(477 days)
The Reza Band® UES Assist Device is indicated for patients 18 years and older to reduce the symptoms of larvngopharyngeal reflux (LPR) disease by reducing the regurgitation of stomach contents from passing through the upper esophageal sphincter. The device is worn by the patient when sleeping.
The Reza Band® UES Assist Device (Reza Band) (Figure 1) is a non-invasive, non-sterile device worn by the patient and is designed to provide a set pressure (20-30 mm Hg) on the cricoid cartilage, which increases the luminal pressure within the upper esophageal sphincter (UES). The patient wears the Reza Band after being fit by the physician (Figure 2).
The Reza Band has 5 main components:
- Frame
- Cushion
- Comfort Band
- Clasp
- Comfort Dial
The Reza Band® External Manometer (External Manometer) is a hand-held device and is connected to the Reza Band® Pressure Sensor (Pressure Sensor). It is used by the treating physician, is powered by a AAA battery and displays the pressure being applied to the cricoid cartilage region by the Reza Band in millimeters of Mercury (mm Hg) as the Reza Band® is being fitted (Figure 3).
The Pressure Sensor connected to the External Manometer is regulated as a miniature pressure transducer (21 CFR Part 890.1615) which is Class I exempt. The Pressure Sensor and the External Manometer were assessed to ensure that the Reza Band® was accurately applying the specified pressure.
The Reza Band® Upper Esophageal Sphincter (UES) Assist Device did not undergo a study that assessed its performance against specific, pre-defined acceptance criteria with a quantifiable metric (e.g., accuracy, sensitivity, specificity). Instead, the studies focused on demonstrating the safety and effectiveness of the device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, there isn't a direct table of "acceptance criteria" where a specific quantitative metric (like accuracy or AUC) is listed alongside a target value and then the device's performance against that target for a classification task. The studies provided focus on demonstrating safety and symptomatic improvement.
Bench Test Acceptance Criteria and Results (from Table 2):
| Test | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Reza Band Neck Ring Lifetime Test | Retention of intended functionality over 6-month use period. | All established acceptance criteria were met. |
| Reza Band Mechanical Test | - Comfort Band: No significant change in length after pull testing. |
- Frame Pusher: No damage/failures; Comfort Dial functions as intended after pull testing.
- Frame Body: No failure, damage, or deformation after force application. | - Comfort Band: Length not significantly different after being pulled.
- Frame Pusher: No damage or failures; Comfort Dial continued to function.
- Frame Body: Did not fail; no damage noted after being subjected to force. |
| Reza Band Accelerated Aging Shelf Life Testing | Retention of intended functionality over simulated 6-month shelf life. | With the exception of observations regarding Frame Body magnets (rationale provided), acceptance criteria were met. |
| Reza Band, External Manometer and Pressure Sensor Shipping Test | Withstand damage and retain intended functionality after simulated shipping conditions. | Demonstrated continued functionality and conformance with specifications. |
| External Manometer Pressure Measurement Accuracy Testing | Pressure measurement accuracy within design specifications. | Within (b)(4) mmHg as specified over the (b)(4) range. |
| External Manometer Life Test | Maintain functionality over its intended 600-use lifetime. | All established acceptance criteria were met following (b)(4) (in excess of 600-use requirement). |
Clinical Study Effectiveness Endpoint (from Study #1):
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Primary Effectiveness Endpoint: Percent reduction in Reflux Symptom Index (RSI) from Baseline to Visit 3 (Week 4) | - Mean % change in RSI from Baseline to Visit 3: -54.3% (p25%): |
§ 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.