(167 days)
Not Found
No
The description focuses on the physical device and its function in temperature regulation and gastric decompression, with no mention of AI/ML algorithms or data processing for decision-making.
Yes
The device is described as a "thermal regulating device" intended to "control patient temperature" and "reduce the likelihood of ablation-related esophageal injury," which are therapeutic functions. It also provides "gastric decompression and suctioning," which are therapeutic interventions.
No
Explanation: The device is a thermal regulating device intended to control patient temperature, reduce esophageal injury during cardiac ablation, and provide gastric decompression and suctioning. It does not diagnose any condition or disease.
No
The device description clearly states it is a "multi-lumen silicone tube" and describes its physical components and how it connects to external hardware (heat exchangers). This indicates it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The ensoETM™ is a thermal regulating device placed in the esophagus. Its primary functions are to control patient temperature, reduce the likelihood of esophageal injury during cardiac ablation, and provide gastric decompression and suctioning.
- Lack of Sample Analysis: The device does not analyze any samples taken from the patient's body. It directly interacts with the patient's internal environment (esophagus and stomach) for therapeutic and supportive purposes.
- Intended Use: The intended use clearly describes a therapeutic and supportive function, not a diagnostic one based on analyzing biological samples.
Therefore, the ensoETM™ falls under the category of a therapeutic or supportive medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The ECD01 model of ensoETM™ is indicated as follows:
The ensoETM™ is a thermal regulating device, intended to:
-
- connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to control patient temperature.
-
- connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures, and
-
- provide gastric decompression and suctioning.
The ECD02 model of ensoETM™ is indicated as follows:
The ensoETM™ is a thermal regulating device, intended to:
-
- connect to a Gentherm/Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System to control patient temperature.
-
- connect to a Gentherm/Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia Systemto reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures, and
-
- provide gastric decompression and suctioning.
Product codes (comma separated list FDA assigned to the subject device)
QXV
Device Description
The ensoETM is a multi-lumen silicone tube that is placed in the esophagus in a manner similar to a standard orogastric tube. The primary function of the ensoETM™ is to connect to an external heat exchanger to either (1) cool or warm a patient or (2) cool the esophagus to reduce the likelihood of thermal injurv after radiofrequency (RF) cardiac ablation procedures.
The external heat exchanger circulates warmed or chilled water through the two outer lumens of the ensoETMTM. One outer lumen serves as the water inflow, while the other serves as the water outflow. The distal end of the ensoETM™ contains an opening between the two outer lumens, allowing the water to circulate back to the external heat exchanger without contacting the patient.
The central lumen of the ensoETM™ is open to the stomach to allow for gastric decompression and suction.
The ensoETM™ is primarily composed of standard medical-grade silicone. The ensoETMIM is a single-use, disposable, non-implantable device with an intended duration of use of 72 hours or less. Figure 1 shows a depiction of the ensoETM™ device placed in the esophagus.
The ensoETM™ may be individually packaged with a bite block and/or lubrication jelly packets. These accessories are legally marketed in the United States under their own name and are not manufactured by Attune Medical. The accessories are recommended for use with the ensoETM™ and may be included in unit packages as a convenience to the customer.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Esophagus
Indicated Patient Age Range
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Nonclinical/Bench Studies:
The subject device is identical in design and materials to the devices reviewed under DEN 140018 (ECD01 model of the ensoETMTM) and K170009 (ECD02 model of the ensoETMIM). The following nonclinical/bench studies were performed and were used to support this De Novo classification request.
- Biocompatibility/Materials: Biocompatibility testing was originally performed under DEN140018. No changes have been made to the patient contacting aspects of the device. The ensoETM™ is a surface device that contacts the mucosal membrane with prolonged exposure (≤ 72 hours). Devices were cut into pieces and extracted in appropriate media for the specific biocompatibility tests. Biocompatibility evaluation has been completed according to FDA Guidance, Use of International Standard ISO 10993-1. The test articles were found non-cytotoxic per ISO 10993-5, non-sensitizing in tests for skin sensitization per ISO 10993-10, and non-irritating in tests for irritation per ISO 10993-10.
- Shelf Life/Sterility: The device is provided non-sterile. Shelf life for ensoETM™ is 3 years. Performance testing on devices which had completed 3-year accelerated aging was used to demonstrate that the device and packaging materials did not experience significant degradation. Packaging testing was performed according to ASTM F2096-11 under DEN140018.
- Magnetic Resonance (MR) Compatibility:
- Model ECD01: MR Safe
- Model ECD02: MR Conditional. Testing according to ASTM F2503 determined that for ECD02 model of the ensoETM: The magnetically induced displacement angle and magnetically induced torque results indicate that these effects do not pose significant risk to a patient in a clinical MR environment with a static magnetic field of 1.5 T or 3.0 T and a maximum magnetic spatial gradient of 12 T/m. The RF heating results establish that a patient with an Esophageal Cooling Device may be safely scanned in a 1.5 T or 3.0 T MR system at a whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes. The RF heating results indicate that the maximum temperature rise under these conditions is 2.61 ℃. The maximum distance the image artifact extended from the test articles was measured to be 103 mm.
- Performance Testing - Bench: ensoETM™ underwent the following bench performance tests under DEN140018:
- Tensile Test: Acceptance criterion was bond strength of ≥15 N.
- Burst Strength Test: Acceptance criterion was >15 psi.
- Ultimate Material Strength Test: Acceptance criterion was ≥ 5 Mpa.
- Leakage Test: Acceptance criterion was no visible evidence of leaks.
- Vacuum Resistance Test: Acceptance criterion was device does not collapse under 200 mmHg of negative pressure.
- End Cap Axial Deflection Test: Acceptance criterion was required force to bend is less that that needed for NeoMed enteral feeding connector.
- Dimensional testing confirming accurate dimensions of: Extruded Tube, Extension Tube, Proximal End Cap, Distal End Cap.
- Compatibility Testing was performed under DEN140018 and K170009 with relevant External Heater/Coolers with acceptance criteria of: Flow Rate: > 31 L/hr, Temperature Accuracy: Within ± 1.0 ℃, Alarm Trigger: Alarms at ≤ 29 ℃ and ≥ 45 ℃ and when flow occluded, System pressures under Occlusive situation:
N/A
0
DE NOVO CLASSIFICATION REQUEST FOR
ENSOETMIMIM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Temperature regulation device for esophageal protection during cardiac ablation procedures. This device is placed in the lumen of the esophagus to reduce the likelihood of thermal injury or a specific adverse event during cardiac ablation procedures. The device uses temperature regulation to control the temperature of the esophagus during cardiac ablation.
NEW REGULATION NUMBER: 21 CFR 870.5720
CLASSIFICATION: Class II
PRODUCT CODE: QXV
BACKGROUND
DEVICE NAME: ensoETMTM
SUBMISSION NUMBER: DEN230021
DATE DE NOVO RECEIVED: March 30, 2023
SPONSOR INFORMATION:
Advanced Cooling Therapy, Inc. d/b/a Attune Medical 3440 S. Dearborn St. #215-South Chicago. IL 60616
INDICATIONS FOR USE
The ECD01 model of ensoETM™ is indicated as follows:
The ensoETM™ is a thermal regulating device, intended to:
-
- connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to control patient temperature.
-
- connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System or Stryker Altrix Precision Temperature Management System to reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures, and
1
-
- provide gastric decompression and suctioning.
The ECD02 model of ensoETM™ is indicated as follows:
- provide gastric decompression and suctioning.
The ensoETM™ is a thermal regulating device, intended to:
-
- connect to a Gentherm/Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia System to control patient temperature.
-
- connect to a Gentherm/Cincinnati Sub-Zero Blanketrol II or Blanketrol III Hyper-Hypothermia Systemto reduce the likelihood of ablation-related esophageal injury resulting from radiofrequency cardiac ablation procedures, and
-
- provide gastric decompression and suctioning.
LIMITATIONS
The sale, distribution, and use of the ensoETM™ are restricted to prescription use in accordance with 21 CFR 801.109.
PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The ensoETM is a multi-lumen silicone tube that is placed in the esophagus in a manner similar to a standard orogastric tube. The primary function of the ensoETM™ is to connect to an external heat exchanger to either (1) cool or warm a patient or (2) cool the esophagus to reduce the likelihood of thermal injurv after radiofrequency (RF) cardiac ablation procedures.
The external heat exchanger circulates warmed or chilled water through the two outer lumens of the ensoETMTM. One outer lumen serves as the water inflow, while the other serves as the water outflow. The distal end of the ensoETM™ contains an opening between the two outer lumens, allowing the water to circulate back to the external heat exchanger without contacting the patient.
The central lumen of the ensoETM™ is open to the stomach to allow for gastric decompression and suction.
The ensoETM™ is primarily composed of standard medical-grade silicone. The ensoETMIM is a single-use, disposable, non-implantable device with an intended duration of use of 72 hours or less. Figure 1 shows a depiction of the ensoETM™ device placed in the esophagus.
The ensoETM™ may be individually packaged with a bite block and/or lubrication jelly packets. These accessories are legally marketed in the United States under their own name and are not manufactured by Attune Medical. The accessories are recommended for use with the ensoETM™ and may be included in unit packages as a convenience to the customer.
2
Image /page/2/Picture/0 description: This image shows a diagram of a medical procedure involving the insertion of a tube into a patient's body. The tube goes through the mouth, down the esophagus, and into the stomach. The diagram also shows a close-up of the tube, which has a chilled or warmed water inflow and outflow, as well as a gastric access point. The text in the image labels the different parts of the tube and the procedure.
Figure I : Depiction of the subject device. Left Placed into the Esophagus. Right Cross-sectional view of lumen arrangement and function.
A version of the ensoETM™ was previously granted marketing authorization under DEN140018 for the following indication:
The Esophageal Cooling Device is a thermal regulating device, intended to:
- . connect to a Gaymar Medi-Therm III Conductive Hyper/Hypothermia System to control patient temperature, and
- provide gastric decompression and suctioning. .
The indication granted under DEN140018 is incorporated by reference into the indication granted under this De Novo classification request.
SUMMARY OF NONCLINICAL/BENCH STUDIES
The subject device is identical in design and materials to the devices reviewed under DEN 140018 (ECD01 model of the ensoETMTM) and K170009 (ECD02 model of the ensoETMIM). The following nonclinical/bench studies were performed and were used to support this De Novo classification request.
BIOCOMPATIBILITY/MATERIALS
Biocompatibility testing was originally performed under DEN140018. No changes have been made to the patient contacting aspects of the device.
The ensoETM™ is a surface device that contacts the mucosal membrane with prolonged exposure (≤ 72 hours). To assess the biocompatibility, the patient contact areas of the
3
device were tested. Devices were cut into pieces and extracted in appropriate media for the specific biocompatibility tests.
Biocompatibility evaluation has been completed according to FDA Guidance, Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process"
(https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Guidan ceDocuments/UCM348890.pdf).
The test articles were found non-cytotoxic per ISO 10993-5.
The test articles were found to be non-sensitizing in tests for skin sensitization per ISO 10993-10.
The test articles were found to be non-irritating in tests for irritation per ISO 10993-10.
SHELF LIFE/STERILITY
The device is provided non-sterile, which was determined to be acceptable based upon an evaluation of reports submitted to FDA under 21 CFR Part 803 and through an evaluation of complaints collected from Real-World Data (RWD) using the device for the proposed indication.
The shelf life for ensoETM™ is 3 years. Performance testing on devices which had completed 3-year accelerated aging was used to demonstrate that the device and packaging materials did not experience significant degradation.
Packaging testing was performed according to ASTM F2096-11 under DEN140018.
MAGNETIC RESONANCE (MR) COMPATIBILITY
Model ECD01: MR Safe Model ECD02: MR Conditional
Testing according to ASTM F2503 determined that for ECD02 model of the ensoETM:
The magnetically induced displacement angle and magnetically induced torque results indicate that these effects do not pose significant risk to a patient in a clinical MR environment with a static magnetic field of 1.5 T or 3.0 T and a maximum magnetic spatial gradient of 12 T/m. The RF heating results establish that a patient with an Esophageal Cooling Device may be safely scanned in a 1.5 T or 3.0 T MR system at a whole body averaged specific absorption rate (SAR) of 2.0 W/kg for 15 minutes. The RF heating results indicate that the maximum temperature rise under these conditions is 2.61 ℃. The maximum distance the image artifact extended from the test articles was measured to be 103 mm.
PERFORMANCE TESTING - BENCH
4
ensoETM™ underwent the following bench performance tests under DEN140018:
- Tensile Test: Acceptance criterion was bond strength of ≥15 N .
- . Burst Strength Test: Acceptance criterion was >15 psi
- Ultimate Material Strength Test: Acceptance criterion was ≥ 5 Mpa .
- Leakage Test: Acceptance criterion was no visible evidence of leaks .
- Vacuum Resistance Test: Acceptance criterion was device does not collapse . under 200 mmHg of negative pressure.
- . End Cap Axial Deflection Test: Acceptance criterion was required force to bend is less that that needed for NeoMed enteral feeding connector
- Dimensional testing confirming accurate dimensions of: .
- o Extruded Tube
- Extension Tube o
- o Proximal End Cap
- o Distal End Cap
- . Compatibility Testing was performed under DEN140018 and K170009 with relevant External Heater/Coolers with acceptance criteria of:
- Flow Rate: > 31 L/hr o
- o Temperature Accuracy: Within ± 1.0 ℃
- Alarm Trigger: Alarms at ≤ 29 ℃ and ≥ 45 ℃ and when flow occluded o
- · System pressures under Occlusive situation: 5mm | Grade 1:
Mild Injury |
| Grade 2a: Superficial
ulceration, erosions,
friability, blisters, exudates,
hemorrhages, whitish
membranes | Grade 2:
Superficial
ulceration | Grade 4a: Superficial
ulceration (clean)
Grade 4b: Superficial
ulceration (visible clot) | Grade 2:
Moderate
injury |
| Grade 2b: Grade 2a plus
deep discrete or
circumferential ulcerations
Grade 3a: Small scattered
areas of multiple ulceration
and areas of necrosis with
brown-black or greyish
discoloration
Grade 3b: Extensive
necrosis | Grade 3:
Deep ulceration
Grade 4:
Fistula/perforation | Grade 5a: Deep ulceration
(clean)
Grade 5b: Deep ulceration
(visible clot)
Grade 6: Perforation | Grade 3:
Severe injury |
Table 1:The esophageal injury grading scheme which was used in each of the randomized controlled studies (RCT) and the combined scoring scheme used for the combined analysis
The Riverside study of 6 patients showed: In the 3 control patients, 1 had no evidence of esophageal mucosal damage, I had diffuse sloughing of the esophageal mucosa and multiple ulcerations, and 1 had a superficial ulcer with a large clot. Both patients with lesions were classified as 2a cases using the Zargar grading scheme for caustic injury. In the 3 patients treated with the cooling device, 1 had no evidence of esophageal mucosal damage. 1 had esophageal erythema (Zargar grade 1), and 1 had a solitary Zargar grade 2a lesion. At 3 months of follow-up, 1 patient in each group had recurrence of atrial fibrillation.
The Penn study had 44 patients who completed the study (22 device group, 22 control group). Adjunctive posterior wall isolation was performed more frequently in the device group (11/22, 50% vs. 4/22, 18%). Endoscopically-detected esophageal lesions (EDELs) through upper endoscopy by 48 hours were detected in 5/22 (23%) control group patients, with mild or moderate injury in 2/5 patients (40%) and severe thermal injury in 3/5 patients (60%). In the device group, EDELs were detected in 8/22 (36%) patients, with mild or moderate injury in 7/8 (87%) patients and severe thermal injury in 1/8 (12%) patients. There were no acute perforations or atrioesophageal fistulas (AEF) identified during follow-up.
In the St. George's study (IMPACT), endoscopic examination was performed at 7 days post-ablation and, of 188 patients, 120 underwent endoscopy (the remaining 66 withdrew consent for esophagogastroduodenoscopy (EGD) but were not lost to follow up). EDELs
7
to the mucosa were significantly more common in the control group than in those receiving esophageal protection (12/60 vs. 2/60; p=0.008). There was no difference between groups in the duration of RF or in the force applied (p-value range=0.2 to 0.9). Procedure duration and fluoroscopy duration were similar (p=0.97, p=0.91, respectively).
The sponsor pooled the available data from the three studies. Differences in patient demographics and clinical protocols adds uncertainty to the representativeness of the pooled results. Demographics are shown in Table 2:
| Riverside | Penn | St. George's | |||||
|---|---|---|---|---|---|---|---|
| Control | |||||||
| (n=3) | EnsoETM | ||||||
| (n=3) | Control | ||||||
| (n=22) | EnsoETM | ||||||
| (n=22) | Control | ||||||
| (n=60) | EnsoETM | ||||||
| (n=60) | |||||||
| Age (avg) (years) | 55-71 | ||||||
| (61.3) | 58-70 | ||||||
| (64.7) | 63.6 ± 9.3 | 62.8 ± 9.6 | 65 ± 9 | 65 ± 10 | |||
| Sex male, n (%) | 67 | 100 | 16 (73) | 14 (64) | 37 (61.7) | 36 (60) | |
| BMI | NR | 31.0 ± 5.1 | 30.5 ± 7.3 | 29.8 ± 6.98 | 28.5 ± 5.3 | ||
| Obesity (n) | 1 | 2 | NR | NR | |||
| Paroxysmal AF, n (%) | 100 | 14 (64) | 11 (50) | 30 (50) | 27 (45) | ||
| Left atrial size (avg) (cm) | 3.8- | ||||||
| 4.2(3.9) | 4.1-5.7 | ||||||
| (4.7) | NR | 4.2 ± 0.6 | 4.1 ± 0.9 | ||||
| LVEF (%) | NR | 55.8 ± 9.4 | 54.7 ± | ||||
| 11.4 | 52 ± 8 | 55 ± 9 | |||||
| EF |