(115 days)
No
The device description focuses on the mechanical function of the oral appliance and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are also marked as "Not Found".
Yes
The device is intended to alleviate medical conditions (snoring and sleep apnea) by repositioning the mandible to increase pharyngeal space and prevent airway collapse.
No
Explanation: The device is intended to treat snoring and sleep apnea by repositioning the mandible, not to diagnose these conditions. Its function is to alleviate symptoms or prevent events, which falls under treatment rather than diagnosis.
No
The device description clearly states it is an "intra oral device" consisting of "two (2) custom orthotics" made from "acrylics," which are physical hardware components.
Based on the provided information, the ZQuiet® Pro-Plus oral appliance is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- ZQuiet® Pro-Plus Function: The ZQuiet® Pro-Plus is an intraoral device that physically repositions the mandible to improve airflow and reduce snoring and sleep apnea. It works mechanically within the body, not by analyzing biological samples.
- Intended Use: The intended use clearly states it's for reducing or alleviating snoring and sleep apnea, which are conditions treated by a physical intervention, not a diagnostic test.
- Device Description: The description details the physical components and how they function to reposition the jaw, not how it analyzes biological samples.
Therefore, the ZQuiet® Pro-Plus falls under the category of a therapeutic medical device, specifically an oral appliance, rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ZQuiet® Pro-Plus oral appliance is intended to reduce or alleviate nighttime snoring and/or mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older.
Product codes
LRK, LRR
Device Description
The ZQuiet® Pro-Plus is an intra oral device used for treating snoring and sleep apnea. It functions to reposition the mandible to increase the patient's pharyngeal space to increase airflow, reduce the vibrations of the soft palate associated with snoring, and/or prevent the collapse of the airway associated with apneic events. The device consists of two (2) custom orthotics; one for the maxillary arch and one for the mandibular arch, made from acrylics widely used and approved for use in the dental industry. The orthotic employs a buccal cam mechanism, consisting of an apposing fin and buttress, that maintains the orthotics in an anteriorized relationship when worn during sleep.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult patients 18 years of age 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)
Non-Clinical Testing:
Biocompatibility test results are known for this device as well as tests for tear resistance tear strength, tensile strength, elongation yield, and modulus of elasticity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
The SomnoMed MAS RxA (K050592)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
KIQ2473
Image /page/0/Picture/1 description: The image shows the logo for ZQuiet, a company owned by Sleeping Well, LLC. The logo features the word "ZQuiet" in a stylized font, with a crescent moon above the "i". Below the logo, the text "Sleeping Well, LLC" and "PO Box 1240" are printed in a smaller, simpler font.
Shelburne, VT 05482
510(k) Summary as required by 21 CFR 807.92(c)
- Submitter's Identification:
Submitter:
Address:
Daniel Webster, Vice President
Sleeping Well, LLC 5247 Shelburne Rd., #204 PO Box 1240 Shelburne, VT 05482
Telephone: Fax:
Email:
Correspondent:
Date of Submission:
(802) 985-3013 (802) 985-9298
(Same As Submitter)
August 9, 2012
2. Device Name & Classification:
Device Trade Name:
Common Name:
Classification Name:
Product Code:
Classification Regulation
Class:
Number:
RR
21 CFR § 872.5570
Device, Anti-snoring
Obstructive Sleep Apnea
Intraoral Devices for Snoring and
LRK
Anti-
ZQuiet® Pro-Plus
LRR
ll
7 2012
DEC
1
3. Device Description:
The ZQuiet® Pro-Plus is an intra oral device used for treating snoring and sleep apnea. It functions to reposition the mandible to increase the patient's pharyngeal space to increase airflow, reduce the vibrations of the soft palate associated with snoring, and/or prevent the collapse of the airway associated with apneic events. The device consists of two (2) custom orthotics; one for the maxillary arch and one for the mandibular arch, made from acrylics widely used and approved for use in the dental industry. The orthotic employs a buccal cam mechanism, consisting of an apposing fin and buttress, that maintains the orthotics in an anteriorized relationship when worn during sleep.
4. Statement of Intended Use:
The ZQuiet® Pro-Plus oral appliance is intended to reduce or alleviate nighttime snoring and/or mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older.
5. Identification of Legally Marketed Predicate Device:
The ZQuiet® Pro-Plus oral appliance is substantially equivalent to other legally marketed devices in the United States, and has the same intended use and technological characteristics as the following predicate device: The SomnoMed MAS RxA (K050592), by SomnoMed Limited.
6. Technological Comparison:
The ZQuiet® Pro-Plus oral appliance utilizes the same technological design features as the predicate device to advance the mandible for the intended use of treating snoring and/or mild to moderate obstructive sleep apnea. Both utilize separate, custom fit, upper and lower dental orthotics. The jaw advancement and relative positioning of the trays is maintained by apposing fin and buttress features, and contain embedded expansion screws for adjustment. Both devices allow vertical jaw movement and enable mouth breathing. The proposed device has one optional design difference that has no relation to the technology associated with the intended use. The upper tray can be made with an omeqa loop of stainless steel wire located at the anterior midline to relieve palatal stress.
7. Summary of Substantial Equivalence:
The ZQuiet® Pro-Plus oral appliance is substantially equivalent to the SomnoMed MAS RxA. Both devices have the same intended use/indications for use and technology. Both devices are custom made adjustable mandibular repositioning devices fabricated in registered establishments. Both are prescription devices indicated for patients suffering from snoring and/or mild to moderate obstructive sleep apnea. The fundamental scientific technology
2
of the device is identical to the referenced predicate device, and furthermore, it has been demonstrated in this 510(k) submission that the differences between the ZQuiet® Pro-Plus oral appliance and the predicate device do not raise any questions regarding their safety and effectiveness.
8. Non-Clinical Testing:
Biocompatibility test results are known for this device as well as tests for tear resistance tear strength, tensile strength, elongation yield, and modulus of elasticity.
9. Conclusion
The descriptive characteristics of the ZQuiet® Pro-Plus oral appliance are precise enough to ensure comparability with the predicate when manufactured according to specifications. By comparing designs to the predicate device and the materials used it's concluded that the ZQuiet® Pro-Plus is as safe, as effective, and performs as well as the predicate device.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three wing-like extensions.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
December 7, 2012
Mr. Daniel Webster Vice President Sleeping Well, Limited Liability Company 5247 Shelburne Road, Suite 204 Shelburne, Vermont 05482
Re: K122475
Trade/Device Name: ZQuiet® Pro-Plus Appliance Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: November 2, 2012
Received: November 15, 2012
Dear Mr. Webster:
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.
4
Please be advised that FDA's issuance of a substantial equivalence determination does not mean 1 Teast be advised that 1 Dr 3 130aantes vour device complies with other requirements of the Act that I Dr Has made a and regulations administered by other Federal agencies. You must or any I cocharter and regulanents ancluding, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical CI K Part 607), laooning (21 OFR 803); good manufacturing practice requirements as set de rice-related duverse orchite) (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please 11 you desire operatio aov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the 1 ou may of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Kwame O. Ulmer
Anthony D. Watson, B.S. M.S., M.B.A. Director
Division of Anesthesiology, General Hospital,
Respiratory. Infection Control and Dental Devices
Office of Device Evaluation Center for Devices and
Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known): LLLLLLLL
ZQuiet® Pro-Plus Appliance Device Name:
Indications for Use: .
The ZQuiet® Pro-Plus oral appliance is intended to reduce or alleviate i nighttime snoring and/or mild to moderate obstructive sleep apnea (OSA) in adult patients 18 years of age or older.
Over-The-Counter Use Prescription Use × AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
2012.12.06 Susan Runner DDS, MA-13:59:00 -05'00'
Page 1 of 1
(Division Sign-Off) (Division Sign-Oil)
Division of Anesthesiology, General Hospital Division of Antol. Dental Devices
510(k) Number:
24