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.

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 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.

AI/ML Overview

Here's an analysis of the provided text regarding the Auradorm Sleep Appliance, focusing on acceptance criteria and supporting study details.

Important Note: The provided document is a 510(k) summary, which is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device. It typically does not contain detailed information about a comprehensive clinical study to prove the device meets specific performance acceptance criteria through quantitative metrics like accuracy, sensitivity, or specificity. Instead, the focus is on showing similarity in intended use, technological characteristics, and safety/efficacy principles to existing, approved devices. Therefore, many of the requested items (e.g., sample sizes for test/training, number of experts, adjudication methods, MRMC studies, standalone performance, specific ground truth types with quantitative results) are not present in this type of submission.

Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission, the "acceptance criteria" are primarily related to demonstrating substantial equivalence to predicate devices, rather than meeting specific quantifiable performance metrics from a dedicated clinical trial for a novel device. The criteria are implicitly met by showing similarity in design, materials, and intended use, and by highlighting the device's design features that address potential risks.

Acceptance Criterion (Implied by 510(k))	Reported Device Performance (Auradorm)
Intended Use: Reduce snoring and effects of mild to moderate obstructive sleep apnea (OSA) for patients ≥ 18 years.	- "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."- "The Auradorm is substantially equivalent to the predicates because the device has the same intended uses..."
Similar Technological Characteristics to Predicates:	- Overnight use: Yes- Single patient multi-use: Yes- Easily removed from mouth: Yes- Can be adjusted or refit: Yes- Cleaned and inspected daily: Yes- Placed in mouth each night: Yes- Use at home or sleep lab: Yes- Prevents grinding of teeth: Yes- Dentist prescribed device: Yes- Mandibular repositioning: Yes- Custom fit for each patient: Yes- Acrylic fits over upper and lower teeth: Yes- Materials: Non-sterile Dental Acrylic (Methyl methacrylate), Dental Resin, Metal Ball Clasps (Stainless Steel), Orthodontic metal braid (Stainless Steel). Differences in materials (Dental Resin, Orthodontic metal braid) are noted but deemed not to raise new safety/effectiveness questions.
Addressed Safety Concerns (Risks to Health):	- Gingival soreness: "Appliance is custom fit to the patient's natural dentition and does not rest on or touch gingival tissue."- TMD Concerns: "Prescribing dentist should perform a TMJ examination prior to using the Auradorm... Some patients do report sensations... but these are usually transitory... Dentist can also slightly alter the jaw position... If discomfort persists a new bite registration can be taken..."- Obstruction of Oral Breathing: "Anterior opening created in the design... increases the airway by limiting the amount of acrylic on the lingual aspect of the teeth."- Loosening or flaring of teeth: "Fabricated to minimize tooth movement due to occlusal coverage of all teeth except the maxillary central and lateral incisors... reduces local forces and pressure... Dentist is also able to easily control pressure on teeth by adjusting the acrylic."- Polysomnogram Results (Potential alteration): "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... Follow-up sleep studies with the patient using the device is highly recommended..."- Material Composition (Safety): "Fabricated from known dental materials used for decades throughout the industry." (Stainless Steel, Methyl methacrylate).
No New Questions of Safety or Effectiveness Raised by Differences:	- "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."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable / Not Provided: The 510(k) summary does not describe a specific clinical study with a "test set" in the context of device performance metrics (e.g., accuracy, sensitivity) for a diagnostic or therapeutic effect. The demonstration of substantial equivalence relies on comparing the device's characteristics to already legally marketed devices, not on new clinical data proving effectiveness quantitatively in a test cohort.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable / Not Provided: As no specific clinical test set for performance comparison is described, there's no mention of experts or ground truth establishment in this manner. The "ground truth" for the device's claims is largely based on the established effectiveness and safety profile of the predicate devices and the general understanding of mandibular repositioning for sleep apnea/snoring by the dental/medical community.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable / Not Provided: No adjudication method is mentioned as there is no specific clinical test set or review process involving multiple experts for quantitative performance.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable: This device is a physical oral appliance, not an AI-powered diagnostic or assistance tool for human readers. Therefore, an MRMC study or AI-related effectiveness metrics are irrelevant and not part of the submission.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable: This is a physical medical device, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this 510(k) submission is primarily derived from:
- Regulatory Predicate Equivalence: The established safety and effectiveness of the legally marketed predicate devices (Lamberg Sleep Well Device K062333, Snore Guard K103004, Acrylic Herbst Appliance K083209).
- Commonly Accepted Dental/Medical Principles: The document references "It is commonly accepted in the dental community that anterior positioning of the tongue and mandible increases pharyngeal space that improves air exchange." and "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."
- Material Safety: The use of "FDA approved dental acrylic or resin" and "known dental materials used for decades throughout the industry."

8. The sample size for the training set

Not Applicable / Not Provided: There is no "training set" in the context of an algorithm or a clinical trial for this type of 510(k) submission. The device design and safety principles are based on existing knowledge and predicate devices.

9. How the ground truth for the training set was established

Not Applicable / Not Provided: As there is no training set mentioned, this question is not relevant to the information provided.

Summary

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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

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:

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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 DeviceK062333	Snore GuardK103004	Acrylic Splint HerbstK083209
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:

1. An acrylic or resin based oral appliance
1. Jaw Repositioning
1. Single patient custom fit
1. Dentist prescribed intra-oral device
1. Environment home/sleep laboratory
1. Removable
1. Non- Sterile
1. Intended to reduce snoring and mild to moderate obstructive sleep apnea
1. 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

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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)

Regulation Number and Section

§ 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.”