Acrylic Herbst Appliance with Micro-Recorder

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. November 16, 2017 Gergen's Orthodontic Lab % Karen E. Warden, Ph.D. President BackRoads Consulting PO Box 566, Chesterland, Ohio 44026-0566 Re: K170606 Trade/Device Name: Acrylic Herbst Appliance 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: October 10, 2017 Received: October 11, 2017 Dear Karen E. Warden, Ph.D .: 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. {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); good manufacturing practice requirements as set forth in 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. 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. For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Mary S. Runner -S 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 {2}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration # Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page. 510(k) Number (if known) Device Name Acrylic Herbst Appliance with Micro-Recorder #### Indications for Use (Describe) The Acrylic Herbst Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep appea (OSA) in adults 18 years of age or older. When a DentiTrac® micro-recorder is embeded into the Acrylic Herbst Appliance, the micro-recorder is intended to measure patient compliance to oral device/appliance therapy in combination with the DentiTrac® System. Type of Use (Select one or both, as applicable) 区 Prescription Use (Part 21 CFR 801 Subpart D) _ Over-The-Counter Use (21 CFR 801 Subpart C) ## PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. ### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) {3}------------------------------------------------ This section applies only to requirements of the Paperwork Reduction Act of 1995. # *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ | 510(k) Summary | K170606 | |------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Date: | 27 February 2017 | | Sponsor: | Gergen's Orthodontic Lab Inc.<br>1745 West Deer Valley Rd, Suite 112<br>Phoenix, AZ 85027<br>Phone: 623-879-6066<br>Fax: 623-879-6166 | | Contact Person: | Chris Morrison, Lab Manager | | 510(k) Contact: | Karen E. Warden, PhD<br>BackRoads Consulting Inc.<br>PO Box 566<br>Chesterland, OH 44026<br>Office: 440.729.8457 | | Proposed Trade Name | Acrylic Herbst Appliance with Micro-Recorder | | Common Name: | Sleep appliance with patient monitoring | | Regulatory Class: | Class II | | Classification Name,<br>Regulation, Product<br>Code: | Intraoral devices for snoring and intraoral devices for snoring and<br>obstructive sleep apnea, 872.5570, PLC | | Device Description: | The Acrylic Herbst Appliance with Micro-Recorder is comprised of upper<br>and lower customized acrylic splints which are connected bilaterally via a<br>telescoping Herbst mechanism for the treatment of mild to moderate sleep<br>apnea. The micro-recorder is embedded within the appliance.<br>The device aims to improve the patient's air exchange thereby reduce<br>snoring and apnea by increasing the pharyngeal space through anterior<br>repositioning of the mandible. The micro-recorder permits a patient's<br>compliance to prescribed oral therapy to be monitored.<br>The patient contacting portions of the appliance are comprised of medical<br>grade polymethylmethacrylate (acrylic splints) and) which are connected<br>bilaterally via a stainless steel (Herbst) mechanism. | | Indications for use: | The Acrylic Herbst Appliance is intended for the reduction of night time<br>snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18<br>years of age or older.<br>When a DentiTrac® micro-recorder is embedded into the Acrylic Herbst<br>Appliance, the micro-recorder is intended to measure patient compliance to<br>oral device/appliance therapy in combination with the DentiTrac® System. | | Materials: | The patient contacting portions of the appliance are comprised of medical<br>grade polymethylmethacrylate (acrylic splints) and) which are connected<br>bilaterally via a stainless steel (Herbst) mechanism. | | Primary Predicate: | SomnoDent® with Micro-Recorder (SomnoMed, Inc., K150369) | | Reference Device: | Acrylic Herbst Appliance (Gergen's Orthodontic Lab, K113126) | | Performance Data: | The materials and fabrication processes used in the manufacture of the<br>subject device are identical to the materials and fabrication processes used<br>in the manufacture of the predicate device.<br>Because material biocompatibility was accepted for the predicate and<br>because there are no differences in manufacturing which could affect<br>biocompatibility, additional biocompatibility testing was not supplied in<br>support of this clearance.<br>Data regarding mechanical and thermal performance testing of the device<br>material and provided as follows: | {5}------------------------------------------------ | Mechanical | | Thermal | | |-------------------------|----------|-----------------------|-------------| | Test | Standard | Test | Standard | | Tensile strength | | Vicat softening point | ISO 306 (B) | | Elongation at tear | ISO 527 | Thermoform resistance | ISO 75 (A) | | E-modulus | | | ISO 75 (B) | | Flexion strength | ISO 178 | | | | Impaction strength 23°C | ISO 179 | | | | Notched 23°C | | | | | Rockwell hardness | ISO 2039 | | | Because the identical material is used for both the subject and predicate devices, these performance results were found to be satisfactory and therefore support the finding of substantial equivalence. Clinical testing of the subject device was not used in support of clearance. Per the Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA, a risk analysis was performed with respect to the subject device. The risks identified in the guidance (e.g., intraoral gingival, palatal, or dental soreness; TMJ Dysfunction Syndrome; obstruction of oral breathing and loosening or flaring of lower anterior teeth or general tooth movement) and those detected by the risk analysis were mitigated though the use of biocompatible materials identical to those used in the predicate and the use of appropriate labeling. #### Technoloqical The fundamental scientific technology of the Acrylic Herbst Appliance with Characteristics: Micro-Recorder is the same as the previously cleared device shown below, i.e., each of the design features is common to a predicate. | System: | Acrylic Herbst<br>Appliance with Micro-<br>Recorder | SomnoDent® with<br>Micro-Recorder | Acrylic Herbst<br>Appliance | |--------------------|---------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------| | Manufacturer: | Gergen's Orthodontic<br>Lab | SomnoMed, Inc. | Gergen's Orthodontic<br>Lab | | 510(k): | Under review | K150369 | K113126 | | Intended use: | The reduction of night<br>time snoring and mild to<br>moderate obstructive<br>sleep apnea (OSA) and<br>measurement of patient<br>compliance | The reduction of night<br>time snoring and mild to<br>moderate obstructive<br>sleep apnea (OSA) and<br>measurement of patient<br>compliance | The reduction of night<br>time snoring and mild to<br>moderate obstructive<br>sleep apnea (OSA) | | Target population: | Adults | Adults | Adults | | Prescription use: | Prescription only | Prescription only | Prescription only | | Basic Design: | Upper and lower splints<br>having an adjustment<br>mechanism and fully<br>embedded micro-<br>recorder | Upper and lower splints<br>having an adjustment<br>mechanism and fully<br>embedded micro-<br>recorder | Upper and lower splints<br>having an adjustment<br>mechanism | {6}------------------------------------------------ | System: | Acrylic Herbst<br>Appliance with Micro-<br>Recorder | SomnoDent® with<br>Micro-Recorder | Acrylic Herbst<br>Appliance | |------------------------------|--------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------| | Manufacturer: | Gergen's Orthodontic<br>Lab | SomnoMed, Inc. | Gergen's Orthodontic<br>Lab | | 510(k): | Under review | K150369 | K113126 | | Materials of<br>manufacture: | Medical grade acrylic,<br>stainless steel and<br>DentiTrac® micro-<br>recorder | Hard surface acrylic<br>with soft lining material,<br>surgical grade stainless<br>steel and embedded<br>DentiTrac® Micro-<br>recorder | Medical grade acrylic<br>and stainless steel | | Adjustability: | Yes, by prescribing<br>dentist or physician | Yes, by prescribing<br>dentist or physician | Yes, by prescribing<br>dentist or physician | | Adjustment<br>mechanism: | Yes, telescopic | Yes, turnbuckle | Yes, telescopic | | Adjustable range: | 5.5mm | 6mm (-0.5, +5.5mm) | 5.5mm | | Method of<br>manufacture: | Patient-specific<br>customized fabrication | Patient-specific<br>customized fabrication | Patient-specific<br>customized fabrication | | Sterility: | Non-sterile | Non-sterile | Non-sterile | Conclusion: In comparison to the predicate devices, the Acrylic Herbst Appliance with Micro-Recorder has - the same intended use (as described above), . - . the same technological characteristics (as described above) and so does not raise new questions of safety and effectiveness. Therefore the Acrylic Herbst Appliance with Micro-Recorder is as safe and as effective for its intended use, and performs as well as the predicate devices. The Acrylic Herbst Appliance with Micro-Recorder can be found substantially equivalent to the predicate devices.