(270 days)
The TrueFunction® Adjustable Herbst Appliance is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
The TrueFunction® Adjustable Herbst Appliance is a prescription only appliance that is customized by True Function Laboratory to dentist specific instructions.
TrueFunction® - Adjustable Herbst Appliances are primarily polymer trays that are used intraorally over the dentition to make the mandible protrude. Material composition of the proposed devices include acrylic PMMA, dual laminate polymers, stainless steel ball clasps, exing elements and adjustment key and colorant. Also provided with the device is a stainless steel key used to make necessary mandibular protrusion adjustments by turning the screws as needed.
They are available in three mandibular advancement models: The Dual Laminate, the Acrylic with Clasp, and the Acrylic without Clasp model.
The Dual Laminate - this model has a soft, rubbery surface on the inside of each piece and a hard acrylic surface on the outside without metal clasps for retention. The appliance is held in place by the soft, rubbery liner. Patients must have adequate natural undercuts for retention of the Dual Laminate model, because retention cannot be increased during treatment, and the appliance cannot be modified to accommodate new tooth restorations or the loss of posterior teeth.
The Acrylic with Clasp and Acrylic without Clasp - the acrylic with clasp model has several metal ball clasps, which can be adjusted to increase retention on teeth that have insufficient undercuts. The ball clasps can often be modified, should further dental work be performed and adjustments required. For the non-clasp model, the patient must have adequate natural undercuts because retention cannot be increased during treatment, and the appliance cannot be modified to accommodate new tooth restorations or the loss of posterior teeth.
TrueFunction® - Adjustable Herbst Appliances mandible protrusion is controlled by stainless steel tubes & rods or screws for all three mandibular advancement designs. Each device is fabricated to the prescription of a dentist.
TrueFunction® - Adjustable Herbst Appliances device components comes in contact with the patient's gum (please reference the diagram below), and are composed of Methyl Methacrylate, Thermoplastic Polyurethane and high grade Chromium-nickel steel.
Here's a breakdown of the requested information based on the provided text, focusing on the TrueFunction Adjustable Herbst Appliances:
1. Table of Acceptance Criteria and Reported Device Performance
The FDA clearance for the TrueFunction Adjustable Herbst Appliances is based on substantial equivalence to predicate devices, not on specific performance metrics with acceptance criteria like a diagnostic algorithm would have. Therefore, there's no table of numerical acceptance criteria or performance values provided for this type of device.
Instead, the acceptance criteria are met by demonstrating that the device has:
- Same intended use: "The reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA)" in adults, prescribed by a dentist, and customized by True Function Laboratory.
- Technological characteristics that do not raise new questions of safety and effectiveness: This is assessed by comparing design, function, and materials to previously cleared predicate devices.
- Compliance with relevant standards: ISO 7405 and ISO 10993 part 5 and part 10 for biocompatibility, as referenced in 21 CFR 872.5570.
Reported Device Performance:
The document states:
- "The TrueFunction® - Adjustable Herbst Appliances are essentially identical in indications for use to the predicate devices..."
- "Technological characteristics which do not raise new questions of safety and effectiveness."
- "The material composition... to comply with the Standard ISO 7405 and ISO 10993 part 5 and part 10..."
- "The material characteristic... meeting ASTM standards, have been found to be substantially equivalent to the predicate device material characteristics."
- "No new materials are used... all materials are already used in dental laboratories for previously cleared devices..."
- "No new concerns are introduced with the new TrueFunction® - Adjustable Herbst Appliances that are not present in the predicate devices."
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a medical device clearance based on substantial equivalence, not a study involving a test set of data points as would be typical for an AI/algorithm-based device. No patient data (test set) was used for this clearance.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No ground truth for a test set was established as no clinical study was performed.
4. Adjudication Method for the Test Set
Not applicable. No test set was used.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. This document does not mention any MRMC comparative effectiveness study or AI assistance. The device is a physical intraoral appliance, not an AI software.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is a physical device, not an algorithm.
7. The type of ground truth used
Not applicable. No clinical data or ground truth in the context of diagnostic performance was used for this 510(k) clearance. The "ground truth" for clearance is the established safety and effectiveness of the predicate devices and the demonstration that the new device is substantially equivalent to them.
8. The sample size for the training set
Not applicable. No training set was used.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
Summary of the K170578 Clearance for TrueFunction Adjustable Herbst Appliances:
This 510(k) clearance is for a physical medical device (intraoral appliance) and not for an AI diagnostic algorithm. Therefore, many of the questions related to clinical study design, test sets, training sets, ground truth, and expert adjudication are not applicable. The clearance is based on demonstrating substantial equivalence to already legally marketed predicate devices through a comparison of intended use, technological characteristics (design, function, materials), and compliance with relevant performance standards (biocompatibility). No new clinical data or human performance studies were required or submitted, leveraging the "least burdensome provisions" of the FDA Modernization Act of 1997.
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True Function Laboratory, Inc
November 24, 2017
% Nicolas Azar Managing Director Azar & Associates Po Box 800914 Santa Clarita, California 91380
Re: K170578
Trade/Device Name: True Function Adjustable Herbst Appliances 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: LRK Dated: October 27, 2017 Received: November 1, 2017
Dear Nicolas Azar:
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.
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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 (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.
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
For 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
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Indications for Use
510(k) Number (if known) K170578
Device Name
TrueFunction® Adjustable Herbst Appliance
Indications for Use (Describe)
"The TrueFunction® Adjustable Herbst Appliance is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
The TrueFunction® Adjustable Herbst Appliance is a prescription only appliance that is customized by True Function Laboratory to dentist specific instructions."
| 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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K170578 510(k) SUMMARY
| CONTACT: | Mr. Frank MadrigalTrue Function Laboratory, Inc.7851 University Ave., #102La Mesa, CA 91942Tel: (619) 466-1872Fax: (619) 466-2383 |
|---|---|
| DATE PREPARED: | October 27, 2017 |
| TRADE OR PROPRIETARY NAME: | TrueFunction® - Adjustable Herbst Appliances |
| CLASSIFICATION NAME: | Device, Anti Snoring |
| REGULATION NUMBER: | CFR 872.5570 |
| REGULATION NAME: | Intraoral devices for snoring and obstructive sleepapnea |
| PRODUCT CODE: | LRK |
| CLASSIFICATION PANEL: | Dental Devices |
| REGULATORY CLASS: | Class II |
| PREDICATE DEVICE: | ACRYLIC SPLINT HERBST (K113126)/PrimaryDORSAL ADJUSTABLE K130130) /ReferenceDynaFlex® (K103076)/ Reference |
DEVICE DESCRIPTION:
TrueFunction® - Adjustable Herbst Appliances are primarily polymer trays that are used intraorally over the dentition to make the mandible protrude. Material composition of the proposed devices include acrylic PMMA, dual laminate polymers, stainless steel ball clasps, exing elements and adjustment key and colorant. Also provided with the device is a stainless steel key used to make necessary mandibular protrusion adjustments by turning the screws as needed.
They are available in three mandibular advancement models: The Dual Laminate, the Acrylic with Clasp, and the Acrylic without Clasp model.
The Dual Laminate - this model has a soft, rubbery surface on the inside of each piece and a hard acrylic surface on the outside without metal clasps for retention. The appliance is held in place by the soft, rubbery liner. Patients must have adequate natural undercuts for retention of the Dual Laminate model, because retention cannot be increased during treatment, and the appliance cannot be modified to accommodate new tooth restorations or the loss of posterior teeth.
The Acrylic with Clasp and Acrylic without Clasp - the acrylic with clasp model has several metal ball clasps, which can be adjusted to increase retention on teeth that have insufficient
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undercuts. The ball clasps can often be modified, should further dental work be performed and adjustments required. For the non-clasp model, the patient must have adequate natural undercuts because retention cannot be increased during treatment, and the appliance cannot be modified to accommodate new tooth restorations or the loss of posterior teeth.
TrueFunction® - Adjustable Herbst Appliances mandible protrusion is controlled by stainless steel tubes & rods or screws for all three mandibular advancement designs. Each device is fabricated to the prescription of a dentist.
TrueFunction® - Adjustable Herbst Appliances device components comes in contact with the patient's gum (please reference the diagram below), and are composed of Methyl Methacrylate, Thermoplastic Polyurethane and high grade Chromium-nickel steel.
INTENDED USE:
The TrueFunction® Adjustable Herbst Appliance is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.
The TrueFunction® Adjustable Herbst Appliance is a prescription only appliance, that is customized by True Function Laboratory to dentist specific instructions.
TECHNOLOGICAL CHARACTERISTICS vs. THE PREDICATE DEVICES:
The TrueFunction® - Adjustable Herbst Appliances are essentially identical in indications for use to the predicate devices of DynaFlex® (K103076) Anti-snoring and Sleep Apnea Devices; Acrylic Splint HERBST (K113126) appliance; and DORSAL Adjustable (K130130) Appliances. Both the present and predicate devices are customized for the patient using a prescription from the dentist. The scientific principle for the device is mandibular advancement determined by the design of the device.
Three model designs of the TrueFunction® Adjustable Herbst Appliances are included which are denoted as TrueFunction® Adjustable Dual Laminate, TrueFunction® Adjustable Acrylic with Clasp, and TrueFunction® Adjustable Acrylic, which we believe are equivalent to the predicate DynaFlex® (K103076) Anti-snoring and Sleep Apnea Devices; Acrylic Splint HERBST (K113126) appliance; and DORSAL Adjustable (K130130) Appliances, respectively. The TrueFunction® - Adjustable Herbst Appliances and the predicate Anti-Snoring & Sleep Apnea
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Devices are composed primarily of dental polymers. Dental acrylic and dual-laminate polymers, and stainless steel are used in the predicate and TrueFunction® Adjustable Herbst Appliances designs.
The following provides an overview of the predicate devices with common design and application features, previously cleared by the FDA, compared to the proposed device.
| System: | HerbstAdjustableAppliance | DorsalAppliance | Acrylic HerbstAppliance(Primary) | DynaFlex Anti-Snoring & SleepApnea Device |
|---|---|---|---|---|
| Manufacturer: | True FunctionLaboratory | Gergen'sOrthodontics | Gergen'sOrthodontics | DynaFlex |
| 510(k): | K170578 | K130130 | K113126 | K103076 |
| Intended Use: | The reduction ofnight time snoringand mild tomoderateobstructive sleepapnea (OSA) | The reduction ofnight time snoringand mild tomoderateobstructive sleepapnea (OSA) | The reduction ofnight time snoringand mild tomoderateobstructive sleepapnea (OSA) | The reduction ofnight time snoringand mild tomoderateobstructive sleepapnea (OSA) |
| Target population: | Adult | Adult | Adult | Adult |
| Prescription use: | Prescription only | Prescription only | Prescription only | Prescription only |
| Basic Design: | Upper and lowersplints having anadjustmentmechanism | Upper and lowersplints having anadjustmentmechanism | Upper and lowersplints having anadjustmentmechanism | Upper and lowersplints having anadjustmentmechanism |
| Function: | To increase thepatient's thepharyngeal spaceand improve airexchange therebyreduce snoringand apnea byanteriorrepositioning ofthe mandible | To increase thepatient's thepharyngeal spaceand improve airexchange therebyreduce snoringand apnea byanteriorrepositioning ofthe mandible | To increase thepatient's thepharyngeal spaceand improve airexchange therebyreduce snoringand apnea byanteriorrepositioning ofthe mandible | To increase thepatient's thepharyngeal spaceand improve airexchange therebyreduce snoringand apnea byanteriorrepositioning ofthe mandible |
| Materials ofmanufacturer: | Medical gradeacrylic andstainless steel | Medical gradeacrylic andstainless steel | Medical gradeacrylic andstainless steel | Medical gradeacrylic andstainless steel |
| Adjustability: | Yes, byprescribingdentist orphysician | Yes, byprescribingdentist orphysician | Yes, byprescribingdentist orphysician | Yes, byprescribingdentist orphysician |
| System: | HerbstAdjustableAppliance | DorsalAppliance | Acrylic HerbstAppliance | DynaFlex Anti-Snoring & SleepApnea Device |
| Adjustmentmechanism: | Yes, turnbuckle | Yes, turnbuckle | Yes, telescopic | Yes, turnbuckle |
| Adjustable range: | 5mm | 5mm | 5.5mm | 5mm |
| Method ofmanufacturer: | Patient-specificcustomizedfabrication | Patient-specificcustomizedfabrication | Patient-specificcustomizedfabrication | Patient-specificcustomizedfabrication |
| Sterility: | Non-sterile | Non-sterile | Non-sterile | Non-sterile |
Material Composition
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From the chart above, the only differences between the subject device and the primary predicate is the type of advancement mechanism used and the adjustable range allowed by the devices. Although the advancement mechanism differs, the type used for the subject device is also used in other similar intra-oral devices such as the reference predicate device (Dorsal Appliance). Therefore, the difference in the type of advancement mechanism does not raise any new safety and effectiveness questions.
The adjustable range of the Herbst Acrylic predicate device is slightly higher than the subject device; however this range falls within the limits of other similar predicate devices.
In comparison to the predicate device, the TrueFunction® - Adjustable Herbst Appliances have
- · the same intended use (as described above).
- · technological characteristics which do not raise new questions of safety and effectiveness.
Therefore TrueFunction® - Adjustable Herbst Appliances as designed and manufactured can be found substantially equivalent to the referenced predicate devices.
NON CLINICAL PERFORMANCE DATA:
TrueFunction® Adjustable Herbst Appliances conforms to the requirements of the FDA Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA published on November 12, 2002. True Function Laboratory, Inc. performed no non-clinical testing, However, evaluation of the materials of construction and design were performed and found that the material composition of the TrueFunction® Adjustable Herbst Appliances (polymethyl methacrylate acrylic-PMMA, dual laminate polymers, stainless steel ball clasps, and stainless steel fixing elements) to comply with the Standard ISO 7405 and ISO 10993 part 5 and part 10 referenced per 21 CFR 872.5570 Intraoral devices for snoring and/or obstructive sleep apnea, product code LRK. The material characteristic of the TrueFunction® Adjustable Herbst Appliances, meeting ASTM standards, have been found to be substantially equivalent to the predicate device material characteristics.
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No new materials are used in the TrueFunction® - Adjustable Herbst Appliances; all materials are already used in dental laboratories for previously cleared devices of a related nature. The Material Safety Data Sheet (MSDS) of all material used in the fabrication of the TrueFunction® -Adjustable Herbst Appliances have been included in this submission for your review No new concerns are introduced with the new TrueFunction® - Adjustable Herbst Appliances that are not present in the predicate devices.
BIOCOMPATIBILITY:
The materials and fabrication of the proposed and predicate device are identical. The Material Safety Data Sheet (MSDS) for all material composition (polymethyl methacrylate acrylic-PMMA, dual laminate polymers, stainless steel ball clasps, and stainless steel fixing elements) of the TrueFunction® - Adjustable Herbst Appliances have been provided with this submission and same materials was found to comply with the Standard ISO 10993 part 5 and part 10 referenced per 21 CFR 872.5570 Intraoral devices for snoring and/or obstructive sleep apnea, product code LRK.
CLINICAL DATA:
None is provided, in accordance with the least burdensome provisions of the FDA Modernization Act of 1997. Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA issued November 12, 2002 item 8, Clinical testing states, the agency does not request clinical studies for new devices whose intended use is identical to that of the claimed predicate device, having similar design and technology.
CONCLUSIONS:
By comparison and analysis of the new and predicate devices, we note herein that the intended use, the designs, the functions, and the polymeric and stainless steel materials for the acrylic and the dual-laminate polymer models of TrueFunction® - Adjustable Herbst Appliances are the same as the predicate.
We believe that the analysis provided herein supports the substantial equivalence of the proposed device to its predicate devices, and as such, the proposed TrueFunction® - Adjustable Herbst Appliances are substantially equivalent to the legally marketed predicate devices.
§ 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.”