Advanced Dental Applicance

K172991 · Dasoft Partners · LRK · Jul 10, 2018 · Dental

Device Facts

• Record ID: K172991
• Device Name: Advanced Dental Applicance
• Applicant: Dasoft Partners
• Product Code: LRK · Dental
• Decision Date: Jul 10, 2018
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 872.5570
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Intraoral device for reduction in snoring.

Device Story

Intraoral appliance worn during sleep to reduce snoring; utilizes manually adjustable tongue sleeve to position tongue and surrounding tissues anteriorly; increases pharyngeal space to improve air exchange and decrease turbulence; custom-fitted by patient using boil-and-bite method; manufactured from medical-grade ethylene vinyl acetate (EVA) polymer; non-sterile; intended for adult use.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993 (cytotoxicity, irritation, sensitization). Performance testing conducted for tensile properties (ISO 527-1,2:2012), flexural properties (ISO 178:2010/Amd.1:2013), and water absorption (ISO 62:2008).

Technological Characteristics

Material: Medical grade ethylene vinyl acetate (EVA) polymer. Form factor: Custom-fitted intraoral appliance. Principle: Anterior tongue repositioning. Standards: ISO 10993 (biocompatibility), ISO 527-1,2:2012 (tensile), ISO 178:2010/Amd.1:2013 (flexural), ISO 62:2008 (water absorption). Non-sterile.

Indications for Use

Indicated to reduce snoring in adult patients aged 18 years or older.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

• MPowRx (K081965)

Reference Devices

• SnoreRx (K112205)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains two logos. On the left is the Department of Health & Human Services USA logo, which features a stylized human figure. To the right of that is the FDA U.S. Food & Drug Administration logo. The FDA logo is in blue and white.

July 10, 2018

DaSoft Partners % Alyssa Schwartz Principal, Regulatory Affairs Consultant ASchwartz Consulting 1225 Hall Road West Chester, Pennsylvania 19380

## Re: K172991

Trade/Device Name: Advanced Dental Applicance 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: May 30, 2018 Received: May 31, 2018

## Dear Alyssa Schwartz:

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 (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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 ([e-mail]) or phone [phone] 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)

#### Device Name

DaSoft Advanced Dental Appliance

Indications for Use (Describe)

The DaSoft Advanced Dental Appliance is indicated to reduce snoring in adult patients aged 18 years or older.

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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## 510(k) Summary

| Submitted By: | DaSoft Partners<br>4079 Governer Drive, #111<br>San Diego, CA 92122<br>619-405-1530 | | |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact Person: | Alyssa Schwartz<br>Regulatory Affairs Consultant<br>1225 Hall Road<br>West Chester, PA 19380<br>610-806-6895 | | |
| Date Prepared: | July 9, 2018 | | |
| Trade Name: | DaSoft Advanced Dental Appliance | | |
| Common Name:<br>Classification Name:<br>Device Class: | Anti-snoring device<br>Intraoral Devices for Snoring and Intraoral Devices for Snoring and<br>Obstructive Sleep Apnea<br>Class II | | |
| Product Code: | LRK | | |
| Regulation No .: | 21 CFR 872.5570 | | |
| Predicate Device:<br>Reference Device: | MPowRx K081965<br>SnoreRx K112205 | | |
| Device Description: | The DaSoft Advanced Dental Appliance is an intraoral device designed to be<br>worn during sleep to reduce snoring. The device includes a manually<br>adjustable tongue sleeve to position the tongue and surrounding tissues<br>forward in order to increase the patient's pharyngeal space, improving the<br>ability to exchange air and decreases air turbulence. The device is<br>manufactured using only medical grade ethylene vinyl acetate (EVA)<br>polymer. | | |
| Intended Use: | Intraoral device for reduction in snoring. | | |
| Indications for Use: | The DaSoft Advanced Dental Appliance is indicated to reduce snoring in<br>adult patients age 18 years or older. | | |
| Technology Comparison: | The subject and predicate devices are nearly identical in design and<br>functionality. Both the DaSoft Advanced Dental Appliance and its predicates<br>are intraoral mouth pieces that are molded to the patient's teeth using a boil<br>and bite method. The DaSoft Advanced Dental Appliance includes the<br>tongue sleeve which gently positioning the tongue in a forward position while<br>sleeping, which provides a snoring reduction mechanism, which is<br>substantially equivalent to the mode of action of the predicates. The subject<br>and predicate device are provided non-sterile and use similar packaging<br>systems. Table 1 below summaries the comparison. | | |

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| Table 1: Substantial Equivalence Summary |
|------------------------------------------|
|------------------------------------------|

| Attribute | Subject Device<br>DaSoft Dental<br>Appliance for Anti-<br>Snoring | Predicate<br>MPowRx Snoring<br>Solution<br>K081965 | Reference<br>SnoreRx<br>K112205 | Differences and<br>Justification |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification<br>and Product<br>Code | Class II<br>21 CFR 872.5570<br>LRK | Class II<br>21 CFR 872.5570<br>LRK | Class II<br>21 CFR 872.5570<br>LRK | No Differences |
| Intended Use | Intraoral device for<br>snoring | Intraoral device for<br>snoring | Intraoral device for<br>snoring | No Differences |
| Indications for<br>Use | Intended to reduce<br>snoring in adult<br>patients aged 18<br>years or older. | Intended for the<br>treatment of mild to<br>moderate snoring. | Intended for use on<br>adult patients 18<br>years of age or older<br>as an aid for the<br>reduction of snoring. | No Differences |
| Mode of Action | Repositions the<br>tongue and related<br>tissues anteriorly in<br>order to increase the<br>patient's pharyngeal<br>space, which<br>improves the ability to<br>exchange air and<br>decreases air<br>turbulence. | Tongue retention<br>within the protrusion<br>of the device, forward<br>retention of the<br>tongue keeps the<br>upper respiratory air<br>passages open to<br>relieve snoring. | Mandibular<br>repositioning device<br>that advances the<br>lower jaw to increase<br>pharyngeal space. | Mechanism of action for<br>snoring reduction is<br>equivalent. |
| Materials | Medical grade<br>Ethylene vinyl acetate<br>polymer, heat<br>sensitive impressible<br>material | Common oral<br>appliance material,<br>specifics not<br>available. | Polycarbonate resin<br>Ethylene vinyl<br>acetate (EVA)<br>copolymer, heat<br>sensitive impressible<br>material in addition to<br>Eastar Copolyester<br>MN058 | EVA is commonly used in<br>dental and consumer<br>products intended for use<br>in the mouth. |
| Design | Custom fitted intraoral<br>device. | Single-sized, tongue<br>positioner, fits<br>between lips and<br>teeth with protruding<br>aperture for holding<br>the tongue by<br>suction. | Custom fitted<br>intraoral device<br>Repositions mandible<br>anteriorly up to 6mm | The positioning and<br>placement of the subject<br>device is known to be<br>efficacious for reducing<br>snoring, and the materials<br>are characterized to be<br>substantially equivalent to<br>predicates. |
| Sterility | Non-sterile | Non-sterile | Non-sterile | No Differences |
| Biocompatibility | Tested per ISO<br>10993 | Not available | Tested per ISO<br>10993 | No Differences |

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| Non-Clinical Testing: | The DaSoft Advanced Dental Appliance material (EVA) was tested for | | | |
|-----------------------|----------------------------------------------------------------------------------|--|--|--|
| | cytotoxicity, irritation, and sensitization and it was concluded the material is | | | |
| | biocompatible per ISO 10993. Biocompatibility test reports are submitted as | | | |
| | part of the filing. In addition, the DaSoft Advanced Dental Appliance was | | | |
| | tested for tensile properties (ISO 527-1,2:2012), flexural properties (ISO | | | |
| | 178:2010/Amd.1:2013), and water absorption properties for plastics (ISO | | | |
| | 62:2008). Performance testing reports are submitted as part of the filing. | | | |
| | | | | |

- Conclusion of Comparison: DaSoft has demonstrated that the DaSoft Advanced Dental Appliance is substantially equivalent to the predicate devices.