(371 days)
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Not Found
No
The summary describes a device that measures electrical conductivity (impedance) of esophageal tissue and displays the raw measurement. There is no mention of AI/ML algorithms being used for analysis, interpretation, or decision support based on these measurements. The performance studies focus on the accuracy and stability of the impedance measurement itself, not on the performance of any AI/ML model.
No.
The device is used to measure esophageal epithelial impedance, aiding in evaluation, but it does not directly treat or provide therapy to the patient.
No
The submission states, "The device is not for use as a sole diagnostic screening tool." It aids in evaluating esophageal epithelial integrity but is not intended for stand-alone diagnosis.
No
The device description explicitly states it includes "associated signal conditioning, hardware, and software". The performance studies also include testing on hardware components like the balloon probe and electrical safety testing.
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 performed outside of the body.
- Device Description: The Mucosal Integrity Conductivity Test System directly interacts with the esophageal epithelium inside the body during an endoscopy. It measures electrical conductivity in situ.
- Intended Use: The device is used during an endoscopy to obtain a real-time measurement of esophageal epithelial impedance. This is a direct measurement within the body, not a test on a sample taken from the body.
Therefore, the device's function and intended use clearly place it outside the definition of an In Vitro Diagnostic. It is an in vivo diagnostic device.
N/A
Intended Use / Indications for Use
The Mucosal Integrity Conductivity Test System is indicated for use by gastroenterologists, surgeons, and medically trained personnel during an endoscopy to obtain a real time measurement of esophageal epithelial impedance. The device is not for use as a sole diagnostic screening tool.
Product codes
QIS
Device Description
The Mucosal Integrity Conductivity (MI) Test System provides real-time measurements of alterations in esophageal evithelial integrity. The device is intended to aid in the evaluation of esophageal epithelial integrity by means of a balloon probe with direct electrical contact with the mucosal epithelium of the esophagus along with associated signal conditioning, hardware, and software for measuring and displaying information.
The patient undergoing an esophageal mucosal impedance study will first have an endoscope placed with the distal end of the scope proximal to the area under study. The MI Probe is advanced into the patient's esophagus by guiding it alongside the endoscope. The MI Probe is positioned under visual guidance using the optics of the endoscope. The probe also contains proximal markings on the catheter portion outside the patient to aid in positioning. The total time of deployment for collecting mucosal impedance values is expected to be less than 5 minutes. Figure 1 shows the MI Probe and its components along with its inflated and deflated state.
The impedance values are transmitted from the MI Probe to the non-patient contacting MI Adapter as standard impedance signals, measured, converted to digital data and are then transmitted to the Central Unit via the MI Cable. The Central Unit then transfers the processed data to the PC for display and analysis through the MI Software. This data is displayed through the use of a color map for easy identification of impedance values. The color map displays realtime impedance measurements for the duration of the individual study, and results are reported as both raw data and a summary.
The inflation and deflation of the probe is controlled via the MI Inflator Gauge Box, which has a pressure gauge to display the pressure within the balloon.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Esophagus
Indicated Patient Age Range
Not Found
Intended User / Care Setting
gastroenterologists, surgeons, and medically trained personnel during an endoscopy
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Non-clinical/bench studies conducted on the MI Test System to demonstrate a reasonable assurance of safety and effectiveness of the device are summarized:
Balloon Functionality Testing Summary: Sample size of n=10 for Double Wall Thickness, Compliance Diameter @ 0.5atm, and Burst Pressure. All tests passed.
Dimensional Design Verification Testing Summary: Tested Probe Overall Length, Probe, Balloon Diameter when Inflated (n=33), and Probe Weight. All tests passed.
Bond between Sensors and Balloon Testing Summary: Adhesive Strength after Exposure to Saline was tested and passed.
Tensile Strength, Distal Tip to Catheter of MI Probe: Initial pull test (ng) and another test (n=4) aligning with EN 1617 for max break force of sterile drainage catheters. All tests passed.
Impedance Measurements of MI Probe Sensors: Impedance Measurement Accuracy, Impedance Signal Noise, Impedance Thermal Stability, and Impedance Temporal Stability were tested using a single probe with all sensors in saline. All tests passed.
Clinical Information:
- A first prospective study included 0149 patients undergoing esophagogastroduodenoscopy (24 with GERD symptoms, 21 with active eosinophilic esophagitis, 24 with normal EGD and pH). The device was able to measure esophageal mucosal impedance in ohms for all patients. One reported adverse event (chest pain unrelated to device).
- Another prospective study included 23 adult patients with EoE (18 active, 5 inactive) and 10 control patients (8 undergoing endoscopy for Bravo capsule placement, 2 for celiac disease evaluation). The MI Test System was able to measure esophageal mucosal impedance in ohms for all 23 patients. No reported adverse events.
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.1450 Esophageal tissue characterization system.
(a)
Identification. An esophageal tissue characterization system is a device intended for obtaining measurements of electrical properties within esophageal tissue.(b)
Classification. Class II (special controls). The special controls for this device are:(1) All patient contacting components of the device must be demonstrated to be biocompatible.
(2) Performance testing must demonstrate the device can accurately measure the designated electrical characteristics.
(3) Mechanical safety testing must demonstrate that the device will withstand forces encountered during use.
(4) Software verification, validation, and hazard analysis must be performed.
(5) Electromagnetic compatibility and electrical safety, mechanical safety, and thermal safety of the device must be performed.
(6) Performance data must validate the reprocessing instructions for any reusable components of the device.
(7) Labeling must include:
(i) Specific instructions regarding the proper placement and use of the device;
(ii) Instructions for reprocessing of any reusable components; and
(iii) An expiration date for single use components.
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DE NOVO CLASSIFICATION REQUEST FOR MUCOSAL INTEGRITY CONDUCTIVITY (MI) TEST SYSTEM
REGULATORY INFORMATION
FDA identifies this generic type of device as the following:
Esophageal tissue characterization system. An esophageal tissue characterization system is a device intended for obtaining measurement of electrical properties within esophageal tissue.
NEW REGULATION NUMBER: 21 CFR 876.1450
CLASSIFICATION: Class II
PRODUCT CODE: QIS
BACKGROUND
DEVICE NAME: Mucosal Integrity Conductivity (MI) Test System
SUBMISSION NUMBER: DEN180067
DATE DE NOVO RECEIVED: December 20, 2018
CONTACT:
Diversatek Healthcare, Inc. 102 East Keefe Avenue Milwaukee, WI 53212
INDICATIONS FOR USE
The Mucosal Integrity Conductivity Test System is indicated for use by gastroenterologists, surgeons, and medically trained personnel during an endoscopy to obtain a real time measurement of esophageal epithelial impedance. The device is not for use as a sole diagnostic screening tool.
LIMITATIONS
The sale, distribution, and use of the Mucosal Integrity Conductivity (MI) System are restricted to prescription use in accordance with 21 CFR 801.109.
The MI Test System should be used as directed in the labeling to avoid adverse interaction within the esophagus.
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PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The Mucosal Integrity Conductivity (MI) Test System provides real-time measurements of alterations in esophageal evithelial integrity. The device is intended to aid in the evaluation of esophageal epithelial integrity by means of a balloon probe with direct electrical contact with the mucosal epithelium of the esophagus along with associated signal conditioning, hardware, and software for measuring and displaying information.
The patient undergoing an esophageal mucosal impedance study will first have an endoscope placed with the distal end of the scope proximal to the area under study. The MI Probe is advanced into the patient's esophagus by guiding it alongside the endoscope. The MI Probe is positioned under visual guidance using the optics of the endoscope. The probe also contains proximal markings on the catheter portion outside the patient to aid in positioning. The total time of deployment for collecting mucosal impedance values is expected to be less than 5 minutes. Figure 1 shows the MI Probe and its components along with its inflated and deflated state.
Image /page/1/Figure/4 description: The image shows three different views of a medical device. The first image shows the device inflated, with labels pointing to the distal esophagus, sensor column (10 cm), and proximal esophagus. The second image shows the device deflated, and the third image shows the device inflated again.
Figure 1. Inflated and Deflated Probe.
The impedance values are transmitted from the MI Probe to the non-patient contacting MI Adapter as standard impedance signals, measured, converted to digital data and are then transmitted to the Central Unit via the MI Cable. The Central Unit then transfers the processed data to the PC for display and analysis through the MI Software. This data is displayed through the use of a color map for easy identification of impedance values. The color map displays realtime impedance measurements for the duration of the individual study, and results are reported as both raw data and a summary.
The inflation and deflation of the probe is controlled via the MI Inflator Gauge Box, which has a pressure gauge to display the pressure within the balloon. The components are illustrated in
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Figure 2 below. The impedance values are transmitted from the MI Probe to the non-patient contacting MI Adapter as standard impedance signals, measured, converted to digital data and are then transmitted to the Central Unit via the MI Cable. The Central Unit then transfers the processed data to the PC for display and analysis through the MI Software. This data is displayed through the use of a color map for identification of impedance values. The color map displays real-time impedance measurements for the duration of the individual study, and results are reported as both raw data and a summary.
Image /page/2/Figure/1 description: The image shows a medical device called an MI Inflator Gauge Box, along with its various components. The components include an inflator, a cable, an air supply line to the probe, an MI adapter module, and an MI probe. The image also shows an inflated balloon of the MI probe with the sheath removed. The MI Inflator Gauge Box appears to be the central control unit for the device.
Figure 2. The complete MI System with all components aside from the Central Unit
SUMMARY OF NONCLINICAL/BENCH STUDIES
Non-clinical/bench studies conducted on the MI Test System to demonstrate a reasonable assurance of safety and effectiveness of the device are summarized below.
REPROCESSING
As illustrated in Figure 3 below, the MI Probe makes direct patient contact and is connected to reusable components that do not make direct patient contact. Those reusable components will be manipulated by the user at the same time they are using the patientcontacting probe, thereby making cross-contamination between the probe and the reusable components possible. This risk was addressed by the inclusion of validated reprocessing instructions in the labeling for the reusable components.
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Image /page/3/Figure/0 description: The image shows a diagram of a system with several components. The components include an MI Probe, MI Probe Cable, Inflator Gauge Box, MI Adapter for Central Unit, Cable for Central Unit, Central Unit (inSIGHT Ultima), USB, and a Computer running System software (Zvu adapted for MI). The diagram also indicates the areas of patient contact, clinician, and technician.
Figure 3. Diagram of patient contacting and non-patient contacting components. This involved the use of cleaning instructions and disinfection instructions per FDA's 2015 reprocessing guidance document, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling". The instructions for the MI Test System provide step-by-step instructions for the user to first clean and then low-level disinfect the reusable components using a Sani-Cloth wipe.
The instructions indicate that reprocessing should occur immediately following use, they include the words "thoroughly clean," they provide endpoints for each step (i.e., visibly clean for cleaning and contact time of 2 minutes per wipe manufacturer's instructions for disinfection), they include a visual inspection step following cleaning and state that the user should repeat the cleaning steps if still visibly dirty, and they include drying steps post-cleaning and disinfection.
Furthermore, the reuse inspection instructions to indicate that the user should inspect the device for damage, corrosion, cuts, punctures, and cracked seals following cleaning and disinfection.
SOFTWARE
Software documentation was provided in accordance with the FDA Guidance Document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," (issued May 11, 2005) for a Moderate Level of Concern (LOC). A Moderate LOC is deemed appropriate as malfunction of the device software or a latent design flaw in the device software may lead to a delay in the delivery of appropriate medical care, which would likely result in minor injury, but would likely not result in serious injury or death due to the availability of other patient vital signs.
Cybersecurity information was provided in accordance with the FDA Guidance Document, "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices - Guidance for Industry and Food and Drug Administration Staff" (issued October 02, 2014).
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BIOCOMPATIBILITY/MATERIALS
The MI Test System is classified as mucosal membrane contacting for repeat, prolonged contact during clinical use ( 15 eosinophils per high-power field (eos/HpF), and 5 patients had inactive EoE (4 patients were effectively treated with budesonide and 1 with omeprazole). There were 10 additional control patients consisting of 8 adults undergoing endoscopy for clinically-indicated Bravo capsule placement for assessment of GERD, and 2 patients were undergoing endoscopy for evaluation of possible celiac disease. The study results show that the MI Test System was able to measure the esophageal mucosal impedance in ohms for all 23 patients. There were no reported adverse events and there was no follow-up of the patients after the procedure ended.
Pediatric Extrapolation
In this De Novo request, existing clinical information was not leveraged to support the use of the device in pediatric patient population
LABELING
The labeling comprises physician labeling that includes the device indications for use, a description of the device, warnings, and precautions, clinical data on the device, and instructions for the safe and effective use of the device. The labeling satisfies the requirements of 21 CFR 801.109 Prescription devices.
Per the special controls for this generic type of device, labeling includes the following:
- Specific instructions regarding proper placement and use of the device. ●
- . An expiration date and shelf life for single use components.
- . Reprocessing instructions for the reusable components.
RISKS TO HEALTH
The table below (Table 4) identifies the risks to health that may be associated with use of the esophageal tissue characterization system and the measures necessary to mitigate these risks.
| Identified Risks to Health | Mitigation Measures |
|---|---|
| Device Malfunction Related to: | Non-clinical performance testing |
| • Breaking | Shelf life testing |
| • Fractures | Software verification, validation, and hazard |
| • Unintentional separation of components | analysis |
| • Inaccurate reading | Labeling |
| • Failure to sense | |
| • Endoscope incompatibility | |
| Adverse tissue reaction | Biocompatibility evaluation |
Table 4: Identified Risks to Health and Mitigation Measures
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| Electrical shock and electrical interference
from other devices | Electrical safety testing
Electromagnetic compatibility (EMC) testing
Labeling |
|-------------------------------------------------------------------------------|--------------------------------------------------------------------------------------|
| Procedural risks (which may include
procedures of endoscopy with sedation) | Labeling |
| Infection/cross-contamination | Reprocessing validation
Labeling |
SPECIAL CONTROLS
In combination with the general controls of the FD&C Act, the esophageal tissue characterization system is subject to the following special controls:
- (1) All patient contacting components of the device must be demonstrated to be biocompatible.
- (2) Performance testing must demonstrate the mucosal impedance system can accurately measure the designated electrical characteristics.
- (3) Mechanical safety testing must demonstrate that the device will withstand forces encountered during use.
- (4) Software verification, validation, and hazard analysis must be performed.
- (5) Electromagnetic compatibility and electrical safety, mechanical, and thermal safety testing of the device must be performed.
- (6) Performance data must validate the reprocessing instructions for any reusable components of the device.
- (7) Labeling must include:
- Specific instructions regarding the proper placement and use of the device; (i)
- (ii) Instructions for reprocessing of any reusable components; and
- (iii) An expiration date for single use components.
BENEFIT-RISK DETERMINATION
The probable benefits of the device are based on the ability to obtain the electrical characteristic of the esophageal tissue. In the case of the MI Test System, the device can be used by gastroenterologists, surgeons, and medically trained personnel during an endoscopy to obtain a real time measurement of esophageal epithelial impedance. This information as an adjunct to standard clinical practice can provide the clinician with information to assist in making a more informed decision for patient care.
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The probable risks of the device include the risks associated with endoscopy and sedation, device malfunction, adverse tissue reaction, electrical shock and electrical interference, and crosscontamination or infection. Device-related adverse events were not reported in the clinical studies. The risk of device malfunctions includes the risk of inaccurate reading which could result in an incorrect determination by the clinician.
Based on the available performance data, the probability of such harmful events is low, and the incidence is reduced with the mitigation measures and special controls identified above.
The probable benefits of the device outweigh the probable risks.
Patient Perspectives
This submission did not include specific information on patient perspectives for this device.
Benefit/Risk Conclusion
In conclusion, given the available information above, for the following indication statement:
The Mucosal Integrity Conductivity Test System is indicated for use by gastroenterologists, surgeons, and medically trained personnel during an endoscopy to obtain a real time measurement of esophageal epithelial impedance. The device is not for use as a sole diagnostic screening tool.
The probable benefits outweigh the probable risks for the MI Test System. The device provides benefits, and the risks can be mitigated using general controls and the identified special controls.
CONCLUSION
The De Novo request for the Mucosal Integrity Conductivity Test System is granted and the device is classified as follows:
Product Code: QIS Device Type: Esophageal tissue characterization system Regulation Number: 21 CFR 876.1450 Class: Class II