(147 days)
No
The device description and performance studies focus on the mechanical design, materials, and compliance tracking via a micro-recorder. There is no mention of AI or ML being used for diagnosis, treatment planning, or device operation.
Yes
The device is intended to reduce night time snoring and mild to moderate obstructive sleep apnea, which are medical conditions, thereby providing a therapeutic effect.
No
The primary intended use of the device is to reduce night time snoring and mild to moderate obstructive sleep apnea. While an optional micro-recorder measures patient compliance to therapy, it does not diagnose a medical condition.
No
The device description clearly states it consists of physical maxillary and mandibular devices that are CAD/CAM generated and manufactured. While it includes an optional embedded micro-recorder and associated software system, the core device is a physical oral appliance.
Based on the provided information, the MICRODENTAL, Inc. MicrO2 device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- MicrO2 Function: The MicrO2 device is an oral appliance designed to physically reposition the mandible during sleep. Its function is mechanical and aims to improve airflow, not to analyze biological samples.
- DentiTrac® Micro-recorder: While the optional DentiTrac® micro-recorder measures patient compliance through temperature and movement, this data is related to device usage and patient behavior, not the analysis of biological specimens for diagnostic purposes.
Therefore, the MicrO2 device, even with the embedded DentiTrac® micro-recorder, falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The MICRODENTAL, Inc. Micr02 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 MicrO2 device, the microrecorder is intended to measure patient compliance to oral device/appliance therapy in combination with the DentiTrac® System
Product codes
PLC
Device Description
The MicrO2 OSA device series consists of maxillary and mandibular devices that when interfaced together reduce snoring and mild to moderate sleep apnea by holding the mandible forward during sleep, providing increased pharyngeal space. These separate upper and lower arch devices are designed with twin-mated posts and are CAD/CAM generated specifically for each prescription. Designed as a patient-specific device, the MicrO2 series consists of one or multiple lower device(s) together with one or multiple mated-post upper device(s) that are manufactured to the dentist prescriber's requested advancement positions to provide a selection of gentle adjustments according to patient comfort and need. As such, prescribed advancements can be achieved by simply removing the current upper or lower device and inserting the next upper or lower device in the mandibular advancing series. The MicrO2 does not have any adjustment mechanisms to modify or maintain the mandibular position such as pistons, screws, straps or repositioning elastics. The MicrO2's twin-mated post and lingualess design yields a small and a comfortable patient-specific mandibular advancement device. The design of the device maximizes tongue space and mandibular movement resulting in the ability to open and close during wear.
The Micr02 OSA device with Micro-recorder is identical to the primary predicate device, Somnomed with Micro-Recorder except for the difference in the adjustment mechanism. The MicrO2 uses twin mated posts to adjust whereas the Somnomed uses embedded screws. Without the compliance chip the subject device is identical in materials and manufacturing to the reference predicate MicrO2 OSA device. Any differences introduced by these modifications when compared to the predicate device, do not introduce any new concerns.
This submission adds the option for any clinician to decide to incorporate a DentiTrac® Microrecorder compliance chip embedded into a MicrO2 OSA device to record a patient's compliance to the prescribed oral appliance therapy. The MicrO2 OSA device with Micro-recorder is to be used in combination with the DentTrac® System which includes a base station at the provider's office used to upload the data from the chip to a web application for cloud based reporting and tracking. During scheduled visits, the data within the DentiTrac® can be uploaded to a web application for cloud-based reporting and tracking using a DentiTrac® Base Station at the clinician's office. The DentiTrac® micro-recorder monitors the wear time through the oral temperature, as well as tracks movements and head position. This is the identical chip that is included in the predicate device – the Somnodent with Micro-Recorder. The inclusion of the embedded DentiTrac® micro-recorder, provides additional information when used in combination with the DentiTrac® System, but does not impact the operating principles of the Micr02 OSA device as established by the reference device, the MicrO2 OSA without the DentiTrac® Micro-recorder.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults
Intended User / Care Setting
dentists or physicians / 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
Risk assessment, biocompatibility assessment in accordance with ISO 10993-1 and process validation for manufacturing was generated by MicroDental Laboratories to ensure that the MicrO2 OSA devices can be repeatedly and reliably embedded with the DentiTrac® and retain the same Quality Control functionality of the MicrO2 and DentiTrac®.
MicroDental Laboratories has generated process validation for the manufacturing process. Throughout the manufacturing process, MicroDental Laboratories performs 100% visual and functional inspection to ensure that the device meets manufacturing specifications for the MicrO2 OSA device with the inclusion of the DentiTrac® MicroRecorder Compliance Chip.
There are no new materials that have been added to the subject device from the reference predicate. As such, the biocompatibility assessment that was performed for the reference predicate MicrO2 OSA device is supportive of the subject device.
Clinical testing was not conducted on the subject device.
Compression and shear testing to approximate the mechanical force applied during use of the device was performed on the reference predicate. Since the addition of the DentiTrac® Micro-Recorder compliance chip does not impact the structural integrity of the device, this testing is still applicable to demonstrate performance and support substantial equivalence.
Monomer leachability testing was performed on the reference predicate. The materials in the subject device have been changed, thus the leachability testing continues to support biocompatibility and substantial equivalence to the reference predicate.
Key Metrics
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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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, arranged in a way that resembles a bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 7, 2016
Microdental, Inc. David Kuhns, PhD Senior Director of Product Development And Technical Sales 5601 Arnold Rd. Dublin, California 94568
Re: K161624
Trade/Device Name: MicrO2 OSA Device with Micro-Recorder 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: August 9, 2016 Received: August 9, 2016
Dear Dr. Kuhns:
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. 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.
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 (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely.
Michael J. Ryan -S
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
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Indications for Use
510(k) Number : K161624
Device Name: MicrO2 OSA Device with Micro-recorder
Indications for Use:
The MICRODENTAL, Inc. Micr02 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 MicrO2 device, the microrecorder is intended to measure patient compliance to oral device/appliance therapy in combination with the DentiTrac® System
Prescription Use _YES (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use NO (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
3
510(k) Summary 3
| 1. Date Summary Prepared: | October 10, 2016 |
|---|---|
| Submitter Information: | MICRODENTAL, Inc. |
| 5601 Arnold Rd | |
| Dublin, CA 94568 | |
| Contact Person: | David Kuhns, PhD |
| Senior Director of Product Development and Technical Sales | |
| 2. Device Name: | |
| Proprietary/Trade name: | MicrO2 OSA Device with Micro-recorder |
| Common name: | Mandibular Advancement Device |
| Classification name: | Intraoral devices for snoring and sleep apnea and obstructive |
| sleep apnea | |
| Device Classification: | II |
21 CFR 872.5570
Product code PLC
Device Classification.
Regulation number:
3. Identification of Predicate Device(s)
Primary Predicate:
Device Name: SomnoDent with Micro-Recorder Manufacturer: SomnoMed, Ltd. 510(k) Number: K150369
Reference Predicate:
Device Name: Micr02 OSA Device Manufacturer: MicroDental Laboratories, Inc. 510(k) Number: K133683
4. Device Description:
The MicrO2 OSA device series consists of maxillary and mandibular devices that when interfaced together reduce snoring and mild to moderate sleep apnea by holding the mandible forward during sleep, providing increased pharyngeal space. These separate upper and lower arch devices are designed with twin-mated posts and are CAD/CAM generated specifically for each prescription. Designed as a patient-specific device, the MicrO2 series consists of one or multiple lower device(s) together with one or multiple mated-post upper device(s) that are manufactured to the dentist prescriber's requested advancement positions to provide a selection of gentle adjustments according to patient comfort and need. As such, prescribed advancements can be achieved by simply removing the current upper or lower device and inserting the next upper or lower device in the mandibular advancing series. The MicrO2 does
4
not have any adjustment mechanisms to modify or maintain the mandibular position such as pistons, screws, straps or repositioning elastics. The MicrO2's twin-mated post and lingualess design yields a small and a comfortable patient-specific mandibular advancement device. The design of the device maximizes tongue space and mandibular movement resulting in the ability to open and close during wear.
The Micr02 OSA device with Micro-recorder is identical to the primary predicate device, Somnomed with Micro-Recorder except for the difference in the adjustment mechanism. The MicrO2 uses twin mated posts to adjust whereas the Somnomed uses embedded screws. Without the compliance chip the subject device is identical in materials and manufacturing to the reference predicate MicrO2 OSA device. Any differences introduced by these modifications when compared to the predicate device, do not introduce any new concerns.
This submission adds the option for any clinician to decide to incorporate a DentiTrac® Microrecorder compliance chip embedded into a MicrO2 OSA device to record a patient's compliance to the prescribed oral appliance therapy. The MicrO2 OSA device with Micro-recorder is to be used in combination with the DentTrac® System which includes a base station at the provider's office used to upload the data from the chip to a web application for cloud based reporting and tracking. During scheduled visits, the data within the DentiTrac® can be uploaded to a web application for cloud-based reporting and tracking using a DentiTrac® Base Station at the clinician's office. The DentiTrac® micro-recorder monitors the wear time through the oral temperature, as well as tracks movements and head position. This is the identical chip that is included in the predicate device – the Somnodent with Micro-Recorder. The inclusion of the embedded DentiTrac® micro-recorder, provides additional information when used in combination with the DentiTrac® System, but does not impact the operating principles of the Micr02 OSA device as established by the reference device, the MicrO2 OSA without the DentiTrac® Micro-recorder.
5. Indications for Use:
The MICRODENTAL, Inc. MicrO2 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 into the MicrO2 appliance, the micro-recorder is intended to measure patient compliance to the oral appliance therapy in combination with the DentiTrac® System.
The Indications for Use Statement for the MicroDental, Inc. MicrO2 device with Micro-recorder is identical to the Somnodent with Micro-Recorder with the exception of the name. Both the subject and predicate devices have the same intended use for the treatment of OSA by mandibular repositioning.
6. Comparison of Technological Characteristics with the Predicate Device
Mandibular repositioning is the technological principle for both the subject and predicate devices. It is based on the movement of the mandible to increase the pharyngeal space. At a high level, the subject and predicate devices are based on the following elements:
5
- A mandible tray
- . An tray on the upper jaw
- Use of a protrusion mechanism for the mandible
- Optional use of the compliance chip to monitor patient compliance with the therapy
- Material composition - PMMA
The following technological differences exist between the subject and predicate devices:
- . The protrusion mechanism in the subject device is by use of a fin that is a part of the lower tray
- . The digital milling process
From a technical design perspective, the subject device and the predicate devices improve the flow of air through the patient's pharyngeal space during sleep by repositioning the mandible and the use of upper and lower trays. While the device mechanics are slightly different between the subject device and the Somnomed with Micro-Recorder, they both advance the lower jaw forward in order to increase the pharyngeal space. The Somnomed with Micro-Recorder uses screws to advance the lower tray whereas the MicrO2 with Micro-recorder and the MicrO2 reference device both use a twin mated post for advancement.
The mechanism of the subject device and the predicate devices allows for adjustment of the amount of advancement based on dentist prescription and are patient specific. The dentist prescribes the amount of advancement increments for the MicroO2 with Microrecorder subject device and the MicrO2 OSA reference device according the physician professional assessment. The dentist prescribes these increments in the same way that the dentist adjusts the mandibular position with the pistons, screws, straps or repositioning elastics of the Somnomed with Micro-Recorder predicate device.
The MicrO2 OSA with Micro-recorder subject devices and both predicate devices use primarily the same material – PMMA – to provide a rigid tray.
The MicrO2 OSA with Micro-recorder is digitally milled identically to the MicrO2 reference device whereas the Somnomed with Micro-Recorder is manually manufactured.
Both the MicrO2 OSA with Micro-recorder and the SomnoMed with Micro-Recorder have an additional pocket to encase the Microrecorder. They both follow the same pocket process to include the DentiTrac® micro-recorder chip into the base device. The MicrO2 reference device does not have this pocket for the Microrecorder, thus the subject device – the MicrO2 OSA with Micro-recorder compliance chip is wider to include the pocket and the chip.
7. Performance Testing: Non-clinical Testing
6
Risk assessment, biocompatibility assessment in accordance with ISO 10993-1 and process validation for manufacturing was generated by MicroDental Laboratories to ensure that the MicrO2 OSA devices can be repeatedly and reliably embedded with the DentiTrac® and retain the same Quality Control functionality of the MicrO2 and DentiTrac®.
MicroDental Laboratories has generated process validation for the manufacturing process. Throughout the manufacturing process, MicroDental Laboratories performs 100% visual and functional inspection to ensure that the device meets manufacturing specifications for the MicrO2 OSA device with the inclusion of the DentiTrac® MicroRecorder Compliance Chip.
There are no new materials that have been added to the subject device from the reference predicate. As such, the biocompatibility assessment that was performed for the reference predicate MicrO2 OSA device is supportive of the subject device.
Clinical Data
Clinical testing was not conducted on the subject device
8. Substantial Equivalence
MICRODENTAL, Inc. has chosen the traditional 510(k) route of submission for marketing clearance of the Micr02 OSA Device.
Method of Action and Physical Characteristics: SomnoDent with Micro-Recorder cleared by K150369.
| Substantial Equivalent Table | MicrO2 OSA
Device with
Micro-recorder
K161624 | Primary
Predicate:
SomnoDent with
Micro-Recorder
K150369 | Reference
Predicate:
MicrO2 OSA Device
K133683 |
|----------------------------------------------------------------------|--------------------------------------------------------|----------------------------------------------------------------------|---------------------------------------------------------|
| Intended Use | | | |
| Intended as an intraoral device | YES | YES | YES |
| Intended to be worn during sleep only | YES | YES | YES |
| Intended to reduce snoring or help
alleviate snoring | YES | YES | YES |
| Intended to reduce or help alleviate
mild to moderate sleep apnea | YES | YES | YES |
| For single patient, multi-use | YES | YES | YES |
| For personal use at home or in sleep
laboratories | YES | YES | YES |
| For adult patient populations | YES | YES | YES |
| Prescription device | YES | YES | YES |
| Cleaned daily | YES | YES | YES |
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| Option to monitor patient compliance | YES | YES | NO |
|---|---|---|---|
| Design | |||
| Separate upper & lower tray pieces | YES | YES | YES |
| All rigid tray pieces for more stable fit | YES | YES | YES |
| Custom fit, unique per patient | YES | YES | YES |
| Advances the lower jaw | YES | YES | YES |
| Advancement position maintained by | |||
| ramp design | YES | YES | YES |
| Can be adjusted, repaired and/or refit | YES | YES | YES |
| Ease of insertion | YES | YES | YES |
| Ease of removal | YES | YES | YES |
| Allows the patient to open & close | |||
| mouth during wear | YES | YES | YES |
| Permits patient to breathe through the | |||
| mouth | YES | YES | YES |
| Material | |||
| Hard PMMA material | YES | YES | YES |
| Non-sterile | YES | YES | YES |
| DentiTrac® Micro-recorder embedded | |||
| into MicrO2 | YES | YES | NO |
Substantial Equivalence Based on Mode of Action
The Micr02 OSA device with Micro-recorder has the same intended use as the Somnomed with Micro-Recorder in terms of providing increased pharyngeal space through mandibular repositioning for the relief of snoring and nighttime mild to moderate sleep apnea. The MicrO2 OSA and the predicate devices are both classified as mandibular positioning devices that are designed to increase the pharyngeal space. The subject device and the primary predicate maintain the option of embedding the DentiTrac® Micro-recorder compliance chip that monitors patient compliance with the device. Without the compliance chip the subject device is identical in mode of action to the reference predicate MicrO2 OSA device.
Substantial Equivalence Based on Bench Testing
The choice of reference predicate device, MicrO2 OSA is made from currently marketed devices which have identical intended use, and, which provide equivalent physical parameters, in terms of vertical shear, horizontal shear, horizontal compression and leachability.
The added compliance chip does not negatively impact the design and does not invalidate the original performance testing as performance testing as performed in support of clearance of the reference predicate device MicrO2 OSA
8
Both the Micr02 OSA device with the Micro-recorder as well as the Somnomed and MicrO2 predicates are prescribed and fitted by dentists or physicians. All of the devices have a mechanical/physical mode of action; the materials used for the fabrication of the subject device are identical to the materials used for the subject device.
Compression and shear testing to approximate the mechanical force applied during use of the device was performed on the reference predicate. Since the addition of the DentiTrac® Micro-Recorder compliance chip does not impact the structural integrity of the device, this testing is still applicable to demonstrate performance and support substantial equivalence.
Monomer leachability testing was performed on the reference predicate. The materials in the subject device have been changed, thus the leachability testing continues to support biocompatibility and substantial equivalence to the reference predicate.
Substantial Equivalence with the Addition of the DentiTrac® Micro-recorder Compliance Chip
The addition of the DentiTrac® Micro-Recorder to the MicrO2 device does not change the intended use of the MicrO2 device for the treatment of night time snoring and mild to moderate obstructive sleep apnea in adult patients 18 years of age or older. Based on the process of embedding the DentiTrac® Micro-recorder inside the MicrO2 device, the patient will not be physically exposed to the micro-recorder. The DentiTrac® is completely sealed under a layer of PMMA within the MicrO2 device in the identical fashion as the SomnoDent with Micro-recorder has embedded the DentiTrac®. Furthermore, the size, position and location of the embedded DentiTrac® Micro-recorder in the MicrO2 device as there is ample space in the patient's oral cavity to accommodate the additional volume.
9. Conclusion
Based on the comparison technologic characteristics and the indications for use, together with the non-clinical performance testing,
MicrO2 Obstructive Sleep Apnea Device with Micro-recorder is substantially equivalent to the predicate devices SomnoDent with Micro-Recorder and Micr02 OSA Device.