21 CFR 874.5900 — External Upper Esophageal Sphincter (Ues) Compression Device
Ear, Nose, Throat (EN) · Part 874 Subpart F—Therapeutic Devices · § 874.5900
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.
Classification Rationale
Class II (special controls). The special controls for this device are:
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| PKA | External Upper Esophageal Sphincter (Ues) Compression Device | 2 | 2 |
Special Controls
PKA — External Upper Esophageal Sphincter (Ues) Compression Device
In combination with the general controls of the FD&C Act, the External UES Compression Device is subject to the following special controls:
De Novo Order DEN130046
PKA — External Upper Esophageal Sphincter (Ues) Compression Device
*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.
eCFR
PKA — External Upper Esophageal Sphincter (Ues) Compression Device
(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.
Ecfr Llm
