(529 days)
No
The device description details a purely mechanical mandibular advancement device with no mention of software, sensors, or any computational elements that would suggest the use of AI/ML.
No
The device is indicated for the reduction of snoring, which is typically considered a cosmetic or comfort issue rather than a disease or condition requiring therapy. Its function is to alleviate a symptom, not to treat a underlying medical condition.
No
The device is indicated for use as an aid for the reduction of snoring and its description focuses on its mechanical function to advance the mandible. There is no mention of the device being used to capture, analyze, or interpret any physiological data for diagnostic purposes.
No
The device description clearly states it is an intra-oral device made of injection molded thermoplastic trays and advancement bars, which are physical hardware components.
Based on the provided information, the SmartGuard Anti-Snore Device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
- SmartGuard Function: The SmartGuard Anti-Snore Device is an intra-oral device that physically repositions the mandible to reduce snoring. It does not analyze any biological specimens.
- Intended Use: The intended use is for the reduction of snoring, which is a physical intervention, not a diagnostic test.
- Device Description: The description details a physical device worn in the mouth, not equipment for analyzing samples.
Therefore, the SmartGuard Anti-Snore Device falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
SmartGuard Anti-Snore Device is indicated for use on adult patients 18 years or older as an aid for the reduction of snoring.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
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"(Fig). Both trays are custom fitted by the end user via "Boil-and-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 (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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral cavity, custom fit to dentition
Indicated Patient Age Range
adult patients 18 years or older
Intended User / Care Setting
During sleep, at home
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
No clinical testing was performed in association with this submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
SnoreRx (K170285)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Snoreeze (K181396), Orinis (K150566), SmartGuard Dental Guard (K123161)
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue box, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
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
1
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
2
Indications for Use
510(k) Number (if known)
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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3
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.
4
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 2A
Layton, UT 84041
Phone: 623-349-3984
Fax: 855-887-2721
Email: Brian@SmartGuardRx.com |
|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Brian Larsen
SmartGuard Rx Inc.
2112 North Hill Field Rd. Suite 2A
Layton, UT 84041
Phone: 623-349-3984
Fax: 855-887-2721
Email: Brian@SmartGuardRx.com |
| Date Prepared: | February 14, 2020 |
| Proprietary Name: | SmartGuard® Anti-Snore Device |
| Common Name: | Intra-oral Device for Snoring, Mandibular
Advancement 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.
5
DESCRIPTION OF THE DEVICE
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"(Fig). 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 (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.
6
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 | |
| Product | ||||||
| Code | LRK | LRK | LRK | LRK | ||
| Class. | ||||||
| Name | Intraoral Device for Snoring and | |||||
| Obstructive Sleep Apnea | Intraoral Device for Snoring and | |||||
| Obstructive Sleep Apnea | Intraoral Device for Snoring and | |||||
| Obstructive Sleep Apnea | Intraoral Device for Snoring and | |||||
| Obstructive Sleep Apnea | None | |||||
| Intended use | Intended for use on adult | |||||
| patients 18 years of age or | ||||||
| older as an aid for the | ||||||
| reduction of snoring. | Intended for use on adult | |||||
| patients 18 years of age or | ||||||
| older as an aid for the | ||||||
| reduction of snoring. | Intended for use on adult | |||||
| patients 18 years of age or | ||||||
| older as an aid for the | ||||||
| reduction of snoring. | Intended for use on adult | |||||
| patients 18 years of age or | ||||||
| older as an aid for the | ||||||
| reduction of snoring. | None | |||||
| Indication for | ||||||
| use | Rx or OTC | OTC | OTC/RX | OTC/RX | RX | OTC |
| Patient | ||||||
| population | Adults | Adults | Adults | Adults | None | |
| Cautions,Warnings and | ||||||
| Contraindications | Labeling contains all warnings | |||||
| cautions and contraindications | ||||||
| contained in FDA guidance documents | ||||||
| for Anti-Snore devices | Labeling contains all warnings | |||||
| cautions and contraindications | ||||||
| contained in FDA guidance documents | ||||||
| for Anti-Snore devices | Labeling contains all warnings | |||||
| cautions and contraindications | ||||||
| contained in FDA guidance | ||||||
| documents for Anti-Snore devices | ||||||
| Mandibular advancement device | ||||||
| (MAD) that advances the lower | Labeling contains all warnings | |||||
| cautions and contraindications | ||||||
| contained in FDA guidance | ||||||
| documents for Anti-Snore devices | None | |||||
| Mode of action | Mandibular advancement device | |||||
| (MAD) that advances the lower jaw to | ||||||
| increase pharyngeal space and | ||||||
| alleviate snoring | Mandibular advancement device (MAD) | |||||
| that advances the lower jaw to increase | ||||||
| pharyngeal space and alleviate snoring | jaw to increase pharyngeal space | |||||
| and | ||||||
| alleviate snoring | Mandibular advancement device | |||||
| (MAD) that advances the lower jaw | ||||||
| to increase pharyngeal space and | ||||||
| alleviate 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 to | |||
| dentition | Oral cavity, custom fit to | |||||
| dentition | 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's | |||||
| mouth using a "boil and bite” approach | ||||||
| and thermal setting (heat sensitive) | ||||||
| resins. Molded to the entire upper and | ||||||
| lower arch of teeth. | Custom impression to each | |||||
| individual's mouth using a "boil | ||||||
| and bite" approach and thermal | ||||||
| setting (heat sensitive) resins. | ||||||
| Molded to the entire upper and | ||||||
| lower arch of teeth. | Custom impression to each | |||||
| individual's mouth using a | ||||||
| "boil and bite" approach and | ||||||
| thermal setting (heat | ||||||
| sensitive) resins. Molded to | ||||||
| the entire upper and lower | ||||||
| arch of teeth. | Custom impression to each | |||||
| individual's mouth using a | ||||||
| "boil and bite" approach and | ||||||
| thermal setting (heat | ||||||
| sensitive) resins. Molded to | ||||||
| the entire upper and lower | ||||||
| arch of teeth. | Proposed device is molded | |||||
| one arch at a time and is | ||||||
| adjustable to arch shape. | ||||||
| Design | Consists of an upper and lower tray. | |||||
| Outer shell provides with structural | ||||||
| support and over mold is softer | ||||||
| material that is heat sensitive and thus | ||||||
| allows for custom fitting. | Consists of an upper and lower | |||||
| tray. Outer shell provides with | ||||||
| structural support and over mold is | ||||||
| softer material that is heat | ||||||
| sensitive and thus allows for | ||||||
| custom fitting. | Consists of an upper and lower | |||||
| tray. Outer shell provides with | ||||||
| structural support and over mold | ||||||
| is softer material that is heat | ||||||
| sensitive and thus allows for | ||||||
| custom fitting. | Consists of an upper and lower | |||||
| tray. Outer shell provides with | ||||||
| structural support and over mold is | ||||||
| softer material that is heat | ||||||
| sensitive and thus allows for | ||||||
| custom fitting. | None | |||||
| Adjustments | Anterior advancement of the | |||||
| mandible is increased as the user | ||||||
| chooses interconnecting bars | ||||||
| varying in length by 1mm with up to | ||||||
| 6 sizes to chose from. Allowing up | ||||||
| to 6 mm of protrusion. | Squeeze mouthpiece in a | |||||
| 'C' position and adjust. | ||||||
| • The upper and lower trays are | ||||||
| adjustable in 1mm increments up to | ||||||
| 6mm. | Advancement of the | |||||
| relative position of the | ||||||
| trays by the use of screw | ||||||
| adjustment to obtain a | ||||||
| fixed advancement up to 6 | ||||||
| mm | Oniris device comes with 9 | |||||
| connectors of varying | ||||||
| length. Enables up to | ||||||
| 11mm of protrusion. | Proposed device is adjustable | |||||
| as user chooses | ||||||
| Advancement Bars, varying by | ||||||
| 1mm in length. The upper and | ||||||
| lower trays are only connected | ||||||
| by the bars which allows | ||||||
| vertical articulation and | ||||||
| comfort. | ||||||
| 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 and | |||||
| toothpaste or with effervescent oral device | ||||||
| cleaning tablets. Deep clean once per week. | Clean/rinse daily with toothbrush and | |||||
| toothpaste or with effervescent oral | ||||||
| device cleaning tablets. Deep clean | ||||||
| once per week. | Clean/rinse daily with | |||||
| toothbrush and toothpaste or | ||||||
| with effervescent oral device | ||||||
| cleaning tablets. Deep clean | ||||||
| once per week. | Clean/rinse daily with | |||||
| toothbrush and toothpaste or | ||||||
| with effervescent oral device | ||||||
| cleaning tablets. Deep clean | ||||||
| once per week. | None | |||||
| Sterile | No | No | No | No | None | |
| Materials | Polycarbonate | |||||
| and | ||||||
| ethylene | ||||||
| vinyl acetate copolymer | Polycarbonate resin | |||||
| Ethylene vinyl acetate copolymer | Polycarbonate resin | |||||
| Ethylene vinyl acetate copolymer | Polycarbonate resin | |||||
| Ethylene vinyl acetate copolymer | None | |||||
| Biocompatibility | Meets ISO 10993-1 for a surface device | |||||
| contacting mucosal membrane for a | ||||||
| prolonged contact duration (> 24h to 30 | ||||||
| days): cytotoxicity, sensitization and | ||||||
| irritation | Meets ISO 10993-1 for a surface device | |||||
| contacting mucosal membrane for a | ||||||
| prolonged contact duration (> 24h to 30 | ||||||
| days): cytotoxicity, sensitization and | ||||||
| irritation | Meets ISO 10993-1 for a | |||||
| surface device contacting | ||||||
| mucosal membrane for a | ||||||
| prolonged contact duration (> | ||||||
| 24h to 30 days): cytotoxicity, | ||||||
| sensitization and irritation | Meets ISO 10993-1 for a | |||||
| surface device contacting | ||||||
| mucosal membrane for a | ||||||
| prolonged contact duration (> | ||||||
| 24h to 30 days): cytotoxicity, | ||||||
| sensitization and irritation | None |
7
K200657
Comparison Chart for SmartGuard® Anti-Snore Device and Predicate Devices
8
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.