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.

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 staff places 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.

AI/ML Overview

This document describes the Snorer's Friend, an intra-oral mandibular advancement device, and its substantial equivalence to a predicate device. It does not contain information about an AI-based device, nor details of acceptance criteria or a study proving that an "AI-device" meets those criteria. Therefore, most of the requested information cannot be extracted.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (SomnoGuard) for a traditional medical device (Snorer's Friend), not an AI-enabled one. As such, information regarding acceptance criteria, studies for AI performance, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance are not applicable or present in this document.

However, some relevant information regarding the device and its comparison to the predicate is available:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state "acceptance criteria" in the context of measurable performance metrics typically associated with AI devices (e.g., sensitivity, specificity, AUC). Instead, substantial equivalence is based on similar intended use, design, technology, materials, and performance characteristics compared to a predicate device.

The table below summarizes the comparison presented between the Snorer's Friend and its predicate, which implicitly serves as the "performance" benchmark for establishing equivalence.

Feature / Characteristic	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.
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	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	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	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

2. Sample size used for the test set and the data provenance:

Not applicable as this is not an AI-device study. The equivalence is based on design and material comparisons, not a clinical "test set" in the context of an AI algorithm.
The document states: "Snorer's Friend has similar design, technology, and indications for use as the predicate SomnoGuard and therefore Section 8 - Clinical Data is not applicable."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as this is not an AI-device study requiring expert-established ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable.

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:

No, this was not done as it is not an AI-enabled device.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

No, this was not done as it is not an AI-enabled device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable. For this type of device, "ground truth" would relate to its physical properties, biocompatibility, and user-fitting success, which are addressed through design verification and validation activities and comparison to the predicate.

8. The sample size for the training set:

Not applicable as this is not an AI-device study.

9. How the ground truth for the training set was established:

Not applicable as this is not an AI-device study.

Summary

{0}------------------------------------------------

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.

{1}------------------------------------------------

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

{2}------------------------------------------------

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

SNORER'S FRIEND 510(K) SUMMARY 510(K) NUMBER K171529

I. GENERAL INFORMATION

Submitter (510k Owner):	Scope Healthcare Technologies Pty LtdSuite 5, 20 Taylors Avenue MorphettVale SA 5162 AustraliaEstablishment Registration No. TBDOwner Operator Number: TBD
Contact Person:	Ben OlsenScope Healthcare Technologies Pty LtdSuite 5, 20 Taylors AvenueMorphett Vale SA 5162 AustraliaEmail: 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-SnoringProduct Code: LRKClass: II
Regulation:	CFR 872.5570Intraoral devices for snoring and intraoral devicesfor snoring and obstructive sleep apnea.
Review Panel:	Dental
III. PREDICATE DEVICE
Predicate Device(s):	SomnoGuard (original) manufactured by TOMEDDr. Toussaint, GmbH (K061688)(This predicate has not been subject to any productrecalls).
Reference Device(s):	SleepPro manufactured by Michael D. WilliamsDDS PA (K132506)
	Predicate (SomnoGuard)	Snorer's Friend
Indications for Use	The SomnoGuard series ofmandibular advancementdevices is intended for thetreatment of night-time snoringand mild to moderateobstructive sleep apnea (OSA)in adults.	Snorer's Friend is an intra-oralmandibular advancementdevice used during sleep toreduce snoring and treat mildto moderate obstructive sleepapnea (OSA) in adults.

{4}------------------------------------------------

IV. DEVICE DESCRIPTION

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

{5}------------------------------------------------

Snorer's Friend Abbreviated 510(k) 510(k) Summary K171529 (as required by section 807.92(c))

Design	Prefabricated “boil & bite” onepiece mandibularadvancement device designedto be fitted to upper and lowerteeth.	Prefabricated “boil & bite” onepiece mandibularadvancement device designedto be fitted to upper and lowerteeth.
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 iscontraindicated 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 iscontraindicated 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 ofoperation/meansof mandibularadvancement	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
Cleaningprocedure	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

{6}------------------------------------------------

Snorer's Friend Abbreviated 510(k) 510(k) Summary K171529 (as required by section 807.92(c))

{7}------------------------------------------------

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.

{8}------------------------------------------------

Regulation Number and Section

§ 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.”