The OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor is intended to reduce snoring and mild to moderate obstructive sleep apnea (OSA) and monitor patient usage in an adult population.

Device Description

The OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor are simple hardware devices. They are oral appliances and will be manufactured by a dental laboratory to and on the order of a dentist, physician or licensed practitioner. Each appliance is customized for patients.

The OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor are intraoral devices used for treating and mild to moderate Obstructive Sleep Apnea (OSA). They consists of two custom fitted trays which fit over the upper and lower dentition of a patient and engage by means of adjustable metal screws or lugs. The devices function as mandibular repositioners, which act to increase the patient's pharyngeal space by reducing obstructions of the airway during sleep and improve their ability to exchange air. Additionally nasal dilator buttons are attached to the upper appliance, that when engaged stretch the nasio-label tissue in order to increase space in the nasal airway passage thus reducing tissue obstructions that aid in reducing snoring and OSA.

The devices are retained on the teeth by labial and lingual positioned ball clasps, typically located in the undercuts of each splint and by the base material engaging the undercuts of the teeth.

The devices are custom made for each patient and have an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.

Additionally, the devices include the Dentitrac ® patient monitoring system as characterized under the Braebon Dentitrac MAF 2557 to help monitor patient compliance to prescribed usage.

AI/ML Overview

The provided text describes a 510(k) submission for the "OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor". This submission focuses on demonstrating substantial equivalence to a predicate device and does not involve a clinical study with specific acceptance criteria that would typically be found in direct performance evaluations of a new medical device's efficacy or diagnostic accuracy. Instead, the "acceptance criteria" are related to established safety and performance standards for similar devices and the successful integration of the monitoring system.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance (Summary from Provided Text)
Biocompatibility (per ISO 10993-1, -5, -12)	Passed: in vitro cytotoxicity, skin sensitization, mutagenicity (Ames test), and chemical characterization tests.
Risk Analysis (per ISO 14971)	Formal Risk Assessment performed; risks mitigated to acceptable levels.
Non-clinical Performance Testing (General)	Passed all internal performance testing standards.
Electrical Safety & EMC (for DentiTrac® system)	Evaluated and confirmed (details in MAF 2557).
Software Elements (for DentiTrac® system)	Evaluated and confirmed (details in MAF 2557).
Process Validation (for DentiTrac® integration)	Certified by Braebon.
Manufacturing Quality (for DentiTrac® integration)	100% visual and functional inspections throughout production process to meet specifications.
Substantial Equivalence (to predicate device)	Determined to be substantially equivalent based on comparison of indications for use, principles of operation, technological characteristics, and performance testing.

2. Sample Size Used for the Test Set and Data Provenance

The provided text does not describe a test set or data provenance in the context of a clinical study or performance evaluation with human subjects for the OASYS device itself. The evidence presented is primarily based on:

Comparison to predicate devices: This involves structural and functional similarities, and the predicate device (K030440) served as the primary benchmark.
Non-clinical testing: This refers to laboratory-based evaluations for biocompatibility, electrical safety, software, and general performance. The text does not specify sample sizes for these tests (e.g., how many units were tested for biocompatibility, though such tests are typically conducted on representative samples).
Reference to Master File (MAF 2557): The DentiTrac® Patient Monitoring System's specific testing details (biocompatibility, electrical, performance, and characterization) are contained in a larger "Master File," which is a confidential document submitted to the FDA. The details of any test sets or sample sizes within that MAF are not disclosed in this summary.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the submission is a 510(k) for substantial equivalence, relying on non-clinical testing and comparison to existing devices rather than a de novo clinical study requiring expert-established ground truth on a test set.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as #3.

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

This information is not applicable. The device is an oral appliance for treating snoring and sleep apnea, and a DentiTrac® monitoring system. It is not an AI-assisted diagnostic or assistive technology that would involve "human readers" or an MRMC study.

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

This information is not applicable. The DentiTrac® system monitors patient usage; it's a data collection system rather than an algorithm performing a diagnostic or assistive function that would have "standalone performance" in the context of AI.

7. The Type of Ground Truth Used

For the biocompatibility and performance testing, the ground truth is based on established international and national standards (e.g., ISO 10993-1, ISO 14971) and internal requirements/specifications. For the DentiTrac® system, the ground truth for its performance would be against its own specifications, validated as acceptable in MAF 2557, likely using calibrated instruments for accuracy of usage time measurement. There is no mention of expert consensus, pathology, or outcomes data being used to establish ground truth for this 510(k) submission.

8. The Sample Size for the Training Set

This information is not applicable. There is no mention of a "training set" as the device is not an AI/machine learning system that requires training data.

9. How the Ground Truth for the Training Set was Established

This information is not applicable for the same reason as #8.

Summary

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Indications for Use

510(k) Number (if known) K181571

Device Name

OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------	--

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor

1. Submission Sponsor

Dream Systems LLC

660 Commerce Dr. Suite C

Roseville

CA, 95678

United States

Contact: Mark Abramson D.D.S.

Title: CEO

2. Submission Correspondent

FisherMed Consulting, LLC

820 Civic Center Drive

Santa Clara, CA 95050

Office Phone: (408) 410-5920

Email: cherylfisher3@comcast.net

Contact: Cheryl Fisher

Title: Principal Consultant, RA/QA

3. Date Prepared

04/19/2019

4. Device Identification

Trade/Proprietary Name:	OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® PatientMonitor
Common/Usual Name:	Sleep Appliances with Patient Monitoring
Classification Name:	Intraoral Devices for Snoring and/or Obstructive Sleep Apnea
Regulation Number:	872.5570

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Product Code:	PLC
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Device Class: Class II

Classification Panel: Dental

5. Legally Marketed Predicate Device(s)

Primary Predicate

K030440 OASYS Oral/Nasal Airway System, by Dream Systems LLC

Reference Device K083209 Acrylic Splint Herbst Appliance, by Specialty Appliances

Reference Device K150369 SomnoDent with Micro-Recorder, by SomnoMed, Inc.

Reference Device

K170692 Respire Pink with DentiTrac, by Respire Medical LLC

Reference Device

K974727 Jet Acrylic Liquid-Monomer, Ortho Jet Powder-Polymer, Plasticized Methacrylate Homopolymer, Methacrylate Copolymer, METR, by J.B.C and CO.

Reference Device K002048 JBC Opaque and Glitter, by J.B.C and CO.

6. Indication for Use Statement

7. Device Description

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snoring and OSA.

The devices are retained on the teeth by labial and lingual positioned ball clasps, typically located in the undercuts of each splint and by the base material engaging the undercuts of the teeth.

The devices are custom made for each patient and have an adjustment mechanism enabling the amount of mandibular advancement to be set by the dentist or physician at the time of fitting the device.

Additionally, the devices include the Dentitrac ® patient monitoring system as characterized under the Braebon Dentitrac MAF 2557 to help monitor patient compliance to prescribed usage.

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8. Substantial Equivalence Discussion

The following table compares the OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor to the predicate device and reference device with respect to indications for use, principles of operation, technological characteristics, and performance testing. The comparison of the devices provides more detailed information regarding the basis for the determination of substantial equivalence. The subject device does not raise any new issues of safety or effectiveness based on the similarities to the predicate devices.

Feature	SubjectOASYS Oral/NasalAirway System andOASYS Herbst withDentitrac ® PatientMonitor	Primary PredicateOASYS Oral/NasalAirway System	Reference PredicateDeviceAcrylic Splint HerbstAppliance(1)	Reference Device(1)SomnoDent withMicro-Recorder	Reference Device(2)Respire Pink withDentiTrac	Comparison
510 (k) Number	K181571	K030440	K083209	K150369	K170692	Same method
Manufacturer	Dream Systems LLC	Dream Systems LLC	Specialty Appliances(Assimilated intoDream Systems LLCportfolio)	SomnoMed, Inc.	Respire MedicalLLC	NA
Classification #	872-5570	872-5570	872-5570	872-5570	872-5570	Same
Product Code	Primary: PLC	Primary: LRKSecondary, LWF	Primary: LRK	Primary: PLC	Primary: PLC perSummary, LRK perFDA Website	The OASYS devices andthe associatedreference devices sharethe same productcode(s). The predicateand primary predicate
	Indications foruse					devices only referenceproduct code LRKbecause they do notcontain patientmonitoring capabilityas is the subject of thissubmission
	The OASYSOral/Nasal AirwaySystem and OASYSHerbst with Dentitrac® Patient Monitor isintended to reducesnoring and mild tomoderate obstructivesleep apnea (OSA)	OASYS Oral AirwaySystem is intendedfor use to reduce oreleviate snoring andobstructive sleepapnea	The Acrylic SplintHerbst Appliance isintended for use inpatients 18 years ofage or older for thereduction of snoringand mild tomoderateobstructive sleep	The SonmoDent®intraoral devicesare intended forthe treatment of	The Respire PinkSeries intraoralappliances areintended to treatsnoring and mildto moderateObstructive SleepApnea (OSA) inadult patients 18	Similar, only minorchanges in wording butthe same meaning andintended use for theadult population
	and monitor patientusage in an adultpopulation.		apnea. The AcrylicSplint HerbstAppliance is wornwhile sleeping tosupport the lowerjaw in a forwardposition prescribedby the dentist. Theappliance isremovable by thepatient	18 years of age orolder.Optionally, if theDentiTrac® patientmonitoringsystem iscompletelyembedded intothe SomnoDent®device, thepatientmonitoring	years of age orolder.Optionally theDentiTrac® patientmonitoringsystem may beincorporated intoa Respire PinkSeries device. Thepatientmonitoringsystem is intended
				system is intendedto measure	to measurepatient
				patientcompliance to oraldevice/appliancetherapy incombination withthe DentiTrac®System	compliance to oralappliance therapyin combinationwith theDentiTrac® System
Mode of Action	These devicesfunction as amandibularrepositioner, whichacts to increase thepatient's pharyngealspace, by reducingobstructions of theairway and improvingtheir ability toexchange air duringsleep.Additionally, nasaldilators are used toopen the nasalpathway improvingair flow through thenose and reducingsoft palatal vibrationsinducing snoringFinally, monitoringcapability is included	This devicefunctions as amandibularrepositioner,maintaining thelower jaw in aforward positionduring sleep. Thismechanicalprotrusion acts toincrease thepatient'spharyngeal space,improving the abilityto exchange airduring sleep byreducing mechanicalobstructions of theairway.Additionally, nasaldilators are used to	This devicefunctions as amandibularrepositioner,maintaining thelower jaw in aforward positionduring sleep. Thismechanicalprotrusion acts toincrease thepatient'spharyngeal space,improving the abilityto exchange airduring sleep byreducing mechanical	The devicefunctions as amandibularrepositioner,which acts toimprove thepatient's ability tobreathe, withoutobstruction of thepharyngeal airwayAdditionally,monitoringcapability isincluded utilizingthe DentiTrac®patientcompliancemonitoringtechnology.	The devicefunctions as amandibularrepositioner,which acts toimprove thepatient's ability tobreathe withoutobstruction of thepharyngealairway,Additionally,monitoringcapability isincluded utilizingthe DentiTrac®patientcompliancemonitoringtechnology.	Similar modes ofaction.The subject device andthe predicate have thesame modes of actioni.e. increasing thepharyngeal space andincreasing the nasalspace by keeping it freeof obstruction by theuse of continuousgentle force to alleviatesnoring and OSA.The subject device hasthe addition of theDentiTrac® patientcompliance monitoringtechnology. Which thepredicate device doesnot have. However, theDentiTrac patientcompliance monitoring technology.

Table 5A – Comparison of Characteristics

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utilizing the	open the nasal	The mechanism of	The mechanism of	technology is utilized
DentiTrac® patientcompliancemonitoringtechnology.	pathway improvingair flow through thenose and reducingsoft palatalvibrations inducingsnoring	action iscontinuous gentleforce	action iscontinuous gentleforce	in both ReferenceDevices 1 and 2.
The mechanism ofaction is continuousgentle forcestretching the nasallabial fold fromunder the upper lipto pull on the nasalvalve andmechanically dilatingthe area of the nasalvalve increasingairflow though thenasal valve.	The mechanism ofaction is continuousgentle force			Reference devices 1and 2 share thecapability of increasingof pharyngeal space bycontinuous gentle forcebut do not share thefunction of increasingthe nasal airwaythrough the use ofnasal dilators as thisfunctionality is sharedbetween the subjectdevice and thepredicate device only.
				As the subject device inconjunction with thepredicate, referencepredicate and thereference devicesinclude no additionalmodes of action thereis no increased riskinherent in thefunctionality of thesubject device

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Material
Heat sensitiveImpression MaterialRigid TrayAdvancementmechanism surgicalgrade stainless steelDentiTrac® Patientmonitoring systemembeddedinto OASYS devices	Heat sensitiveImpression MaterialRigid TrayAdvancementmechanism surgicalgrade stainless steel	Heat sensitiveImpression MaterialRigid TrayAdvancementmechanism surgicalgrade stainless steel	Trays constructedfrom a softliningmaterial adheredto a hard surfaceacrylic.Advancementmechanism isconstructed ofsurgical gradeStainless SteelDentiTrac®Patientmonitoringsystemembeddedinto SomnoDent	Acrylic fittingsurface,Acrylic/Wironitfitting surfacesAdvancementmechanismsurgical gradestainless steelDentiTrac® Patientmonitoring systemembeddedinto Respire PinkSeries devices	Subject device,reference predicateand predicate devicesare made of an Heatsensitive impressionmaterial and rigid trayThe reference device 1is made of a softliningmaterial adhered toacrylic, while thereference device 2 ismade of acrylic. Acrylicis the bases for therigid trays in thesubject and predicatedevicesThe Advancementdevices are made ofstainless steel in thesubject and bothreference devices.And the subject device,and 2 referencedevices embed theDentiTrac® Micro-

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Mode of Care	Adjustable by Dentistor Physician duringthe duration of use	Adjustable byDentist or Physicianduring the durationof use	Adjustable byDentist or Physicianduring the durationof use	Adjustable byDentist orPhysician duringthe duration ofuse	Adjustable byDentist orPhysician duringthe duration ofuse	Same
Usage	Removable andReusable by thesame patient.Night Time UsageOnly	Removable andReusable by thesame patient.Night Time UsageOnly	Removable andReusable by thesame patient.Night Time UsageOnly	Removable andReusable by thesame patient.Night Time UsageOnly	Removable andReusable by thesame patient.Night Time UsageOnly	Same
Biocompatible	Yes	Yes	Yes	Yes	Yes	Same
OTC or Rx	Rx	Rx	Rx	Rx	Rx	Same
Insertion	2 piece design allowsfor the upperappliance to beinserted firstfollowed by thelower appliance	2 piece designallows for the upperappliance to beinserted firstfollowed by thelower appliance	2 piece designallows for the upperappliance to beinserted firstfollowed by thelower appliance	2 piece designallows for theupper applianceto be inserted firstfollowed by thelower appliance	2 piece designallows for theupper applianceto be inserted firstfollowed by thelower appliance	Two piece designallows greater ease ofinsertion and incurs noadditional risk to thepatient
PatientcomplianceMonitoringCapability	YesDentiTrac® Micro-recorder	No	No	YesDentiTrac® Micro-recorder	YesDentiTrac® Micro-recorder	The subject devicecontains a DentiTrac®Patient monitoringsystem while thepredicate device doesnot. However, thesubject device and bothreference devices use
							the DentiTrac® Micro-recorder

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9. Non-Clinical Performance Data

Same as predicate. OASYS Oral/Nasal Airway System under K030440

And

#	Testing
1	Dentitrac ® Patient Monitoring System, biocompatibility, electrical, performance andcharacterization testing in MAF 2557
2	Material, physical properties and biocompatibility in K974727 and K002048

The OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor passed all the testing in accordance with internal requirements, applied national standards, and applied international standards shown below to support substantial equivalence of the subject device: Biocompatibility - The biological safety of the components of the OASYS were evaluated in accordance with ISO 10993-1 and guidance document entitled Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing within a Risk Management Process". Under this, for the stated indications for use, components of the device's biological safety were evaluated for in vitro cytotoxicity, skin sensitization, and mutagenicity and chemical characterization.

Biocompatibility testing per ISO 10993-1 Biological Evaluation of Medical Devices: Part 1: Evaluation and Testing within a Risk Management Process: Passed
Biocompatibility testing per ISO 10993-5 Cytotoxicity: Passed
Biocompatibility testing HET-CAM Tests for irritation and skin sensitization: Passed
Biocompatibility testing mutagenicity (Ames test): Passed
Biocompatibility testing per ISO 10993-12 chemical analysis of eluted components acc.: Passed

Risk Analysis - Formal Risk Assessment of the OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor was performed in accordance with ISO 14971.

Non-clinical performance testing: The OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor passed all internal performance testing standards.

The addition of the DentiTrac® patient monitoring system does not adversely affect the original design, therefore, not introducing any new issues of concern. A risk assessment shows that risks are mitigated to acceptable levels, and performance testing related to the DentiTrac® patient monitoring system confirms that EMC and electrical safety, biocompatibility, and software elements were evaluated. DentiTrac® performance testing is located in the Braebon DentiTrac® Master File MAF 2557. Process validation concerning the incorporation and functionality of the DentiTrac® patient monitoring system is

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certified by Braebon. Dream Systems LLC Medical performs 100% visual and functional inspections throughout the production process to ensure that the device meets manufacturing specifications for the OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor device and specifications for the incorporation of the DentiTrac® patient monitoring system.

10. Statement of Substantial Equivalence

The performance testing provided demonstrates that the subject device(s) is substantially equivalent to the predicate device and reference device (s). The Dream Systems LLC, OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor, as designed and manufactured, is determined to be substantially equivalent to the referenced predicate devices.

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April 19, 2019

Dream System LLC c/o Cheryl Fisher Principal Consultant FisherMed Consulting LLC 820 Civic Center Drive Santa Clara, California 95050

Re: K181571

Trade/Device Name: OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac® Patient Monitor Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: Class II Product Code: PLC Dated: March 20, 2019 Received: March 22, 2019

Dear Cheryl Fisher:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Tina Kiang, Ph.D. Acting Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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.”