(80 days)
- 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.
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.
This document is a 510(k) summary for the Full Breath Sleep Appliance. The device is intended for the treatment of mild and moderate Obstructive Sleep Apnea, the treatment of snoring, and the prevention of bruxism.
The key information provided includes:
- Acceptance Criteria and Device Performance: Not explicitly stated as acceptance criteria in the prompt's sense. However, the device is considered substantially equivalent to predicate devices, implying it meets similar performance expectations. The efficacy is based on its design incorporating features from existing devices known to achieve these indications.
- Sample Size and Data Provenance: No specific study data, sample size, or provenance (country of origin, retrospective/prospective) is provided in this 510(k) summary. The submission focuses on substantial equivalence to predicate devices rather than new clinical trials.
- Ground Truth Establishment: Not applicable as no new clinical study validating performance against a ground truth is presented.
- Expert and Adjudication Methods: Not applicable as no new clinical study validating performance against a ground truth is presented.
- MRMC Comparative Effectiveness Study: Not performed or reported in this document. The submission is not related to assessing AI assistance.
- Standalone Performance: Not applicable as this is not a standalone algorithm, but a physical medical device.
- Type of Ground Truth: Not applicable, as detailed above.
- Training Set Sample Size and Ground Truth: Not applicable, as this is not an AI/algorithm-based device requiring a training set.
Summary of Device Performance (Implied by Substantial Equivalence):
The Full Breath Sleep Appliance (AB and ABB) is described as a simple enhancement to existing predicate devices (Quiet Night & Quiet Night MA - K032410, and NTI - K010867). Its design incorporates the anterior discluding element for bruxism and control of vertical dimension and anterior mandibular advancement for reduction/elimination of snoring, similar to the NTI. It also includes a posterior trans-palatal bar, which is stated to prevent tongue sealing against the palate, reduce snoring, and restrain the tongue from up and back movement, leading to "reduced AHI/RDI's and reduction of ODI's."
Predicate Device Comparison Table:
| Product Name | 510(k) | Product Code | Indicated Use | Method of Delivery |
|---|---|---|---|---|
| Full Breath Sleep Appl. | Pending | LQZ | Treatment of Mild & Mod. OSA, Prevent Bruxism, Snoring | By prescription |
| Quiet Night Quiet Nt. MA | K032410 | LQZ | Prophylactic treatment of medically diagnosed migraine pain, Prevent Bruxism | By prescription |
| NTI Tension Suppression System | K010876 | LQZ | Prophylactic treatment of medically diagnosed migraine pain, Prevent Bruxism | By prescription |
| Breathe EZ Anti-Snoring Device | K022891 | LRK | Treatment of snoring, Prevent Bruxism | By prescription |
| Sleepbite | K103808 | LRK | Treatment of snoring, Prevent Bruxism | By Prescription |
| Dr. B's Mouthpiece | K991948 | LRK | Treatment of snoring, Prevent Bruxism | By prescription |
Note: The FDA's 510(k) clearance process involves demonstrating substantial equivalence to a legally marketed predicate device, rather than requiring new clinical trials that explicitly define acceptance criteria and studies to meet them in the manner described in the prompt for AI/algorithm-based devices. The "study" in this context is the comparison to existing, approved devices and the rationale for how the new device's design achieves similar intended effects.
{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.
| ProductName | Full BreathSleep Appl. | Quiet NightQuiet Nt. MA | NTI TensionSuppressionSystem | Breathe EZAnti-SnoringDevice | Sleepbite | Dr. B'sMouthpiece |
|---|---|---|---|---|---|---|
| 510(k) | Pending | K032410 | K010876 | K022891 | K103808 | K991948 |
| ProductCode | LQZ | LQZ | LQZ | LRK | LRK | LRK |
| IndicatedUse | Treatment ofMild & Mod.OSA | Prophylactictreatment ofmedicallydiagnosedmigraine pain | Prophylactictreatment ofmedicallydiagnosedmigraine pain | Treatment ofsnoring | Treatment ofsnoring | Treatment ofsnoring |
| -- | -- | -- | -- | -- | -- | |
| PreventBruxism | PreventBruxism | PreventBruxism | PreventBruxism | PreventBruxism | PreventBruxism | |
| Method ofDelivery | 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.
{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 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
§ 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.”