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Closed Loop Auto Titration Device For Oral Appliances

Page Type
Product Code
Definition
A closed-loop autotitration device for intraoral appliances uses a feedback control to record changes in the patient’s respiratory status related to repositioning of the mandible during an overnight study. The data are analyzed by a Healthcare Provider and can then be used to prospectively identify patients with mild to moderate obstructive sleep apnea who may be suitable for therapy with an oral appliance and to recommend a target mandibular position.
Physical State
Temporary intraoral mouthpiece attached to recorders and sensors to monitor physiologic responses to airflow and oxygen desaturation during sleep.
Technical Method
Device functions as a closed loop auto titration device.
Target Area
Oral cavity.
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.5571
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.5571 Auto titration device for oral appliances

§ 872.5571 Auto titration device for oral appliances.

(a) Identification. An auto-titration device for oral appliances is a prescription home use device that determines a target position to be used for a final oral appliance for the reduction of snoring and mild to moderate obstructive sleep apnea.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing must evaluate the following:

(i) Performance characteristics of the algorithm; and

(ii) All adverse events.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, including the following:

(i) Validation of the closed loop algorithm;

(ii) Mechanical integrity over the expected use life;

(iii) Characterization of maximum force, distance, and speed of device movement; and

(iv) Movement accuracy of intraoral components.

(3) Performance testing must demonstrate the wireless compatibility, electrical safety, and electromagnetic compatibility of the device in its intended use environment.

(4) Software verification, validation, and hazard analysis must be performed.

(5) The patient-contacting components of the device must be demonstrated to be biocompatible.

(6) Performance data must validate the reprocessing instructions for any reusable components.

(7) Patient labeling must include:

(i) Information on device use, including placement of sensors and mouthpieces;

(ii) A description of all alarms; and

(iii) Instructions for reprocessing any reusable components.

(8) A human factors assessment must evaluate simulated use of the device in a home use setting.

[84 FR 5000, Feb. 20, 2019]

Closed Loop Auto Titration Device For Oral Appliances

Page Type
Product Code
Definition
A closed-loop autotitration device for intraoral appliances uses a feedback control to record changes in the patient’s respiratory status related to repositioning of the mandible during an overnight study. The data are analyzed by a Healthcare Provider and can then be used to prospectively identify patients with mild to moderate obstructive sleep apnea who may be suitable for therapy with an oral appliance and to recommend a target mandibular position.
Physical State
Temporary intraoral mouthpiece attached to recorders and sensors to monitor physiologic responses to airflow and oxygen desaturation during sleep.
Technical Method
Device functions as a closed loop auto titration device.
Target Area
Oral cavity.
Regulation Medical Specialty
Dental
Review Panel
Dental
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
872.5571
GMP Exempt?
No
Summary Malfunction Reporting
Ineligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 872.5571 Auto titration device for oral appliances

§ 872.5571 Auto titration device for oral appliances.

(a) Identification. An auto-titration device for oral appliances is a prescription home use device that determines a target position to be used for a final oral appliance for the reduction of snoring and mild to moderate obstructive sleep apnea.

(b) Classification. Class II (special controls). The special controls for this device are:

(1) Clinical performance testing must evaluate the following:

(i) Performance characteristics of the algorithm; and

(ii) All adverse events.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions for use, including the following:

(i) Validation of the closed loop algorithm;

(ii) Mechanical integrity over the expected use life;

(iii) Characterization of maximum force, distance, and speed of device movement; and

(iv) Movement accuracy of intraoral components.

(3) Performance testing must demonstrate the wireless compatibility, electrical safety, and electromagnetic compatibility of the device in its intended use environment.

(4) Software verification, validation, and hazard analysis must be performed.

(5) The patient-contacting components of the device must be demonstrated to be biocompatible.

(6) Performance data must validate the reprocessing instructions for any reusable components.

(7) Patient labeling must include:

(i) Information on device use, including placement of sensors and mouthpieces;

(ii) A description of all alarms; and

(iii) Instructions for reprocessing any reusable components.

(8) A human factors assessment must evaluate simulated use of the device in a home use setting.

[84 FR 5000, Feb. 20, 2019]