The DaSoft Advanced Dental Appliance is an intraoral device designed to be worn during sleep to reduce snoring. The device includes a manually adjustable tongue sleeve to position the tongue and surrounding tissues forward in order to increase the patient's pharyngeal space, improving the ability to exchange air and decreases air turbulence. The device is manufactured using only medical grade ethylene vinyl acetate (EVA) polymer.

AI/ML Overview

The provided text describes the DaSoft Advanced Dental Appliance, an intraoral device intended to reduce snoring. The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study proving the device meets specific acceptance criteria related to its clinical efficacy.

Therefore, the information requested regarding acceptance criteria, device performance, sample size, ground truth, expert opinions, and comparative effectiveness studies for the device's efficacy in reducing snoring is not available in the provided document. The document primarily focuses on biocompatibility and material properties as part of its non-clinical testing to establish substantial equivalence.

Here's a breakdown of what can be extracted and what is missing:

A table of acceptance criteria and the reported device performance:
- Acceptance Criteria for Biocompatibility/Material Testing: (Implicit from ISO standards)
  - Cytotoxicity: Material should not be cytotoxic.
  - Irritation: Material should not cause irritation.
  - Sensitization: Material should not cause sensitization.
  - Tensile Properties: Tested per ISO 527-1,2:2012.
  - Flexural Properties: Tested per ISO 178:2010/Amd.1:2013.
  - Water Absorption Properties: Tested per ISO 62:2008.
- Reported Device Performance (for Biocompatibility/Material Testing):
  - The DaSoft Advanced Dental Appliance material (EVA) was concluded to be biocompatible per ISO 10993 (cytotoxicity, irritation, and sensitization).
  - Tensile properties, flexural properties, and water absorption properties were tested as per the specified ISO standards.
  - Specific values or numerical results of these tests (e.g., tensile strength, flexural modulus, water absorption percentage) are not provided in this summary.
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not available for clinical efficacy in this document.
- For biocompatibility/material testing, sample sizes are typically determined by the specific ISO standard, but the specific numbers are not stated in this summary.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable/available for clinical efficacy in this document. The biocompatibility testing relies on standardized laboratory methods rather than expert interpretation of clinical data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/available for clinical efficacy in this document.
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 is not an AI-assisted device, and no MRMC study is mentioned for its clinical efficacy.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This is a physical medical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not available for clinical efficacy in this document.
- For biocompatibility/material testing, the ground truth is established by adherence to ISO standards and laboratory-derived results.
The sample size for the training set:
- Not applicable/available. This is not a machine learning device, and no clinical training set is mentioned.
How the ground truth for the training set was established:
- Not applicable/available.

Summary of available information from the document:

The 510(k) summary focuses on demonstrating that the DaSoft Advanced Dental Appliance is substantially equivalent to existing predicate devices (MPowRx K081965 and SnoreRx K112205), particularly in terms of:

Classification and Product Code: Class II, 21 CFR 872.5570, LRK (same as predicates).
Intended Use: Intraoral device for snoring (same as predicates).
Indications for Use: To reduce snoring in adult patients aged 18 years or older (no differences from predicates).
Mode of Action: Although the device uses a tongue sleeve while one predicate uses tongue retention by suction and the other mandibular repositioning, the document states the "Mechanism of action for snoring reduction is equivalent."
Materials: Medical grade Ethylene vinyl acetate (EVA) polymer. This is justified as commonly used in dental and consumer products, with biocompatibility tested per ISO 10993.
Design: Custom fitted intraoral device. Justified as efficacious (based on predicate equivalence) and materials characterized as substantially equivalent.
Sterility: Non-sterile (same as predicates).
Biocompatibility: Tested per ISO 10993 and concluded to be biocompatible (cytotoxicity, irritation, sensitization).
Performance Testing (Non-Clinical): Tested for tensile properties (ISO 527-1,2:2012), flexural properties (ISO 178:2010/Amd.1:2013), and water absorption properties (ISO 62:2008).

The document does not provide details of clinical studies or trials demonstrating the efficacy of the DaSoft Advanced Dental Appliance in reducing snoring against specific acceptance criteria. Its clearance is based on substantial equivalence, which often means demonstrating that device characteristics (design, materials, intended use, mode of action, performance) are sufficiently similar to a legally marketed predicate device that no new questions of safety or effectiveness are raised.

Summary

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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Mary S. Runner -S

For Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

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 Partners4079 Governer Drive, #111San Diego, CA 92122619-405-1530
Contact Person:	Alyssa SchwartzRegulatory Affairs Consultant1225 Hall RoadWest Chester, PA 19380610-806-6895
Date Prepared:	July 9, 2018
Trade Name:	DaSoft Advanced Dental Appliance
Common Name:Classification Name:Device Class:	Anti-snoring deviceIntraoral Devices for Snoring and Intraoral Devices for Snoring andObstructive Sleep ApneaClass II
Product Code:	LRK
Regulation No .:	21 CFR 872.5570
Predicate Device:Reference Device:	MPowRx K081965SnoreRx K112205
Device Description:	The DaSoft Advanced Dental Appliance is an intraoral device designed to beworn during sleep to reduce snoring. The device includes a manuallyadjustable tongue sleeve to position the tongue and surrounding tissuesforward in order to increase the patient's pharyngeal space, improving theability to exchange air and decreases air turbulence. The device ismanufactured using only medical grade ethylene vinyl acetate (EVA)polymer.
Intended Use:	Intraoral device for reduction in snoring.
Indications for Use:	The DaSoft Advanced Dental Appliance is indicated to reduce snoring inadult patients age 18 years or older.
Technology Comparison:	The subject and predicate devices are nearly identical in design andfunctionality. Both the DaSoft Advanced Dental Appliance and its predicatesare intraoral mouth pieces that are molded to the patient's teeth using a boiland bite method. The DaSoft Advanced Dental Appliance includes thetongue sleeve which gently positioning the tongue in a forward position whilesleeping, which provides a snoring reduction mechanism, which issubstantially equivalent to the mode of action of the predicates. The subjectand predicate device are provided non-sterile and use similar packagingsystems. Table 1 below summaries the comparison.

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Table 1: Substantial Equivalence Summary
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Attribute	Subject DeviceDaSoft DentalAppliance for Anti-Snoring	PredicateMPowRx SnoringSolutionK081965	ReferenceSnoreRxK112205	Differences andJustification
Classificationand ProductCode	Class II21 CFR 872.5570LRK	Class II21 CFR 872.5570LRK	Class II21 CFR 872.5570LRK	No Differences
Intended Use	Intraoral device forsnoring	Intraoral device forsnoring	Intraoral device forsnoring	No Differences
Indications forUse	Intended to reducesnoring in adultpatients aged 18years or older.	Intended for thetreatment of mild tomoderate snoring.	Intended for use onadult patients 18years of age or olderas an aid for thereduction of snoring.	No Differences
Mode of Action	Repositions thetongue and relatedtissues anteriorly inorder to increase thepatient's pharyngealspace, whichimproves the ability toexchange air anddecreases airturbulence.	Tongue retentionwithin the protrusionof the device, forwardretention of thetongue keeps theupper respiratory airpassages open torelieve snoring.	Mandibularrepositioning devicethat advances thelower jaw to increasepharyngeal space.	Mechanism of action forsnoring reduction isequivalent.
Materials	Medical gradeEthylene vinyl acetatepolymer, heatsensitive impressiblematerial	Common oralappliance material,specifics notavailable.	Polycarbonate resinEthylene vinylacetate (EVA)copolymer, heatsensitive impressiblematerial in addition toEastar CopolyesterMN058	EVA is commonly used indental and consumerproducts intended for usein the mouth.
Design	Custom fitted intraoraldevice.	Single-sized, tonguepositioner, fitsbetween lips andteeth with protrudingaperture for holdingthe tongue bysuction.	Custom fittedintraoral deviceRepositions mandibleanteriorly up to 6mm	The positioning andplacement of the subjectdevice is known to beefficacious for reducingsnoring, and the materialsare characterized to besubstantially equivalent topredicates.
Sterility	Non-sterile	Non-sterile	Non-sterile	No Differences
Biocompatibility	Tested per ISO10993	Not available	Tested per ISO10993	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.

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.”