(80 days)
No
The description focuses on the mechanical design and physical components of the device, with no mention of AI, ML, or related concepts.
Yes
The device is intended for the treatment of mild and moderate Obstructive Sleep Apnea and snoring, and for the prevention of bruxism, which are all therapeutic applications.
No
The provided text explicitly states the device is for "treatment" and "prevention" of certain conditions, not for diagnosis. There is no mention of the device performing any diagnostic functions such as measurement, imaging, or analysis to identify medical conditions.
No
The device description clearly states it is a "custom fabricated device" and describes physical components like an "anterior discluding element," "posterior trans-palatal bar," and "tongue restraint," indicating it is a physical appliance, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended uses are for the treatment of sleep apnea, snoring, and the prevention of bruxism. These are all related to physical conditions and their management within the body.
- Device Description: The device is a custom-fabricated oral appliance used to physically manipulate the jaw and tongue position.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a physiological state, health, or disease.
IVD devices are specifically designed to perform tests on samples taken from the human body to aid in diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
- AN ORA/ Appliance to be used for the theatment of mild And Moderate Obstructive Sleep ApNCA
- For the treatment of SNORING
- For the prevENTION OF DRUKIEM.
Product codes (comma separated list FDA assigned to the subject device)
LOZ
Device Description
The Full Breath Sleep Appliance is a custom fabricated device typically by a professional dental laboratory and delivered by a dentist.
This is a simple enhancement to the design of the Quiet Night & Quiet Night MA (K032410). It incorporates the Quiet Night and the NTI (K010867) anterior discluding element for bruxism and control of vertical dimension and anterior mandibular advancerient for reduction/elimination of snoring. It also has the posterior trans-palatal bar to prevent the tongue from sealing against the palate and reducing snoring, and restrains the tongue from up and back movement. The tongue restraint has resulted in reduced AHI/RDI's and reduction of ODI's.
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
Dentist
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.
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.”
0
Image /page/0/Picture/0 description: The image shows a date and a number. The date is "DEC 30 2005", indicating December 30, 2005. Below the date is the number "K052862", which appears to be a serial number or identification code. The number is handwritten in a cursive style.
510(k) Summary Full Breath Sleep Appliance - AB (Anterior Bite) Full Breath Sleep Appliance - ABB (Anterior Bite with Bumps)
Applicant
Bryan Keropian DDS 18607 Ventura Blvd., Suite 206 Tarzana, CA 91356
Product Name
Full Breath Sleep Appliance - AB (Anterior Bite) Full Breath Sleep Appliance - ABB (Anterior Bite with Bumps)
Proposed Product Code LOZ
Proposed Device Classification Jaw Repositioning Device
Contact Person
Bryan Keropian DDS tmjrelief@msn.com
Telephone
W - 818-881-7233 H - 818-716-0579 C - 818-251-0541
Fax
818-881-7541
510(k) Application Preparation Bryan Keropian, DDS
1
510(k) Summary (continued)
This is a simple enhancement to the design of the Quiet Night & Quiet Night MA (K032410). It incorporates the Quiet Night and the NTI (K010867) anterior discluding element for bruxism and control of vertical dimension and anterior mandibular advancerient for reduction/elimination of snoring. It also has the posterior trans-palatal bar to prevent the tongue from sealing against the palate and reducing snoring, and restrains the tongue from up and back movement. The tongue restraint has resulted in reduced AHI/RDI's and reduction of ODI's.
DEVICE SPECIFICATIONS
The Full Breath Sleep Appliance is a custom fabricated device typically by a professional dental laboratory and delivered by a dentist.
| Product
Name | Full Breath
Sleep Appl. | Quiet Night
Quiet Nt. MA | NTI Tension
Suppression
System | Breathe EZ
Anti-Snoring
Device | Sleepbite | Dr. B's
Mouthpiece |
|-----------------------|------------------------------------|-------------------------------------------------------------------------|-------------------------------------------------------------------------|--------------------------------------|-------------------------|-------------------------|
| 510(k) | Pending | K032410 | K010876 | K022891 | K103808 | K991948 |
| Product
Code | LQZ | LQZ | LQZ | LRK | LRK | LRK |
| Indicated
Use | Treatment of
Mild & Mod.
OSA | Prophylactic
treatment of
medically
diagnosed
migraine pain | Prophylactic
treatment of
medically
diagnosed
migraine pain | Treatment of
snoring | Treatment of
snoring | Treatment of
snoring |
| | -- | -- | -- | -- | -- | -- |
| | Prevent
Bruxism | Prevent
Bruxism | Prevent
Bruxism | Prevent
Bruxism | Prevent
Bruxism | Prevent
Bruxism |
| Method of
Delivery | By prescription | By prescription | By prescription | By prescription | By prescription | By prescription |
PREDICATE DEVICE COMPARISON TABLE:
INDICATIONS FOR USE
-
- An oral appliance to be used for the treatment of mild and moderate Obstructive Sleep Apnea.
-
- For the treatment of snoring.
-
- For the prevention of bruxism.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized waves or stripes, which is a common element in the department's branding.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 3 0 2005
Dr. Bryan Keropian Bryan Keropian DDS A Professional Corporation 18607 Ventura Boulevard, Suite 206 Tarzana, California 91356
Re: K052862
Trade/Device Name: Full Breath Sleep Appliance-ABCAnterior Bite) Full Breath Sleep Appliance-ABB (Anterior Bite with Bumps) Regulation Number: 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LQZ Dated: October 11, 2005 Received: October 11, 2005
Dear Dr. Keropian:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
3
Page 2 - Dr. Keropian
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); 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 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Shiela R. Murphy, D.O. for C. fan, M.D. 12/30/
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
U.S. Food and Drug Administration
Image /page/4/Picture/3 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle on the left and the words "Department of Health and Human Services" on the right. The text is stacked in three lines.
CENTER FOR DEVICES AND RADIOLOGICAL HEALTH
FDA Home Page | CDRH Home Page | Search | CDRH A-Z Index | Contact CDRH
Indications for Use
510(k) Number (if known): K 052862
Device Name: Full BREAth Sleep AppliAnce - AB(ANterion Bire) Full Breath Steep AppliAnce - ABBC Anterior Bit with Bumps Indications for Use:
- AN ORA/ Appliance to be used for the theatment of
mild And Moderate Obstructive Sleep ApNCA - For the treatment of SNORING
- For the prevENTION OF DRUKIEM.
Angela Blackwell for MSK
on Tology, Ganeral Houpil Control, Danial Davices
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (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)
http://www.fda.gov/cdrh/ode/INDICATE.HTML
12/10/2005