(256 days)
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.
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.
The provided document describes "The Snorkel," a mandibular repositioning device for reducing snoring and treating mild to moderate obstructive sleep apnea. The submission for this device is a 510(k) premarket notification, which establishes substantial equivalence to a predicate device rather than providing extensive clinical trial data for new acceptance criteria.
Therefore, the following information is extracted from the document:
1. A table of acceptance criteria and the reported device performance:
Since this is a 510(k) submission, there are no explicit "acceptance criteria" defined in the typical sense of a clinical trial with performance metrics. Instead, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to the predicate device, K955503 (Adjustable PM Positioner), across various characteristics.
| Acceptance Criteria (Implicit from Substantial Equivalence Basis) | Reported Device Performance (as stated in the 510(k) Summary) |
|---|---|
| Indications for Use Equivalence | The Snorkel is intended for use in patients, for the reduction of snoring and to treat mild to moderate obstructive sleep apnea, which are the same indications as the predicate. |
| Technological Characteristics Equivalence | "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's 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." |
| Material Equivalence | Biocompatibility assessment performed; device is biocompatible "based on the similarity of the materials of construction to the predicate device." |
| Performance "Specifications" Equivalence | "The Snorkel meets the same specifications as set for the predicate device." (No specific quantitative specifications are provided in the document.) |
| Safety | Risks and mitigating controls identified by the FDA for mandibular repositioning devices have been addressed. Adequate warnings and precautions are found in the "Instructions for Use" manual. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. No human clinical study was conducted for this 510(k) submission to evaluate the safety or effectiveness of The Snorkel device itself. The evaluation relied on non-clinical testing and comparison to the predicate device.
- Data Provenance: Not applicable for a "test set" in the context of clinical performance. The data provenance would be from internal non-clinical testing (physical properties, biocompatibility) and regulatory guidelines regarding risk assessment for such devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. No "ground truth" was established based on expert review of a test set for this device in the context of a clinical performance study. The assessment was based on engineering design, material characteristics, and comparison to a predicate device.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. As no clinical test set was used, there was no need for an adjudication method by experts.
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:
- MRMC Study Done: No. This is a physical medical device (mandibular repositioning device), not an AI/software-as-a-medical-device (SaMD) or diagnostic imaging device that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Type of Ground Truth: For the purpose of this 510(k) submission, the "ground truth" for demonstrating substantial equivalence was the established safety, effectiveness, and technological characteristics of the predicate device (Adjustable PM Positioner, K955503), as well as the successful completion of non-clinical tests (physical properties, biocompatibility) and a risk assessment. There was no clinical ground truth established for The Snorkel itself through direct human clinical testing.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. There was no "training set" of data in the context of machine learning or clinical trials for this device.
9. How the ground truth for the training set was established:
- How Ground Truth for Training Set was Established: Not applicable. No training set was used.
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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.
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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.
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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.
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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.
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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
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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
§ 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.”