(420 days)
No
The summary describes a mechanical mandibular advancement device and a compliance recorder. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended to reduce snoring and mild to moderate Obstructive Sleep Apnea (OSA), which are conditions that impact a patient's health, thus functioning as a therapeutic device.
No
The device is described as a mandibular advancement device intended to treat snoring and Obstructive Sleep Apnea (OSA) by holding the jaw in a forward position. While a component can measure patient compliance, the primary function of the device itself is therapeutic, not diagnostic.
No
The device is a physical intraoral appliance (mandibular advancement device) made of materials with mechanical properties, and it may include an embedded hardware micro-recorder (DentiTrac). It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The BFit Intraoral Appliance is a physical device worn in the mouth to reposition the jaw and improve airflow during sleep. It directly interacts with the patient's anatomy.
- Intended Use: The intended use is to reduce snoring and mild to moderate Obstructive Sleep Apnea by physically altering the airway. The optional DentiTrac measures compliance, which is also a physical measurement of device usage, not a diagnostic test on a biological sample.
- Lack of Biological Sample Testing: There is no mention of the device analyzing or testing any biological samples from the patient.
The BFit Intraoral Appliance is a therapeutic device used to treat a condition, not a diagnostic device used to identify or monitor a condition through in vitro testing.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
PLC, LRK
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.
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
adult patients 18 years of age or older.
Intended User / Care Setting
Fitted by a clinician, used at home.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing was provided by the material manufacturer:
- 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: Durability of the appliance under normal wearing and cleaning conditions was performed. The appliance passed all testing.
Biocompatibility Testing: A final, finished Bfit with an installed DentiTrac was tested for cytotoxicity, sensitization and irritation as per ISO 10993. All tests resulted in a pass.
- Cytotoxicity - MEM Elution Study# 1082899-S01: Results in 0=No reactivity Pass.
- Sensitization - Kligman Maximization Test Study# 1082901-S01: Results in 0=No reaction Pass.
- Irritation - Primary Oral (Buccal) Irritation Test-Acute Exposure Study# 1082900-S01: Results in 0=No irritation Pass.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Respire Pink Series with DentiTrac, K170692
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
ASD Elastic, K163580
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Summary
| Applicant's Name | Residential Home Sleep Services
4602 Beckley Rd
Battle Creek, MI 49015-7932
269.963.4118 |
|-------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Chris Gillette
4602 Beckley Rd
Battle Creek, MI 49015-7932
269.963.4118
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
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
Reference Device: ASD Elastic, K163580 |
| Intended Use/Indications for
Use | 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.
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
5
Substantial Equivalence Comparison Table
Table 5-1:
| Attribute | Bfit Intraoral
Appliance
(Subject) | Respire Pink Series
with DentiTrac,
K170692
(Primary Predicate) | ASD Elastic,
K163580
(Reference Device) |
|-----------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification
Status | Class II per regulations
872.5570 | Same: Class II per
regulations 872.5570 | Class II per regulations
872.5570 |
| Product Code | PLC, LRK | PLC, LRK | LRK |
| Indications for
Use | 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 a Bfit. The
Micro-Recorder is intended
to measure patient
compliance to oral appliance
therapy in combination with
the DentiTrac System. | The Respire Pink Series
intraoral appliances are
intended to treat 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 a Respire
Pink Series device. The
micro-recorder is intended
to measure patient
compliance to oral appliance
therapy in combination with
the DentiTrac system. | The ASD Oral Appliances are
intended for the reduction
of night time snoring and
mild to moderate
obstructive sleep apnea
(OSA) in individuals 18 years
of age or older. |
| Target Population | Adults 18 years and older | Adults 18 years and older | Adults 18 years and older |
| Environment of
Use | Fitted by a clinician, used at
home | Fitted by a clinician, used at
home | Fitted by a clinician, used at
home |
| Principle of
Operation | Once fitted to the patient,
the device positions the
lower jaw forward,
preventing soft tissue of the
throat from collapsing and
obstructing the airway,
therefore alleviating or
reducing the symptoms of
nighttime snoring and mild
to moderate Obstructive
Sleep Apnea (OSA) | Once fitted to the patient,
the device positions the
lower jaw forward,
preventing soft tissue of the
throat from collapsing and
obstructing the airway,
therefore alleviating or
reducing the symptoms of
nighttime snoring and mild
to moderate Obstructive
Sleep Apnea (OSA) | Once fitted to the patient,
the device positions the
lower jaw forward,
preventing soft tissue of the
throat from collapsing and
obstructing the airway,
therefore alleviating or
reducing the symptoms of
nighttime snoring and mild
to moderate Obstructive
Sleep Apnea (OSA) |
| Attribute | Bfit Intraoral
Appliance | Respire Pink Series
with DentiTrac,
K170692 | ASD Elastic,
K163580 |
| | (Subject) | (Primary Predicate) | (Reference Device) |
| Design | Mandibular repositioner
having upper and lower
polymer trays and elastic
bands or stainless steel
springs with stainless steel
anchors. | Mandibular repositioner
having upper and lower
polymer trays with bilateral
Herbst mechanisms. | Mandibular repositioner
having upper and lower
polymer trays and elastic
bands or straps with
stainless steel anchors. |
| Materials | | | |
| Polymer Splint | PMMA, EVA | Acrylic | PETG/TPU, EVA |
| Connecting
Mechanism | Latex-free Polymer or
Stainless Steel | Stainless Steel | Latex-free Polymer |
| Sterility | Not sterile. Device is cleaned
between uses by the patient
following instructions
provided by its
manufacturer. | Not sterile. Device is cleaned
between uses by the patient
following instructions
provided by its
manufacturer. | Not sterile. Device is
cleaned between uses by
the patient following
instructions provided by its
manufacturer. |
| Micro-Recorder
may be
embedded into
device | Yes | Yes | No |
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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
Description | Test Method/
Applicable
Standard | Acceptance
Criteria | Unexpected
Results | Results |
|------------------------------------------------------------------|-----------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------|-----------------------|-------------------------|
| Cytoxicity
MEM Elution
Study# 1082899-S01 | Bfit with DentiTrac | MEM Elution
STP0032 Rev 10
ISO 10993-5,
Biological
evaluation of
medical devices-
Part 5: Tests for in
vitro cytoxicity | no greater than 2
(Mild) | None | 0=No reactivity
Pass |
| Sensitization
Kligman Maximization Test
Study# 1082901-S01 | Bfit with DentiTrac | Kligman
Maximization Test
ISO 10993-10,
Biological
evaluation of
medical devices-
Part 10: Tests for
irritation and
delayed-type
hypersensitivity | 0 No reaction | None | 0=No reaction
Pass |
8
Bfit Intraoral Appliances Traditional 510(k) Submission
| Irritation
Primary Oral (Buccal)
Irritation Test-Acute
Exposure
Study# 1082900-S01 | Bfit with DentiTrac | 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 | None | 0=No irritation
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.