(128 days)
Not Found
No
The device description focuses on mechanical mechanisms (adjustable lugs, Herbst mechanism, acrylic fins) for mandibular repositioning. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are also marked as "Not Found".
Yes
The device is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea, which are medical conditions, and functions by repositioning the mandible to improve airflow, thereby providing a therapeutic benefit.
No
The device is described as an intraoral device for treating snoring and sleep apnea by repositioning the mandible. It does not mention any function for diagnosing conditions.
No
The device description clearly states it is an intraoral device consisting of custom-fitted trays and adjustable mechanisms, which are physical components, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The DynaFlex® Anti-Snoring & Sleep Apnea Devices are intraoral devices that are worn by the patient to physically reposition the lower jaw. They function mechanically to improve airflow during sleep.
- Lack of Biological Sample Testing: The description does not mention any testing of biological samples. The device's function is entirely based on its physical interaction with the patient's anatomy.
Therefore, the DynaFlex® Anti-Snoring & Sleep Apnea Devices fall under the category of a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
LRK
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pharyngeal space, lower jaw, teeth
Indicated Patient Age Range
adults
Intended User / Care Setting
dentist or physician, patient, sleeping
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.”
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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 |
| devices for snoring and obstructive sleep | |
| apnea | |
| CDRH Regulation Number: | 872.5570 |
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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:
-
- Somnomed Limited
-
- 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.
- Somnomed MAS RXA
- Acrylic Splint Herbst Appliance
- TAP T |
|-----------------------------------|-----------------------------------------------------------------------------------------------------|
| 510(k)'s: | 1. K050592 - K083209
- K061732 |
| CDRH Product Classification Name: | Device, Anti-Snoring |
| CDRH Product Code: | LRK |
| CDRH Regulation Name: | Intraoral devices for snoring and intraoral
devices for snoring and obstructive sleep
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.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name arranged vertically along the left side, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" stacked on top of each other. To the right of the text is an abstract symbol consisting of three curved lines that resemble a stylized human figure or a bird in flight.
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.
4
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