(13 days)
Not Found
No
The device description and performance studies do not mention any software, algorithms, or data processing that would indicate the use of AI or ML. It is a physical, mechanical device.
Yes.
The device is intended for the treatment of nighttime snoring, indicating a therapeutic purpose.
No
Explanation: The device is intended for the treatment of nighttime snoring, not for diagnosing it.
No
The device description clearly states it is a physical mouthpiece made of thermoplastic elastomer, which is a hardware component.
Based on the provided information, the ZQuiet Anti-Snoring device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "treatment of nighttime snoring in adults." This is a therapeutic purpose, not a diagnostic one.
- Device Description: The device is a physical mouthpiece designed to be worn intraorally. It does not involve the analysis of biological samples (like blood, urine, or tissue) which is a core characteristic of IVDs.
- Lack of IVD Characteristics: There is no mention of analyzing samples, detecting biomarkers, or providing diagnostic information.
IVDs are devices used to examine specimens from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. The ZQuiet device does not fit this description.
N/A
Intended Use / Indications for Use
The ZQuiet Anti-Snoring device is intended for the treatment of nightime snoring in adults.
The ZQuiet mandibular advancement device is intended for the treatment of nighttime snoring in adults.
Product codes
LRK
Device Description
The ZQuiet ® Mouthpiece is an Anti-Snoring device consisting of :
- Two trayed plates fitted in front and between the upper and lower teeth and gums . and integrated with each other with the same material as the upper and lower plates.
- The device is made of Thermoplastic elastomer .
- ◆ May be used as supplied
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
Intended User / Care Setting
Home and sleep laboratories
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 Performance Data
ZQuiet® Anti-Snoring Device has been evaluated for safety through in vitro tests and animal safety studies.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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
510(k) Summary 807.92(c)
| SPONSOR | 807.92(a)(1) | |
|---|---|---|
| Company Name: | Sleeping Well, LLC | |
| Company Address | PO Box 1240 | |
| Shelburne, VT 05482 | MAR 10 2009 | |
| Telephone: | 802-985-3013 | |
| 888-978-4389 | ||
| Fax: | ||
| Contact Person: | Daniel A. Webster | |
| Summary Preparation Date: | January 20, 2009 | |
| DEVICE NAME | 807.92(a)(2) | |
| Trade Name: | ZQuiet® Mouthpiece | |
| Common/Usual Name: | Anti-Snoring Device/Mandibular Advancement Device | |
| Classification Name: | Device, Anti-snoring | |
| Regulation Number: | CFR21 872.5570 | |
| Product Code: | LRK |
PREDICATE DEVICE
Device Class:
807.92(a)(3)
Legally Marketed Equivalent Device Company Tomed Dr. Toussaint GmbH.
Product 510(k) # Anti-Snoring/Sleep Apnea Device K061688
DEVICE DESCRIPTION
807.92(a)(4)
The ZQuiet ® Mouthpiece is an Anti-Snoring device consisting of :
Class II
- Two trayed plates fitted in front and between the upper and lower teeth and gums . and integrated with each other with the same material as the upper and lower plates.
- The device is made of Thermoplastic elastomer .
- ◆ May be used as supplied
DEVICE INTENDED USE
807.92(a)(5)
The ZQuiet Anti-Snoring device is intended for the treatment of nightime snoring in adults.
92(a)(2)
1
Target Population: Adult patients
and the state of the state of the states
..............................................................................................................................................................................
.
:
Environment of Use: Home and sleep laboratories
| COMPARISON OF TECHNICAL CHARACTERISTICS 807.92(a)(6) | ||
|---|---|---|
| Device | Similarities | |
| New Device | ||
| ZQuiet® | Predicate Device | |
| SomnoGuard Series | ||
| K Number | K061688 | |
| Classification Name | Device, Anti-Snoring | Device, Anti-Snoring |
| Product Code | LRK | LRK |
| INTENDED USE | ||
| Mandibular Advancement | ||
| device | Yes | Yes |
| Intended as an intraoral | ||
| device | Yes | Yes |
| Intended to reduce | ||
| snoring or help alleviate | ||
| snoring | Yes | Yes |
| Indicated for single | ||
| patient multi use | Yes | Yes |
| Indicated for use at home | ||
| or sleep laboratories | Yes | Yes |
| Prescription device | Yes | Yes |
| MATERIALS | ||
| Device material | Thermoplastic elastomer | Thermoplastic elastomer |
| Non-sterile | Yes | Yes |
| THEORY OF OPERATION | ||
| Advancement of lower | ||
| jaw to open upper airway | Yes | Yes |
| DEVICE DESIGN | ||
| Ready-to-Use | Yes | Yes |
| Upper and lower trays | Yes | Yes |
| One piece design | Yes | Yes |
| Ready-to-use device | Yes | Yes |
| PATIENT USE | ||
| Permits patient to breathe | ||
| through the mouth | Yes | Yes |
| Placed in user's mouth | ||
| each evening | Yes | Yes |
| Cleaned daily | Yes | Yes |
| Easily removed from the | ||
| mouth | Yes | Yes |
| DIFFERENCES | ||
| Boil and Bite fitting | No | Yes |
| Indicated for use with | ||
| patients with mild to | No | Yes |
And Antiques and Children
. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
,
19
.......
and the consideration of the comments of the comments of
. . . ......
. .
2
Substantial Equivalence Discussion
ZQuiet Anti-Snoring Device is similar to the predicate device in intended use, materials and design and does not raise any new issues concerning safety and effectiveness.
NONCLINICAL AND CLINICAL TEST
807.92(b)
SAFETY and EFFECTIVENESS
BIOCOMPATIBILITY
Non-Clinical Performance Data
ZQuiet® Anti-Snoring Device has been evaluated for safety through in vitro tests and animal safety studies.
CONCLUSION
807.92(b)(3)
20
ZQuiet® Anti-Snoring Device is similar to the predicate device in intended use, materials and design and does not raise any new issues concerning safety and effectiveness.
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 features a stylized eagle with three stripes forming its wing and body. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Sleeping Well, LLC C/o Mr. Ned Devine Responsible Third Party Official Underwriters Laboratories Incorporated 333 Pfingsten Road Northbrook, Illinois 60062
MAR 1 0 2009
K090503 Trade/Device Name: ZQuiet® Mouthpiece 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: February 20, 2009 Received: February 25, 2009
Dear Mr. Devine:
Re:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
Page 2 - Mr. Devine
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Surete by Nicholas.
Ginette Y. Michaud, M.D. Acting Director Division of Anesthesiology, General Hospital, 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): _ 109.0502
Device Name: ZQuiet® Mouthpiece
Indications for Use:
The ZQuiet mandibular advancement device is intended for the treatment of nighttime snoring in adults.
(Part 21 Prescription Use X AND/OR CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Bunner
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K070503
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