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

The Advance CS Coronary Sinus Infusion Catheter is intended for temporary occlusion of the coronary sinus for infusion of contrast media, drugs, or therapeutic agents; or possible introduction of devices into the coronary venous system.

Device Description

The Advance® CS Coronary Sinus Infusion Catheter is an over-the-wire catheter. The 5.0 Fr balloon catheter is compatible with a 0.035 inch diameter wire guide. The device will be supplied sterile and intended for one-time use.

AI/ML Overview

The Cook Advance® CS Coronary Sinus Infusion Catheter underwent a series of non-clinical bench and animal tests to establish its safety and performance. The primary goal of these tests was to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Balloon Minimum Burst Strength	Balloons burst at or above the minimum rated burst pressure, with all failure modes being linear tears.	Predetermined acceptance criteria met; balloons burst at or above minimum rated burst pressure, linear tears.
Sheath Compatibility	Qualitative and quantitative evaluations show compatibility with a 5, 6, or 7 Fr sheath.	Predetermined acceptance criteria met; compatible with 5, 6, or 7 Fr sheath.
Balloon Profile	Measurement of catheter shaft, bonds, and folded balloon diameter shows compatibility with a 5, 6, or 7 Fr sheath (0.074, 0.087, or 0.100 inch profile).	Predetermined acceptance criteria met; compatible with 5, 6, or 7 Fr sheath.
Balloon Compliance	Balloon inflates to the stated balloon size.	Predetermined acceptance criteria met; balloon inflates to stated size.
Dynamic Burst of the Distal Lumen	All test articles withstand at least pressures in excess of 300 psig, regardless of injection media type (saline and contrast agent).	Predetermined acceptance criteria met; all test articles withstood >300 psig.
Static Burst of the Distal Lumen	Similar test articles fail at or above 100 psig.	Predetermined acceptance criteria met; similar test articles fail at or above 100 psig.
Freedom from Leakage	Balloon catheter withstands pressurization to 200 psi for 15 seconds without leaking or significantly increasing in outside diameter.	Predetermined acceptance criteria met; withstood 200 psi for 15 seconds without leak/significant OD increase.
Balloon Fatigue	Balloons are free from leakage and damage on inflation, withstanding 10 cycles of inflation.	Predetermined acceptance criteria met; free from leakage and damage after 10 inflation cycles.
Bond and Materials Strength	The tensile force during normal use does not fracture or rupture the balloon catheter bonds or materials.	Predetermined acceptance criteria met; tensile force during normal use does not fracture/rupture bonds/materials.
Inflation / Deflation Time	Balloon inflates within 60 seconds and fully deflates within 60 seconds.	Predetermined acceptance criteria met; inflates/deflates within 60 seconds.
Torque Strength	Catheter withstands two full rotations without failure.	Predetermined acceptance criteria met; withstood two full rotations without failure.
Kink and Flexibility	Catheter does not kink at a radius equal to or greater than 13mm.	Predetermined acceptance criteria met; no kinking at radius ≥ 13mm.
Particulate	Balloon does not create particulates that exceed reference limits.	Predetermined acceptance criteria met; particulates do not exceed reference limits.
Dimensional Verification	Devices meet dimensional specifications.	Predetermined acceptance criteria met; devices meet dimensional specifications.
Animal Evaluation	Acute safety and biologic response characterized approximately 48 hours following acute inflation of the balloon in the porcine coronary sinus.	Safety and biologic response characterized; no specific acceptance quantifiable criteria are provided beyond characterization.
Biocompatibility Testing	In conformance with applicable sections of ISO 10993-1, device is biocompatible (cytotoxicity, sensitization, irritation, systemic toxicity, hemocompatibility).	Predetermined acceptance criteria met; device is biocompatible per ISO 10993-1.

Study Details:

2. Sample Size and Data Provenance:
- The document does not explicitly state the specific number of devices or samples used for each individual test. However, the phrasing "all test articles" and "similar test articles" suggests that multiple units were tested for each criterion.
- The testing was performed by Cook Medical, a U.S.-based company. The animal evaluation was conducted in vivo, likely in a controlled laboratory setting (indicated by "acute inflation of the balloon in the porcine coronary sinus"). This suggests prospective testing for device validation.
3. Number of Experts and Qualifications for Ground Truth:
- This section is not applicable as the study involves non-clinical bench testing and animal evaluations, not studies requiring human expert assessment of images or data for ground truth establishment.
4. Adjudication Method:
- This section is not applicable for non-clinical bench and animal testing. The results are typically objectively measured and evaluated against predefined engineering specifications.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No MRMC comparative effectiveness study was done. This type of study is relevant for diagnostic devices interpreting medical images, not for the performance testing of a catheter.
6. Standalone Performance (Algorithm Only):
- This section is not applicable as the device is a physical medical catheter, not a software algorithm.
7. Type of Ground Truth Used:
- The ground truth for these tests was established through:
  - Engineering Specifications/Standards: Predetermined acceptance criteria based on product design specifications, recognized industry standards (e.g., ISO 10993-1 for biocompatibility), and regulatory requirements for medical devices.
  - Physical Measurements: Direct measurements of device attributes (e.g., burst pressure, dimensions, inflation/deflation times, force resistance).
  - Qualitative Observations: Visual inspection for leaks, damage, and compatibility.
  - Biological Response Assessment: In the animal study, the safety and biological response were characterized, implying observation and evaluation by veterinarians or researchers.
8. Sample Size for the Training Set:
- This section is not applicable. There is no "training set" in the context of physical medical device performance testing, as these are not machine learning or AI models. The testing described focuses on verifying the device's adherence to specifications.
9. How the Ground Truth for the Training Set was Established:
- This section is not applicable for the reasons stated above.

Summary

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).