(260 days)
The Acrylic Herbst Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep appea (OSA) in adults 18 years of age or older.
When a DentiTrac® micro-recorder is embeded into the Acrylic Herbst Appliance, the micro-recorder is intended to measure patient compliance to oral device/appliance therapy in combination with the DentiTrac® System.
The Acrylic Herbst Appliance with Micro-Recorder is comprised of upper and lower customized acrylic splints which are connected bilaterally via a telescoping Herbst mechanism for the treatment of mild to moderate sleep apnea. The micro-recorder is embedded within the appliance. The device aims to improve the patient's air exchange thereby reduce snoring and apnea by increasing the pharyngeal space through anterior repositioning of the mandible. The micro-recorder permits a patient's compliance to prescribed oral therapy to be monitored. The patient contacting portions of the appliance are comprised of medical grade polymethylmethacrylate (acrylic splints) and) which are connected bilaterally via a stainless steel (Herbst) mechanism.
The provided document is a 510(k) summary for a medical device (Acrylic Herbst Appliance with Micro-Recorder) seeking FDA clearance. It focuses on demonstrating substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study to prove they are met in the way a clinical trial for a novel AI device would.
Here's an analysis based on the information provided, noting what is explicitly stated and what is not applicable or not detailed in this type of submission:
1. Table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance |
|---|---|
| Biocompatibility: | Accepted based on identical materials and fabrication processes to the predicate device. |
| Mechanical Performance: | Satisfactory, based on testing of the identical material used for both the subject and predicate devices against ISO standards for Tensile strength, Elongation at tear, E-modulus, Flexion strength, Impaction strength, and Rockwell hardness. |
| Thermal Performance: | Satisfactory, based on testing of the identical material used for both the subject and predicate devices against ISO standards for Vicat softening point and Thermoform resistance. |
| Intended Use: | The same as the predicate devices: reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults 18 years or older, and measurement of patient compliance (with micro-recorder). |
| Technological Characteristics: | The fundamental scientific technology and basic design (upper and lower splints with adjustment mechanism, embedded micro-recorder) are the same as predicate devices. |
| Safety and Effectiveness: | The device does not raise new questions of safety and effectiveness as it has the same intended use and technological characteristics as predicate devices. Risks identified were mitigated through biocompatible materials and appropriate labeling. |
2. Sample size used for the test set and the data provenance
- Not Applicable. This submission is for a physical medical device (intraoral appliance), not an AI/software device. The "test set" for performance was material testing, not patient data in the typical sense of AI evaluation.
- The material performance data appears to be from in-vitro laboratory testing, not specific patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. This information is irrelevant for a physical device where "ground truth" relates to material properties validated by standardized tests.
4. Adjudication method for the test set
- Not Applicable. No human adjudication of patient data for 'ground truth' was performed or described in this type of submission. Material testing results are objective measurements against standards.
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
- Not Applicable. This is not an AI device. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this device's performance relies on:
- Material Standards (ISO): For mechanical and thermal properties.
- Predicate Device Equivalence: The primary "ground truth" for the overall device's safety and effectiveness is its substantial equivalence to previously cleared predicate devices, meaning that if the predicate was safe and effective, and this device is sufficiently similar, then it is also considered safe and effective for its stated use.
- Risk Analysis: Per the Class II Special Controls Guidance Document to identify and mitigate risks.
8. The sample size for the training set
- Not Applicable. This is not an AI device.
9. How the ground truth for the training set was established
- Not Applicable. This is not an AI device.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study proving the device meets acceptance criteria, as described in this 510(k) summary, is not a clinical trial or an AI performance study, but rather a demonstration of substantial equivalence to legally marketed predicate devices.
The key "studies" presented are:
- Material Performance Testing: The device's materials were subjected to mechanical (Tensile strength, Elongation at tear, E-modulus, Flexion strength, Impaction strength, Rockwell hardness) and thermal (Vicat softening point, Thermoform resistance) performance tests against ISO standards. The results were found "satisfactory" because the identical material is used for both the subject and predicate devices, implying that the material properties are equivalent and thus acceptable.
- Biocompatibility Justification: No additional biocompatibility testing was supplied as the materials and fabrication processes are identical to the predicate device, which had already established biocompatibility.
- Comparative Analysis of Technological Characteristics: A detailed comparison table ([pages 5-6]) highlights the similarities in intended use, target population, prescription status, basic design, adjustability, and manufacturing methods between the proposed device and two predicate devices (SomnoDent® with Micro-Recorder K150369 and Acrylic Herbst Appliance K113126). The "differences" (e.g., adjustment mechanism, materials for the micro-recorder variant, adjustable range) were deemed not to raise new questions regarding safety or effectiveness.
- Risk Analysis: A risk analysis was performed per FDA guidance for intraoral devices for snoring and OSA, and identified risks were mitigated through the use of biocompatible materials (identical to predicate) and appropriate labeling.
In essence, the "study" is a regulatory comparison and material characterization, establishing that the new device is fundamentally the same as already cleared devices, and therefore does not require new clinical data to prove its safety and effectiveness. Clinical testing of the subject device was explicitly stated as not used in support of clearance.
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November 16, 2017
Gergen's Orthodontic Lab % Karen E. Warden, Ph.D. President BackRoads Consulting PO Box 566, Chesterland, Ohio 44026-0566
Re: K170606
Trade/Device Name: Acrylic Herbst Appliance with Micro-Recorder 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 Dated: October 10, 2017 Received: October 11, 2017
Dear Karen E. Warden, Ph.D .:
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 (OS) 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
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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement on last page.
510(k) Number (if known)
Device Name
Acrylic Herbst Appliance with Micro-Recorder
Indications for Use (Describe)
The Acrylic Herbst Appliance is intended for the reduction of night time snoring and mild to moderate obstructive sleep appea (OSA) in adults 18 years of age or older.
When a DentiTrac® micro-recorder is embeded into the Acrylic Herbst Appliance, the micro-recorder is intended to measure patient compliance to oral device/appliance therapy in combination with the DentiTrac® System.
Type of Use (Select one or both, as applicable)
区 Prescription Use (Part 21 CFR 801 Subpart D)
_ Over-The-Counter Use (21 CFR 801 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)
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| 510(k) Summary | K170606 |
|---|---|
| Date: | 27 February 2017 |
| Sponsor: | Gergen's Orthodontic Lab Inc.1745 West Deer Valley Rd, Suite 112Phoenix, AZ 85027Phone: 623-879-6066Fax: 623-879-6166 |
| Contact Person: | Chris Morrison, Lab Manager |
| 510(k) Contact: | Karen E. Warden, PhDBackRoads Consulting Inc.PO Box 566Chesterland, OH 44026Office: 440.729.8457 |
| Proposed Trade Name | Acrylic Herbst Appliance with Micro-Recorder |
| Common Name: | Sleep appliance with patient monitoring |
| Regulatory Class: | Class II |
| Classification Name,Regulation, ProductCode: | Intraoral devices for snoring and intraoral devices for snoring andobstructive sleep apnea, 872.5570, PLC |
| Device Description: | The Acrylic Herbst Appliance with Micro-Recorder is comprised of upperand lower customized acrylic splints which are connected bilaterally via atelescoping Herbst mechanism for the treatment of mild to moderate sleepapnea. The micro-recorder is embedded within the appliance.The device aims to improve the patient's air exchange thereby reducesnoring and apnea by increasing the pharyngeal space through anteriorrepositioning of the mandible. The micro-recorder permits a patient'scompliance to prescribed oral therapy to be monitored.The patient contacting portions of the appliance are comprised of medicalgrade polymethylmethacrylate (acrylic splints) and) which are connectedbilaterally via a stainless steel (Herbst) mechanism. |
| Indications for use: | The Acrylic Herbst Appliance is intended for the reduction of night timesnoring and mild to moderate obstructive sleep apnea (OSA) in adults 18years of age or older.When a DentiTrac® micro-recorder is embedded into the Acrylic HerbstAppliance, the micro-recorder is intended to measure patient compliance tooral device/appliance therapy in combination with the DentiTrac® System. |
| Materials: | The patient contacting portions of the appliance are comprised of medicalgrade polymethylmethacrylate (acrylic splints) and) which are connectedbilaterally via a stainless steel (Herbst) mechanism. |
| Primary Predicate: | SomnoDent® with Micro-Recorder (SomnoMed, Inc., K150369) |
| Reference Device: | Acrylic Herbst Appliance (Gergen's Orthodontic Lab, K113126) |
| Performance Data: | The materials and fabrication processes used in the manufacture of thesubject device are identical to the materials and fabrication processes usedin the manufacture of the predicate device.Because material biocompatibility was accepted for the predicate andbecause there are no differences in manufacturing which could affectbiocompatibility, additional biocompatibility testing was not supplied insupport of this clearance.Data regarding mechanical and thermal performance testing of the devicematerial and provided as follows: |
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| Mechanical | Thermal | ||
|---|---|---|---|
| Test | Standard | Test | Standard |
| Tensile strength | Vicat softening point | ISO 306 (B) | |
| Elongation at tear | ISO 527 | Thermoform resistance | ISO 75 (A) |
| E-modulus | ISO 75 (B) | ||
| Flexion strength | ISO 178 | ||
| Impaction strength 23°C | ISO 179 | ||
| Notched 23°C | |||
| Rockwell hardness | ISO 2039 |
Because the identical material is used for both the subject and predicate devices, these performance results were found to be satisfactory and therefore support the finding of substantial equivalence.
Clinical testing of the subject device was not used in support of clearance. Per the Class II Special Controls Guidance Document: Intraoral Devices for Snoring and/or Obstructive Sleep Apnea; Guidance for Industry and FDA, a risk analysis was performed with respect to the subject device. The risks identified in the guidance (e.g., intraoral gingival, palatal, or dental soreness; TMJ Dysfunction Syndrome; obstruction of oral breathing and loosening or flaring of lower anterior teeth or general tooth movement) and those detected by the risk analysis were mitigated though the use of biocompatible materials identical to those used in the predicate and the use of appropriate labeling.
Technoloqical The fundamental scientific technology of the Acrylic Herbst Appliance with Characteristics: Micro-Recorder is the same as the previously cleared device shown below, i.e., each of the design features is common to a predicate.
| System: | Acrylic HerbstAppliance with Micro-Recorder | SomnoDent® withMicro-Recorder | Acrylic HerbstAppliance |
|---|---|---|---|
| Manufacturer: | Gergen's OrthodonticLab | SomnoMed, Inc. | Gergen's OrthodonticLab |
| 510(k): | Under review | K150369 | K113126 |
| Intended use: | The reduction of nighttime snoring and mild tomoderate obstructivesleep apnea (OSA) andmeasurement of patientcompliance | The reduction of nighttime snoring and mild tomoderate obstructivesleep apnea (OSA) andmeasurement of patientcompliance | The reduction of nighttime snoring and mild tomoderate obstructivesleep apnea (OSA) |
| Target population: | Adults | Adults | Adults |
| Prescription use: | Prescription only | Prescription only | Prescription only |
| Basic Design: | Upper and lower splintshaving an adjustmentmechanism and fullyembedded micro-recorder | Upper and lower splintshaving an adjustmentmechanism and fullyembedded micro-recorder | Upper and lower splintshaving an adjustmentmechanism |
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| System: | Acrylic HerbstAppliance with Micro-Recorder | SomnoDent® withMicro-Recorder | Acrylic HerbstAppliance |
|---|---|---|---|
| Manufacturer: | Gergen's OrthodonticLab | SomnoMed, Inc. | Gergen's OrthodonticLab |
| 510(k): | Under review | K150369 | K113126 |
| Materials ofmanufacture: | Medical grade acrylic,stainless steel andDentiTrac® micro-recorder | Hard surface acrylicwith soft lining material,surgical grade stainlesssteel and embeddedDentiTrac® Micro-recorder | Medical grade acrylicand stainless steel |
| Adjustability: | Yes, by prescribingdentist or physician | Yes, by prescribingdentist or physician | Yes, by prescribingdentist or physician |
| Adjustmentmechanism: | Yes, telescopic | Yes, turnbuckle | Yes, telescopic |
| Adjustable range: | 5.5mm | 6mm (-0.5, +5.5mm) | 5.5mm |
| Method ofmanufacture: | Patient-specificcustomized fabrication | Patient-specificcustomized fabrication | Patient-specificcustomized fabrication |
| Sterility: | Non-sterile | Non-sterile | Non-sterile |
Conclusion:
In comparison to the predicate devices, the Acrylic Herbst Appliance with Micro-Recorder has
- the same intended use (as described above), .
- . the same technological characteristics (as described above)
and so does not raise new questions of safety and effectiveness.
Therefore the Acrylic Herbst Appliance with Micro-Recorder is as safe and as effective for its intended use, and performs as well as the predicate devices. The Acrylic Herbst Appliance with Micro-Recorder can be found substantially equivalent to the 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.”