(70 days)
Not Found
Not Found
No
The device description focuses on mechanical components and materials, with no mention of software, algorithms, or data processing that would indicate AI/ML. The reference to imaging is about studies supporting the use of oral appliances in general, not about the device itself using imaging or AI/ML for its function.
Yes
The device is indicated for use in patients who are snorers or have mild to moderate obstructive sleep apnea, with the aim of reducing and managing their condition. This directly addresses health conditions, which is the definition of a therapeutic device.
No.
The NOrAD device is indicated for use in patients who are snorers or have mild to moderate obstructive sleep apnea, not for diagnosing these conditions. It is a therapeutic device designed to reduce and manage these conditions, often after they have been medically diagnosed or recommended by a physician.
No
The device description clearly outlines a physical appliance with hard and heat-sensitive components designed to fit in the patient's mouth and reposition the jaw. This is a hardware device, not software.
Based on the provided text, 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 description clearly states that the NOrAD device is an appliance that fits to the patient's teeth and is used to reposition the jaw. It is a physical device worn by the patient.
- Intended Use: The intended use is to reduce and manage snoring and mild to moderate obstructive sleep apnea by physically altering the position of the mandible during sleep. This is a mechanical action, not a diagnostic test performed on a biological sample.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, chemical reactions, or diagnostic measurements.
The device is an oral appliance used for the treatment and management of a condition, not for diagnosing it.
N/A
Intended Use / Indications for Use
The NOrAD device (appliance) is indicated for use in patients who are snorers or have mild to moderate obstructive sleep apnea that has been medically diagnosed or are intolerant to nasalCPAP and wish to reducc and manage their condition while sleeping.
The device may be used in individuals who have had an overnight sleep study and do not have apaca or have mild to moderate obstructive sleep apnea and their physician has recommended the appliance. The device may also be indicated for a patient that snores and may have obstructive sleep apnea but their physician does not feel a sleep study is indicated and has recommended or referred the patient for appliance therapy. In many instances the decision will have been made after consultation has occurred between the dentist and the physician.
Product codes (comma separated list FDA assigned to the subject device)
LRK
Device Description
This device has a hard outer component with heat sensitive material contained within that component. The heat sensitive material is softened and is what fits the appliance to the patient's teeth for securing the appliance in place. Hooks for conventional Orthodontic elastics exist on the outer component for the purpose of attaching the elastics to prevent the mandible from retruding. The upper component has two (2) hooks and the lower component has one (1) hook. This allows for various methods of elastic placement depending on the need(s) of the patient. There is ramping on both the upper and the lower to facilitate and guide the mandible forward when the patient is in occlusion. These ramps also provide a posterior stop for support of the mandible. The appliance also provides for full coverage of the dentition to prevent any tooth movement or occlusal changes. The teeth at the anterior of the appliance allow for indexing of the appliance at a position most acceptable to the patient during wear and allows the patient to determine the most effective jaw position for repositioning dependent on sleep position. The teeth index in such a way to allow for freedom of movement of the jaw during sleep while remaining in an indexed position.
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
Not Found
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)
Substantial Equivalence is based on non-clinical data. In addition the literature supports the historical significance of oral devices that reposition the jaw and reduce and mange snoring as well as sleep apnea. Pancer et al described this in an article published in the journal CHEST in 1998, where they concluded that mandibular repositioning appliances were 95% successful in reducing and/or controlling snoring and were 83% effective in managing sleep apnea. In addition the American Academy of Sleep Medicine (formerly the American Sleep Disorders Association) published in 1995 their Standards of Practice and Guidelines which demonstrated that oral appliances were effective in the management of snoring and mild to moderate sleep apnea.
Based on clinical data, it is demonstrated in a variety of articles that looked at oral appliances and their use for the treatment of snoring and sleep apnea, oral appliance therapy is an effective means by which these conditions can be managed. This effectiveness is embraced from a variety of aspects including safety, convenience and cost.
In conclusion, a number of studies have shown improvement of the airway utilizing imaging associated with the use of oral appliances (also referred to as Oral Airway Dilators), which aids in the management and reduction of Snoring and sleep apnea.
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.
Not Found
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
MAY 2 8 2002
Dennis R. Bailey, D.D.S.
Elow, Nesemy of Crisity - Feliavy, International College of Develse, Thisman, Americal Router of Partical Partilat Por " "Patomy of Circuidiatory - Rilow, Repressonal Caling of Devels - Pakenal Policial Proience Posterial Proinces Preisy
GENERAL DENTIST: PRACTICE RESTRICTED TO CRANIOFACIAL PAIN & RELATED HEADACHE DISORDERS. OROFACIAL PAIN & TEMPOROMANDIBULAR JOINT DISORDERS, INTRAORAL APPLIANCE THERAPY FOR SNORING & RELATED BHEATHING DISORDERS. ORTHODONTICS
Premarket Notification [510(k)] Summary
Contact Person:
Date Prepared :
Dennis R. Bailey, DDS March 7, 2002
Name of the Device:
Trade Name:
NOrAD
NOrAD
Common Name:
Mandibular repositioning appliance (device) Device, Anti-Snoring and to Manage Sleep Apnea Classification Name: Substantial Equivalence is being made to other "boil and bite" or "boil and fit" devices, specifically the Silencer Custom and the TAP, as well as a custom fit Device (EMA) that uses an elastic module to secure the upper and lower as well as reposition the jaw and are advocated for the management of snoring and sleep apnea.
Description of the Device: This device has a hard outer component with heat sensitive material contained within that component. The heat sensitive material is softened and is what fits the appliance to the patient's teeth for securing the appliance in place. Hooks for conventional Orthodontic elastics exist on the outer component for the purpose of attaching the elastics to prevent the mandible from retruding. The upper component has two (2) hooks and the lower component has one (1) hook. This allows for various methods of elastic
Page 5-1
7901 F. Belleview Aventie - Suite 200 Finglewood, Colorado 80111 Pirone 303-770-3300 * Fax 303-804-0500
o-mail RMC4E@adl.com
801 N. Cascado Avenue - Suite 35 Colorado Springs, Colorado 80903 Phone 719-471-0100 * Fax 303-804-0500
1
placement depending on the need(s) of the patient. There is ramping on both the upper and the lower to facilitate and guide the mandible forward when the patient is in occlusion. These ramps also provide a posterior stop for support of the mandible. The appliance also provides for full coverage of the dentition to prevent any tooth movement or occlusal changes. The teeth at the anterior of the appliance allow for indexing of the appliance at a position most acceptable to the patient during wear and allows the patient to determine the most effective jaw position for repositioning dependent on sleep position. The teeth index in such a way to allow for freedom of movement of the jaw during sleep while remaining in an indexed position.
Intended Use: This device is intended for the reduction and management of sleep apnea, as well as snoring.
Technologic Characteristics: Compared to the Silencer Custom, the EMA and the TAP appliance the NOrAD appliance does not hold or lock the jaw into a set position while also repositioning the mandible. The NOrAD allows for free movement both vertically as well as laterally and to some degree horizontally. This allows the patient the ability to move the jaw during sleep without inducing increased muscle activity.
Substantial Equivalence is based on non-clinical data. In addition the literature supports the historical significance of oral devices that reposition the
Page 5-2
2
jaw and reduce and mange snoring as well as sleep apnea. Pancer et al described this in an article published in the journal CHEST in 1998, where they concluded that mandibular repositioning appliances were 95% successful in reducing and/or controlling snoring and were 83% effective in managing sleep apnea. In addition the American Academy of Sleep Medicine (formerly the American Sleep Disorders Association) published in 1995 their Standards of Practice and Guidelines which demonstrated that oral appliances were effective in the management of snoring and mild to moderate sleep apnea.
Based on clinical data, it is demonstrated in a variety of articles that looked at oral appliances and their use for the treatment of snoring and sleep apnea, oral appliance therapy is an effective means by which these conditions can be managed. This effectiveness is embraced from a variety of aspects including safety, convenience and cost.
In conclusion, a number of studies have shown improvement of the airway utilizing imaging associated with the use of oral appliances (also referred to as Oral Airway Dilators), which aids in the management and reduction of Snoring and sleep apnea.
Page 5-3
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 with three curved lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 2002
Dr. Dennis R. Bailey 7901 East Belleview Avenue, Suite 200 Englewood, Colorado 80111
Re: K020893
Trade/Device Name: NOrAD Regulation Number: None Regulation Name: Intra-Oral Mandibular Repositioner Regulatory Class: Unclassified Product Code: LRK Dated: March 7, 2002 Received: March 19, 2002
Dear Dr. Dennis R. Bailey:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo have to revea you 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 mendments, 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 approvisions of the Act. The general controls provisions of the Act include comeons provincias or 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 (1 will), it ind of our anyon 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 statutes and regulations administered by other Federal agencies.
4
Page 2 - Dr. Dennis R. Bailey
You must comply with all the Act's requirements, including, but not limited to: registration You must comply with and the riobeling (21 CFR Part 801); good manufacturing practice and listing (21 CFR Part 007), labeling (21 cm (QS) regulation (21 CFR Part 820); and if requirents as act fortin in the quarty by steam (Sections (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 11113 letter will and w you to cogin interest in 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 If you desire specific as not 2009.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for questions on the promotion and 160 advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under notheation (11 OF ICP at From the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Timothy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K020893
Page 1 of 1
510(k) Number (if known): NO-AD Device Name:_
Indications For Use:
The NOrAD device (appliance) is indicated for use in patients who are snorers or have mild to moderate obstructive sleep apnea that has been medically diagnosed or are intolerant to nasalCPAP and wish to reducc and manage their condition while sleeping.
The device may be used in individuals who have had an overnight sleep study and do not have apaca or have mild to moderate obstructive sleep apnea and their physician has recommended the appliance. The device may also be indicated for a patient that snores and may have obstructive sleep apnea but their physician does not feel a sleep study is indicated and has recommended or referred the patient for appliance therapy. In many instances the decision will have been made after consultation has occurred between the dentist and the physician.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
ાર
Over-The-Counter Use_
(Optional Formal 1-2-9(
Suror Ruiseg
(Division Sign-Off) Division of Dental, Infection Contro and General Hospital Devices ( 510(k) Number