(80 days)
No
The device description focuses on mechanical design and a compliance sensor, with no mention of AI or ML.
Yes
The device is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults, which falls under the definition of a therapeutic purpose.
No
The device is intended to treat snoring and sleep apnea by repositioning the mandible, and optionally measures patient compliance; it does not diagnose a condition.
No
The device description clearly states it is an "oral device" and consists of "maxillary and mandibular devices" which are physical components. It also mentions an optional "micro-recorder" which is a hardware component.
Based on the provided information, the ProSomnus® EVO Sleep and Snore Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The ProSomnus® EVO device is an oral appliance that is placed in the mouth to physically reposition the mandible and improve airflow. It does not analyze any biological samples like blood, urine, or tissue.
- The intended use is therapeutic. The device is intended to reduce snoring and mild to moderate obstructive sleep apnea, which is a treatment or management function, not a diagnostic one.
- The optional micro-recorder measures patient compliance. While this provides data, it's about the use of the device, not about diagnosing a condition by analyzing a biological sample.
The device description and intended use clearly indicate it's a physical medical device used for treatment and monitoring of device usage, not for performing diagnostic tests on biological specimens.
N/A
Intended Use / Indications for Use
The ProSomnus® EVO Sleep and Snore Device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Optionally, if the DentiTrac micro-recorder is completely embedded in the ProSomnus® EVO Sleep and Snore Device. the micro-recorder is intended to measure patient compliance therapy in combination with the DentiTrac System.
Product codes (comma separated list FDA assigned to the subject device)
LRK, LQZ, PLC
Device Description
The ProSomnus® EVO Sleep and Snore Device is an oral device, which improves the flow of air through the patient's pharyngeal space during sleep by repositioning the mandible. The ProSomnus® EVO Sleep and Snore Device and the ProSomnus® EVO Sleep and Snore Device with Patient Monitoring consists of maxillary and mandibular devices that when interfaced together reduce snoring and mild to moderate obstructive sleep apnea by holding the mandible forward during sleep, providing increased pharyngeal space. These separate upper and lower device arches are CAD/CAM designed with twin-mated posts and are digitally milled to be patient-specific according to physician prescription. Customizable ergonomic features are available to improve patient comfort. Prescribed advancements can be achieved by simply removing the current upper or lower device arch and inserting the next upper or lower device arch in the mandibular advancement series. The device does not have any adjustment mechanisms to modify or maintain the mandibular position such as pistons, screws, straps, or repositioning elastics. The device is supplied nonsterile.
A micro-recorder is completely embedded in the ProSomnus® EVO Sleep and Snore Device with Patient Monitoring. The micro-recorder is a compliance sensor, which logs the time the device is worn.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
pharyngeal space, mandible, mouth
Indicated Patient Age Range
adults
Intended User / Care Setting
For personal use at home or in sleep laboratories
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)
Product bench testing was performed to support the above indications for use as well as the claim of Substantial Equivalence.
| Performance Specification | Subject Device ProSomnus® EVO Sleep and Snore Device | Predicate Device ProSomnus MicrO2 OSA Device | Acceptance Criteria | Results (Pass/Fail) |
|---|---|---|---|---|
| Anterior-Posterior (AP) Shear Strength (lbf) | 235.4 | 239.8 | Must be greater than 200 lbf | Pass |
| Stroke (in) | 0.17 | 0.11 | Must be greater than 0.1 | Pass |
| Anterior-Posterior Directional Torque (lbf-in) | 235.4 lbf * 0.17 in = 40.0 lbf-in | 239.8 lbf * 0.11 in = 26.4 lbf-in | Must be equal or better than predicate device | Pass |
| Lateral Direction Shear Strength (lbf) | 71.5 | 94.2 | Must be greater than 50 lbf | Pass |
| Stroke (in) | 0.17 | 0.11 | Must be greater than 0.1 | Pass |
| Lateral Directional Torque (Ibf-in) | 71.5 lbf * 0.17 in = 12.2 lbf-in | 94.2 lbf * 0.11 in = 10.4 lbf-in | Must be equal or better than predicate device | Pass |
| Durability when elastic bands pull on hooks at peak force (mm & lbs.) | 135.55 mm stretch length with an average peak force of 5.06 lbs. With no visible damage to the device and its metal-free hooks. | 135.55 mm stretch length with an average peak force of 4.74 lbs. With no visible damage to the device and its metal-free hooks. | Must be equal or more durable then predicate device | Pass |
Non-Clinical Performance Testing:
Product biocompatibility testing and risk analysis were performed, and the following standards were utilized:
- ISO 10993-1: 2018 Biological Evaluation of medical devices Part 1: Evaluation and testing within a risk management process
- ISO 10993-2 Second edition 2006-07-15 Biological Evaluation of medical devices -Part 2: Animal welfare requirements
- ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
- ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization
- ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
- ISO 10993-12 Fourth edition 2012-07-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
- ISO 7405: 2018 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
- ISO 14971:2012 Medical Devices Application of Risk Management to Medical Devices
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 872.5570 Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea.
(a)
Identification. Intraoral devices for snoring and intraoral devices for snoring and obstructive sleep apnea are devices that are worn during sleep to reduce the incidence of snoring and to treat obstructive sleep apnea. The devices are designed to increase the patency of the airway and to decrease air turbulence and airway obstruction. The classification includes palatal lifting devices, tongue retaining devices, and mandibular repositioning devices.(b)
Classification. Class II (special controls). The special control for these devices is the FDA guidance document entitled “Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA.”
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Image /page/0/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, with the letters "FDA" in a blue box. To the right of the blue box is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
November 20, 2020
ProSomnus Sleep Technologies, Inc. Divya Mavalli Ouality and Regulatory Manager 5860 West Las Positas Blvd. Pleasanton, California 94588
Re: K202529
Trade/Device Name: ProSomnus EVO Sleep and Snore Device, ProSomnus EVO Sleep and Snore Device with Patient Monitoring 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: LRK, LQZ, PLC Dated: October 23, 2020 Received: October 26, 2020
Dear Divya Mavalli:
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.
1
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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-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 Srinivas "Nandu" Nandkumar, Ph.D. Director DHT1B: Division of Dental Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K202529
Device Name
ProSomnus® EVO Sleep and Snore Device ProSomnus® EVO Sleep and Snore Device with Patient Monitoring
Indications for Use (Describe)
The ProSomnus® EVO Sleep and Snore Device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Optionally, if the DentiTrac micro-recorder is completely embedded in the ProSomnus® EVO Sleep and Snore Device. the micro-recorder is intended to measure patient compliance therapy in combination with the DentiTrac System.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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Image /page/3/Picture/0 description: The image shows the logo for ProSomnus Sleep Technologies. The logo features a blue circular design on the left, followed by the company name "ProSomnus" in a larger, bolder blue font. Below "ProSomnus" is the text "SLEEP TECHNOLOGIES" in a smaller, lighter blue font. The logo is clean and professional, suggesting a focus on sleep-related technology.
K202529 510(K) SUMMARY
1. Manufacturer and Submitter
| Company Name: | ProSomnus® Sleep Technology, Inc |
|---|---|
| Company Address: | 5860 West Las Positas Blvd. |
| Suite 25 | |
| Pleasanton, CA 94588 | |
| Contact Person: | Divya Mavalli |
| Email: dmavalli@prosomnus.com | |
| Phone: 925.307.5337 | |
| Date Prepared: | October 23, 2020 |
2. Device Name and Classification
| Trade/Proprietary Name: | ProSomnus® EVO Sleep and Snore Device
ProSomnus® EVO Sleep and Snore Device with Patient
Monitoring |
|-------------------------|---------------------------------------------------------------------------------------------------------------|
| Common Name: | Mandibular Advancement Device |
| Classification Name: | Intraoral devices for snoring and intraoral devices for snoring
and obstructive sleep apnea. |
| Regulatory Class: | II |
| Regulatory Number: | 21 CFR 872.5570 |
| Product Code: | LRK (Device, Anti-snoring), LQZ (Device, Jaw Repositioning)
PLC (Sleep Appliances with Patient Monitoring) |
| Panel: | Dental |
| Predicate Device | |
| Device Name: | ProSomnus® MicrO2 Obstructive Sleep Apnea Device |
| 510(k) Number: | K133683 |
| Reference Device | |
| Device Name: | ProSomnus® MicrO2 Obstructive Sleep Apnea Device with
Micro-Recorder |
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Image /page/4/Picture/0 description: The image shows the logo for ProSomnus Sleep Technologies. The logo consists of a blue circular design on the left, with the text "ProSomnus" in blue to the right of the circle. Below "ProSomnus" is the text "Sleep Technologies" in a smaller font, also in blue. The logo is clean and modern, with a focus on the company's name and its area of expertise.
510(k) Number: K161624
4. Device Description
The ProSomnus® EVO Sleep and Snore Device is an oral device, which improves the flow of air through the patient's pharyngeal space during sleep by repositioning the mandible. The ProSomnus® EVO Sleep and Snore Device and the ProSomnus® EVO Sleep and Snore Device with Patient Monitoring consists of maxillary and mandibular devices that when interfaced together reduce snoring and mild to moderate obstructive sleep apnea by holding the mandible forward during sleep, providing increased pharyngeal space. These separate upper and lower device arches are CAD/CAM designed with twin-mated posts and are digitally milled to be patient-specific according to physician prescription. Customizable ergonomic features are available to improve patient comfort. Prescribed advancements can be achieved by simply removing the current upper or lower device arch and inserting the next upper or lower device arch in the mandibular advancement series. The device does not have any adjustment mechanisms to modify or maintain the mandibular position such as pistons, screws, straps, or repositioning elastics. The device is supplied nonsterile.
A micro-recorder is completely embedded in the ProSomnus® EVO Sleep and Snore Device with Patient Monitoring. The micro-recorder is a compliance sensor, which logs the time the device is worn.
5. Intended Use/Indication for Use
The ProSomnus® EVO Sleep and Snore Device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
Optionally, if the DentiTrac micro-recorder is completely embedded in the ProSomnus® EVO Sleep and Snore Device, the micro-recorder is intended to measure patient compliance to oral device/appliance therapy in combination with the DentiTrac System.
6. Technological Characteristics
Both the predicate and subject devices use upper and lower device arches to reposition the mandible.
The below table provides a comparison of technological characteristics to models of the predicate and reference devices.
| Characteristics | ProSomnus®
EVO Sleep and
Snore Device
(Subject
Device) | ProSomnus®
EVO Sleep and
Snore Device
with Patient
Monitoring | ProSomnus
MicrO2
Obstructive
Sleep Apnea
Device | ProSomnus
MicrO2
Obstructive
Sleep Apnea |
|--------------------------------------------------|--------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | (Subject Device
with Micro-Recorder) | (Predicate
Device) | Device with
Micro-Recorder
(Reference
Device) |
| Body Material | Medical Grade
Polymer | Medical Grade
Polymer | Polymethyl
methacrylate
(PMMA) | Polymethyl
methacrylate
(PMMA) |
| Usability | Single-patient,
multiple use | Single-patient,
multiple use | Single-patient,
multiple use | Single-patient,
multiple use |
| Splint | Comprised of
two or more
customizable
splints (upper
and lower) | Comprised of
two or more
customizable
splints (upper
and lower) | Comprised of
two or more
customizable
splints (upper
and lower) | Comprised of
two or more
customizable
splints (upper
and lower) |
| Technical Method | Advances the
patient's
mandible in a
forward
position to
increase
airway space | Advances the
patient's
mandible in a
forward
position to
increase airway
space and
additionally
monitors the
patient
compliance to
oral appliance
therapy | Advances the
patient's
mandible in a
forward
position to
increase airway
space | Advances the
patient's
mandible in a
forward
position to
increase airway
space and
additionally
monitors the
patient
compliance to
oral appliance
therapy |
| Ergonomic
Features - Splint
Design | The scalloped
and contoured
edge allows for
patient
comfort | The scalloped
and contoured
edge allows for
patient
comfort | Straight-line
plane at the
edge of the
splint around
the front of the
teeth | Straight-line
plane at the
edge of the
splint around
the front of the
teeth |
| Ergonomic
Features - Post
Style | The dual radius
posts to allow
for patient
comfort | The dual radius
posts to allow
for patient
comfort | The post angle
to the splint is a
standard 90
degrees | The post angle
to the splint is a
standard 90
degrees |
| Ergonomic
Features -
Anterior Airway | Anterior
airway opening | Anterior airway
opening | No anterior
airway opening | No anterior
airway opening |
| Ergonomic
Features -
Anterior
Discluder | The prescribing
provider can
request the
addition of a
vertical
element | The prescribing
provider can
request the
addition of a
vertical
element | No discluder
option is
provided | No discluder
option is
provided |
| Ergonomic
Features -
Lingual Coverage | Prescriber may
request
posterior or
full lingual
coverage | Prescriber may
request
posterior or full
lingual
coverage | No posterior or
full lingual
coverage
provided | No posterior or
full lingual
coverage
provided |
| Ergonomic
Features - Plastic
Hooks | Plastic hooks
incorporated
into the design | Plastic hooks
incorporated
into the design | Uses stainless
steel balls or
hooks to secure
rubber bands in
those
prescriptions
where they are
indicated | Uses stainless
steel balls or
hooks to secure
rubber bands in
those
prescriptions
where they are
indicated |
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Image /page/5/Picture/0 description: The image shows the logo for ProSomnus Sleep Technologies. The logo consists of a blue circular design on the left, followed by the text "ProSomnus" in a larger, bolder blue font. Below "ProSomnus" is the text "SLEEP TECHNOLOGIES" in a smaller, lighter blue font. The logo is clean and modern, suggesting a focus on technology and sleep solutions.
6
Image /page/6/Picture/0 description: The image shows the logo for ProSomnus Sleep Technologies. The logo consists of a blue circular design on the left, followed by the text "ProSomnus" in a larger, bolder blue font. Below "ProSomnus" is the text "SLEEP TECHNOLOGIES" in a smaller, lighter blue font. The overall design is clean and professional, conveying a sense of innovation and expertise in the field of sleep technology.
7. Performance Data
Product bench testing was performed to support the above indications for use as well as the claim of Substantial Equivalence.
| Performance
Specification | Subject Device
ProSomnus®
EVO Sleep and
Snore Device | Predicate Device
ProSomnus
MicrO2 OSA
Device | Acceptance
Criteria | Results
(Pass/Fail) |
|----------------------------------------------------------|---------------------------------------------------------------|---------------------------------------------------------------|--------------------------------------------------------|------------------------|
| Anterior-
Posterior (AP)
Shear Strength
(lbf) | 235.4 | 239.8 | Must be greater
than 200 lbf | Pass |
| Stroke (in) | 0.17 | 0.11 | Must be greater
than 0.1 | Pass |
| Anterior-
Posterior
Directional
Torque (lbf-in) | $235.4 \text{ lbf } * 0.17 \text{ in } = 40.0 \text{ lbf-in}$ | $239.8 \text{ lbf } * 0.11 \text{ in } = 26.4 \text{ lbf-in}$ | Must be equal
or better than
predicate
device | Pass |
| Lateral
Direction Shear
Strength (lbf) | 71.5 | 94.2 | Must be greater
than 50 lbf | Pass |
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Image /page/7/Picture/0 description: The image shows the logo for ProSomnus Sleep Technologies. The logo consists of a blue circular design on the left, followed by the company name "ProSomnus" in a larger, bolder blue font. Below "ProSomnus", the words "SLEEP TECHNOLOGIES" are written in a smaller, lighter blue font. The overall design is clean and professional, conveying a sense of innovation and expertise in the field of sleep technology.
| Stroke (in) | 0.17 | 0.11 | Must be greater
than 0.1 | Pass |
|-----------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------|------|
| Lateral
Directional
Torque (Ibf-in) | $71.5 \text{ lbf } * 0.17 \text{ in } = 12.2 \text{ lbf-in}$ | $94.2 \text{ lbf } * 0.11 \text{ in } = 10.4 \text{ lbf-in}$ | Must be equal
or better than
predicate
device | Pass |
| Durability when
elastic bands
pull on hooks at
peak force (mm
& lbs.) | 135.55 mm
stretch length
with an average
peak force of
5.06 lbs. With
no visible
damage to the
device and its
metal-free
hooks. | 135.55 mm stretch
length with an
average peak force
of 4.74 lbs. With
no visible damage
to the device and
its metal-free
hooks. | Must be equal
or more durable
then predicate
device | Pass |
Non-Clinical Performance Testing
Product biocompatibility testing and risk analysis were performed, and the following standards were utilized:
-
ISO 10993-1: 2018 Biological Evaluation of medical devices Part 1: Evaluation and testing within a risk management process
- A ISO 10993-2 Second edition 2006-07-15 Biological Evaluation of medical devices -Part 2: Animal welfare requirements
-
ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity
-
ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices -Part 10: Tests for irritation and skin sensitization
-
ISO 10993-11 Third edition 2017-09 Biological evaluation of medical devices Part 11: Tests for systemic toxicity
-
ISO 10993-12 Fourth edition 2012-07-01 Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
-
ISO 7405: 2018 Dentistry Evaluation of biocompatibility of medical devices used in dentistry
-
ISO 14971:2012 Medical Devices Application of Risk Management to Medical Devices
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Image /page/8/Picture/0 description: The image shows the logo for ProSomnus Sleep Technologies. The logo consists of a blue circular design on the left and the company name on the right. The circular design is made up of three curved lines that form a circle. The text "ProSomnus" is in a larger, bolder font, while the text "Sleep Technologies" is in a smaller font below it.
8. Substantial Equivalence
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Image /page/9/Picture/0 description: The image shows the logo for ProSomnus Sleep Technologies. The logo consists of a blue circular design on the left, followed by the text "ProSomnus" in a larger, bolder blue font. Below "ProSomnus" is the text "SLEEP TECHNOLOGIES" in a smaller, lighter blue font. The logo is clean and modern, suggesting a focus on technology and sleep solutions.
| Substantially
Equivalent
Connection | ProSomnus®
EVO Sleep and
Snore Device | ProSomnus®
EVO Sleep and
Snore Device
with Patient
Monitoring | ProSomnus
Micro2
Obstructive
Sleep Apnea
Device | ProSomnus
Micro2
Obstructive
Sleep Apnea
Device with
Micro-Recorder |
|-------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K202529 | K202529 | K133683 | K161624 |
| Manufacturer | ProSomnus
Sleep
Technologies | ProSomnus
Sleep
Technologies | ProSomnus
Sleep
Technologies | ProSomnus
Sleep
Technologies |
| Relation | Subject Device | Subject Device
with Patient
Monitoring | Predicate
Device | Predicate
Device with
Micro-Recorder |
| Device | Device, Anti-
Snoring
Device, Jaw
Repositioning | Sleep
Appliances with
Patient
Monitoring | Device, Anti-
Snoring | Sleep
Appliances with
Patient
Monitoring |
| Product Code | LRK
LQZ | PLC | LRK | PLC |
| Indications for
Use | The device is
intended to
reduce night
time snoring
and mild to
moderate
obstructive
sleep apnea
(OSA) in adults. | The device is
intended to
reduce night
time snoring
and mild to
moderate
obstructive
sleep apnea
(OSA) in adults. | The device is
intended to
reduce night
time snoring
and mild to
moderate
obstructive
sleep apnea
(OSA) in adults. | The device is
intended to
reduce night
time snoring
and mild to
moderate
obstructive
sleep apnea
(OSA) in adults. |
| Usability | Single patient,
multiple use | Single patient,
multiple use | Single patient,
multiple use | Single patient,
multiple use |
| Target
Population | Adult patients | Adult patients | Adult patients | Adult patients |
| Where Used | For personal
use at home or
in sleep
laboratories | For personal
use at home or
in sleep
laboratories | For personal
use at home or
in sleep
laboratories | For personal
use at home or
in sleep
laboratories |
| Prescription | Yes | Yes | Yes | Yes |
| Principle of
Operation | Mandibular
Repositioners | Mandibular
Repositioners | Mandibular
Repositioners | Mandibular
Repositioners |
| Non-Sterile | Yes | Yes | Yes | Yes |
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Image /page/10/Picture/0 description: The image contains the logo for ProSomnus Sleep Technologies. The logo features a blue circular graphic on the left, followed by the text "ProSomnus" in a larger, bolder blue font. Below "ProSomnus", the words "SLEEP TECHNOLOGIES" are written in a smaller, lighter blue font. The overall design is clean and professional, suggesting a focus on sleep-related technology and solutions.
| Design | Allows space
for tongue and
mandibular
movement of
mouth opening
and closing
during wear | Allows space
for tongue and
mandibular
movement of
mouth opening
and closing
during wear | Allows space
for tongue and
mandibular
movement of
mouth opening
and closing
during wear | Allows space
for tongue and
mandibular
movement of
mouth opening
and closing
during wear |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Adjustment
Mechanism | No adjustment
mechanisms
such as pistons,
screws, straps,
or repositioning
elastics are
used to modify
or maintain the
mandibular
position | No adjustment
mechanisms
such as pistons,
screws, straps,
or repositioning
elastics are
used to modify
or maintain the
mandibular
position | No adjustment
mechanisms
such as pistons,
screws, straps,
or repositioning
elastics are
used to modify
or maintain the
mandibular
position | No adjustment
mechanisms
such as pistons,
screws, straps,
or repositioning
elastics are
used to modify
or maintain the
mandibular
position |
9. Conclusion
Based on the comparison of technology and the indications for use, we find that ProSomnus® EVO Sleep and Snore Device is substantially equivalent to ProSomnus® MicrO2 Obstructive Sleep Apnea Device.