(381 days)
Not Found
No
The device description focuses on the physical construction and materials of a custom-fit oral appliance, with no mention of software, algorithms, or data processing that would indicate AI/ML. The "Mentions AI, DNN, or ML" and "Description of the training set..." sections are explicitly marked as "Not Found".
Yes
The device is intended to reduce the incidence of snoring and the effects of mild to moderate obstructive sleep apnea, which are medical conditions, and it is a prescribed medical device.
No
The device is a therapeutic appliance used to reduce snoring and the effects of mild to moderate obstructive sleep apnea, not to diagnose a condition.
No
The device description clearly states it is a physical oral appliance made of dental acrylic or resin, stainless steel ball clasps, and orthodontic stainless steel braid. It is a hardware device.
Based on the provided information, the Auradorm sleep appliance is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Auradorm's Function: The Auradorm sleep appliance is a physical device worn in the mouth. Its function is to mechanically reposition the mandible to reduce snoring and the effects of sleep apnea. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states it's a "mandibular repositioning device worn during sleep." This is a mechanical function, not a diagnostic test.
- Device Description: The description details the physical components and how it fits in the mouth. There is no mention of analyzing samples or providing diagnostic information based on biological markers.
Therefore, the Auradorm sleep appliance falls under the category of a medical device, specifically a Class II medical device (based on the predicate devices listed, which are also Class II), but it is not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Auradorm sleep appliance is a dentist prescribed mandibular repositioning device worn during sleep to reduce the incidence of snoring and reduce the effects of mild to moderate obstructive sleep apnea for patients 18 years or older.
Product codes
LRK
Device Description
The Auradorm Sleep Appliance is a one piece oral appliance used for reducing snoring and the effects of mild to moderate obstructive sleep apnea. The one piece upper and lower tooth engaging appliance covers the occlusal and buccal aspects of the entire lower arch teeth and the occlusal and buccal aspects of the posterior maxillary teeth to include the maxillary canines. The maxillary central and lateral incisors do not touch the appliance. The device does not rest or imping on soft tissue. The oral appliance is prescribed by a dentist and custom fit to the patient's mouth in the dental clinic. The oral appliance is made of FDA approved dental acrylic or resin, stainless steel ball clasps and orthodontic stainless steel braid embedded in the acrylic for strengthening purposes. The appliance is designed to limit the amount of material on the lingual aspect of the teeth and still maintain the anti-snoring functionality based on the predicate devices. The appliance has an anterior opening to prevent restriction of mouth breathing and is reinforced with orthodontic stainless steel metal braid embedded in the acrylic. Ball clasps are situated in the appliance to provide upper and lower tooth retention and adjustability for patient comfort.
The prescribing dentist determines the exact repositioning of the lower jaw via a bite registration obtained from the patient in the clinic. The dentist is able to fine tune the jaw position clinically by trying different bite registrations. The final bite registration is held in the patient's mouth to discern jaw comfort and ability to breath comfortably.
The functional relationship built into the appliance positions the mandible forward and open more vertically from it's normal location which causes a protrusion of the mandible in relation to the maxilla. This forward repositioning, which is temporary while the appliance is being used increases pharyngeal space which assists the patient with improved air exchange.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
oral cavity, mandibular teeth, maxillary teeth, pharyngeal space
Indicated Patient Age Range
18 years or older
Intended User / Care Setting
dentist/dental clinic, home/sleep laboratory
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.
Lamberg Sleep Well Device K062333, Snore Guard K103004, Acrylic Herbst Appliance K083209
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
Image /page/0/Picture/0 description: The image shows a handwritten sequence of characters and numbers. The sequence starts with the letter 'K', followed by the number '10', then '11', and ends with what appears to be the number '33', written in a stylized or cursive manner. The writing is in black ink against a white background, and the characters are spaced apart.
MAY 1 2 2011
· SLEEPWRIGHT 27 TIMBERWICK RD. SANTA FE, NM 87508 Phone (505)989-7866 FAX (505) 983-8395
t
510-(K) SUMMARY
This summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.
SUBMITTER INFORMATION: Cynthia Wright CDT 27 Timberwick Rd Santa Fe, New Mexico 87508
Date Summary Prepared: March 21, 2011
- Cynthia Wright CDT Contact Person: 27 Timberwick Rd Santa Fe, NM 87508 505-989-7866 Cell 505-204-8658 e-mail cynthia@cwrightn.com Dr. Jeff S. Luffey 505-294-4700 Cell 505-366-3178 e-mail jeffluffey@yahoo.com
Device Name: Auradorm Device Classification Name: Anti-snoring (21CFR 872.5570) Manufacturer: SLEEPWRIGHT Panel: Dental Product Code: LRK Classification: Class II 510K # K101155/
Devices for Which Substantial Equivalence is Claimed:
Lamberg Sleep Well Device K062333 Snore Guard K103004 Acrylic Herbst Appliance K083209
Device Description:
The Auradorm Sleep Appliance is a one piece oral appliance used for reducing snoring and the effects of mild to moderate obstructive sleep apnea. The one piece upper and lower tooth engaging appliance covers the occlusal and buccal aspects of the entire lower arch teeth and the occlusal and buccal aspects of the posterior maxillary teeth to include the
1
maxillary canines. The maxillary central and lateral incisors do not touch the appliance. The device does not rest or impinge on soft tissue. The oral appliance is prescribed by a dentist and custom fit to the patient's mouth in the dental clinic. The oral appliance is made of FDA approved dental acrylic or resin, stainless steel ball clasps and orthodontic stainless steel braid embedded in the acrylic for strengthening purposes. The appliance is designed to limit the amount of material on the lingual aspect of the teeth and still maintain the anti-snoring functionality based on the predicate devices. The appliance has an anterior opening to prevent restriction of mouth breathing and is reinforced with orthodontic stainless steel metal braid embedded in the acrylic. Ball clasps are situated in the appliance to provide upper and lower tooth retention and adjustability for patient comfort.
The prescribing dentist determines the exact repositioning of the lower jaw via a bite registration obtained from the patient in the clinic. The dentist is able to fine tune the jaw position clinically by trying different bite registrations. The final bite registration is held in the patient's mouth to discern jaw comfort and ability to breath comfortably.
The functional relationship built into the appliance positions the mandible forward and open more vertically from it's normal location which causes a protrusion of the mandible in relation to the maxilla. This forward repositioning, which is temporary while the appliance is being used increases pharyngeal space which assists the patient with improved air exchange.
Intended Use of the Device:
The Auradorm Sleep Appliance is a dentist prescribed mandibular repositioning device worn during sleep to reduce the incidence of snoring and reduce the effects of mild to moderate obstructive sleep apnea for patients 18 years or older.
Comparison to Predicate Device:
| DEVICE: | AURADORM | Lamberg Sleep Well Device
K062333 | Snore Guard
K103004 | Acrylic Splint Herbst
K083209 |
|-----------------------------------------|----------|--------------------------------------|------------------------|----------------------------------|
| Attribute: | | | | |
| Overnight use | Yes | Yes | Yes | Yes |
| Single patient multi-use | Yes | Yes | Yes | Yes |
| Easily removed from the mouth | Yes | Yes | Yes | Yes |
| Can be adjusted or refit | Yes | Yes | Yes | Yes |
| Cleaned and inspected daily | Yes | Yes | Yes | Yes |
| Placed in mouth each night | Yes | Yes | Yes | Yes |
| Use at home or sleep lab | Yes | Yes | Yes | Yes |
| Prevents grinding of teeth | Yes | Yes | Yes | Yes |
| Dentist prescribed device | Yes | Yes | Yes | Yes |
| FEATURES: | | | | |
| ACTION: | | | | |
| Mandibular repositioning | Yes | Yes | Yes | Yes |
| | | | | |
| DESIGN: | | | | |
| Custom fit for each patient | Yes | Yes | Yes | Yes |
| Acrylic fits over upper and lower teeth | Yes | Yes | Yes | Yes |
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| Materials: | ||||
|---|---|---|---|---|
| Non-sterile Dental Acrylic | ||||
| (Methyl methacrylate) | Yes | Yes | Yes | Yes |
| Dental Resin | Yes | No | No | Yes |
| Metal Ball Clasps | ||||
| (Stainless Steel) | Yes | Yes | No | Yes |
| Orthodontic metal braid | ||||
| (Stainless Steel) | Yes | No | No | No |
Technological Characteristics Summary of Auradorm:
-
- An acrylic or resin based oral appliance
-
- Jaw Repositioning
-
- Single patient custom fit
-
- Dentist prescribed intra-oral device
-
- Environment home/sleep laboratory
-
- Removable
-
- Non- Sterile
-
- Intended to reduce snoring and mild to moderate obstructive sleep apnea
-
- Custom fit to mandibular teeth and engages the maxillary teeth
Safety and Efficacy:
The Auradorm Sleep Appliance is based on the principles of repositioning the mandible to open the airway which is similar to many marketed anti-snoring devices. This appliance is made of FDA approved dental acrylic, ball clasps and embedded orthodontic stainless steel braid.
Risks to Health: Oral appliances can cause gingival soreness, movement of teeth, periodontal issues, temporomandibular joint or muscle pain, may obstruct the airway or change results of a polysomnogram. The auradorm sleep appliance has addressed these risks through specific design features as noted below:
Soft tissue soreness: The appliance is custom fit to the patient's natural dentition and does not rest on or touch gingival tissue.
TMD Concerns: The Auradorm accomplishes the goal of increasing the airway by repositioning the lower jaw down and forward. It is recognized by the dental community that this altered jaw relationship can also affect the temporomandibular joints. The prescribing dentist should perform a TMJ examination prior to using the Auradorm to make sure the patientis not predisposed to TMD risks that may be aggravated by using the appliance. Some patients do report sensations in the TMJ area in the early stages of appliance wear, but these are usually transitory with continued use. The prescribing dentist can also slightly alter the jaw position by adjusting the acrylic of the appliance. If discomfort persists a new bite registration can be taken to fabricate a new appliance. Should TMJ pain persist, the patient can decide with their dentist to stop discontinue treatment with this modality.
Obstruction of Oral Breathing: The Auradorm will not obstruct oral breathing due to the anterior opening created in the design of the appliance. The Auradorm also increases the airway by limiting the amount of acrylic on the lingual aspect of the teeth. This allows more tongue space in the anterior part of the oral cavity and increases the pharyngeal space which is the goal of all anterior repositioning devices. It is commonly accepted in the dental community that anterior positioning of the tongue and mandible increases pharyngeal space
3
that improves air exchange.
Loosening or flaring of teeth: The auradorm is fabricated to minimize tooth movement due to occlusal coverage of all teeth except the maxillary central and lateral incisors. The full posterior occlusal coverage of teeth reduces local forces and pressure on inidvidual teeth or segments of teeth like lower anteriors . The dentist is also able to easily control pressure on teeth by adjusting the acrylic which can reduce the forces directed to individual teeth and supporting alveolar structures.
Polysomnogram Results: Before a dentist prescribes an Auradorm, the patient must receive a complete dental examination, a complete TMJ evaluation, and a complete medical examination which includes a sleep study by a certified sleep physician. The prescribing dentist should consider the medical history of the patients, including history of asthma, breathing or respiratory disorders, or other relevant health problems and should refer the patient to the appropriate health care provider before prescribing the device. Follow-up sleep studies with the patient using the device is highly recommended to ensure that the desired effects are achieved.
Material Composition: The Auradorm is fabricated from known dental materials used for decades throughout the industry.
The Auradorm contains or uses the following materials:
Stainless Steel (304 or 316) - Stainless steel is a commonly accepted material for dental products. All Auradorm metal components are manufactured with 304 or 316 Stainless Steel. Dental Acrylic - The Auradorm is typically made with a methyl methacrylate for the acrylic portions of the appliance. Methyl methacrylate has been used in the dental industry for well over 50 years and does not pose any known health hazards to the patient in its polymerized form. The dentist may also request the appliance to be fabricated with FDA approved dental resin.
Intended Use Statement: The Auradorm is a dentist prescribed sleep appliance which is worn during sleep by individuals 18 years or older, who want to reduce the incidence of snoring or mild to moderate obstructive sleep apnea.
Summary Report: The Auradorm is substantially equivalent to the predicates because the device is a one piece maxillary and mandibular teeth engaging oral appliance made of FDA approved dental acrylic or resin, and commonly used orthodontic materials. This device has the same intended uses as the Snore Guard, Lamberg Sleep Well Device, and Acrylic Splint Herbst appliance, and is constructed with the same materials currently used by dentists to make anti-bruxing or night quards. The minor differences in the Auradorm's technological characteristics do not raise any new questions of safety or effectiveness, thus the Auradorm is substantially equivalent to the referenced predicate devices.
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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
MAY 1 2 2011
Ms. Cynthia Wright Auradorm Sleepwright 27 Timberwick Road Santa Fe. New Mexico 87508
Re: K101155
Trade/Device Name: Auradorm (Neuromuscular Sleep) Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Device for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK
Dated: March 21, 2011 Received: March 31, 2011
Dear Ms. Wright:
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.
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Page 2- Ms. Wright
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), pleasing the 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 vours.
for
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
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SLEEPWRIGHT 27 TIMBERWICK RD. SANTA FE, NM 87508 Phone (505)989-7866 FAX (505) 983-8395
INDICATIONS FOR USE STATEMENT
Revision Date: February 27, 2011
SUBMITTER INFORMATION: Cynthia Wright CDT 505-989-7866 27 Timberwick Rd Santa Fe, New Mexico 87508
Indications for Use
Common Name: Anti-snoring appliance Device Classification Name: Anti-snoring (21CFR 872.5570) Manufacturer: SLEEPWRIGHT Panel: Dental Product Code: LRK Classification: Class II 510K # K101155/ >
The Auradorm sleep appliance is a dentist prescribed mandibular repositioning device worn during sleep to reduce
the incidence of snoring and reduce the effects of mild to moderate obstructive sleep apnea for palients 18 years or
older.
Prescription Use _YES AND/OR Over-The-Counter Use __ NO (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Susan Luar
(Division Sign-Off) Division of Anesthesiology, General Hospital nfection Control, Dental Devic
510(k)