(366 days)
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.
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. The Connecting Tube is used for the transfer of liquids (heparinized saline) between the 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.
The provided text describes a medical device, the EchoTip® Insight™ Portosystemic Pressure Gradient Measurement System, and its regulatory approval process, including performance testing. However, it does not explicitly define acceptance criteria in a table format with specific numerical targets. The "acceptance criteria" are implied by the successful completion of various tests and the statement that the probable benefits outweigh the probable risks.
Since a table of acceptance criteria and reported device performance, and several other requested pieces of information are not explicitly stated, I will extract and infer as much as possible from the provided text.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
As mentioned, explicit numerical acceptance criteria are not provided. The "reported device performance" is described through the successful completion of various tests.
| Acceptance Criteria Category (Inferred) | Stated Performance / Evidence |
|---|---|
| Biocompatibility | All device components were evaluated according to FDA guidance (ISO 10993-1, ISO 10993-4) and found to be biocompatible for its use. |
| Sterility | Sterilization methods (EO) have been validated in accordance with ISO 11135-1:2007 to ensure a sterility assurance level of 10-6. Components tested for pyrogenicity using LAL (Limulus Amebocyte Lysate test). |
| Shelf Life/Package Integrity | Accelerated aging to support a 3-year shelf life performed per ASTM F1980-07. Expiration date of 3 years verified by demonstrating package integrity through dye penetration and burst testing on stored products. |
| Mechanical Performance/Product Integrity | Needle crumple testing, tensile strength testing, product integrity testing for Connecting Tube, dimensional verification for needle and Connecting Tube, and design verification/validation testing were conducted and passed. (Non-clinical performance data generated to mitigate risk of component/material failure.) |
| Accuracy of Pressure Measurement (Bench Test) | Simulated use test performed to measure pressures of known values. Device tested for its ability to measure three known pressures created by filling a column of liquid at three different points. The ability of an end user to accomplish tasks under simulated use conditions was verified. |
| Accuracy of Pressure Measurement (Animal Study) | Excellent correlation between the subject device and transjugular approach at all pressure ranges. Pearson's correlation coefficient (R) of 0.999 for all vessels, 0.985 for all veins, 0.988 for PV and WHVP, and 0.986 for free HV pressure. |
| Clinical Safety (Human Study) | No patient experienced intraprocedural or postprocedural adverse events (e.g., bleeding, perforation, infection, pain) in 28 patients. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Bench Performance Test (Simulated Use): "A statistically significant number of distinct needle devices, connecting tubes, and Compass CT transducers were tested..." (Actual number not specified). This was a prospective, benchtop test.
- Animal Study: 17 pressure measurements were carried out in three swine. This was a prospective animal study. Data provenance not explicitly stated, but the authors are from "Gastrointestinal Endoscopy, 2016 Aug" and "2017 May", implying likely US-based research or internationally recognized publication.
- Human Clinical Study: 28 patients. This was a single-center, prospective human pilot study. Data provenance not explicitly stated (journal and authors provided, but not specific country of origin).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The concept of "ground truth" and "experts" as typically understood in AI/ML validation (e.g., for image classification) does not directly apply to this device. This device measures a physiological parameter directly.
- Bench Performance Test: "Known values" of pressure were created by filling a column of liquid. The ground truth was these known physical pressures. No human experts were involved in establishing this ground truth.
- Animal Study: The comparative method used was an "interventional radiologic (IR) trans-jugular balloon catheter tip," which is considered the standard of care for obtaining indirect portal/hepatic pressure. This method itself provides the "ground truth" for comparison. The study was conducted by researchers (likely experts in gastroenterology/endoscopy and interventional radiology, as implied by the journal type and comparison method reference in the title).
- Human Clinical Study: The study provided confirmatory evidence that the device could safely measure PPG. The "ground truth" for pressure measurements was established by the device itself in a clinical setting compared to expected physiological ranges, with safety as the primary endpoint. The clinicians performing the procedure (e.g., gastroenterologists) were experts in their field, overseeing the measurements.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers interpret data (e.g., images) and their decisions need to be reconciled. This device is a measurement system, not an interpretive one. Therefore, no formal adjudication method was required or described for assessing its performance.
- In the animal study, the comparison was between two measurement techniques.
- In the human study, the focus was on safety and the device's ability to obtain measurements.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No such MRMC comparative effectiveness study was done. This device is not an AI-assisted diagnostic tool that aids human readers in interpretation. It is a direct physiological measurement device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not directly applicable. The device is a standalone measurement system in that it physically measures pressure. However, it requires a human operator for insertion and operation, and the Compass CT pressure transducer contains an "integrated, pre-programmed diagnostic computer chip with a liquid crystal display" for measurement and monitoring, effectively making its measurement "standalone" once the physical connection is made. There's no separate "algorithm only" performance reported distinct from the device's main function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Bench Performance Test: Known physical pressures created by a liquid column.
- Animal Study: Measurements obtained from the standard interventional radiologic (IR) trans-jugular balloon catheter method.
- Human Clinical Study: The device's direct pressure measurements, assessed primarily for safety and its ability to obtain these measurements in a clinical setting. Clinical signs and symptoms indicative of cirrhosis in 19 patients provided context for the measurements.
8. The sample size for the training set
No training set is mentioned or applicable to this type of device. The EchoTip® Insight™ is a physical measurement system, not a machine learning model that requires a distinct training phase. The Compass CT pressure transducer has a pre-programmed chip, but its "programming" doesn't involve a machine learning training set in the typical sense.
9. How the ground truth for the training set was established
Not applicable, as there is no mention of a training set for a machine learning model.
§ 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.