(119 days)
The EkoSonic® Endovascular System is indicated for the:
- Ultrasound facilitated, controlled and selective infusion of physician-specified fluids, including thrombolytics, into the vasculature for the treatment of pulmonary embolism.
- Infusion of solutions into the pulmonary arteries.
- Controlled and selective infusion of physician-specified fluids, including thrombolytics, into the peripheral vasculature.
The EkoSonic Endovascular System consists of an EkoSonic Endovascular Device and the Control System (Control Unit and Connector Interface Cables). The EkoSonic Endovascular Device consists of a single-use, disposable infusion catheter with removable ultrasound core. The infusion catheter contains multiple side holes distributed over the length of the treatment zone. The ultrasound core contains up to 30 ultrasound elements, evenly spaced over the treatment zone. Thermal sensors in the treatment zone monitor catheter temperature. The Control System generates and controls the delivery of radiofrequency energy to the ultrasound core while monitoring and controlling the temperature of the treatment zone.
This notification is being made due to the modification of the MSD hub portion of the EkoSonic Endovascular Device.
Here's an analysis of the provided text regarding the acceptance criteria and supporting study for the EkoSonic Endovascular Device:
1. Table of Acceptance Criteria and Reported Device Performance:
The document describes several device-level and system-level tests performed to demonstrate substantial equivalence, particularly focusing on modifications to the MSD hub portion of the device. The reported performance for all tests is "Pass," indicating that the device met the established acceptance criteria for each test.
| Product Specification | Purpose | Acceptance Criteria (Implied) | Reported Device Performance (T=0) | Reported Device Performance (Artificially Aged (T=3 Years)) |
|---|---|---|---|---|
| Device Level Testing | ||||
| Tensile Strength | Redesign of shaft-to-cable and Luer-to-cover joints (replaces lap joint with soldered PCB, Luer-to-cover epoxy with snap-on cover). | Maintain structural integrity | Pass | Pass |
| Catheter Interlock | Redesigned catheter interlock, replacing watertight epoxy seal with copolyester overmold. | Maintain watertight seal | Pass | Pass |
| Impedance | Redesigns connection between shaft-to-cable, which is the RF energy path. | Maintain electrical conductivity | Pass | Pass |
| Resonant Frequency | (Associated with Impedance testing) | Maintain optimal frequency | Pass | Pass |
| Luers | Redesigned Luer barb to facilitate snap-on cover. | Maintain proper Luer function | Pass | Pass |
| Electrical Isolation | Redesigns leakage current pathway from connector to external fluid. | Maintain electrical safety | Pass | Pass |
| Sterilization | Device undergoes shipping, storage, sterilization, and shelf life simulation to provide representative test articles. | Maintain sterile barrier/integrity | Pass | Pass |
| Shipping | (Part of simulating representative test articles) | Withstand shipping stresses | Pass | Pass |
| Storage | (Part of simulating representative test articles) | Withstand storage conditions | Pass | Pass |
| Shelf Life | (Part of simulating representative test articles) | Maintain function over shelf life | Pass | Pass |
| Burst Strength | Redesigns Luer-to-cover interface, affecting resistance to high static pressure. | Maintain resistance to burst | Pass | Pass |
| Fluid Immersion | Redesigns and replaces primary seal with overmold; assessed continuity before and after fluid immersion. | Maintain fluid integrity/continuity | Pass | Pass |
| Bending Force | Replaces Luer and strain relief with new Luer barb and snap-on cover; assessed bending force of snap-on cover. | Maintain structural flexibility | Pass | Pass |
| System Level Testing | ||||
| System Integration with PT-3B | MSD hub changes affect connection between MSD and Control System. | Maintain system compatibility | Pass | N/A |
| System Integration with CU4.0 | MSD hub changes affect connection between MSD and Control System. | Maintain system compatibility | Pass | validation testing. |
2. Sample Size Used for the Test Set and Data Provenance:
The document states "Testing has confirmed that the EkoSonic Endovascular Device functions as intended and is substantially equivalent to the predicate device." However, it does not explicitly state the sample sizes used for each of the various tests (e.g., tensile strength, burst strength). It also does not specify the data provenance (e.g., country of origin, retrospective or prospective). The nature of the tests (physical and electrical performance) generally implies laboratory testing rather than clinical data provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The study described is focused on the physical and electrical performance of the device components due to a modification. It is not a diagnostic device study that would typically involve establishing ground truth based on expert consensus of medical images or patient outcomes. Therefore, there is no mention of experts or their qualifications for establishing ground truth in the context of these engineering performance tests. The "ground truth" here is the expected physical and electrical performance as defined by engineering specifications and standards.
4. Adjudication Method for the Test Set:
Given that this is a technical performance study of device components, an "adjudication method" in the clinical sense (like 2+1 or 3+1 consensus for medical image interpretation) is not applicable and not mentioned. The results of these engineering tests ("Pass") would be determined by whether the device meets pre-defined quantitative or qualitative engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or performed. The device is an EkoSonic Endovascular Device used for ultrasound-facilitated, controlled, and selective infusion of fluids. It's a therapeutic device, not a diagnostic imaging device typically evaluated with MRMC studies comparing human readers with and without AI assistance.
6. Standalone Performance Study:
The study is inherently about the standalone performance of the modified device components and its integration with the control unit. The listed tests (tensile strength, impedance, electrical isolation, etc.) evaluate the device's intrinsic physical and electrical characteristics. There is no "algorithm only" aspect as it's a physical medical device. It's not an AI-driven diagnostic tool that would have a separate standalone algorithm performance.
7. Type of Ground Truth Used:
The ground truth for this type of performance study is based on engineering specifications, design requirements, and established industry standards for medical device safety and functionality. For example, burst strength would have a defined pressure threshold, and electrical isolation would have maximum leakage current limits. The "Pass" results indicate that the device met these predefined engineering criteria.
8. Sample Size for the Training Set:
This document describes a study for a physical medical device. It does not involve a "training set" in the context of machine learning or artificial intelligence. The performance data presented are for validation testing of the modified device.
9. How the Ground Truth for the Training Set Was Established:
As there is no training set for this type of device performance study, this question is not applicable. The "ground truth" for evaluating the test items relates to engineering specifications as described in point 7.
§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).