(205 days)
No
The description focuses on the mechanical design and customization of the oral appliance, with no mention of AI or ML technologies for diagnosis, treatment planning, or device function.
Yes
The device is intended to reduce nighttime snoring and/or mild to moderate obstructive sleep apnea, which are medical conditions, and it achieves this by guiding the mandible forward to prevent airway collapse, thus providing a therapeutic effect.
No
Explanation: The ApnoDent® appliance is designed to reduce snoring and sleep apnea by repositioning the jaw, which is a therapeutic function. It does not gather information about a patient's condition for the purpose of diagnosis.
No
The device description clearly outlines a physical oral appliance made of acrylics and wires, which is a hardware device, not software.
Based on the provided information, the ApnoDent® appliance is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The ApnoDent® appliance is a physical device worn in the mouth to treat a condition (snoring and sleep apnea).
- The intended use clearly states it's for reducing snoring and sleep apnea in adult patients. This is a therapeutic purpose, not a diagnostic one.
- The device description details its physical structure and how it works mechanically to reposition the jaw. There is no mention of analyzing biological samples.
- There is no mention of any laboratory testing or analysis of patient specimens.
Therefore, the ApnoDent® appliance falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ApnoDent® appliance is intended to reduce nighttime snoring and/or mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older.
Product codes (comma separated list FDA assigned to the subject device)
LRK, LOZ
Device Description
The ApnoDent® appliance is a customized oral device featuring both lower and upper trays and interlocking system. The product is non-sterile, biocompatible, and provided in a sealed box with instructions for use.
The ApnoDent® appliance reduces snoring and mild to moderate sleep apnea by guiding the mandible forward during sleep, preventing the tongue and soft tissues of the throat from collapsing into the airway. Designed as a patient-specific device, the ApnoDent® series are manufactured to the dentist prescriber's requested advancement positions to provide a selection of gentle adjustments according to patient comfort and need. As such, prescribed advancements can be achieved by simply turning the advancing screws on both sides which are in contact with the inside of the lower teeth and guide the lower jaw forward.
The ApnoDent® design vields a small and a comfortable patient-specific mandibular advancement device. The design of the device maximizes tongue space and mandibular movement resulting in the ability to open and close during wear for patient comfort.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
mouth
Indicated Patient Age Range
18 years of age or older
Intended User / Care Setting
Prescription Use
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)
A biocompatibility and physical properties assessment was completed based on the material composition of the primary predicate, which concluded that the subject device was substantially equivalent to the primary predicate device. A risk assessment has also been conducted with the subject device, which concluded there are no additional risks as compared to the predicate device(s).
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
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November 24, 2018
ApnoMed, Inc. % Colette Cozean Regulatory Consultant Dr. Colette Cozean, PhD 21581 Midcrest Drive Lake Forest, California 92630
Re: K181123
Trade/Device Name: ApnoDent 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, LOZ Dated: October 18, 2018 Received: October 19, 2018
Dear Colette Cozean:
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/cfpmp/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
1
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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (QS) 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 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.
Digitally signed by Mar Mary S. S Runner - 53 Runner - S3 - Date: 2018.11.21 11:29:46 -05'00 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
2
Indications for Use
510(k) Number (if known) K181123
Device Name ApnoDent
Indications for Use (Describe)
The ApnoDent® appliance is intended to reduce nighttime snoring and/or mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age 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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5. 510(k) Summary
| Applicant: | ApnoMed, Inc.
1515 116th Ave NE. Suite 105C
Bellevue WA, 98004
(425) 443-4020 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Colette Cozean, PhD
21581 Midcrest Drive
Lake Forest, CA 92630
(949) 855-2885
colettecozean@gmail.com |
| Date Prepared | August 31, 2018 |
| Proprietary Name | ApnoDent® Appliance |
| Common Name | Device, Snoring and Mild to Moderate Sleep Apnea |
| Classification Name | Intraoral devices for snoring; intraoral devices for snoring and obstructive sleep apnea
(Class II, 21 CFR872.5570, Product Code LRK, LQZ) |
| Primary Predicate Device | mRNA (K130067) |
| Reference Predicate Devices | DynaFlex (K103076), OASYS-Oral Airway (K030440), Apinator-Oral Airway (K160123) |
Description: The ApnoDent® appliance is a customized oral device featuring both lower and upper trays and interlocking system. The product is non-sterile, biocompatible, and provided in a sealed box with instructions for use.
The ApnoDent® appliance reduces snoring and mild to moderate sleep apnea by guiding the mandible forward during sleep, preventing the tongue and soft tissues of the throat from collapsing into the airway. Designed as a patient-specific device, the ApnoDent® series are manufactured to the dentist prescriber's requested advancement positions to provide a selection of gentle adjustments according to patient comfort and need. As such, prescribed advancements can be achieved by simply turning the advancing screws on both sides which are in contact with the inside of the lower teeth and guide the lower jaw forward.
The ApnoDent® design vields a small and a comfortable patient-specific mandibular advancement device. The design of the device maximizes tongue space and mandibular movement resulting in the ability to open and close during wear for patient comfort.
Indications for Use: The ApnoDent® appliance is intended to reduce nighttime snoring and/or mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older.
Technological Characteristics: The ApnoDent® appliance consists of upper and lower interlocking. customized trays. The ApnoDent® appliance is customized on models of the patient's teeth, using standard orthodontic acrylics and standard orthodontic wires for clasps and retention. The ApnoDent® appliance allows for inter locking of the upper and lower trays to adjust the mandibular position of the user. The technical characteristics are identical to the predicate devices.
All predicate devices (mRNA, DynaFlex, OASYS, Apinator-Oral Airway) also function as mandibular advancement devices to increase the patient's pharyngeal space and improve the ability to exchange air during
4
sleep. They each have customized upper and lower trays that interlock to advance the mandible. In all technological characteristics the subject device is substantially equivalent to the predicate devices.
| | Subject Device | Primary
Predicate | Reference
Predicate #1 | Reference
Predicate #2 | Reference
Predicate #3 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| | ApnoDent® | mRNA Appliance | DynaFlex Anti-
Snoring and
Sleep Apnea
Devices | Apinator-Oral
Airway System | OASYS-Oral
Airway System |
| 510(k) Number | K181123 | K130067 | KI03076 | K160123 | K030440 |
| Indication for
Use | Intended to
reduce night
time snoring and
mild to
moderate
obstructive sleep
apnea (OSA) in
adults. | Intended to
reduce night
time snoring and
mild to
moderate
obstructive sleep
apnea (OSA) in
adults. | Intended to
reduce night
time snoring and
mild to
moderate
obstructive sleep
apnea (OSA) in
adults. | Intended for use
on adult patients
18 years of age
and older as an
aid for the
reduction and/or
alleviation of
snoring and mild
to moderate
obstructive sleep
apnea | Intended to
reduce night
time snoring and
mild to
moderate
obstructive sleep
apnea (OSA) in
adults. |
| Classification
Name | Device, Anti-
Snoring and
Obstructive
Sleep Apnea | Device, Anti-
Snoring and
Obstructive
Sleep Apnea | Device, Anti-
Snoring and
Obstructive
Sleep Apnea | Device, Anti-
Snoring and
Obstructive
Sleep Apnea | Device, Anti-
Snoring and
Obstructive
Sleep Apnea |
| Class | II | II | II | II | II |
| Product Code | LRK, LQZ | LRK, LQZ | LRK, LQZ | LRK, LQZ | LRK, LQZ |
| May be used in
СРАР
Intolerance | yes | yes | yes | yes | yes |
| Area of Use | mouth | mouth | mouth | mouth | mouth |
Technological Characteristics
5
| Construction | Industry-
standard dental
acrylic, stainless
steel orthodontic
wires,
orthodontic
adjustment
screws | Industry-
standard dental
acrylic, stainless
steel orthodontic
wires,
orthodontic
adjustment
screws | Industry-
standard dental
acrylic, stainless
steel orthodontic
wires,
orthodontic
adjustment
screws | Industry-
standard dental
acrylic, stainless
steel orthodontic
wires,
orthodontic
adjustment
screws | Industry-
standard dental
acrylic, stainless
steel orthodontic
wires,
orthodontic
adjustment
screws |
|---------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Fabrication | Customized | Customized | Customized | Customized | Customized |
| Mechanism of
Action | Advancing the
mandible | Advancing the
mandible | Advancing the
mandible | Advancing the
mandible | Advancing the
mandible |
| Method of
positioning of
the mandible | Screw
adjustment | Screw
adjustment | Screw
adjustment | Screw
adjustment | Screw
adjustment |
| Amount of
mandible
protrusion | 6-8 mm | 6-8 mm | 6-8 mm | 6-8 mm | 6-8 mm |
| Prescription only | yes | yes | yes | yes | yes |
Clinical and Non-Clinical Data: A biocompatibility and physical properties assessment was completed based on the material composition of the primary predicate, which concluded that the subject device was substantially equivalent to the primary predicate device. A risk assessment has also been conducted with the subject device, which concluded there are no additional risks as compared to the predicate device(s).
Summary: Based on the intended use, technical characteristics, and other data provided in this submission, the ApnoDent® appliance demonstrates substantial equivalence to the predicate devices in both safety and