(99 days)
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.
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.
The provided text describes a 510(k) premarket notification for the ProSomnus® EVO™ [PH] Sleep and Snore Device. This device is an intraoral appliance intended to reduce nighttime snoring and mild to moderate obstructive sleep apnea (OSA) in adults. An optional micro-recorder embedded in the device measures patient compliance.
The document does not describe acceptance criteria as typically found in a clinical study report (e.g., a specific sensitivity or specificity threshold). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices through bench testing and a comparison of technological characteristics.
Here's a breakdown of the information that can be extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for this 510(k) submission are not expressed as specific performance metrics (like sensitivity, specificity, or adverse event rates) against predetermined thresholds. Instead, the "acceptance criteria" are implied by the requirements to demonstrate substantial equivalence to predicate devices and adherence to relevant standards and guidance documents. The reported device performance is described through various bench tests and biocompatibility assessments, all of which "support the above indications for use as well as the claim of Substantial Equivalence."
The document states: "Product performance testing was performed to support the above indications for use as well as the claim of Substantial Equivalence." This indicates that the device met the requirements for these tests.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Material Properties: | All tests met requirements, implicitly demonstrating equivalence or suitability for intended use. |
| - Metal-Free Button Hook Strength | Tested |
| - Shear Testing | Tested |
| - Loctite 3922 Cure Time Test | Tested |
| - Polymer Adhesive Pull Test | Tested |
| - Modulus of elasticity (tensile) | Tested |
| - Tensile strength at yield | Tested |
| - Elongation at break | Tested |
| - Flexural strength | Tested |
| - Modulus of elasticity (flexural) | Tested |
| - Compression strength | Tested |
| - Compression modulus | Tested |
| - Notched impact strength (Izod) | Tested |
| - Rockwell hardness | Tested |
| - Deflection temperature | Tested |
| - Moisture absorption | Tested |
| Biocompatibility (ISO 10993-1, -5, -10, -11, -12, -23): | All tests met requirements, implicitly demonstrating biocompatibility. |
| - Cytotoxicity | Tested |
| - Sensitization | Tested |
| - Irritation | Tested |
| Packaging (ASTM D4169, Distribution Cycle 13, Assurance Level II): | Tested |
2. Sample Size Used for the Test Set and Data Provenance
The document explicitly states: "Bench testing was conducted on finished devices, unless otherwise specified." It does not provide specific sample sizes (N) for each individual bench test.
Regarding data provenance for a test set (implying patient data), this submission primarily relies on non-clinical performance data (bench testing) and comparison to predicate devices, rather than a clinical study with a test set of patient data. Therefore, information on country of origin or retrospective/prospective nature of a clinical test set is not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. Since the submission relies on bench testing and comparison to predicate devices, it does not involve the establishment of ground truth by human experts in the context of a diagnostic or clinical performance study. The "ground truth" for the engineering and biocompatibility tests would be established by validated testing methods and industry standards.
4. Adjudication Method for the Test Set
This is not applicable as there is no mention of a human-reviewed test set or a clinical study that would require an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted or reported in this document. The device is a physical intraoral appliance, not an AI or diagnostic imaging device that would typically involve MRMC studies for comparative effectiveness with human readers.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
This is not applicable. The device is a physical medical device, not an algorithm or AI system. The "performance" refers to its physical and biological characteristics, as well as its mechanical function, as demonstrated through bench testing.
7. Type of Ground Truth Used
The "ground truth" for this submission is based on:
- Established engineering and materials standards (e.g., ASTM, ISO standards) for physical properties testing.
- Established biocompatibility guidelines (ISO 10993 series).
- The performance and established safety/effectiveness profiles of the predicate and reference devices (K182661 and K170692), which the subject device aims to be substantially equivalent to.
8. Sample Size for the Training Set
This is not applicable. The device is a physical appliance and does not involve AI/machine learning models that require training sets in the computational sense. The design and manufacturing are CAD/CAM based, but this refers to engineering design and fabrication, not AI model training.
9. How the Ground Truth for the Training Set Was Established
This is not applicable for the reasons stated in point 8.
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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, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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.
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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/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
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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 25Pleasanton, 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 PatientMonitoring | |
| Common Name: | Mandibular Advancement Device |
| Classification Name:and | Intraoral devices for snoring and intraoral devices for snoringobstructive sleep apnea. |
| Regulatory Class: | II (special controls) |
| Regulatory Number: | 21 CFR 872.5570 |
| Product Code: | LRK (Device, Anti-snoring), LQZ (Device, Jaw Repositioning), andPLC (Sleep Appliances with Patient Monitoring) |
| Panel: | Dental |
3. Predicate and Reference Devices
| Device Names: | Kava and Kava with HerbstRespire Pink Series with DentiTrac |
|---|---|
| 510(k) Numbers: | K182661K170692 |
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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] Sleepand Snore Device(Subject Device) | Kava and Kava withHerbst(Predicate Device) | Respire Pink Serieswith DentiTrac(Reference Device) |
|---|---|---|---|
| Body Material | Medical GradePolymer | Polymethylmethacrylate(PMMA) | Polymethylmethacrylate(PMMA) |
| Usability | Single-patient,multiple use | Single-patient,multiple use | Single-patient,multiple use |
| Splint | Comprised of twocustomizablesplints (upper andlower) | Comprised of twosplints (upper andlower) | Comprised of twosplints (upper andlower) |
| Splints Jointure | Herbst styleadjustable medicalgrade stainlesssteel advancementmechanism | Adjustable metalscrews or lugs | Surgical gradestainless steelherbst hardware |
| Technical Method | Advances thepatient's mandiblein a forwardposition to increaseairway space.Optionally,monitors patient'scompliance to theoral appliancetherapy. | Advances thepatient's mandiblein a forward positionto maintain an openairway. | Advances thepatient's mandiblein a forwardposition tomaintain an openairway. Optionally,monitors thepatient complianceto oral appliancetherapy. |
| 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 SnoreDevice (Subject Device) | Kava and Kava withHerbst(Predicate Device) | Respire Pink Serieswith DentiTrac(Reference Device) | Indications forUse | The ProSomnus®EVOTM [PH] Sleep andSnore Device isintended to reducenight time snoring andmild to moderateobstructive sleep apnea(OSA) in adults.Optionally, if theDentiTrac micro-recorder is completelyembedded in theProSomnus® EVOTM[PH] Sleep and SnoreDevice, the micro-recorder is intended tomeasure patientcompliance to oraldevice/appliancetherapy in combinationwith the DentiTracSystem. | The Kava and Kavawith Herbst device(s)are intended to reducenighttime snoring andmild to moderateobstructive sleepapnea (OSA) in adults. | The Respire PinkSeries intraoralappliances areintended to treatsnoring and mild tomoderateObstructive SleepApnea (OSA) inadult patients 18years of age orolder.Optionally, theDentiTrac micro-recorder may beincorporated into aRespire Pink Seriesdevice. The micro-recorder isintended tomeasure patientcompliance to oralappliance therapyin combinationwith the DentiTracsystem. |
|---|---|---|---|---|---|---|---|
| EquivalentConnection | Usability | Single patient, multipleuse | Single patient, multipleuse | Single patient,multiple use | |||
| 510(k) Number | K221889 | K182661 | K170692 | TargetPopulation | Adult patients | Adult patients | Adult patients |
| Manufacturer | ProSomnus SleepTechnologies | Sketchpad InnovationsLLC | Respire MedicalHolding | Where Used | For personal nighttimeuse at home or in sleeplaboratories | For personal use | For personal use |
| Relation | Subject Device | Predicate Device | Reference Devicewith PatientMonitoring | Biocompatible | Yes | Yes | Yes |
| Device | • Device, Anti-Snoring• Device, JawRepositioning• Sleep Applianceswith PatientMonitoring | • Device, Anti-Snoring• Device, JawRepositioning | Sleep Applianceswith PatientMonitoring | Anatomical Site | Oral Cavity | Oral Cavity | Oral Cavity |
| Product Code | LRKLQZPLC | LRKLQZ | PLC | Prescription | Yes | Yes | Yes |
| DeviceClassification | Class II | Class II | Class II | Principle ofOperation | MandibularRepositioners | MandibularRepositioners | MandibularRepositioners |
| RegulationNumber | 21 CFR 872.5570 | 21 CFR 872.5570 | 21 CFR 872.5570 | Non-Sterile | Yes | Yes | Yes |
| Design | Allows mandibularmovement and to openand close mouth duringwear | Allows mandibularmovement and to openand close mouthduring wear | Allows mandibularmovement and toopen and closemouth 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.
| AdjustmentMechanism | Herbst styleadvancement | Herbst styleadvancement | Herbst styleadvancement |
|---|---|---|---|
| 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.
§ 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.”