(137 days)
No
The device description and performance studies focus on mechanical adjustments and clinical outcomes, with no mention of AI or ML technologies.
Yes
The device is intended for the "Treatment of nasal respiratory dysfunction of obstructive sleep apnea and snoring," which signifies a therapeutic purpose.
No
The device is described as an "Elastic Mandibular Advancement appliance" for the "Treatment of nasal respiratory dysfunction of obstructive sleep apnea and snoring". It is used to position the mandible and increase the patient's air space, which is a therapeutic function, not a diagnostic one. Clinical testing involved measuring the apnea-hypopnea index, but this was to evaluate the device's treatment efficacy, not to diagnose a condition.
No
The device description clearly describes a physical appliance (Elastic Mandibular Advancement appliance) with physical components like clasps, bite blocks, and elastic bands. It is a hardware device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "Treatment of nasal respiratory dysfunction of obstructive sleep apnea and snoring." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is described as a "modified functional orthodontic appliance" that repositions the mandible. This is a physical intervention, not a test performed on biological samples.
- Performance Studies: The performance studies involve overnight sleep studies to measure the impact of the device on apnea-hypopnea index. This is evaluating the therapeutic effect of the device, not its ability to diagnose a condition.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), using reagents, or providing diagnostic information about a patient's health status.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
Treatment of nasal respiratory dysfunction of obstructive sleep apnea and snoring in those patients where repositioning of the mandible can increase the patients air space.
Product codes
LRK
Device Description
The Elastic Mandibular Advancement appliance is a modified functional orthodontic appliance. The modifications are: 1) clasps are not needed as the appliance is retained firmly to the teeth by pressure formed plastic into the undercut areas. Each tray holds the teeth in their present location not allowing tooth movement. 2) the bite is opened as in the SNOAR and NAPA appliances but not in one fixed position. Multiple bite openings are possible because of removable bite blocks or bite planes of varying thicknesses. 3) the mandible is advanced as in both the SNOAR and NAPA appliances except not in a fixed position , but in various amounts of forward advancement because of removable, replaceable elastic bands or straps to pull the mandible forward.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Clinical testing was done at The University of Texas Medical Branch at Galveston. Overnight sleep studies with and without the EMA device were performed on 13 obstructive sleep apnea (OSA) patients with a mean apnea-hypopnea index of 60 events/hr. without the appliance. The EMA appliance advanced the mandible by an average 9 mm. EMA reduced the mean apnea-hypopnea index to 21 events/hr.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Image /page/0/Picture/1 description: The image is a logo for "Design Frantz Incorporated". The logo is in a black and white color scheme. The word "FRANTZ" is in a bold, sans-serif font and is the most prominent element of the logo. The words "DESIGN" and "INCORPORATED" are above and below the word "FRANTZ", respectively, in a smaller font size.
SEP 2 9 1997
510(k) Summary
May 14, 1997 Date:
Donald Frantz, D.D.S. Frantz Design Incorporated 400 Medical Center. # 209 Webster. Texas 77598
Phone: (281) 338-6631 (281) 554-3033 Fax:
Device Name:
Trade/Proprietary Name: Elastic Mandibular Advancement (EMA) appliance Common Name: Sleep Apnea/Anti-snoring device Classification Name: Activator dental appliance
Substantial Equivalence Comparison:
The Elastic Mandibular Advancement (EMA) appliance is substantially equivalent to the NAPA [510(k) # K902790] and the SNOAR [510(k) # K880956] appliances.
Description:
The Elastic Mandibular Advancement appliance is a modified functional orthodontic The modifications are: 1) clasps are not needed as the appliance is appliance. retained firmly to the teeth by pressure formed plastic into the undercut areas. Each tray holds the teeth in their present location not allowing tooth movement. 2) the bite is opened as in the SNOAR and NAPA appliances but not in one fixed position. Multiple bite openings are possible because of removable bite blocks or bite planes of varying thicknesses. 3) the mandible is advanced as in both the SNOAR and NAPA appliances except not in a fixed position , but in various amounts of forward advancement because of removable, replaceable elastic bands or straps to pull the mandible forward.
Intended Use:
Treatment of nasal respiratory dysfunction of obstructive sleep apnea and snoring in those patients where repositioning of the mandible can increase the patients air space.
1
Technological characteristics:
The NAPA. SNOAR and EMA appliances advance the mandible to an anterior and inferior position with regard to the maxilla. This repositioning of the mandible pulls the tongue forward and increases the patient's airspace, thereby decreasing upper airway obstruction. Such obstruction can be a causative factor in snoring and obstructive sleep apnea. All three devices are prescribed for patients after diagnosis of obstructive sleep apnea by a physician. None of the appliances are indicated for the treatment of central sleep apnea.
The NAPA, SNOAR and EMA appliances are similar in that they all are individually customized mouthpieces that fit uniquely into patients mouths. None of the appliances allow for movement of the teeth. While the NAPA and SNOAR appliances maintain dental integrity with the use of wire the EMA appliance extends the appliance material into the undercut areas of the teeth, therefore maintaining integrity.
The NAPA, SNOAR and EMA appliances all allow for nasal and/or oral breathing. The NAPA and SNOAR appliances advance the mandible and hold it in place rigidly. The EMA appliance advances the mandible but allows for opening of the mouth therefore eliminating the need for a "breathing beak" as the NAPA appliance has.
Clinical Data:
Clinical testing was done at The University of Texas Medical Branch at Galveston. Overnight sleep studies with and without the EMA device were performed on 13 obstructive sleep apnea (OSA) patients with a mean apnea-hypopnea index of 60 events/hr. without the appliance. The EMA appliance advanced the mandible by an average 9 mm. EMA reduced the mean apnea-hypopnea index to 21 events/hr.
Clinical tests conclusions:
Use of the EMA device significantly reduced episodes of obstructive sleep apnea.
Sincerely,
Donald Frantz A.O.S.
Donald Frantz, D.D.S. 400 Medical Center, #209 Webster. Texas 77598 Phone (281) 338-6631 Fax (281) 554-3033
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
SEP 2 9 1997
Donald Frantz, D.D.S. Frantz Design Incorporated 400 Medical Center, #209 Webster, Texas 77598
Re : K971794 Elastic Mandibular Advancement (EMA) Trade Name: Appliance Regulatory Class: Unclassified Product Code: LRK July 17, 1997 Dated: Received: July 21, 1997
Dear Dr. Frantz:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
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Page 2 - Dr. Frantz
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timot A Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Advancement (EMA) appliance Device Name: Elastic Mandibular
Indications For Use:
Indications for use: Treatment of nasal respiratory dysfunction of obstructive sleep apnea and snoring in those patients where advancement of the mandible and opening the bite can increase the patients air space.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Runner
(Division Sign-Off) Division of Dental, Infection Control, Division of Dental, Infection
and General Hospital Device 510(k) Number
Prescription Use r 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)