Who is the manufacturer of Oravan Herbst?

Oravanosa, LLC filed the 510(k) submission for Oravan Herbst (K152159).

What is the FDA product code for Oravan Herbst?

LRK. It is classified under 21 CFR 872.5570 as a Class 2 device in the Dental panel.

What is the regulatory pathway for Oravan Herbst?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Oravan Herbst?

SomnoDent Herbst (K130558); Oravan OSA (K121285).

Who can help prepare an FDA 510(k) submission like Oravan Herbst?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Oravan Herbst

K152159 · Oravanosa, LLC · LRK · Oct 29, 2015 · Dental

Device Facts

Record ID	K152159
Device Name	Oravan Herbst
Applicant	Oravanosa, LLC
Product Code	LRK · Dental
Decision Date	Oct 29, 2015
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.5570
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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

Device Story

Oravan Herbst is a custom-fitted, two-piece intraoral device consisting of upper and lower orthodontic acrylic trays and a Herbst-style titration assembly. Used by adults during sleep to reduce snoring and mild to moderate sleep apnea. The device is prescribed by a physician and custom-fabricated based on dental impressions. The Herbst assembly enables mandibular advancement, which increases the patient's pharyngeal opening, improving air exchange and reducing vibrations. The physician or patient adjusts the advancement mechanism using a supplied Allen key to achieve the desired therapeutic effect. The device is intended for home use.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Materials: Medical-grade, biocompatible two-part Polymethylmethacrylate (acrylic) and medical-grade stainless steel. Design: Two-piece custom-fitted trays with Herbst-style titration assembly (fixing elements, Allen screws, guiding telescope). Standards: ISO 20795-2:2005 (orthodontic base polymers), ISO 14971 (risk management). No electronics or software.

Indications for Use

Indicated for adults with snoring and mild to moderate sleep apnea.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

SomnoDent Herbst (K130558)
Oravan OSA (K121285)

Related Devices

K121285 — ORAVAN OSA · New Jersey Snoring Solutions · Mar 8, 2013
K170578 — True Function Adjustable Herbst Appliances · True Function Laboratory, Inc. · Nov 24, 2017
K130558 — SOMNODENT HERBST; CLASSIC, FLEX · Somnomed, Inc. · May 17, 2013
K113126 — ACRYLIC HERBST APPLIANCE · Gergens Orthodontic Lab · Jul 17, 2013
K140429 — CRANE ACRYLIC HERBST APPLIANCE · Crane Dental Laboratory, Inc. · Sep 11, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are black and are arranged in a way that suggests a sense of unity and collaboration. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image. 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. {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}------------------------------------------------ ## 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) ### 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." {3}------------------------------------------------ # SECTION 5 # 510(k) Summary #### Submitter's Name and Contact Information 1. | Company Name: | OravanOSA, LLC | |-----------------|-----------------------------------------------------------| | Address: | 769 Northfield Avenue, Suite 160 West Orange, NJ 07052 | | Contact Person: | Deborah Stein Vice 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: 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). {4}------------------------------------------------ #### 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 Device K121285 | Reference Predicate Device K130558 | |-----------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Device Name | Oravan Herbst | Oravan OSA | SomnoDent Herbst | | Submitter | OravanOSA, LLC | New Jersey Snoring Solutions (n.b.a OravanOSA, LLC) | SomnoMed Inc. | | Characteristics / Features | | | | | Indications for Use | Oravan Herbst is intended to reduce snoring and mild to moderate sleep apnea in adults. | Oravan OSA is intended to reduce snoring and mild to moderate sleep apnea in adults. | The SomnoDent Herbst is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. | | Prescription / OTC Use | Prescription only | Prescription only | Prescription only | | | Note: Custom-fitted to each patient, based on dental impressions | Note: Custom-fitted to each patient, based on dental impressions | Note: Custom-fitted to each patient, based on dental impressions | | | Subject Device | Predicate Device | Reference Predicate Device | | Device Name | Oravan Herbst | K121285 | K130558 | | Submitter | OravanOSA, LLC | Oravan OSA New Jersey Snoring Solutions (n.b.a OravanOSA, LLC) | SomnoDent Herbst SomnoMed Inc. | | Characteristics / Features | | | | | Device components/ parts | • Orthodontic Acrylic trays • Herbst Assembly • Wire with ball clasps • Allen key | • Orthodontic Acrylic trays • Expansion Screws • Wire with ball clasps • Allen key | • Orthodontic Acrylic trays • Herbst Assembly • Wire with ball clasps • Allen key | | Device configuration | Two-piece design: Upper acrylic tray covers top posterior teeth | Two-piece design: Upper acrylic tray covers top posterior teeth | Two-piece design: Upper acrylic tray covers top teeth | | | Lower acrylic tray covers bottom posterior teeth | Lower acrylic tray covers bottom posterior teeth | Lower acrylic tray covers bottom teeth | | 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 adjustable mechanism (a standard Herbst style titration mechanism). The Herbst assembly includes • Fixing Elements with Allen Screws and Wrench • Long Herner Guiding Telescope | Works by mandibular advancement using component advancement screws. Extension wings hold maxillary and mandibular sections in relative approximation once advancement is fixed. | Works by mandibular advancement using adjustable mechanism (a standard Herbst style titration mechanism). The Herbst assembly includes • Fixing Elements with Allen Screws and Wrench • Long Herner Guiding Telescope | | | 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 | | | Subject Device | Predicate Device K121285 | Reference Predicate Device K130558 | | Device Name | Oravan Herbst | Oravan OSA | SomnoDent Herbst | | Submitter | OravanOSA, LLC | New Jersey Snoring Solutions (n.b.a OravanOSA, LLC) | SomnoMed Inc. | | Characteristics / Features | | | | | Mandibular Advancement range | Up to 5 mm | Up to 6 mm | Up to 5 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 (Medical grade, biocompatible) | | • Colorants | No colorants | No colorants | Not specified | | • Wire with ball clasps | Medical Grade Stainless Steel | Medical Grade Stainless Steel | Medical Grade Stainless Steel | | • Advancement Mechanism - herbst assembly | Medical Grade Stainless Steel | Not Applicable | Medical Grade Stainless Steel | | • Advancement Mechanism - expansion screws | Not Applicable | Medical Grade Stainless Steel | Not Applicable | {5}------------------------------------------------ {6}------------------------------------------------ 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. {7}------------------------------------------------ #### 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.