FULL BREATH SLEEP APPLIANCE LOWER (FBSL)

K091035 · Bryan Keropian Dds · LQZ · Jun 24, 2009 · Dental

Device Facts

Record IDK091035
Device NameFULL BREATH SLEEP APPLIANCE LOWER (FBSL)
ApplicantBryan Keropian Dds
Product CodeLQZ · Dental
Decision DateJun 24, 2009
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 872.5570
Device ClassClass 2
AttributesTherapeutic

Intended Use

1. Full Breath Sleep Appliance Lower- This appliance is indicated for the treatment of snoring. 2. Full Breath Sleep Appliance Lower This appliance is indicated for the treatment of mild to moderate obstructive sleep apnea.

Device Story

Full Breath Sleep Appliance Lower is a custom-fabricated oral appliance; essentially the Full Breath Posterior Tongue Restrainer (FBPTR) device inverted for placement on the lower dental arch. Used by dentists to treat snoring and mild-to-moderate obstructive sleep apnea. Device functions by applying a tongue depression technique to open the oropharyngeal airway. Custom-fabricated by dental laboratories; delivered via prescription. Benefits include eradication of snoring and reduction of apnea-hypopnea index (AHI).

Clinical Evidence

No new clinical data provided. Substantial equivalence is based on data previously gathered for the predicate device (K061228).

Technological Characteristics

Custom-fabricated intraoral jaw repositioning device. Mechanical design utilizes tongue depression to maintain airway patency. No electronic components, software, or energy sources.

Indications for Use

Indicated for patients with snoring and mild to moderate obstructive sleep apnea.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

{0}------------------------------------------------ 1 of 2 K091035 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 {1}------------------------------------------------ K091035 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. | Product<br>Name | Quiet Night<br>Quite Nt. MA | Full Breath<br>Sleep Appl.<br>FBAB | Full Breath<br>Sleep Appl.<br>FBPB | Full Breath<br>Sleep Appl.<br>FBPTR | |-----------------------|------------------------------------|------------------------------------|------------------------------------|-------------------------------------| | 510(k) | K032410 | K052862 | KO53065 | K061228 | | Product<br>Code | LOZ | LOZ | LOZ | LOZ | | Indicated<br>Use | Treatment of<br>Mild & Mod.<br>OSA | Treatment of<br>Mild & Mod.<br>OSA | Treatment of<br>Mild & Mod<br>OSA | Treatment of<br>Mild & Mod<br>OSA | | | Treatment of<br>Snoring | Treatment of<br>snoring | Treatment of<br>snoring | Treatment of<br>snoring | | Method of<br>Delivery | By prescription | By prescription | By prescription | By prescription | # PREDICATE DEVICE COMPARISON TABLE: ## INDICATIONS FOR USE - 1. An oral appliance to be used for the treatment of mild and moderate Obstructive Sleep Apnea. - 2. An oral appliance to be used for the treatment of snoring. {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 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. {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); 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 {4}------------------------------------------------ K09 1035 # Indications for Use 510(k) Number (if known): Device Name: Full Breath Sleep Appliance Lower Indications For Use: - 1. Full Breath Sleep Appliance Lower- This appliance is indicated for the treatment of snoring. - 2. 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:
Innolitics
510(k) Summary
Decision Summary
Classification Order
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