Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac

{0}------------------------------------------------ Image /page/0/Picture/2 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square and the words "U.S. Food & Drug Administration". Residential Home Sleep Services Chris Gillette Director of Dental Sleep Medicine 4602 Beckley Road Battle Creek, Michigan 49015-7932 #### Re: K190353 Trade/Device Name: Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac 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, LRK Dated: March 4, 2020 Received: March 4, 2020 #### Dear Chris Gillette: 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. 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 {1}------------------------------------------------ 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 medical devices and radiation-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 Srivinas 'Nandu' Nandkumar, Ph.D. Director DHT1B: Division of Dental 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) K190353 Device Name Bfit Sleep; Bfit Sleep with DentiTrac; Bfit Engage; Bfit Engage with DentiTrac #### Indications for Use (Describe) The BFit Intraoral Appliances are likely to reduce 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 the Bft device. The DentiTrac is intended to measure patient compliance to oral appliance therapy in combination with the DentiTrac System. Type of Use (Select one or both, as applicable) | <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | |-------------------------------------------------------------------------------------------------------| | <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. 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." {3}------------------------------------------------ # 510(k) Summary | Applicant's Name | Residential Home Sleep Services<br>4602 Beckley Rd<br>Battle Creek, MI 49015-7932<br>269.963.4118 | |-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person | Chris Gillette<br>4602 Beckley Rd<br>Battle Creek, MI 49015-7932<br>269.963.4118<br>bfitsleep@gmail.com | | Date Prepared | January 24 2019 | | Trade Name | Bfit Sleep; Bfit Sleep with DentiTrac; Bfit Engage; Bfit Engage with DentiTrac | | Common or Usual Name | Oral appliance, Oral appliance with patient monitoring | | Classification Name | Intraoral Devices for Snoring and Intraoral Devices for Snoring and Obstructive<br>Sleep Apnea | | Medical Specialty | Dental | | Product Code | PLC, LRK | | Device Class | II | | Regulation Number | 872.5570 | | Panel | Dental | | Predicate Devices | Primary Predicate Device: Respire Pink Series with DentiTrac, K170692<br>Reference Device: ASD Elastic, K163580 | | Intended Use/Indications for<br>Use | The BFit Intraoral Appliances are likely to reduce snoring and mild to<br>moderate Obstructive Sleep Apnea (OSA) in adult patients 18 years of age or<br>older.<br><br>Optionally, the DentiTrac Micro-Recorder may be incorporated into the Bfit<br>device. The DentiTrac is intended to measure patient compliance to oral<br>appliance therapy in combination with the DentiTrac System.<br><br>Target Population: Adults 18 years and older.<br><br>Environment of Use: Fitted by a clinician, used at home. | {4}------------------------------------------------ # K190353 #### Bfit Intraoral Appliances Traditional 510(k) Submission Device Description The Bfit Intraoral Appliances are mandibular advancement devices which function by holding the jaw in a forward position during sleep (the principle of operation). The forward placement moves the tongue and pharyngeal tissue into a position to maintain an open airway, which allows the passage of more air per breath and helps in the treatment of snoring and mild to moderate Obstructive Sleep Apnea (OSA) - the intended effect. The Bfit Sleep and Bfit Engage use mild elastic pull during the different stages of sleep where muscle activity is lost. In addition, both models of the oral appliance may be provided to the patient with an embedded DentiTrac micro-recorder used to capture the patient's compliance to the prescribed oral appliance therapy. Each oral appliance is custom-fit to the patient. The Bfit is available in four possible configurations which differ only in connecting mechanism and whether a DentiTrac is installed: Bfit Sleep (elastics), Bfit Sleep with DentiTrac, Bfit Engage (tension springs), and Bfit Engage with DentiTrac. Device Characteristics The Bfit is provided non-sterile to the patient. It is custom-fit to the patient by the clinician. The materials used to manufacture the Bfit intraoral Appliances are commonly used dental materials; safety is demonstrated via biocompatibility testing. Environment of Use The Bfit is fitted by a clinician, used at home {5}------------------------------------------------ # Substantial Equivalence Comparison Table Table 5-1: | Attribute | Bfit Intraoral<br>Appliance<br>(Subject) | Respire Pink Series<br>with DentiTrac,<br>K170692<br>(Primary Predicate) | ASD Elastic,<br>K163580<br>(Reference Device) | |-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Classification<br>Status | Class II per regulations<br>872.5570 | Same: Class II per<br>regulations 872.5570 | Class II per regulations<br>872.5570 | | Product Code | PLC, LRK | PLC, LRK | LRK | | Indications for<br>Use | The Bfit intraoral appliances<br>are likely to reduce snoring<br>and mild to moderate<br>Obstructive Sleep Apnea<br>(OSA) in adult patients 18<br>years of age or older.<br>Optionally, the DentiTrac<br>Micro-Recorder may be<br>incorporated into a Bfit. The<br>Micro-Recorder is intended<br>to measure patient<br>compliance to oral appliance<br>therapy in combination with<br>the DentiTrac System. | The Respire Pink Series<br>intraoral appliances are<br>intended to treat snoring<br>and mild to moderate<br>Obstructive Sleep Apnea<br>(OSA) in adult patients 18<br>years of age or older.<br>Optionally, the DentiTrac<br>micro-recorder may be<br>incorporated into a Respire<br>Pink Series device. The<br>micro-recorder is intended<br>to measure patient<br>compliance to oral appliance<br>therapy in combination with<br>the DentiTrac system. | The ASD Oral Appliances are<br>intended for the reduction<br>of night time snoring and<br>mild to moderate<br>obstructive sleep apnea<br>(OSA) in individuals 18 years<br>of age or older. | | Target Population | Adults 18 years and older | Adults 18 years and older | Adults 18 years and older | | Environment of<br>Use | Fitted by a clinician, used at<br>home | Fitted by a clinician, used at<br>home | Fitted by a clinician, used at<br>home | | Principle of<br>Operation | Once fitted to the patient,<br>the device positions the<br>lower jaw forward,<br>preventing soft tissue of the<br>throat from collapsing and<br>obstructing the airway,<br>therefore alleviating or<br>reducing the symptoms of<br>nighttime snoring and mild<br>to moderate Obstructive<br>Sleep Apnea (OSA) | Once fitted to the patient,<br>the device positions the<br>lower jaw forward,<br>preventing soft tissue of the<br>throat from collapsing and<br>obstructing the airway,<br>therefore alleviating or<br>reducing the symptoms of<br>nighttime snoring and mild<br>to moderate Obstructive<br>Sleep Apnea (OSA) | Once fitted to the patient,<br>the device positions the<br>lower jaw forward,<br>preventing soft tissue of the<br>throat from collapsing and<br>obstructing the airway,<br>therefore alleviating or<br>reducing the symptoms of<br>nighttime snoring and mild<br>to moderate Obstructive<br>Sleep Apnea (OSA) | | Attribute | Bfit Intraoral<br>Appliance | Respire Pink Series<br>with DentiTrac,<br>K170692 | ASD Elastic,<br>K163580 | | | (Subject) | (Primary Predicate) | (Reference Device) | | Design | Mandibular repositioner<br>having upper and lower<br>polymer trays and elastic<br>bands or stainless steel<br>springs with stainless steel<br>anchors. | Mandibular repositioner<br>having upper and lower<br>polymer trays with bilateral<br>Herbst mechanisms. | Mandibular repositioner<br>having upper and lower<br>polymer trays and elastic<br>bands or straps with<br>stainless steel anchors. | | Materials | | | | | Polymer Splint | PMMA, EVA | Acrylic | PETG/TPU, EVA | | Connecting<br>Mechanism | Latex-free Polymer or<br>Stainless Steel | Stainless Steel | Latex-free Polymer | | Sterility | Not sterile. Device is cleaned<br>between uses by the patient<br>following instructions<br>provided by its<br>manufacturer. | Not sterile. Device is cleaned<br>between uses by the patient<br>following instructions<br>provided by its<br>manufacturer. | Not sterile. Device is<br>cleaned between uses by<br>the patient following<br>instructions provided by its<br>manufacturer. | | Micro-Recorder<br>may be<br>embedded into<br>device | Yes | Yes | No | {6}------------------------------------------------ Table 5-1: {7}------------------------------------------------ # Non-clinical Performance Testing The following non-clinical performance testing was provided by the material manufacturer to the FDA as part of this submission: - Tensile strength (ASTM D-638) - . Flexural Strength (ASTM D-790) - Flexural Modulus of Elasticity (ASTM D-790) - . Compressive Strength (ASTM D-695) - . Density (ASTM D-792) - . Melt Flow Rate (ASTM D-1238) - Melting Point (ASTM D-3418) - . Vicat Softening Point (ASTM D-1525) ## Bench Testing - . Bench testing to ensure durability of the appliance under normal wearing and cleaning conditions was also performed. The appliance passed all testing. # Biocompatibility Testing A final, finished Bfit with an installed DentiTrac was tested for cytoxicity, sensitization and irritation as per ISO 10993. All tests resulted in a pass. | Test Performed | Device<br>Description | Test Method/<br>Applicable<br>Standard | Acceptance<br>Criteria | Unexpected<br>Results | Results | |------------------------------------------------------------------|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-----------------------|-------------------------| | Cytoxicity<br>MEM Elution<br>Study# 1082899-S01 | Bfit with DentiTrac | MEM Elution<br>STP0032 Rev 10<br>ISO 10993-5,<br>Biological<br>evaluation of<br>medical devices-<br>Part 5: Tests for in<br>vitro cytoxicity | no greater than 2<br>(Mild) | None | 0=No reactivity<br>Pass | | Sensitization<br>Kligman Maximization Test<br>Study# 1082901-S01 | Bfit with DentiTrac | Kligman<br>Maximization Test<br>ISO 10993-10,<br>Biological<br>evaluation of<br>medical devices-<br>Part 10: Tests for<br>irritation and<br>delayed-type<br>hypersensitivity | 0 No reaction | None | 0=No reaction<br>Pass | {8}------------------------------------------------ ## Bfit Intraoral Appliances Traditional 510(k) Submission | Irritation<br>Primary Oral (Buccal)<br>Irritation Test-Acute<br>Exposure<br>Study# 1082900-S01 | Bfit with DentiTrac | Primary Oral<br>(Buccal) Irritation<br>Test-Acute<br>Exposure<br>ISO 10993-10,<br>Biological<br>evaluation of<br>medical devices-<br>Part 10: Tests for<br>irritation and<br>delayed-type<br>hypersensitivity | 0 No irritation | None | 0=No irritation<br>Pass | |------------------------------------------------------------------------------------------------|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|------|-------------------------| |------------------------------------------------------------------------------------------------|---------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|------|-------------------------| ## Conclusion In comparison to the predicate devices, the Bfit Intraoral Appliance has: - the same intended use - . the same technological characteristics and so does not raise new questions of safety and effectiveness. The Bfit is deemed substantially equivalent to the Respire Pink Series with DentiTrac, K170692 and ASD Elastic, K163580.