(888 days)
The X-SIZER Catheter System is indicated for the mechanical removal of thrombus in synthetic hemodialysis grafts.
The X-SIZER System is a single-use, disposable medical device intended for the selective removal of thrombus from blood vessels. The device consists of a 135cm coaxial, dual lumen hydrophilic coated outer catheter shaft connected to a hand-held Control Module. The inner lumen of the catheter is composed of a hollow torque cable encapsulated in a polyamide tube (flexible drive shaft). A helical cutter is contained within the cutter housing located at the distal tip of the catheter. The outer lumen of the catheter is the path in which the excised debris is removed by vacuum. In use, the cutter is rotated at approximately 2,100 pm by the motor, which is powered by a 9-volt alkaline battery. In addition to turning the helical cutter, the inner lumen provides the space through which a coronary guidewire is placed. The hand-held Control Module contains the motor, battery, circuitry, indicators, and various valves and manifolds for the vacuum removal of thrombotic debris. The X-SIZER System is available in the 1.5mm and 2.0mm diameter models.
The provided document describes the X-SIZER® Catheter System, a thrombectomy device. However, it does not include detailed acceptance criteria or a study designed to explicitly prove the device meets these criteria in a quantitative, statistical manner as would be expected for a typical AI/software device. Instead, it focuses on demonstrating substantial equivalence to predicate devices through comparative performance testing.
Therefore, many of the requested fields cannot be directly populated from the input provided. I will fill in what can be inferred or directly stated and note when information is unavailable.
Here's a breakdown based on the provided text:
Acceptance Criteria and Device Performance Study for X-SIZER® Catheter System
The provided documentation details the X-SIZER® Catheter System's premarket notification (510(k)) for substantial equivalence to legally marketed predicate devices. The performance data presented focuses on demonstrating that the X-SIZER® Catheter System is as safe and effective as these predicate devices, rather than meeting pre-defined quantitative acceptance criteria with specific threshold values for performance metrics.
1. Table of Acceptance Criteria and Reported Device Performance
Since explicit acceptance criteria with numerical thresholds are not provided, the table below reflects the comparative performance assessment described in the document.
| Performance Aspect | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| In vitro Bench Tests | Basic functional operation is satisfactory. | "Basic functional operation, leak tests, battery life test, corrosion resistance, motor current and trackability test, hydrophilic coating test, flow rate test, device output test, kink resistance test, tensile tests, bond tests, joint tests, torque tests, flexibility (deflection) tests, shaft torque resistance, cutter/housing binding" were subjected to testing. |
| Thrombus Cutting/Extraction (Bench) | Equivalent performance to predicate device (Edwards Lifesciences Thrombex PMT System) in clot extraction and safety within synthetic graft material. | "The X-SIZER Catheter System performed equivalently to the Thrombex PMT System when assessing clot extraction and safety within a synthetic graft material." |
| Vessel Trauma (In vivo) | Equivalent performance to predicate device (Edwards Lifesciences Thrombex PMT System) in minimizing vessel trauma. | "The X-SIZER System performed equivalently to the Thrombex PMT System when assessing vessel trauma..." |
| Distal Embolization (In vivo) | Equivalent performance to predicate device (Edwards Lifesciences Thrombex PMT System) in minimizing distal embolization. | "...distal embolization..." |
| Overall Device Performance (In vivo) | Equivalent performance to predicate device (Edwards Lifesciences Thrombex PMT System) for thrombus removal in occluded dialysis grafts. | "...and overall device performance for the removal of thrombus in occluded dialysis grafts." |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not explicitly stated in terms of number of samples/cases. The document refers to "a bench model simulating synthetic hemodialysis grafts" and "an in vivo animal model utilizing thrombosed hemodialysis grafts" for comparative testing. Specific numbers of grafts or experimental runs are not provided.
- Data Provenance: The studies were in vitro (bench model) and in vivo (animal model). The country of origin is not specified but is presumably overseen by the US regulatory system given the FDA submission. These appear to be prospective studies conducted specifically for this 510(k) submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this device's performance is established through direct physical measurements and observations in in vitro and in vivo models, not through expert review of data/images. The assessment of "equivalence" would involve technical experts (engineers, scientists, veterinarians) conducting and analyzing the tests. Their number or specific qualifications beyond general expertise in medical device testing are not detailed.
4. Adjudication method for the test set
Not applicable. As the performance assessment is based on physical and physiological measurements/observations in bench and animal models rather than expert interpretation of data, there is no expert adjudication method like 2+1 or 3+1.
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
Not applicable. This device is a mechanical thrombectomy catheter, not an AI or imaging device that involves human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical thrombectomy catheter, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth or reference standard for this device's performance is based on:
- In vitro measurements: Direct quantitative measurements from bench tests (e.g., flow rate, output, tensile strength, battery life, corrosion resistance, clot extraction efficiency).
- In vivo observations/measurements: Direct observations and possibly post-procedure analysis (e.g., histology for vessel trauma, assessment of distal embolization, overall efficacy in thrombus removal) in the animal model.
8. The sample size for the training set
Not applicable. This device is a mechanical thrombectomy catheter, not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device.
§ 870.4875 Intraluminal artery stripper.
(a)
Identification. An intraluminal artery stripper is a device used to perform an endarterectomy (removal of plaque deposits from arterisclerotic arteries.)(b)
Classification. Class II (performance standards).