DeviceK130558
Device Name	Oravan Herbst	Oravan OSA	SomnoDent Herbst
Submitter	OravanOSA, LLC	New Jersey SnoringSolutions(n.b.a OravanOSA, LLC)	SomnoMed Inc.
Characteristics /Features
Indications for Use	Oravan Herbst isintended to reducesnoring and mild tomoderate sleep apneain adults.	Oravan OSA is intended toreduce snoring and mild tomoderate sleep apnea inadults.	The SomnoDent Herbstis intended for thetreatment of nighttimesnoring and mild tomoderate obstructivesleep apnea in patients18 years of age or older.
Prescription / OTCUse	Prescription only	Prescription only	Prescription only
	Note: Custom-fitted toeach patient, based ondental impressions	Note: Custom-fitted toeach patient, based ondental impressions	Note: Custom-fitted toeach patient, based ondental impressions
	Subject Device	Predicate Device	ReferencePredicate Device
Device Name	Oravan Herbst	K121285	K130558
Submitter	OravanOSA, LLC	Oravan OSANew Jersey SnoringSolutions(n.b.a OravanOSA, LLC)	SomnoDent HerbstSomnoMed Inc.
Characteristics /Features
Devicecomponents/ parts	• Orthodontic Acrylictrays• Herbst Assembly• Wire with ball clasps• Allen key	• Orthodontic Acrylic trays• Expansion Screws• Wire with ball clasps• Allen key	• Orthodontic Acrylictrays• Herbst Assembly• Wire with ball clasps• Allen key
Deviceconfiguration	Two-piece design:Upper acrylic traycovers top posteriorteeth	Two-piece design:Upper acrylic tray coverstop posterior teeth	Two-piece design:Upper acrylic traycovers top teeth
	Lower acrylic traycovers bottom posteriorteeth	Lower acrylic tray coversbottom posterior teeth	Lower acrylic traycovers bottom teeth
DeviceFunctionality	The device allows forincrease in the patient'spharyngeal opening,improving their ability toexchange air duringsleep and reducevibrations.	The device allows forincrease in the patient'spharyngeal opening,improving their ability toexchange air during sleepand reduce vibrations.	The device allows forincrease in the patient'spharyngeal opening,improving their ability toexchange air duringsleep and reducevibrations.
	Works by mandibularadvancement usingadjustable mechanism(a standard Herbst styletitration mechanism).The Herbst assemblyincludes• Fixing Elementswith Allen Screwsand Wrench• Long HernerGuiding Telescope	Works by mandibularadvancement usingcomponent advancementscrews.Extension wings holdmaxillary and mandibularsections in relativeapproximation onceadvancement is fixed.	Works by mandibularadvancement usingadjustable mechanism(a standard Herbst styletitration mechanism).The Herbst assemblyincludes• Fixing Elementswith Allen Screwsand Wrench• Long HernerGuiding Telescope
	Lower jawadvancement isadjustable using asupplied adjustmentkey	Lower jaw advancement isadjustable using asupplied adjustment key	Lower jaw advancementis adjustable using asupplied adjustment key
	Subject Device	Predicate DeviceK121285	ReferencePredicate DeviceK130558
Device Name	Oravan Herbst	Oravan OSA	SomnoDent Herbst
Submitter	OravanOSA, LLC	New Jersey SnoringSolutions(n.b.a OravanOSA, LLC)	SomnoMed Inc.
Characteristics /Features
MandibularAdvancementrange	Up to 5 mm	Up to 6 mm	Up to 5 mm
Materials
• OrthodonticAcrylic	Two partPolymethylmethacrylatesupplied by Dentaurum;(Medical grade,biocompatible)	Two partPolymethylmethacrylatesupplied by Dentaurum;(Medical grade,biocompatible)	Two partPolymethylmethacrylate(Medical grade,biocompatible)
• Colorants	No colorants	No colorants	Not specified
• Wire with ballclasps	Medical GradeStainless Steel	Medical Grade StainlessSteel	Medical Grade StainlessSteel
• AdvancementMechanism -herbstassembly	Medical GradeStainless Steel	Not Applicable	Medical Grade StainlessSteel
• AdvancementMechanism -expansionscrews	Not Applicable	Medical Grade StainlessSteel	Not Applicable

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The Oravan Herbst is a modification to Oravan OSA (K121285), the main difference being the type of adjustment mechanism. The Oravan OSA works by mandibular advancement using component advancement screws. In contrast, the Oravan Herbst has a herbst style titration mechanism which is the same as that in the SomnoDent Herbst.

The Oravan Herbst and the predicate devices enable mandibular advancement through adjustment mechanism. At the time of fitting the device, the advancement mechanism can be adjusted up to 5 mm (in case of Oravan Herbst and SomnoDent Herbst) and up to 6 mm (in case of Oravan OSA), after placement. This difference is minor and does not raise any new concerns of equivalence as the purpose of this adjustment mechanism is to increase the patient's pharyngeal opening, thus improving ability to exchange air during sleep and reduce vibrations.

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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 Herbst. 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. This performance data is the same as submitted in K121285 for predicate Oravan OSA. In addition, risk analysis was performed for the Oravan Herbst per standard ISO 14971. The potential risks/hazards include improper fit (due to incorrect registry and impression), minor discomfort due to rigid positioning, component/device failure, material reaction and risks resulting from failure to follow instructions for use. Based on the use of biocompatible materials, well characterized design, labeling, performance testing; the results of the risk analysis demonstrate that the hazards associated with the use of the Oravan Herbst are acceptable in regard to the product's intended use and the risk acceptance criteria.

Clinical Testing 8.

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 nonclinical information provided in the submission; the proposed 'Oravan Herbst' is substantially equivalent to the referenced predicate devices.

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.”