The SonmoDent® intraoral devices are intended for the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

Optionally, if the DentiTrac® micro-recorder is completely embedded into the SomnoDent® device, the microrecorder is intended to measure patient compliance to oral device/appliance therapy in combination with the DentiTrac® System.

Device Description

The SomnoDent family of intraoral devices consists of the following models: Classic, Flex, G2, Herbst Advance, and Fusion. The devices 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 devices are patient specific (they are customized for each patient) and have an adjustable coupling mechanism enabling the amount of mandibular advancement to be seep dentist at the time of fitting the device. The devices can then be adjusted by the sleep dentist to control the treatment to find the best possible adjustment.

This submission adds the option for any clinician to decide to incorporate a DentiTrac® microrecorder embedded into a SomnoDent® to record a patient's compliance to the prescribed oral appliance therapy in combination with the DentiTrac® System. This option can be incorporated into the family member models listed above. During scheduled visits, the data within the DentiTrac® can be uploaded to a web application for cloud-based reporting and tracking using a DentiTrac® Base Station at the clinician's office. The DentiTrac® micro-recorder monitors the wear time through the oral temperature, as well as tracks movements and head position. The inclusion of the embedded DentiTrac® micro-recorder provides additional information when used in combination with the DentiTrac® System, but does not impact the operating principles or safety of the SomnoDent®

AI/ML Overview

This document describes the SomnoDent® with Micro-Recorder, an oral appliance intended for the treatment of snoring and mild to moderate obstructive sleep apnea, with an optional embedded micro-recorder to measure patient compliance.

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not provide specific, quantifiable acceptance criteria or reported device performance metrics in a readily extractable table for the SomnoDent® with Micro-Recorder itself.

Instead, the submission for the SomnoDent® with Micro-Recorder relies on demonstrating substantial equivalence to a previously cleared predicate device (SomnoDent® Fusion Classic and SomnoDent® Fusion Flex, K140278). The key argument is that the addition of the DentiTrac® micro-recorder does not change the intended use or safety/effectiveness of the SomnoDent device for treating sleep apnea and snoring.

The table in Section 7.0 ("Comparison to the Predicate") lists several "Technological Characteristics" and indicates whether both the predicate and proposed device possess these characteristics. This table serves as a comparison to show that the fundamental design and intended use of the SomnoDent device itself remain unchanged. The only difference highlighted is the presence of the DentiTrac® Micro-recorder in the proposed device.

Technological Characteristics	Predicate SomnoDent® Fusion K140278	Proposed SomnoDent® Family with DentiTrac® Micro-Recorder
Intended as an intraoral device	Yes	Yes
Intended to reduce snoring or help alleviate snoring	Yes	Yes
Treatment of mild to moderate obstructive sleep apnea	Yes	Yes
Intended for nighttime use	Yes	Yes
Indicated for single patient multiuse	Yes	Yes
Indicated for use at home or sleep laboratories	Yes	Yes
Target population: adults	Yes	Yes
Prescription device	Yes	Yes
Customized fit for each patient	Yes	Yes
Separate upper and lower tray pieces	Yes	Yes
Works by mandibular advancement	Yes	Yes
Can be adjusted or refit	Yes	Yes
Lower jaw adjustment using supplied components	Yes	Yes
Permits patient to breathe through mouth	Yes	Yes
Upper and lower trays disengage for easy removal	Yes	Yes
Cleaned and inspected daily by patient	Yes	Yes
Trays constructed from a soft lining material adhered to a hard surface acrylic	Yes (Flex retention) / No (Classic retention)	Yes (Flex retention) / No (Classic retention)
Advancement mechanism constructed of surgical grade stainless steel	Yes	Yes
DentiTrac® Micro-recorder embedded into SomnoDent®	No	Yes

The section 8.0 Performance Testing states: "Since the characteristics of the SomnoDent® did not change, no new clinical performance data was necessary to substantiate this change." This indicates that no new clinical performance metrics or acceptance criteria for treatment effectiveness were established or evaluated for this 510(k) submission, as it is assumed to be equivalent to the predicate.

The performance testing mentioned focuses on the new component (DentiTrac® micro-recorder) and its integration:

EMC and electrical safety
Biocompatibility
Software elements
Process validation to ensure reliable embedding and retention of Quality Control functionality.

2. Sample Size Used for the Test Set and Data Provenance

The document does not mention a traditional test set sample size in the context of clinical performance for the SomnoDent® with Micro-Recorder itself. The claim is substantial equivalence based on the predicate device's existing performance.

For the embedded DentiTrac® micro-recorder, the document refers to "Risk assessments and non-clinical testing." It mentions data being reported in "master file, MAF2557" which would presumably contain details on the testing of the micro-recorder's functionality, but the specifics of sample sizes or data provenance (country, retrospective/prospective) are not detailed in this 510(k) summary. Given the nature of these tests (EMC, electrical safety, biocompatibility, software, process validation), they typically involve testing of components or prototypes rather than large human subject cohorts.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

This information is not provided as no new clinical study to establish ground truth for treatment effectiveness was necessary for this submission. For the non-clinical testing of the micro-recorder, expert involvement (e.g., in risk assessment or evaluation of test results) is implied for the master file, but not explicitly detailed regarding number or qualifications.

4. Adjudication Method for the Test Set

This information is not provided as no clinical adjudication for a human subject test set is mentioned.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, a MRMC comparative effectiveness study was not done. The device is a physical intraoral appliance with an optional compliance recorder, not an imaging or diagnostic AI requiring human reader interaction.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

For the SomnoDent® device itself (for treatment of sleep apnea/snoring), it's a physical device that a clinician fits and adjusts. There is no algorithm-only performance in the typical sense.

For the DentiTrac® micro-recorder, its function is to objectively measure wear time, movements, and head position. This is an objective data collection function. While it uses internal algorithms to process raw sensor data into meaningful metrics (like wear time based on oral temperature), the document does not describe a standalone performance study of these algorithms in terms of accuracy against a ground truth for wear time. It refers to "software elements were assessed and tested" and "Process validation was generated from SomnoMed to ensure that the SomnoDent® devices can be repeatedly and reliably embedded and retain the Quality Control functionality of SomnoDent® and the DentiTrac®." This implies internal validation, but no external standalone study is detailed in this document.

7. Type of Ground Truth Used

For the SomnoDent® device's substantial equivalence, the "ground truth" for its effectiveness is implicitly the established effectiveness of the predicate device (K140278) which would have undergone its own clinical validation.

For the DentiTrac® micro-recorder, the "ground truth" for its compliance measurement function (wear time based on oral temperature, movement, head position) is not explicitly detailed in this document. It's likely that internal validation studies would have demonstrated the accuracy of its sensors and algorithms against known physical conditions or reference measurements, but these specifics are absent from the 510(k) summary.

8. Sample Size for the Training Set

This information is not applicable in the context of this 510(k) submission. The device is not an AI/ML algorithm that requires a separate training set. The DentiTrac® micro-recorder contains software, but it operates based on defined sensor input and algorithms, not machine learning models trained on large datasets in the way typical AI devices are.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reasons stated in point 8.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are simple and abstract, with only the outlines of the faces visible.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 18, 2015

SomnoMed, Inc. c/o Kien T. Nguyen, Ph.D., MBA President - North America 7460 Warren Parkway, Suite 190 Frisco, Texas, 75034

Re: K150369

Trade/Device Name: SomnoDent® with Micro-Recorder 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: PLC Dated: May 19, 2015 Received: May 19, 2015

Dear Dr. Nguyen:

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 device-related 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR 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
Kianq-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)

K150369

Device Name

SomnoDent® with Micro-Recorder

Indications for Use (Describe)

The SonmoDent® intraoral devices are intended for the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

Type of Use (Select one or both, as applicable)

■ 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}------------------------------------------------

510(k) Summary

(As required by 21 CFR 807.92) SomnoDent® with Micro-Recorder

1.0 Submitter

SomnoMed, Inc. 7460 Warren Parkway, #190 Frisco, TX 75034 Telephone: 972-377-3400 Fax: 972-377-3404

Official Contact

Kien Nguyen, Ph.D., MBA President - North America Telephone: 972-377-3400, Ext. 101 Email: knguyen@somnomed.com

2.0 Date Prepared

June 16, 2015

3.0 Device Identification

Proprietary Names:	SomnoDent® with Micro-Recorder
Common Name:	Device, Anti-Snoring
Classification Name:	Intraoral device for snoring and Intraoral devices
	for snoring and obstructive sleep apnea
Device Classification:	Class II
Product Code:	PLC
Regulation Number:	21 CFR 872.5570

4.0 Legally Marketed Predicate Device

Candidate(s)	Predicate	Manufacturer	DocumentNumber
SomnoDent® withMicro-Recorder	SomnoDent® Fusion Classic,SomnoDent® Fusion Flex	SomnoMed, Inc.	K140278

The SomnoDent with Micro-Recorder is substantially equivalent to the SomnoDent® Fusion Classic and Flex products listed above, currently in commercial distribution.

Device Description 5.0

{4}------------------------------------------------

6.0 Intended Use

The SomnoDent® intraoral devices are intended for the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

Optionally, if the DentiTrac® micro-recorder is completely embedded into the SomnoDent® appliance, the micro-recorder is intended to measure patient compliance to oral appliance therapy in combination with the DentiTrac® System.

7.0 Comparison to the Predicate

Technological Characteristics	PredicateSomnoDent® FusionK140278	ProposedSomnoDent® Family withDentiTrac® Micro-Recorder
Intended Use
Intended as an intraoral device	Yes	Yes
Intended to reduce snoring or helpalleviate snoring	Yes	Yes
Treatment of mild to moderateobstructive sleep apnea	Yes	Yes
Intended for nighttime use	Yes	Yes
Indicated for single patient multiuse	Yes	Yes
Indicated for use at home or sleeplaboratories	Yes	Yes
Target population: adults	Yes	Yes
Prescription device	Yes	Yes
Design
Customized fit for each patient	Yes	Yes
Separate upper and lower tray pieces	Yes	Yes
Works by mandibular advancement	Yes	Yes
Can be adjusted or refit	Yes	Yes
Lower jaw adjustment using suppliedcomponents	Yes	Yes
Permits patient to breathe through mouth	Yes	Yes
Upper and lower trays disengage for easyremoval	Yes	Yes
Cleaned and inspected daily by patient	Yes	Yes
Material
Trays constructed from a soft liningmaterial adhered to a hard surface acrylic	Yes (Flex retention)	Yes (Flex retention)
	No (Classic retention)	No (Classic retention)
Advancement mechanism constructed ofsurgical grade stainless steel	Yes	Yes
DentiTrac® Micro-recorder embeddedinto SomnoDent®	No	Yes

{5}------------------------------------------------

The addition of the DentiTrac Micro-Recorder to the SomnoDent device does not change the intended use of the SomnoDent device for the treatment of night time snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. Based on how the DentiTrac Micro-Recorder is embedded inside the SomnoDent device, the patient will not be physically exposed to the micro-recorder. The DentiTrac Micro-Recorder is completely sealed under a layer of acrylic within the SomnoDent device. Furthermore, the size, position and location of the embedded DentiTrac Micro-Recorder in the SomnoDent device does not increase any risk to patient safety as there is ample space in the patient's oral cavity to accommodate the additional volume.

8.0 Performance Testing

The SomnoDent® family of devices with DentiTrac® micro-recorder are identical to the predicate devices with the exception of the addition of the DentiTrac® micro-recorder. Since the characteristics of the SomnoDent® did not change, no new clinical performance data was necessary to substantiate this change. Risk assessments and non-clinical testing demonstrated that EMC and electrical safety, biocompatibility, and software elements were assessed and The data is reported in master file, MAF2557. Process validation was generated from tested. SomnoMed to ensure that the SomnoDent® devices can be repeatedly and reliably embedded and retain the Quality Control functionality of SomnoDent® and the DentiTrac®.

9.0 Conclusion

Based on the similarities in the primary intended use, principles of operation, functional design, established materials and medical use, and the information presented in the summary and in Masterfile MAF2557, the conclusions demonstrate that the SomnoDent® family members with an embedded DentiTrac® micro-recorder are as safe, as effective, and performs as well as the predicate device. The submitted information in this premarket notification is complete and supports a substantial equivalence decision.

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.”