(75 days)
- Full Breath Sleep Appliance Lower- This appliance is indicated for the treatment of snoring.
- Full Breath Sleep Appliance Lower This appliance is indicated for the treatment of mild to moderate obstructive sleep apnea.
The Full Breath Soution Lower is a custom fabricated device which is typically done by a professional dental laboratory and delivered by a dentist.
There is no information in the provided text about acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary and FDA letter for a PREDICATE DEVICE COMPARISON TABLE:
dental appliance, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed study results against specific acceptance criteria.
The document indicates that "All the research and data gathered for 510(k) K061228 are applicable for this application for certification," referring to a previously cleared device. However, the details of that prior research and data, including acceptance criteria and study particulars, are not included in the provided text.
Therefore, I cannot fulfill your request for the tables and details regarding acceptance criteria and a study that proves the device meets them based on the given information.
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510(k) Summary Full Breath Sleep Appliance Lower
Applicant
JUN 24 2009
Bryan Keropian DDS 18663 Ventura Blvd., Suite 200 Tarzana, CA 91356
Product Name Full Breath Sleep Appliance Lower
Proposed Product Code LQZ
510(k) # of device being modified K061228 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
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510(k) Summary (continued)
This is a change in usage to the Full Breath Posterior Tongue Restrainer FBPTR (K061228). The FBPTR is for usage on the maxillary arch. The Full Breath Solution Lower FBSL is the same appliance (FBPTR) turned over and placed on the lower arch. All the research and data gathered for 510(k) K061228 are applicable for this application for certification. In addition. It is being utilized with the added the tongue depression technique to open the oropharyngeal airway. The net result is eradication of snoring and reduction of AHI.
DEVICE SPECIFICATIONS
The Full Breath Soution Lower is a custom fabricated device which is typically done by a professional dental laboratory and delivered by a dentist.
| ProductName | Quiet NightQuite Nt. MA | Full BreathSleep Appl.FBAB | Full BreathSleep Appl.FBPB | Full BreathSleep Appl.FBPTR |
|---|---|---|---|---|
| 510(k) | K032410 | K052862 | KO53065 | K061228 |
| ProductCode | LOZ | LOZ | LOZ | LOZ |
| IndicatedUse | Treatment ofMild & Mod.OSA | Treatment ofMild & Mod.OSA | Treatment ofMild & ModOSA | Treatment ofMild & ModOSA |
| Treatment ofSnoring | Treatment ofsnoring | Treatment ofsnoring | Treatment ofsnoring | |
| Method ofDelivery | 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.
-
- An oral appliance to be used for the treatment of snoring.
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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract human figure with three flowing lines extending upwards, resembling a flame or a stylized representation of human services.
Public Health Service
1 UN 2 4 2009
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Bryan Keropian, D.D.S. Operation Manager Bryan Keropian DDS 18663 Ventura Boulevard, Suite 200 Tarzana, California 91356
Re: K091035
Trade/Device Name: Full Breath Sleep Appliance Lower 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: LQZ Dated: April 3, 2009 Received: April 10, 2009
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 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- 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. 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 contact the CDRH/Office of Surveillance and Biometrics/Division of Postmarket Surveillance at 240-276-3464. For more information regarding the reporting of adverse events, please go to http://www.fda.gov/cdrh/mdr/.
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
Susan Runner, D.D.S., M.A.
Acting 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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K09 1035
Indications for Use
510(k) Number (if known):
Device Name: Full Breath Sleep Appliance Lower
Indications For Use:
-
- Full Breath Sleep Appliance Lower- This appliance is indicated for the treatment of snoring.
-
- Full Breath Sleep Appliance Lower This appliance is indicated for the treatment of mild to moderate obstructive sleep apnea.
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)
Susan
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Anesthesiology, General Hospital Infection Control, Dental Devices
409 102
510(k) Number:
§ 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.”