What is the regulatory pathway for OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor?

510(k) clearance (submission type: Traditional).

What are the predicate devices for OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor?

OASYS Oral/Nasal Airway System (K030440).

Who can help prepare an FDA 510(k) submission like OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

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

Q: Who is the manufacturer of OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor?

Mark Abramson, D.D.S., Inc. filed the 510(k) submission for OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor (K181571).

Q: What is the FDA product code for OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor?

PLC. It is classified under 21 CFR 872.5570 as a Class 2 device in the Dental panel.

K181571 · Mark Abramson, D.D.S., Inc. · PLC · Apr 19, 2019 · Dental

Device Facts

Record ID	K181571
Device Name	OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor
Applicant	Mark Abramson, D.D.S., Inc.
Product Code	PLC · Dental
Decision Date	Apr 19, 2019
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 872.5570
Device Class	Class 2
Attributes	Therapeutic

Intended Use

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 Story

Intraoral appliances (OASYS Oral/Nasal Airway System and OASYS Herbst) function as mandibular repositioners to increase pharyngeal space and reduce airway obstruction during sleep. Nasal dilator buttons on the upper appliance stretch nasio-labial tissue to increase nasal airway space. Devices are custom-fitted by dental laboratories per dentist/physician order, featuring adjustable metal screws/lugs for mandibular advancement. The integrated DentiTrac patient monitor tracks compliance with prescribed usage. Used at home by patients during sleep; adjusted by clinicians. Output (usage data) allows healthcare providers to monitor patient adherence to therapy, potentially improving treatment outcomes for snoring and OSA.

Clinical Evidence

No clinical data provided. Substantial equivalence supported by bench testing, including biocompatibility (ISO 10993-1, -5, -12, HET-CAM, Ames test), risk analysis (ISO 14971), and performance characterization of the DentiTrac monitor (referenced in MAF 2557).

Technological Characteristics

Custom-fitted intraoral appliances; heat-sensitive impression material; rigid trays; surgical-grade stainless steel advancement mechanism; nasal dilator buttons. Integrated DentiTrac patient monitoring system. Biocompatibility per ISO 10993. Manufactured per dentist/physician prescription.

Indications for Use

Indicated for adult patients (18+ years) to reduce snoring and mild to moderate obstructive sleep apnea (OSA) and monitor patient usage.

Regulatory Classification

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.

Special Controls

*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.”

Predicate Devices

OASYS Oral/Nasal Airway System (K030440)

Reference Devices

Acrylic Splint Herbst Appliance (K083209)
SomnoDent with Micro-Recorder (K150369)
Respire Pink with DentiTrac (K170692)
Jet Acrylic Liquid-Monomer, Ortho Jet Powder-Polymer, Plasticized Methacrylate Homopolymer, Methacrylate Copolymer, METR (K974727)
JBC Opaque and Glitter (K002048)

Related Devices

K170606 — Acrylic Herbst Appliance with Micro-Recorder · Gergen'S Orthodontic Lab · Nov 16, 2017
K161624 — MicrO2 OSA Device with Micro-Recorder · Microdental, Inc. · Nov 7, 2016
K172859 — Prosomnus [CA] Sleep and Snore Device and Prosomnus [CA] Sleep and Snore Device with Micro-recorder · Prosomnous Sleep Technologies · Nov 22, 2017
K233497 — Rest Assure System · Somnomed, Inc. · Oct 3, 2024
K160239 — TAP 3, TAP 1 · Airway Management, Inc. · Aug 10, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ # 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) 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. | 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {1}------------------------------------------------ ### 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 ® Patient Monitor | |-------------------------|-------------------------------------------------------------------------------------| | Common/Usual Name: | Sleep Appliances with Patient Monitoring | | Classification Name: | Intraoral Devices for Snoring and/or Obstructive Sleep Apnea | | Regulation Number: | 872.5570 | {2}------------------------------------------------ | Product Code: | PLC | |---------------|-----| |---------------|-----| 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 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. # 7. 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 {3}------------------------------------------------ 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. {4}------------------------------------------------ #### 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 | Subject OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor | Primary Predicate OASYS Oral/Nasal Airway System | Reference Predicate Device Acrylic Splint Herbst Appliance (1) | Reference Device (1) SomnoDent with Micro-Recorder | Reference Device (2) Respire Pink with DentiTrac | Comparison | |------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510 (k) Number | K181571 | K030440 | K083209 | K150369 | K170692 | Same method | | Manufacturer | Dream Systems LLC | Dream Systems LLC | Specialty Appliances (Assimilated into Dream Systems LLC portfolio) | SomnoMed, Inc. | Respire Medical LLC | NA | | Classification # | 872-5570 | 872-5570 | 872-5570 | 872-5570 | 872-5570 | Same | | Product Code | Primary: PLC | Primary: LRK Secondary, LWF | Primary: LRK | Primary: PLC | Primary: PLC per Summary, LRK per FDA Website | The OASYS devices and the associated reference devices share the same product code(s). The predicate and primary predicate | | | Indications for use | | | | | devices only reference product code LRK because they do not contain patient monitoring capability as is the subject of this submission | | | 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) | OASYS Oral Airway System is intended for use to reduce or eleviate snoring and obstructive sleep apnea | The Acrylic Splint Herbst Appliance is intended for use in patients 18 years of age or older for the reduction of snoring and mild to moderate obstructive sleep | The SonmoDent® intraoral devices are intended for the treatment of | The Respire Pink Series intraoral appliances are intended to treat snoring and mild to moderate Obstructive Sleep Apnea (OSA) in adult patients 18 | Similar, only minor changes in wording but the same meaning and intended use for the adult population | | | and monitor patient usage in an adult population. | | apnea. The Acrylic Splint Herbst Appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient | 18 years of age or older. Optionally, if the DentiTrac® patient monitoring system is completely embedded into the SomnoDent® device, the patient monitoring | years of age or older. Optionally the DentiTrac® patient monitoring system may be incorporated into a Respire Pink Series device. The patient monitoring system is intended | | | | | | | system is intended to measure | to measure patient | | | | | | | patient compliance to oral device/appliance therapy in combination with the DentiTrac® System | compliance to oral appliance therapy in combination with the DentiTrac® System | | | Mode of Action | These devices function as a mandibular repositioner, which acts to increase the patient's pharyngeal space, by reducing obstructions of the airway and improving their ability to exchange air during sleep. Additionally, nasal dilators are used to open the nasal pathway improving air flow through the nose and reducing soft palatal vibrations inducing snoring Finally, monitoring capability is included | This device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient's pharyngeal space, improving the ability to exchange air during sleep by reducing mechanical obstructions of the airway. Additionally, nasal dilators are used to | This device functions as a mandibular repositioner, maintaining the lower jaw in a forward position during sleep. This mechanical protrusion acts to increase the patient's pharyngeal space, improving the ability to exchange air during sleep by reducing mechanical | The device functions as a mandibular repositioner, which acts to improve the patient's ability to breathe, without obstruction of the pharyngeal airway Additionally, monitoring capability is included utilizing the DentiTrac® patient compliance monitoring technology. | The device functions as a mandibular repositioner, which acts to improve the patient's ability to breathe without obstruction of the pharyngeal airway, Additionally, monitoring capability is included utilizing the DentiTrac® patient compliance monitoring technology. | Similar modes of action. The subject device and the predicate have the same modes of action i.e. increasing the pharyngeal space and increasing the nasal space by keeping it free of obstruction by the use of continuous gentle force to alleviate snoring and OSA. The subject device has the addition of the DentiTrac® patient compliance monitoring technology. Which the predicate device does not have. However, the DentiTrac patient compliance monitoring technology. | ### Table 5A – Comparison of Characteristics {5}------------------------------------------------ {6}------------------------------------------------ {7}------------------------------------------------ | utilizing the | open the nasal | The mechanism of | The mechanism of | technology is utilized | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | DentiTrac® patient compliance monitoring technology. | pathway improving air flow through the nose and reducing soft palatal vibrations inducing snoring | action is continuous gentle force | action is continuous gentle force | in both Reference Devices 1 and 2. | | The mechanism of action is continuous gentle force stretching the nasal labial fold from under the upper lip to pull on the nasal valve and mechanically dilating the area of the nasal valve increasing airflow though the nasal valve. | The mechanism of action is continuous gentle force | | | Reference devices 1 and 2 share the capability of increasing of pharyngeal space by continuous gentle force but do not share the function of increasing the nasal airway through the use of nasal dilators as this functionality is shared between the subject device and the predicate device only. | | | | | | As the subject device in conjunction with the predicate, reference predicate and the reference devices include no additional modes of action there is no increased risk inherent in the functionality of the subject device | {8}------------------------------------------------ | Material | | | | | | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Heat sensitive Impression Material Rigid Tray Advancement mechanism surgical grade stainless steel DentiTrac® Patient monitoring system embedded into OASYS devices | Heat sensitive Impression Material Rigid Tray Advancement mechanism surgical grade stainless steel | Heat sensitive Impression Material Rigid Tray Advancement mechanism surgical grade stainless steel | Trays constructed from a softlining material adhered to a hard surface acrylic. Advancement mechanism is constructed of surgical grade Stainless Steel DentiTrac® Patient monitoring system embedded into SomnoDent | Acrylic fitting surface, Acrylic/Wironit fitting surfaces Advancement mechanism surgical grade stainless steel DentiTrac® Patient monitoring system embedded into Respire Pink Series devices | Subject device, reference predicate and predicate devices are made of an Heat sensitive impression material and rigid tray The reference device 1 is made of a softlining material adhered to acrylic, while the reference device 2 is made of acrylic. Acrylic is the bases for the rigid trays in the subject and predicate devices The Advancement devices are made of stainless steel in the subject and both reference devices. And the subject device, and 2 reference devices embed the DentiTrac® Micro- | {9}------------------------------------------------ | Mode of Care | Adjustable by Dentist or Physician during the duration of use | Adjustable by Dentist or Physician during the duration of use | Adjustable by Dentist or Physician during the duration of use | Adjustable by Dentist or Physician during the duration of use | Adjustable by Dentist or Physician during the duration of use | Same | | |---------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------| | Usage | Removable and Reusable by the same patient. Night Time Usage Only | Removable and Reusable by the same patient. Night Time Usage Only | Removable and Reusable by the same patient. Night Time Usage Only | Removable and Reusable by the same patient. Night Time Usage Only | Removable and Reusable by the same patient. Night Time Usage Only | Same | | | Biocompatible | Yes | Yes | Yes | Yes | Yes | Same | | | OTC or Rx | Rx | Rx | Rx | Rx | Rx | Same | | | Insertion | 2 piece design allows for the upper appliance to be inserted first followed by the lower appliance | 2 piece design allows for the upper appliance to be inserted first followed by the lower appliance | 2 piece design allows for the upper appliance to be inserted first followed by the lower appliance | 2 piece design allows for the upper appliance to be inserted first followed by the lower appliance | 2 piece design allows for the upper appliance to be inserted first followed by the lower appliance | Two piece design allows greater ease of insertion and incurs no additional risk to the patient | | | Patient compliance Monitoring Capability | Yes DentiTrac® Micro- recorder | No | No | Yes DentiTrac® Micro- recorder | Yes DentiTrac® Micro- recorder | The subject device contains a DentiTrac® Patient monitoring system while the predicate device does not. However, the subject device and both reference devices use | | | | | | | | | | the DentiTrac® Micro- recorder | {10}------------------------------------------------ {11}------------------------------------------------ #### 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 and characterization 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 {12}------------------------------------------------ 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. {13}------------------------------------------------ Image /page/13/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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. {14}------------------------------------------------ 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

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

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

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Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

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Special Controls

Predicate Devices

Reference Devices

Related Devices

Submission Summary (Full Text)

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