FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The Cantata® 2.9 Microcatheters are intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use.

Device Description

The Cantata 2.9 Microcatheters are braided microcatheters with hydrophilic coating, designed for use in small vessel or superselective anatomy for diagnostic and interventional procedures including neuro, peripheral, or coronary use. The devices include one radiopaque marker band to assist in fluoroscopic visualization of the catheter during use. The catheters are available in 2.9 French shafts and are available in 100, 110, 135, and 150 centimeter lengths. The devices are compatible with a 0.038 inch (0.97 millimeters) diameter angiographic catheter and can accept 0.018 inch (0.46 millimeters) and 0.021 inch (0.53 millimeters) diameter wire guides.

AI/ML Overview

The provided text describes performance testing for the Cantata® 2.9 Microcatheter. This is a medical device, not an AI/ML algorithm, therefore most of the requested information about AI model specifics (training set, experts, MRMC studies, etc.) is not applicable.

Here's the information that can be extracted relevant to the performance of the Cantata® 2.9 Microcatheter:

Acceptance Criteria and Device Performance

Test	Acceptance Criteria	Reported Device Performance
Air Leakage Testing	Device does not exhibit air leakage during proper clinical use.	Testing showed that the catheter does not exhibit air leakage during proper clinical use. Device met the predetermined acceptance criteria.
Liquid Leakage Testing	Device shall not leak liquid during proper clinical use.	Testing shows that the catheter shall not leak liquid during proper clinical use. Testing demonstrated that the device met the predetermined acceptance criteria.
Tensile Testing	The resulting force required to break the shaft was greater than 5 Newtons (in conformance with ISO 10555-1:1995).	Testing showed that under proper clinical use of the device the peak load value shall be greater than 5 Newtons. In conformance with ISO 10555-1:1995, the predetermined acceptance criteria were met.
Kink Radius Testing	Kink radius of the device is ≤ 3 millimeters.	Testing showed that under proper clinical use the kink radius of the device is ≤ 3 millimeters. Testing demonstrated that the device met the predetermined acceptance criteria.
Dynamic Failure Pressure Testing	Device can withstand a pressure of 1000 pounds per square inch without signs of failure (leaking, rupture, or swelling of the shaft greater than twice the original diameter).	Testing demonstrated that under proper clinical use the device can withstand a pressure of 1000 pounds per square inch without signs of failure. Testing demonstrated that the device met the predetermined acceptance criteria.
Injection Pressures and Flow Rate Testing	(No explicit acceptance criteria stated; test is for characterization)	Injection pressures and flow rates of the device were characterized.
Embolic Particle Size Testing	Device can deliver embolic particles in the 710 – 1000 micron range without complete blockage of the lumen.	The device can deliver embolic particles in the 710 – 1000 micron range.
Ancillary Device Compatibility Testing	Device is compatible with a standard microwire guide and a 0.038 inch inner diameter angiographic catheter when advanced through a simulated tortuosity fixture.	Device is compatible with a Standard micro wire guide and a 0.038 inch diameter angiographic catheter.
Evaluation of Device in an Animal Model	The device and compatible device/embolization medium must receive an acceptable rating in terms of preparation, introduction, pushability, trackability, and radiopacity.	The device and the compatible device/embolization medium must receive an acceptable rating in terms of preparation, introduction, pushability, trackability, and radiopacity. (Implies performance met, as it's stated as a requirement that was met according to the conclusion).
Trackability Testing	Device is able to be consistently tracked to the location of the internal carotid artery siphon.	Testing showed that the device is able to be consistently tracked to the location of the internal carotid artery siphon. Testing demonstrated that the device met the predetermined acceptance criteria.
Cytotoxicity – ISO MEM Elution Assay	Test article scores 0 for lysis (same as negative and cell control) at 24, 48, and 72 ± 4 hours.	Non-cytotoxic (Test article scored a 0 for lysis at 24, 48, and 72 ± 4 hours).
Sensitization	Test article does not elicit a sensitization response greater than '0' for normal saline extract and cottonseed oil extract.	The test article did not elicit a sensitization response (Normal saline extract and cottonseed oil extract had a sensitization response of '0' under valid test conditions).
Intracutaneous Reactivity	Differences in the mean test and control scores of the extract dermal observations were less than 1.0.	The requirements of the ISO Intracutaneous Reactivity Test have been met (Differences in the mean test and control scores of the extract dermal observations were less and 1.0).
Systemic Toxicity	No clinical signs consistent with toxicity observed in test article treated animals at any observation periods.	The requirements of the ISO Acute System Injection Test have been met (None of the test article treated animals were observed with clinical signs consistent with toxicity at any of the observations periods).
Hemolysis	Non-hemolytic (Implicit; based on industry standards for medical devices in contact with blood).	Non-hemolytic (Test article exhibited an Average Blank Corrected % Hemolytic Index of % (same as blank control)).
Complement Activation	(No specific acceptance criteria provided, test is for characterization/comparison)	Under conditions of the C3a assay the test article and the comparison article activation at 2.1% and 3.5%, respectively, of the normalized C3a concentration produced by CVF. (No ranges or levels established as acceptable were explicitly mentioned in the "Conclusions" column).
Partial Thromboplastin Time	Minimal-activator of intrinsic coagulation pathway (Implicit; based on safety standards for blood-contacting devices, indicating it doesn't significantly activate clotting).	Minimal-activator of intrinsic coagulation pathway (Test article had an average clotting time of 297.0 seconds, which is 99% of the negative control).

Study Information (Non-AI Device)

Sample size used for the test set and the data provenance: Not explicitly stated for each test in terms of a "test set" for an algorithm. These are physical device tests. Sample sizes would refer to the number of physical devices or animal subjects used, which is not detailed beyond "test article(s)" or "animal model." The provenance is internal testing by Cook Incorporated, a U.S. company. The studies are prospective in nature, as they involve testing newly manufactured devices.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these physical and biocompatibility tests is established through standardized methodologies and objective measurements, not expert consensus on interpretations.
Adjudication method for the test set: Not applicable. Test results are objective measurements against predetermined physical or biological criteria.
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 is not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
The type of ground truth used:
- Physical Properties: Objective measurements against engineering specifications (e.g., force in Newtons, pressure in kPa/psi, diameter in mm, radius in mm).
- Biocompatibility: Established ISO standards and direct biological response (e.g., lysis score, sensitization response, observation of toxicity, hemolytic index, clotting time).
- Functional Performance: Qualitative and quantitative assessment of device behavior in simulated environments (e.g., tracking through a tortuosity fixture, ability to deliver particles) or animal models (e.g., preparation, introduction, pushability, trackability, radiopacity).
The sample size for the training set: Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established: Not applicable. This is not an AI/ML device.

Summary

Regulation Number and Section

§ 870.1210 Continuous flush catheter.

(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).