(87 days)
No
The device description and supporting information focus on the mechanical function of the device and material properties, with no mention of AI or ML.
Yes
The device is indicated to reduce snoring, which is a therapeutic purpose.
No
The device is described as repositioning the tongue and tissues to reduce snoring, which is a treatment, not a diagnostic function.
No
The device description explicitly states the device is manufactured using a physical material (medical grade ethylene vinyl acetate (EVA) polymer), indicating it is a physical medical device, not software-only.
Based on the provided information, the DaSoft Advanced Dental Appliance is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "reduce snoring in adult patients". This is a physical intervention to address a physiological issue (snoring), not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The device is a physical appliance that repositions tissues. It does not involve any reagents, instruments, or procedures for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing blood, urine, tissue, or other bodily fluids.
- Providing diagnostic information.
- Using laboratory equipment.
Therefore, the DaSoft Advanced Dental Appliance falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The DaSoft Advanced Dental Appliance is indicated to reduce snoring in adult patients age 18 years or older.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
The DaSoft Advanced Dental Appliance, previously cleared under K172991, repositions the tongue and related tissues anteriorly in order to increase the patient's pharyngeal space, which improves the ability to exchange air and decreases air turbulence; a causative factor in snoring. The device is manufactured using medical grade ethylene vinyl acetate (EVA) polymer, which is a material that has a "generally recognized as safe" (GRAS) designation from FDA.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pharyngeal space, oropharynx, hypopharynx, and velopharynx
Indicated Patient Age Range
adult patients age 18 years or older.
Intended User / Care Setting
Over the counter (OTC)
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)
Usability Testing: To evaluate the consumer's understanding of the Over-the-Counter (OTC) device labeling and instructions for use, a usability study was conducted following FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices", issued February 3, 2016. Results demonstrated that the OTC consumer can appropriately prepare, fit, and adjust the DaSoft Advanced Dental Appliance.
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.
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.
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 logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & 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.
DaSoft Partners % Kimberly Lane President and Principal Regulatory Consultant J Blane, LLC 980 N Sinagua Heights Dr Flagstaff, Arizona 86004
Re: K203462
Trade/Device Name: Advanced Dental Appliance 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 20, 2020 Received: November 24, 2020
Dear Kimberly Lane:
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,
Michael E. Adjodha, M.ChE. Assistant Director DHT1B: Division of Dental 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)
K203462
Device Name Advanced Dental Appliance
Indications for Use (Describe)
The DaSoft Advanced Dental Appliance is indicated to reduce snoring in adult patients age 18 years or older.
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)
Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2020
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3
510(k) Summary
This 510(k) Summary is in accordance with the requirements of the Safe Medical Device Act (SMDA) of 1990. The content of this 510(k) summary is provided in conformance with 21 CFR Part 807.92.
1 SPONSOR INFORMATION
Sponsor/Manufacturer:
DaSoft Partners Name: Address: 4079 Governor Drive, #111 San Diego, CA 92122 USA (619) 405-1530 Phone: Contact: Dante Togliatti Email: dtogliatti@gmail.com
Official Correspondent:
| Name: | Kimberly Lane |
|---|---|
| Address: | J Blane, LLC |
| 980 N Sinagua Heights Dr. | |
| Flagstaff, AZ 86004 | |
| Phone: | (928) 707-2852 |
Establishment Reg. No.: 10061658
Date Prepared: November 20, 2020
2 DEVICE NAME
| Trade Name: | Advanced Dental Appliance |
|---|---|
| Common Name: | Anti-snoring Device |
| Classification Name: | Intraoral device for snoring |
| Classification Number: | 21 CFR 872.5570 (Class II) |
| Product Code: | LRK |
| Classification Panel: | Dental |
4
Abbreviated 510(k) DaSoft Partners Advanced Dental Device
PREDICATE DEVICES 3
| Primary Predicate: | Zyppah Anti-Snoring device (K182312) |
|---|---|
| Reference Predicates: | DaSoft Partners Advanced Dental Appliance (K172991) |
| SnoreRx® device (K170825) |
INTENDED USE 4
The DaSoft Advanced Dental Appliance is indicated to reduce snoring in adult patients age 18 years or older.
5 DEVICE DESCRIPTION
The DaSoft Advanced Dental Appliance, previously cleared under K172991, repositions the tongue and related tissues anteriorly in order to increase the patient's pharyngeal space, which improves the ability to exchange air and decreases air turbulence; a causative factor in snoring. The device is manufactured using medical grade ethylene vinyl acetate (EVA) polymer, which is a material that has a "generally recognized as safe" (GRAS) designation from FDA.
TECHNOLOGICAL CHARACTERISTICS 6
The subject device is equivalent in basic technology to the primary predicate Zyppah device (K181212). Both the subject device and the primary predicate devices work by mandibular advancement and tongue displacement.
The subject device is equivalent in design, materials and functionality to the reference predicate, DaSoft Advanced Dental Appliance (K172991) and has similar labeling as the reference predicate devices, DaSoft device (K172991) and SnoreRx (K170825). All devices are non-sterile and are customized to the individual patient by a standard 'boil and bite' method. A comparison table of the subject and predicate technological characteristics is provided below in Table 1.
5
Abbreviated 510(k) DaSoft Partners Advanced Dental Device
Table 1: Substantial Equivalence Comparison
| Feature | DaSoft Advanced Dental
Appliance
(THIS SUBMISSION) | PRIMARY PREDICATE:
Zyppah® Anti-Snoring Device | REFERENCE PREDICATE 1:
DaSoft Advanced Dental
Appliance | REFERENCE PREDICATE 2:
SnoreRx |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|---------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | TBD | K182312 | K172991 | K170825 |
| Manufacturer | DaSoft Partners | Always More Marketing, Inc. | Same as subject device | Apnea Sciences Corporation |
| Classification Name | Device, anti-snoring | Same as subject device | Same as subject device | Same as subject device |
| Classification # &
Product Code | 21 CFR 872.5570 (Class II)
LRK | Same as subject device | Same as subject device | Same as subject device |
| Intended Use | Indicated to reduce snoring in adult
patients aged 18 years or older. | Same as subject device | Same as subject device | Same as subject device |
| Type of Use
(Rx or OTC) | Over the counter (OTC) | Same as subject device | Prescription Only | Same as subject device |
| Mechanism of Action | Repositions the tongue and related
tissues anteriorly in order to
increase the patient's pharyngeal
space, which improves the ability to
exchange air and decreases air
turbulence. | Repositions the tongue in
conjunction with a slight
advancement of the mandible. | Same as subject device | Repositions the jaw anteriorly in
order to increase the patient's
pharyngeal space, which improves
the ability to exchange air and
decreases air turbulence. |
| Design | Single tray unit fits in mouth over
teeth, with single-sized protruding
aperture (tongue sleeve) for holding
the tongue by suction. | Single tray unit with tongue strap
that spans across tray. | Same as subject device | The device consists of two custom
fabricated trays that fit separately
over the upper and lower dental
arches and engage each other in
the anterior area of the mouth. |
| Materials | 100% Medical grade Ethylene vinyl
acetate (EVA) polymer. | Hard outer shell with thermoplastic
filling material and silicone tongue
strap. | Same as subject device | - Polycarbonate resin
Ethylene vinyl acetate copolymer |
| Biocompatibility | ISO 10993 | Same as subject device | Same as subject device | Same as subject device |
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6.1 Mechanism of Action
The maintenance of the tongue in a forward position creates an increase in cross-sectional area in the oropharynx, hypopharynx, and velopharynx, reducing resistance and therefore the chance for turbulent air flow.
The subject device and its primary and reference predicates, Zyppah device (K181212) and DaSoft Advanced Dental Appliance (K172991) and respectively, are identical in mechanism of action. They work by positioning the tongue in a forward position while sleeping, which provides a snoring reduction mechanism.
DEVICE TESTING 7
7.1 Nonclinical Testing
Device materials were previously tested for various physical properties. The tray material was tested for flexural modulus and strength (ISO 178), stress and strain at break (ISO 527), and water absorption (ISO 62). All materials met device specifications.
7.2 Biocompatibility Testing
Cytotoxicity, irritation, and sensitization were previously completed and results showed the DaSoft Advanced Dental Appliance to be biocompatible, in accordance with ISO 10993.
USABILITY TESING 8
To evaluate the consumer's understanding of the Over-the-Counter (OTC) device labeling and instructions for use, a usability study was conducted following FDA Guidance, "Applying Human Factors and Usability Engineering to Medical Devices", issued February 3, 2016. Results demonstrated that the OTC consumer can appropriately prepare, fit, and adjust the DaSoft Advanced Dental Appliance.
CONCLUSION 9
The DaSoft Advanced Dental Appliance and its predicates are technologically identical. Use in an OTC environment does not raise any new questions of safety or effectiveness. Therefore, the subject device (Advanced Dental Appliance) is determined to be substantially equivalent to the predicate devices.