(225 days)
Not Found
Not Found
No
The device description and performance studies focus on mechanical and vacuum-based esophageal displacement, with no mention of AI or ML technologies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
No
The device aids in preventing injury during a therapeutic procedure but does not directly treat a disease or condition. Its purpose is protective and adjunctive, not therapeutic.
No
The device is a retractor, intended to displace the esophagus to prevent injury during cardiac ablation procedures, not to diagnose a condition.
No
The device description clearly states it is a "catheter-based device" with physical components (outer sheath, inner mechanical displacement plates, handle and control knob) that exert mechanical force and vacuum suction. This indicates it is a hardware device, not software only.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The esolution® Esophageal Retractor is a surgical device used during a medical procedure (cardiac catheter ablation). Its function is to physically manipulate an anatomical structure (the esophagus) to reduce the risk of injury from the ablation energy. It does not analyze or test any biological specimens.
- Intended Use: The intended use clearly states it's for "deviate the esophagus away from the ablation energy source." This is a mechanical action within the body, not an in vitro test.
The information provided about the device's description, intended use, anatomical site, and performance studies all point to it being a device used in vivo (within the living body) during a surgical procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The esolution® Esophageal Retractor is indicated for use in patients undergoing percutaneous cardiac catheter ablation of atrial fibrillation to deviate the esophagus away from the ablation energy source and to reduce the risk of ablation-related esophageal injury.
Product codes
QXU
Device Description
The esolution® Esophageal Retractor is a catheter-based device designed to displace the esophagus away from the source of ablation energy during percutaneous cardiac catheter ablation procedures and to reduce the risk of ablation energy-induced esophageal injury. The esolution® Esophageal Retractor uses both mechanical force and vacuum suction to grasp the esophagus and deflect it away from the posterior wall of the left atrium in both left and right directions. The device comprises three components: (1) outer sheath, (2) inner mechanical displacement plates, and (3) handle and control knob. The distal end of the outer sheath features two eyelets for attaching a temperature probe (a temperature probe is not required for use of the esolution® Esophageal Retractor). Additional third-party components required for use of the esolution® Esophageal Retractor include:
- Intubation introducer (15 Fr x 70 cm, any manufacturer). .
- . Vacuum line with inner diameter 1/2 in., wall thickness 1/16 in., connected to wall vacuum port (any manufacturer).
- Lubricants: viscous lidocaine and medical lubricant (any manufacturer). .
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Esophagus, left atrium
Indicated Patient Age Range
The mean age of subjects is 61.6 years in the esolution group and 65.3 years in the Control group. Minimum 38.0, Maximum 79.0.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The sponsor conducted a small pilot OUS clinical trial and a pivotal IDE trial (EASY AF study, G200264) to support the clinical performance of the esolution® Esophageal Retractor.
The EASY AF Study is a prospective. randomized, controlled, single-blinded multicenter study of a catheter-based device designed to displace the esophagus away from the source of ablation energy during ablation of atrial fibrillation (AF) and to minimize the risk of esophageal injury.
The study was designed to assess a reduction of esophageal lesions attributable to radiofrequency (RF) ablation with use of the esolution® Esophageal Retractor in comparison to conventional therapy (no use of an esophageal retractor). The randomization is with a 1:1 randomization scheme assigning consecutive patients who meet inclusion and exclusion criteria to either: placement of a luminal esophageal temperature probe (LET) (control group); or, to placement of a LET and insertion esolution® Esophageal Retractor (intervention group). In the control group, there was no deviation of the esophagus and in the intervention group, esolution® Esophageal Retractor was utilized to deviate the esophagus during RF catheter ablation.
The primary study endpoint was the incidence of ablation related esophageal lesions noted on post ablation esophageal endoscopy completed at least > 15 hours to
N/A
0
DE NOVO CLASSIFICATION REQUEST FOR ESOLUTION® ESOPHAGEAL RETRACTOR
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Mechanical deviation device for esophageal protection during cardiac ablation procedures. This device is placed in the lumen of the esophagus to reduce the likelihood of injury or a specific adverse event during cardiac ablation procedures. The device uses mechanical means to deviate the esophagus away from the source of ablation energy.
NEW REGULATION NUMBER: 21 CFR 870.5710
CLASSIFICATION: Class II
PRODUCT CODE: QXU
BACKGROUND
DEVICE NAME: esolution® Esophageal Retractor
SUBMISSION NUMBER: DEN230006
DATE DE NOVO RECEIVED: 01/24/2023
SPONSOR INFORMATION:
S4 Medical Corp. 34 South Main St. Suite 200 Chagrin Falls, Ohio 44022
INDICATIONS FOR USE
The esolution® Esophageal Retractor is indicated as follows:
The esolution® Esophageal Retractor is indicated for use in patients undergoing percutaneous cardiac catheter ablation of atrial fibrillation to deviate the esophagus away from the ablation energy source and to reduce the risk of ablation-related esophageal injury.
LIMITATIONS
The sale, distribution, and use of the esolution® Esophageal Retractor are restricted to prescription use in accordance with 21 CFR 801.109.
1
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The esolution® Esophageal Retractor is a catheter-based device designed to displace the esophagus away from the source of ablation energy during percutaneous cardiac catheter ablation procedures and to reduce the risk of ablation energy-induced esophageal injury. The esolution® Esophageal Retractor uses both mechanical force and vacuum suction to grasp the esophagus and deflect it away from the posterior wall of the left atrium in both left and right directions. The device comprises three components: (1) outer sheath, (2) inner mechanical displacement plates, and (3) handle and control knob. The distal end of the outer sheath features two eyelets for attaching a temperature probe (a temperature probe is not required for use of the esolution® Esophageal Retractor). Additional third-party components required for use of the esolution® Esophageal Retractor include:
- Intubation introducer (15 Fr x 70 cm, any manufacturer). .
- . Vacuum line with inner diameter 1/2 in., wall thickness 1/16 in., connected to wall vacuum port (any manufacturer).
- Lubricants: viscous lidocaine and medical lubricant (any manufacturer). .
Image /page/1/Picture/6 description: The image shows an unassembled ESolution device. The device consists of a control handle, stacking plates, a deflecting arm, and an outer sheath with vacuum suction holes. The components are laid out on a brown surface, with labels indicating each part of the device.
Image /page/1/Picture/8 description: The image shows an E solution device with a sheath assembly. The device is white and has a long, thin tube with eyelets at the end. The device also has a handle with a knob on the end. The text in the image labels the eyelets.
Figure 2: esolution® Esophageal Retractor with temperature probe eyelets highlighted.
2
Image /page/2/Picture/0 description: The image shows a medical device, specifically a flexible endoscope, against a plain background. The device is mostly white and silver, with a control knob on one end and a curved, angled tip on the other. Text in the image indicates that the device is in left deflection and that the control knob arrow is facing to the left, suggesting the direction of the device's movement or orientation. A blue arrow points to the control mechanism, highlighting its role in the device's operation.
solution® Esophageal Retractor with distal portion de
Image /page/2/Picture/2 description: The image shows a medical device on a brown surface. The device is white and has a long, thin tube with a bent end. The handle of the device is larger and has a control knob. There is a blue arrow pointing to the control knob with the text "Device in right deflection NOTE: Control Knob Arrow facing to the right".
Figure 4: esolution® Esophageal Retractor with distal portion deflected to
To use, after lubrication of the device and attachment of the vacuum line and temperature probe (optional), the introducer is shaped and inserted into the outer sheath. The outer sheath is inserted into the esophagus via the mouth and visualized, if needed, under fluoroscopy. The device is moved to ensure proper positioning of the outer sheath relative to the cardiac anatomy. The introducer is removed and replaced with the inner mechanical displacement plates. Placement is confirmed under fluoroscopy. When desired, the esophagus is deviated by turning the Control Knob in the intended direction. Please refer to the labeling for the complete directions for use.
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The esolution® Esophageal Retractor is a surface device that contacts the mucosal membrane with limited exposure ( 15 hours to 15 and 4 mm, benign suction 4 mm) were seen in the device group. .
Reduction in ablation lesions (particularly type 2a) without concomitant increase in device related lesions is noted. No type 2b or 3 lesions were seen in either group.
Adverse events:
Serious and non-serious adverse events did not differ between groups. There were no unexpected device adverse events, device related adverse events, or deaths. In addition to the overall findings of no difference between the groups, the individual adverse events did not appear to have a pattern of harm in the intervention group.
15
| | Control N
(%) Subjects | esolution N
(%) Subjects | Chi-
Square
P-value |
|----------------|---------------------------|-----------------------------|---------------------------|
| All AE | 21 / 66 (31.8%) | 12 / 54 (22.2%) | 0.119 |
| Serious AE | 9 / 66 (13.6%) | 3 / 54 (5.6%) | 0.0932 |
| Non-Serious AE | 14 / 66 (21.2%) | 9 / 54 (16.7%) | 0.3443 |
Image /page/15/Figure/1 description: The image is a bar graph comparing the percentage of patients with adverse events in the control group versus the Esolution group. The graph shows three types of adverse events: all AEs, serious AEs, and non-serious AEs. The percentage of patients with all AEs is higher in the control group (around 32%) than in the Esolution group (around 22%). The percentage of patients with serious AEs is higher in the control group (around 14%) than in the Esolution group (around 6%).
Primary Effectiveness Endpoints:
The primary endpoint of this study is the occurrence of esophageal injury attributable to radiofrequency ablation energy as noted on post ablation endoscopy. Per definition of published literature, esophageal lesions related to injury from RF ablation energy are acute lesions that occur on the anterior wall of the mid-segment of the esophagus. For this study, each esophageal ablation lesion will be characterized using the Kansas City Classification.
In addition to showing superiority over the Control treatment with respect to esophageal injury attributable to RF ablation energy, the observed rate of esophageal injury attributable to RF ablation energy in patients randomized to the esolution device was required to be ≤ 15%.
The interim analysis results met the criteria for early stopping for efficacy. Of the 53 esolution and 65 control subjects with endoscopy results, 3 esolution subjects and 23 Control subjects had ablation lesions (5.7% and 35.4%, respectively). Analysis results supported the rejection of the null hypothesis and a conclusion that the proportion of esolution subjects with an ablation lesion is significantly lower than the proportion of Control subjects with an ablation lesion.
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| Imputation Number | Risk Difference, C-E
(Ablation Lesion=Yes) | ASE | Lower 95%
Confidence Limit | Upper 95%
Confidence Limit | Fishers Exact
P-value |
|------------------------------------------------------------------------------------|-----------------------------------------------|--------|-------------------------------|-------------------------------|--------------------------|
| 1 | 0.295 | 0.0641 | 0.1693 | 0.4205 | 0.00002 |
| 4 | 0.295 | 0.0641 | 0.1693 | 0.4205 | 0.00002 |
| 2 | 0.279 | 0.0659 | 0.1497 | 0.4079 | 0.00007 |
| 3 | 0.279 | 0.0659 | 0.1497 | 0.4079 | 0.00007 |
| 5 | 0.279 | 0.0659 | 0.1497 | 0.4079 | 0.00007 |
| N Nonmissing = 53 esolution and 65 Control
N Imputed= 9 esolution and 2 Control | | | | | |
Table 19. Primary Analysis - Presence of Ablation Lesion (ITT)
- . All Fishers Exact one-sided p values are 65% of subjects, and did not meet that goal. Additional details were provided to demonstrate that the distance of 20mm is not consistent with RF biophysics, and does not apply to the design of esolution. The pre-clinical animal studies, clinical studies, and bench testings show that the esolution can retract an esophageal segment away from the left atrial posterior wall effectively and safely.
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| Parameter | Frequency | Percent | 95%
Lower
Conf
Limit | 95%
Upper
Conf
Limit | P-value |
|-----------------------------------------|-----------|---------|-------------------------------|-------------------------------|---------|
| Deviation of > 20mm in any
direction | 34/53 | 64.15 | 0.4980 | 0.7686 | 0.8969 |
Secondary analysis #3 was that the proportion of subjects with PVI would be greater in the esolution group. Both groups had 100% PVI achieved.
| Parameter | Statistic | eSolution | Control | P-value |
|---|---|---|---|---|
| Was Pulmonary vein | ||||
| entrance block achieved | ||||
| for all veins | Yes, n (%) | 53 (100.0%) | 65 (100.0%) | NA |
Secondary analysis #4 was to test if the proportion of subjects with gastric hypomotility would be less in the esolution group. The percentages were similar in the two group.
| Parameter | Statistic | eSolution | Control | P-value |
|---|---|---|---|---|
| Gastroparesis present | No, n (%) | 32 (60.4%) | 42 (64.6%) | 0.7035 |
| Yes, n (%) | 21 (39.6%) | 23 (35.4%) |
Secondary analysis #5 was to compare procedure duration between groups.
.
| Parameter | Statistic | eSolution | Control | Difference
(Control - Esolution) |
|-----------------------------------|-------------------|--------------|---------------|-------------------------------------|
| Total Procedure time
(minutes) | N | 53 | 65 | |
| | MEAN (STD) | 99.9 (53.85) | 101.3 (58.91) | 1.33 |
| | STANDARD
ERROR | 7.40 | 7.31 | 10.49 |
| | 95% CI | 85.1, 114.8 | 86.7, 115.9 | -19.45, 22.12 |
| | MINIMUM | 36.0 | 28.0 | |
| | MAXIMUM | 278.0 | 280.0 | |
Secondary analysis #6 was to assess the proportion of subjects with KCC type 2b or 3 lesions between groups. No subjects had a type 2b or 3 lesion in either group.
| Parameter | Statistic | eSolution | Control | P-value |
|---|---|---|---|---|
| Incidence of KCC Type | ||||
| 2b and Type 3 lesions | N, n (%) | 0/53 (0.0%) | 0/65 (0.0%) | NA |
Other exploratory analyses:
- . Esophageal temperature change-peak LET and change in temperature from baseline was reduced in the device group.
- . There was no significant difference in mean RF ablation parameters between the groups
- . The device was in the esophagus for a mean of 99.9 minutes with suction on for an average of 23.5 minutes.
- . There was an average of 6.7 deviations per patient, 3.26 to the left and 3.43 to the right.
- RF energy application was stopped/reduced in 55% of the control and 9.4% of the device . group (p