SomnoDent Avant

K183443 · Somnomed, Inc. · LRK · May 8, 2019 · Dental

Device Facts

• Record ID: K183443
• Device Name: SomnoDent Avant
• Applicant: Somnomed, Inc.
• Product Code: LRK · Dental
• Decision Date: May 8, 2019
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The SomnoDent Avant is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

Device Story

SomnoDent Avant is a custom-fitted intraoral mandibular repositioning device used for treating snoring and mild to moderate obstructive sleep apnea. It consists of upper and lower dental trays connected by an adjustable strap mechanism. The device is worn during sleep to hold the mandible in a protrusive position, increasing pharyngeal space to improve airway patency. It is prescribed by a physician or dentist and fitted to the patient's anatomy. The device is adjusted by replacing straps of varying lengths to set the degree of mandibular advancement. It is intended for use at home or in sleep laboratories.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing (cytotoxicity, sensitization, irritation per ISO 10993-5 and ISO 10993-10), material conformance testing (ISO 20795-1), and risk analysis (ISO 14971).

Technological Characteristics

Custom-fitted intraoral device. Materials: PMMA (tray), SMH B-Flex (soft liner), Polyamide (advancement mechanism). Principle: Mandibular advancement via adjustable strap coupling. Manufacturing: CAD/CNC machining. No energy source. Non-sterile.

Indications for Use

Indicated for patients 18 years of age or older with nighttime snoring and mild to moderate obstructive 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 Flex (K073004)

Reference Devices

• Narval CC (K113201)
• MicrO2 OSA Device (K133683)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 8, 2019

SomnoMed Inc. % Dorene Markwiese Director Regulatory Affairs and Quality Assurance SonoMed Inc. 820 Civic Center Dr. Santa Clara, California 95050

Re: K183443

Trade/Device Name: SomnoDent Avant Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices For Snoring And Obstructive Sleep Apnea Regulatory Class: Class II Product Code: LRK, LOZ Dated: January 28, 2019 Received: February 7, 2019

Dear Dorene Markwiese:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Malvina Eydelman, M.D. Director OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Image /page/2/Picture/0 description: The image is a logo for SomnoMed. The logo features a blue graphic element above the company name, "SomnoMed," which is written in gray. Below the name, in smaller font, are the words "Dental • Sleep • Medical" also in gray.

# Indications for Use

#### 510(k) Number (if known):

Device Name: SomnoDent Avant

#### Indications for Use:

The SomnoDent Avant is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

Prescription Use _ X AND/OR (Part 21 CFR 801 Subpart D)

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

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Image /page/3/Picture/0 description: The image shows the logo for SomnoMed. The logo consists of a blue, stylized shape resembling two overlapping curved shapes, positioned above the text "SomnoMed" in a gray, sans-serif font. Below the name, in a smaller font, are the words "Dental • Sleep • Medical".

# 510(k) Summary (21 CFR 807.92)

#### 510(k) Number: K183443

| Submission Owner: | SomnoMed, Inc.<br>6513 Windcrest Drive<br>Suite 100<br>Plano, TX 75024<br>Phone: [phone]<br>Email: [e-mail] |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Dorene Markwiese |
| Date Prepared: | May 6, 2019 |
| Trade Name: | SomnoDent® Avant |
| Common Name: | Intraoral device for snoring and mild to moderate obstructive<br>sleep apnea (OSA) |
| Classification Name: | Intraoral devices for snoring and intraoral devices for snoring<br>and obstructive sleep apnea |
| Regulation Number: | 21 CFR 872.5570 |
| Product Code: | LRK / PLC |
| Class: | II |
| Panel: | Dental |
| Primary Predicate:<br>Reference Devices | K073004, SomnoDent Flex<br>Narval CC (K113201)<br>MicrO2 OSA Device (K133683) |

#### Description of the device:

The SomnoDent Avant device is an intraoral device used for treating Snoring and Sleep Apnea. The device functions as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to exchange air during sleep. The device is customized for each patient and has an adjustable coupling mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The SomnoDent Avant is a modification to the SomnoDent Flex (K073004). The SomnoDent Avant is identical to SomnoDent Flex, except for differences in the adjustment mechanism (strap set material), and a change in adjustable range from -1.0mm to +8.0mm.

#### Indications for Use:

The SomnoDent Avant is intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

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# 510(k) Summary

"

## Substantial Equivalence:

,

Substantial Equivalence Table

| Substantial Equivalence Table | | | | |
|----------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | SomnoDent Avant | PRIMARY<br>PREDICATE<br>SomnoDent Flex<br>(FDA K073004) | REFERENCE<br>Narval CC<br>(FDA K113201) | REFERENCE<br>MicrO2 OSA Device<br>(FDA K133683) |
| | Image: SomnoDent Avant | Image: SomnoDent Flex | Image: Narval CC | Image: Micro2 OSA Device |
| Materials | | | | |
| Tray | PMMA | PMMA | Polyamide | PMMA |
| Soft Liner | SMH B-Flex | SMH B-Flex | (none) | (none) |
| Advancement<br>Mechanism | Polyamide | PMMA, Stainless<br>Steel | Polyamide | PMMA |
| Intended Use | | | | |
| Indication for<br>Use | The SomnoDent<br>Avant is intended for<br>the treatment of<br>nighttime snoring<br>and mild to<br>moderate<br>obstructive sleep<br>apnea in patients 18<br>years of age and<br>older. | The SomnoMed<br>MAS Flex "S" is<br>intended to<br>reduce or alleviate<br>night time snoring<br>and mild to<br>moderate<br>Obstructive Sleep<br>Apnea (OSA). | The Narval CC is<br>intended to<br>reduce or<br>alleviate snoring<br>and mild to<br>moderate<br>obstructive sleep<br>apnea (OSA) in<br>adults. | The MICRODENTAL,<br>Inc. Micro02 is<br>intended to reduce<br>night time snoring<br>and mild to<br>moderate<br>obstructive sleep<br>apnea (OSA) in<br>adults. |
| Intended as an<br>intraoral device | Yes | Yes | Yes | Yes |
| Intended to<br>reduce snoring or<br>help alleviate<br>snoring | Yes | Yes | Yes | Yes |
| Treatment of mild<br>to moderate<br>obstructive sleep<br>apnea | Yes | Yes | Yes | Yes |
| Intended for<br>night-time use | Yes | Yes | Yes | Yes |
| Indicated for<br>single patient<br>multi-use | Yes | Yes | Yes | Yes |
| Indicated for use<br>at home or sleep<br>laboratories | Yes | Yes | Yes | Yes |
| Target<br>population:<br>adults | Yes | Yes | Yes | Yes |
| Prescription<br>device | Yes | Yes | Yes | Yes |
| Design | | | | |
| Customized fit for<br>each patient | Yes | Yes | Yes | Yes |
| Works by<br>mandibular<br>advancement | Yes | Yes | Yes | Yes |
| Connected upper<br>and lower tray<br>pieces | Yes | No | Yes | No |
| Manufacture<br>technology | Uses computer-<br>aided design (CAD)<br>and manufactured<br>using CNC<br>machining | Uses hand-made<br>manufacture on<br>dental models | Uses computer-<br>aided design<br>(CAD) and<br>manufactured<br>using selective<br>laser sintering | Uses computer-<br>aided design (CAD)<br>and manufactured<br>using CNC<br>machining |

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# 510(k) Summarv

#### Substantial Equivalence Discussion:

The SomnoDent Avant is considered to be substantially equivalent to the SomnoDent Flex device. SomnoDent Avant is an oral appliance used for the treatment of snoring and mild to moderate Obstructive Sleep Apnea (OSA). The SomnoDent Avant and predicate device function as a mandibular repositioner, which acts to increase the patient's pharyngeal space during sleep. The increase in the patient's pharyngeal space improves their ability to exchange air during sleep. The devices are customized for each patient and have an adjustable coupling mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.

The device consists of two travs customized to fit over the upper and lower teeth and the lower tray is held in a protrusive position by an advancement mechanism consisting of a strap attached to an upper anterior quide and two lower fixing elements. The devices the mandible in the sagittal plane to increase the patient's pharyngeal space during sleep and reduce the apnoeic symptoms.

SomnoDent Avant is retained to the teeth by a polymeric material (called SMH B-Flex) which forms a soft, flexible lining between the teeth and dental acrylic. This material continuously engages the undercut along the entire arch on both labial and linqual sides. This polymeric material, SMH B- flex, is the same material previously cleared by FDA under K073004.

SomnoDent Avant is adjusted by switching out the strap for another strap with a different length. This adjustment may be required to fine-tune treatment, increase comfort or to ensure ongoing effectiveness as the patient's anatomy adapts.

The device has a device special control guidance document entitled "Class II Special Controls Guidance Document: Intracral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA."

The SomnoDent Avant is identical to SomnoDent Flex, except for differences in the adjustment mechanism (strap set material), and a change in adjustable range, i.e., increments of 1mm, from -1.0mm to +8.0mm, and the additional Avant Strap Sets. Any differences introduced by these modifications, when compared to the predicate product, do not affect substantial equivalence.

#### Summary of Non-Clinical Testing:

Bench testing of the new adjustment mechanism and evaluation of the additional strap set material confirms substantial equivalence of the SomnoDent Avant to the predicate device.

- Biocompatibility Evaluation per FDA Guidance Use of International Standard ISO 10993-1, . "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
- Conducted Cytotoxicity, Sensitization and Irritation biocompatibility testing per ISO o 10993-5 and ISO 10993-10
- Evaluation of material conformance to ISO 20795-1 Dentistry -- Polymers Part 1 Denture . Base Polymers
- Risk Analysis of the modification per ISO 14971 .

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## Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807, and based on the information provided in this premarket notification, it is concluded that the SomnoDent Avant is substantially equivalent to the predicate devices.

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