The SmartGuard® Anti-Snore Device is an intra-oral device composed of two independent injection molded thermoplastic (Polycarbonate) trays, over molded with thermoforming resin (EVA). One tray is for the maxillary arch, labeled "Upper", and one tray is fitted to the mandibular arch, labeled "Lower". Both trays are custom fitted by the end user via "Boiland-Bite" process at home. A molding aid is included in the packaging to assist the user in the customization of the trays. The molding aid is constructed with the same Polycarbonate material as the upper and lower trays, as well as the Advancement Bars. Once the trays are molded to the user's teeth, the trays are connected via the insertion of Advancement Bars, which are available in 6 sizes, varying in length by 1mm. The Advancement Bars interlock with the mandibular and maxillary trays and holds the mandible forward which improves the ability to exchange air and decreases air turbulence, a causative factor in snoring. Because the trays are independent, the user can articulate vertically, allowing for greater airflow and comfort. As with all listed predicate devices, SmartGuard® Anti-Snore Device is a Mandibular Advancement Device (MAD) and is easily adjusted by the user to allow for up to 6mm of protrusion. The user can interchange the various sizes of Advancement Bars to find the size that comfortably advances the mandible and reduces snoring.

AI/ML Overview

The SmartGuard Anti-Snore Device is substantially equivalent to predicate devices in terms of its technological characteristics, materials, and intended use as an aid for the reduction of snoring. The device itself is a Mandibular Advancement Device (MAD) that advances the lower jaw to increase pharyngeal space and alleviate snoring. It is made from polycarbonate and ethylene vinyl acetate copolymer, materials commonly used in similar devices, and is custom-fitted by the user at home via a "boil-and-bite" process.

Here's an overview of the acceptance criteria and the studies performed:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provided does not contain a specific table of quantitative acceptance criteria for the SmartGuard Anti-Snore Device's effectiveness in reducing snoring, nor does it present direct performance metrics for the device itself in terms of snoring reduction. Instead, the substantial equivalence argument relies heavily on its similarity to legally marketed predicate devices.

The acceptance criteria are implicitly met by demonstrating that:

The device has similar indications for use to predicate devices: "SmartGuard Anti-Snore Device is indicated for use on adult patients 18 years or older as an aid for the reduction of snoring."
The device shares similar technological characteristics (e.g., MAD mechanism, materials, custom fitting method, adjustability) with predicate devices.
The device meets biocompatibility standards (e.g., ISO 10993-1) for its materials, which are identical to those in predicate devices and a previously cleared device from the same submitter.
Risk analysis (ISO 14971:2007) was conducted, and identified risks were addressed.
Usability testing (Human Factors and Usability Engineering) confirmed ease of use and understanding of labeling by laypersons.
Non-clinical bench testing confirmed physical properties of materials met device specifications.

2. Sample Size Used for the Test Set and Data Provenance:

Human Factors and Usability Engineering (HFE/UE) study: The document refers to a "summary report for the Usability Test contained in section 21." However, the provided excerpt does not include section 21 or provide details on the sample size for this test.
For other aspects, such as biocompatibility and material testing, specific sample sizes for test sets are not mentioned. The document relies on established standards and the identity of materials with existing cleared devices.
Data Provenance: Not explicitly stated for any of the tests, but the nature of the studies (e.g., HFE/UE, non-clinical bench testing) suggests these were conducted by or on behalf of SmartGuard Rx Inc.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not detail the use of experts to establish 'ground truth' in the context of device performance for snoring reduction. The clinical effectiveness for snoring reduction is inferred from substantial equivalence to predicate devices that are already cleared for this indication.
For the Usability Engineering study, the "ground truth" would be the observed user interactions and comprehension. No specific number or qualification of experts defining this 'ground truth' is provided, beyond the implication that the study was designed and evaluated by human factors professionals.

4. Adjudication Method for the Test Set:

No information is provided regarding an adjudication method for any specific test set. This type of method is typically employed in clinical trials or studies where subjective assessments (e.g., image interpretation, symptom severity) require expert consensus, which does not appear to be the primary method for demonstrating equivalence in this submission.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No MRMC comparative effectiveness study was done. The submission explicitly states: "No clinical testing was performed in association with this submission."

6. If a Standalone Study (algorithm only without human-in-the-loop performance) was done:

This device is a physical intra-oral appliance, not an algorithm or AI system. Therefore, the concept of an "algorithm only" or "standalone" performance study in that context is not applicable. The device's performance is intrinsically tied to its physical interaction with the user's anatomy.

7. The Type of Ground Truth Used:

For regulatory clearance, the "ground truth" for the SmartGuard Anti-Snore Device is its substantial equivalence to predicate devices, meaning it shares similar indications, technological characteristics, materials, and safety profiles.
For the Human Factors and Usability Engineering study, the "ground truth" would be the actual observed user behavior and comprehension of the device's labeling and instructions for use, aiming to ensure safe and effective home use by laypersons.
For biocompatibility and material testing, the "ground truth" is adherence to established international standards (e.g., ISO 10993-1, ISO 527, ISO 178, ISO 62) and material identity to previously cleared devices.

8. The Sample Size for the Training Set:

This information is not applicable. The SmartGuard Anti-Snore Device is a physical medical device. It does not involve machine learning or AI that would require a "training set" in the computational sense.

9. How the Ground Truth for the Training Set Was Established:

Not applicable, as there is no "training set" in the context of this device's submission.

Summary

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August 23, 2021

SmartGuard Rx Inc. Brian Larsen Director 2112 North Hill Field Rd. Suite 2A Layton, Utah 84041

Re: K200657

Trade/Device Name: SmartGuard Anti-Snore Device 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: July 14, 2021 Received: July 20, 2021

Dear Brian Larsen:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K200657

Device Name

SmartGuard Anti-Snore Device

Indications for Use (Describe)

SmartGuard Anti-Snore Device is indicated for use on adult patients 18 years or older as an aid for the reduction of snoring.

Type of Use (Select one or both, as applicable)

| Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows the logo for SmartGuard Rx Inc. The logo features a blue shield on the left side, followed by the words "SmartGuard" in a bold, blue font. Below "SmartGuard" is the text "Rx Inc." in a smaller, blue font. The logo is simple and professional, and the use of blue gives it a sense of trustworthiness and security.

4.0 Indications for Use: SmartGuard® Anti-Snoring Device is indicated for use on adult patients 18 years or older as an aid for the reduction of snoring.

Indications for Use Comparison for Predicate Devices

SnoreRx K170285: The SnoreRx is intended for use on adult patients 18 years of age or older as an aid for the reduction of snoring.

Oral Device-s (Snoreeze) K181396: The Oral Device-S is intended to reduce nighttime snoring for adults 18 and older.

Oniris K150566: The Oniris device is indicated in the treatment of snoring and/or mild to moderate obstructive sleep apnea in adults.

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Image /page/4/Picture/0 description: The image contains the logo for SmartGuard Rx Inc. The logo consists of a blue shield icon on the left, followed by the text "SmartGuard Rx Inc" in a blue sans-serif font. The shield icon has a curved line running through it.

Section 5 510(k) Summary

Prepared in accordance to 21 CFR 807.92

Applicant:	SmartGuard Rx Inc.2112 North Hill Field Rd. Suite 2ALayton, UT 84041Phone: 623-349-3984Fax: 855-887-2721Email: Brian@SmartGuardRx.com
Contact Person:	Brian LarsenSmartGuard Rx Inc.2112 North Hill Field Rd. Suite 2ALayton, UT 84041Phone: 623-349-3984Fax: 855-887-2721Email: Brian@SmartGuardRx.com
Date Prepared:	February 14, 2020
Proprietary Name:	SmartGuard® Anti-Snore Device
Common Name:	Intra-oral Device for Snoring, MandibularAdvancement Device
Classification	Device, Anti-Snoring
Name: Device Class:	Class II
Product Code:	LRK
Regulation Number:	21 CFR 872.5570
Predicate Device:Reference Devices:	SnoreRx (K170285)Snoreeze (K181396)Orinis (K150566)SmartGuard Dental Guard (K123161)

Image /page/4/Picture/6 description: The image contains the logo for SmartGuard Night Guard. The logo features a blue shield on the left side, followed by the word "SmartGuard" in a bold, sans-serif font. Below "SmartGuard" is the text "NIGHT GUARD" in a smaller, lighter font.

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DESCRIPTION OF THE DEVICE

Once the trays are molded to the user's teeth, the trays are connected via the insertion of Advancement Bars, which are available in 6 sizes, varying in length by 1mm. The Advancement Bars interlock with the mandibular and maxillary trays and holds the mandible forward which improves the ability to exchange air and decreases air turbulence, a causative factor in snoring (Fig2). Because the trays are independent, the user can articulate vertically (Fig3), allowing for greater airflow and comfort.

As with all listed predicate devices, SmartGuard® Anti-Snore Device is a Mandibular Advancement Device (MAD) and is easily adjusted by the user to allow for up to 6mm of protrusion. The user can interchange the various sizes of Advancement Bars to find the size that comfortably advances the mandible and reduces snoring.

Image /page/5/Picture/6 description: The image contains three figures of a mouthguard. Figure 1 shows an exploded view of the mouthguard, with the top and bottom pieces separated. Figure 2 shows the mouthguard assembled, and Figure 3 shows the mouthguard being worn.

INDICATIONS FOR USE:

SmartGuard® Anti-Snore Device is indicated for use on adult patients 18 years of age or older as an aid for the reduction of snoring.

COMPARISSION OF TECHNOLOGICAL CHARACTERISTICS:

The subject device uses the same or similar technological characteristics as the predicate devices to function as a Mandibular Advancement Devices are substantially equivalent in design, materials, labeling, and function.

As with the predicate devices, SmartGuard® Anti-Snore Device consists of an upper and lower tray constructed with a hard Polycarbonate outer shell and over molded with thermoforming resin which is fitted to the user via "boil and bite" process at home.

See comparison chart below:

Image /page/5/Picture/14 description: The image contains the logo for SmartGuard Night Guard. The logo features a blue shield on the left side, followed by the text "SmartGuard" in a stylized blue font. Below "SmartGuard" is the text "NIGHT GUARD" in a smaller, gray font.

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K200657

Comparison Chart for SmartGuard® Anti-Snore Device and Predicate Devices

		Proposed device	Predicate device	Reference Device	Reference device	Differences - Proposed
Manufacturer		SmartGuard Rx Inc.	Apnea Sciences, Inc.	Passion for Life	SAS Oniris	vs Predicate
Device Name		SmartGuard Anti-Snore Device	SnoreRx®	Oral Device S (Snoreeze)	Orinis
510(k)		K200657	K170825	K181396	K150566
Class		Class II	Class II	Class II	Class II
Classification	Reg	21 CFR 872.5570	21 CFR 872.5570	21 CFR 872.5570	21 CFR 872.5570
	ProductCode	LRK	LRK	LRK	LRK
	Class.Name	Intraoral Device for Snoring andObstructive Sleep Apnea	Intraoral Device for Snoring andObstructive Sleep Apnea	Intraoral Device for Snoring andObstructive Sleep Apnea	Intraoral Device for Snoring andObstructive Sleep Apnea	None
Intended use		Intended for use on adultpatients 18 years of age orolder as an aid for thereduction of snoring.	Intended for use on adultpatients 18 years of age orolder as an aid for thereduction of snoring.	Intended for use on adultpatients 18 years of age orolder as an aid for thereduction of snoring.	Intended for use on adultpatients 18 years of age orolder as an aid for thereduction of snoring.	None
Indication foruse	Rx or OTC	OTC	OTC/RX	OTC/RX	RX	OTC
	Patientpopulation	Adults	Adults	Adults	Adults	None
Cautions,Warnings andContraindications		Labeling contains all warningscautions and contraindicationscontained in FDA guidance documentsfor Anti-Snore devices	Labeling contains all warningscautions and contraindicationscontained in FDA guidance documentsfor Anti-Snore devices	Labeling contains all warningscautions and contraindicationscontained in FDA guidancedocuments for Anti-Snore devicesMandibular advancement device(MAD) that advances the lower	Labeling contains all warningscautions and contraindicationscontained in FDA guidancedocuments for Anti-Snore devices	None
Mode of action		Mandibular advancement device(MAD) that advances the lower jaw toincrease pharyngeal space andalleviate snoring	Mandibular advancement device (MAD)that advances the lower jaw to increasepharyngeal space and alleviate snoring	jaw to increase pharyngeal spaceandalleviate snoring	Mandibular advancement device(MAD) that advances the lower jawto increase pharyngeal space andalleviate snoring	None
Environment		During sleep, at home	During sleep at home	During sleep at home	During sleep at home	None
Placement of device		Oral cavity, custom fit to dentition	Oral cavity, custom fit to dentition	Oral cavity, custom fit todentition	Oral cavity, custom fit todentition	None
	Proposed device	Predicate device	Reference Device	Reference device	Differences - Proposed
Manufacturer	SmartGuard Rx Inc.	Apnea Sciences, Inc.	Passion for Life	SAS Oniris	vs. Predicate
Device Name	SmartGuard Anti-Snore Device	SnoreRx®	Oral Device S (Snoreeze)	Orinis
510(k)	K200657	K170825	K181396	K150566


Molding / Fitting	Custom impression to each individual'smouth using a "boil and bite” approachand thermal setting (heat sensitive)resins. Molded to the entire upper andlower arch of teeth.	Custom impression to eachindividual's mouth using a "boiland bite" approach and thermalsetting (heat sensitive) resins.Molded to the entire upper andlower arch of teeth.	Custom impression to eachindividual's mouth using a"boil and bite" approach andthermal setting (heatsensitive) resins. Molded tothe entire upper and lowerarch of teeth.	Custom impression to eachindividual's mouth using a"boil and bite" approach andthermal setting (heatsensitive) resins. Molded tothe entire upper and lowerarch of teeth.	Proposed device is moldedone arch at a time and isadjustable to arch shape.
Design	Consists of an upper and lower tray.Outer shell provides with structuralsupport and over mold is softermaterial that is heat sensitive and thusallows for custom fitting.	Consists of an upper and lowertray. Outer shell provides withstructural support and over mold issofter material that is heatsensitive and thus allows forcustom fitting.	Consists of an upper and lowertray. Outer shell provides withstructural support and over moldis softer material that is heatsensitive and thus allows forcustom fitting.	Consists of an upper and lowertray. Outer shell provides withstructural support and over mold issofter material that is heatsensitive and thus allows forcustom fitting.	None
Adjustments	Anterior advancement of themandible is increased as the userchooses interconnecting barsvarying in length by 1mm with up to6 sizes to chose from. Allowing upto 6 mm of protrusion.	Squeeze mouthpiece in a'C' position and adjust.• The upper and lower trays areadjustable in 1mm increments up to6mm.	Advancement of therelative position of thetrays by the use of screwadjustment to obtain afixed advancement up to 6mm	Oniris device comes with 9connectors of varyinglength. Enables up to11mm of protrusion.	Proposed device is adjustableas user choosesAdvancement Bars, varying by1mm in length. The upper andlower trays are only connectedby the bars which allowsvertical articulation andcomfort.
Single Use / Reusable	Single user, multi-use	Single user, multi-use	Single user, multi-use	Single user, multi-use	None
Cleaning instructions	Clean/rinse daily with toothbrush andtoothpaste or with effervescent oral devicecleaning tablets. Deep clean once per week.	Clean/rinse daily with toothbrush andtoothpaste or with effervescent oraldevice cleaning tablets. Deep cleanonce per week.	Clean/rinse daily withtoothbrush and toothpaste orwith effervescent oral devicecleaning tablets. Deep cleanonce per week.	Clean/rinse daily withtoothbrush and toothpaste orwith effervescent oral devicecleaning tablets. Deep cleanonce per week.	None
Sterile	No	No	No	No	None
Materials	Polycarbonateandethylenevinyl acetate copolymer	Polycarbonate resinEthylene vinyl acetate copolymer	Polycarbonate resinEthylene vinyl acetate copolymer	Polycarbonate resinEthylene vinyl acetate copolymer	None
Biocompatibility	Meets ISO 10993-1 for a surface devicecontacting mucosal membrane for aprolonged contact duration (> 24h to 30days): cytotoxicity, sensitization andirritation	Meets ISO 10993-1 for a surface devicecontacting mucosal membrane for aprolonged contact duration (> 24h to 30days): cytotoxicity, sensitization andirritation	Meets ISO 10993-1 for asurface device contactingmucosal membrane for aprolonged contact duration (>24h to 30 days): cytotoxicity,sensitization and irritation	Meets ISO 10993-1 for asurface device contactingmucosal membrane for aprolonged contact duration (>24h to 30 days): cytotoxicity,sensitization and irritation	None

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K200657

Comparison Chart for SmartGuard® Anti-Snore Device and Predicate Devices

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Image /page/8/Picture/0 description: The image shows the logo for SmartGuard Rx Inc. The logo consists of a blue shield on the left and the company name on the right. The shield has a white line running through it. The company name is written in a blue sans-serif font.

Biocompatibility

The predicate and subject devices are considered to be external communicating devices of permanent exposure (>30 days) per ISO 7405 and surface-contacting devices (mucosa) of permanent contact (>30 days) per ISO 10993-1. There are no new materials being used in the proposed device. Materials utilized for the SmartGuard® Anti-Snore Device are identical to the primary materials used in the predicate devices for the same intended use. Both the predicate and SmartGuard®Anti-Snore Device are made from polycarbonate and EVA.

The SmartGuard® Anti-Snore Device 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".

Use of Fourier Transform Infrared (FTIR) Spectroscopy was used to identify of the hard shell material of the subject device (PC) as well as the predicate devices.

The liner material (EVA) is identical to the material used in the previously cleared device marketed by the submitter (K123161).

The materials used in the subject device in its final finished form are identical to the predicate devices in formulation, processing, and no other chemicals have been added (e.g., plasticizers, fillers, additives, cleaning agents, mold release agents),

As all materials used in the device are used in many other currently marketed medical devices, no additional biocompatibility testing was conducted.

Risk Analysis and Usability Engineering

SmartGuard Rx Inc conducted a risk analysis on the proposed device in accordance with ISO 14971:2007 and by considering the issues raised in the FDA guidance document "Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea" (November 12, 2002). All identified risks have been addressed through device design, verification/validation or through labeling and instructions for use provided to the consumer.

A Human Factors and Usability Engineering (HFE/UE) study was performed of the SmartGuard® Anti-Snore Device in accordance to FDA guidance document "Applying Human Factors and Usability Engineering to Medical Devices" issued on Feb 3, 2016. The summary report for the Usability Test is contained in section 21. The results of the UE test verified the proposed device labeling, including directions for use, warnings, contraindications and indications are easily understood by the lay person and validated the ease of customizing the device for personal use at home.

NON-CLINICAL BENCH TESTING

The device materials were tested for various physical properties including Tensile Modulus (ISO 527) Flexural Modulus and Flexural Strength (ISO 178), and Water Absorption (ISO 62). All materials met device specifications.

Image /page/8/Picture/15 description: The image shows the logo for "SmartGuard NIGHT GUARD". The logo features a blue shield on the left side, followed by the text "SmartGuard" in a bold, sans-serif font. Below "SmartGuard", the words "NIGHT GUARD" are written in a smaller font size. The overall design is clean and modern, suggesting a sense of security and protection.

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Image /page/9/Picture/0 description: The image contains the logo for SmartGuard Rx Inc. The logo consists of a blue shield with a white swoosh inside, followed by the text "SmartGuard Rx Inc" in a dark blue sans-serif font. The shield is on the left side of the text.

CLINICAL TESTING

No clinical testing was performed in association with this submission.

CONCLUSION:

The results of the comparison of design, intended use, technological characteristics, materials, and labeling demonstrate the subject device is substantially equivalent in safety and effectiveness to the legally marketed predicate devices and does not introduce any new risks.

Image /page/9/Picture/7 description: The image shows the logo for SmartGuard Night Guard. The logo features a blue shield on the left side, with a white curved line running across it. To the right of the shield is the text "SmartGuard" in a bold, blue font. Below "SmartGuard" is the text "NIGHT GUARD" in a smaller, gray font.

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.”