(63 days)
- 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.
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.
This 510(k) premarket notification for the Full Breath Sleep Appliance (PB and PBB) does not contain a study that establishes acceptance criteria or demonstrates device performance against those criteria. The submission primarily focuses on establishing substantial equivalence to previously cleared predicate devices.
Here's a breakdown of what can be inferred from the provided text regarding a study, and what information is missing:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated or defined in the provided document. The 510(k) relies on substantial equivalence to predicate devices, implying that acceptable performance is generally aligned with those devices.
- Reported Device Performance: The document only makes a qualitative claim: "The tongue restraint has resulted in reduced AHI/RDI's, and elevation of the O2 low saturation (nadir) when sleeping." No quantitative data or metrics are provided to support this claim. Therefore, a table comparing acceptance criteria to reported performance cannot be constructed from this document.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- This information is not provided in the document. The statement "The tongue restraint has resulted in reduced AHI/RDI's, and elevation of the O2 low saturation (nadir) when sleeping" is a general claim without details of a specific study, sample size, or data provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This information is not provided because no specific study with a "test set" and "ground truth" establishment is detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- This information is not provided as no specific study or test set is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- This is not applicable to the Full Breath Sleep Appliance. This device is a physical intraoral appliance, not an AI or imaging diagnostic tool that would involve "human readers" or AI assistance in interpretation.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This is not applicable to the Full Breath Sleep Appliance, for the same reasons as point 5.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- This information is not provided as no specific study with established ground truth is detailed.
8. The sample size for the training set
- This information is not provided. This device is not an AI/machine learning model, and thus does not have a "training set" in that context. If a clinical study was undertaken, it would involve participants to evaluate clinical outcomes, but details of such a study are absent.
9. How the ground truth for the training set was established
- This information is not provided as there is no "training set" in the context of an AI/machine learning model.
Summary of Study Information in the K053065 510(k):
The provided 510(k) summary for the Full Breath Sleep Appliance is focused on demonstrating substantial equivalence to predicate devices (Quiet Night & Quiet Night MA, Breathe EZ Anti-Snoring Device, Sleepbite, The Silencer) that have already been cleared for similar indications. It does not include detailed clinical study data or a statistical analysis of performance against specific acceptance criteria.
The only statement related to performance is: "The tongue restraint has resulted in reduced AHI/RDI's, and elevation of the O2 low saturation (nadir) when sleeping." This is a general claim about the device's effect, but no supporting data (e.g., from a clinical trial, sample size, methodology, statistical significance) are presented in the provided text. For a 510(k) submission, particularly for Class II devices, clinical data demonstrating safety and effectiveness may not always be required if substantial equivalence to a predicate device can be established through technological characteristics and indications for use.
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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
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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.
| ProductName | Full BreathSleep Appl. | Quiet NightQuiet Nt. MA | Breathe EZAnti-SnoringDevice | Sleepbite | TheSilencer |
|---|---|---|---|---|---|
| 510(k) | Pending | K032410 | K022891 | K103808 | K954530 |
| ProductCode | LQZ | LQZ | LRK | LRK | LRK |
| IndicatedUse | Treatment ofMild & Mod.OSA | Treatment ofMild & ModOSA | Treatment ofSnoring | Treatment ofSnoring | Treatment ofMild & ModOSA |
| -- | -- | -- | |||
| Treatment ofSnoring | Treatment ofSnoring | Treatment ofSnoring |
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.
-
- For the treatment of snoring.
-
- For the prevention of bruxism.
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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.
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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); 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
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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 |
|---|
| ------------------------------------------- |
| K053065 | 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.”