The SomnoDent Herbst 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 Herbst 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 Herbst is a modification to the SomnoDent Classic (K050592) and SomnoDent Flex (K073004). The labeling is a modification to the SomnoDent G2 (K121340). The SomnoDent Herbst is identical to SomnoDent Classic and SomnoDent Flex, except for differences in the adjustment mechanism (which is a Herbst style titration mechanism). Any differences introduced by these modifications, when compared to the predicate product, do not introduce new safety issues.

AI/ML Overview

The provided text describes a 510(k) summary for the SomnoDent Herbst device. This is a premarket notification for a medical device seeking to demonstrate substantial equivalence to a predicate device, rather than providing a detailed study that proves acceptance criteria for a novel device's performance.

Therefore, many of the requested items related to a comprehensive study (like specific acceptance criteria values, sample sizes for test sets, expert-established ground truth, adjudication methods, MRMC studies, standalone performance, and training set details) are not explicitly present in this type of regulatory submission. The document focuses on demonstrating that the new device (SomnoDent Herbst) is as safe and effective as previously cleared predicate devices through a comparison of design, intended use, and mechanical testing.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Specific quantitative acceptance criteria with numerical targets are not provided in the document. This submission relies on demonstrating substantial equivalence to predicate devices rather than establishing new performance benchmarks.

The reported device performance is described qualitatively:

Feature/Test	Acceptance Criteria (Implied)	Reported Device Performance
Mechanical Performance (Advancement Mechanism)	Withstand applicable pressures (implied from predicate devices)	"The mechanism withstands applicable pressures"
Safety and Effectiveness	As safe and effective as predicate devices	"ensuring the device is safe and effective."
Overall Performance (Compared to Predicate Devices)	Performs as well as or better than predicate devices	"performs as well as or better than the predicate devices"

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

Sample Size for Test Set: Not specified. The "mechanical testing" mentioned refers to tests performed on the device's mechanism itself, not a clinical trial with human subjects.
Data Provenance: The mechanical testing was conducted on the "Herbst style titration mechanism of the subject device." No country of origin for data or retrospective/prospective nature is mentioned, as it's a verification test of the device components.

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

This information is not applicable and not provided. The "ground truth" for mechanical testing is typically based on engineering specifications and standards, not expert clinical consensus.

4. Adjudication Method for the Test Set

Not applicable and not provided. This relates to clinical studies with ambiguous outcomes, which is not the case for mechanical testing described here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study would involve human readers interpreting medical images or data, which is not relevant for this device (an intraoral device).

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

No, a standalone performance study was not done. This device is a physical intraoral device, not an algorithm or AI system.

7. The Type of Ground Truth Used

For the mechanical testing, the ground truth is based on engineering specifications and performance requirements for medical devices of this type, ensuring the mechanism can withstand applicable pressures and function as intended. It's not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. The Sample Size for the Training Set

Not applicable/Not provided. This device does not involve a "training set" in the context of machine learning or algorithms. It's a manufactured physical product.

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

Not applicable/Not provided. As there is no training set for this type of device, no ground truth needed to be established in that context.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for SomnoMed, a company that specializes in dental, sleep, and medical solutions. The logo features a stylized graphic above the company name, with the words "Dental - Sleep - Medical" appearing in smaller font beneath the name. The overall design is clean and professional, reflecting the company's focus on healthcare and well-being.

510(k) Summary (21 CFR 807.92)

MAY 1 7 2013

Page 1 of 3

510(k) Number: K (3 0558

Submission Owner:

Date Prepared:

Common Name:

Product Code:

Class:

Panel:

Trade Name:

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 March 1, 2013 SomnoDent® Herbst Intraoral device for snoring and mild to moderate obstructive sleep apnea (OSA) Classification Name: Device. Anti-Snoring Regulation Number: 21 CFR 872.5570 LRK . Dental Predicate Devices: K050592, SomnoDent Classic K073004, SomnoDent Flex K121340, SomnoDent G2

Description of the device:

Indications for Use:

The SomnoDent Herbst 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 black graphic above the company name. Below the name, in smaller font, are the words "Dental, Sleep, Medical".

510(k) Summary (21 CFR 807.92)

Page 2 of 3

Substantial Equivalence:

··

Substantial Equivalence Table

: .

	SomnoDentHerbst	SomnoDentClassicK050592	SomnoDentFlexK073004	SomnoDentG2K121340
Intended Use
Intended as an intraoraldevice	Yes	Yes	Yes	Yes
Intended to reducesnoring or help alleviatesnoring	Yes	Yes	Yes	Yes
Treatment of mild tomoderate obstructivesleep apnea	Yes	Yes	Yes	Yes
Intended for nighttime use	Yes	Yes	Yes	Yes
Indicated for singlepatient multiuse	Yes	Yes	Yes	Yes
Indicated for use at homeor sleep laboratories	Yes	Yes	Yes	Yes
Target population: adults	Yes	Yes	Yes	Yes
Prescription device	Yes	Yes	Yes	Yes
Design
Customized fit for eachpatient (patient specific)	Yes	Yes	Yes	Yes
Separate upper and lowertray pieces	Yes	Yes	Yes	Yes
Works by mandibularadvancement	Yes	Yes	Yes	Yes
Can be adjusted or refit	Yes	Yes	Yes	Yes
Lower jaw adjustmentusing suppliedcomponents	Yes	Yes	Yes	Yes
Permits patient to breathethrough mouth	Yes	Yes	Yes	Yes
Upper and lower traysdisengage for easyremoval	Yes	Yes	Yes	Yes
Cleaned and inspecteddaily by patient	Yes	Yes	Yes	Yes
	SomnoDent Herbst	SomnoDent ClassicK050592	SomnoDent FlexK073004	SomnoDent G2K121340
Material
Trays constructed from asoft lining materialadhered to a hard surfaceacrylic	Yes (Flex)No (Classic)	No	Yes	Yes (Flex)No (Classic)
Advancement mechanismconstructed of surgicalgrade stainless steel	Yes	Yes	Yes	No

・

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Image /page/2/Picture/0 description: The image shows the logo for SomnoMed, a company specializing in dental, sleep, and medical solutions. The logo features a stylized graphic above the company name, resembling two overlapping shapes. Below the name, the words "Dental • Sleep • Medical" are printed in a smaller font, indicating the company's areas of focus.

510(k) Summary (21 CFR 807.92)

Page 3 of 3

Substantial equivalence discussion:

The SomnoDent Herbst is considered to be substantially equivalent to the SomnoDent Classic, Flex, and G2 device. The SomnoDent Herbst 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 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 Herbst is identical to SomnoDent Classic, Flex, and G2 except for differences in the adjustment mechanism (which is a Herbst style titration mechanism. The SomnoDent Herbst 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 Herbst style titration 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 Herbst, is as safe, as effective, and performs as well as or better than the predicate devices, the SomnoDent Classic and SomnoDent Flex.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 17, 2013

Ms. Kathryn A. Jayne SomnoMed, Incorporated 7460 Warren Parkway, Suite 190 FRISCO TX 75034

Re: K130558

Trade/Device Name: SomnoDent Herbst 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: LRK Dated: April 5, 2013 Received: April 17, 2013

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 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.

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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Kwame O. Ulmer -S for

Anthony D. Watson, B.S., M.S., M.B.A. 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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Image /page/5/Picture/0 description: The image shows the logo for SomnoMed, a company that specializes in dental, sleep, and medical solutions. The logo features a stylized graphic above the company name, with the words "Dental - Sleep - Medical" written in a smaller font below. The logo is simple and modern, and it conveys the company's focus on health and wellness.

Indications for Use

510(k) Number (if known): K130558

Device Name: SomnoDent Herbst

Indications for Use:

The SomnoDent Herbst 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)

Susan Runner, DDSMA

Digitally signed by Mary S. Runner -S
DN: US/o=U.S. Government, ou=HHS,
Our FDA, ou People, cn=Mary S. Runner

0.9.2342.19200300.100.1.1-1300087950
Date: 2013.05.17 11:39:00-04'00'

ivision Sign-Offi on of Anesthesiology, General Hospital Infection Control. Dent

510(k) Number: K120558

SomnoMed Herbst Special 510(k) Submission

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.”