(232 days)
The ZQuiet mandibular advancement device is intended for the treatment of nighttime snoring in adults 18 years or older.
The ZQuiet anti-snoring device is a single piece anti-snoring device, which moves the lower jaw forward and helps reduce the likelihood of snoring. This is achieved by covering the upper and lower teeth with a resilient non-toxic thermoplastic elastomer compound. The ZQuiet is easy to wear and simple to use. The single shot manufacturing process incorporates a resilient hinge in the molar area to provide a single piece device. The anti-snore device comprises an upper member adapted to engage the maxillary dentition of a human and a lower member adapted to engage the mandibular dentition of the human, the upper and lower members being resiliently hinged together.
The ZQuiet Mouthpiece is an anti-snoring device. The study performed for its clearance was a non-clinical evaluation rather than a clinical study. The device claims substantial equivalence to its predicate device (K090503 ZQuiet Mouthpiece) based on identical intended use and design, with a material change that was tested to ensure safety.
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Standard/Methodology | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|---|
| Agar Diffusion Test (in vitro cytotoxicity) | ISO 10993-5: 1999 "Tests for in vitro cytotoxicity" | Not cytotoxic | Pass - Not considered cytotoxic |
| Primary Dermal Irritation in Rabbits | Federal Hazardous Substances Act Regulations (16 CFR 1500.41) | Not a primary dermal irritant | Pass - Not a primary dermal irritant |
| Guinea Pig Closed Patch Sensitization Test | ISO 10993-10: 2002 Tests for irritation and delayed type hypersensitivity | No sensitizing properties | Pass - No sensitizing properties |
| Oral Mucosal Irritation Study | ISO 10993 – Part 10 – Tests for Irritation and Delayed-Type Hypersensitivity | Minimal irritant or less | Considered to be a minimal irritant. |
2. Sample size used for the test set and the data provenance:
- Agar Diffusion Test: Not specified (in vitro test).
- Primary Dermal Irritation in Rabbits: Rabbits (specific number not provided but typically a small group for such tests). The data provenance is pre-clinical animal testing.
- Guinea Pig Closed Patch Sensitization Test: Guinea pigs (specific number not provided). The data provenance is pre-clinical animal testing.
- Oral Mucosal Irritation Study: Not specified (likely animal model or in vitro, but typically animal models for irritation studies). The data provenance is pre-clinical testing.
The document does not specify country of origin for the data, but these are standard international bio-compatibility tests.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. The tests performed were bio-compatibility and safety studies (in vitro and animal models), not human clinical studies involving expert interpretation of results. The "ground truth" was established by the scientific methodologies of the respective ISO standards and regulations.
4. Adjudication method for the test set:
Not applicable. These were laboratory tests with objective endpoints (e.g., cytotoxicity, irritation scores) rather than subjective assessments requiring adjudication by multiple experts.
5. If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
No. This was a non-clinical safety evaluation for a material change, not a study assessing diagnostic or treatment effectiveness involving human readers or cases.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No. This device is a physical anti-snoring mouthpiece, not a software algorithm.
7. The type of ground truth used:
The ground truth used was based on established scientific methodologies and standards for biocompatibility and safety testing (e.g., ISO 10993 standards, Federal Hazardous Substances Act Regulations). The "truth" refers to the cytotoxic, irritating, or sensitizing potential of the material under test.
8. The sample size for the training set:
Not applicable. This device does not use machine learning, so there is no "training set."
9. How the ground truth for the training set was established:
Not applicable. There is no training set as it's not an AI/ML device.
{0}------------------------------------------------
JUN 2 2 2010
510(k) Summary
807.92(c)
SPONSOR
807.92(a)(1) Sleeping Well, LLC
Company Address
Company Name:
PO Box 1240
Shelburne, VT 05482 .
Telephone: 802-985-3013 Fax: 888-978-4389
Contact Person:
Daniel A. Webster
ZQuiet® Mouthpiece
Anti-Snoring Device Device, Anti-snoring
CFR21 872.5570
Summary Preparation Date: May 27, 2010
DEVICE NAME
807.92(a)(2)
Trade Name: Common/Usual Name: Classification Name: Regulation Number: Product Code: Device Class:
PREDICATE DEVICE
807.92(a)(3)
| Legally Marketed Equivalent Device | ||
|---|---|---|
| Company | Product | 510(k) # |
| Sleeping Well, LLC | ZQuiet Mouthpiece | K090503 |
LRK
Class II
DEVICE DESCRIPTION
807.92(a)(4)
The ZQuiet anti-snoring device is a single piece anti-snoring device, which moves the lower jaw forward and helps reduce the likelihood of snoring. This is achieved by covering the upper and lower teeth with a resilient non-toxic thermoplastic elastomer compound. The ZQuiet is easy to wear and simple to use. The single shot manufacturing process incorporates a resilient hinge in the molar area to provide a single piece device.
The anti-snore device comprises an upper member adapted to engage the maxillary dentition of a human and a lower member adapted to engage the mandibular dentition of the human, the upper and lower members being resiliently hinged together.
DEVICE INTENDED USE / INDICATION FOR USE 807.92(a)(5)
The ZQuiet mandibular advancement device is intended for the treatment of nighttime snoring in adults 18 years are older.
{1}------------------------------------------------
Caution: Federal (USA) law restricts this device to sale by or on the order of a licensed Dentist.
Target Population: Adult patients
r
Environment of Use: Home and sleep laboratories
COMPARISON OF TECHNICAL CHARACTERISTICS
807.92(a)(6)
| K Number | K090503 | |
|---|---|---|
| Classification Name | Device, Anti-Snoring | Device, Anti-Snoring |
| Product Code | LRK | LRK |
| Indications for Use | The ZQuiet Anti-Snoring device isintended for the treatment ofnighttime snoring in adults 18years or older. | The ZQuiet Anti-Snoring device isintended for the treatment ofnighttime snoring in adults. |
| Intended as an intraoraldevice | Intended as an intraoral device | Intended as an intraoral device |
| Intended to reducesnoring or help alleviatesnoring | Intended to reduce snoring or helpalleviate snoring | Intended to reduce snoring or helpalleviate snoring |
| Indicated for singlepatient multi use | Indicated for single patient multiuse | Indicated for single patient multiuse |
| Indicated for use at homeor sleep laboratories | Indicated for use at home or sleeplaboratories | Indicated for use at home or sleeplaboratories |
| Prescription device | Prescription device | Prescription device |
| Non-sterile | Non-sterile | Non-sterile |
| Upper and lower traysOne piece design | Upper and lower traysOne piece design | Upper and lower traysOne piece design |
| Permits patient to breathethrough the mouth | Permits patient to breathe throughthe mouth | Permits patient to breathe throughthe mouth |
| Placed in user's moutheach evening | Placed in user's mouth eachevening | Placed in user's mouth eachevening |
| Cleaned daily | Cleaned daily | Cleaned daily |
| Easily removed from themouth | Easily removed from the mouth | Easily removed from the mouth |
| Device material | Dynaflex G2701-1000-02 | Dynaflex G27-0001 |
{2}------------------------------------------------
NONCLINICAL AND CLINICAL TEST
807.92(b)
ZQuiet® Anti-Snoring Device has been evaluated through in vitro tests and animal safety studies. All data is consistent in indicating that this product is safe for use as an antisnoring device. The materials used in the following studies are identical to the material under review Dynaflex G2701-1000-02. The categories of safety tests and the safety test conclusions are as follows:
| Test Performed | Standard/Methodology | Results |
|---|---|---|
| Agar Diffusion Test (ISO | ISO 10993-5: 1999 "Tests forin vitro cytotoxicity | PassNot considered cytotoxic |
| Primary Dermal Irritation inRabbits | Federal Hazardous SubstancesAct Regulations (16 CFR1500.41 | PassNot a primary dermal irritant |
| Guinea Pig Closed PatchSensitization Test | ISO 10993-10: 2002 Tests forirritation and delayed typehypersensitivity | PassNo sensitizing properties |
| Oral Mucosal Irritation Study | ISO 10993 – Part 10 – Testsfor Irritation and Delayed-Type Hypersensitivity | Under conditions of this study,and based on the IrritationIndex the test article wasconsidered to be a minimalirritant. |
CONCLUSION
807.92(b)(3)
ZQuiet Anti-Snoring Device is identical to the predicate device in intended use, and design. The material change has been tested according to ISO 10993 and is found safe for the intended use. The ZQuiet Anti-Snoring Device does not raise any new issues concerning safety and effectiveness.
{3}------------------------------------------------
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle or bird-like symbol with three curved lines representing its body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
1111 . 25 .
JUN 22 2010
Sleeping Well, LLC C/O Yolanda Smith Smith Associates 1468 Harwell Avenue Crofton, Maryland 21114
Re: K093407
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: June 4, 2010 Received: June 4, 2010
Dear Ms. Smith:
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}------------------------------------------------
Page 2- Ms. Smith
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 (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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to
http://www.fda.gov/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 Division 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,
Susan Russo
Anthony D. Watson, B.S., M.S., M.B.A. Director
Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{5}------------------------------------------------
K.Q93407
Indications for Use
510(k) Number (if known): __ _____
Device Name: . ZQuiet® Mouthpiece
Indications for Use:
The ZQuiet mandibular advancement device is intended for the treatment of nighttime snoring in adults 18 years or older.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician
Prescription Use X CFR 801 Subpart D)
(Part 21) AND/OR
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 Rose
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K093407
§ 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.”