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 Bfit device. The DentiTrac is intended to measure patient compliance to oral appliance therapy in combination with the DentiTrac System.

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.

AI/ML Overview

The provided text does not contain information about the acceptance criteria and performance of the device in the context of clinical studies to prove its effectiveness in reducing snoring or OSA.

The document is a 510(k) summary for the Bfit Intraoral Appliances, which focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance testing and biocompatibility testing. It does not present clinical studies with human participants to establish clinical efficacy or define acceptance criteria for such efficacy.

Therefore, I cannot fulfill your request for:

A table of acceptance criteria and reported device performance (for clinical efficacy).
Sample size used for the test set and data provenance (for clinical efficacy).
Number of experts and qualifications for ground truth (for clinical efficacy).
Adjudication method (for clinical efficacy).
MRMC comparative effectiveness study results.
Standalone algorithm performance (as this is a physical device, not an AI algorithm).
Type of ground truth used (for clinical efficacy).
Sample size for the training set (for clinical efficacy).
How ground truth for the training set was established (for clinical efficacy).

What the document does provide regarding testing and criteria is related to the device materials and mechanical performance:

1. A table of acceptance criteria and the reported device performance (for non-clinical aspects):

Test Performed	Test Method/Applicable Standard	Acceptance Criteria	Results
Cytotoxicity (MEM Elution Study# 1082899-S01)	MEM Elution STP0032 Rev 10 ISO 10993-5, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity	No greater than 2 (Mild)	0 = No reactivity (Pass)
Sensitization (Kligman Maximization Test Study# 1082901-S01)	Kligman Maximization Test ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity	0 No reaction	0 = No reaction (Pass)
Irritation (Primary Oral (Buccal) Irritation Test-Acute Exposure Study# 1082900-S01)	Primary Oral (Buccal) Irritation Test-Acute Exposure ISO 10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and delayed-type hypersensitivity	0 No irritation	0 = No irritation (Pass)

In addition, the following non-clinical tests were performed by the material manufacturer, and "Bench testing to ensure durability of the appliance under normal wearing and cleaning conditions was also performed. The appliance passed all testing." No specific numerical acceptance criteria or performance metrics are detailed in the provided text for these tests:

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)

2. Sample sized used for the test set and the data provenance: Not applicable to clinical efficacy in this document. For biocompatibility, the sample sizes are embedded within the "Study#" identifiers but not explicitly stated as number of units tested. Data provenance is implied by the testing standards (e.g., ISO, ASTM).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as this document focuses on non-clinical and biocompatibility testing, not expert-adjudicated clinical outcomes.

4. Adjudication method for the test set: Not applicable for non-clinical testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done: No, this is a physical medical device, not an AI algorithm requiring MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, this is a physical medical device, not an algorithm.

7. The type of ground truth used: For biocompatibility, the ground truth is based on established biological and physical test standards (e.g., ISO 10993, absence of reactivity/irritation/sensitization). For the other non-clinical tests, it is based on the material properties and durability assessments.

8. The sample size for the training set: Not applicable, as this is not an AI model requiring a training set.

9. How the ground truth for the training set was established: Not applicable.

Summary

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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

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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

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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)

☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Applicant's Name	Residential Home Sleep Services4602 Beckley RdBattle Creek, MI 49015-7932269.963.4118
Contact Person	Chris Gillette4602 Beckley RdBattle Creek, MI 49015-7932269.963.4118bfitsleep@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 ObstructiveSleep 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, K170692Reference Device: ASD Elastic, K163580
Intended Use/Indications forUse	The BFit Intraoral Appliances are likely to reduce snoring and mild tomoderate Obstructive Sleep Apnea (OSA) in adult patients 18 years of age orolder.Optionally, the DentiTrac Micro-Recorder may be incorporated into the Bfitdevice. The DentiTrac is intended to measure patient compliance to oralappliance therapy in combination with the DentiTrac System.Target Population: Adults 18 years and older.Environment of Use: Fitted by a clinician, used at home.

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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

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Substantial Equivalence Comparison Table

Table 5-1:

Attribute	Bfit IntraoralAppliance(Subject)	Respire Pink Serieswith DentiTrac,K170692(Primary Predicate)	ASD Elastic,K163580(Reference Device)
ClassificationStatus	Class II per regulations872.5570	Same: Class II perregulations 872.5570	Class II per regulations872.5570
Product Code	PLC, LRK	PLC, LRK	LRK
Indications forUse	The Bfit intraoral appliancesare likely to reduce snoringand mild to moderateObstructive Sleep Apnea(OSA) in adult patients 18years of age or older.Optionally, the DentiTracMicro-Recorder may beincorporated into a Bfit. TheMicro-Recorder is intendedto measure patientcompliance to oral appliancetherapy in combination withthe DentiTrac System.	The Respire Pink Seriesintraoral appliances areintended to treat snoringand mild to moderateObstructive Sleep Apnea(OSA) in adult patients 18years of age or older.Optionally, the DentiTracmicro-recorder may beincorporated into a RespirePink Series device. Themicro-recorder is intendedto measure patientcompliance to oral appliancetherapy in combination withthe DentiTrac system.	The ASD Oral Appliances areintended for the reductionof night time snoring andmild to moderateobstructive sleep apnea(OSA) in individuals 18 yearsof age or older.
Target Population	Adults 18 years and older	Adults 18 years and older	Adults 18 years and older
Environment ofUse	Fitted by a clinician, used athome	Fitted by a clinician, used athome	Fitted by a clinician, used athome
Principle ofOperation	Once fitted to the patient,the device positions thelower jaw forward,preventing soft tissue of thethroat from collapsing andobstructing the airway,therefore alleviating orreducing the symptoms ofnighttime snoring and mildto moderate ObstructiveSleep Apnea (OSA)	Once fitted to the patient,the device positions thelower jaw forward,preventing soft tissue of thethroat from collapsing andobstructing the airway,therefore alleviating orreducing the symptoms ofnighttime snoring and mildto moderate ObstructiveSleep Apnea (OSA)	Once fitted to the patient,the device positions thelower jaw forward,preventing soft tissue of thethroat from collapsing andobstructing the airway,therefore alleviating orreducing the symptoms ofnighttime snoring and mildto moderate ObstructiveSleep Apnea (OSA)
Attribute	Bfit IntraoralAppliance	Respire Pink Serieswith DentiTrac,K170692	ASD Elastic,K163580
	(Subject)	(Primary Predicate)	(Reference Device)
Design	Mandibular repositionerhaving upper and lowerpolymer trays and elasticbands or stainless steelsprings with stainless steelanchors.	Mandibular repositionerhaving upper and lowerpolymer trays with bilateralHerbst mechanisms.	Mandibular repositionerhaving upper and lowerpolymer trays and elasticbands or straps withstainless steel anchors.
Materials
Polymer Splint	PMMA, EVA	Acrylic	PETG/TPU, EVA
ConnectingMechanism	Latex-free Polymer orStainless Steel	Stainless Steel	Latex-free Polymer
Sterility	Not sterile. Device is cleanedbetween uses by the patientfollowing instructionsprovided by itsmanufacturer.	Not sterile. Device is cleanedbetween uses by the patientfollowing instructionsprovided by itsmanufacturer.	Not sterile. Device iscleaned between uses bythe patient followinginstructions provided by itsmanufacturer.
Micro-Recordermay beembedded intodevice	Yes	Yes	No

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Table 5-1:

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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	DeviceDescription	Test Method/ApplicableStandard	AcceptanceCriteria	UnexpectedResults	Results
CytoxicityMEM ElutionStudy# 1082899-S01	Bfit with DentiTrac	MEM ElutionSTP0032 Rev 10ISO 10993-5,Biologicalevaluation ofmedical devices-Part 5: Tests for invitro cytoxicity	no greater than 2(Mild)	None	0=No reactivityPass
SensitizationKligman Maximization TestStudy# 1082901-S01	Bfit with DentiTrac	KligmanMaximization TestISO 10993-10,Biologicalevaluation ofmedical devices-Part 10: Tests forirritation anddelayed-typehypersensitivity	0 No reaction	None	0=No reactionPass

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Bfit Intraoral Appliances Traditional 510(k) Submission

IrritationPrimary Oral (Buccal)Irritation Test-AcuteExposureStudy# 1082900-S01	Bfit with DentiTrac	Primary Oral(Buccal) IrritationTest-AcuteExposureISO 10993-10,Biologicalevaluation ofmedical devices-Part 10: Tests forirritation anddelayed-typehypersensitivity	0 No irritation	None	0=No irritationPass
------------------------------------------------------------------------------------------------	---------------------	---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------	-----------------	------	-------------------------

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.

Regulation Number and Section

§ 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.”