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

• K Number: K181571
• Device Name: OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac Patient Monitor
• Manufacturer: Mark Abramson, D.D.S., Inc
• Date Cleared: 2019-04-19 ( 309 days)
• Product Code: PLC
• Regulation Number: 872.5570

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 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.

Predicate Devices

K030440

Reference Devices

K083209, K150369, K170692, K974727, K002048

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on the mechanical function of the oral appliance and the Dentitrac system is described as a "patient monitoring system" with no mention of AI/ML capabilities. The "Mentions AI, DNN, or ML" field is also marked as "Not Found".

Therapeutic

Yes

The device is intended to reduce snoring and mild to moderate obstructive sleep apnea (OSA) by acting as a mandibular repositioner and increasing pharyngeal and nasal airway space, thus directly treating a medical condition.

Diagnostic

No

This device is an oral appliance primarily intended for treatment of snoring and mild to moderate obstructive sleep apnea (OSA) by physically repositioning the jaw and expanding nasal airways. While it includes a patient monitoring system for usage compliance (Dentitrac®), this refers to monitoring the device's use, not diagnosing the patient's condition.

SaMD (Software as a Medical Device)

No

The device description explicitly states that the OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor are "simple hardware devices" and "intraoral devices." While it includes a patient monitoring system (Dentitrac ®), the core device is a physical oral appliance.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
• Device Function: The OASYS Oral/Nasal Airway System and OASYS Herbst with Dentitrac ® Patient Monitor is a physical, custom-fitted oral appliance. Its function is to mechanically reposition the jaw and dilate nasal passages to improve airflow during sleep. It also includes a monitoring system to track usage.
• Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. It is a physical device that interacts with the patient's anatomy.
• Intended Use: The intended use is to reduce snoring and mild to moderate obstructive sleep apnea and monitor patient usage. This is a therapeutic and monitoring function, not a diagnostic test performed on a biological sample.

Therefore, the device falls under the category of a medical device, specifically an oral appliance for treating sleep apnea, rather than an in vitro diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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.

Product codes

PLC

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

oral/nasal airway passage, pharyngeal space, nasal valve

Indicated Patient Age Range

adult population

Intended User / Care Setting

dentist, physician or licensed practitioner

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)

Non-Clinical Performance Data: Same as predicate. OASYS Oral/Nasal Airway System under K030440.
Testing of Dentitrac ® Patient Monitoring System, biocompatibility, electrical, performance and characterization was done in MAF 2557.
Material, physical properties and biocompatibility testing was done 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.
Biocompatibility testing per ISO 10993-1, ISO 10993-5, HET-CAM Tests for irritation and skin sensitization, and mutagenicity (Ames test) all passed.
Biocompatibility testing per ISO 10993-12 chemical analysis of eluted components passed.
Formal Risk Assessment of the device was performed in accordance with ISO 14971.
The device passed all internal performance testing standards.
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 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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K030440

Reference Device(s)

K083209, K150369, K170692, K974727, K002048

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.”

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)

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)

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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: [phone]

Email: [e-mail]

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 |

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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

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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 | 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

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6

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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

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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-

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| 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 |

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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 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

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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 ([e-mail]) or phone [phone] 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