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510(k) Data Aggregation
(477 days)
Sensor connected to the External Manometer is regulated as a miniature pressure transducer (21 CFR Part 890.1615
Sensor connected to the External Manometer is regulated as a miniature pressure transducer (21 CFR Part 890.1615
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%): |
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(57 days)
Palpometer
Common Name: palpometer
Classification Name: Miniature pressure transducer (per 21 CFR 890.1615
Boxborough, Massachusetts 01719
Re: K060125
Trade/Device Name: Sonic Palpometer Regulation Number: 21 CFR 890.1615
The intended use of the Sonic Palpometer is to assess patient sensitivity to tactile stimulus by providing quantification of fingertip pressure, for tactile response procedures and freatments that use digital palpation.
The Palpometer is a simple device that combines the fine motor and sensory attributes of manual examination with the precision measurements made with pressure gauges. By measuring the amount of pressure between the device and a soft tissue, the Palpometer standardizes pain response by controlling the pressure of the examiner's palpating finger. The Palpometer consists of a thin sensor, positioned on the palpating portion of the examiner's finger. The sensor changes its electrical resistance caused by varying the pressure exercised by the examining finger. The Palpometer beeps in a different tone as you pass through each programmable pressure threshold (of which there are five).
The Palpometer is a device designed to quantify fingertip pressure during digital palpation to assess patient sensitivity to tactile stimuli. The provided documentation (K060125) describes the device and references several studies to demonstrate its equivalence and performance relative to conventional pain measurement methods.
Here's an analysis of the acceptance criteria and the studies mentioned:
1. Table of Acceptance Criteria and the Reported Device Performance
The submission does not explicitly state formal "acceptance criteria" with specific quantitative thresholds that the device must meet for approval. Instead, it presents a summary of "Substantial Equivalence Data" by comparing the Palpometer's performance with established methods of pain measurement found in published literature. The reported performance focuses on correlations, reliability, and differences in statistical significance.
| Acceptance Criteria (Inferred from study outcomes and comparisons) | Reported Device Performance (as described in the studies cited) |
|---|---|
| Intraobserver reliability (compared to conventional methods) | Atkins et al. (1992): Intraobserver error of 0.12 for Palpometer vs. 0.2 for conventional method (in rheumatoid arthritis tender joint scores), indicating superior reliability. |
| Construct Validity / Correlation with conventional measurements (indicating agreement or ability to measure the same underlying construct) | Atkins et al. (1992): Correlation coefficient between Palpometer and conventional measurements increased from 0.62 to 0.78 (excluding less sensitive instruments), indicating a high level of construct validity. |
| Interobserver agreement/reliability (demonstrating consistency across different observers) | Bendtsen et al. (1995): Sum of tenderness scores by two observers using conventional palpation differed significantly (P=0.0003), while results did not differ using pressure-controlled palpation (P=0.89), demonstrating improved interobserver reliability with the Palpometer. |
| Correlation with pain intensity (demonstrating the device's ability to measure pain) | Bendtsen et al. (1995): Positive linear correlation between pressure and pain intensity (P=0.00006) in headache tender point scores. |
| Correlation with conventional scores / Test-retest reliability (in specific conditions like fibromyalgia) | Bennet et al. (1996): Good correlation (point estimates >0.7) between Palpometer and conventional scores in fibromyalgia. Test-retest measurements showed similar correlation (>0.7), indicating good reliability. |
| Ability to show a linear relationship between pressure and pain (as expected in controls) | Bendsten et al. (1997): In controls, a linear relationship between pressure and pain was found in a double logarithmic plot (slope (ß) was 3.5 ± 0.66 log mm/log Uj P |
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