(106 days)
No reference devices were used in this submission.
Unknown
The summary mentions "disease probabilities generated by the MiVu System" and "display and analysis" by the Zvu software, which could potentially involve algorithms that utilize AI/ML, but there is no explicit mention of AI, ML, or related terms like DNN. The description focuses on the hardware and signal processing.
No.
The device is indicated for use to obtain real-time measurement of esophageal epithelial integrity as an adjunct for the evaluation of esophageal disorders, not for treatment.
Yes
The "Intended Use / Indications for Use" states that the system is used "to obtain real-time measurement of esophageal epithelial integrity as an adjunct for the evaluation of esophageal disorders." It also explicitly states, "The device is not for use as a sole diagnostic screening tool," indicating its role in diagnosis even if not primary.
No
The device description explicitly details hardware components, including a patient-contacting sensor tip with gold-plated pads, a thermoplastic elastomeric tube, a polyurethane conduit tube, interconnecting wires, a circuit board, and a connector housing. The submission also includes non-clinical performance data related to electrical safety, EMC, and mechanical safety tests, which are indicative of hardware components. While the system includes PC-based software for display and analysis, the core device being described and evaluated is a physical accessory with patient-contacting hardware.
Based on the provided information, the MiVu Mucosal Integrity Testing System, including the MiVu Esophageal Endo Cap accessory, is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The device is used during an endoscopy to obtain real-time measurement of esophageal epithelial integrity. This is a measurement taken directly from the patient's tissue in vivo, not from a sample of bodily fluid or tissue that has been removed from the body and tested in vitro (in a lab setting).
- Device Description: The device involves a sensor tip that contacts the patient's tissue directly during the endoscopic procedure.
- Lack of IVD Characteristics: The description does not mention the analysis of biological samples (blood, urine, tissue biopsies, etc.) in a laboratory setting, which is a hallmark of IVD devices.
The device is a medical device used for in vivo measurement during a clinical procedure.
N/A
Intended Use / Indications for Use
The MIVu Mucosal Integrity Testing System is indicated for use by gastroenterologists, surgeons, and medical personnel trained in endoscopic procedures during an endoscopy to obtain real-time measurement of esophageal epithelial integrity as an adjunct for the evaluation of esophageal disorders. The device is not for use as a sole diagnostic screening tool.
Product codes (comma separated list FDA assigned to the subject device)
QIS
Device Description
The candidate MiVu Esophageal Endo Cap device is intended to replace the predicate MiVu Balloon Probe when used with the MiVu System.
The MiVu Esophageal Endo Cap device consists of a patient contacting sensor tip that is installed over the working end of an endoscope. The tip is a flexible thermoplastic elastomeric tube with a single row of four (4) gold plated pads, providing three (3) impedance sensors evenly spaced along the length of the impedance sensors are mounted on a pivoting platform to promote even contact of all sensor pads with the tissue. A polyurethane conduit tube containing interconnecting wires connects the individual impedance sensor pads on the sensor tip to the circuit board inside the connector housing. The connector is then attached to the remainder of the predicate MiVu System through the MiVu Endo Cap Cable. The MiVu System digitizes the impedance signals and passes the data to the PC-based Zvu software for display and analysis.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Esophageal epithelial integrity / Esophagus / Gastrointestinal Tract
Indicated Patient Age Range
Adult use only
Intended User / Care Setting
Gastroenterologists, surgeons, and medical personnel trained in endoscopic procedures / Professional Healthcare Office Environment, which includes hospitals, clinics, endoscopy suites, and clinical laboratories
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
Under the auspices of an IRB, clinical studies were performed by three gastroenterologists at the same United States located facility who were familiar with both MiVu System configurations. Seventeen (17) random patients were tested using both devices to obtain comparative studies. An additional seven (7) random patients were tested using only the MiVu Esophageal Endo Cap device because the physician chose not to perform the balloon study based on the patient's condition and/or time constraints but preferred to acquire an Esophageal Endo Cap study. Patients were of adult age ranging from 20 to 70 years, with 12 males, 8 females and 4 unknowns (data not provided). Study patients were selected based on the known or highly suspected esophageal disease type (GERD, non-GERD, EoE), and their willingness to consent to the study. Since both the balloon probe study and the Endo Cap study were performed in conjunction with an endoscopic study, the patients were sedated. All studies were completed with no patient adverse effects or complications reported.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Clinical Testing: The MiVu Mucosal Integrity Testing System (MiVu System) utilizing the MiVu Esophageal Endo Cap was tested against the same MiVu System utilizing the predicate MiVu Balloon Probe to demonstrate equivalence in a clinical environment and to validate usability requirements.
Sample size: Seventeen (17) random patients were tested using both devices, and an additional seven (7) random patients were tested using only the MiVu Esophageal Endo Cap device, for a total of 24 patients.
Key results: All studies found the MiVu System with the MiVu Esophageal Endo Cap device provided clinically equivalent or better results than the MiVu Balloon Probe based on the disease probabilities generated by the MiVu System.
Non-Clinical Performance Data: Performed bench testing to support substantial equivalence including: Compatibility with the MiVu Mucosal Integrity Testing System; Comparison to Predicate Function and Performance; Biocompatibility per ISO 10993-1; Electrical Safety and EMC (IEC 60601-1:2005 (Ed 3) + Corr. 1:2006 + Corr. 2:2007 + A1:2012, IEC 60601-1-6:2010 (Third Edition) + A1:2013, and IEC 60601-1-2:2014 + Amd1:2020 (Ed 4.1)); Mechanical Safety Tests (tensile testing per ISO 10555-1:2013+A1:2017, pull test of retention on a 9.9mm diameter endoscope); Reprocessing of Non-single Use Components (MiVu Endo Cap Cable reprocessing instructions validated); Bioburden and Shipping Simulation.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
0
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized human figure. To the right of it is the FDA logo, with the acronym "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
April 25, 2023
Diversatek Healthcare Jim Prinster Senior Design and Development Engineer 9150 Commerce Center Circle, Suite 500 Highlands Ranch, CO 80129
Re: K230056 Trade/Device Name: MiVu™ Esophageal Endo Cap Regulation Number: 21 CFR 876.1450 Regulation Name: Esophageal tissue characterization system Regulatory Class: Class II Product Code: QIS Dated: March 27, 2023 Received: March 27, 2023
Dear Jim Prinster:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR
1
- for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medicaldevice-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advicecomprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerelv.
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of GastroRenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
K230056
Device Name MiVu™ Esophageal Endo Cap
Indications for Use (Describe)
The MIVu Mucosal Integrity Testing System is indicated for use by gastroenterologists, surgeons, and medical personnel trained in endoscopic procedures during an endoscopy to obtain real-time measurement of esophageal epithelial integrity as an adjunct for the evaluation of esophageal disorders. The device is not for use as a sole diagnostic screening tool.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
510(k) Premarket Notification: Traditional
Diversatek Healthcare, Inc.
Section 5
510(k) Summary
4
510(k) Summary
The 510(k) summary of safety and effectiveness information is being submitted in accordance with the requirements of the Safe Medical Devices Act of 1990 and 21 CFR 807.92.
1. Submission Sponsor and Contact
| Submitter's Name: | Diversatek Healthcare |
|---|---|
| Submitter's Address: | 9150 Commerce Center Circle, Suite 500 |
| Highlands Ranch, CO 80129 | |
| Establishment Registration No.: | 2023374 |
| Contact Person: | Jim Prinster |
| Senior Design and Development Engineer | |
| Telephone: | 303-865-8028 |
| Email: | jprinster@diversatek.com |
| Date Prepared: | January 6, 2023 |
2. Candidate Device Identification
| Trade Device Name: | MiVu™ Esophageal Endo Cap |
|---|---|
| FDA Product Code | QIS |
| Classification Name: | Esophageal tissue characterization system |
| Classification Number: | 21 CFR 876.1450 |
| Regulatory Class: | II |
3. Predicate Device Identification
| Predicate De Novo No.: | DEN180067 |
|---|---|
| Predicate Trade Name: | MiVu™ Balloon Probe |
| Predicate FDA Product Code: | QIS |
| Predicate FDA Classification Name: | Esophageal tissue characterization system |
| Predicate Regulation No.: | 21 CFR 876.1450 |
| Predicate Regulatory Class: | II |
This predicate device has not been subject to a design-related recall.
No reference devices were used in this submission.
4. MiVu Mucosal Integrity Testing System (MiVu System) Technology Overview
The Diversatek Healthcare MiVu Esophageal Endo Cap is the candidate accessory device for use with the approved predicate Diversatek Healthcare's MiVu Mucosal Integrity Testing system (MiVu System). The MiVu Esophageal Endo Cap is a new patient-contacting
5
accessory that will be used in place of the MiVu Balloon Probe already approved as part of the MiVu System.
The operating principle of the MiVu System is based on the known changes in mucosal conductivity which occur in the epithelial cells of the esophagus relative to the health of the tissue. The dilation of the intercellular spaces varies depending on the tissue condition presented (as described in the De Novo submission for the MiVu System DEN180067) such as gastroesophageal reflux disease (GERD), non-GERD, and eosinophilic esophagitis (EoE). With these conditions, as the intercellular spacing increases due to cellular damage, hydrogen ions permeate the voids between the epithelial cells. As a result, the mucosa becomes detectably more conductive than normal tissue, and as such, an impedance measurement (the inverse of conductivity) drops with increasing mucosal damage. The MiVu System is able to detect and acquire these impedance measurements for display and analysis.
During a typical procedure, the MiVu System is used to obtain impedance measurements of the esophageal tissue at various locations of interest. This is currently accomplished using the MiVu Balloon Probe which has impedance sensors (see section 5 Predicate Device Description below) that are placed in contact with the patient's esophageal mucosa, and measurement readings are taken. From these measurements, the system can generate a probability of the tissue disease type (GERD, non-GERD, EoE) which is used by the physician as an input to the treatment plan for the patient.
5. Predicate Device Description
The predicate device is the MiVu Balloon Probe which is an accessory probe for use with the MiVu Mucosal Integrity Testing System (MiVu System). The MiVu Balloon Probe consists of a patient contacting, non-compliant balloon with two rows (only a single row is required) of ten (10) impedance sensors positioned on opposite sides of the balloon. A conduit contains flexible circuits which connects the individual impedance sensor pads on the balloon to the circuit board inside the connector housing. The connector is then attached to the remainder of the predicate MiVu System through the MiVu Cable. The MiVu System digitizes the impedance signals and passes the data to the PC-based Zvu software for display and analysis.
Image /page/5/Picture/8 description: The image shows a 3D rendering of a medical device. The device has a cylindrical body with a clear outer layer, revealing an internal structure of orange squares. A purple, marked tube extends from the top of the cylinder, with numbers ranging from 15 to 20. A white nozzle is attached to the bottom of the cylinder.
Figure 1 - MiVu Balloon Probe (predicate device)
6
The remainder of the MiVu System consists of the following components:
- PriZm Central Unit digitizes impedance data and passes data to the PC-based Zyu ● software over a USB connection.
- MiVu Cable connects the probe to the PriZm Central Unit. ●
- . MiVu Requlator - facilitates inflation of the balloon probe. (This component is not used with the candidate device.)
- Zvu Software – acquires impedance data from the PriZm Central Unit, displays the data to facilitate analysis, applies an algorithm for determining disease probabilities, and generates a report which will be used as one of the inputs for developing the patient's treatment plan.
- PC and monitor ●
Image /page/6/Figure/9 description: The image shows a diagram of a system with several components. The components include a MiVu Balloon Probe, a MiVu Cable, a MiVu Regulator, a PriZm Central Unit, a USB connection, and a computer running Zvu Software. The MiVu Balloon Probe is labeled as a predicate device. The components are connected by lines, indicating the flow of information or data through the system.
Figure 2 - MiVu System Components (predicate system)
A typical mucosal integrity study is performed at the conclusion of an endoscopic study. Once the endoscope is removed, the deflated MiVu Balloon Probe is intubated into the patient's esophaqus and positioned just proximal to the patient's squamocolumnar junction (SCJ) based on the indexing measurements taken during the endoscopic study. The balloon is inflated using a syringe and the MiVu Regulator accessory. The impedance sensors that are along the sides of the balloon are pressed against the esophageal mucosa, a measurement reading is taken, and the balloon is deflated. The cycle of inflation-measurement-deflation is repeated several times to obtain a set of measurements the software will use to create a composite color-coded contour image of the impedance readings (see inset of Figure 3 and Figure 4). A study report may then be generated which is used as one of the inputs for developing the patient's treatment plan.
7
510(k) Premarket Notification: Traditional MiVu Esophageal Endo Cap Diversatek Healthcare, Inc.
Image /page/7/Picture/3 description: The image shows a medical device being inserted into a blood vessel. The device appears to be a catheter with a balloon at the end, which is being used to open up a blocked or narrowed artery. The image also includes a scale indicating a measurement of 2 cm, possibly indicating the size of the blockage or the diameter of the vessel. Additionally, there is a small inset image showing a color map, which could represent blood flow or tissue density.
Figure 3 - Inflated MiVu Balloon Probe positioned in the esophagus
Image /page/7/Figure/5 description: The image shows a medical report with impedance values and contour measurements. The report includes a table of impedance values for different sensors, with corresponding L and R values. The impedance contour is displayed as a color-coded graph, showing the distribution of impedance values. The report also includes measurement metrics, probabilities, and study metrics, such as GERD, EoE, and Non-GERD percentages, along with a study summary and diagnostic tags.
Figure 4 - Zvu Software MiVu study screen
6. Candidate Device Description
The candidate MiVu Esophageal Endo Cap device is intended to replace the predicate MiVu Balloon Probe when used with the MiVu System.
The MiVu Esophageal Endo Cap device consists of a patient contacting sensor tip that is installed over the working end of an endoscope. The tip is a flexible thermoplastic elastomeric tube with a single row of four (4) gold plated pads, providing three (3) impedance sensors evenly spaced along the length of the impedance sensors are
8
versatek
510(k) Premarket Notification: Traditional MiVu Esophageal Endo Cap Diversatek Healthcare, Inc.
mounted on a pivoting platform to promote even contact of all sensor pads with the tissue. A polyurethane conduit tube containing interconnecting wires connects the individual impedance sensor pads on the sensor tip to the circuit board inside the connector housing. The connector is then attached to the remainder of the predicate MiVu System through the MiVu Endo Cap Cable. The MiVu System digitizes the impedance signals and passes the data to the PC-based Zvu software for display and analysis.
Image /page/8/Picture/4 description: The image shows a close-up of a gray and white object with a purple stripe running along the top. The object appears to be made of plastic or metal, and it has a smooth, shiny surface. The purple stripe is thin and straight, and it contrasts with the gray and white colors of the object. The object has a handle on the left side.
Figure 5 - MiVu Esophageal Endo Cap sensor tip on endoscope
Image /page/8/Figure/6 description: The image shows a diagram of a system with several components connected by lines. The components are labeled as follows: "MiVu Esophageal Endo Cap (candidate device)", "MiVu Endo Cap Cable (candidate device)", "PriZm Central Unit (same as predicate)", "USB (same as predicate)", and "Computer running System Zvu Software (same as predicate)". The diagram illustrates the connections and relationships between these components within the system.
Figure 6 - MiVu System Components (candidate system)
In a typical study, the MiVu Esophageal Endo Cap is installed over the end of the endoscope prior to the intubation of the scope as shown in Figure 5 above. The tubular design of the tip allows for the lighting, optics and working channel of the endoscope to be used unimpeded. The sensor area of the device is denoted by a small protrusion that is visible with the endoscope camera to aid in locating the sensors against the esophageal tissue. When properly placed, the physician will rotate the tip of the sensors by turning the larger control wheel of the scope. This light pressure will cause the proximal end of the Endo Cap to pivot into the tissue, providing a constant pressure along the measurement region. Any luminal air or liquid between the sensors and mucosal tissue will be pressed away from the tissue being measured. During the endoscopic procedure, the physician will take multiple impedance readings of the epithelial layer spanning a minimum of 10 consecutive centimeters of the esophagus which the Zvu software will use to construct
9
ersatek
a composite image. Once enough readings are obtained over 10 consecutive centimeters of the esophagus, the Zvu software will use the impedance values to calculate the disease probabilities for GERD (Gastro-Esophageal Reflux Disease), non-GERD and EoE (Eosinophilic Esophagitis) according to the algorithm used with the predicate balloon probe.
Image /page/9/Figure/4 description: The image shows a medical device interface with various measurements and settings. On the left, there are protocol steps for acquiring measurements, including instructions for probe intubation and capturing data at different depths. The interface also displays study settings, measurement data quality, and live data, along with a composite measurement and measurement thumbnails. On the right, study metrics such as algorithm, caption, and probabilities for GERD and non-GERD are displayed, along with a study summary section for notes, impressions, and diagnostic tags.
Figure 7 - Zvu Software MiVu Esophageal Endo Cap study acquisition screen
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510(k) Premarket Notification: Traditional MiVu Esophageal Endo Cap Diversatek Healthcare, Inc.
7. Intended Use
The MiVu Mucosal Integrity Testing System is intended to evaluate esophageal epithelial integrity to determine esophageal abnormalities by means of a device with direct electrical contact with the esophageal mucosal epithelium. The system includes associated signal conditioning hardware and software for measuring and displaying information.
8. Indications for Use
The MiVu Mucosal Integrity Testing System is indicated for use by gastroenterologists, surgeons, and medical personnel trained in endoscopic procedures during an endoscopy to obtain real-time measurement of esophageal epithelial integrity as an adjunct for the evaluation of esophageal disorders. The device is not for use as a sole diagnostic screening tool.
9. Technological Characteristics
The following table is a summary of the candidate MiVu Esophageal Endo Cap device technological characteristics as compared to the predicate MiVu Balloon Probe.
| Characteristic | MiVu Esophageal
Endo Cap
(candidate device) | MiVu Balloon Probe
(predicate device) | Comparison |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------|
| De Novo/510(k)
Number | TBD | DEN180067 | N/A |
| FDA Product
Code | QIS | QIS | Identical |
| FDA
Classification
Number | 876.1450 | 876.1450 | Identical |
| FDA
Classification
Name | Esophageal tissue
characterization system | Esophageal tissue
characterization system | Identical |
| Patient
Contacting
Materials | Tip: Thermoplastic
Elastomer,
Impedance Sensors: Gold-
plated ENIG on a
ceramic substrate,
Outer Conduit Tube:
Polyurethane
Adhesive: Medical grade
epoxy
Conductor Covering Heat
Shrink Tubing | Tip: Polyurethane,
Balloon: Polyethylene
terephthalate (PET),
Inflation Tube:
Polyurethane tubing,
Impedance Sensors: Gold-
plated copper on a
polyimide substrate,
Outer Heat Shrink Tube:
Polyether/Polyamide | Similar |
| Characteristic | MiVu Esophageal
Endo Cap
(candidate device) | MiVu Balloon Probe
(predicate device) | Comparison |
| | Polyethylene
terephthalate (PET) | | |
| System
Compatibility | MiVu Mucosal Integrity
Testing System
Reference: DEN180067 | MiVu Mucosal Integrity
Testing System
Reference: DEN180067 | Identical |
| Intended Use | The MiVu Mucosal
Integrity Testing System is
intended to evaluate
esophageal epithelial
integrity to determine
esophageal abnormalities
by means of a device with
direct electrical contact
with the esophageal
mucosal epithelium. The
system includes
associated signal
conditioning hardware and
software for measuring
and displaying information. | The MiVu™ Mucosal
Integrity Testing System is
intended to evaluate
esophageal epithelial
integrity to determine
esophageal abnormalities
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. | Similar |
| Indications for
Use | The MiVu Mucosal
Integrity Testing System is
indicated for use by
gastroenterologists,
surgeons, and medical
personnel trained in
endoscopic procedures
during an endoscopy to
obtain real-time
measurement of
esophageal epithelial
integrity as an adjunct for
the evaluation of
esophageal disorders.
The device is not for use
as a sole diagnostic
screening tool. | The MiVu Mucosal
Integrity Testing System is
indicated for use by
gastroenterologists,
surgeons, and medically
trained personnel during
an endoscopy to obtain
real-time measurement of
esophageal epithelial
integrity as an adjunct for
the evaluation of
esophageal disorders. The
device is not for use as a
sole diagnostic screening
tool. | Similar |
| Environment | Professional Healthcare
Office Environment, which
includes hospitals, clinics,
endoscopy suites, and
clinical laboratories | Professional Healthcare
Office Environment, which
includes hospitals, clinics,
endoscopy suites, and
clinical laboratories | Identical |
| Characteristic | MiVu Esophageal
Endo Cap
(candidate device) | MiVu Balloon Probe
(predicate device) | Comparison |
| Patient
Population | Patients with suspected GI
mucosal damage.
Adult use only | Patients with suspected GI
mucosal damage.
Adult use only | Identical |
| Patient Contact
Categorization | Gastrointestinal Tract | Gastrointestinal Tract | Identical |
| Configuration | Non-sterile single-use
disposable device | Non-sterile single-use
disposable device | Identical |
| Reusable
Device | No | No | ldentical |
| Shelf Life | 6 months (initially) | 6 months (initially) | Identical |
| Sensor Strips | 1 | 2 | Similar (see
discussion
below) |
| Sensors per
strip | 3 | 10 | Similar (see
discussion
below) |
Table 1 - Summary of design, features and principles of operation
11
ek
Healthcare
12
Design Differences
The candidate MiVu Esophageal Endo Cap differs from the predicate MiVu Balloon Probe in the following features:
- a) Sensor strips: The Endo Cap device utilizes only one strip of sensors while the predicate balloon probe utilizes two strips placed on opposite sides of the balloon. In a clinical study using the predicate MiVu Balloon Probe device, it was determined that only a sinqle sensor strip was necessary to obtain data for a useful study. In a clinical study, it was found that the distinction of the MI patterns (GERD, non-GERD, and EoE) is presented along the esophageal axis, and radial measurements were not found to provide additional diagnostic utility.
10. Non-Clinical Performance Data
Diversatek Healthcare performed bench testing to support substantial equivalence. The following testing was performed on samples from initial production lots (where applicable):
-
a) Compatibility with the MiVu Mucosal Integrity Testing System
The MiVu Esophageal Endo Cap and MiVu Endo Cap Cable were tested to verify the accessory components were compatible with the MiVu Mucosal Integrity Testing System (MiVu System). Functional testing demonstrated the acquisition of impedance data and the authentication of the Endo Cap device. -
b) Comparison to Predicate Function and Performance
13
510(k) Premarket Notification: Traditional MiVu Esophageal Endo Cap Diversatek Healthcare, Inc.
The MiVu System utilizing the MiVu Esophageal Endo Cap was tested against the same MiVu System utilizing the predicate MiVu Balloon Probe device to demonstrate equivalence. This bench testing utilized a test medium that would allow for a true impedance reading (both AC and DC components such as measured with tissue) that was consistent across all sensors.
-
c) Biocompatibility
Biocompatibility testing was completed on the MiVu Esophageal Endo Cap per ISO 10993-1. This device complies with all applicable parts of the standard. -
d) Electrical Safety and EMC
Electrical safety and EMC testing were conducted on the MiVu System utilizing a MiVu Esophageal Endo Cap and the MiVu Endo Cap Cable. This system configuration complies with the applicable requirements of IEC 60601-1:2005 (Ed 3) + Corr. 1:2006 + Corr. 2:2007 + A1:2012, IEC 60601-1-6:2010 (Third Edition) + A1:2013, and IEC 60601-1-2:2014 + Amd1:2020 (Ed 4.1). -
e) Mechanical Safety Tests
The MiVu Esophageal Endo Cap device was subjected to tensile testing according to the test method described in ISO 10555-1:2013+A1:2017 Intravascular catheters - Sterile and single-use intravascular catheters – Part 1: General reguirements, Annex B Method for determining peak tensile force.
The device was also subjected to a pull test of the retention of the device on a 9.9mm diameter endoscope.
- f) Reprocessing of Non-single Use Components
The MiVu Esophageal Endo Cap device is a single-use disposable device, and as such, is not reprocessed.
The MiVu Endo Cap Cable is a reusable component of the MiVu System that has the potential for incidental contact with patient mucous when the soiled Endo Cap device is being disconnected and disposed. Because of this potential for incidental soiling, the MiVu Endo Cap Cable should be reprocessed after each use. The reprocessing instructions outlined in the MiVu System IFU for cleaning and low-level disinfection were validated by a third-party testing lab.
- g) Bioburden and Shipping Simulation
The MiVu Esophageal Endo Cap device is a single-use disposable device. The devices are manufactured in a controlled environment that is reqularly monitored for bioburden. The Endo Cap devices were tested for bioburden levels pre- and post- shipping simulation to verify the packaging effectiveness and verify the mechanical integrity of the packaging.
11. Software
The MiVu Mucosal Integrity Testing System (MiVu System) utilizes both embedded firmware and PC-based software. The embedded firmware runs on microprocessors in the PriZm
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Central Unit and the MiVu Endo Cap Cable accessory component. The PC-based software, called Zvu, is used for the acquisition and analysis of clinical data for both the predicate device configuration and the candidate device configuration. Both the firmware and software are classified as a "minor level of concern" since both components do not control aspects of the system that might impact patient safety. As such, a failure or latent flaw in the software or firmware will not pose any risk of harm to the patient or user.
12. Clinical Testing
The MiVu Mucosal Integrity Testing System (MiVu System) utilizing the MiVu Esophageal Endo Cap was tested against the same MiVu System utilizing the predicate MiVu Balloon Probe to demonstrate equivalence in a clinical environment and to validate usability requirements.
Under the auspices of an IRB, clinical studies were performed by three gastroenterologists at the same United States located facility who were familiar with both MiVu System configurations. Seventeen (17) random patients were tested using both devices to obtain comparative studies. An additional seven (7) random patients were tested using only the MiVu Esophageal Endo Cap device because the physician chose not to perform the balloon study based on the patient's condition and/or time constraints but preferred to acquire an Esophageal Endo Cap study. Patients were of adult age ranging from 20 to 70 years, with 12 males, 8 females and 4 unknowns (data not provided). Study patients were selected based on the known or highly suspected esophageal disease type (GERD, non-GERD, EoE), and their willingness to consent to the study. Since both the balloon probe study and the Endo Cap study were performed in conjunction with an endoscopic study, the patients were sedated. All studies were completed with no patient adverse effects or complications reported.
All studies found the MiVy System with the MiVy Esophageal Endo Cap device provided clinically equivalent or better results than the MiVu Balloon Probe based on the disease probabilities generated by the MiVu System.
13. Conclusion
The MiVu Mucosal Integrity Testing System (MiVu System) utilizing the MiVu Esophageal Endo Cap device has a substantially equivalent indications for use and intended use to the MiVu System utilizing the predicate MiVu Balloon Probe.
Based on the technological characteristics and overall performance of the devices in bench testing and clinical testing, Diversatek Healthcare believes the proposed MiVu Mucosal Integrity Testing System utilizing the MiVu Esophageal Endo Cap and the predicate device configuration are substantially equivalent.
Through risk assessment and testing, Diversatek Healthcare has concluded the MiVu Mucosal Integrity Testing System utilizing the MiVu Esophageal Endo Cap does not raise any new issues of safety and effectiveness and performs as well as the legally marketed predicate device.