(228 days)
Not Found
No
The summary describes a physical mandibular repositioning device and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is described as being for "treatment of nighttime incidents of snoring and/or mild to moderate obstructive sleep apnea," which indicates a therapeutic purpose.
No
This device is a mandibular repositioning device intended for "treatment of nighttime incidents of snoring and/or mild to moderate obstructive sleep apnea." It is not described as diagnosing any condition; rather, it requires a "sleep study diagnosis" before it is prescribed.
No
The device description explicitly states it is a "mandibular repositioning/advancement device" and a "mandibular repositioning device," which are physical appliances worn during sleep. This indicates a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The PAsr/QuietNite is a physical device worn in the mouth (a mandibular repositioning/advancement device). It does not analyze samples from the body.
- Intended Use: Its intended use is for the treatment of snoring and mild to moderate obstructive sleep apnea, not for diagnosing these conditions through the analysis of biological samples.
Therefore, the PAsr/QuietNite falls under the category of a medical device, but not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The PAsr/QuietNite, a dentist prescribed mandibular repositioning/advancement device is intended for the treatment of nighttime incidents of snoring and/or mild to moderate obstructive sleep apnea in persons 18years of age or older.
These devices are not indicated for the treatment of central apnea or severe obstructive sleep apnea, and should only be prescribed by a Dentist after the undertaking of a sleep study.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
The PAsr QuietNite, a dentist prescribed mandibular repositioning device, is worn during sleep and is indicated for persons 18 years or older, who wish to reduce the incidence of snoring and/or mild to moderate obstructive sleep apnea. Before a dentist prescribes a PAsr QuietNite appliance for treatment, it is recommended that the patient receive a medical examination including a sleep study diagnosis.
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
18 years of age or older
Intended User / Care Setting
Dentist prescribed. Home/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)
Not Found
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.
Not Found
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
510(k) Summary
August 23, 2009
exact
PRECISION DENTAL SUPPLIES
1072
Exact Supplies Ltd The Stables Brightwell Baldwin Oxfordshire, OX49 5NP UK
JUN 1 1 2010
Establishment Registration Number: 510(k) Number:
Contact Person: Telephone: Cell: E-mail: Address:
Jonathan Parkinson +44 1865 400 877 +44 798749941 consultancy@allportgroup.co.uk The Stables Brightwell Baldwin Oxfordshire, OX49 5NP
Device
Trade Name: Common Name: Classification Name: Product Code: Class: Regulation Number:
PAsr QuietNite I Asi Quick Sleep Apnea Device Device, Anti-Snoring LRK II 872.5570 Approved
European CE mark:
Approved
Granted European Patent: Pending USA Patent:
Description of Device:
Description of Device:
The PAsr QuietNite, a dentist prescribed mandibular repositioning device, is Dhe PAsr QuietNite, a dentist prescribed manalouiar repositions.
worn during sleep and is indicated for persons 18 years or older, who wish to
worn during sleep and is and is worn during sicep and is indicated for persons 15 years of street, and one of the sleep
reduce the incidence of snoring and/or mild to moderate obstructive sleep work the incidence of snoring and/or mild to modelate of treatment, it
apnea. Before a densis in the time reseive a PAsr QuietNite appliance for treatment, it
a mea. Before a apnea. Before a dentist prescrives a 1 1 123
- Indications for use
Function Mandibular Repositioning Device > - Single Patient V
- Multi-Use >
- Prescription Device V
- iption Device
Custom Fabricated (Fit) from Common Orthodontic Appliance .- Materials/Techniques
- Adjustable .
- iption Device
-
-
-
- Adjustable
-
-
Environment Home/Sleep Laboratories
- Removable ●
- Non Sterile .
- ✓ Identical Materials
2
Image /page/2/Picture/0 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 symbol that resembles a caduceus, a traditional symbol of medicine, but with three bars instead of one.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. Jonathan Parkinson Exact Supplies Limited The Stables, Brightwell Baldwin Watlington, Oxfordshire United Kingdom OX49 5NP
JUN 1 1 2010
Re: K093340
Trade/Device Name: PAsr/QuietNite Regulation Number: 21 CFR 872.5570 Regulation Name: 21 OFF of 21207218879
Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: April 20, 2010 Received: June 9, 2010
Dear Mr. Parkinson:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your bother over 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 interstate comments, or to thay 20, 1978, and saified in accordance with the provisions of Amendinches, or to devroes that have of the election of require approval of a premarket the Federal Food, Drug, and Cosment . For crose, enarket the device, subject to the general approval appreadon (1 Mill). I The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, requirents for unitude roginst misbranding and adulteration. Please note: CDRH does labeling, and promotions against information 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 (I MA), It may be subject to adame Federal Regulations, Title 21, Parts 800 to 898. In device can be lound in the Coud of Peachar regains concerning your device in the Federal Register.
3
Page 2- Mr. Parkinson
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/ReportalProblem/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.
Anthone O. awate
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
4
187
Indications for Use Form Indications for Use 510(k) Number (if known): _
Device Name: PAsr/QuietNite
Indications for Use:
The PAsr/QuietNite, a dentist prescribed mandibular The FAST/Quictivite) a donotes in intended for the treatment of repositioning/duvancement of and/or mild to moderate obstructive sleep apnea in persons 18years of age or older.
These devices are not indicated for the treatment of central apnea or These devices are not maleated to the should only be prescribed by a Dentist after the undertaking of a sleep study.
Prescription Use _ X (Part 21 CFR 801 Subpart D) 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)
.
Keri Hailey for MSP
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
510(k) Number: K093340
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