Predicate Devices

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on mechanical adjustments and material properties, with no mention of AI or ML.

Therapeutic

Yes
The device is described as being "intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea," indicating a therapeutic purpose.

Diagnostic

No
Explanation: The device is intended for the treatment of snoring and sleep apnea, not for diagnosing these conditions. It functions as a mandibular repositioner to improve air exchange.

SaMD (Software as a Medical Device)

No

The device description clearly states it is an "intraoral device" and describes physical components and materials, indicating it is a hardware device, not software-only.

IVD (In Vitro Diagnostic)

Based on the provided information, the SomnoDent Avant is not an IVD (In Vitro Diagnostic) device.

Here's why:

Intended Use: The intended use is for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea. This is a therapeutic purpose, not a diagnostic one.
Device Description: The device is an intraoral mandibular repositioner that physically alters the patient's airway during sleep. It does not analyze biological samples (like blood, urine, or tissue) to provide diagnostic information.
Lack of Diagnostic Activity: There is no mention of the device being used to diagnose sleep apnea or any other condition. Its function is purely mechanical and aimed at treating a diagnosed condition.

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The SomnoDent Avant does not fit this description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / 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.

Product codes (comma separated list FDA assigned to the subject device)

LRK, LOZ

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.

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

18 years of age or older

Intended User / Care Setting

Not Found

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)

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 .

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.

K073004

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.

K113201, K133683

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.”

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 Drive
Suite 100
Plano, TX 75024
Phone: 888-447-6673
Email: 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 obstructive
sleep apnea (OSA) |
| Classification Name: | Intraoral devices for snoring and intraoral devices for snoring
and obstructive sleep apnea |
| Regulation Number: | 21 CFR 872.5570 |
| Product Code: | LRK / PLC |
| Class: | II |
| Panel: | Dental |
| Primary Predicate:
Reference Devices | K073004, SomnoDent Flex
Narval CC (K113201)
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
PREDICATE
SomnoDent Flex
(FDA K073004)	REFERENCE
Narval CC
(FDA K113201)	REFERENCE
MicrO2 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)
Advancement
Mechanism	Polyamide	PMMA, Stainless
Steel	Polyamide	PMMA
Intended Use
Indication 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 and
older.	The SomnoMed
MAS Flex "S" is
intended to
reduce or alleviate
night time snoring
and mild to
moderate
Obstructive Sleep
Apnea (OSA).	The Narval CC is
intended to
reduce or
alleviate snoring
and mild to
moderate
obstructive sleep
apnea (OSA) in
adults.	The MICRODENTAL,
Inc. Micro02 is
intended to reduce
night time snoring
and mild to
moderate
obstructive sleep
apnea (OSA) in
adults.
Intended as an
intraoral device	Yes	Yes	Yes	Yes
Intended to
reduce snoring or
help alleviate
snoring	Yes	Yes	Yes	Yes
Treatment of mild
to moderate
obstructive sleep
apnea	Yes	Yes	Yes	Yes
Intended for
night-time use	Yes	Yes	Yes	Yes
Indicated for
single patient
multi-use	Yes	Yes	Yes	Yes
Indicated for use
at home or sleep
laboratories	Yes	Yes	Yes	Yes
Target
population:
adults	Yes	Yes	Yes	Yes
Prescription
device	Yes	Yes	Yes	Yes
Design
Customized fit for
each patient	Yes	Yes	Yes	Yes
Works by
mandibular
advancement	Yes	Yes	Yes	Yes
Connected upper
and lower tray
pieces	Yes	No	Yes	No
Manufacture
technology	Uses computer-
aided design (CAD)
and manufactured
using CNC
machining	Uses hand-made
manufacture on
dental models	Uses computer-
aided design
(CAD) and
manufactured
using selective
laser sintering	Uses computer-
aided design (CAD)
and manufactured
using CNC
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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