(51 days)
The Octane aspiration 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 aspiration system consists of two components: the Octane catheter and the Octane hand pump. The Octane aspiration catheter has a working length of 115cm, is compatible with introducer sheaths ≥ 8F, guidewires ≤ 0.018" in diameter, 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 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 aspiration 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 aspiration catheter hub. The Octane aspiration system has been sterilized with ethylene oxide.
This document is a 510(k) Summary for the Octane Aspiration System, a medical device intended for the removal of embolic material from blood vessels. The summary describes the device, its intended use, and the studies conducted to demonstrate its substantial equivalence to a predicate device (Pronto XL). However, it does not contain information about acceptance criteria and device performance in a format that directly addresses the user's request for AI/algorithm-related performance metrics or human reader studies.
The document specifies bench testing and biocompatibility testing to demonstrate substantial equivalence, focusing on the physical and material properties of the device, rather than the diagnostic or interpretative performance of an AI system.
Therefore, many of the requested categories related to AI performance, ground truth, expert opinions, and sample sizes for AI training/testing sets cannot be directly answered from the provided text.
Here's a breakdown of what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
The document broadly states: "The results of the verification tests met the specified acceptance criteria and did not raise new safety or performance issues." However, it does not provide a specific table detailing the numerical acceptance criteria for each test and the corresponding reported device performance values. It only lists the tests performed.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Bench Testing | |
| Track force | Met specified criteria |
| Radiopacity | Met specified criteria |
| Collection bag pressure | Met specified criteria |
| Syringe seal attachment | Met specified criteria |
| Check valve crack pressure | Met specified criteria |
| Synthetic clot extraction | Met specified criteria |
| Proximal seal leak | Met specified criteria |
| Aspiration | Met specified criteria |
| Liquid leak | Met specified criteria |
| Bond/joint tensile | Met specified criteria |
| Torque capacity | Met specified criteria |
| Corrosion resistance | Met specified criteria |
| Therapeutic agent conditioning | Met specified criteria |
| Static pressure | Met specified criteria |
| Package integrity | Met specified criteria |
| Biocompatibility Testing | |
| Cytotoxicity | Passed |
| Sensitization | Passed |
| Irritation | Passed |
| Acute systemic toxicity | Passed |
| Material mediated pyrogenicity | Passed |
| Hemolysis | Passed |
| Complement activation | Passed |
| Thrombogenicity | Passed |
2. Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for each bench or biocompatibility test. These tests typically involve a certain number of device units.
- Data provenance (e.g., country of origin, retrospective/prospective) is not applicable or provided as these are bench and lab tests, not clinical or image-based studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable. The studies described are physical and material tests of a medical device, not diagnostic or AI-driven interpretations requiring expert consensus for ground truth.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This is not applicable. These are objective engineering and laboratory tests, not subjective interpretations requiring adjudication.
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 MRMC or comparative effectiveness study involving human readers or AI assistance was performed or reported in this document. The device is an aspiration catheter, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No standalone algorithm performance study was done as the device is a physical medical instrument, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the bench tests would be established by engineering specifications, physical measurements, and standardized laboratory procedures. For biocompatibility, it's defined by the ISO 10993 standards. It's not based on expert consensus, pathology, or outcomes data in the way an AI diagnostic would be.
8. The sample size for the training set:
- Not applicable, as this device does not involve an AI algorithm that requires a training set.
9. How the ground truth for the training set was established:
- Not applicable, as this device does not involve an AI algorithm.
§ 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).