(87 days)
No
The device description and performance studies focus on the physical properties and mechanical function of a custom-fitted oral appliance, with no mention of AI or ML technologies.
Yes
The device is intended to reduce snoring and mild to moderate sleep apnea in adults, which are medical conditions, and it works by physically improving the patient's ability to exchange air, indicating a therapeutic function.
No
Explanation: The device is intended to reduce snoring and mild to moderate sleep apnea, not to diagnose these conditions. It is a treatment device, specifically an oral appliance that repositions the mandible to increase the pharyngeal opening.
No
The device description explicitly states it is made of "orthodontic acrylic trays and herbst assembly," which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce snoring and mild to moderate sleep apnea in adults. This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a physical appliance designed to mechanically adjust the jaw position. It does not involve testing samples from the human body (like blood, urine, or tissue) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, or analysis of biological samples.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Oravan Herbst does not fit this description.
N/A
Intended Use / Indications for Use
Oravan Herbst 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 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).
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
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 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.
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
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.”
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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)
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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 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.