(256 days)
No
The summary describes a mechanical oral device and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is intended for the treatment of mild to moderate obstructive sleep apnea, which is a medical condition.
No
The device is described as a treatment for sleep apnea, not for diagnosing it. Its function is to alleviate airway obstruction by advancing the mandible, not to identify or measure any physiological condition for diagnosis.
No
The device description clearly states that the Snorkel is an "oral mandibular advancement device" and a "single mouth piece" that is "custom-made and fitted based on dental impressions." This indicates a physical, hardware-based device, not a software-only one.
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 Function: The Snorkel is a physical device that is worn by the patient during sleep. It mechanically alters the position of the mandible and tongue to improve airflow. It does not analyze any biological samples.
- Intended Use: The intended use is to treat obstructive sleep apnea by reducing tongue-induced airway obstructions, which is a physical intervention, not a diagnostic test.
The description clearly indicates a physical, custom-fitted oral appliance used for treatment, not for diagnosing a condition by analyzing biological samples.
N/A
Intended Use / Indications for Use
The Snorkel is used to reduce tongue induced airway obstructions. The Snorkel is intended for use in patients, for the treatment of mild to moderate obstructive sleep apnea.
Product codes
LQZ
Device Description
The Snorkel is an oral mandibular advancement device whose function is to artificially protrude the chin (mandible) forward so as to pull the tongue away from the back of the throat, thereby reducing tongue-induced airway obstruction.
The Snorkel device is custom-made and fitted based on dental impressions and used by the patient during sleep. The single mouth piece fits snugly onto the upper and lower crowns of the patient's teeth. As the patient falls asleep, thus relaxing their mandible, a silicon band provides tension such that the mandible is pulled forward along with the tongue.
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
Not Found
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
Non-clinical testing included assessment of the physical properties of the SNORKEL and its ability to achieve its intended use. The Snorkel meets the same specifications as set for the predicate device. A biocompatibility assessment was performed to ensure biocompatibility, which was established based on the similarity of materials to the predicate device. Human clinical studies were not deemed necessary to evaluate safety or effectiveness because the device does not use designs dissimilar from the predicate, does not use new technologies, and does not deviate from the indications for use of the predicate. Risks and mitigating controls were addressed in a "Risk Assessment" and in the "Instructions for Use" manual.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KI12766
510(k) SUMMARY
JUN - 4 2012
Date Prepared: August 01, 2011. Updated: April 12, 2012 Submitter Information:
John Felldin, Inventor/Owner Fellmar Co. 2670 S. Myrtle Ave. #106 Monrovia, CA 91016 Email: jfelldin@fellmar.com Ph: 626-205-0122
Preparer: Wayne Marshall, Acting Manager Fellmar Co. 2670 S. Myrtle Ave. #106 Monrovia, CA 91016 Email: wmarshall@ordoarcanum.com Ph: 213-537-5924
Device Information:
| Trade Name: | The Snorkel, Jaw Repositioning Device, K112766 |
|---|---|
| Common Name: | The Snorkel |
| Classification Name: | Mandibular Repositioning Device |
| Product Code: | LQZ |
| Regulation: | 21 CFR 872.5570 |
Device for which Substantial Equivalence (SE) is claimed:
| Common Name: | Adjustable PM Positioner, K955503 |
|---|---|
| Classification Name: | Mandibular Repositioning Device |
| Product Code: | LQZ |
| Regulation: | 21 CFR 872.5570 |
Like the Adjustable PM Positioner (K955503), the Snorkel is a mouth splint appliance comprised of an acrylic upper body and an acrylic lower body, which are coupled together to push the lower jaw forward. The Snorkel is intended for use in patients, for the reduction of snoring and to treat mild to moderate obstructive sleep apnea.
1
DEVICE DESCRIPTION
The Snorkel is an oral mandibular advancement device whose function is to artificially protrude the chin (mandible) forward so as to pull the tongue away from the back of the throat, thereby reducing tongue-induced airway obstruction.
The Snorkel device is custom-made and fitted based on dental impressions and used by the patient during sleep. The single mouth piece fits snugly onto the upper and lower crowns of the patient's teeth. As the patient falls asleep, thus relaxing their mandible, a silicon band provides tension such that the mandible is pulled forward along with the tongue.
INDICATIONS FOR USE
The Snorkel is used to reduce tongue induced airway obstructions. The Snorkel is intended for use in patients, for the treatment of mild to moderate obstructive sleep apnea.
SUMMARY OF NON-CLINICAL TESTING
The non-clinical testing included assessment of the physical properties of the SNORKEL and its ability to achieve its intended use. The Snorkel meets the same specifications as set for the predicate device.
A biocompatibility assessment of the device was performed. The purpose of the biocompatibility assessment was to ensure that biocompatibility had been established for the device. The device is biocompatible, based on the similarity of the materials of construction to the predicate device (The Adjustable PM Positioner) marketed by Airway Management Inc.
SUMMARY OF CLINICAL TESTING
Human clinical studies were not deemed necessary to evaluate the safety or effectiveness of the Snorkel. The Snorkel does not: Use designs dissimilar from the predicate device and other previously cleared devices under a 510(k); The Snorkel does not use new technologies different from legally marketed intramandibular repositioning devices for snoring and/ or obstructive sleep apnea; and the Snorkel does not deviate from the indications for use identified in the predicate device: Adjustable PM Positioner.
In lieu of human clinical testing, the risks and mitigating controls associated with the use of mandibular repositioning devices, as identified by the FDA, have been addressed in the "Risk Assessment". In addition, adequate warnings and precautions are found in the "Instructions for Use" manual.
STATEMENT OF EQUIVALENCE
The Snorkel is substantially equivalent to the currently marketed Adjustable PM Positioner based on a comparison of the indications for use and the technological characteristics of the device. The only design difference is in the nature of the adjustable mechanisms in the two devices.
2
CONCLUSION
The Snorkel is substantially equivalent to the currently marketed Adjustable PM Positioner based on the indications for use, technological characteristics, and materials of construction and principals of operations of the device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The eagle is depicted in a simple, black and white design.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Wayne Marshall Acting Manager Fellmar Co. 2670 S Myrtle Avenue #106 Monrovia, California 91016
JUN - 4 2012
Re: K112766
Trade/Device Name: The Snorkel 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: May 8, 2012
Received: May 14, 2012
Dear Mr. Marshall:
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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.
4
Page 2 - Mr. Marshall
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
ನ್ನಾಗಿ
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation
Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): K112766
Device Name: The Snorkel
Indications For Use:
The Snorkel is used to reduce tongue induced airway obstructions. The Snorkel is intended for use in patients, for the treatment of mild to moderate obstructive sleep apnea.
Prescription Use · AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Rinner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number. K112766