DynaFlex® Anti-Snoring & Sleep Apnea Devices are intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The devices are worn while sleeping to support the lower jaw in a forward position prescribed by the dentist, and is removable by the patient.

Device Description

The proposed DynaFlex® Anti-Snoring & Sleep Apnea Devices are intraoral devices used for treating snoring and sleep apnea, and will consist of two custom fitted trays which fit over the upper and lower teeth and engage by means of adjustable lugs, or by the industry standard Herbst mechanism which is a rod and tube type assembly that orientates the jaws in a predetermined relationship. These devices function as a mandibular re-positioner which acts to increase the patient's pharyngeal space, improving their ability to exchange air during sleep. The devices will be custom made for each patient and have the ability of the adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The devices will be sold by prescription only.

The LISA Appliance is a one piece, non-adjustable design. The LISA II Appliance is a dynamic, adjustable design. The Dorsal Appliance is a two-piece design with separate upper and lower acrylic portions that when engaged posture the mandible into protrusive position via acrylic fins built in the lower acrylic portion. The adjustable Herbst Appliance is a one piece construction held together by two adjustment mechanisms on the buccal or outer are of the upper and lower appliance.

AI/ML Overview

The provided text describes a 510(k) summary for DynaFlex® Anti-Snoring & Sleep Apnea Devices. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against specific acceptance criteria. Therefore, the requested information regarding acceptance criteria and a study proving the device meets these criteria is largely not present in the provided text.

The document states: "It has been shown in this 510(k) submission that the differences between the DynaFlex® Anti-Snoring & Sleep Apnea Devices and the predicate devices do not raise any questions regarding their safety and effectiveness. DynaFlex® Anti-Snoring & Sleep Apnea Devices, as designed and manufactured, are therefore determined to be substantially equivalent to the referenced predicate devices."

This implies that the predicate devices have established safety and effectiveness, and the DynaFlex device is considered equivalent based on its similar intended use and technological characteristics (or differences that don't raise new questions). There is no standalone performance study described for the DynaFlex device with specific acceptance criteria.

However, based on the information provided, here's an attempt to answer the questions, noting where information is absent:

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

This information is not present in the provided text. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, not on proving performance against specific quantitative acceptance criteria in a dedicated study.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not present in the provided text. No specific test set or study data for the DynaFlex device is described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not present in the provided text. As no specific test set or study is detailed, there's no mention of experts establishing ground truth.

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

This information is not present in the provided text.

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

This information is not present in the provided text. The device is a physical intraoral device, not an AI software.

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

This information is not present in the provided text. The device is a physical intraoral device, not an algorithm.

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

This information is not present in the provided text.

8. The sample size for the training set

This information is not present in the provided text. As this is not an AI device, the concept of a "training set" in this context is not applicable.

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

This information is not present in the provided text.

Summary

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EMERGO GROUP

ノ07 ラ

FEB 2 3 2011

SECTION 5 - 510(k) SUMMARY

Submission Correspondent

Company Name: Company Address:

Company Contact:

Country: Phone: Fax: Website: Submission Date:

Submission Sponsor

Company Name: Company Address:

Country: Phone: Fax: Website: Emergo Group, Inc. 611 West 5th Street Third Floor Austin, TX 78701 Stuart R. Goldman Senior Consultant CQM, CQA, CBA, QMS-A 512.600.7616 USA 512.327.9997 512.327.9998 www.emergogroup.com September 29, 2010 -

DynaFlex 10403 International Plaza St. Ann, MO 63074 USA 314.426.4020 314.429.7575 www.dynaflex.com

Device Classification

DynaFlex® Anti-Snoring & Sleep Apnea Devices

Device Sponsor:	DynaFlex
CDRH Product Classification Name:	Device, Anti-Snoring
CDRH Product Code:	LRK
CDRH Regulation Name:	Intraoral devices for snoring and intraoraldevices for snoring and obstructive sleepapnea
CDRH Regulation Number:	872.5570

K103076

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K103076 EMERGOGROUP
2007

CDRH Classification Panel:

CDRH Regulatory Class:

Dental Devices

Class II

Device Description

The proposed DynaFlex® Anti-Snoring & Sleep Apnea Devices are intraoral devices used for treating snoring and sleep apnea, and will consist of two custom fitted trays which fit over the upper and lower teeth and engage by means of adjustable lugs, or by the industry standard Herbst mechanism which is a rod and tube type assembly that orientates the jaws in a predetermined relationship. These devices function as a mandibular re-positioner which acts to increase the patient's pharyngeal space. improving their ability to exchange air during sleep. The devices will be custom made for each patient and have the ability of the adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device. The devices will be sold by prescription only.

Any slight differences in the materials, fit and function of DynaFlex® Anti-Snoring & Sleep Apnea Devices with those of the predicate devices do not raise any new concerns over safety and effectiveness.

Intended Use

Predicate Devices

DynaFlex has selected the following devices as it predicates for its 510(k) submission.

Device Sponsors:

1. Somnomed Limited
1. Specialty Appliances Works, Inc.

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Image /page/2/Picture/1 description: The image shows the text "EMERGO GROUP" with a logo in between the two words. The logo is a stylized letter "E" inside of a circle. To the left of the text is the number "K103076" and to the right is the number "3063".

Devices:	3. Airway Management, Inc.1. Somnomed MAS RXA2. Acrylic Splint Herbst Appliance3. TAP T
510(k)'s:	1. K0505922. K0832093. K061732
CDRH Product Classification Name:	Device, Anti-Snoring
CDRH Product Code:	LRK
CDRH Regulation Name:	Intraoral devices for snoring and intraoraldevices for snoring and obstructive sleepapnea
CDRH Regulation Number:	872.5570
CDRH Classification Panel:	Dental Devices
CDRH Regulatory Class:	Class II

Safety and Effectiveness

By definition, a device is substantially equivalent to a predicate device when the device has the same intended use and the same technological characteristics as the previously cleared predicate device, or has the same intended use and different technological characteristics, and it can be demonstrated that the device is substantially equivalent to the predicate device, and that the new device does not raise different questions regarding its safety and effectiveness as compared to the predicate device.

It has been shown in this 510(k) submission that the differences between the DynaFlex® Anti-Snoring & Sleep Apnea Devices and the predicate devices do not raise any questions regarding their safety and effectiveness. DynaFlex® Anti-Snoring & Sleep Apnea Devices, as designed and manufactured, are therefore determined to be substantially equivalent to the referenced predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -W066-G609 Silver Spring, MD 20993-0002

Dynaflex C/O Mr. Stuart R. Goldman Emergo Group Incorporated 611 West 5th Street Third Floor Austin, Texas 78701

FEB 2 3 2011

Re: K103076

Trade/Device Name: DynaFlex® Anti-Snoring & Sleep Apnea Devices (Lisa Appliance, Lisa II Appliance, Dorsal Appliance, Herbst Adjustable Appliance) 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: February 15, 2011 Received: February 16, 2011

Dear Mr. Goldman:

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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Page 2- Mr. Goldman

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 go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 yours,

Susan Dunne

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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EMERGO GROUP

SECTION 4 - INDICATIONS FOR USE

510(k) Number (if known): م) 7 0 3 0 ) جا

Device Name:

DynaFlex® Anti-Snoring & Sleep Apnea Devices (Lisa Appliance, Lisa II Appliance, Dorsal Appliance, Herbst Adjustable Appliance)

Indications for Use:

DynaFlex® Anti-Snoring & Sleep Apnea Devices are intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults. The devices are worn while sleeping to support the lower jaw in a forward ( on ) in advise. The devices dentist, and is removable by the patient.

Prescription Use _ X

AND/OR ·

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital
infection Control, Dental Devices

1 510(k) Number: K103076

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.”