REMOTELY CONTROLLED MANDIBULAR POSITIONER, RCMP

{0}------------------------------------------------ K|03704 MAR 2 3 2012 #### 510(k) Summary Section 2. | Manufacture Name: | Zephyr Sleep Technologies Inc. | |-------------------|----------------------------------------------------------| | Contact Name: | Sabina Bruehlmann, PhD | | Postal Address: | #306, 3553 31 Street NW<br>Calgary, AB CANADA<br>T2L 2K7 | | Phone Number: | 403-210-6824 | | Title: | Director, Research & Development | | Date: | December 17, 2010 | | Device Proprietary Name: | Remotely Controlled Mandibular Positioner,<br>RCMP | |------------------------------|-------------------------------------------------------------| | Device Common or Usual Name: | Temporary Sleep Apnea/anti-snoring appliance | | Classification Name: | Activator Dental Appliance | | Classification Code: | Class II (special controls) | | Product Codes: | LRK (anti-snoring device)<br>LQZ (jaw repositioning device) | | Regulation Number: | 21 CFR 872.5570 | Predicate Device Substantial equivalence is claimed to the EMA-T, Elastic Mandibular Advancement -Substantial equivalence is claimed to the EMA-1, design characteristics and certain technology. Constantial equivalence is claimed to the DemeTECH Polypropylene Surgical Sutures s of the counter and estables material Substantial Cquivalories contacting material. (21) = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = = Substantial 'equivaliation trays. # Description of the Device Description of the Device used in the clinical setting to identify patients with an oral appliance. A The RCMP appliance is a device used in the Chincal setting to nomed appliance. A obstructive sleep aparte that will be successfully and reversibly advances obstructive sleep appliance fits to the patient's teeth and incrementally and reversibly advances temporary appliance fits to the patient's respect to the maxilla while the p temporary appliance fits to the patient's teefn and nice the patient is under full the patient's mandible anteriorly with respect to the maxible pulls the tongue the patient's mandible anteriorly with respectioning of the mandible pulls the tongue polysomnographic monitoring. The repositioning of the mandible pulls the toneye polysomnographic monitoring. The repositioning of the manages provincians. forward and increases the pative, feator, in obstructive sleep apner and snoring. The forward increases the patient's arspace, includives sleep apnea and snoring. The Such obstruction can be a causative factor in oustractive advance the mandible until the RCMP is used in the clinical setting by a technical to action. The device is used to polysomnographic data indicates removal of the obstruction of airflow in recommend a target mandibular position that will reduce obstruction of airflow in recommend a target mandibular position that will reculce obstruction of airflow in the recom recommend a target manditoular position patients determined to be suitable for oral appliance therapy. {1}------------------------------------------------ The RCMP appliance consists of upper and lower disposable dental titration trays that are s attach to the consisted by any of a quick set retention material. The trays attach The RCMP appliance consists of upper and lower users! The trays attach to used to hold onto the technique and extends a rod to adjust the trays attach to used to hold onto the teeth by means of a quick-set receins a rod to adjust the tray positioning by a mandibular position of the massesses. By extending the linear actuator r a mandibular positioner thar retracts and extending the linear actuator rod attached to means of a small force linear actuator. By extending the Initia dover teeth, thus the upper tray, the RCMP pushes on the upper teen and pomoor and and and displacing the jaw. RCMP software interacts with the porsonnely of the mandible. allows the technician to control fine adjustments of the relative position of the mandible. # Intended Use/Indications for Use Intended Use/Indications or Use Overnight use of a temporary oral appliance to determine in which patients with reduce Overnight use of a temporary oral appliancement by an oral appliance will reduce obstructive sleep apnea mandibulate identify patients suitable for oral appliance therapy. obstruction of airflow and thereby to identify patients suitable for oral appliance therapy. obstruction of airflow and thereby to identify patients suitable for oral applian obstruction of airflow and thereby to identify patients suitibular position that will reduce The device is also used to recommend a target mandibular position therapy. The device is also used to recommend a target mandiound possible for oral appliance therapy. ## Patient Population Patient Population The RCMP is intended to be used on adult patients that have been previously diagnosed The RCMP is intended to be used on adult patient mail boom por of the more intended for use with obstructive sleep apnea, severe respiratory disorders, loose teeth or advanced on patients with central should and of economy disorders, loose teeth or advanced and and on patients with contral with a mean of age. # Technological Characteristics Technological Characteristics The RCMP appliance is used in a clinical setting under full polysomnographic cardio-The RCMP appliance is used in a clinical setting with plane and that will be respiratory monitoring to identify patients with bostiation monitors the respiratory air successfully treated with an oral appliance. The technicial moment and titrates the flow and the mandible to reestablish normal flow. The final assessment and position of the mandible to restablish now. Include is completed by a physician who recommendation for treatment by an oral appliator reaction. recommendation for treatment by an orar uppliated reviews the positioning data and associated cardio-respiratory reaction. The oral appliances consist of single patient use dental titration trays that are individually f the consistent of the formation restigation mouth . The titration trays are c The oral appliances consist of single patient's mouth. The titration trays are connected customized to fit uniquely into the patient s mound." The that allows movement in the such that the jaw is held in a fixed occussal bite planet that allows movement in the st such that the jaw is held in a fixed occusal ble patient on the night of the study anterior-posterior direction. The trays are inserted by the patient on the night of the stu anterior-posterior direction. The araje a trained technician. The oral appliances are connected to a reusable mandibular positioner consisting of a reas and and and and except except software. Moyement of the positioner is The oral appliances are connected to a reusable manufacturer of the positioner is linear actuator, a controller and costuare interface linear actuator, 'a' controllor 'un- 'eoftware interface. {2}------------------------------------------------ # Substantial Equivalence Comparison The Remote Controlled Mandibular Positioner (RCMP), is substantially equivalent to the The Remote Controlled Mandibular Fosmoner (NA-T, (K-77884) manufactured Elastic Mandibular Advances have the same intended use of the Research population, by Frantz Design Inc. The devices have the same intended use of the RCMP has been by Frantz Design Inc. The use. Note the stated intended use of the RCMP has been conditions and environment of use. Note the sated intended use of the following table conditions and environment of the inte succe and additional detail. The following table modified from that of the predicate for clarity and additional detail. The following t modified from that of and design of the two devices. ## inhiect 1 BREMP Titration Trays College | Appliance retention by U-shaped<br>trays filled with impression<br>material | Yes | Yes | |--------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------|-----------------------------------------------------------------| | Relative displacement visible via<br>a scale on mounting bracket | Yes, and on software | Yes | | Jaw constrained to move in the<br>anterior-posterior direction | Yes | Yes | | Tray Materials | Moplen HP600N<br>polypropylene<br>** predicate (K043330) | Spectar (PETG)<br>copolyester | | Impression Material, polysiloxane | Yes | Yes | | Single patient use | Yes | Yes | | Mandibular Positioner | | | | Repositioning controlled by a<br>trained technician based on<br>readings from a polysomnogram | Yes | Yes | | The dental trays are repositioned<br>by .... | a mandibular positioner<br>consisting of a linear<br>actuator, a controller and<br>custom software. | a technician using<br>their own force to<br>adjust the mandible | | The force to the teeth is related to<br>the distance of mandibular<br>protrusion and is exerted on the<br>teeth by the impression material | Yes | Yes | {3}------------------------------------------------ | Technological Feature | Subject Device<br>RCMP | Predicate (K973884)<br>EMA | |----------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------| | The maximum possible force<br>applied is.... | restricted by the motor<br>capacity of $2.45 +/- 0.50$<br>kgf | unknown and variable<br>by technician | | The protrusive step size is.... | is set by the technician,<br>between 0.2 to 2 mm. | is held by a peg in<br>holes at 3mm<br>spacings. | | Therapeutic feedback during the<br>repositioning is ... | immediate, the technician<br>observes the response<br>during the repositioning | delayed, as the<br>technician needs to<br>return to the control<br>room | | The adjusted position is held<br>by.... | the linear actuator; is<br>measured by the software | the insertion of the<br>peg in the hole on the<br>mounting bracket | | The observation and recording of<br>mandibular position is made by<br>.... | a technician using<br>software, with the ability<br>to verify against the<br>scale. No writing or<br>transcribing is required. | a technician | | The data is reviewed and the<br>diagnosis is made by a physician | Yes | Yes | | Usage | The titration trays are<br>single patient use, and<br>the mandibular positioner<br>is reusable. | None, the trays are a<br>single use design | | Source of energy | Electrically powered | No energy source,<br>human exertion | # Substantial Equivalence Discussion The technological differences are directed towards increasing the effectiveness while I he technological unferences are urocied to was subjected to non-clinical testing and manitalining the safety of the Govers safe and effective performance. The primary technological differences are as follows: - 1. The RCMP adjusts the mandible in fine increments (0.2mm) by a remotely The RCMI "adjusts the manufels in technician observes the immediate cardiocontrolled intear actuator writte the vace of sleep. In contrast, with the EMA-T, respiratory response in the dosired by the technician in set 3 mm increments and the manufic is manually aroused from their sleep. Clinical testing performed demonstrating safety and effectiveness. - 2. The RCMP device is controlled through a software interface. Bench testing and clinical testing performed. {4}------------------------------------------------ - 3. The RCMP device includes a linear actuator, a controller, custom software and an t and the many of the form of a formal Electromentia Compatibility The RCMP device includes a inisur as a fine and Electromagnetic Compatibility electrical energy source. Electrical Safety and 60601 1 2 electrical energy source: Electrical Sub-Shite C-60601-1 and 60601-1-2. testing was performed in accordance with IEC 60601-1 and 60601-1-2. - testing was performed in accordance while the EMA-T has no reusable 4. The RCMP mandibular positioner is reusable while the EMA-T has no reusable The RCMF mandiounar position validation was performed. Substantial equivalence is claimed to the DemeTECH Polypropylene Surgical Sutures Substantial equivalence is claimed to the Deals which in contact with the patient. The (KD43330) for the material of the titlation are while to thours. In contrast, the trays are plecicate is inserted into veosal tissue for less than 24 hours. Substantial equivalence is claimed to the Apnea Guard (K111110) for the cleaning There have a more and many many man me may the Appear have Substantial equivalence is claimed to the Apara Quard the Apnea Guard have a instructions for the disposable titration trays. The RCMP as are fit by a dentist instructions for the disposable infation frays. The Reviews and interpression fit by a dentist and then provided to the patient for a subsequent use. ### Performance Testing Bench Testing included: - Patient fit, performance and userability of the titration trays . - Impression material retention testing . - Impression matchar recomion would be performance of the actuator rod, . and enclosure seals for adherence to the specifications - and enclosure seals for admitis to the upon and any conformance between the . Mandibular Positioner performance accerably, and early our under load conditions - Software specification and performance evaluation . - Software specific cleaning and disinfection instructions . - v andation of the electromagnetic compatibility testing performed in . accordance with IEC 60601-1 and 60601-1-2. - accordance with IDC 00001 and its of the reusable mandibular positioner . Conclusion: The bench tests demonstrated that the RCMP device meets the design Conclusion: The belieft tosts domonomated that may new safety or efficacy issues in comparison to the predicate. #### Clinical Testing: A 66 patient clinical study was completed to demonstrate that using prospectively A 66 patient clinical study was completed to select favourable candidates for oral determined criteria, the RCMP test can accurately select favorates and a determined criteria, the RCMF test can accurated that the RCMP test can recommend a a nd a study also demonstrated that the RCMP test can recommend a appliance therapy. The study also anive distance for the therapy. The study was therapeutically enective target prouds.ve unstine study) that were recruited performed on patients with sleep apnea (RDI >10 in a baseline study) that were recruited performed on patients with strep uplied (news and include the following). from a sleep centre and dentist. The strengths of the study include the following successio from a sieep centre and dentist. The strengthe or and therapetics success; prospectively determined criterion for inclusion, interpretation and opproprises prospectively determined criterion for mension, increations of patient characteristics; and, appropriate recruitment sources (sleep center and dentist). {5}------------------------------------------------ The validation study provides evidence that the RCMP test, when implemented in a nd the dental The validation study provides evidence that the recimician, is safe. As well, the dental polysomnographic setting by a trained sleep technician, is safe. As well, the dental polysomnographic setting by a traned sieep technicial, is subt 1 to woser friendly to both titration procedure and approach was shown to be comfortable for the patient. titration procedure and approach was miunvely undersonnelle for the patient. the technician and the sleep expert; and was shown to be comfortable for the patient. the technician and the sleep expert; and walysis that demonstrated that the RCMP test does The study included a detailed arousal analysis that demonstrated that the RCM sleep The study included a detailed arousal analysis that demonstance that and the results of the sleep. not wake the patient and therefore the titration can be completed during RE Conclusion: The clinical study demonstrated that the RCMP is at least as safe and ed the same of the same in the sendidates for oral appliance therapy. Conclusion: The clinical study demonstrated that the Resm' - a 11. effective as the predicate device at selecting candidates for oral appliance therapy. ## Conclusion Conclusion Based on the information provided in this 510(k) premarket notification, the RCMP is t the information and consisted of affectiveness to the predicate device Based on the information provided in this 510(x) premation with identified above. {6}------------------------------------------------ #### DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle. #### Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002 Dr. Sabina Bruchlmann Director Research & Development Zephyr Sleep Technologies, Inc. 2513 17 Street SE Calgary; Alberta CANADA T2L 2K7 MAR 2 3 2012 Re: K103704 Trade/Device Name: RCMP, Remotely Controlled Mandibular Positioner Regulation Number: 21 CFR 872.5570 Regulation Name: Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive Sleep Apnea Regulatory Class: II Product Code: LRK Dated: March 17, 2012 Received: March 19, 2012 Dear Dr. Bruchlmann: 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. {7}------------------------------------------------ #### Page 2 - Dr. Bruchlmann 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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Sincerely yours. h. for Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital. Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {8}------------------------------------------------ #### Indications for Use Statement Section 1. 510(k) Number: K103704 Device Name: RCMP, Remotely Controlled Mandibular Positioner Intended Use: Overnight use of a temporary oral appliance to determine in which e and and the counter and as annos mandibular advancement by Overnight use of a temporary orar applance to as a vancement by patients with obstructive sleep apnea mandibular advancement by patients with obstructive sleep aplica individual woman thereby to an oral appliance will reduce obstruction of airflow and thereby to an oral appliance will reduce obstraction of there ... The device is identify patients suitable for oral appliance therapy. The device is that will identify patients suitable for orar upprahoo - position that will also used to recommend a target mandioural provinced to be suitable reduce obstruction of airflow in patients determined to be suitable for oral appliance therapy. Prescription Use _____________________________________________________________________________________________________________________________________________________________ And/Or 510(k) Over the Counter Use (21 CFR Part 801 Subpart C) (21 CFR Part 801 Subpart D) CI NO THE Concurrence of CDRH, Office of Device Evaluation (ODE) Susan Ruase Division Sign-Off Office of Device Evaluation Susan Quan (Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices 510(k) Number: K103704 2