(366 days)
Not Found
No
The device description mentions a "pre-programmed diagnostic computer chip" but does not describe any AI or ML capabilities. The performance studies focus on pressure measurement accuracy and safety, not on algorithmic performance.
No.
The device is indicated to directly measure pressures, which is a diagnostic function, not a therapeutic one.
Yes
Explanation: The device is used to "directly measure pressures in the hepatic and portal venous vasculatures," which is a physiological measurement used to diagnose conditions like portal hypertension. The Compass CT component also explicitly includes a "pre-programmed diagnostic computer chip."
No
The device description clearly outlines multiple hardware components including a needle, connecting tube, syringe, stopcock, and a pressure transducer with an embedded sensor and computer chip. While the pressure transducer has a digital display and likely involves software for processing, the system is fundamentally a hardware-based measurement system.
Based on the provided information, the EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "directly measure pressures in the hepatic and portal venous vasculatures". This is a measurement of physiological parameters within the body, not an analysis of samples taken from the body (like blood, urine, or tissue).
- Device Description: The system is designed to access blood vessels and measure pressure in situ. It involves a needle for access and a pressure transducer to measure the pressure directly within the veins.
- Lack of In Vitro Analysis: There is no mention of analyzing samples outside of the body. The measurement is performed directly within the patient's vasculature.
- Input Imaging Modality: The use of ultrasound is for guidance during the procedure to place the needle correctly within the veins, not for analyzing images of samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic purposes. This device measures a physiological parameter (blood pressure) directly within the body.
N/A
Intended Use / Indications for Use
The EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System is indicated to directly measure pressures in the hepatic and portal venous vasculatures and is used in conjunction with an ultrasound endoscope.
Product codes (comma separated list FDA assigned to the subject device)
OIJ, QIJ
Device Description
The EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System is a system used to provide endoscopic access to the portal and hepatic veins to measure local blood pressure. As shown in Figure 1, the system is composed of: 1. EchoTip Insight Endoscopic Ultrasound Needle 2. Connecting Tube 3. 10 mL syringe 4. Stopcock 5. Compass CT Pressure Transducer (K133624). The EchoTip® Insight™ Needle functions to provide access to the venous vasculature related to the portal circulation and hepatic outflow to facilitate the measurement of physiological pressure by the Compass® CT pressure transducer, a disposable manometer (cleared under K133624). The needle is enclosed within a 5.2 Fr. outer sheath for protection. The sheath has an adjustable length (0-5 cm) to allow the user to adjust for the working length of the endoscope. The sheath length extension lock ring allows the sheath to be secured in place by tightening the thumbscrew. The needle extension is also adjustable and ranges from 0-8 cm. The "zero" reference ensures complete needle retraction within the sheath. The handle has a safety ring that slides and locks using the thumbscrew at the desired needle extension.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound guidance
Anatomical Site
hepatic and portal venous vasculatures
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)
Non-clinical performance data was generated to mitigate the risk associated with the failure of the device components and/or materials. The following tests were conducted and passed: needle crumple testing, tensile strength testing, product integrity testing for Connecting Tube, dimensional verification for needle and Connecting Tube, package integrity testing on all device components post distribution, and design verification/validation testing. A simulated use test was performed to measure pressures of known values. The simulated use testing consisted of design verification and validation of the EchoTip Insight Portosystemic Pressure Gradient Measuring System. After passing the device through an echoendoscope, the device was tested for its ability to measure three known pressures, which were created by filling a column of liquid at three different points. A statistically significant number of distinct needle devices, connecting tubes, and Compass CT transducers were tested, and the ability of an end user to accomplish each of the tasks conducted to obtain a pressure measurement under simulated use conditions was verified.
The EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System was compared versus the standard trans-jugular approach, in which an indirect portal/hepatic pressure is obtained with the use of a balloon catheter. In this study, 17 pressure measurements were carried out in three swine at baseline, and then following induction of portal hypertension (PH) by rapid peripheral infusion of Dextran-40. Manometric data were obtained using an interventional radiologic (IR) trans-jugular balloon catheter tip from the right hepatic vein (both free and wedged pressures) and then using the subject device to obtain pressure gradients of the portal and hepatic veins. The correlation between the 2 methods of measurement was charted in scatter plots, and the Pearson's correlation coefficient (R) was calculated. Among other measurements, the authors calculated the correlation of 17 paired manometric data points from Wedge Hepatic Venous Pressure (WHVP) using the transjugular method, and Portal Venous Pressure (PV) using the subject device. There was excellent correlation between the subject device and transjugular approach at all pressure ranges. The authors calculated a Pearson's correlation coefficient of 0.999 for all vessels, 0.985 for all veins, 0.988 for PV and WHVP, and 0.986 for free HV pressure.
A published clinical study was provided to FDA as confirmatory evidence that the device could safely measure portal pressure gradient (PPG) (i.e the difference between hepatic and portal vein pressures). In this single center study, PPG was determined in 28 patients. Of these patients, 19 patients had clinical signs or symptoms that were highly suspicious of cirrhosis. The study excluded pregnant women, patients at risk of bleeding (International Normalized Ratio > 1.5, platelet count
§ 876.1050 Endoscopic transhepatic venous access needle.
(a)
Identification. An endoscopic transhepatic venous access needle is inserted through the liver into the patient's portal/hepatic venous system under endoscopic ultrasound guidance. It is connected to a separate device intended to measure a physiological parameter.(b)
Classification. Class II (special controls). The special controls for this device are:(1) The patient-contacting components of the device must be demonstrated to be biocompatible.
(2) Performance data must demonstrate the sterility of the patient-contacting components of the device.
(3) The patient-contacting components of the device must be demonstrated to be non-pyrogenic.
(4) Performance testing must support the shelf life of device components provided sterile by demonstrating continued sterility and package integrity over the labeled shelf life.
(5) Non-clinical performance testing must demonstrate that the device performs as intended under anticipated conditions of use. The following must be tested:
(i) Needle crumple testing;
(ii) Tensile testing;
(iii) Dimensional verification for all components; and
(iv) Simulated use testing.
(6) Labeling must include the following:
(i) Instructions for use, including specific instructions regarding device preparation;
(ii) The recommended training for safe use of the device; and
(iii) A shelf life for any sterile components.
0
DE NOVO CLASSIFICATION REQUEST FOR ECHOTIP® INSIGHT™ PORTOSYSTEMIC PRESSURE GRADIENT MEASUREMENT SYSTEM
REGULATORY INFORMATION
FDA identifies this generic type of device as:
Endoscopic transhepatic venous access needle. An endoscopic transhepatic venous access needle is inserted through the liver into the patient's portal/hepatic venous system under endoscopic ultrasound guidance. It is connected to a separate device intended to measure a physiological parameter.
NEW REGULATION NUMBER: 21 CFR 876.1050
CLASSIFICATION: Class II
PRODUCT CODE: OIJ
BACKGROUND
DEVICE NAME: EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System
SUBMISSION NUMBER: DEN180062
DATE DE NOVO RECEIVED: November 19, 2018
- Cook Ireland, Ltd CONTACT: O'Halloran Road, National Technology Park Limerick Ireland
INDICATIONS FOR USE
The EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System is indicated to directly measure pressures in the hepatic and portal venous vasculatures and is used in conjunction with an ultrasound endoscope.
LIMITATIONS
The sale, distribution, and use of the EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System are restricted to prescription use in accordance with 21 CFR 801.109.
The device is not intended for uses other than that described in the labeling.
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PLEASE REFER TO THE LABELING FOR A COMPLETE LIST OF WARNINGS, PRECAUTIONS AND CONTRAINDICATIONS.
DEVICE DESCRIPTION
The EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System is a system used to provide endoscopic access to the portal and hepatic veins to measure local blood pressure.
As shown in Figure 1, the system is composed of:
-
- EchoTip Insight Endoscopic Ultrasound Needle
-
- Connecting Tube
-
- 10 mL syringe
-
- Stopcock
-
- Compass CT Pressure Transducer (K133624).
Image /page/1/Figure/9 description: The image shows a medical device setup with labeled components. The components include an EchoTip Insight Needle (1), a connecting tube (2), a syringe (3), a stopcock (4), and a Compass CT Pressure Transducer (5). The needle and syringe are connected by the tube, with the stopcock and transducer placed in between.
Figure 1. EchoTip Insight needle, with Connecting Tube and Compass CT transducer
The EchoTip® Insight™ Needle functions to provide access to the venous vasculature related to the portal circulation and hepatic outflow to facilitate the measurement of physiological pressure by the Compass® CT pressure transducer, a disposable manometer (cleared under K133624).
The needle is enclosed within a 5.2 Fr. outer sheath for protection. The sheath has an adjustable length (0-5 cm) to allow the user to adjust for the working length of the endoscope. The sheath length extension lock ring allows the sheath to be secured in place by tightening the thumbscrew.
The needle extension is also adjustable and ranges from 0-8 cm. The "zero" reference ensures complete needle retraction within the sheath. The handle has a safety ring that slides and locks using the thumbscrew at the desired needle extension.
The Connecting Tube is used for the transfer of liquids (heparinized saline) between the
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EchoTip® Insight™ Needle and the Compass® CT pressure transducer. The Connecting Tube uses a female Luer lock to connect to the Compass CT pressure transducer, and a male Luer lock to connect to the stopcock. The Compass CT is a disposable, point-of-use blood pressure measurement and monitoring device that incorporates an embedded pressure sensor and an integrated, pre-programmed diagnostic computer chip with a liquid crystal display.
Once the system is connected and primed with heparinized saline, the EchoTipe Insight™ Needle is passed through the accessory channel of an ultrasound endoscope and the needle is advanced to the desired vasculature (portal or hepatic vein) through the liver parenchyma. Using ultrasound guidance, the needle is placed at the desired location, allowed to stabilize, and a measurement reading is taken.
Table 1 provides a technological description of the device.
| Device Component | Attribute |
|---|---|
| Needle | 25 gauge |
| 0-8 cm length | |
| Beveled tip | |
| Stainless steel | |
| Echogenic texturing | |
| Sheath | 5 Fr. |
| 142 cm | |
| 0-5 cm adjustable length | |
| Polyetheretherketone (PEEK) Material | |
| Handle | Proximal female luer |
| Sheath and needle adjustment controls | |
| Connectors | Luer connection |
| Access/visualization | |
| technique | Manually advanced through the working |
| channel (2.8 mm) of an ultrasound | |
| endoscope under ultrasound visualization |
Table 1. Description of Technology for the EchoTip Insight Portosystemic Pressure Gradient Measurement System.
SUMMARY OF NONCLINICAL/BENCH STUDIES
BIOCOMPATIBILITY/MATERIALS
The Connecting Tube, stopcock, and syringe are externally communicating devices with indirect contact with blood for a limited (≤24 hrs) duration. As such, the following tests are expected: Cytotoxicity, Sensitization, Irritation, Acute systemic toxicity, material mediated pyrogenicity, hemocompatibility. The EchoTip Insight needle is categorized as an externally communicating device in direct contact with circulating blood for a limited (≤24 hrs) duration. As such, the same tests were expected, with the addition of genotoxicity. The device system therefore, has components that have direct and indirect
3
patient contact. All device components were evaluated according to the FDA guidance (2016). "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," and the ISO 10993-4:2017, "Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood." From the evaluations and supporting information, the components of the device were found to be biocompatible for its use.
SHELF LIFE/STERILITY
The EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System is a sterile, single use system. All device components are single use devices provided sterile to the end user. Device components in contact with blood were also tested for pyrogenicity using the LAL (Limulus Amebocyte Lysate test).
Sterilization methods for the EchoTip Insight needle and Connecting Tube have been validated in accordance with ISO 11135-1:2007 "Sterilization of Health Care Products-Ethylene Oxide – Part 1: Requirements for Development. Validation and Routine Control of a Sterilization Process for Medical Devices," to ensure a sterility assurance level of 10-6 before the device is marketed.
Accelerated aging to support a 3-year shelf life was performed for the EO sterilized EchoTip Insight needle and Connecting Tube per ASTM F1980-07, Standard Guidance for Accelerated Aging of Sterile Medical Device Packages. The expiration date of 3 years was verified by demonstrating package integrity through dye penetration and burst testing on the stored products.
PERFORMANCE TESTING - BENCH
Non-clinical performance data was generated to mitigate the risk associated with the failure of the device components and/or materials. The following tests were conducted and passed: needle crumple testing, tensile strength testing, product integrity testing for Connecting Tube, dimensional verification for needle and Connecting Tube, package integrity testing on all device components post distribution, and design verification/validation testing.
A simulated use test was performed to measure pressures of known values. The simulated use testing consisted of design verification and validation of the EchoTip Insight Portosystemic Pressure Gradient Measuring System. After passing the device through an echoendoscope, the device was tested for its ability to measure three known pressures, which were created by filling a column of liquid at three different points. A statistically significant number of distinct needle devices, connecting tubes, and Compass CT transducers were tested, and the ability of an end user to accomplish each of the tasks conducted to obtain a pressure measurement under simulated use conditions was verified.
4
PERFORMANCE TESTING - ANIMAL TESTING
The EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System was compared versus the standard trans-jugular approach, in which an indirect portal/hepatic pressure is obtained with the use of a balloon catheter . In this study, 17 pressure measurements were carried out in three swine at baseline, and then following induction of portal hypertension (PH) by rapid peripheral infusion of Dextran-40. Manometric data were obtained using an interventional radiologic (IR) trans-jugular balloon catheter tip from the right hepatic vein (both free and wedged pressures) and then using the subject device to obtain pressure gradients of the portal and hepatic veins. The correlation between the 2 methods of measurement was charted in scatter plots, and the Pearson's correlation coefficient (R) was calculated. Among other measurements, the authors calculated the correlation of 17 paired manometric data points from Wedge Hepatic Venous Pressure (WHVP) using the transjugular method, and Portal Venous Pressure (PV) using the subject device. There was excellent correlation between the subject device and transjugular approach at all pressure ranges. The authors calculated a Pearson's correlation coefficient of 0.999 for all vessels, 0.985 for all veins, 0.988 for PV and WHVP, and 0.986 for free HV pressure.
1 Huang, J., Samarasena, J., Tsujino, T., Chang, K. EUS Guided portal pressure gradient measurement with a novel 25-gauge needle device versus standard transjugular approach: A comparison animal study. Gastrointestinal Endoscopy, 2016 Aug; 84(2), p. 358-362.
SUMMARY OF CLINICAL INFORMATION
A published clinical study2 was provided to FDA as confirmatory evidence that the device could safely measure portal pressure gradient (PPG) (i.e the difference between hepatic and portal vein pressures). In this single center study, PPG was determined in 28 patients. Of these patients, 19 patients had clinical signs or symptoms that were highly suspicious of cirrhosis. The study excluded pregnant women, patients at risk of bleeding (International Normalized Ratio > 1.5, platelet count