(286 days)
SnoreRx K112205
No
The device description and performance studies focus on the mechanical function and material properties of a physical intraoral device, with no mention of AI or ML terms, data sets, or algorithmic performance metrics.
Yes
The device is indicated to reduce snoring, which is a therapeutic purpose.
No
The device is described as an intraoral appliance designed to reduce snoring, which is a therapeutic function, not a diagnostic one. It aims to physically modify the airway to improve breathing and decrease air turbulence, rather than to identify or characterize a medical condition.
No
The device description explicitly states it is an "intraoral device" made of "medical grade ethylene vinyl acetate (EVA) polymer," indicating it is a physical hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. These tests are performed outside the body (in vitro).
- Device Function: The DaSoft Advanced Dental Appliance is an intraoral device worn inside the mouth to physically reposition the tongue and surrounding tissues. It does not perform any tests on bodily samples.
- Intended Use: The intended use is to reduce snoring by physically altering the airway, not by analyzing biological markers or performing diagnostic tests.
The information provided clearly describes a physical medical device used for a therapeutic purpose (reducing snoring), not a diagnostic test performed on samples.
N/A
Intended Use / Indications for Use
The DaSoft Advanced Dental Appliance is indicated to reduce snoring in adult patients aged 18 years or older.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intraoral / pharyngeal space
Indicated Patient Age Range
18 years or older
Intended User / Care Setting
Not Found
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)
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.
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.
MPowRx K081965
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.
SnoreRx K112205
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
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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 Partners
4079 Governer Drive, #111
San Diego, CA 92122
619-405-1530 | | |
|-------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact Person: | Alyssa Schwartz
Regulatory Affairs Consultant
1225 Hall Road
West Chester, PA 19380
610-806-6895 | | |
| Date Prepared: | July 9, 2018 | | |
| Trade Name: | DaSoft Advanced Dental Appliance | | |
| Common Name:
Classification Name:
Device Class: | Anti-snoring device
Intraoral Devices for Snoring and Intraoral Devices for Snoring and
Obstructive Sleep Apnea
Class II | | |
| Product Code: | LRK | | |
| Regulation No .: | 21 CFR 872.5570 | | |
| Predicate Device:
Reference Device: | MPowRx K081965
SnoreRx K112205 | | |
| Device Description: | 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. | | |
| Intended Use: | Intraoral device for reduction in snoring. | | |
| Indications for Use: | The DaSoft Advanced Dental Appliance is indicated to reduce snoring in
adult patients age 18 years or older. | | |
| Technology Comparison: | The subject and predicate devices are nearly identical in design and
functionality. Both the DaSoft Advanced Dental Appliance and its predicates
are intraoral mouth pieces that are molded to the patient's teeth using a boil
and bite method. The DaSoft Advanced Dental Appliance includes the
tongue sleeve which gently positioning the tongue in a forward position while
sleeping, which provides a snoring reduction mechanism, which is
substantially equivalent to the mode of action of the predicates. The subject
and predicate device are provided non-sterile and use similar packaging
systems. Table 1 below summaries the comparison. | | |
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Table 1: Substantial Equivalence Summary |
---|
------------------------------------------ |
| Attribute | Subject Device
DaSoft Dental
Appliance for Anti-
Snoring | Predicate
MPowRx Snoring
Solution
K081965 | Reference
SnoreRx
K112205 | Differences and
Justification |
|---------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification
and Product
Code | Class II
21 CFR 872.5570
LRK | Class II
21 CFR 872.5570
LRK | Class II
21 CFR 872.5570
LRK | No Differences |
| Intended Use | Intraoral device for
snoring | Intraoral device for
snoring | Intraoral device for
snoring | No Differences |
| Indications for
Use | Intended to reduce
snoring in adult
patients aged 18
years or older. | Intended for the
treatment of mild to
moderate snoring. | Intended for use on
adult patients 18
years of age or older
as an aid for the
reduction of snoring. | No Differences |
| Mode 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. | Tongue retention
within the protrusion
of the device, forward
retention of the
tongue keeps the
upper respiratory air
passages open to
relieve snoring. | Mandibular
repositioning device
that advances the
lower jaw to increase
pharyngeal space. | Mechanism of action for
snoring reduction is
equivalent. |
| Materials | Medical grade
Ethylene vinyl acetate
polymer, heat
sensitive impressible
material | Common oral
appliance material,
specifics not
available. | Polycarbonate resin
Ethylene vinyl
acetate (EVA)
copolymer, heat
sensitive impressible
material in addition to
Eastar Copolyester
MN058 | EVA is commonly used in
dental and consumer
products intended for use
in the mouth. |
| Design | Custom fitted intraoral
device. | Single-sized, tongue
positioner, fits
between lips and
teeth with protruding
aperture for holding
the tongue by
suction. | Custom fitted
intraoral device
Repositions mandible
anteriorly up to 6mm | The positioning and
placement of the subject
device is known to be
efficacious for reducing
snoring, and the materials
are characterized to be
substantially equivalent to
predicates. |
| Sterility | Non-sterile | Non-sterile | Non-sterile | No Differences |
| Biocompatibility | Tested per ISO
10993 | Not available | Tested per ISO
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.