(25 days)
The Octane Mechanical Thrombectomy System is intended for the removal/aspiration of embolic material (thrombus/ debris) from vessels of the arterial and deep venous system, and to infuse/deliver diagnostic or therapeutic agents.
The Octane Mechanical Thrombectomy System consists of two components: the Octane mechanical thrombectomy catheter and the Octane hand pump. The Octane mechanical thrombectomy catheter has a working length of 115cm, is compatible with introducer sheaths ≥ 8F and it is intended for use in vessels ≥ 3 mm in diameter. The catheter has a rapid exchange design and includes sliding, co-axial inner and outer lumens. The rapid exchange guidewire lumen is compatible with guidewires ≤ 0.018" in diameter and the 6F inner catheter lumen is compatible with guidewires ≤ 0.038" in diameter. The catheter inner lumen tip has three side wall slot ports and the catheter's outer lumen has a beveled radiopaque tip. To alleviate plugging of the catheter tip caused by thrombus, the actuator on the proximal end of the catheter slides the catheter's outer lumen back and forth over the inner lumen distal tip. The actuator on the proximal end of the catheter is also used to control the directionality of the torque-able catheter. Directionality is further achieved through the gradual curve in the shaft materials at the distal end. The Octane hand pump provides suction to the inner lumen of the Octane mechanical thrombectomy catheter and is manually operated using a spring-loaded handle. It consists of a pump handle fitted with a 30ml piston syringe, tubing, a series of one-way valves, and a 500ml collection bag. The hand pump tubing has a standard luer fitting for connection to the Octane mechanical thrombectomy catheter hub. The Octane Mechanical Thrombectomy System has been sterilized with ethylene oxide.
The provided text describes the Octane Mechanical Thrombectomy System (K182232) and compares it to a predicate device, the Octane Aspiration System (K173266). The submission claims substantial equivalence based on the device's design, intended use, materials, and operating mechanisms.
However, the document does not include a table of acceptance criteria or details of a study that proves the device meets specific acceptance criteria in the manner usually associated with clinical performance or algorithm-based devices. Instead, it focuses on bench testing to demonstrate substantial equivalence to a predicate device following a labeling change.
Therefore, for aspects related to specific acceptance criteria, statistical performance, and ground truth establishment, the information is not present in the provided text.
Here's a breakdown of the available information based on your request:
1. Table of Acceptance Criteria and Reported Device Performance
Not explicitly provided in the document.
The document states: "The results of the verification test met the specified acceptance criteria and did not raise different questions of safety and effectiveness." However, the specific acceptance criteria themselves (e.g., specific metrics like effectiveness rates, aspiration volume, etc.) and the reported device performance against those criteria are not detailed in the text. The evaluation method described is "bench tests" to evaluate technological differences and "concomitant device compatibility tests" to support labeling modifications.
2. Sample Size Used for the Test Set and Data Provenance
Not applicable/Not provided.
This document describes bench testing, not a clinical trial with a "test set" in the context of patient data. The "sample size" would refer to the number of devices or test conditions, which is not specified. The concept of "data provenance" (country of origin, retrospective/prospective) is not relevant for bench testing.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable/Not provided.
As this was bench testing for substantial equivalence, the concept of establishing ground truth by medical experts for a "test set" (e.g., imaging studies) is not relevant. The "ground truth" would be engineering specifications and measurements, overseen by engineers and quality assurance personnel.
4. Adjudication Method for the Test Set
Not applicable/Not provided.
Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies or studies involving expert consensus on medical data. This information is not relevant for the bench testing described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No.
The document does not mention an MRMC study. The study described is bench testing for substantial equivalence to a predicate device, not a comparative effectiveness study involving human readers and 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 system, not an AI algorithm. Therefore, the concept of "standalone performance" for an algorithm is not relevant.
7. The Type of Ground Truth Used
Engineering Specifications and Bench Test Measurements.
For bench testing of a medical device, the "ground truth" refers to established engineering specifications, mechanical properties, and performance benchmarks measured in a controlled environment. The document states "The results of the verification test met the specified acceptance criteria," indicating that the device's performance was measured against predetermined engineering and design standards.
8. The Sample Size for the Training Set
Not applicable/Not provided.
This refers to bench testing for device performance and substantial equivalence, not the training of an AI algorithm. Therefore, a "training set" in this context is not applicable.
9. How the Ground Truth for the Training Set Was Established
Not applicable/Not provided.
As there is no mention of a "training set" for an algorithm, this question is not relevant. The "ground truth" for the device's performance relies on engineering design specifications and test methods.
§ 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).