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 Description

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.

AI/ML Overview

Here's an analysis of the provided text regarding the SomnoDent Avant device, focusing on acceptance criteria and the study proving it meets them.

The provided document is a 510(k) summary for the SomnoDent Avant, which primarily focuses on demonstrating substantial equivalence to predicate devices. It does not contain information about a clinical study with human subjects to prove the device's performance against specific acceptance criteria for effectiveness (e.g., reduction in AHI, improved snoring). Instead, the performance evaluation relies heavily on bench testing and material conformance to show that the modified device (SomnoDent Avant) is as safe and effective as its predicate (SomnoDent Flex).

Therefore, many of the requested sections (e.g., sample size for test set, number of experts, MRMC study, training set details) cannot be answered from the provided text, as such studies were not the basis for this 510(k) clearance.

Key takeaway: This 510(k) relies on demonstrating the new device is fundamentally similar to an already cleared device, not on new clinical performance data.

Acceptance Criteria and Device Performance (As Inferred from the 510(k) Summary)

Since a clinical performance study with acceptance criteria for clinical outcomes (e.g., AHI reduction) is not detailed, the "acceptance criteria" here are best characterized as design and material characteristics demonstrating substantial equivalence to the predicate, and bench test results confirming the safety and functional integrity of the modifications.

Acceptance Criterion (Inferred)	Reported Device Performance (from 510(k) Summary)
Material Biocompatibility	- Passes Cytotoxicity testing (ISO 10993-5)
	- Passes Sensitization testing (ISO 10993-10)
	- Passes Irritation testing (ISO 10993-10)
Material Conformance	- Conforms to ISO 20795-1 (Dentistry -- Polymers Part 1 Denture Base Polymers)
Adjustment Mechanism Functionality	- Bench testing confirms functionality of new adjustment mechanism (strap set material).
Adjustable Range	- Range of -1.0mm to +8.0mm, with 1mm increments, confirmed.
Risk Mitigation	- Risk Analysis conducted per ISO 14971.
Functional Equivalence to Predicate	- Device (SomnoDent Avant) functions as a mandibular repositioner, increasing pharyngeal space, similar to predicate.
Design Equivalence (Custom Fit)	- Customized fit for each patient, similar to predicate.
Intended Use Equivalence	- Intended for treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years or older, matching predicate.

Study Details Proving Device Meets Acceptance Criteria

Given that this 510(k) relies on substantial equivalence and bench testing, direct answers to many of the typical clinical study questions are not available from the provided text.

Sample Size Used for Test Set and Data Provenance:
- Test Set Sample Size: Not applicable in the context of clinical performance evaluation. The "test set" refers to materials or mechanical components undergoing bench testing. The specific number of samples for each bench test (biocompatibility, material conformance, adjustment mechanism) is not provided.
- Data Provenance: The document does not specify a country of origin for the bench testing data. It mentions "Bench testing of the new adjustment mechanism and evaluation of the additional strap set material," implying laboratory testing. The studies were non-clinical (Summary of Non-Clinical Testing).
Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Not applicable. Ground truth for clinical performance was not established through expert consensus in this 510(k). The "ground truth" for material properties and functionality was established by adherence to specified ISO standards and validated test methods.
Adjudication Method for the Test Set:
- Not applicable. This was not a human-reader study requiring adjudication.
If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done or reported in this 510(k) summary. The submission focuses on substantial equivalence through design, materials, and non-clinical bench testing.
If a Standalone (Algorithm Only) Performance Study was done:
- Not applicable. This device is a physical intraoral appliance, not an AI algorithm.
The Type of Ground Truth Used:
- The "ground truth" for the acceptance criteria was based on established international standards (ISO) for biocompatibility, material properties, and risk management (ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 20795-1, ISO 14971) and engineering principles for mechanical function. This is consistent with a 510(k) for a physical device demonstrating substantial equivalence.
The Sample Size for the Training Set:
- Not applicable. No "training set" in the context of machine learning or AI models was used. The device is physically manufactured based on patient scans and a prescribed design.
How the Ground Truth for the Training Set Was Established:
- Not applicable, as no training set was used.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

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.6513 Windcrest DriveSuite 100Plano, TX 75024Phone: 888-447-6673Email: dmarkwiese@somnomed.com
Official Correspondent:	Dorene Markwiese
Date Prepared:	May 6, 2019
Trade Name:	SomnoDent® Avant
Common Name:	Intraoral device for snoring and mild to moderate obstructivesleep apnea (OSA)
Classification Name:	Intraoral devices for snoring and intraoral devices for snoringand obstructive sleep apnea
Regulation Number:	21 CFR 872.5570
Product Code:	LRK / PLC
Class:	II
Panel:	Dental
Primary Predicate:Reference Devices	K073004, SomnoDent FlexNarval CC (K113201)MicrO2 OSA Device (K133683)

Description of the device:

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	PRIMARYPREDICATESomnoDent Flex(FDA K073004)	REFERENCENarval CC(FDA K113201)	REFERENCEMicrO2 OSA Device(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)
AdvancementMechanism	Polyamide	PMMA, StainlessSteel	Polyamide	PMMA
Intended Use
Indication forUse	The SomnoDentAvant is intended forthe treatment ofnighttime snoringand mild tomoderateobstructive sleepapnea in patients 18years of age andolder.	The SomnoMedMAS Flex "S" isintended toreduce or alleviatenight time snoringand mild tomoderateObstructive SleepApnea (OSA).	The Narval CC isintended toreduce oralleviate snoringand mild tomoderateobstructive sleepapnea (OSA) inadults.	The MICRODENTAL,Inc. Micro02 isintended to reducenight time snoringand mild tomoderateobstructive sleepapnea (OSA) inadults.
Intended as anintraoral device	Yes	Yes	Yes	Yes
Intended toreduce snoring orhelp alleviatesnoring	Yes	Yes	Yes	Yes
Treatment of mildto moderateobstructive sleepapnea	Yes	Yes	Yes	Yes
Intended fornight-time use	Yes	Yes	Yes	Yes
Indicated forsingle patientmulti-use	Yes	Yes	Yes	Yes
Indicated for useat home or sleeplaboratories	Yes	Yes	Yes	Yes
Targetpopulation:adults	Yes	Yes	Yes	Yes
Prescriptiondevice	Yes	Yes	Yes	Yes
Design
Customized fit foreach patient	Yes	Yes	Yes	Yes
Works bymandibularadvancement	Yes	Yes	Yes	Yes
Connected upperand lower traypieces	Yes	No	Yes	No
Manufacturetechnology	Uses computer-aided design (CAD)and manufacturedusing CNCmachining	Uses hand-mademanufacture ondental models	Uses computer-aided design(CAD) andmanufacturedusing selectivelaser sintering	Uses computer-aided design (CAD)and manufacturedusing CNCmachining

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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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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.”