(99 days)
No
The description focuses on mechanical design, CAD/CAM manufacturing, and material properties. There is no mention of AI/ML algorithms for diagnosis, treatment planning, or device function. The DentiTrac component measures compliance, which is data collection, not AI/ML processing.
Yes
The device is intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults, which is a therapeutic function.
No
The device is intended to treat snoring and mild to moderate obstructive sleep apnea by holding the mandible forward during sleep. While it may include a micro-recorder to measure compliance, its primary function is therapeutic, not diagnostic.
No
The device description clearly details physical components (maxillary and mandibular arches, herbst advancer, medical grade polymer, stainless steel herbst arms, biocompatible adhesive) and bench testing related to these physical properties and materials. While CAD/CAM is mentioned for manufacturing, the device itself is a physical intraoral device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to reduce snoring and mild to moderate obstructive sleep apnea by physically repositioning the mandible. This is a therapeutic intervention, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The device is a physical appliance worn in the mouth. It does not involve the analysis of biological samples for diagnostic purposes.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing blood, urine, tissue, or other biological specimens to diagnose a condition.
- Performance Studies: The performance studies described are bench testing related to the physical properties and durability of the device, as well as biocompatibility. These are typical for medical devices, but not specifically for IVDs which would focus on analytical and clinical performance related to diagnostic accuracy.
The optional DentiTrac micro-recorder measures patient compliance, which is also not a diagnostic function.
Therefore, the ProSomnus® EVO™ [PH] Sleep and Snore Device is a therapeutic medical device, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The ProSomnus® EVO™ [PH] 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™ [PH] Sleep and Snore Device, the micro-recorder is intended to measure patient compliance therapy in combination with the DentiTrac System.
Product codes
LRK, LQZ, PLC
Device Description
The ProSomnus® EVO™ [PH] Sleep and Snore Device consists of maxillary and mandibular device arches 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 connected with the herbst advancer. The device is designed and manufactured using Computer Aided Design/Computer Aided Manufacturing (CAD/CAM) dental technologies, which allows the delivery of a well-fitting, aesthetic, and durable intraoral device for the patient. These devices are digitally milled to be patient-specific according to physician prescription. Prescribed advancements can be achieved by simply rotating the telescopic advancer hex nut or pinhole mechanism in an upward direction to increase the forward positioning of the mandible by smaller increments and according to the physician schedule. Advancements up to 12 mm past the initial bite position may be achieved with additional arches as prescribed by the physician The patient will be able to move the lower jaw forward, side-to-side, and open and close the mouth while wearing the device. The proposed device materials include medical grade polymer, stainless steel herbst arms, and biocompatible adhesive. The device is supplied nonsterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Oral Cavity
Indicated Patient Age Range
Adults
Intended User / Care Setting
For personal nighttime 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)
Bench testing was conducted to support the indications for use and the claim of Substantial Equivalence. This included:
- Metal-Free Button Hook Strength Testing
- Shear Testing
- Loctite 3922 Cure Time Test
- Polymer Adhesive Pull Test
Additional tests included:
- Packaging distribution testing following ASTM D4169 procedure, Distribution Cycle 13 at Assurance Level II.
- Biocompatibility testing per ISO 10993-1: Cytotoxicity, Sensitization, and Irritation.
- Physical Properties Testing: Modulus of elasticity (tensile test), Tensile strength at yield, Elongation at break (tensile test), Flexural strength, Modulus of elasticity (flexural test), Compression strength, Compression modulus, Notched impact strength (Izod), Rockwell hardness, Deflection temperature, Moisture absorption.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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October 6, 2022
ProSomnus Sleep Technologies Divya Mavalli Director of Regulatory & Quality 5860 W Las Positas Blvd. Suite 25 Pleasanton, California 94588
Re: K221889
Trade/Device Name: ProSomnus EVO [PH] Sleep and Snore Device, ProSomnus EVO [PH] Sleep and Snore Device with Patient Monitoring Regulation Number: 21 CFR 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: August 26, 2022 Received: August 29, 2022
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 Michael E. Adjodha, M. ChE. Assistant Director DHT1B: Division of Dental and ENT Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K221889
Device Name
ProSomnus® EVO™ [PH] Sleep and Snore Device ProSomnus® EVO™ [PH] Sleep and Snore Device with Patient Monitoring
Indications for Use (Describe)
The ProSomnus® EVO™ [PH] 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™ [PH] 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 consists of a blue circular graphic 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, suggesting a focus on sleep-related technology and solutions.
510(K) SUMMARY - K221889
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: August 30, 2022
2. Device Name and Classification
| Trade/Proprietary Name: | ProSomnus® EVO™ [PH] Sleep and Snore Device |
|---|---|
| ProSomnus® EVO™ [PH] Sleep and Snore Device with Patient | |
| Monitoring | |
| Common Name: | Mandibular Advancement Device |
| Classification Name: | |
| and | Intraoral devices for snoring and intraoral devices for snoring |
| obstructive sleep apnea. | |
| Regulatory Class: | II (special controls) |
| Regulatory Number: | 21 CFR 872.5570 |
| Product Code: | LRK (Device, Anti-snoring), LQZ (Device, Jaw Repositioning), and |
| PLC (Sleep Appliances with Patient Monitoring) | |
| Panel: | Dental |
3. Predicate and Reference Devices
| Device Names: | Kava and Kava with Herbst
Respire Pink Series with DentiTrac |
|-----------------|-----------------------------------------------------------------|
| 510(k) Numbers: | K182661
K170692 |
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Image /page/4/Picture/0 description: The image contains the logo for ProSomnus Sleep Technologies. The logo consists of a blue circular graphic 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, suggesting a focus on technology and sleep-related products or services.
4. Device Description
The ProSomnus® EVO™ [PH] Sleep and Snore Device consists of maxillary and mandibular device arches 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 connected with the herbst advancer. The device is designed and manufactured using Computer Aided Design/Computer Aided Manufacturing (CAD/CAM) dental technologies, which allows the delivery of a well-fitting, aesthetic, and durable intraoral device for the patient. These devices are digitally milled to be patient-specific according to physician prescription. Prescribed advancements can be achieved by simply rotating the telescopic advancer hex nut or pinhole mechanism in an upward direction to increase the forward positioning of the mandible by smaller increments and according to the physician schedule. Advancements up to 12 mm past the initial bite position may be achieved with additional arches as prescribed by the physician The patient will be able to move the lower jaw forward, side-to-side, and open and close the mouth while wearing the device. The proposed device materials include medical grade polymer, stainless steel herbst arms, and biocompatible adhesive. The device is supplied nonsterile.
5. Intended Use/Indication for Use
The ProSomnus® EVO™ [PH] 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™ [PH] 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. Non-Clinical Performance Data
Product performance testing was performed to support the above indications for use as well as the claim of Substantial Equivalence.
Bench testing of the ProSomnus® EVO™ [PH] Sleep and Snore Device was conducted in accordance with ProSomnus Sleep Technologies' risk analysis and all applicable FDA guidance documents and international standards, including:
ISO 10993-1, Biological evaluation of medical device – Part 1 Evaluation and testing within a risk management process
ISO 10993-5 - Biological evaluation of medical device - Part 5 Tests for in vitro cytoxicity
ISO 10993-10 – Biological evaluation of medical device – Part 10 Tests irritation and skin sensitization
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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 and the company name on the right. The circular design is made up of curved lines that create a sense of movement. The text "ProSomnus" is in a larger, bolder font, while "Sleep Technologies" is in a smaller font below it.
ISO 10993-11 – Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
ISO 10993-12 – Biological evaluation of medical devices - Part 12: Sample preparation and reference materials
ISO 10993- 23 Biological evaluation of medical devices – Part 23: Tests for irritation
ISO 14971 Medical devices - Application of risk management to medical devices
Guidance for industry and FDA Staff: Class II Special Controls Intraoral Devices for Snoring and/or Obstructive Sleep Apnea
Bench testing was conducted on finished devices, unless otherwise specified. The following testing was completed:
- . Metal-Free Button Hook Strength Testing
- . Shear Testing
- . Loctite 3922 Cure Time Test
- . Polymer Adhesive Pull Test
Packaging
Packaging distribution testing was performed following ASTM D4169 procedure, following Distribution Cycle 13 at Assurance Level II.
Biocompatibility
Biocompatibility testing, per ISO 10993-1 was performed, which included the following tests: Cytotoxicity, Sensitization, and Irritation
Physical Properties Testing
| Modulus of elasticity (tensile test) | ASTM D 638 |
|---|---|
| Tensile strength at yield | ASTM D 638 |
| Elongation at break (tensile test) | ASTM D 638 |
| Flexural strength | ASTM D 790 |
| Modulus of elasticity (flexural test) | ASTM D 790 |
| Compression strength | ASTM D 695 |
| Compression modulus | ASTM D 790 |
| Notched impact strength (Izod) | ASTM D 256 |
| Rockwell hardness | ASTM D 785 |
| Deflection temperature | ASTM D 648 |
| Moisture absorption | ASTM D 570 |
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Image /page/6/Picture/0 description: The image shows the logo for ProSomnus Sleep Technologies. The logo consists of a blue circular graphic on the left and the company name on the right. The words "SLEEP TECHNOLOGIES" are written in a smaller font size below the company name.
7. Comparison of Technological Characteristics
The ProSomnus® EVO™ [PH] Sleep and Snore Device has the same intended use as the predicate and reference devices. The materials, design, and performance characteristics are similar to the predicate and reference devices.
The below table provides a comparison of technological characteristics to predicate and reference devices.
| Characteristics | ProSomnus®
EVOTM [PH] Sleep
and Snore Device
(Subject Device) | Kava and Kava with
Herbst
(Predicate Device) | Respire Pink Series
with DentiTrac
(Reference Device) |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Body Material | Medical Grade
Polymer | Polymethyl
methacrylate
(PMMA) | Polymethyl
methacrylate
(PMMA) |
| Usability | Single-patient,
multiple use | Single-patient,
multiple use | Single-patient,
multiple use |
| Splint | Comprised of two
customizable
splints (upper and
lower) | Comprised of two
splints (upper and
lower) | Comprised of two
splints (upper and
lower) |
| Splints Jointure | Herbst style
adjustable medical
grade stainless
steel advancement
mechanism | Adjustable metal
screws or lugs | Surgical grade
stainless steel
herbst hardware |
| Technical Method | Advances the
patient's mandible
in a forward
position to increase
airway space.
Optionally,
monitors patient's
compliance to the
oral appliance
therapy. | Advances the
patient's mandible
in a forward position
to maintain an open
airway. | Advances the
patient's mandible
in a forward
position to
maintain an open
airway. Optionally,
monitors the
patient compliance
to oral appliance
therapy. |
| Embed Micro-
Recorder | Optional | No | Optional |
-
- Substantial Equivalence
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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 and the words "ProSomnus" and "SLEEP TECHNOLOGIES" on the right. The word "ProSomnus" is in a larger font than the words "SLEEP TECHNOLOGIES". The logo is simple and modern.
| Substantially | ProSomnus® EVO™
[PH] Sleep and Snore
Device (Subject Device) | Kava and Kava with
Herbst
(Predicate Device) | Respire Pink Series
with DentiTrac
(Reference Device) | Indications for
Use | The ProSomnus®
EVOTM [PH] 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® EVOTM
[PH] Sleep and Snore
Device, the micro-
recorder is intended to
measure patient
compliance to oral
device/appliance
therapy in combination
with the DentiTrac
System. | The Kava and Kava
with Herbst device(s)
are intended to reduce
nighttime snoring and
mild to moderate
obstructive sleep
apnea (OSA) in adults. | The Respire Pink
Series intraoral
appliances are
intended to treat
snoring and mild to
moderate
Obstructive Sleep
Apnea (OSA) in
adult patients 18
years of age or
older.
Optionally, the
DentiTrac micro-
recorder may be
incorporated into a
Respire Pink Series
device. The micro-
recorder is
intended to
measure patient
compliance to oral
appliance therapy
in combination
with the DentiTrac
system. |
|--------------------------|--------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------|-----------------------------------------------------------------------------|---------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Equivalent
Connection | | | | Usability | Single patient, multiple
use | Single patient, multiple
use | Single patient,
multiple use |
| 510(k) Number | K221889 | K182661 | K170692 | Target
Population | Adult patients | Adult patients | Adult patients |
| Manufacturer | ProSomnus Sleep
Technologies | Sketchpad Innovations
LLC | Respire Medical
Holding | Where Used | For personal nighttime
use at home or in sleep
laboratories | For personal use | For personal use |
| Relation | Subject Device | Predicate Device | Reference Device
with Patient
Monitoring | Biocompatible | Yes | Yes | Yes |
| Device | • Device, Anti-Snoring
• Device, Jaw
Repositioning
• Sleep Appliances
with Patient
Monitoring | • Device, Anti-
Snoring
• Device, Jaw
Repositioning | Sleep Appliances
with Patient
Monitoring | Anatomical Site | Oral Cavity | Oral Cavity | Oral Cavity |
| Product Code | LRK
LQZ
PLC | LRK
LQZ | PLC | Prescription | Yes | Yes | Yes |
| Device
Classification | Class II | Class II | Class II | Principle of
Operation | Mandibular
Repositioners | Mandibular
Repositioners | Mandibular
Repositioners |
| Regulation
Number | 21 CFR 872.5570 | 21 CFR 872.5570 | 21 CFR 872.5570 | Non-Sterile | Yes | Yes | Yes |
| Design | Allows mandibular
movement and to open
and close mouth during
wear | Allows mandibular
movement and to open
and close mouth
during wear | Allows mandibular
movement and to
open and close
mouth during wear | | | | |
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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 words "ProSomnus" and "SLEEP TECHNOLOGIES" on the right. The word "ProSomnus" is in a larger font than "SLEEP TECHNOLOGIES". The color of the text is also blue.
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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 and the company name on the right. The words "ProSomnus" are in a larger font than the words "Sleep Technologies", which are stacked below the first word.
| Adjustment
Mechanism | Herbst style
advancement | Herbst style
advancement | Herbst style
advancement |
|-------------------------|-----------------------------|-----------------------------|-----------------------------|
| Clean | Daily | Daily | Daily |
9. Conclusion
The ProSomnus® EVO™ [PH] Sleep and Snore Device is substantially equivalent to the predicate device with respect to safety and effectiveness.