(24 days)
Not Found
No
The summary describes a physical appliance for treating snoring and sleep apnea and contains no mention of AI, ML, image processing, or data analysis that would suggest the use of such technologies.
Yes
The device is indicated for the treatment of medical conditions (snoring, mild to moderate obstructive sleep apnea), which defines it as a therapeutic device.
No
The device is indicated for the treatment of snoring and mild to moderate obstructive sleep apnea, not for diagnosis.
No
The 510(k) summary describes a "Full Breath Sleep Appliance," which is a physical device (an appliance) used for treating snoring and sleep apnea. There is no mention of software in the provided text.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The description and intended use clearly state that this is a "Full Breath Sleep Appliance With Posterior Tongue Depressor" indicated for the treatment of snoring and mild to moderate obstructive sleep apnea. This is a physical device used within the mouth to address a physiological issue, not a test performed on a sample.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting biomarkers or pathogens.
- Providing diagnostic information based on laboratory analysis.
Therefore, this device falls under the category of a medical device used for treatment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
-
- Full Breath Sleep Appliance With Posterior Tongue Depressor- This appliance is indicated for the treatment of snoring.
-
- Full Breath Sleep Appliance With Posterior Tongue Depressor This appliance is indicated for the treatment of mild to moderate obstructive sleep apnea.
Product codes
LQZ
Device Description
Not Found
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
By prescription
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
K032410, K052862, K053065, K022891, K103808, K991948, K010876
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.”
0
MAY 2 6 2006
510(k) Summary Full Breath Sleep Appliance Anterior Bite With Posterior Tongue Depressor Full Breath Sleep Appliance Posterior Bite With Posterior Tongue Depressor
Applicant
Bryan Keropian DDS 18607 Ventura Blvd., Suite 206 Tarzana, CA 91356
Product Name
Full Breath Sleep Appliance Anterior Bite With Posterior Tongue Depressor Full Breath Sleep Appliance Posterior Bite With Posterior Tongue Depressor
Proposed Product Code LQZ
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
K06/228
20fz
510(K) Summary (continued)
For the treatment of mild and moderate OSA, the Full Breath Sleep Appliance With Posterior Tongue Restrainer is substantially equivalent (SE) to the Quiet Night & Quiet Night MA (K032410), The Full Breath Sleep Appliance Anterior Bite With and Without Bumps (K052862), and the Full Breath Sleep Appliance Posterior Bite With and Without Bumps (K053065)
For the treatment of snoring, the Full Breath Appliance With Posterior Tongue Restrainer is SE to the Quiet Night & Quiet Night MA (K032410), The Full Breath Sleep Appliance Anterior Bite With and Without Bumps (K052862), and the Full Breath Sleep Appliance Posterior Bite With and Without Bumps (K053065), the Breathe EZ Anti-Snoring Device (K022891), the SleepBite (K103808), and Dr. B's Mouthpiece (K991948).
| For the treatment of bruxism, the Full Breath Sleep Appliance is SE to the NTI Tension | |
|---|---|
| Supression System (K010876), the Breathe EZ Anti-Snoring device (K022891), the SleepBite | |
| (K103808). And Dr. B's Mouthpiece (K991948). |
| Product
Name | Full Breath
Sleep Appl.
FBAB&FBPB | Quiet Night
Quiet Nt. MA | NTI Tension
Suppression
System | Breathe EZ
Anti-Snoring
Device | Sleepbite | Dr. B's
Mouthpiece |
|-----------------------|------------------------------------------|------------------------------------------|-------------------------------------------------------------------------------|--------------------------------------|-------------------------------|-------------------------------|
| 510(k) | K052862
K053065 | K032410 | K010876 | K022891 | K103808 | K991948 |
| Product
Code | LOZ | LOZ | LOZ | LRK | LRK | LRK |
| Indicated
Use | Treatment of
Mild & Mod.
OSA
-- | Treatment of
Mild & Mod.
OSA
-- | Prophylactic
treatment of
medically
diagnosed
migraine pain
-- | | | |
| | Treatment of
Snoring
-- | Treatment of
Snoring
-- | | Treatment of
snoring
-- | Treatment of
snoring
-- | Treatment of
| snoring |
|---|
| Bruxism |
| Bruxism |
| Bruxism |
| Bruxism |
| Bruxism |
| Bruxism |
| Method of |
| Delivery |
2
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 stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black. The overall design is simple and recognizable, representing the department's focus on health and human welfare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 6 2006
Dr. Bryan Keropian Bryan Keropian, DDS 18607 Ventura Boulevard, Suite 206 Tarzana, California 91356
Re: K061228
Trade/Device Name: Full Breath Sleep Appliance with Posterior Tongue Depressor Regulation Number: 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: LQZ Product Code: II Dated: May 2, 2006
Received: May 2, 2006
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 (Sections 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 wours,
Susan Runox
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
Indications for Use
510(k) Number (if known):
Device Name: Full Breath Sleep Appliance With Posterior Tongue Depressor
Indications For Use:
-
- Full Breath Sleep Appliance With Posterior Tongue Depressor- This appliance is indicated for the treatment of snoring.
-
- Full Breath Sleep Appliance With Posterior Tongue Depressor This appliance is indicated for the treatment of mild to moderate obstructive sleep apnea.
X 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 IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan
(vision Sign-C
Envision of Anesthesiology, General Hospital,
Infection Control, Dental Devices
510(%) Number ..