K Number
K053065
Device Name
FULL BREATH SLEEP APPLIANCE - PB (POSTERIOR BITE AND PBB (POSTERIOR BITE WITH BUMPS)
Manufacturer
Date Cleared
2006-01-03

(63 days)

Product Code
Regulation Number
872.5570
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
1. An oral appliance to be used for the treatment of mild and moderate Obstructive Sleep Apnea. 2. For the treatment of snoring. 3. For the prevention of bruxism.
Device Description
The Full Breath Sleep Appliance PB & PBB is a custom device fabricated 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 function of control of vertical dimension and mandibular advancement for reduction/elimination of snoring. It also incorporates the posterior trans-palatal bar of the Quiet Night and Quiet Night MA to prevent the tongue from sealing against the palate and thus reduce snoring. It also restrains the tongue from up and back movement. The tongue restraint has resulted in reduced AHI/RDI's, and elevation of the O2 low saturation (nadir) when sleeping.
More Information

No
The device description focuses on mechanical design features and enhancements to a predicate device, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".

Yes
The device is intended for the treatment of mild and moderate Obstructive Sleep Apnea, the treatment of snoring, and the prevention of bruxism, all of which are therapeutic interventions.

No
The device is described as an oral appliance for treatment and prevention, not for diagnosis.

No

The device description clearly states it is a custom fabricated oral appliance, which is a physical hardware device.

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: The description clearly states that this is an oral appliance used for the treatment of sleep apnea, snoring, and bruxism. It is a physical device worn in the mouth.
  • Intended Use: The intended uses are all related to treating conditions by physically altering the position of the jaw and tongue, not by analyzing biological samples.

Therefore, this device falls under the category of a medical device, but not an in vitro diagnostic device.

N/A

Intended Use / Indications for Use

  • I. An oral appliance to be used for the treatment of mild and moderate Obstructive Sleep Apnea.
    1. For the treatment of snoring.
    1. For the prevention of bruxism.

Product codes (comma separated list FDA assigned to the subject device)

LQZ

Device Description

The Full Breath Sleep Appliance PB & PBB is a custom device fabricated 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 function of control of vertical dimension and mandibular advancement for reduction/elimination of snoring. It also incorporates the posterior trans-palatal bar of the Quiet Night and Quiet Night MA to prevent the tongue from sealing against the palate and thus reduce snoring. It also restrains the tongue from up and back movement. The tongue restraint has resulted in reduced AHI/RDI's, and elevation of the O2 low saturation (nadir) when sleeping.

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

Prescription Use

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.

K032410

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.

K022891, K103808, K954530

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

K053065

JAN 3 2006

510(k) Summary Full Breath Sleep Appliance - PB (Posterior Bite) Full Breath Sleep Appliance - PBB (Posterior Bite with Bumps)

Applicant

Bryan Keropian DDS 18607 Ventura Blvd., Suite 206 Tarzana, CA 91356

Product Name

Full Breath Sleep Appliance -- PB (Posterior Bite) Full Breath Sleep Appliance - PBB (Posterior Bite with Bumps)

Proposed Product Code LQZ

Proposed Device Classification Jaw Repositioning Device

Contact Person Bryan Keropian DDS tm|relief|d`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 function of control of vertical dimension and mandibular advancement for reduction/elimination of snoring. It also incorporates the posterior trans-palatal bar of the Quiet Night and Quiet Night MA to prevent the tongue from sealing against the palate and thus reduce snoring. It also restrains the tongue from up and back movement. The tongue restraint has resulted in reduced AHI/RDI's, and elevation of the O2 low saturation (nadir) when sleeping.

DEVICE SPECIFICATIONS

The Full Breath Sleep Appliance PB & PBB is a custom device fabricated typically by a Professional dental laboratory and delivered by a dentist.

| Product
Name | Full Breath
Sleep Appl. | Quiet Night
Quiet Nt. MA | Breathe EZ
Anti-Snoring
Device | Sleepbite | The
Silencer |
|------------------|------------------------------------|-----------------------------------|--------------------------------------|-------------------------|-----------------------------------|
| 510(k) | Pending | K032410 | K022891 | K103808 | K954530 |
| Product
Code | LQZ | LQZ | LRK | LRK | LRK |
| Indicated
Use | Treatment of
Mild & Mod.
OSA | Treatment of
Mild & Mod
OSA | Treatment of
Snoring | Treatment of
Snoring | Treatment of
Mild & Mod
OSA |
| | -- | -- | | | -- |
| | Treatment of
Snoring | Treatment of
Snoring | | | Treatment of
Snoring |

Method of Delivery -By prescription By prescription By prescription By prescription By prescription

INDICATIONS FOR USE

  • I. An oral appliance to be used for the treatment of mild and moderate Obstructive Sleep Apnea.
    1. For the treatment of snoring.
    1. 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 AND HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

2006 JAN 3

Dr. Brvan Keropian 18607 Ventura Boulevard, Suite 206 Tarzana, California 91356

Re: K053065

Trade/Device Name: Full Breath Sleep Appliance – PB (Posterior Bitc) Full Breath Sleep Appliance – PBB (Posterior Bite with Bump) 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: October 31, 2005 Received: November 1, 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 (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 vour 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 responsibilitics 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.litml.

Sincerely yours,

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

K053065

U.S. Food and Drug Administration FDA

Image /page/4/Picture/2 description: The image contains a logo and some text. The logo is on the left side of the image and appears to be a stylized graphic. To the right of the logo, there are three lines of text. The text is difficult to read due to the image quality, but it seems to be some kind of heading or title.

Center for Devices and Radiological Health FDA Home Page | CDRH Họme Page | Search | CDRH A-Z | ndex | Contact CDRH

Indications for Use

510(k) Number (if known): K 05:3 Occd 3 C

Device Name: Full Breath Sleep AppliAnce - PB CPasterior Bric. Full BREAth Steep Appliance - PBB (Pasterior Bitc with Bumps , Indications for Use: ns for Use:
I) AN oral Appliance to be used For the tree the champ a moderate Obstructive Steep Aprea mild And J . F CHORING

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Prescription Use
(Part 21 CFR 801 Subpart D) X

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
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K05306512/10/2005
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