DYNAFLEX
Device Facts
| Record ID | K103076 |
|---|---|
| Device Name | DYNAFLEX |
| Applicant | Dyna Flex |
| Product Code | LRK · Dental |
| Decision Date | Feb 23, 2011 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 872.5570 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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 position prescribed by the dentist, and is removable by the patient.
Device Story
Custom-fitted intraoral mandibular repositioning devices; used to treat snoring and mild-to-moderate OSA. Input: patient dental anatomy (custom-molded trays). Operation: trays fit over upper/lower teeth; engage via adjustable lugs or Herbst rod-and-tube mechanism to posture mandible forward; increases pharyngeal space to improve airflow. Output: physical mandibular advancement. Used in home setting; patient-operated (removable). Dentist/physician sets advancement level at fitting. Benefit: reduced snoring and improved airway patency during sleep.
Clinical Evidence
No clinical data provided; substantial equivalence based on design, material, and functional comparison to legally marketed predicate devices.
Technological Characteristics
Intraoral mandibular repositioning devices; custom-fitted acrylic trays; adjustable lugs or Herbst rod-and-tube mechanism; non-powered; mechanical operation.
Indications for Use
Indicated for adults with mild to moderate obstructive sleep apnea (OSA) and night time snoring. Prescription use only.
Regulatory Classification
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.
Special Controls
*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.”
Predicate Devices
Submission Summary (Full Text)
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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 intraoral<br>devices for snoring and obstructive sleep<br>apnea |
| 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.
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.
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
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.
### Predicate Devices
DynaFlex has selected the following devices as it predicates for its 510(k) submission.
Device Sponsors:
- 1. Somnomed Limited
- 2. 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.<br>1. Somnomed MAS RXA<br>2. Acrylic Splint Herbst Appliance<br>3. TAP T |
|-----------------------------------|-----------------------------------------------------------------------------------------------------|
| 510(k)'s: | 1. K050592<br>2. K083209<br>3. K061732 |
| CDRH Product Classification Name: | Device, Anti-Snoring |
| CDRH Product Code: | LRK |
| CDRH Regulation Name: | Intraoral devices for snoring and intraoral<br>devices for snoring and obstructive sleep<br>apnea |
| 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
