(222 days)
No
The device description and performance studies focus on the physical mechanism of mandibular advancement and material properties, with no mention of AI/ML algorithms or data processing.
Yes
The device is described as treating mild to moderate Obstructive Sleep Apnea (OSA) and is listed as complying with "FDA Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea", which indicates it has a therapeutic purpose.
No
The device description clearly states that "Snorer's Friend is an intra-oral mandibular advancement device used during sleep to reduce snoring and treat mild to moderate Obstructive Sleep Apnea (OSA) in adults." It is a treatment device, not a diagnostic one.
No
The device description clearly describes a physical, intra-oral mandibular advancement device made of a material that is molded to the patient's teeth. It does not mention any software components.
Based on the provided information, the "Snorer's Friend" device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce snoring and treat mild to moderate Obstructive Sleep Apnea (OSA) by physically advancing the lower jaw. This is a therapeutic and mechanical action within the body.
- Device Description: The device is an intra-oral appliance that is custom-fitted to the patient's teeth. It works by physically altering the position of the jaw and tongue.
- Lack of Diagnostic Function: There is no mention of the device being used to diagnose a condition, analyze samples from the body (like blood, urine, or tissue), or provide information about a patient's health status based on such analysis.
- Anatomical Site: The device is used intra-orally, which is a physical location within the body, not a sample being tested in vitro.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Snorer's Friend does not fit this description. It is a therapeutic medical device.
N/A
Intended Use / Indications for Use
Snorer's Friend is an intra-oral mandibular advancement device used during sleep to reduce snoring and treat mild to moderate Obstructive Sleep Apnea (OSA) in adults.
Product codes
LRK
Device Description
The 'Snorer's Friend' is an intra-oral mandibular advancement device used during sleep to reduce snoring by advancing the lower jaw and thereby minimizing air obstruction and turbulence. It advances the lower jaw and tongue forward so the airway will remain open during sleep.
The device is fitted to the patient by, or under the direction of, physicians (e.g., ENT doctors, sleep lab doctors or dentists) or their trained medical staff by immersing it in boiling water for approximately 17 seconds. Once removed from the hot water, it is very gently rotated to allow excess water to run off.
Snorer's Friend is custom fitted to the upper and lower teeth, in a similar fashion to an athletic mouth guard. When boiled, the material softens which allows the device to be molded to the shape of the patient's teeth. To prepare for the fitting, the spatula provided is used to place the device in boiled water for 17 seconds. Holding the mouth of the patient open and the lower jaw forward, the physician or their trained medical staffplaces the device in the mouth and the patient bites down firmly.The device is then placed in cold water.
The Snorer's Friend is simple to fit and does not require impressions or lab-fabrication. As such, it is a more economical and timesaving alternative to more costly labfabricated mandibular advancement devices.
Snorer's Friend intra-oral mandibular advancement devices are only to be fitted/re-fitted by, or under the direction of, physicians (e.g., ENT doctors, sleep lab doctors or dentists) or their trained medical staff. The patient should undergo a comprehensive oral health assessment by a dentist before the device is fitted to the patient. The maximum mandibular advancement to be performed with this device is 5 mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Mandibular, oral cavity
Indicated Patient Age Range
Adult patients 18 years and older
Intended User / Care Setting
Physicians (e.g., ENT doctors, sleep lab doctors or dentists) or their trained medical staff.
Environments of use: Home, Sleep laboratories
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
The Snorer's Friend is equivalent in terms of intended use, design and performance requirements to the predicate device.
The Snorer's Friend complies with the FDA Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.
All design verification and validation (V&V) activities were performed according to 21 CFR 820.30 including dimensional analysis, visual inspection, product testing and evaluation of returned product.
The Snorer's Friend complies with the FDA guidance document "Use of International Standard ISO 10993 Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", as demonstrated by using the reference device K132506.
NOTE: Snorer's Friend has similar design, technology, and indications for use as the predicate SomnoGuard and therefore Section 8 - Clinical Data is not applicable.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
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.”
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Scope Healthcare Technologies Pty Ltd Ben Olsen Director Suite 5, 20 Taylors Avenue Morphett Vale, South Australia 5162 AUSTRALIA
January 2, 2018
Re: K171529
Trade/Device Name: Snorer's Friend Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: Class II Product Code: LRK Dated: November 19, 2017 Received: December 13, 2017
Dear Ben Olsen:
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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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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Mary S. Runner -S
For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, 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) K171529
Device Name Snorer's Friend
Indications for Use (Describe)
Snorer's Friend is an intra-oral mandibular advancement device used during sleep to reduce snoring and treat mild to moderate Obstructive Sleep Apnea (OSA) in adults.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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SNORER'S FRIEND 510(K) SUMMARY 510(K) NUMBER K171529
I. GENERAL INFORMATION
| Submitter (510k Owner): | Scope Healthcare Technologies Pty Ltd
Suite 5, 20 Taylors Avenue Morphett
Vale SA 5162 Australia
Establishment Registration No. TBD
Owner Operator Number: TBD | |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Ben Olsen
Scope Healthcare Technologies Pty Ltd
Suite 5, 20 Taylors Avenue
Morphett Vale SA 5162 Australia
Email: support@snorers-friend.com | |
| Date Prepared: | December 22, 2017 | |
| II. DEVICE DETAILS | | |
| Trade Name: | Snorer's Friend | |
| Common or Usual Name: | Anti-Snoring Device | |
| Classification: | Device, Anti-Snoring
Product Code: LRK
Class: II | |
| Regulation: | CFR 872.5570
Intraoral devices for snoring and intraoral devices
for snoring and obstructive sleep apnea. | |
| Review Panel: | Dental | |
| III. PREDICATE DEVICE | | |
| Predicate Device(s): | SomnoGuard (original) manufactured by TOMED
Dr. Toussaint, GmbH (K061688)
(This predicate has not been subject to any product
recalls). | |
| Reference Device(s): | SleepPro manufactured by Michael D. Williams
DDS PA (K132506) | |
| | Predicate (SomnoGuard) | Snorer's Friend |
| Indications for Use | The SomnoGuard series of
mandibular advancement
devices is intended for the
treatment of night-time snoring
and mild to moderate
obstructive sleep apnea (OSA)
in adults. | Snorer's Friend is an intra-oral
mandibular advancement
device used during sleep to
reduce snoring and treat mild
to moderate obstructive sleep
apnea (OSA) in adults. |
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IV. DEVICE DESCRIPTION
The 'Snorer's Friend' is an intra-oral mandibular advancement device used during sleep to reduce snoring by advancing the lower jaw and thereby minimizing air obstruction and turbulence. It advances the lower jaw and tongue forward so the airway will remain open during sleep.
The device is fitted to the patient by, or under the direction of, physicians (e.g., ENT doctors, sleep lab doctors or dentists) or their trained medical staff by immersing it in boiling water for approximately 17 seconds. Once removed from the hot water, it is very gently rotated to allow excess water to run off.
Snorer's Friend is custom fitted to the upper and lower teeth, in a similar fashion to an athletic mouth guard. When boiled, the material softens which allows the device to be molded to the shape of the patient's teeth. To prepare for the fitting, the spatula provided is used to place the device in boiled water for 17 seconds. Holding the mouth of the patient open and the lower jaw forward, the physician or their trained medical staffplaces the device in the mouth and the patient bites down firmly.The device is then placed in cold water.
The Snorer's Friend is simple to fit and does not require impressions or lab-fabrication. As such, it is a more economical and timesaving alternative to more costly labfabricated mandibular advancement devices.
Snorer's Friend intra-oral mandibular advancement devices are only to be fitted/re-fitted by, or under the direction of, physicians (e.g., ENT doctors, sleep lab doctors or dentists) or their trained medical staff. The patient should undergo a comprehensive oral health assessment by a dentist before the device is fitted to the patient. The maximum mandibular advancement to be performed with this device is 5 mm.
V. INDICATIONS FOR USE
Snorer's Friend is an intra-oral mandibular advancement device used during sleep to reduce snoring and treat mild to moderate Obstructive Sleep Apnea (OSA) in adults.
VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
The Snorer's Friend presented in this 510(k) is substantially equivalent to the predicate in terms of intended use, fundamental scientific technology, operating principles and mechanism of action.
A summary comparison between the Snorer's Friend and predicate is provided in Table 1 below. A more detailed comparison is provided in Section 12 of this submission.
Table 1. Summary Comparison of the Snorer's Friend and Predicate
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Snorer's Friend Abbreviated 510(k) 510(k) Summary K171529 (as required by section 807.92(c))
| Design | Prefabricated “boil & bite” one
piece mandibular
advancement device designed
to be fitted to upper and lower
teeth. | Prefabricated “boil & bite” one
piece mandibular
advancement device designed
to be fitted to upper and lower
teeth. |
|-----------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Components | Monobloc mouthpiece. Filler material. Storage case. Wooden spatula. User instructions. | 2 x mandibular advancement devices. Storage case. 2x Wooden spatulas. User instructions. |
| Environments of use | Home, Sleep laboratories | Home, Sleep laboratories |
| Patient Population | Adult patients 18 years and older | Adult patients 18 years and older |
| Contraindications | SomnoGuard is
contraindicated for patients who have:
Central sleep apnea, Mandibular joint disorder, (Strong) gag reflex, larger gaps between the teeth, unstable dental crowns, decay, periodontitis – Limited mandibular advancement. Patients with sleep apnea should be able to extend their lower jaw forward at least 7mm. Restricted breathing through the nasal passages | Snorer's Friend is
contraindicated for patients who:
people under the age of 18 years old, those whom have been diagnosed with central sleep apnea, have a severe respiratory disorder/s, have loose teeth or advanced periodontal disease. Have loose dental work, dentures, unstable dental crowns, or other oral conditions which would be adversely affected by wearing dental appliances |
| Prescription | Prescription use | Prescription use |
| Patient use | Single patient, multiple use. | Single patient, multiple use. |
| Duration of use | No limitation | No limitation |
| Principle of
operation/means
of mandibular
advancement | Repositions the lower jaw and thereby holds the base of the tongue forward. The airway remains open, by increasing the clearance between the back of the tongue and the back of the throat. | Repositions the lower jaw and thereby holds the base of the tongue forward. The airway remains open, by increasing the clearance between the back of the tongue and the back of the throat. |
| Fixed tray sizes | Yes | Yes |
| Fitting procedure | Custom Fitting (boil & bite) | Custom Fitting (boil & bite) |
| Movement | Lateral and vertical | Lateral and vertical |
| Cleaning
procedure | Brushing with a soft toothbrush and 2 to 3 drops of a washing-up liquid or a liquid denture cleaner | Brushing with a normal toothbrush and toothpaste, as often as required. |
| Sterile | No | No |
| Material | Thermoplastic copolymers | Thermoplastic copolymers |
| Biocompatibility | Biocompatible | Biocompatible |
| Expected Lifetime | Up to two years | 4-24 months |
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Snorer's Friend Abbreviated 510(k) 510(k) Summary K171529 (as required by section 807.92(c))
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VII. PERFORMANCE DATA
The Snorer's Friend is equivalent in terms of intended use, design and performance requirements to the predicate device.
The Snorer's Friend complies with the FDA Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA, including:
- Section 4 Scope; .
- . Section 5 - Risks to Health;
- Section 6 Material Composition; .
- . Section 7 - Biocompatibility;
- Section 9 Labeling; .
NOTE: Snorer's Friend has similar design, technology, and indications for use as the predicate SomnoGuard and therefore Section 8 - Clinical Data is not applicable.
All design verification and validation (V&V) activities were performed according to 21 CFR 820.30 including dimensional analysis, visual inspection, product testing and evaluation of returned product.
The Snorer's Friend complies with the FDA guidance document "Use of International Standard ISO 10993 Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", as demonstrated by using the reference device K132506.
VIII. CONCLUSIONS
Based on the information provided in this submission, the Snorer's Friend is substantially equivalent to the predicate SomnoGuard device and does not raise any new questions relating to safety and/or effectiveness.
The Snorer's Friend and SomnoGuard have the same intended use for treating snoring and mild to moderate obstructive sleep apnea (OSA). Both devices have similar designs, technology, materials, and performance characteristics. Both devices employ a 'boil and bite' design to provide a custom impression for each patient. Both devices have similar environments of use and intended user populations, with similar warnings and contraindications.
Any differences between the Snorer's Friend and SomnoGuard are not significant and do not affect the substantial equivalence of the proposed device to the predicate device.
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