The SomnoDent Fusion 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 Fusion is an intraoral device intended for the treatment of nighttime snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. 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 patient specific (it 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 Fusion is a modification to the SomnoDent Classic (K050592), SomnoDent Flex (K073004), SomnoDent G2 (K121340) and SomnoDent Herbst (K130558). The SomnoDent Fusion is identical to SomnoDent Classic, SomnoDent Flex, SomnoDent G2, and SomnoDent Herbst except for differences in the adjustment mechanism. Any differences introduced by these modifications, when compared to the predicate product, do not introduce new safety issues.

AI/ML Overview

Here's the analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Device: SomnoDent Fusion (an intraoral device for snoring and mild to moderate obstructive sleep apnea)

1. A table of acceptance criteria and the reported device performance

Based on the provided document, the "acceptance criteria" are implied by demonstrating substantial equivalence to predicate devices through mechanical testing. The performance is reported as meeting this equivalence.

Acceptance Criterion (Implied)	Reported Device Performance
Withstand applicable pressures (mechanical performance)	Testing results indicate that the mechanism withstands applicable pressures, ensuring the device is safe and effective.
Substantial equivalence to predicate device in mechanical performance	The testing concluded that the advancement of the subject device is substantially equivalent to the predicate device with regards to mechanical performance.

2. Sample size used for the test set and the data provenance

The document states: "Mechanical testing was conducted on the calibration mechanism of the subject device." However, it does not specify the sample size for this mechanical testing. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective) of this testing data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided in the document as the study described is mechanical testing, not a clinical study involving human assessment or ground truth established by experts.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable as the described study is mechanical testing, not a clinical study involving human judgment or adjudication.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

A multi-reader multi-case (MRMC) comparative effectiveness study was not performed, nor is it applicable to this device. The SomnoDent Fusion is a physical intraoral device, not an AI or imaging diagnostic tool that would be evaluated with human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

A standalone performance test in the context of an algorithm or AI was not performed, nor is it applicable to this device. The device is a physical intraoral appliance. The "standalone" performance described is the mechanical testing of the device itself.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the mechanical testing, the "ground truth" would be the engineering specifications and performance benchmarks established based on the predicate devices. The document implies that the "truth" is the "applicable pressures" and successful functioning compared to the predicate.

8. The sample size for the training set

This information is not applicable as the described study is mechanical testing for substantial equivalence, not a machine learning model requiring a training set.

9. How the ground truth for the training set was established

This information is not applicable as there is no training set for a machine learning model.

Summary

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510(k) Summary (21 CFR 807.92)

JUN 2 0 2014

Page 1 of 4

510(k) Number: К | Чб278

Submission Owner:	SomnoMed, Inc.
	7460 Warren Parkway
	Suite 190
	Frisco, TX 75034
	Phone: 888-447-6673 x106
	Fax: 972-377-3404
	Email: kjayne@somnomed.com
Official Correspondent:	Kathryn A. Jayne
Date Prepared:	January 31, 2014
Trade Name:	SomnoDent® Fusion
Common Name:	Intraoral device for snoring and mild to moderate obstructive
	sleep apnea (OSA)
Classification Name:	Device, Anti-Snoring
Regulation Number:	21 CFR 872.5570
Product Code:	LRK
Class:	II
Panel:	Dental
Predicate Devices:	K050592, SomnoDent Classic
	K073004, SomnoDent Flex
	K121340, SomnoDent G2

Description of the device:

Indications for Use:

The SomnoDent Fusion 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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Image /page/1/Picture/0 description: The image shows the logo for SomnoMed. The logo consists of a stylized graphic above the company name. Below the name, the words "Dental * Sleep * Medical" are printed in a smaller font.

510(k) Summary (21 CFR 807.92)

Substantial Equivalence:

Substantial Equivalence Table

	SomnoDentFusion	SomnoDentClassicK050592	SomnoDentFlexK073004	SomnoDentG2K121340	SomnoDentHerbstK130558
Intended Use
Intended as anintraoral device	Yes	Yes	Yes	Yes	Yes
Intended toreduce snoringor help alleviatesnoring	Yes	Yes	Yes	Yes	Yes
Treatment ofmild tomoderateobstructivesleep apnea	Yes	Yes	Yes	Yes	Yes
Intended fornighttime use	Yes	Yes	Yes	Yes	Yes
Indicated forsingle patientmultiuse	Yes	Yes	Yes	Yes	Yes
Indicated foruse at home orsleeplaboratories	Yes	Yes	Yes	Yes	Yes
Targetpopulation:adults	Yes	Yes	Yes	Yes	Yes
Prescriptiondevice	Yes	Yes	Yes	Yes	Yes
Design
Customized fitfor each patient(patientspecific)	Yes	Yes	Yes	Yes	Yes
Separate upperand lower traypieces	Yes	Yes	Yes	Yes	Yes
Works bymandibularadvancement	Yes	Yes	Yes	Yes	Yes
	SomnoDentFusion	SomnoDent ClassicK050592	SomnoDent FlexK073004	SomnoDent G2K121340	SomnoDent HerbstK130558
Can beadjusted or refit	Yes	Yes	Yes	Yes	Yes
Lower jawadjustmentusing suppliedcomponents	Yes	Yes	Yes	Yes	Yes
Permits patientto breathethrough mouth	Yes	Yes	Yes	Yes	Yes
Upper andlower traysdisengage foreasy removal	Yes	Yes	Yes	Yes	Yes
Cleaned andinspected dailyby patient	Yes	Yes	Yes	Yes	Yes
Material
Traysconstructedfrom a softlining materialadhered to ahard surfaceacrylic	Yes(Flex retention)No(Classic retention)	No	Yes	Yes(Flex retention)No(Classic retention)	Yes(Flex retention)No(Classic retention)
Advancementmechanismconstructed ofsurgical gradestainless steel	Yes	Yes	Yes	No	Yes

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Image /page/2/Picture/0 description: The image shows the logo for SomnoMed. The logo consists of a stylized black shape above the name "SomnoMed" in a bold, sans-serif font. Below the name, in a smaller font, are the words "Dental • Sleep • Medical".

510(k) Summary (21 CFR 807.92) Page 4 of 4

SomnoMed SomnoDent Fusion 510(k) Submission

5 - 4

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510(k) Summary (21 CFR 807.92) Page 4 of 4

Substantial equivalence discussion:

The SomnoDent Fusion is considered to be substantially equivalent to the SomnoDent Classic, Flex, G2, and Herbst device. The SomnoDent Fusion and predicate devices 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 patient specific (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 SomnoDent Fusion is identical to SomnoDent Classic, Flex, G2, and SomnoDent Herbst except for differences in the adjustment. The SomnoDent Fusion will be available in one of two material types, acrylic (identical to SomnoDent Classic) or soft lining adhered to acrylic (SomnoDent Flex). Any differences introduced by these modifications, when compared to the predicate product, do not introduce new safety issues.

Summary of Testing:

To demonstrate substantial equivalence, testing was conducted on the advancement mechanism to ensure the device performed as intended and is safe and effective. Mechanical testing was conducted on the calibration mechanism of the subject device. Testing results indicate that the mechanism withstands applicable pressures, ensuring the device is safe and effective. The testing concluded that the advancement of the subject device is substantially equivalent to the predicate device with regards to mechanical performance. Testing demonstrates that the subject device, the SomnoDent Fusion, is as safe, as effective, and performs as well as or better than the predicate devices, the SomnoDent Classic, SomnoDent Flex, SomnoDent G2, and SomnoDent Herbst.

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Public Health Service

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

June 20, 2014

SomnoMed. Incorporated Ms. Kathryn Jayne Regulatory Affairs/Quality Assurance Manager 7460 Warren Parkway, Suite 190 Frisco, TX 75034

Re: K140278

Trade/Device Name: SomnoDent Fusion Classic, Somnodent Fusion Flex Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea Regulatory Class: Il

Product Code: LRK Dated: June 4, 2014 Received: June 5, 2014

Dear Ms. Jayne:

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 10 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.

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Page 2 - Ms. Jayne

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 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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,

Mary S. Runner -S

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

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DEPARTMENT OF KEALTH AND HUMAN SERVICES

Food and Drug Administration Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.

610(k) Number (if known)

K140278

Device Name SonnoDent Fusion

Indications for Use (December)

Indications for Use (Decorde)
The Sommonlews Fission is imment of sightines maring and mild to modests obstructive sloep spass 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)
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PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)	Sheena A. Green -S
	2014.06.20 13:21:29 -04'00'
FORM FDA 3881 (1/14)	Page 1 of 2

CONFIDENTIAL SomnoMed SomnoDent Fusion Special 510(k) Submission

4 - 2

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.”