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External Upper Esophageal Sphincter (Ues) Compression Device

Page Type
Product Code
Definition
The external UES compression device is intended to reduce the symptoms of laryngopharyngeal reflux (LPR) disease by reducing the regurgitation of stomach contents from passing through the upper esophageal sphincter.
Physical State
The external UES compression device consists of an externally worn band. The band typically consists of a cushion, a comfort band, a frame, comfort dial and clasp.
Technical Method
The external UES compression device is worn by the patient and is designed to provide a set pressure on the cricoid cartilage, which increases the luminal pressure within the upper esophageal sphincter (UES).
Target Area
An upper esophageal sphincter (UES) compression device, which applies external pressure on the cricoid cartilage right below the Adam's apple.
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
874.5900
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 874.5900 External upper esophageal sphincter compression device

§ 874.5900 External upper esophageal sphincter compression device.

(a) Identification. An external upper esophageal sphincter compression device is a prescription device used to apply external pressure on the cricoid cartilage for the purpose of reducing the symptoms of laryngopharyngeal reflux disease.

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

(1) The patient contacting components must be demonstrated to be biocompatible.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be demonstrated:

(i) Mechanical integrity testing (e.g., tensile strength testing, fatigue testing) and

(ii) Shelf life testing.

(3) The technical specifications must include pressure measurement accuracy to characterize device performance.

(4) Clinical performance testing must document any adverse events observed during clinical use, and demonstrate that the device performs as intended under anticipated conditions of use.

(5) Labeling must include the following:

(i) Appropriate warnings and precautions,

(ii) A detailed summary of the clinical testing pertinent to use of the device including a detailed summary of the device-related complications or adverse events,

(iii) Detailed instructions on how to fit the device to the patient, and

(iv) Instructions for reprocessing of any reusable components.

(6) Patient labeling must be provided and must include:

(i) Relevant warnings, precautions, and adverse effects/complications,

(ii) Information on how to correctly wear the device,

(iii) The potential risks and benefits associated with the use of the device,

(iv) Alternative treatments, and

(v) Reprocessing instructions.

[80 FR 46194, Aug. 4, 2015]

External Upper Esophageal Sphincter (Ues) Compression Device

Page Type
Product Code
Definition
The external UES compression device is intended to reduce the symptoms of laryngopharyngeal reflux (LPR) disease by reducing the regurgitation of stomach contents from passing through the upper esophageal sphincter.
Physical State
The external UES compression device consists of an externally worn band. The band typically consists of a cushion, a comfort band, a frame, comfort dial and clasp.
Technical Method
The external UES compression device is worn by the patient and is designed to provide a set pressure on the cricoid cartilage, which increases the luminal pressure within the upper esophageal sphincter (UES).
Target Area
An upper esophageal sphincter (UES) compression device, which applies external pressure on the cricoid cartilage right below the Adam's apple.
Regulation Medical Specialty
Ear, Nose, Throat
Review Panel
Ear, Nose, Throat
Submission Type
510(K)
Device Classification
Class 2
Regulation Number
874.5900
GMP Exempt?
No
Summary Malfunction Reporting
Eligible
Implanted Device
No
Life-Sustain/Support Device
No
Third Party Review
Not Third Party Eligible

CFR § 874.5900 External upper esophageal sphincter compression device

§ 874.5900 External upper esophageal sphincter compression device.

(a) Identification. An external upper esophageal sphincter compression device is a prescription device used to apply external pressure on the cricoid cartilage for the purpose of reducing the symptoms of laryngopharyngeal reflux disease.

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

(1) The patient contacting components must be demonstrated to be biocompatible.

(2) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following performance characteristics must be demonstrated:

(i) Mechanical integrity testing (e.g., tensile strength testing, fatigue testing) and

(ii) Shelf life testing.

(3) The technical specifications must include pressure measurement accuracy to characterize device performance.

(4) Clinical performance testing must document any adverse events observed during clinical use, and demonstrate that the device performs as intended under anticipated conditions of use.

(5) Labeling must include the following:

(i) Appropriate warnings and precautions,

(ii) A detailed summary of the clinical testing pertinent to use of the device including a detailed summary of the device-related complications or adverse events,

(iii) Detailed instructions on how to fit the device to the patient, and

(iv) Instructions for reprocessing of any reusable components.

(6) Patient labeling must be provided and must include:

(i) Relevant warnings, precautions, and adverse effects/complications,

(ii) Information on how to correctly wear the device,

(iii) The potential risks and benefits associated with the use of the device,

(iv) Alternative treatments, and

(v) Reprocessing instructions.

[80 FR 46194, Aug. 4, 2015]